[Senate Report 114-67]
[From the U.S. Government Publishing Office]
Calendar No. 121
114th Congress } { Report
SENATE
1st Session } { 114-67
======================================================================
FRANK R. LAUTENBERG CHEMICAL SAFETY FOR THE 21ST CENTURY ACT
_______
June 18, 2015.--Ordered to be printed
_______
Mr. Inhofe, from the Committee on Environment and Public Works,
submitted the following
R E P O R T
together with
MINORITY VIEWS
[To accompany S. 697]
[Including cost estimate of the Congressional Budget Office]
The Committee on Environment and Public Works, to which was
referred the bill (S. 697) to amend the Toxic Substances
Control Act to reauthorize and modernize that Act, and for
other purposes, having considered the same, reports favorably
thereon with an amendment in the nature of a substitute and
recommends the bill, as amended, do pass.
General Statement and Background
S. 697, the Frank R. Lautenberg Chemical Safety for the
21st Century Act, amends the Toxic Substances Control Act
(TSCA), the fundamental Federal law regulating the manufacture,
processing, distribution in commerce, use and disposal of
chemical substances.
The Act is named for the late Frank R. Lautenberg, the
Senate's long time champion for effective reform of TSCA in
order to protect against risks to human health and the
environment. Before 2012, Senator Lautenberg (D-NJ) had
introduced TSCA reform legislation in five consecutive
Congresses. Beginning in early 2013, Senator Lautenberg worked
closely with Senator David Vitter (R-LA) to craft the Chemical
Safety Improvement Act (CSIA), which was introduced in May,
2013 (S. 1009). The bill represented the very first bi-partisan
TSCA reform proposal, and garnered the support of 26 additional
members of the Senate. Sadly, Senator Lautenberg passed away
shortly after S. 1009 was introduced. Although the Committee
held a hearing on general TSCA reform with discussions of S.
1009, no further action on the bill was taken before the 113th
Congress adjourned.
Following Senator Lautenberg's death, Senator Tom Udall (D-
NM) stepped in to fill the late Senator's leadership role
working to pass bipartisan TSCA reform. Senators Udall and
Vitter introduced a modified version of S. 1009 on March 10,
2015, which reflected over a year of negotiations and building
upon the original CSIA. The new bill, S. 697, contains many
important enhancements to the framework first negotiated by
Senators Lautenberg and Vitter.
On April 28, 2015, the Committee held a business meeting on
S. 697. The Committee adopted an amendment in the nature of a
substitute offered by Senator Vitter that won the support of
Senators Whitehouse (D-RI), Merkley (D-OR), Booker (D-NJ) and
Carper (D-DE). The substitute reflects additional modifications
to the bill intended to address the concerns of stakeholders in
several key areas. The bi-partisan substitute marks an
important milestone in TSCA reform, and reflects the spirit of
compromise that Frank Lautenberg championed during his tenure
in the Senate.
TSCA (Pub.L. 94-469, 90 Stat. 2004, 15 U.S.C. 2601 et seq.)
was enacted in 1976. TSCA gives EPA the authority to review new
chemicals before they are manufactured, to gather information
on existing chemicals in commerce, and to regulate unreasonable
risks to health and the environment from the manufacture,
processing, distribution in commerce, use or disposal of
chemical substances. TSCA is one of many statutes that regulate
chemicals; its unique focus is on industrial chemicals in
commerce. TSCA does not give EPA the authority to regulate
pesticides; food, drugs and cosmetics; nuclear materials,
firearms and ammunition, or tobacco.
In the years since TSCA was first enacted, it has become
clear that effective implementation of TSCA by the
Environmental Protection Agency (EPA) has been challenged by
shortcomings in the statute itself, and by several key
decisions of Federal Courts and the Agency's interpretation of
those decisions. S. 697, as reported by the Committee, is
intended to enhance confidence in the federal chemical
regulatory system, provide EPA the authority necessary for
efficient and effective regulation of chemical risks, and
foster safety and innovation in commercial chemistry.
Importantly, S. 697 is designed to ensure that the competitive
advantage of the U.S. chemical industry is not eroded by
regulatory mandates and that industry is subject to a more
consistent set of regulations that equally protect citizens
across the nation.
S. 697 is intended to address significant concerns about
the existing provisions of TSCA and its implementation.
Testing of chemical substances and mixtures
Section 4 of TSCA provides EPA the authority to require
manufacturers to test chemicals, but requires EPA to justify a
testing requirement based on either a finding that the
substance may present an unreasonable risk of injury to health
or the environment, or that the production of a substantial
quantity of the substance may create exposures to humans or the
environment. EPA can require testing through test rules or
through enforceable consent agreements (ECAs).
Concern has been raised that EPA's decisions to require
testing must be supported by an a priori finding that is often
difficult to make in the absence of the information that
testing would provide. EPA has succeeded in requiring the
testing under section 4 of only about 200 chemicals in TSCA's
almost 40 years. In addition, the existing TSCA rulemaking
process can place a significant burden on EPA, and test rules
can sometimes take many years to complete. When EPA has
proposed TSCA test rules, EPA has sometimes required testing
based on a ``checklist,'' rather than identifying specific
information needs to inform what testing is required.
Manufacturing and processing notices
A new chemical (not on the TSCA inventory) cannot be
manufactured in or imported to the U.S. without EPA review
under TSCA section 5. The section also provides EPA authority
to identify and review significant new uses of a chemical
substance. Companies must first submit a pre-manufacture notice
(PMN) and EPA must review the PMN. Current law gives the Agency
the authority to deny a PMN and prevent the substance from
moving into commerce. The PMN must include information on
chemical identity, anticipated production volumes, intended
categories of use, molecular formula and any available test
data on that chemical. EPA uses this information to develop
hazard and exposure/release profiles for the chemical which are
based on both actual data on the notified chemical, as well as
data from other structurally similar chemicals and information
derived from computer modeling. EPA can determine that more
testing is needed to complete its review, allow manufacture to
commence with restrictions, or not allow manufacture to
commence. Once manufacture commences, a chemical is added to
the TSCA Inventory only after the manufacturer files a ``Notice
of Commencement'' with EPA. At that point, other companies may
manufacture, process or use the chemical without prior
notification unless EPA has designated such activity as a
significant new use requiring such notification.
Despite the completion of many reviews of new chemicals
under section 5, concerns have been raised that it does not
require EPA to make an affirmative finding that a new chemical
or a significant new use is not likely to present an
unreasonable risk. EPA's test rule authority constrains the
Agency's ability to mandate new testing when necessary to
support review of a new chemical or significant new use.
Regulation of hazardous chemical substances and mixtures
Section 6 of TSCA provides EPA broad authority to regulate
existing chemicals. Based on an EPA finding that a chemical
substance or mixture ``presents or will present an unreasonable
risk of injury to health or the environment,'' EPA can impose a
variety of risk management measures, including use
restrictions, limitations on production volumes, warning
labels, recordkeeping or product or disposal bans. When EPA
chooses to impose restrictions under Section 6, it must use the
``least burdensome'' requirements.
EPA must apply its section 6 authority through rulemaking.
In applying the unreasonable risk standard, EPA must consider a
variety of risk-related and cost/benefit factors including: the
effects of a substance on health and the magnitude of exposure
of humans; the effects of a substance on the environment and
the magnitude of exposure of the environment; the benefits of
the substance for various uses and the availability of
substitutes for such uses; and the reasonably ascertainable
economic consequences of the rule, after considering the effect
on the national economy, small business, technological
innovation, the environment and public health.
Between 1978 and 1990, EPA successfully used Section 6 to
regulate specific uses of the following chemical substances:
halogenated chlorofluoroalkanes; TCDD; three new chemical
substances used in metalworking fluids; and hexavalent
chromium. None of these rulemakings were judicially challenged.
In contrast to these rulemakings, EPA's regulation to ban
asbestos from most products through a TSCA section 6(a) rule
was much broader in scope and was challenged in Corrosion Proof
Fittings et al. v. U.S. EPA. The Fifth Circuit Court of Appeals
decision in this case struck down the asbestos rule, in part
because of ``the agency's reliance upon flawed methodology and
its failure to consider factors and alternatives that TSCA
explicitly requires it to consider.'' Despite direction from
the court, EPA did not re-propose its rulemaking on asbestos
and EPA has never used Section 6 since that decision.
Substantial stakeholder attention has been focused on the
shortcomings in section 6, and S. 697 attempts to address these
concerns. EPA's application of the ``unreasonable risk''
standard for regulatory action has been hampered by the
statutory language itself, which suggests that cost and benefit
considerations must be applied to the Agency's decisions on the
health and environmental risks posed by a chemical substance.
The requirement that EPA choose the ``least burdensome''
regulatory control for a chemical substance has been viewed as
a requirement that EPA assess the costs and burdens of all
possible regulatory and chemical options. Further, there is no
requirement in section 6 that EPA systematically assess
existing chemicals in commerce, and no direction to the Agency
on how the Agency identifies what chemical substances warrant
assessment.
Reporting and retention of information
Section 8 is the information gathering and reporting
section of TSCA. Under the section, EPA can require companies
to submit information on categories of use, quantities, by-
products, and health and environmental effects of chemicals,
and has used this authority to require periodic updating of
chemicals on the TSCA Inventory that meet certain production
volume thresholds. The section also requires EPA to compile and
maintain the TSCA Inventory, which represents all chemicals
commercialized under TSCA since its inception. Some chemicals
may no longer be in commerce but continue to be listed on the
Inventory.
The section also requires companies to record and retain
allegations of significant adverse reactions to any substances;
to submit, where requested by rule, lists/copies of ongoing and
completed, or unpublished health and safety studies; and to
immediately report information--not otherwise available to
EPA--which reasonably supports the conclusion that a chemical
presents a ``substantial risk'' to health or the environment.
Several aspects of Section 8 have been the subject of
stakeholder concerns. The TSCA Inventory does not accurately
reflect the number of chemicals actually in commerce, as it is
a historical database containing those substances
``grandfathered'' into TSCA in 1979 (when EPA established the
Inventory by rule) and those substances added to the Inventory
after the pre-manufacturing review process. Additionally, some
of the substances on the Inventory are the subject of
confidentiality claims that have not been systematically
reviewed by the Agency.
Disclosure of data
Section 14 of TSCA provides an affirmative, broad statement
of protection from disclosure for information qualifying under
the section 552(b)(4) exemption of the Freedom of Information
Act (FOIA), i.e., ``trade secrets and commercial or financial
information obtained from a person and privileged or
confidential.'' Generally, EPA cannot disclose confidential
business information (CBI), and where disclosure is allowed,
the Agency must follow procedures designed to protect the
submitter's rights, such as advance written notice to the
submitter. Section 14 does specifically permit EPA to release
CBI to U.S. government employees in connection with their
official duties to protect health or environment or for law
enforcement purposes, to Federal contractors for work related
to TSCA, when necessary to protect health or the environment
from unreasonable risk of injury, or when relevant in a court
proceeding under TSCA.
Section 14 also provides that the broad protection afforded
CBI does not prohibit the disclosure of health and safety
information in studies related a chemical or mixture that is in
commercial distribution, that is the subject of a TSCA section
4 test rule, or is subject to a PMN or a significant new use
notice (SNUN) requirement under section 5. Nothing in the
section authorizes EPA to release any data that would disclose
processes used in the manufacturing or processing of a chemical
or mixture or, in the case of a mixture, the portion of the
mixture comprised by any of the chemicals in the mixture.
Section 14 and EPA's implementation of it has been
criticized by some for failing to require a systematic review
of confidentiality claims, or up-front substantiation of
confidentiality claims. Lacking any mechanism for review by EPA
or for companies to declassify past CBI claims that are no
longer needed, stakeholders have indicated a concern that there
is an over-abundance of CBI claims, some of which may not be
legitimate. Concern has also been raised that TSCA does not
authorize EPA to share CBI with State governments or other
professionals such as first responders, who may need access to
it in the performance of their duties.
Preemption
TSCA Section 18 recognizes that States can have a role in
regulating chemicals, and preempts State action only when EPA
has acted on a chemical through a rule or order under TSCA.
Under the section, new and existing State requirements on a
chemical substance can be established or continue in effect if
they are identical to the EPA requirement, if they are adopted
under the authority of the Clean Air Act or any other federal
law, or if they prohibit the use of such substance or mixture
in such State or political subdivision. Upon application of a
State or political subdivision of a State, EPA can waive the
preemptive effect of an EPA rule or order on State action, if
1) compliance with an action taken under State law would not
cause violations of the EPA rule or order and 2) the State
action provides a significantly higher level of protection from
risk and does not unduly burden interstate commerce.
Some stakeholders have raised concern that TSCA has not
fostered a robust Federal chemical regulatory system, which has
resulted in a number of States becoming more active on chemical
regulatory matters. In their view, a proliferation of different
State requirements will create confusion for the general
public, and significantly increase the cost and burden of
regulatory compliance for chemical manufacturers, importers and
users while failing to apply any protections to more than a
relatively small number of citizens. Others have expressed
concern that States not be constrained in their ability to
protect health and the environment, particularly when state or
local conditions associated with chemical substances subject to
TSCA raise potential concerns. These stakeholders also point
out that actions by even one state can affect products
nationwide.
Administration
Section 26 of TSCA authorizes EPA to require the payment of
a reasonable fee from any person required to submit data under
sections 4 or 5. The fee is capped at $2,500, or in the case of
a small business, $100. To date, EPA has established a fee only
for the submittal of pre-manufacturing notices under section 5.
In FY2014, EPA generated approximately $1.1 million in fee
revenue under this requirement. This revenue is directed to the
general treasury, not directly to EPA.
All stakeholders have indicated an interest in ensuring
that EPA has the resources necessary to implement a robust
chemical regulatory system, including prioritization screening,
safety assessments and determinations, and regulation of new
and existing chemical substances where required to manage risks
to health and the environment.
Objectives of the Legislation
S. 697 would reauthorize and modernize the Toxic Substances
Control Act (TSCA).
Section-by-Section Analysis
Section 1. Short title
Names S. 697 as the ``Frank R. Lautenberg Chemical Safety
for the 21st Century Act.'' The late Senator Frank Lautenberg
was an ardent proponent of modifications to TSCA during his
lifetime.
Section 2. Findings, policy and intent
Section 2 of S. 697 amends Section 2 of TSCA in several
respects to make clear Congressional intent for reforming TSCA
to provide broad protection of human health and the
environment, to improve availability of information about
chemicals, and to clarify that nothing in the bill is intended
to affect common law rights and remedies.
S. 697 does not amend TSCA's existing policy provisions in
Section 2(b), indicating the Committees intent to leave intact
existing TSCA policy relating to the need for adequate data
about chemicals, adequate authority to regulate chemicals that
present an unreasonable risk, and the exercise of EPA's
authority in a manner that does not create unnecessary economic
barriers to technological innovation.
Section 3. Definitions
Section 3 of S. 697 incorporates several new definitions in
TSCA. Definitions of ``conditions of use,'' ``potentially
exposed or susceptible population'', ``safety assessment,''
``safety determination'' and ``safety standard'' are included
in the bill. S. 697 does not change other existing TSCA
definitions, such as the definition of a ``processor'' or what
is defined as or specifically excluded from the definition of a
``chemical substance.''
Further, S. 697 as approved by the Committee reverts to the
term ``injury'' when used in the context of unreasonable risk,
instead of the term ``harm'' as in the bill as introduced. This
change ensures that other provisions of TSCA not amended by S.
697 require no conforming change. The Committee intends no
modification of EPA's interpretation of the term ``injury''.
``Conditions of Use'' is a term used throughout S. 697 to
describe the context in which EPA will apply the safety
standard in safety assessments and determinations. The term
means the ``intended, known, or reasonably foreseeable
circumstances'' under which a chemical substance is
manufactured, processed, distributed in commerce, used or
disposed of. The term is not intended to include ``intentional
misuse'' of chemicals.
``Potentially exposed or susceptible population'' is
defined as ``1 or more groups of individuals'' in the general
population who may be ``differentially exposed'' to a chemical
under the conditions or use, or ``susceptible to greater
adverse health consequences'' from chemical exposures than the
general population. The definition makes clear that when
identified by EPA, it may include groups such as infants,
children, pregnant women, workers and the elderly. The term is
used in the definition of ``safety standard'' to make clear
that in applying the standard to a population, the population
must be ``relevant'' to the safety assessment and determination
for the substance, and that identified risks specific to such
populations must be addressed.
In the context of safety assessments and determinations, if
conditions of use suggest differential exposures to one or more
groups of individuals or the conditions of use impact
individuals who are more susceptible, EPA must take those
exposures into account and establish risk management measures
necessary and sufficient to protect those populations.
Importantly, the definition does not mean that in applying the
safety standard, EPA is required to protect each susceptible
``individual'' in the population or groups of individuals in
all safety assessments and determinations. Rather, in safety
assessments and determinations in which a population is
relevant, the Administrator is to protect that population as
well as the population as a whole from ``unreasonable risk.''
``Safety assessment'' means an assessment of the risk posed
by a chemical substance under the conditions of use,
integrating hazard, use and exposure information about the
chemical. Under S. 697, the safety assessment must precede
EPA's safety determination.
``Safety Determination'' means an EPA determination as to
whether a chemical substance meets the safety standard under
the conditions of use. Under S. 697, if EPA makes a
determination that a chemical substance does not meet the
safety standard, the Agency must establish risk management
measures, by rule, that ensure the safety standard is met under
the conditions of use.
``Safety Standard'' means ``a standard that ensures,
without taking into consideration cost or other nonrisk
factors, that no unreasonable risk of injury to health or the
environment will result from exposure to a chemical substance
under the conditions of use . . .'' This standard uses the same
term as in current TSCA, but makes an important change to
ensure that the standard including its reference to
unreasonable risk, is to be applied by EPA without regard to
cost or other non-risk factors. Furthermore, other relevant
references to the term in the legislation and throughout TSCA
were modified to make clear that when the term ``unreasonable
risk'' is used, the term is to be applied without taking into
account cost and other non-risk factors. This modification
addresses one of the key criticisms of TSCA. The definition
also makes clear that the safety standard applies to specific
``conditions of use'' identified by EPA. The standard is
intended to ensure that EPA protects against unreasonable risks
of injury to the general population as well as any potentially
exposed or susceptible population that EPA has identified as
``relevant'' to the safety assessment and determination for the
chemical.
Section 4. Policies, procedures and guidance
Section 4 of S. 697 creates a new Section 3A in TSCA. The
section requires EPA to develop any necessary policies,
procedures, and guidance, not later than two years after
enactment. In order to ensure that EPA can quickly implement
the Act, existing policies, procedures and guidance can
continue to be used as the new ones are developed and are to be
integrated into them to the maximum extent practicable. EPA is
to review its policies, procedures and guidance every five
years, and to update them to reflect emerging science.
Policies, procedures and guidance are to address testing,
prioritization screening, review of new chemicals and
significant new uses, safety assessments and determinations, as
well as use of science in making these decisions, including
policies aimed at reducing animal testing. The section also
establishes a new Scientific Advisory Committee on Chemicals to
provide EPA independent scientific advice. The section makes
clear the Committee's intent that EPA's policies, procedures
and guidance should reflect the best available science and be
transparent to the public.
It is the Committee's intent that decision-making under
TSCA be ``consistent with the best available science.'' The
science EPA relies on to make safety determinations should
describe and document any assumptions and methods used, and
should address variability, uncertainty, the degree of
independent verification and peer review. The section also
requires that decisions be based on the weight of the
scientific evidence, by which the Committee intends that EPA
consider all information in a systematic and integrative
framework to consider the relevance of different information.
The Committee believes there is significant value, where
available and appropriate, in EPA's use of peer reviewed
information, standardized test design and methods, consistent
data evaluation procedures and good laboratory practices to
ensure transparent, understandable, and reproducible chemical
reviews. EPA guidance should also address transparency about
the sources of funding for generation and assessment of
information and, if appropriate, consideration of
recommendations from NAS reports. The section is intended to
ensure that EPA safety assessments and determinations are clear
to the public, and based on credible, reliable scientific
information.
The section also requires EPA to consider reasonably
available information about potential hazards and exposures of
a chemical substance under the conditions of use when making
decisions under TSCA. The bill gives EPA the authority to
require testing when needed to ensure decisions are based on
sufficient information. The Committee intends that EPA
systematically search for and identify relevant information
that is available to inform safety assessments and
determinations, both to minimize the potential for duplicative
testing and unnecessary animal testing. The information EPA
considers in its decision-making and the quality of that
information is critical to giving the public greater confidence
in EPA decisions.
The section also clarifies that EPA mandates for the
generation of new information relevant to safety assessments
and determinations must be science-based and driven by the need
for the information. EPA is to specifically address exposure
potential as a factor in decisions to require new testing.
The existing provisions of TSCA do not require EPA to
systematically assess and determine the safety of priority
chemicals. Consequently, there are relatively few EPA policies
and procedures in place to address the safety assessment,
safety determination and rulemaking requirements of Section 6.
It is the Committee's intention that EPA rely on existing
processes, such as those established under the Agency's TSCA
Work Plan Chemical program, to manage the process as new
policies and procedures are developed.
The Committee believes strongly that public confidence in
the federal chemical regulatory system will be enhanced with
improved public access to, and an understanding of, the
information on which EPA bases its safety assessments and
determinations. Under this section, EPA is required to make
available to the public a nontechnical summary of each safety
assessment and safety determination, to provide the public an
opportunity to comment on the proposed assessment and safety
determination, and to list the studies EPA considered and the
policies and procedures EPA followed in the safety assessment
and determination. EPA is also to describe the manner in which
aggregate exposures, or significant subsets of exposures, to a
chemical substance under the conditions of use will be
considered, and explain the basis for that consideration in the
final safety assessment.
The section also establishes a new Science Advisory
Committee on Chemicals. The new advisory committee is intended
to provide EPA independent advice on the scientific and
technical aspects of implementation. The advisory committee is
subject to the requirements of the Federal Advisory Committee
Act to ensure transparency, balance and public access to its
deliberations. The Committee intends that the advisory
committee represent a broad range of scientific expertise and
interests including individuals with scientific expertise in
public health and industry.
Section 5: Testing of chemical substances or mixtures
Section 5 of S. 697 amends section 4 of TSCA. The
amendments provide EPA with broad authority to obtain new
information on chemical substances at all stages of the safety
review and evaluation process (for new chemicals; in limited
circumstances for prioritization; for safety assessments and
safety determinations of existing chemicals; and for any
necessary risk management rulemaking) and for export
notification purposes.
The amendments address two significant shortcomings
identified in TSCA: The requirement that testing be conducted
only through rulemaking; and the ``Catch-22'' that EPA must
first make a finding of potential ``unreasonable risk'' or
substantial production and release or exposure before it can
require testing by manufacturers or processors. Under the
section, EPA can mandate new testing by rule, order and consent
agreement. It is the Committee's intent that EPA use its
authority to require the development of new information
judiciously, and only when needed to implement key provisions
of the Act.
In order to avoid duplicative testing, the section allows
one company to conduct toxicity testing on behalf of other
companies and to obtain fair and equitable reimbursement for
developing the data. The bill also clarifies language regarding
the reimbursement period for such testing.
The section makes clear that the EPA may not establish
minimum information requirements for all chemicals. It is the
Committee's expectations that testing requirements will be
tailored to the nature of the chemical substances, hazards,
exposures and conditions of use under consideration in the
review and evaluation process.
For many years, the Committee has supported efforts to
reduce the unnecessary use of animals in chemical testing. S.
697 includes extensive provisions by which EPA is to minimize
the use of animals in testing chemicals under TSCA. EPA is to
consider integrated testing strategies, greater efficiencies in
testing through category approaches and formation of consortia,
tiered testing and assessment strategies, and alternative
testing methods, among others. Importantly, EPA is to develop a
strategic plan to promote the development and implementation of
reliable alternative test methods to reduce, refine, or replace
the use of laboratory animals. The Committee takes note that
EPA's Office of Research and Development (ORD) has and is
developing non-animal screening tests (including the use of
computational toxicology), and continues work on application of
those methodologies in chemical risk assessment.
The Committee recognizes that in some cases, suitable
alternatives for animal tests are not currently available. The
Committee believes, however, that where scientifically reliable
alternatives exist that will generate equivalent information,
EPA can request, and in some cases should require, a non-animal
test to first be used. The Committee does not intend to require
manufacturers or processors to shoulder duplicative test
burdens; EPA should look to the use of non-animal tests that
provide reliable, high quality information that can replace or
supplement animal tests. The testing requirements reflect the
Committee's interest in assuring that the development of new
information under a modernized TSCA should be consistent with
best available science, and as informative, efficient and cost
effective as possible.
Section 5 requires that voluntary testing conducted for
TSCA purposes be first attempted using an alternative or non-
animal test method or approach that the Administrator has
determined to be scientifically reliable, relevant, and capable
of providing information equivalent to that produced by a test
using animals. The Committee expects EPA to be diligent in
developing a list of approved non-animal test methods and
strategies. The provision makes clear that the requirement does
not prohibit the use of an animal test for purposes other than
voluntary testing for TSCA purposes, or for subsequent tests
conducted for TSCA purposes.
Section 6. Prioritization screening.
Section 6 of S. 697 creates a new section 4A in TSCA. The
section requires EPA to establish a risk-based prioritization
screening process, by rule, within one year of enactment. Under
the prioritization screening process, EPA is to designate
substances as high- or low-priority for safety assessment and
determination. This section establishes a process that assures
every chemical in commerce is subject to a systematic review by
EPA through the screening and prioritization process.
In general, EPA is to focus the prioritization screening
process on chemicals that are in active commerce in the United
States. Amendments to section 8 require EPA to identify
substances on the TSCA Inventory that are in active commerce or
inactive. The Committee recognizes, however, that there may be
exposures of concern from substances that are not currently or
no longer in commerce, and the section provides EPA authority
to prioritize inactive substances that meet certain criteria.
The Committee does not expect EPA to prioritize all active
substances at one time. The section requires EPA to conduct
prioritization screening based on EPA's ability to complete
safety assessments and determinations. This approach provides
appropriate notice about the substances subject to the
prioritization process to interested stakeholders, and an
opportunity to provide EPA information relevant to the
prioritization decision and any subsequent safety assessment
and determination. In the Committee's view, this is an
improvement over EPA simply compiling a long list of chemical
priorities that could trigger unwarranted de-selection
decisions in the marketplace or become out of date because of
reliance on older information.
To address concerns that EPA undertake a minimum number of
reviews and increase ``through-put'' in the assessment process
over time, EPA is to establish an initial list of at least 10
high and 10 low priority substances within 180 days of
enactment. Within 3 years of enactment, EPA is to have
designated additional high-priority substances sufficient to
ensure that at least a total of 20 high-priority substances
have undergone or are undergoing safety assessments, and
additional low-priority substances sufficient to ensure that at
least a total of 20 low-priority substances have been so
designated. These numbers are to increase to at least 25 high-
and low-priorities no later than 5 years after enactment. The
section contains explicit authority for EPA to draw on the
existing TSCA Work Plan Chemical list (about 90 substances EPA
has already prioritized based on hazard, exposure, persistence
and bioaccumulation, using its existing TSCA authority). The
Work Plan chemicals are, in effect, substances EPA has already
prioritized for review; the Committee does not intend that EPA
start work anew on these substances. The section requires that
no less than 50% of the substances prioritized by EPA be drawn
from the Work Plan Chemicals list, until safety assessments and
safety determinations have been completed for all Work Plan
Chemicals. As the safety assessment and determination process
is completed for each high priority substance, it must be
replaced by at least one new high priority chemical.
The section establishes general criteria for prioritization
screening decisions, for EPA to use in establishing more
specific criteria by rule. By including these mandatory
criteria in the statute, it is the Committee's intent to
require EPA to ensure that important, broad science-based
considerations, classifications and designations drive the
prioritization screening process, without locking EPA into
specific designations based upon ever-changing science.
The substitute approved by the Committee modifies the
criteria for prioritization designations by authorizing EPA to
designate high priorities on the basis of ``significant''
hazard and exposure, rather than the ``high'' hazard and
``widespread'' exposure thresholds in S. 697 as introduced. A
lack of information is also a sufficient basis to designate a
substance as a high priority.
Persistent, bioaccumulative and toxic (PBT) substances are
a class of substances with recognized health and environmental
concerns arising from their particular hazard and exposure
characteristics. The substitute approved by the Committee
requires EPA to give a preference, in setting the priority
list, to TSCA Work Plan chemicals that are both persistent and
bioaccumulative. Consistent with the risk-based approach of the
legislation, the persistent and bioaccumulative chemicals
listed in the TSCA Work Plan chemicals were so identified
because they also present potential toxicity and exposure
concerns.
Prioritization screening decisions, including decisions to
change a prioritization from low priority to high priority, or
vice versa, are subject to public notice and comment. The
substitute approved by the Committee clarifies that the public
will have 90 days to comment on proposed prioritization
decisions.
EPA decisions to designate a substance as a low priority
must be based on information sufficient to establish that the
substance is likely to meet the safety standard. The Committee
intends that EPA adequately justify prioritization decisions,
which it should fully describe when seeking comment on the
proposed designation. All priority designations are subject to
review and revision at any time, based on information available
to the Administrator.
EPA is to strive to complete the prioritization process of
all chemicals in active commerce in a timely manner, taking
into account the resources available to complete safety
assessments and determinations. Prioritization decisions may be
postponed where development of additional information is
needed, which EPA may request or require using its authority
under section 4. Where testing was required for prioritization,
the Administrator shall designate the chemical substance as a
high or low priority not later than 90 days after receipt of
information satisfying the requirement. The prioritization
screening process is subject to review and modification every 5
years, to ensure that the process is operating efficiently and
effectively.
The Committee also expects that EPA will over time increase
the number of substances for which safety assessments and
determinations are conducted, particularly as the Agency gains
experience and expertise in applying the new process. Several
provisions of this section are aimed at increasing through-put,
and thereby meeting the Committee's objective of addressing the
backlog of unassessed chemicals in commerce, increasing public
confidence, providing more certainty for regulated
manufacturers and processors, and addressing key health and
environmental concerns.
The section provides manufacturers an opportunity to
request that EPA designate a substance as an ``additional
priority'' for safety assessment, subject to the payment of
100% of the costs associated with the safety assessment and
determination. The substitute clarifies that granting a
specific request to designate ``additional priorities'' is at
EPA's discretion, and that such substances are in addition to
substances designated by EPA as high priorities, and hence do
not limit the number of high priorities required to be
designated by EPA; they only add to the total number of
chemicals the Agency can review. In order to ensure that a
significant majority of EPA's activity is focused on the
substances the Agency identified as high priorities, the
substitute approved by the Committee directs that, if
sufficient manufacturer requests are made, a minimum of 25
percent, and a maximum of 30 percent, of the cumulative number
of high-priority chemicals in the safety evaluation process can
be designated under this approach. For example, if EPA has
designated 100 high priority chemicals since the date of
enactment, then EPA can have designated and have conducted or
be conducting safety assessments and safety determinations on a
minimum of 25 and a maximum of 30 industry petitioned chemicals
in addition to the 100 high priority chemicals. This approach
is intended to allow EPA to review more chemicals than their
appropriated resources would otherwise allow.
The section also includes a provision intended to increase
EPA's safety assessment and determination of the TSCA Work Plan
chemicals. For Work Plan chemicals for which EPA has not yet
commenced safety assessments and determinations, manufacturers
can request EPA to do so, subject to an agreement to pay 50% of
the costs of the review. EPA has full discretion to approve or
deny these petitions although the Committee intends for EPA to
utilize this provision, resources allowing, to conduct safety
assessments and determinations of all Work Plan chemicals as
quickly as possible. The fees should allow for additional EPA
priorities to be reviewed where the Agency would otherwise not
have the necessary resources to add throughput into the system.
Requiring manufacturers and processors to defray the costs of
these reviews creates potential cost savings and efficiencies
for EPA.
In order to bring to EPA's attention state governments'
interest in a particular chemical substance, the section also
requires States to notify EPA when they propose or take
administrative action or enact a law to prohibit or restrict a
chemical that EPA has not designated as a high-priority. If
certain conditions are met, EPA must conduct a prioritization
screening for the substance. The provision is intended to
ensure that state concerns and information are entered into the
national system for EPA review and, where appropriate,
assessment and regulation to extend protections nationwide
where they otherwise may have only been limited to an
individual state, thereby serving the greater national
interest. The section makes clear, however, that nothing in the
state notification requirement pre-empts state law or actions,
or requires EPA approval of the state law or actions.
The section also makes clear that an EPA priority
designation shall not be construed to affect the manufacture,
processing, distribution, use or disposal of a chemical or
regulation of those activities. By this, the Committee intends
to clarify that prioritization screening decisions do not have
any formal regulatory effect in and of themselves.
Prioritization designations are not definitive decisions on
whether a chemical substance is safe for intended conditions of
use or not safe and requires risk management. Prioritization
designations are simply designed to identify chemical
substances that are likely to meet the safety standard (in the
case of low priority designations) or identify chemical
substances that require further assessment (in the case of high
priority designations), which in the latter case will lead to a
determination as to whether a chemical substance meets the
safety standard or needs regulation.
Section 7. New chemicals and significant new uses
Section 7 of S. 697 amends section 5 of TSCA. The amendment
modifies the new chemical review process by requiring that EPA
make the determination that a new chemical substance or a
significant new use is likely to meet the safety standard
before it can be commercially manufactured or processed. The
section allows EPA to postpone a decision on a new chemical
until additional information is generated using EPA's authority
under section 4. The section also prohibits manufacture or
processing of a new chemical or significant new use found not
likely to meet the safety standard except in compliance with
any conditions or restrictions imposed by EPA sufficient to
ensure likely safety. As with other provisions of S. 697, the
section ensures transparency in all EPA decisions on new
chemicals or significant new uses. The section also retains EPA
authority to establish or continue appropriate, long-standing
exemptions.
The Committee intends the amendments to section 5 to ensure
that EPA conducts an appropriate review of the potential health
and environmental effects of new chemicals, while supporting
the ability of manufacturers and processors to innovate and
bring to market new chemicals and products through a flexible,
targeted review process. The Committee notes that, in general,
current law gives EPA more authority to review new chemicals
than existing chemicals, and consistent with current law the
Agency should continue the practice of completing new chemical
reviews within 90 days to the maximum extent practicable.
Under this section, EPA is to conduct an initial review of
a pre-manufacture notice (PMN) for a new chemical substance,
develop a profile of the substance and its exposure potential,
and apply the safety standard. Consistent with existing law,
the PMN submitter must provide EPA all available relevant
information, including information on the intended conditions
of use and reasonably anticipated exposures. The Committee
intends that the review of the PMN should be conducted in that
context.
The Committee recognizes that new chemicals may not have as
robust a data set as existing chemicals. The testing authority
provided to EPA under section 5 of S. 697 is intended to ensure
EPA can obtain necessary information to review a PMN
application. It is also the Committee's intent that EPA
continue to apply its professional and scientific expertise,
experience and judgment, developed through its implementation
of TSCA's current new chemicals review program. EPA has
pioneered the application of new approaches such as structure
activity relationships, ``read-across'' information from other
relevant chemicals, and new models and profiles in the new
chemical review program to provide greater predictability and
transparency. While some of these approaches can have
limitations, they should assist EPA in reviewing new chemicals
against the safety standard as applied in this section.
Under this section, where EPA imposes a requirement on the
submitter of a notice under section 5 through a consent
agreement or order, the Agency is required to consider whether
to issue a Significant New Use Rule (SNUR) to extend the
requirements to other manufacturers and processors of the same
chemical after it is added to the TSCA Inventory. Where EPA
decides not to issue a SNUR, it is required to publish a
statement describing the reasons for not doing so. The
Committee does not intend that EPA interpret its authority
under this section to adopt a blanket policy of issuing a
Significant New Use Rule (SNUR) for every new chemical
substance. Rather, the Committee expects that EPA will apply
its SNUR authority judiciously where appropriate and necessary
to ensure protection of health and the environment.
The section clarifies that EPA may require significant new
use notification (SNUN) for import or processing of a chemical
as part of an article or a category of articles, if EPA makes
an affirmative finding in a SNUR that the ``reasonable
potential for exposure'' to the chemical through the article
``warrants notification.'' The Committee intends this provision
to clarify the application of SNUR notification provisions to
imported articles and does not intend this provision to compel
changes to EPA's general policy regarding treatment of articles
in SNURs.
The section also continues current TSCA practice of not
imposing a minimum data set requirement on all new chemicals;
rather, any requirements to develop new information are
determined on a chemical-by-chemical basis. This is consistent
with the Committee's finding that, under S. 697, the
information requirements of section 5, coupled with EPA's
robust new chemical review process, are protective of health
and the environment. With the requirement that EPA find a new
chemical must be ``likely to meet the safety standard,'' the
section provides EPA adequate authority to both review and,
where warranted, regulate new chemical substances, while
preserving the elements of TSCA that promote innovation in new
chemistries. Although the section does not impose a minimum
data requirement for new chemicals, EPA is provided with
improved authority to require testing under section 5 of S.
697, without having to demonstrate potential risk to require
testing. The requirements of section 5 of S. 697 to minimize
animal testing also apply.
If EPA finds that a new chemical substance is not likely to
meet the safety standard, EPA must apply restrictions
sufficient to ensure that the chemical substance is likely to
meet the safety standard under the conditions of use. Under the
section, EPA also retains the authority to approve a PMN for a
new chemical subject to the condition to conduct testing. In
addition, the section adds a new requirement that new chemical
substances that have PBT characteristics be subject to
conditions that reduce potential exposure to the maximum extent
practicable.
The section retains the statutory exemptions from section 5
of TSCA and the regulatory authority for EPA to continue
existing exemptions, such as the polymer and low volume
exemptions, among others. The Committee recognizes that
appropriate exemptions are a critical component of TSCA,
because they help focus EPA's activity on high-priority
potential risks to health and the environment.
Section 8. Safety assessments and safety determinations
Section 8 of S. 697 amends Section 6 of TSCA. The section
requires EPA to conduct a safety assessment and safety
determination for all high priority substances and additional
priorities. Importantly, the section establishes strict,
enforceable deadlines for EPA action under this section: Within
6 months of designation of a chemical substance as a high
priority, EPA must define the scope of the assessment and
determination, including the conditions of use and potentially
exposed or susceptible populations that will be evaluated.
Safety assessments and determinations must be completed within
3 years of designation. If EPA finds a chemical does not meet
the safety standard, risk management measures must be imposed
within 2 years. With the exception of the 6 month deadline for
defining the scope of a safety assessment and determination,
EPA is permitted, with adequate public justification, to extend
the deadlines for an aggregate period not to exceed 2 years.
In order to ensure that relevant ongoing work at EPA
continues, the Agency is expressly authorized to initiate
assessments, or continue assessments that have already been
initiated, prior to establishment of the new policies and
procedures, for substances such as those identified by EPA in
its TSCA Work Plan Chemical program.
In the safety assessment and determination process, EPA is
to determine whether a substance meets the safety standard or
does not meet the safety standard. If a substance is found not
to meet the safety standard, EPA must impose the risk
management measures necessary to ensure the safety standard is
met. If the safety standard cannot be met through other risk
management measures, a ban or phase out of the substance is
generally required, but subject to certain time-limited
exemptions. Consequently, the law is amended so EPA is better
able to ban or phase out the substance. All safety
determinations are subject to public notice and comment, as are
all risk management rules.
EPA has been able to regulate only a handful of existing
chemicals under Section 6 of TSCA over its history. Some have
argued that one of the causes of Section 6's failure was its
blurring the lines between what should be pure safety reviews
with non-risk factors. Under existing TSCA, EPA's authority to
find unreasonable risk and regulate a chemical substance has
been interpreted to require the consideration of cost and
benefits as part of fundamental decisions on safety, to the
detriment of health and environmental protection.
Section 8 of S. 697 addresses this criticism by requiring
that EPA conduct a risk-based safety assessment and make a
risk-based safety determination of each high-priority
substance. The term ``safety determination'' is defined in
section 3 to mean ``a determination by the Administrator as to
whether a chemical substance meets the safety standard under
the conditions of use.'' The term ``safety standard'' is in
turn defined in section 3 to mean:
``a standard that ensures, without taking into
consideration costs or other nonrisk factors, that no
unreasonable risk of injury to human health or the
environment will result from exposure to a chemical
substance under the conditions of use, including no
unreasonable risk of injury to--
(A) the general population; or
(B) any potentially exposed or susceptible population
that the Administrator has identified as relevant to
the safety assessment and safety determination for a
chemical substance.''
The Committee intends that the phrase ``without taking into
consideration costs or other nonrisk factors'' be interpreted
to mean that EPA must determine that a chemical substance meets
the safety standard, or not, based solely on risk to human
health and the environment--the integration of hazard and
exposure information about a chemical--and not on the basis of
other factors such as consideration of the costs or benefits of
the substance or of possible restrictions on the substance.
Thus, this section addresses one of the most significant
problems identified in current TSCA. Under the definition of
the safety standard in section 3 invoked in this section, cost
and other factors such as technical feasibility are to play no
part in EPA's safety determinations. EPA's safety
determinations--whether a substance meets or does not meet the
safety standard--are to be based only on health and
environmental considerations. In addition, if a substance fails
to meet the safety standard, the remedy EPA imposes must enable
the substance to meet the safety standard under the conditions
of use, which again, is based only on health and environmental
considerations. The section therefore ``de-couples'' the
Agency's science-based risk decision about a chemical's safety
under its intended conditions of use from the Agency's decision
on how to manage unreasonable risks where chemicals do not meet
the safety standard under intended conditions of use.
EPA is authorized to postpone a determination (within the
legislation's deadlines) if additional information is
necessary. Consistent with current law, if the chemical
substance is likely to result in a risk of serious or
widespread injury to health or the environment before the
effective date of a rule, EPA is authorized to declare a
proposed rule to be effective upon publication in the Federal
Register. Safety determinations and associated safety
assessments are considered final agency action effective upon
completion and final publication (for substances found to meet
the safety standard) or the date of promulgation of the final
risk management rule (for substances found to not meet the
safety standard).
The substitute approved by the Committee makes several
improvements to the risk management provisions of S. 697.
Consistent with changes made in section 7 related to new
chemicals and significant new uses, section 8 requires EPA to
impose risk management restrictions on persistent,
bioaccumulative and toxic (PBT) substances for uses or
conditions of use found not to meet the safety standard that
reduce exposures ``to the maximum extent practicable.'' For PBT
Work Plan chemicals and in assessing subsequent high priority
chemicals, the Committee believes that EPA's Framework for
Metals Risk Assessment (EPA 120/R-07/001) (March 2007) should
be consulted for metals and metal compounds. In addition,
because the application of criteria applied in the
prioritization screening process is not a definitive assessment
of PBT characteristics, the Agency should consider whether
substances that might otherwise be considered to have PBT
characteristics should be addressed in a different way (e.g.,
substances that bioaccumulate but do not biomagnify), or
whether substances that may not meet traditional PBT criteria
should nonetheless be considered PBTs (e.g., substances that
bioaccumulate in blood rather than fat tissue).
EPA is to impose risk management on articles only to the
extent necessary to address the identified risks of the
chemical substance from the article in order for EPA to
determine that the chemical substance meets the safety
standard. EPA is to exempt replacement parts that are
manufactured prior to the effective date of the rule for
articles that are first manufactured prior to the effective
date of the rule unless it finds the replacement parts
contribute significantly to the identified risk.
It is critical to a workable chemical management structure
that EPA be afforded some level of discretion in implementing a
ban or phase-out. However, to address concerns that the
compliance date for such restrictions on a chemical substance
not be unduly long, the section requires EPA to make compliance
with such a rule mandatory in as short a period as practicable.
Notably, the section eliminates the controversial provision
of existing TSCA that requires EPA to adopt the ``least
burdensome'' regulatory requirement. This has been viewed by
the Agency as a major road block to successful TSCA
implementation because of the evidentiary and analytic burdens
associated with justifying that each proposed regulatory action
was the least burdensome requirement needed to ensure a
chemical did not pose an unreasonable risk. While this
requirement has been removed, the Committee maintains a strong
continued interest in ensuring any regulatory decisions under
this act undergo an implementable yet robust consideration of
costs and benefits. This section requires EPA to assess the
costs, benefits, and feasibility of regulatory options the
Administrator has considered, and describe how that assessment
influenced the choice of regulatory requirements, but is not
intended to establish a least burdensome requirement. EPA is
authorized to exempt certain uses of a chemical substance if
compliance with the regulatory restriction would harm national
security, cause significant disruption of the national economy,
or interfere with critical or essential uses. In the case of a
ban or phase-out of a chemical substance, any exemption adopted
by EPA can only last for a period of 5 years, subject to
renewal.
Section 9. Imminent hazards
Section 9 of S. 697 amends section 7 of TSCA. The
amendments make no substantive policy change in EPA's authority
to protect against unreasonable risks associated with imminent
hazards from certain chemical substances. The amendment updates
and conforms the section to the new authority provided under S.
697.
Section 10: Information collection and reporting
Section 10 of S. 697 amends section 8 of TSCA, the general
information collection and reporting authorities under the Act.
The section ensures that EPA's information collection and
reporting requirements produce a more complete picture of
chemical substances in active commerce in the United States.
The section also requires EPA to review all prior claims for
the protection of confidential chemical identities for active
substances within 5 years of enactment. The section provides
authority to apply reporting and recordkeeping requirements to
both manufacturers and processors.
Although TSCA currently gives authority to EPA to collect
information from processors, EPA has not chosen to do so. It is
the Committee's intent that manufacturers (including importers)
and processors have reporting obligations only where
appropriate and necessary to enable EPA to understand what
chemicals are actually in active commerce, to gain access to
information necessary to implement this Act, and to keep the
information updated. These reporting obligations should be
appropriately tailored to ensure that reporting burdens on any
particular sector are equitable, undue burdens on small
manufacturers and processors are minimized, and reporting
requirements are applied to those persons likely to have
information relevant to the effective implementation of this
title. The Committee expects EPA to use the information
generated by periodic reporting obligations to provide relevant
information on chemical uses and possible exposures, and
improve the ability of the Administrator to conduct
prioritization screening, safety assessments and safety
determinations, and to promulgate and implement appropriate
risk management rules.
TSCA requires a chemical substance to be listed on the TSCA
Inventory before it is commercialized. However, TSCA does not
require EPA on an ongoing basis to identify which substances on
the Inventory are actually in commerce. With approximately
84,000 substances now on the Inventory--but less than 8,000
chemical substances reported under the EPA's Chemical Data
Reporting Rule as being produced in volumes above the rule's
reporting threshold--it is important that EPA (and the American
public) have a better picture of what substances are in actual
commerce at any given time. The failure to identify active
substances has created confusion.
S. 697 addresses this problem by requiring that EPA
categorize the substances on the TSCA Inventory as active or
inactive. The categorization process is critical to the success
of EPA's prioritization process, which focuses primarily on
active substances. Importantly, the section does not authorize
EPA to remove substances from the Inventory. Instead,
manufacturers or processors who wish to designate an inactive
substance as active have an obligation to notify EPA.
Manufacturers of an inactive substance may return the substance
to the active inventory with a simple notification to EPA, at
which time the substance becomes subject to the prioritization
screening, safety assessment and determination processes.
Section 10 also requires EPA to develop a plan within 1
year of enactment to review all prior claims for the protection
of confidential chemical identity that manufacturers or
processors of active substances wish to maintain, within 5
years after the active list is compiled. The Committee intends
that EPA review all such confidentiality claims, consistent
with the requirements of section 14 of this Act, to ensure that
appropriate information relevant to health and safety of
chemicals is publicly available.
Under TSCA, numerous nomenclature conventions exist that
may prevent the efficient distribution of chemicals into
commerce. It is the intent of the Committee that the provisions
of section 10 related to nomenclature will resolve these issues
by requiring the Administrator to develop new guidance that
will establish equivalency between these conventions, while
preserving certain nomenclature approaches that have
significant value. It will also permit any chemical substance
appearing multiple times, each with a different Chemical
Abstract Service (CAS) number, to be treated by the Agency as a
single chemical substance. This will help prevent duplicative
safety assessments and determinations by ensuring that
substantially equivalent chemicals are considered at the same
time, as appropriate. The Committee believes this approach will
also help enhance EPA's ability to evaluate substances from new
sources against existing substances for equivalence, enabling
similar substances to rely on the Inventory listing of an
existing substance. The Committee also intends that EPA's
guidance should address those instances where multiple,
different substances share the same CAS number. These
substances may have different hazard profiles, but these
distinguishing characteristics are not transparent to the
public and stakeholders.
Current TSCA provides EPA the authority to list a category
of substances on the inventory, rather than list individually
each chemical substance within a category. S. 697 maintains
this authority to ensure that minor modification or variations
in the formulation or structure of a chemical substance that
have insignificant health or environmental consequences would
not be automatically subject to the notification requirements
of section 5. The Committee believes that EPA's current policy
of not requiring notification for variations in naturally-
occurring substances or mixtures should generally be continued.
Section 10 continues the practice under current TSCA to
ensure that any substance that is exempt from the
premanufacturing notification (PMN) process under Section 6 of
S. 697 is exempt from designation as active or inactive on the
chemical inventory.
Section 11. Relationship to other Federal laws
Section 11 amends section 9 of TSCA, which provides EPA
discretionary authority to refer a concern about an
unreasonable risk of injury to another Federal Agency, when the
authority to address the risk may be more efficiently or
effectively regulated by the other Agency. For example, if the
Administrator finds that disposal of a chemical substance may
pose risks that could be prevented or reduced under the Solid
Waste Disposal Act, the Administrator should ensure that the
relevant office of the EPA receives that information. Section
11 conforms this authority to the provisions of S. 697. It
further requires EPA to share information relevant to
preventing or mitigating exposures or releases of a chemical
substance under another Federal law with any relevant Federal
agencies or offices within EPA.
Section 12. Research, development, collection, dissemination, and
utilization of data
Section 12 makes a minor conforming amendment to section 10
of TSCA to ensure an appropriate reference to the Department of
Health and Human Services.
Section 13. Exports
Section 13 of S. 697 amends the export notification
requirements established in section 12 of TSCA. The amendments
conform the export notification requirements to the
requirements of the Act by requiring prior notice of exports of
substances that are not likely to meet, or that do not meet,
the safety standard and are subject to proposed or final
restrictions. The section requires EPA to promulgate rules to
implement the notification requirements.
The substitute strikes the amendments to section 13 of TSCA
that were in S. 697 as introduced. Thus, S. 697 makes no
changes to the current import requirements under TSCA.
Section 14. Confidential information
Section 14 of S. 697 amends section 14 of TSCA to make
several important modifications to the process by which
confidential business information (CBI) can be protected
against disclosure or disclosed. In general, it is the
Committee's intent to balance the need for protection from
disclosure for information qualifying under the section b(4)
exemption of the Freedom of Information Act (FOIA) (i.e.,
``trade secrets and commercial or financial information
obtained from a person and privileged or confidential'') with
the needs to ensure access to such information under
appropriate conditions by those who need it to perform their
duties, and to maximize public availability of health and
environmental information relating to chemical substances in
commerce. Striking a balance between protecting trade secrets
and sensitive commercial and financial information and
broadening access to information on chemicals is essential to
encourage innovation and economic competitiveness within the
chemical industry and those industries that use chemistry,
while better informing the decisions made about chemicals by
different levels of government, companies throughout the supply
chain, and the general public.
Under this section, all information sought to be protected
from disclosure must meet certain criteria, and all such claims
must be asserted. Section 14(b) identifies certain commercial
and financial business information that has been consistently
recognized as qualifying as CBI under existing TSCA. This type
of information (e.g., marketing and sales information) does not
require the same degree of substantiation by industry or review
by EPA as other types of information, and is therefore
distinguished from types of information that must be
substantiated and reviewed by EPA.
Section 14(c) identifies the types of information that will
not be protected from disclosure and the circumstances under
which protection will not be afforded. Section 14(c)(1) retains
virtually verbatim the language of existing section 14(b)(1),
relating to the disclosure of confidential information in the
context of a health and safety study. The adoption of this
provision of existing law does not signal the Committee's
intent to agree or disagree with EPA's interpretation of the
provision to date. Rather, it reflects the significant debate
over the scope and interpretation of the provision, which could
not be successfully resolved. The section retains clear
direction that the Administrator is not authorized to release
any information that would disclose a process used in the
manufacturing or processing of a chemical substance or mixture,
or the portion of a mixture comprised by any chemical substance
in the mixture. The Committee expects that EPA will ensure that
health and environmental effects information from health and
safety studies is disclosed, while appropriately protecting CBI
contained within a study.
The section also makes clear the Committee's intent that
EPA disclose all information not entitled to protection, while
ensuring that all information that qualifies for protection
from disclosure that is included in a submission that is
otherwise not entitled to protection from disclosure be
protected. This approach is intended to address the confusion
that can exist when information that qualifies for protection
is included in a submission that is otherwise not entitled to
protection from disclosure.
The section also establishes a rebuttable presumption that
CBI related to substances subject to a ban or phase-out shall
be made public, with the requirement that EPA provide advance
notice of the disclosure to the CBI claimant. The presumption
is based on the principle that the public interest in
disclosing confidential information concerning a chemical
subject to a ban or phase-out can outweigh the claimant's
interest. The required notice provides the CBI claimant an
opportunity to rebut the presumption by appealing or legally
challenging an EPA determination, and ensures that appropriate
information is made public while protecting important property
rights.
Under the section, all new claims for protection of
information not presumed to be protected from disclosure must
be substantiated by the claimant. The section is consistent
with well-established criteria and requirements for the
protection of trade secrets and other confidential information.
For claims to protect chemical identity as confidential, the
claimant must submit a structurally-descriptive generic name
that is to be publicly disclosed. Generic names should disclose
information such as the type, class, or family to which a
chemical belongs, without revealing specific chemical identity.
Section 14(e) identifies exceptions to CBI protection.
Several exceptions--for disclosure to a Federal officer or
employee under any law to protect health and the environment,
for disclosure to Federal contractors under certain
circumstances, and for disclosure when the Administrator
determines disclosure is necessary to protect health and the
environment--are based on existing TSCA. These provisions
signal no change in current policy on these disclosures. It is
also the Committee's intent to make clear that nothing in
section 14 constitutes a bar to the rules of civil or criminal
procedure in cases litigated in the U.S. courts. Appropriate
protections against disclosure in such cases can still be
sought by litigants in a court of law.
The section reflects a change in CBI policy by authorizing
EPA, for the first time, to share CBI with a State or a
political subdivision of a State on written request. It is the
Committee's view that sharing of CBI with State or local
authorities is only authorized under this Act when the
recipient establishes that it has adequate authority and
sufficient mechanisms in place to protect the information, by
agreement with the Administrator. The procedures applied by
State or local authorities to protect confidential information
must be comparable to the procedures used by the Administrator
to safeguard such information. The Committee expects EPA to
ensure that disclosures to State and local governments under
this provision will be protected from disclosure to the same
extent as under Federal law. Without those protections, EPA
should not release CBI to a State or political subdivision of a
State. The Administrator must also notify the person who
submitted the CBI that it has been disclosed to a State or
political subdivision.
The section also includes provisions on sharing CBI with
health and environmental protection professionals in certain
cases and under certain conditions. The provision is modeled on
a similar program established in the Emergency Planning and
Community Right to Know Act (EPCRA). The provision ensures that
treating physicians, nurses, agents of poison control centers,
public health or environmental officials of a State or
political subdivision of a State, and first responders have
appropriate, timely access to information, while still
protecting CBI from disclosures more broadly. The Committee
believes this provision will help remedy a deficiency in
current TSCA by improving access to information while
protecting proprietary information.
Under the current provisions of TSCA there is no effective
mechanism requiring the Administrator to review and evaluate a
CBI claim, or for companies to re-evaluate prior claims or to
re-substantiate claims. Section 14(f) is designed to address
this situation. The section provides clear direction that EPA
should review and make determinations on CBI claims in a timely
manner. All claims for the protection of confidential chemical
identity must be reviewed, and EPA must review a representative
subset of all other CBI claims.
The section also limits CBI protections for substantiated
claims to an initial period of 10 years, renewable upon re-
substantiation. A 10-year period for CBI claims is consistent
with that provided under the vast majority of Federal CBI
programs. The section specifies that the requirements to re-
substantiate a prior claim are to be consistent with and no
more or less burdensome than the original substantiation. The
Committee intends that there be no upper limit on the number of
extensions available for CBI protection, so long as the
claimant can make the appropriation substantiation of the
claim.
The section also provides the Administrator authority or a
mandate to require re-substantiation of CBI claims in certain
circumstances. This provision does not require EPA to review
all CBI claims for chemical substances designated as high
priorities.
Finally, section 14 provides that information that is
required to be disclosed or otherwise made public under Federal
law, or is already publicly available cannot be newly protected
as CBI under TSCA. This provision is consistent with current
law and practice related to CBI protection.
Section 15. Prohibited acts
Section 15 of S. 697 amends section 15 of TSCA to conform
to the requirements of the Act.
Section 16. Penalties
Section 16 of S. 697 amends section 16 of TSCA to increases
civil penalties from $25,000 to $37,500 per violation to be
consistent with other laws administered by EPA. The section
also modifies the existing criminal penalty for violations that
create an imminent danger of death or serious bodily injury,
based on similar provisions in other federal environmental
laws.
Section 17. State-Federal relationship
Section 17 of S. 697 makes several amendments to section 18
of TSCA to address the relationship between federal law and the
laws of states or political subdivisions of states related to
chemical regulation. Because TSCA regulates products
manufactured for national and international commercial use, the
Committee strongly intends S. 697 to establish a robust,
nationally uniform program for the effective regulation of
chemicals consistent with Article 1, Section 8, Clause 3 of the
U.S. Constitution. It is the Committee's view that the
prioritization, safety assessment and determination, and
regulatory provisions establish a credible national program to
protect health and the environment from the unmanaged risks of
chemical substances in such a way that the need for separate
state or local action may be minimized. It is the Committee's
expectation that EPA will make appropriate efforts to engage
State governments--particularly state agencies tasked with
protecting public health and the environment--interested in
chemical regulatory matters in the prioritization screening,
safety assessment and determination, and risk management
processes established under this Act.
The section specifically replaces the term ``requirements''
with the phrase ``statute or administrative action'' in
describing the extent of preemption that would apply to state
actions and any subsequent use of the word ``requirements'' is
not intended to extend to common law tort claims or decisions.
By the addition of several savings clauses, the Committee
wishes to send a strong signal that preemption under section 17
of the legislation does not apply to tort claims.
The section changes in some ways the circumstances under
which certain decisions or actions taken by the Administrator
preempt certain state actions. TSCA section 18 currently
preempts state law when EPA has issued a testing rule under
Section 4 or a rule or order under Sections 5 or 6 with respect
to a chemical substance. More specifically, TSCA generally
preempts State and local requirements applicable to the same
chemical substance if the State or local requirement is
designed to gather the same or similar information as the
Section 4 rule, or to protect against the same risks as the
Section 5 or 6 rule or order, unless the State or local
requirement is identical to the EPA requirement, is adopted
pursuant to another Federal law, or completely prohibits the
manufacture or processing of the substance or mixture within
the State or political subdivision. Under current TSCA, a State
may request that EPA issue a waiver from the preemption
provision.
Section 17's preemption provisions follow a framework that
is in many ways similar to current law. State actions regarding
testing, the notification of significant new uses, and the
restriction of high-priority substances for which EPA has
completed a safety determination and either has found that the
substance meets the safety standard, or has found that it does
not meet the safety standard and has completed a final risk
management rule, would be preempted, to the extent the same
uses and conditions of use are included in the scope of the EPA
action. For example, if EPA has completed a safety assessment
and safety determination for a chemical substance and finds the
chemical substance meets the safety standard, that action
preempts state restrictions on that substance only for the uses
and/or conditions of use included in the EPA review. If EPA
implements risk management requirements on a chemical
substance, that action would also preempt state restrictions on
that chemical substance, but only those state restrictions that
apply to the same uses and/or conditions of use addressed by
EPA's rule. Thus, the section establishes clear direction that
preemptive effects on State law are limited to the specified
regulatory actions taken by EPA with respect to a specific
chemical substance or category of substances, and then only to
the uses or conditions of use addressed by that EPA action.
The Administrator's commencement of a safety assessment of
a high-priority chemical will preempt the implementation of any
new state restriction on that chemical once the scope of the
safety assessment has been defined and published by EPA (under
section 6, no later than 6 months after designation as a high
priority). The preemptive effect will continue until EPA
publishes the safety determination. During this period, states
can continue working on legislation and rules to restrict
chemicals, but this preemption would prevent a final rule from
taking effect unless a waiver is granted, the safety
determination is finalized and the chemical substance is found
to not meet the safety standard, or the deadline for completing
the safety determination lapses also leading to the granting of
a waiver. Existing state statutes or administrative actions on
individual high priority chemicals are in no way preempted by
this provision.
Section 17(d) makes clear that certain state laws that are
not restrictions on chemical manufacturing and use are not
preempted under S. 697. As under current TSCA the section makes
clear that a state or local requirement adopted pursuant to
another federal statute is not preempted. In addition,
restrictions states put in place under their own authority to
protect air quality, water quality, or waste treatment or
disposal are not pre-empted, as long as those restrictions do
not address the same hazards and exposures, with respect to the
same conditions of use, as those included in the scope of the
safety determination but are inconsistent with the action of
the Administrator or would cause a violation of an applicable
action by the Administrator under section 5 or 6. This approach
is appropriate for the considerable body of law regulating
chemical releases to the environment, such as air and water
quality, where the states have traditionally had a significant
regulatory role and often have a uniquely local concern.
The section clarifies that an EPA action will not preempt
state actions that do not directly prohibit or otherwise
restrict the manufacturing, processing, distribution in
commerce of a chemical substance, as well as where the state
action is not otherwise required by or inconsistent with an
action under sections 4, 5 or 6. Similarly, state chemical
disclosure and other information-related obligations would not
be preempted by EPA action under TSCA, as they do not directly
restrict a chemical. The Committee expects that such state laws
are established to enhance information on chemical substances,
rather than being used to impose effective bans or other
substantial restrictions on chemical manufacture, processing,
distribution in commerce, use or disposal.
As in current law, the section also allows states to
enforce State law requirements that are identical to
requirements mandated by EPA under sections 4, 5 or 6. S. 697
provides that either a state or the Federal government can levy
a penalty and sanction a violation of the law, but not both. In
further ensuring equitable and consistent enforcement of
federal chemical regulations, State penalties and sanctions can
be no more stringent than those available to the Federal
government.
The section provides that existing EPA regulations remain
in force unless modified or eliminated under this Act, and that
any preemptive effect of those regulations that pre-dates
enactment of S. 697 continues in accordance with the preemption
provisions in effect when those rules were put in place under
the law. The Committee intends to make clear that nothing in S.
697 affirmatively modifies or eliminates the preemptive effect
of a Federal decision in effect prior to the date of enactment,
nor that EPA's ability to revisit previous rulemakings through
the administrative process is in any way diminished.
In order to efficiently address the potential preemptive
effect of EPA decisions on the body of existing state laws
affecting chemical substances, S. 697 creates an exemption from
preemption for all chemical specific actions taken prior to
August 1, 2015. This provision is intended to ``grandfather''
existing state prohibitions or restrictions on chemical
manufacturing, processing, use, distribution in commerce, or
disposal of a chemical substance.
In addition, the section adopts similar language to section
231(b) of the Consumer Product Safety Improvement Act (CPSIA),
which was intended to exclude California's ``Proposition 65''
requirements from federal preemption under that Act. It is the
Committee's intent that adopting this provision in S. 697 would
effectively achieve the same result.
Currently, TSCA provides states an opportunity to seek a
waiver from preemption following final EPA action, under
certain circumstances. S. 697 adopts a similar approach, and
provides an additional waiver opportunity for states related to
the preemptive effect of EPA's initiation of a safety
assessment and determination on new state regulation.
When EPA has made a final decision or taken an action under
section 4, 5 or 6 that has a preemptive effect, a State may
seek and be granted a waiver when EPA determines that: there
are compelling local health or environmental conditions;
compliance with the state requirement would not unduly burden
interstate commerce (consistent with the Commerce Clause of the
U.S. Constitution); or cause a violation of federal law
(consistent with the Supremacy Clause of the U.S.
Constitution); and the requirement is consistent with sound
objective scientific practices, the weight of the evidence and
the best available science. This waiver opportunity is modeled
on the existing provisions of section 18 of TSCA, but includes
additional conditions for granting such a waiver, consistent
with the Committee's intent that S. 697 establish a robust,
nationally uniform program for the effective regulation of
chemicals.
As noted earlier, EPA's commencement of a safety assessment
preempts certain new state actions on a chemical substance,
running from the date on which the scope of EPA's review is
defined and published, ending on the date the safety
determination is published or the maximum deadline of 5 years
for a determination under Section 6 as amended is missed. Even
during this interim period, a State may seek and EPA shall
grant a waiver when compliance with the state requirement would
not unduly burden interstate commerce (again, consistent with
the Commerce Clause of the U.S. Constitution), or cause a
violation of federal law (again, consistent with the Supremacy
Clause of the U.S. Constitution), and the concern of the state
or political subdivision is based in peer-reviewed science. The
Committee's intent is that this last condition requires that a
State's waiver application should be based on credible science
citing one or more studies published in a peer reviewed
journal, or a study by an institution like the National Academy
of Sciences with a peer review process. This language does not
require that a state's waiver application be evaluated on the
weight of the evidence.
State waiver requests are subject to notice and comment,
and EPA decisions on them must be made within a specified
period of time, and are considered final agency actions subject
to judicial review by any person. If a court does not act on a
petition for judicial review, within 90 days, the waiver again
applies and the state may proceed with implementation of its
restriction. For waivers sought during the period EPA is
reviewing a chemical substance, if EPA fails to adhere to the
deadline established in section 6 for safety assessments and
determinations, or fails to meet the deadlines for action on a
waiver application, a waiver shall be automatically approved.
The Committee intends that the compelling state
circumstances or interests identified in a waiver application
for a state to act after final EPA action should generally
follow the practice of other federal agencies applying similar
provisions. For example, a Department of Energy (``DOE'')
regulation allows States to petition for a preemption exemption
for energy conservation standards for which there is already a
federal standard. 10 C.F.R. Sec. 431.422. The State must show
that an exemption is needed to meet ``unusual and compelling
State or local energy interests.'' This is defined to mean
``interests which are substantially different in nature or
magnitude from those prevailing in the U.S. generally . . .''
Similarly, under the Federal Food, Drug, and Cosmetic Act
(FFDCA), the Food and Drug Administration (FDA) in reviewing
medical devices can exempt a State requirement from preemption
if there are ``compelling local conditions.'' 21 U.S.C.
Sec. 360k. The FDA's regulations define this phrase to mean
``any factors, considerations, or circumstances prevailing in,
or characteristic of, the geographic area or population of the
State or political subdivision that justify exemption
preemption.''
The section authorizes any person to seek judicial review
of an EPA decision to designate a substance as a low priority
chemical. The Committee expects that if EPA applies the low
priority designation based on information sufficient to
establish that the chemical substance is likely to meet the
safety standard, judicial review of a low priority designation
will be sought infrequently, particularly as the ability of
state governments to act on all chemical substances not
designated as a high priority remains intact because low
priority determinations have no preemptive or regulatory
affect.
The section establishes several savings clauses. Federal
court precedent establishes that preemption is a matter of
Congressional intent. Gade v. Nat'l Solid Wastes Mgmt Ass'n,
505 U.S. 88, 96 (1992). The Supreme Court has given effect to
saving clauses and found that they save common law tort claims
from a statute's preemption language. See, e.g., Geier v. Am.
Honda Motor Co., Inc., 529 U.S. 861, 868 (2000) (holding common
law actions not preempted due to a saving clause despite a
preemption clause that could otherwise be reasonably
interpreted broadly to preempt such claims). The savings
clauses in S. 697 are intended as a clear statement that the
preemption provisions do not apply to tort claims.
Current section 18 of TSCA does not preempt or displace any
private common law rights or statutory remedies for civil
relief, or penalties for criminal conduct. Similarly, section
17 of S. 697 makes clear that nothing in the Act should be
interpreted to preempt, supplant, or displace common law rights
or statutorily enacted remedies for civil damages or a criminal
penalty. The Committee believes that this clarification is
useful to ensure that S. 697 results in no unintended
contraction of any private legal rights, and particularly to
further clarify that nothing in the revision of section 18
should be interpreted to apply to tort claims.
Section 18. Judicial review
Section 18 of S. 697 amends section 19 of TSCA. S. 697
makes no change to the existing standard of judicial review in
section 19 of TSCA. Several other provisions of this section
make changes to conform section 19 to the requirements of the
Act.
Section 19. Citizens' petitions
Section 19 of S. 697 amends section 20 of TSCA to make
changes necessary to conform the citizens' petition process to
the requirements of the Act. No substantive or policy change is
intended by these amendments.
Section 20. Employment effects
Section 20 of S. 697 makes a minor conforming change in
section 21 of TSCA.
Section 21. Studies
Section 21 of S. 697 repeals section 25 of TSCA. Section 25
required the Administrator to conduct an indemnification study
and a study on classification, storage and retrieval of
information on chemicals. These studies are not necessary under
a modernized TSCA, particularly given the widespread
availability of information on chemical substances in
electronic format.
Section 22. Administration
Section 22 of S. 697 amends Section 26 of TSCA to expand
EPA's existing TSCA fee authority. In the Committee's view, the
provisions will help ensure that funds sufficient to defray a
substantial portion of EPA expenses in information collection
and processing, prioritization, safety assessment and
determination, and regulation under the Act are provided
through user fees.
The section authorizes EPA to raise fees to defray
approximately 25% of the cost of implementation, to a maximum
of $18 million. All fee revenue would be directed to a new TSCA
Implementation Fund, to ensure that resources will be directly
available to EPA to more efficiently run the program. Similar
to user fees in several other federal product assessment
programs (such as the Pesticide Registration Improvement Act),
fee authority is conditioned on continued federal
appropriations and to subsequent Congressional reauthorization.
The section authorizes EPA to adjust fees for inflation and
to ensure that funds are sufficient to conduct the activities
covered by the fees. The section also directs EPA to avoid
surpluses. As provided in section 4A of S. 697, manufacturers
or processors of chemicals EPA decides to assess as
``additional priorities'' will pay 100% of the costs of safety
assessments and determinations, while 50% of the costs of
conducting company-requested safety assessments and
determinations on TSCA Work Plan chemicals are to be paid by
the company.
The section provides that fees may not be assessed for a
fiscal year unless the amount of appropriations (excluding
fees) is equal to or greater than the amount of appropriations
for fiscal year 2015. This provision is modeled after a similar
provision in the Pesticide Registration Improvement Act. The
Committee intends this provision to ensure that appropriations
are not reduced because of the revenue collected through fees,
but rather that the fees supplement appropriated resources
available to the Agency. The payment of fees for ``additional
priorities'' and for company-requested reviews of TSCA Work
Plan chemicals should not be subject to the condition for
continued federal appropriations.
The section establishes audit and transparency requirements
in EPA's implementation of the fee program.
With these provisions, it is the Committee's intent to
ensure that EPA has the resources it needs to implement the new
and strengthened regulatory requirements of a modernized TSCA.
Section 23. Development and evaluation of test methods and sustainable
chemistry
Section 23 of S. 697 amends section 27 of TSCA to establish
an interagency Sustainable Chemistry program to promote and
coordinate Federal sustainable chemistry research, development,
demonstration, training and other activities. The interagency
group is to include representatives of the National Science
Foundation, the National Institute of Standards and Technology,
and other agencies with interests in sustainable chemistry. The
section provides no new appropriations authority, but directs
the relevant agencies to coordinate their budgets to provide
appropriate support to the program. Section 23 is intended to
ensure that EPA and the federal government support education,
research and development, into new, sustainable chemistries.
The Committee questions whether or to what extent the EPA
labeling program will be needed for, or appropriately applied
to, chemicals for which EPA conducts safety assessments and
determinations under EPA's strengthened authorities under S.
697; specifically, the Committee is concerned that the labeling
program, if applied to chemicals EPA has found meet the safety
standard, could risk consumer confusion in the marketplace if
another program within the Agency then identifies ``safer''
alternatives. It is the expectation of the Committee that,
given the new authorities and responsibilities of the Agency
under S. 697, the agency's toxics office will focus primarily
on implementation and enforcement of S. 697, and consider use
of any existing private sector voluntary consensus standards as
an alternative to further expanding or utilizing certain
aspects of the Safer Choice program.
Section 24. State programs
Section 24 makes a minor conforming change to section 28 of
TSCA, relating to federal grants to support state programs.
Section 25. Authorization of appropriations
Section 25 of S. 697 repeals section 29 of TSCA, relating
to authorized appropriations.
Section 26. Annual report
Section 26 of S. 697 amends section 30 of TSCA to add
several elements to the annual report required of EPA to
Congress on implementation of the Act including the number of
notices received under section 5 as amended, and for chemical
substances subject to a rule, testing consent agreement, or
order under section 4 as amended.
Section 27. Effective date
Section 27 of S. 697 modifies Section 31 of TSCA to make
clear that nothing in the Act shall be interpreted
retroactively to any Federal, State, or maritime legal action
commenced prior to the effective date.
Legislative History
Senator Udall introduced S. 697 on March 10, 2015. The bill
was referred to the Committee on Environment and Public Works.
A legislative hearing on the bill was held on March 18, 2015.
The Committee considered the bill in a business meeting on
April 28, 2015. An amendment in the nature of a substitute was
approved, and the Committee ordered the bill reported to the
Senate.
Roll Call Votes
The Committee on Environment and Public Works met to
consider S. 697 on April 28, 2015. The committee favorably
reported the bill, as amended by a substitute offered by
Senators Vitter, Whitehouse, Merkley and Booker, by a roll call
vote of 15-5.
Amendments rejected
A total of 6 amendments to the bill were offered and not
approved by the Committee, as follows:
1. Gillibrand #1--Amendment striking a section of S. 697
that prohibits states from taking action in regulating high
priority chemicals upon the initiation of the Safety Assessment
by EPA (rejected by a roll call vote of 8 yeas, 12 nays).
2. Boxer-Sanders-Markey #2--Amendment requiring expedited
consideration of the regulation of all forms of asbestos,
instead of requiring a safety assessment be completed (rejected
by a roll call vote of 9 yeas, 11 nays).
3. Markey #1--Amendment including a provision for chemicals
requiring expedited action (rejected by a roll call vote of 8
yeas, 12 nays).
4. Markey #2--Amendment allowing additional time to comply
with certain restrictions in cases of technological
infeasibility (rejected by a roll call vote of 9 yeas, 11
nays).
5. Boxer-Carper #3--Amendment addressing chemical
contamination of drinking water supplies by requiring
consideration of whether a chemical substance is stored near
drinking water sources when prioritizing chemicals for
assessments (rejected by a roll call vote of 10 yeas, 10 nays).
6. Boxer-Markey-Sanders #5--Amendment strengthening
protections for children and communities from disease clusters
and providing community disease cluster technical assistance
grants (rejected by a roll call vote of 10 yeas, 10 nays).
Final Committee vote to report
S. 697, as amended by the Vitter/Whitehouse/Merkley/Booker
substitute, was approved and ordered to be reported to the full
Senate. The roll call vote to report the bill was 15 to 5 in
favor (Senators Inhofe, Vitter, Barrasso, Capito, Crapo,
Boozman, Sessions, Wicker, Fischer, Rounds, Sullivan, Carper,
Whitehouse, Merkley and Booker voted yea, and Senators Boxer,
Cardin, Sanders, Gillibrand, and Markey voted nay).
Regulatory Impact Statement
In compliance with section 11(b) of rule XXVI of the
Standing Rules of the Senate, the committee finds that S. 697
does create additional regulatory burdens on manufacturers,
processors and importers and users of chemical substances.
These burdens include fees authorized under S. 697 of up to $18
million annually. According to the Environmental Protection
Agency, there are approximately 13,500 chemical manufacturing
facilities in the United States owned by more than 9,000
companies. There is no information on the number of users of
chemical substances. It is not practicable to quantify the
number of entities affected, the precise economic impact on
those entities, or the additional paperwork that may result
from regulations to be promulgated under S. 697. However, the
committee notes that the Congressional Budget Office has found
that the cost of the mandates in the bill to private and public
sector entities will not be substantial. The committee finds
that S. 697 will not cause any adverse impact on the personal
privacy of individuals.
Mandates Assessment
In compliance with the Unfunded Mandates Reform Act of 1995
(Public Law 104-4), the committee notes that the Congressional
Budget Office found, ``S. 697 would impose intergovernmental
and private-sector mandates, as defined in the Unfunded
Mandates Reform Act (UMRA), on manufacturers, processors,
importers, and users of chemical substances. The bill also
would impose intergovernmental mandates on state agencies. CBO
estimates that the aggregate cost of those mandates would fall
below the annual thresholds established in UMRA for
intergovernmental and private-sector mandates ($77 million and
$154 million in 2015, respectively, adjusted annually for
inflation).''
Cost of Legislation
June 5, 2015.
Hon. Jim Inhofe,
Chairman, Committee on Environment and Public Works,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 697, the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Susanne S.
Mehlman.
Sincerely,
Keith Hall.
Enclosure.
S. 697--Frank R. Lautenberg Chemical Safety for the 21st Century Act
Summary: S. 697 would modify the Toxic Substances Control
Act (TSCA), the law that regulates the manufacture,
importation, and processing of chemicals, with the aim of
strengthening the Environmental Protection Agency's (EPA's)
ability to evaluate and regulate potentially hazardous
chemicals.
CBO estimates that EPA would incur additional
administrative costs over the 2016-2020 period to meet the new
requirements imposed by S. 697; however, we also estimate that
under the bill EPA would collect sufficient fees from chemical
manufacturers and processors to offset the cost of conducting
the activities proposed under this legislation. On net, we
estimate that implementing this legislation would reduce
discretionary costs by $8 million over the next five years,
assuming appropriation actions consistent with provisions of
the bill.
Enacting S. 697 could affect direct spending and revenues
because the bill would increase some existing civil and
criminal penalties for violations of TSCA. Therefore, pay-as-
you-go procedures apply. CBO estimates that any changes in
revenues and direct spending would not be significant.
S. 697 would impose intergovernmental and private-sector
mandates, as defined in the Unfunded Mandates Reform Act
(UMRA), on manufacturers, processors, importers, and users of
chemical substances. The bill also would impose
intergovernmental mandates on state agencies. CBO estimates
that the aggregate cost of those mandates would fall below the
annual thresholds established in UMRA for intergovernmental and
private-sector mandates ($77 million and $154 million in 2015,
respectively, adjusted annually for inflation).
Major provisions: The bill's major provisions would:
Require EPA to develop policies, procedures,
and guidance to address the process for testing and
evaluating the safety of chemical substances;
Authorize EPA to obtain new information on
chemical substances from manufacturers and processors
at all stages of the safety evaluation process;
Require EPA to establish and implement a
risk-based prioritization process to screen all
chemicals now in use;
Address when federal actions under TSCA
preempt requirements of state and local governments
related to restricting and banning chemical substances;
Require EPA to update its process for
reviewing industry requests that information submitted
to the agency be kept confidential; and,
Require EPA to establish a new schedule for
charging fees to chemical manufacturers who are
required to submit data to the agency or who request
that EPA assess certain chemicals that are not yet
prioritized for review by EPA.
Estimated cost to the Federal Government: The estimated
budgetary impact of S. 697 is shown in the following table. The
costs of this legislation fall within budget function 300
(natural resources and environment).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2016 2017 2018 2019 2020 2016-2020
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Administrative Expenses under TSCA:
Estimated Authorization Level....................... 17 17 17 17 17 85
Estimated Outlays................................... 7 14 17 17 17 72
Offsetting Fee Collections:
Estimated Authorization Level....................... -4 -10 -16 -25 -25 -80
Estimated Outlays................................... -4 -10 -16 -25 -25 -80
Total Changes:
Estimated Budget Authority...................... 13 7 1 -8 -8 5
Estimated Budget Outlays........................ 3 4 1 -8 -8 -8
----------------------------------------------------------------------------------------------------------------
Note: TSCA = Toxic Substances Control Act.
Basis of estimate: For this estimate, CBO assumes that S.
697 will be enacted near the end of 2015 and that the necessary
amounts will be appropriated each year.
Spending subject to appropriation
While some of the requirements in S. 697 are similar to
activities currently performed by EPA under TSCA, CBO estimates
that implementing this legislation would increase EPA's
workload for regulating chemical safety by about 30 percent
each year. That estimate is based on historical information
about how other large regulatory programs have been implemented
by EPA and on expectations of the additional workload provided
by the agency. According to EPA, the agency currently requires,
on average, an appropriation of about $58 million annually to
implement and enforce EPA's Chemical Risk Review and Reduction
program under TSCA. That funding supports roughly 245
employees. Subject to the appropriation of the necessary
amounts, CBO estimates that EPA would require about $17 million
annually over the next five years to cover the costs of
additional personnel, contractors, and other administrative
activities associated with meeting the new requirements of this
legislation.
Over the next two years, CBO expects that EPA would focus
on implementing S. 697 primarily by producing guidance
documents and cost-benefit analyses and performing other
administrative tasks related to the rulemaking process for the
review of the safety of new chemicals and substances currently
in use. EPA would establish internal processes and information
technology systems to prioritize the analysis of tens of
thousands of chemicals. According to the agency, such
activities are routinely carried out by contractors; as a
result, most of the estimated $17 million in annual funding
needed over this period would cover contractor costs. By 2018,
enforcement of the new provisions of TSCA would begin and CBO
estimates that EPA would shift funding to cover additional
government personnel. CBO estimates that spending on new
administrative activities over the next five years would total
$72 million.
Under the legislation EPA would be authorized to charge two
types of fees. One would be imposed on chemical manufacturers
and processors who are required to submit certain types of
notices or requests for exemptions under the bill. In addition,
EPA could charge fees to manufacturers and processors who
request that EPA conduct safety assessments and safety
determinations for chemicals that have not been designated a
priority for further assessment.
Under the bill total collections of fees for firms
submitting notices and requests for exemptions could not exceed
$18 million annually. CBO estimates that EPA would begin
collecting those fees in 2017 and that such collections would
total $6 million in that first year. By 2019, we expect that as
more chemicals are reviewed by EPA, collections would reach $18
million annually. Based on information from EPA, CBO estimates
that collections from firms requesting safety assessments and
determinations would begin in 2016 and would total $4 million
in that year. By 2019 we estimate that collections would total
$7 million annually. S. 697 specifies that all additional fees
collected by EPA would be recorded in the budget as offsetting
collections (an offset to appropriated spending). CBO estimates
that those collections would total $80 million over the next
five years. Thus, enacting this legislation would result in a
net reduction in spending of $8 million over the 2016-2020
period, assuming future appropriations acts are consistent with
CBO's estimates.
Direct spending and revenues
Enacting S. 697 also could affect direct spending and
revenues because this bill would increase some existing civil
and criminal penalties. Criminal penalties are recorded as
revenues, then deposited in the Crime Victims Fund, and later
spent; civil penalties are recorded as revenues. CBO estimates
that any increase in criminal or civil penalties under the bill
would not be significant.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. CBO estimates that any increase in revenues and
direct spending resulting from changes in criminal or civil
penalties would not be significant over the 2016-2025 period.
Intergovernmental and Private-Sector Impact: S. 697 would
impose intergovernmental and private-sector mandates, as
defined in UMRA, on manufacturers, processors, importers, and
users of chemical substances. The bill also would impose
intergovernmental mandates on state agencies. CBO estimates
that the aggregate cost of those mandates would fall below the
annual thresholds established in UMRA for intergovernmental and
private-sector mandates ($77 million and $154 million in 2015,
respectively, adjusted annually for inflation).
Mandates that apply to both public and private entities
S. 697 would modify the standard used to determine whether
a chemical substance poses an unreasonable risk to human health
or the environment and would allow EPA to regulate the
manufacture, processing, distribution, use, and disposal of
chemical substances to ensure the standard is met. If EPA
determines that some chemical substances do not meet the
standard and issues regulations for those substances, the bill
would impose an intergovernmental and private-sector mandate.
EPA would have the authority to adopt a range of regulatory
options to address risks from chemical substances. For example,
EPA could require manufacturers to put warning labels on
selected chemicals. EPA also could require users of chemicals,
such as public and private universities conducting research, to
handle or dispose of selected chemicals in a certain way. Based
on information from industry experts, CBO expects that the
annual cost of any restriction would not be substantial. Also,
because of the amount of time involved in assessing the risk of
each chemical, any restrictions imposed would apply to few
chemicals in the first five years the mandate is in effect.
Therefore, CBO estimates that the cost of the mandate would be
small for both public and private entities during that time.
Mandates that apply to public entities only
The bill would impose an intergovernmental mandate by
preempting state regulations that conflict with the federal
regulation of chemicals, but that preemption would impose no
duty on states that would result in additional spending or a
loss of revenues. The bill also would impose a mandate on state
agencies by requiring them to notify EPA whenever they propose
an administrative action, enact a statute, or take regulatory
action concerning a chemical that EPA has not designated as a
high-priority substance. Information from EPA indicates that
the cost of that notification mandate would be small.
Mandates that apply to private entities only
The bill would amend provisions in TSCA that apply to new
and existing chemicals. The bill would impose new mandates and
increase the cost of existing mandates on manufacturers,
importers, and processors of chemical substances. Additionally,
manufacturers and processors would be required to pay fees and
submit data to EPA for use carrying out safety assessments and
regulations to ensure safety. Finally, the bill could impose a
mandate on importers of some items containing chemical
substances.
Based on information from industry experts, CBO expects
that the incremental cost of those mandates would not be
substantial. The bill would limit the amount of mandatory fees
that EPA could collect to $18 million annually. Manufacturers
and processors of existing chemical substances currently report
information to EPA under programs such as the Chemical Data
Reporting rule and the High Production Volume Challenge
Program, which is voluntary. Based on information from industry
experts, CBO expects that submitting new data to EPA for safety
assessments could cost up to $1 million per chemical substance.
However, the annual number of existing chemicals that would be
subject to the data submission requirements would be limited.
Estimate prepared by: Federal spending: Susanne Mehlman;
Impact on state, local, and tribal governments: Jon Sperl;
Impact on the private sector: Amy Petz.
Estimate approved by: Theresa Gullo, Assistant Director for
Budget Analysis.
Minority Views
----------
MINORITY VIEWS OF BOXER, CARDIN, SANDERS, GILLIBRAND, AND MARKEY ON S.
697, AS REPORTED BY THE EPW COMMITTEE
Protecting people from harmful chemicals is a fundamental
goal. It is clear that our current chemical regulation law--the
Toxic Substances Control Act (TSCA)--is broken. Reform of this
law must avoid creating loopholes that could result in a
failure once again.
In a key 1991 court decision, EPA's plan to phase out
asbestos uses was overturned despite overwhelming evidence
about the dangers of this chemical. Since this case, EPA has
been unable to address the most dangerous chemicals being used
today.
Reform of this failed law is needed. Any action by Congress
must be better than current law and must ensure families have
additional protections. Important clarifications and
improvements are needed to ensure that S. 697, as reported by
the EPW Committee, clearly addresses the threats dangerous
chemicals pose.
The version of the bill reported by the EPW Committee makes
vital improvements to the introduced bill, including removing
preemption of state air and water laws, allowing co-enforcement
of chemical restrictions by the States, allowing judicial
review of chemicals designated as ``low priority'', and
removing a harmful provision that would have undermined EPA's
ability to restrict the import of dangerous chemicals from
foreign countries.
This is important progress. However, the bill needs further
improvement to make sure that TSCA reform addresses the most
dangerous chemicals without being mired in years of litigation.
That is why the following public health, labor, and
environmental organizations do not support the bill reported by
the EPW Committee and have called for additional changes.
Safer Chemicals, Healthy Families Coalition
(represents 450 organizations dedicated to reforming
toxics laws)
Asbestos Disease Awareness Organization
Breast Cancer Fund
AFL-CIO
Center for Environmental Health
Environmental Working Group
California Attorney General
IMPROVEMENTS NEEDED TO S. 697
Allow States to Protect Their Citizens Until EPA Acts--The
bill reported by the EPW Committee stops States from regulating
a chemical as soon as EPA begins its assessment of the chemical
and many years before a Federal restriction is actually put in
place. The bill creates a waiver process that would allow
States to petition EPA to move forward. This process is
complicated, subject to litigation, and leaves great
uncertainty about the ability of States to protect their
citizens before federal safeguards are finalized. States need
greater certainty that they can act until Federal restrictions
under TSCA are in place and effective so that they can ensure
public health is protected.
Act on Known Dangers--The bill should make it clear that
known chemical threats, such as asbestos and chemicals that
accumulate in the body, will be addressed. The bill would
encourage EPA to consider persistent and bioaccumulative
chemicals, but would not require action. Furthermore, asbestos,
which is estimated to kill 15,000 people every year, is not
specifically addressed or prioritized in the bill despite its
known dangers. The bill does not prioritize or address
chemicals stored near sources of drinking water that could
spill and contaminate drinking water supplies. Finally, the
bill should provide the tools necessary to investigate,
undertake actions, and coordinate responses to address disease
clusters. Chemicals that present known threats such as these
should be specifically addressed in the bill to guarantee that
action is taken.
Ensure EPA Can Take Action to Address Dangerous Chemicals--
The current TSCA law contains a number of flaws that make the
adoption of strong public health protections against the most
dangerous types of chemicals an extremely and unnecessarily
difficult task. The bill reported by the EPW Committee does not
sufficiently address these flaws. S. 697 maintains elements of
the current ``unreasonable risk'' safety standard for EPA
actions to ban or restrict exposure to toxic substances. The
bill also maintains the ``substantial evidence'' legal standard
that was an important reason for the failure of the current
TSCA law. Legislation to reform TSCA should be clear that this
legal standard does not create an unnecessary hurdle to
implementing restrictions on chemicals that have been proven to
be a danger.
Meaningfully Improve Scope and Speed of Chemical Reviews--
The bill should do more to ensure meaningful progress to assess
and act on chemicals that present a danger to public health. S.
697 requires EPA to begin studying the safety of 25 chemicals
within the first 5 years. According to EPA there are at least
1,000 chemicals that are dangerous enough to require further
study immediately. The bill should require EPA to address this
concern and provide the resources to assess the most dangerous
chemicals in commerce as quickly as possible.
As S. 697 moves forward, we stand ready to work with our
colleagues to address the issues identified here and pass TSCA
reform that protects our children and families from the threat
of dangerous chemicals.
Barbara Boxer.
Benjamin L. Cardin.
Bernard Sanders.
Kirsten Gillibrand.
Edward Markey.
Changes in Existing Law
In compliance with section 12 of rule XXVI of the Standing
Rules of the Senate, changes in existing law made by the bill
as reported are shown as follows: Existing law proposed to be
omitted is enclosed in [black brackets], new matter is printed
in italic, existing law in which no change is proposed is shown
in roman:
* * * * * * *
TOXIC SUBSTANCES CONTROL ACT
* * * * * * *
SEC. 2. FINDINGS, POLICY, AND INTENT.
(a) Findings.--The Congress finds that--
(1) human beings and the environment are being
exposed each year to a large number of chemical
substances and mixtures.
(2) among the many chemical substances and mixtures
which are constantly being developed and produced,
there are some whose manufacture, processing,
distribution in commerce, use, or disposal may present
an unreasonable risk of injury to health or the
environment; and
(3) the effective regulation of interstate commerce
in such chemical substances and mixtures also
necessitates the regulation of intrastate commerce in
such chemical substances and mixtures.
(b) Policy.--It is the policy of the United States that--
(1) adequate data should be developed with respect to
the effect of chemical substances and mixtures on
health and the environment and that the development of
such data should be the responsibility of those who
manufacture and those who process such chemical
substances and mixtures;
(2) adequate authority should exist to regulate
chemical substances and mixtures which present an
unreasonable risk of injury to health or the
environment, and to take action with respect to
chemical substances and mixtures which are imminent
hazards; and
(3) authority over chemical substances and mixtures
should be exercised in such a manner as not to impede
unduly or create unnecessary economic barriers to
technological innovation while fulfilling the primary
purpose of this Act to assure that such innovation and
commerce in such chemical substances and mixtures do
not present an unreasonable risk of injury to health or
the environment.
(c) Intent of Congress.--[It is the intent]
(1) Administration.--It is the intent of Congress
that the Administrator shall carry out this Act in a
reasonable and prudent manner, and that the
Administrator shall consider the environmental,
economic, and social impact of any action the
Administrator takes or proposes to take under this Act
, as provided under this Act.
(2) Reform.--[It is the intent of Congress that
reform of this Act] This Act, including reforms in
accordance with the amendments made by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act--
(A) shall be administered in a manner that--
(i) protects the health of children,
pregnant women, the elderly, workers,
consumers, the general public, and the
environment from the risks of harmful
exposures to chemical substances and
mixtures; and
(ii) ensures that appropriate
information on chemical substances and
mixtures is available to public health
officials and first responders in the
event of an emergency; and
(B) shall not displace or supplant common law
rights of action or remedies for civil relief.
SEC. 3. DEFINITIONS.
As used in this Act:
(1) The\2\ term ``Administrator'' means the Administrator of
the Environmental Protection Agency.
---------------------------------------------------------------------------
\2\In Public Law 94-469, which enacted this section, the word
``the'' was lower case. ``The'' has been shown capitalized to reflect
the probable intent of Congress.
---------------------------------------------------------------------------
(2)(A) Except as provided in subparagraph (B), the term
``chemical substance'' means any organic or inorganic substance
of a particular molecular identity, including--
(i) any combination of such substances occurring in
whole or in part as a result of a chemical reaction or
occurring in nature, and
(ii) any element or uncombined radical.
(B) Such term does not include--
(i) any mixture,
(ii) any pesticide (as defined in the Federal
Insecticide, Fungicide, and Rodenticide Act) when
manufactured, processed, or distributed in commerce for
use as a pesticide,
(iii) tobacco or any tobacco product,
(iv) any source material, special nuclear material,
or byproduct material (as such terms are defined in the
Atomic Energy Act of 1954 and regulations issued under
such Act),
(v) any article the sale of which is subject to the
tax imposed by section 4181 of the Internal Revenue
Code of 1954 (determined without regard to any
exemptions from such tax provided by section 4182 or
4221 or any other provision of such Code), and
(vi) any food, food additive, drug, cosmetic, or
device (as such terms are defined in section 201 of the
Federal Food, Drug, and Cosmetic Act) when
manufactured, processed, or distributed in commerce for
use as a food, food additive, drug, cosmetic, or
device.
The term ``food'' as used in clause (vi) of this subparagraph
includes poultry and poultry products (as defined in sections
4(e) and 4(f) of the Poultry Products Inspection Act), meat and
meat food products (as defined in section 1(j) of the Federal
Meat Inspection Act), and eggs and egg products (as defined in
section 4 of the Egg Products Inspection Act).
(3) The term ``commerce'' means trade, traffic,
transportation, or other commerce (A) between a place in a
State and any place outside of such State, or (B) which affects
trade, traffic, transportation, or commerce described in clause
(A).
(4) Conditions of use.--The term `conditions of use'
means the intended, known, or reasonably foreseeable
circumstances the Administrator determines a chemical
substance is manufactured, processed, distributed in
commerce, used, or disposed of.
[(4)] (5) The terms ``distribute in commerce'' and
``distribution in commerce'' when used to describe an action
taken with respect to a chemical substance or mixture or
article containing a substance or mixture mean to sell, or the
sale of, the substance, mixture, or article in commerce; to
introduce or deliver for introduction into commerce, or the
introduction or delivery for introduction into commerce of, the
substance, mixture, or article; or to hold, or the holding of,
the substance, mixture, or article after its introduction into
commerce.
[(5)] (6) The term ``environment'' includes water, air, and
land and the interrelationship which exists among and between
water, air, and land and all living things.
[(6)] (7) The term ``health and safety study'' means any
study of any effect of a chemical substance or mixture on
health or the environment or on both, including underlying data
and epidemiological studies, studies of occupational exposure
to a chemical substance or mixture, toxicological, clinical,
and ecological studies of a chemical substance or mixture, and
any test performed pursuant to this Act.
[(7)] (8) The term ``manufacture'' means to import into the
customs territory of the United States (as defined in general
note 2 of the Harmonized Tariff Schedules of the United
States), produce, or manufacture.
[(8)] (9) The term ``mixture'' means any combination of two
or more chemical substances if the combination does not occur
in nature and is not, in whole or in part, the result of a
chemical reaction; except that such term does include any
combination which occurs, in whole or in part, as a result of a
chemical reaction if none of the chemical substances comprising
the combination is a new chemical substance and if the
combination could have been manufactured for commercial
purposes without a chemical reaction at the time the chemical
substances comprising the combination were combined.
[(9)] (10) The term ``new chemical substance'' means any
chemical substance which is not included in the chemical
substance list compiled and published under section 8(b).
(11) Potentially exposed or susceptible population.--
The term `potentially exposed or susceptible
population' means 1 or more groups--
(A) of individuals within the general
population who may be--
(i) differentially exposed to
chemical substances under the
conditions of use; or
(ii) susceptible to greater adverse
health consequences from chemical
exposures than the general population;
and
(B) that when identified by the Administrator
may include such groups as infants, children,
pregnant women, workers, and the elderly.
[(10)] (12) The term ``process'' means the preparation of a
chemical substance or mixture, after its manufacture, for
distribution in commerce--
(A) in the same form or physical state as, or in a
different form or physical state from, that in which it
was received by the person so preparing such substance
or mixture, or
(B) as part of an article containing the chemical
substance or mixture.
[(11)] (13) The term ``processor'' means any person who
processes a chemical substance or mixture.
(14) Safety assessment.--The term `safety assessment'
means an assessment of the risk posed by a chemical
substance under the conditions of use, integrating
hazard, use, and exposure information regarding the
chemical substance.
(15) Safety determination.--The term `safety
determination' means a determination by the
Administrator as to whether a chemical substance meets
the safety standard under the conditions of use.
(16) Safety standard.--The term `safety standard'
means a standard that ensures, without taking into
consideration cost or other nonrisk factors, that no
unreasonable risk of injury to health or the
environment will result from exposure to a chemical
substance under the conditions of use, including no
unreasonable risk of injury to--
(A) the general population; or
(B) any potentially exposed or susceptible
population that the Administrator has
identified as relevant to the safety assessment
and safety determination for a chemical
substance.
[(12)] (17) The term ``standards for the development of test
data'' means a prescription of--
(A) the--
(i) health and environmental effects, and
(ii) information relating to toxicity,
persistence, and other characteristics which
affect health and the environment,
for which test data for a chemical substance or mixture
are to be developed and any analysis that is to be
performed on such data, and
(B) to the extent necessary to assure that data
respecting such effects and characteristics are
reliable and adequate--
(i) the manner in which such data are to be
developed,
(ii) the specification of any test protocol
or methodology to be employed in the
development of such data, and
(iii) such other requirements as are
necessary to provide such assurance.
[(13)] (18) The term ``State'' means any State of the United
States, the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa,
the Northern Mariana Islands, or any other territory or
possession of the United States.
[(14)] (19) The term ``United States'', when used in the
geographic sense, means all of the States.
SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE.
(a) Definition of Guidance.--In this section, the term
`guidance' includes any significant written guidance of general
applicability prepared by the Administrator.
(b) Deadline.--Not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical Safety for the
21st Century Act, the Administrator shall develop, after
providing public notice and an opportunity for comment, any
policies, procedures, and guidance the Administrator determines
to be necessary to carry out sections 4, 4A, 5, and 6,
including the policies, procedures, and guidance required by
this section.
(c) Use of Science.--
(1) In general.--The Administrator shall establish
policies, procedures, and guidance on the use of
science in making decisions under sections 4, 4A, 5,
and 6.
(2) Goal.--A goal of the policies [and,] procedures ,
and guidance described in paragraph (1) shall be to
make the basis of decisions clear to the public.
(3) Requirements.--The policies, procedures, and
guidance issued under this section shall describe the
manner in which the Administrator shall ensure that --
(A) decisions made by the Administrator--
(i) are based on information,
procedures, measures, methods, and
models employed in a manner consistent
with the best available science;
(ii) take into account the extent to
which--
(I) assumptions and methods
are clearly and completely
described and documented;
(II) variability and
uncertainty are evaluated and
characterized; and
(III) the information has
been subject to independent
verification and peer review;
and
(iii) are based on the weight of the
scientific evidence, by which the
Administrator considers all information
in a systematic and integrative
framework to consider the relevance of
different information;
(B) to the extent practicable and if
appropriate, the use of peer review,
standardized test design and methods,
consistent data evaluation procedures, and good
laboratory practices will be encouraged;
(C) a clear description of each individual
and entity that funded the generation or
assessment of information, and the degree of
control those individuals and entities had over
the generation, assessment, and dissemination
of information (including control over the
design of the work and the publication of
information) is made available; and
(D) if appropriate, the recommendations in
reports of the National Academy of Sciences
that provide advice regarding assessing the
hazards, exposures, and risks of chemical
substances are considered.
(d) Existing EPA Policies, Procedures, and Guidance.--The
policies, procedures, and guidance described in subsection (b)
shall incorporate, as appropriate, existing relevant hazard,
exposure, and risk assessment guidelines and methodologies,
data evaluation and quality criteria, testing methodologies,
and other relevant guidelines and policies of the Environmental
Protection Agency.
(e) Review.--Not later than 5 years after the date of
enactment of [this section] the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, and not less frequently than
once every 5 years thereafter, the Administrator shall--
(1) review the adequacy of any policies, procedures,
and guidance developed under this section, including
animal, nonanimal, and epidemiological test methods and
procedures for assessing and determining risk under
this Act; and
(2) after providing public notice and an opportunity
for comment, revise the policies, procedures, and
guidance if necessary to reflect new scientific
developments or understandings.
``(f) Sources of Information.--In [making any decision with
respect to a chemical substance under section 4, 4A, 5, or]
carrying out sections 4, 4A, 5, and 6, the Administrator shall
take into consideration information relating to [the hazards
and exposures of] a chemical substance ,including hazard and
exposure information, under the conditions of use that is
reasonably available to the Administrator, including
information that is--
(1) submitted to the Administrator pursuant to any
rule, consent agreement, order, or other requirement of
this Act, or on a voluntary basis, including pursuant
to any request made under this Act, by--
(A) manufacturers or processors of a
substance;
(B) the public;
(C) other Federal departments or agencies; or
(D) the Governor of a State or a State agency
with responsibility for protecting health or
the environment;
(2) submitted to a governmental entity in any
jurisdiction pursuant to a governmental requirement
relating to the protection of health or the
environment; or
(3) identified through an active search by the
Administrator of information sources that are publicly
available or otherwise accessible by the Administrator.
(g) Testing of Chemical Substances and Mixtures.--
(1) In general.--The Administrator shall establish
policies and procedures for the testing of chemical
substances or mixtures under section 4.
(2) Goal.--A goal of the policies and procedures
established under paragraph (1) shall be to make the
basis of decisions clear to the public.
(3) Contents.--The policies and procedures
established under paragraph (1) shall--
``(A) address how and when the exposure level
or exposure potential of a chemical substance
would factor into decisions to require new
testing, subject to the condition that the
Administrator shall not interpret the lack of
exposure information as a lack of exposure or
exposure potential;
(B) describe the manner in which the
Administrator will determine that additional
information is necessary to carry out this Act,
including information relating to potentially
exposed or susceptible populations;
(C) require the Administrator to consult with
the Director of the National Institute for
Occupational Safety and Health prior to
prescribing epidemiologic studies of employees;
and
(D)require that prior to making a request or
adopting a requirement for testing using
vertebrate animals, [require] the Administrator
[to] shall take into consideration, as
appropriate and to the extent practicable,
reasonably available--
(i) toxicity information;
(ii) computational toxicology and
bioinformatics;
(iii) high-throughput screening
methods and the prediction models of
those methods; and
(iv) scientifically reliable and
relevant alternatives to tests on
animals that would provide equivalent
information.
(h) Safety Assessments and Safety Determinations.--
(1) Schedule.--
(A) In general.--The Administrator shall
inform the public regarding the schedule for
the completion of each safety assessment and
safety determination as soon as practicable
after designation as a high-priority substance
pursuant to section 4A.
(B) Differing times.--The Administrator may
allot different times for different chemical
substances in the schedules under this
paragraph, subject to the condition that all
schedules shall comply with the deadlines
established under section 6.
(C) Annual plan.--At the beginning of each
calendar year, the Administrator shall identify
the substances subject to safety assessments
and safety determinations to be completed that
year.
(2) Policies and procedures for safety assessments
and safety determinations.--
(A) In general.--The Administrator shall
establish, by rule, policies and procedures
regarding the manner in which the Administrator
shall carry out section 6.
(B) Goal.--A goal of the policies and
procedures under this paragraph shall be to
make the basis of decisions of the
Administrator clear to the public.
(C) Minimum requirements.--At a minimum, the
policies and procedures under this paragraph
shall--
(i) describe--
(I) the manner in which the
Administrator will identify
informational needs and seek
that information from the
public;
(II) the information
(including draft safety
assessments) that may be
submitted by interested
individuals or entities,
including States; and
(III) the criteria by which
that information will be
evaluated;
(ii) require the Administrator--
(I)(aa) to define the scope
of the safety assessment and
safety determination to be
conducted under section 6,
including the hazards,
exposures, conditions of use,
and potentially exposed and
susceptible populations that
the Administrator expects to
consider in a safety
assessment;
(bb) to explain the basis for
the scope of the safety
assessment and safety
determination; and
(cc) to accept comments
regarding the scope of the
safety assessment and safety
determination; and
(II)(aa) to identify the
items described in subclause
(I) that the Administrator has
considered in the final safety
assessment; and
(bb) to explain the basis for
the consideration of those
items;
(iii) describe the manner in which
aggregate exposures, or significant
subsets of exposures, to a chemical
substance under the conditions of use
will be considered, and explain the
basis for that consideration in the
final safety assessment;
(iv) require that each safety
assessment and safety determination
shall include--
(I) a description of the
weight of the scientific
evidence of risk; and
(II) a summary of the
information regarding the
impact on health and the
environment of the chemical
substance that was used to make
the assessment or
determination, including, as
available, mechanistic, animal
toxicity, and epidemiology
studies;
(v) establish a timely and
transparent process for evaluating
whether new information submitted or
obtained after the date of a final
safety assessment or safety
determination warrants reconsideration
of the safety assessment or safety
determination; and
(vi) when relevant information is
provided or otherwise made available to
the Administrator, shall consider the
extent of Federal regulation under
other Federal laws.
(D) Guidance.--
(i) In general.--Not later than 1
year after the date of enactment of the
Frank R. Lautenberg Chemical Safety for
the 21st Century Act, the Administrator
shall develop guidance to assist
interested persons in developing their
own draft safety assessments and other
information for submission to the
Administrator, which may be considered
at the discretion of the Administrator.
(ii) Requirement.--The guidance
shall, at a minimum, address the
quality of the information submitted
and the process to be followed in
developing a draft safety assessment
for consideration by the Administrator.
(i) Publicly Available Information.--Subject to section 14,
the Administrator shall--
(1) make publicly available a nontechnical summary,
and the final version, of each safety assessment and
safety determination;
(2) provide public notice and an opportunity for
comment on each proposed safety assessment and safety
determination; and
(3) make public in a final safety assessment and
safety determination--
(A) the list of studies considered by the
Administrator in carrying out the safety
assessment or safety determination; and
(B) the list of policies, procedures, and
guidance that were followed in carrying out the
safety assessment or safety determination.
(j) Consultation With Science Advisory Committee on
Chemicals.--
(1) Establishment.--Not later than 1 year after the
date of enactment of this section, the Administrator
shall establish an advisory committee, to be known as
the `Science Advisory Committee on Chemicals' (referred
to in this subsection as the `Committee').
(2) Purpose.--The purpose of the Committee shall be
to provide independent advice and expert consultation,
on the request of the Administrator, with respect to
the scientific and technical aspects of issues relating
to the implementation of this title.
(3) Composition.--The Committee shall be composed of
representatives of such science, government, labor,
public health, public interest, animal protection,
industry, and other groups as the Administrator
determines to be advisable, including, at a minimum,
representatives that have specific scientific expertise
in the relationship of chemical exposures to women,
children, and other potentially exposed or susceptible
populations.
(4) Schedule.--The Administrator shall convene the
Committee in accordance with such schedule as the
Administrator determines to be appropriate, but not
less frequently than once every 2 years.
(5) Relationship to other law.--All proceedings and
meetings of the Committee shall be subject to the
Federal Advisory Committee Act (5 U.S.C. App.).
SEC. 4. TESTING OF CHEMICAL SUBSTANCES AND MIXTURES.
[(a) Testing Requirements.--If the Administrator finds that--
[(1)(A)(i) the manufacture, distribution in commerce,
processing, use, or disposal of a chemical substance or
mixture, or that any combination of such activities,
may present an unreasonable risk of injury to health or
the environment,
[(ii) there are insufficient data and experience upon
which the effects of such manufacture, distribution in
commerce, processing, use, or disposal of such
substance or mixture or of any combination of such
activities on health or the environment can reasonably
be determined or predicted, and
[(iii) testing of such substance or mixture with
respect to such effects is necessary to develop such
data; or
[(B)(i) a chemical substance or mixture is or will be
produced in substantial quantities, and (I) it enters
or may reasonably be anticipated to enter the
environment in substantial quantities or (II) there is
or may be significant or substantial human exposure to
such substance or mixture,
[(ii) there are insufficient data and experience upon
which the effects of the manufacture, distribution in
commerce, processing, use, or disposal of such
substance or mixture or of any combination of such
activities on health or the environment can reasonably
be determined or predicted, and
[(iii) testing of such substance or mixture with
respect to such effects is necessary to develop such
data; and
[(2) in the case of a mixture, the effects which the
mixture's manufacture, distribution in commerce,
processing, use, or disposal or any combination of such
activities may have on health or the environment may
not be reasonably and more efficiently determined or
predicted by testing the chemical substances which
comprise the mixture;
the Administrator shall by rule require that testing be
conducted on such substance or mixture to develop data with
respect to the health and environmental effects for which there
is an insufficiency of data and experience and which are
relevant to a determination that the manufacture, distribution
in commerce, processing, use, or disposal of such substance or
mixture, or that any combination of such activities, does or
does not present an unreasonable risk of injury to health or
the environment.
[(b)(1) Testing Requirement Rule.--A rule under subsection
(a) shall include--
[(A) identification of the chemical substance or
mixture for which testing is required under the rule,
[(B) standards for the development of test data for
such substance or mixture, and
[(C) with respect to chemical substances which are
not new chemical substances and to mixtures, a
specification of the period (which period may not be of
unreasonable duration) within which the persons
required to conduct the testing shall submit to the
Administrator data developed in accordance with the
standards referred to in subparagraph (B).
[In determining the standards and period to be included,
pursuant to subparagraphs (B) and (C), in a rule under
subsection (a), the Administrator's considerations shall
include the relative costs of the various test protocols and
methodologies which may be required under the rule and the
reasonably foreseeable availability of the facilities and
personnel needed to perform the testing required under the
rule. Any such rule may require the submission to the
Administrator of preliminary data during the period prescribed
under subparagraph (C).
[(2)(A) The health and environmental effects for which
standards for the development of test data may be prescribed
include carcinogenesis, mutagenesis, teratogenesis, behavioral
disorders, cumulative or synergistic effects, and any other
effect which may present an unreasonable risk of injury to
health or the environment. The characteristics of chemical
substances and mixtures for which such standards may be
prescribed include persistence, acute toxicity, subacute
toxicity, chronic toxicity, and any other characteristic which
may present such a risk. The methodologies that may be
prescribed in such standards include epidemiologic studies,
serial or hierarchical tests, in vitro tests, and whole animal
tests, except that before prescribing epidemiologic studies of
employees, the Administrator shall consult with the Director of
the National Institute for Occupational Safety and Health.
[(B) From time to time, but not less than once each 12
months, the Administrator shall review the adequacy of the
standards for development of data prescribed in rules under
subsection (a) and shall, if necessary, institute proceedings
to make appropriate revisions of such standards.
[(3)(A) A rule under subsection (a) respecting a chemical
substance or mixture shall require the persons described in
subparagraph (B) to conduct tests and submit data to the
Administrator on such substance or mixture, except that the
Administrator may permit two or more of such persons to
designate one such person or a qualified third party to conduct
such tests and submit such data on behalf of the persons making
the designation.
[(B) The following persons shall be required to conduct tests
and submit data on a chemical substance or mixture subject to a
rule under subsection (a):
[(i) Each person who manufactures or intends to
manufacture such substance or mixture if the
Administrator makes a finding described in subsection
(a)(1)(A)(ii) or (a)(1)(B)(ii) with respect to the
manufacture of such substance or mixture.
[(ii) Each person who processes or intends to process
such substance or mixture if the Administrator makes a
finding described in subsection (a)(1)(A)(ii) or
(a)(1)(B)(ii) with respect to the processing of such
substance or mixture.
[(iii) Each person who manufactures or processes or
intends to manufacture or process such substance or
mixture if the Administrator makes a finding described
in subsection (a)(1)(A)(ii) or (a)(1)(B)(ii) with
respect to the distribution in commerce, use, or
disposal of such substance or mixture.
[(4) Any rule under subsection (a) requiring the testing of
and submission of data for a particular chemical substance or
mixture shall expire at the end of the reimbursement period (as
defined in subsection (c)(3)(B)) which is applicable to test
data for such substance or mixture unless the Administrator
repeals the rule before such date; and a rule under subsection
(a) requiring the testing of and submission of data for a
category of chemical substances or mixtures shall expire with
respect to a chemical substance or mixture included in the
category at the end of the reimbursement period (as so defined)
which is applicable to test data for such substance or mixture
unless the Administrator before such date repeals the
application of the rule to such substance or mixture or repeals
the rule.
[(5) Rules issued under subsection (a) (and any substantive
amendment thereto or repeal thereof) shall be promulgated
pursuant to section 553 of title 5, United States Code, except
that (A) the Administrator shall give interested persons an
opportunity for the oral presentation of data, views, or
arguments, in addition to an opportunity to make written
submission; (B) a transcript shall be made of any oral
presentation; and (C) the Administrator shall make and publish
with the rule the findings described in paragraph (1)(A) or
(1)(B) of subsection (a) and, in the case of a rule respecting
a mixture, the finding described in paragraph (2) of such
subsection.
[(c) Exemption.--(1) Any person required by a rule under
subsection (a) to conduct tests and submit data on a chemical
substance or mixture may apply to the Administrator (in such
form and manner as the Administrator shall prescribe) for an
exemption from such requirement.
[(2) If, upon receipt of an application under paragraph (1),
the Administrator determines that--
[(A) the chemical substance or mixture with respect
to which such application was submitted is equivalent
to a chemical substance or mixture for which data has
been submitted to the Administrator in accordance with
a rule under subsection (a) or for which data is being
developed pursuant to such a rule, and
[(B) submission of data by the applicant on such
substance or mixture would be duplicative of data which
has been submitted to the Administrator in accordance
with such rule or which is being developed pursuant to
such rule,
the Administrator shall exempt, in accordance with paragraph
(3) or (4), the applicant from conducting tests and submitting
data on such substance or mixture under the rule with respect
to which such application was submitted.
[(3)(A) If the exemption under paragraph (2) of any person
from the requirement to conduct tests and submit test data on a
chemical substance or mixture is granted on the basis of the
existence of previously submitted test data and if such
exemption is granted during the reimbursement period for such
test data (as prescribed by subparagraph (B)), then (unless
such person and the persons referred to in clauses (i) and (ii)
agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to
provide fair and equitable reimbursement (in an amount
determined under rules of the Administrator)--
[(i) to the person who previously submitted such test
data, for a portion of the costs incurred by such
person in complying with the requirement to submit such
data, and
[(ii) to any other person who has been required under
this subparagraph to contribute with respect to such
costs, for a portion of the amount such person was
required to contribute.
[In promulgating rules for the determination of fair and
equitable reimbursement to the persons described in clauses (i)
and (ii) for costs incurred with respect to a chemical
substance or mixture, the Administrator shall, after
consultation with the Attorney General and the Federal Trade
Commission, consider all relevant factors, including the effect
on the competitive position of the person required to provide
reimbursement in relation to the person to be reimbursed and
the share of the market for such substance or mixture of the
person required to provide reimbursement in relation to the
share of such market of the persons to be reimbursed. An order
under this subparagraph shall, for purposes of judicial review,
be considered final agency action.
[(B) For purposes of subparagraph (A), the reimbursement
period for any test data for a chemical substance or mixture is
a period--
[(i) beginning on the date such data is submitted in
accordance with a rule promulgated under subsection
(a), and
[(ii) ending--
[(I) five years after the date referred to in
clause (i), or
[(II) at the expiration of a period which
begins on the date referred to in clause (i)
and which is equal to the period which the
Administrator determines was necessary to
develop such data,
whichever is later.
[(4)(A) If the exemption under paragraph (2) of any person
from the requirement to conduct tests and submit test data on a
chemical substance or mixture is granted on the basis of the
fact that test data is being developed by one or more persons
pursuant to a rule promulgated under subsection (a), then
(unless such person and the persons referred to in clauses (i)
and (ii) agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to
provide fair and equitable reimbursement (in an amount
determined under rules of the Administrator)--
[(i) to each such person who is developing such test
data, for a portion of the costs incurred by each such
person in complying with such rule, and
[(ii) to any other person who has been required under
this subparagraph to contribute with respect to the
costs of complying with such rule, for a portion of the
amount such person was required to contribute.
[In promulgating rules for the determination of fair and
equitable reimbursement to the persons described in clauses (i)
and (ii) for costs incurred with respect to a chemical
substance or mixture, the Administrator shall, after
consultation with the Attorney General and the Federal Trade
Commission, consider the factors described in the second
sentence of paragraph (3)(A). An order under this subparagraph
shall, for purposes of judicial review, be considered final
agency action.
[(B) If any exemption is granted under paragraph (2) on the
basis of the fact that one or more persons are developing test
data pursuant to a rule promulgated under subsection (a) and if
after such exemption is granted the Administrator determines
that no such person has complied with such rule, the
Administrator shall (i) after providing written notice to the
person who holds such exemption and an opportunity for a
hearing, by order terminate such exemption, and (ii) notify in
writing such person of the requirements of the rule with
respect to which such exemption was granted.
[(d) Notice.--Upon the receipt of any test data pursuant to a
rule under subsection (a), the Administrator shall publish a
notice of the receipt of such data in the Federal Register
within 15 days of its receipt. Subject to section 14, each such
notice shall (1) identify the chemical substance or mixture for
which data have been received; (2) list the uses or intended
uses of such substance or mixture and the information required
by the applicable standards for the development of test data;
and (3) describe the nature of the test data developed. Except
as otherwise provided in section 14, such data shall be made
available by the Administrator for examination by any person.]
(a) Development of New Information on Chemical Substances and
Mixtures.--
(1) In general.--The Administrator may require the
development of new information relating to a chemical
substance or mixture in accordance with this section if
the Administrator determines that the information is
necessary--
(A) to review a notice under section 5(d) or
to perform a safety assessment or safety
determination under section 6;
(B) to implement a requirement imposed in a
consent agreement or order issued under section
5(d)(4) or under a rule promulgated under
section 6(d)(3);
(C) pursuant to section 12(a)(4); or
(D) at the request of the implementing
authority under another Federal law, to meet
the regulatory testing needs of that authority.
(2) Limited testing for prioritization purposes.--
(A) In general.--Except as provided in
subparagraph (B), the Administrator may require
the development of new information for the
purposes of section 4A.
(B) Prohibition.--Testing required under
subparagraph (A) shall not be required for the
purpose of establishing or implementing a
minimum information requirement.
(C) Limitation.--The Administrator may
require the development of new information
pursuant to subparagraph (A) only if the
Administrator determines that additional
information is necessary to establish the
priority of a chemical substance.
(3) Form.--[Subject to section 3A(h),] [t] The
Administrator may require the development of
information described in paragraph (1) or (2) by--
(A) promulgating a rule;
(B) entering into a testing consent
agreement; or
(C) issuing an order.
(4) Contents.--
(A) In general.--A rule, testing consent
agreement, or order issued under this
subsection shall include--
(i) identification of the chemical
substance or mixture for which testing
is required;
(ii) identification of the persons
required to conduct the testing;
(iii) test protocols and
methodologies for the development of
[test data and] information for the
chemical substance or mixture,
including specific reference to any
reliable nonanimal test procedures; and
(iv) specification of the period
within which individuals and entities
required to conduct the testing shall
submit to the Administrator the
information developed in accordance
with the procedures described in clause
(iii).
(B) Considerations.--In determining the
procedures and period to be required under
subparagraph (A), the Administrator shall take
into consideration--
(i) the relative costs of the various
test protocols and methodologies that
may be required; and
(ii) the reasonably foreseeable
availability of facilities and
personnel required to perform the
testing.
(b) Statement of Need.--
(1) In general.--In promulgating a rule, entering
into a testing consent agreement, or issuing an order
for the development of additional information
(including information on exposure or exposure
potential) pursuant to this section, the Administrator
shall--
(A) identify the need intended to be met by
the rule, agreement, or order;
(B) explain why information reasonably
available to the Administrator at that time is
inadequate to meet that need, including a
reference, as appropriate, to the information
identified in paragraph (2)(B); and
(C) explain the basis for any decision that
requires the use of vertebrate animals.
(2) Explanation in case of order.--
(A) In general.--If the Administrator issues
an order under this section, the Administrator
shall issue a statement providing a
justification for why issuance of an order is
warranted instead of promulgating a rule or
entering into a testing consent agreement.
(B) Contents.--A statement described in
subparagraph (A) shall contain a description
of--
(i) information that is readily
accessible to the Administrator,
including information submitted under
any other provision of law;
(ii) the extent to which the
Administrator has obtained or attempted
to obtain the information through
voluntary submissions; and
(iii) any information relied on in
safety assessments for other chemical
substances relevant to the chemical
substances that would be the subject of
the order.
(c) Reduction of Testing on Vertebrates.--
(1) In general.--The Administrator shall minimize, to
the extent practicable, the use of vertebrate animals
in testing of chemical substances or mixtures, by--
(A) encouraging and facilitating--
(i) the use of integrated and tiered
testing and assessment strategies;
(ii) the use of best available
science in existence on the date on
which the test is conducted;
(iii) the use of test methods that
eliminate or reduce the use of animals
while providing information of high
scientific quality;
(iv) the grouping of 2 or more
chemical substances into scientifically
appropriate categories in cases in
which testing of a chemical substance
would provide reliable and useful
information on other chemical
substances in the category;
(v) the formation of industry
consortia to jointly conduct testing to
avoid unnecessary duplication of tests;
and
(vi) the submission of information
from--
(I) animal-based studies; and
(II) emerging methods and
models; and
(B) funding research and validation studies
to reduce, refine, and replace the use of
animal tests in accordance with this
subsection.
(2) Implementation of alternative testing methods.--
To promote the development and timely incorporation of
new testing methods that are not based on vertebrate
animals, the Administrator shall--
(A) not later than 2 years after the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, develop a
strategic plan to promote the development and
implementation of alternative test methods and
testing strategies to generate information
under this title that can reduce, refine, or
replace the use of vertebrate animals,
including toxicity pathway-based risk
assessment, in vitro studies, systems biology,
computational toxicology, bioinformatics, and
high-throughput screening;
(B) as practicable, ensure that the strategic
plan developed under subparagraph (A) is
reflected in the development of requirements
for testing under this section;
(C) identify in the strategic plan developed
under subparagraph (A) particular alternative
test methods or testing strategies that do not
require new vertebrate animal testing and are
scientifically reliable, relevant, and capable
of providing information of equivalent
scientific reliability and quality to that
which would be obtained from vertebrate animal
testing;
(D) provide an opportunity for public notice
and comment on the contents of the plan
developed under subparagraph (A), including the
criteria for considering scientific
reliability, relevance, and equivalent
information and the test methods and strategies
identified in subparagraph (C);
(E) beginning on the date that is 5 years
after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century
Act and every 5 years thereafter, submit to
Congress a report that describes the progress
made in implementing this subsection and goals
for future alternative test methods
implementation;
(F) fund and carry out research, development,
performance assessment, and translational
studies to accelerate the development of test
methods and testing strategies that reduce,
refine, or replace the use of vertebrate
animals in any testing under this title; and
(G) identify synergies with the related
information requirements of other jurisdictions
to minimize the potential for additional or
duplicative testing.
(3) Criteria for adapting or waiving animal testing
requirements.--On request from a manufacturer or
processor that is required to conduct testing of a
chemical substance or mixture on vertebrate animals
under this section, the Administrator may adapt or
waive the requirement, if the Administrator determines
that--
(A) there is sufficient evidence from several
independent sources of information to support a
conclusion that a chemical substance or mixture
has, or does not have, a particular property if
the information from each individual source
alone is insufficient to support the
conclusion;
(B) as a result of 1 or more physical or
chemical properties of the chemical substance
or mixture or other toxicokinetic
considerations--
(i) the substance cannot be absorbed;
or
(ii) testing for a specific endpoint
is technically not practicable to
conduct; or
(C) a chemical substance or mixture cannot be
tested in vertebrate animals at concentrations
that do not result in significant pain or
distress, because of physical or chemical
properties of the chemical substance or
mixture, such as a potential to cause severe
corrosion or severe irritation to the tissues
of the animal.
(4) Voluntary testing.--
(A) In general.--Any person developing
information for submission under this title on
a voluntary basis and not pursuant to any
request or requirement by the Administrator
shall first attempt to develop the information
by means of an alternative or nonanimal test
method or testing strategy that the
Administrator has determined under paragraph
(2)(C) to be scientifically reliable, relevant,
and capable of providing equivalent
information, before conducting new animal
testing.
(B) Effect of paragraph.--Nothing in this
paragraph--
(i) requires the Administrator to
review the basis on which the person is
conducting testing described in
subparagraph (A);
(ii) prohibits the use of other test
methods or testing strategies by any
person for purposes other than
developing information for submission
under this title on a voluntary basis;
or
(iii) prohibits the use of other test
methods or testing strategies by any
person, subsequent to the attempt to
develop information using the test
methods and testing strategies
identified by the Administrator under
paragraph (2)(C).
(d) Testing Requirements.--
(1) In general.--The Administrator may require the
development of information by--
(A) manufacturers and processors of the
chemical substance or mixture; and
(B) subject to paragraph (3), persons that
begin to manufacture or process the chemical
substance or mixture--
(i) after the effective date of the
rule, testing consent agreement, or
order; but
(ii) before the period ending on the
later of--
(I) 5 years after the date
referred to in clause (i); or
(II) the last day of the
period that begins on the date
referred to in clause (i) and
that is equal to the period
that the Administrator
determines was necessary to
develop the information.
(2) Designation.--The Administrator may permit 2 or
more persons identified in subparagraph (A) or (B) of
paragraph (1) to designate 1 of the persons or a
qualified third party--
(A) to develop the information; and
(B) to submit the information on behalf of
the persons making the designation.
(3) Exemptions.--
(A) In general.--A person otherwise subject
to a rule, testing consent agreement, or order
under this section may submit to the
Administrator an application for an exemption
on the basis that the information is being
developed by a person designated under
paragraph (2).
(B) Fair and equitable reimbursement to
designee.--
(i) In general.--If the Administrator
accepts an application submitted under
subparagraph (A), the Administrator
shall direct the applicant to provide
to the person designated under
paragraph (2) fair and equitable
reimbursement, as agreed to between the
applicant and the designee.
(ii) Arbitration.--If the applicant
and a person designated under paragraph
(2) cannot reach agreement on the
amount of fair and equitable
reimbursement, the amount shall be
determined by arbitration.
(C) Termination.--If, after granting an
exemption under this paragraph, the
Administrator determines that [a] no person
[covered by the exemption has failed to comply]
designated under paragraph (2) has complied
with the rule, testing consent agreement, or
order, the Administrator shall--
(i) by order, terminate the
exemption; and
(ii) notify in writing each person
that received an exemption of the
requirements with respect to which the
exemption was granted.
(4) Tiered testing.--
(A) In general.--Except as provided in
subparagraph (D), the Administrator shall
employ a tiered screening and testing process,
under which the results of screening-level
tests or assessments of available information
inform the decision as to whether 1 or more
additional tests are necessary.
(B) Screening-level tests.--
(i) In general.--The screening-level
tests required for a chemical substance
or mixture may include tests for hazard
(which may include in silico, in vitro,
and in vivo tests), environmental and
biological fate and transport, and
measurements or modeling of exposure or
exposure potential, as appropriate.
(ii) Use.--Screening-level tests
shall be used--
(I) to screen chemical
substances or mixtures for
potential adverse effects; and
(II) to inform a decision of
the Administrator regarding
whether more complex or
targeted additional testing is
necessary.
(C) Additional testing.--If the Administrator
determines under subparagraph (B) that
additional testing is necessary to provide more
definitive information for safety assessments
or safety determinations, the Administrator may
require more advanced tests for potential
health or environmental effects or exposure
potential.
(D) Advanced testing without screening.--The
Administrator may require more advanced testing
without conducting screening-level testing when
other information available to the
Administrator justifies the advanced testing,
pursuant to guidance developed by the
Administrator under this section.
(e) Transparency.--Subject to section 14, the Administrator
shall make available to the public all testing consent
agreements and orders and all information submitted under this
section.
[(e)] (f) Priority List.--(1)(A) There is established a
committee to make recommendations to the Administrator
respecting the chemical substances and mixtures to which the
Administrator should give priority consideration for the
promulgation of a [rule] rule, testing consent agreement, or
order [under subsection (a)] under this subsection. In making
such a recommendation with respect to any chemical substance or
mixture, the committee shall consider all relevant factors,
including--
(i) the quantities in which the substance or mixture
is or will be manufactured,
(ii) the quantities in which the substance or mixture
enters or will enter the environment,
(iii) the number of individuals who are or will be
exposed to the substance or mixture in their places of
employment and the duration of such exposure,
(iv) the extent to which human beings are or will be
exposed to the substance or mixture,
(v) the extent to which the substance or mixture is
closely related to a chemical substance or mixture
which is known to present an unreasonable risk of
injury to health or the environment , without taking
into account cost or other nonrisk factors,
(vi) the existence of data concerning the effects of
the substance or mixture on health or the environment,
(vii) the extent to which testing of the substance or
mixture may result in the development of data upon
which the effects of the substance or mixture on health
or the environment can reasonably be determined or
predicted, and
(viii) the reasonably foreseeable availability of
facilities and personnel for performing testing on the
substance or mixture.
The recommendations of the committee shall be in the form of a
list of chemical substances and mixtures which shall be set
forth, either by individual substance or mixture or by groups
of substances or mixtures, in the order in which the committee
determines the Administrator should take action [under
subsection (a)] under this subsection with respect to the
substances and mixtures. In establishing such list, the
committee shall give priority attention to those chemical
substances and mixtures which are known to cause or contribute
to or which are suspected of causing or contributing to cancer,
gene mutations, or birth defects. The committee shall designate
chemical substances and mixtures on the list with respect to
which the committee determines the Administrator should, within
12 months of the date on which such substances and mixtures are
first designated, initiate a proceeding [under subsection (a)]
under this subsection. The total number of chemical substances
and mixtures on the list which are designated under the
preceding sentence may not, at any time, exceed 50.
(B) As soon as practicable but not later than nine months
after the effective date of this Act, the committee shall
publish in the Federal Register and transmit to the
Administrator the list and designations required by
subparagraph (A) together with the reasons for the committee's
inclusion of each chemical substance or mixture on the list. At
least every six months after the date of the transmission to
the Administrator of the list pursuant to the preceeding\3\
sentence, the committee shall make such revisions in the list
as it determines to be necessary and shall transmit them to the
Administrator together with the committee's reasons for the
revisions. Upon receipt of any such revision, the Administrator
shall publish in the Federal Register the list with such
revision, the reasons for such revision, and the designations
made under subparagraph (A). The Administrator shall provide
reasonable opportunity to any interested person to file with
the Administrator written comments on the committee's list, any
revision of such list by the committee, and designations made
by the committee, and shall make such comments available to the
public. Within the 12-month period beginning on the date of the
first inclusion on the list of a chemical substance or mixture
designated by the committee under subparagraph (A) the
Administrator shall with respect to such chemical substance or
mixture either initiate a [rulemaking] proceeding [under
subsection (a)] under this subsection or if such a proceeding
is not initiated within such period, publish in the Federal
Register the Administrator's reason for not initiating such a
proceeding.
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\3\So in law. Probably should be ``preceding''.
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(2)(A) The committee established by paragraph (1)(A) shall
consist of eight members as follows:
(i) One member appointed by the Administrator from
the Environmental Protection Agency.
(ii) One member appointed by the Secretary of Labor
from officers or employees of the Department of Labor
engaged in the Secretary's activities under the
Occupational Safety and Health Act of 1970.
(iii) One member appointed by the Chairman of the
Council on Environmental Quality from the Council or
its officers or employees.
(iv) One member appointed by the Director of the
National Institute for Occupational Safety and Health
from officers or employees of the Institute.
(v) One member appointed by the Director of the
National Institute of Environmental Health Sciences
from officers or employees of the Institute.
(vi) One member appointed by the Director of the
National Cancer Institute from officers or employees of
the Institute.
(vii) One member appointed by the Director of the
National Science Foundation from officers or employees
of the Foundation.
(viii) One member appointed by the Secretary of
Commerce from officers or employees of the Department
of Commerce.
(B)(i) An appointed member may designate an individual to
serve on the committee on the member's behalf. Such a
designation may be made only with the approval of the
applicable appointing authority and only if the individual is
from the entity from which the member was appointed.
(ii) No individual may serve as a member of the committee for
more than four years in the aggregate. If any member of the
committee leaves the entity from which the member was
appointed, such member may not continue as a member of the
committee, and the member's position shall be considered to be
vacant. A vacancy in the committee shall be filled in the same
manner in which the original appointment was made.
(iii) Initial appointments to the committee shall be made not
later than the 60th day after the effective date of this Act.
Not later than the 90th day after such date the members of the
committee shall hold a meeting for the selection of a
chairperson from among their number.
(C)(i) No member of the committee, or designee of such
member, shall accept employment or compensation from any person
subject to any requirement of this Act or of any [rule] rule,
testing consent agreement, or order promulgated or order issued
thereunder, for a period of at least 12 months after
termination of service on the committee.
(ii) No person, while serving as a member of the committee,
or designee of such member, may own any stocks or bonds, or
have any pecuniary interest, of substantial value in any person
engaged in the manufacture, processing, or distribution in
commerce of any chemical substance or mixture subject to any
requirement of this Act or of any [rule] rule, testing consent
agreement, or order promulgated or order issued thereunder.
(iii) The Administrator, acting through attorneys of the
Environmental Protection Agency, or the Attorney General may
bring an action in the appropriate district court of the United
States to restrain any violation of this subparagraph.
(D) The Administrator shall provide the committee such
administrative support services as may be necessary to enable
the committee to carry out its function under this subsection.
[(f)] (g) Required Actions.--Upon the receipt of--
(1) any test data required to be submitted under this
Act, or
(2) any other information available to the
Administrator,
which indicates to the Administrator that there may be a
reasonable basis to conclude that a chemical substance or
mixture presents or will present a significant risk of serious
or widespread harm to human beings [from cancer, gene
mutations, or birth defects], the Administrator shall, within
the 180-day period beginning on the date of the receipt of such
data or information, initiate appropriate action under section
5, 6, or 7 to prevent or reduce to a sufficient extent such
risk or publish in the Federal Register a finding that such
risk is not unreasonable , without taking into account cost or
other nonrisk factors. For good cause shown the Administrator
may extend such period for an additional period of not more
than 90 days. The Administrator shall publish in the Federal
Register notice of any such extension and the reasons therefor.
A finding by the Administrator that a risk is not unreasonable
shall be considered agency action for purposes of judicial
review under chapter 7 of title 5, United States Code. [This
subsection shall not take effect until two years after the
effective date of this Act.]
[(g) Petition for Standards for the Development of Test
Data.--A person intending to manufacture or process a chemical
substance for which notice is required under section 5(a) and
who is not required under a rule under subsection (a) to
conduct tests and submit data on such substance may petition
the Administrator to prescribe standards for the development of
test data for such substance. The Administrator shall by order
either grant or deny any such petition within 60 days of its
receipt. If the petition is granted, the Administrator shall
prescribe such standards for such substance within 75 days of
the date the petition is granted. If the petition is denied,
the Administrator shall publish, subject to section 14, in the
Federal Register the reasons for such denial.]
SEC. 4A. PRIORITIZATION SCREENING.
(a) [Establishment and List of Substances].Prioritization
Screening Process--
(1) In general.--Not later than 1 year after the date
of enactment of this section, the Administrator shall
establish, by rule, a risk-based screening process and
explicit criteria for identifying existing chemical
substances that are--
(A) a high priority for a safety assessment
and safety determination under section 6
(referred to in this Act as `high-priority
substances'); and
(B) a low priority for a safety assessment
and safety determination (referred to in this
Act as `low-priority substances').
(2) Initial list of high- and low-priority
substances.--
(A) In general.--Before the date of
promulgation of the rule under paragraph (1)
and not later than 180 days after the date of
enactment of this section, the Administrator--
(i) shall take into consideration and
publish an initial list of high-
priority substances and low-priority
substances; and
(ii) pursuant to section 6(b), may
initiate or continue safety assessments
and safety determinations for those
high-priority substances.
(B) Requirements.--
(i) In general.--The initial list of
chemical substances shall contain at
least 10 high-priority substances, at
least 5 of which are drawn from the
list of chemical substances identified
by the Administrator in the October
2014 TSCA Work Plan and subsequent
updates, and at least 10 low-priority
substances.
(ii) Subsequently identified
substances.--Insofar as possible, at
least 50 percent of all substances
subsequently identified by the
Administrator as high-priority
substances shall be drawn from the list
of chemical substances identified by
the Administrator in the October 2014
TSCA Work Plan and subsequent updates,
until all Work Plan chemicals have been
designated under this subsection.
(iii) Persistence and
bioaccumulation.--In developing the
initial list and in identifying
additional high-priority substances,
the Administrator shall give preference
to chemical substances scored as high
for persistence and bioaccumulation in
the October 2014 TSCA Work Plan and
subsequent updates.
(C) Additional chemical reviews.--The
Administrator shall, as soon as practicable and
not later than--
(i) 3 years after the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act, add additional high-priority
substances sufficient to ensure that at
least a total of 20 high-priority
substances have undergone or are
undergoing the process established in
section 6(a), and additional low-
priority substances sufficient to
ensure that at least a total of 20 low-
priority substances have been
designated; and
(ii) 5 years after the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act, add additional high-priority
substances sufficient to ensure that at
least a total of 25 high-priority
substances have undergone or are
undergoing the process established in
section 6(a), and additional low-
priority substances sufficient to
ensure that at least a total of 25 low-
priority substances have been
designated.
(3) Implementation.--
(A) Consideration of active and inactive
substances.--
(i) Active substances.--In carrying
out paragraph (1), the Administrator
shall take into consideration active
substances, as determined under section
8, which may include chemical
substances on the interim list of
active substances established under
that section.
(ii) Inactive substances.--In
carrying out paragraph (1), the
Administrator may take into
consideration inactive substances, as
determined under section 8, that the
Administrator determines--
(I)(aa) have not been subject
to a regulatory or other
enforceable action by the
Administrator to ban or phase
out the substances; and
(bb) have the potential for
high hazard and widespread
exposure; or
(II)(aa) have been subject to
a regulatory or other
enforceable action by the
Administrator to ban or phase
out the substances; and
(bb) with respect to which
there exists the potential for
residual high hazards or
widespread exposures not
otherwise addressed by the
regulatory or other action.
(iii) Repopulation.--
(I) In general.--On the
completion of a safety
determination under section 6
for a chemical substance, the
Administrator shall remove the
chemical substance from the
list of high-priority
substances established under
this subsection.
(II) Additions.--The
Administrator shall add at
least 1 chemical substance to
the list of high-priority
substances for each chemical
substance removed from the list
of high-priority substances
established under this
subsection, until a safety
assessment and safety
determination is completed for
all high-priority substances.
(III) Low-priority
substances.--If a low-priority
substance is subsequently
designated as a high-priority
substance, the Administrator
shall remove that substance
from the list of low-priority
substances.
(B) Timely completion of prioritization
screening process.--
(i) In general.--The Administrator
shall--
(I) exept as provided under
paragraph (2),not later than
180 days after the effective
date of the final rule under
paragraph (1), begin the
prioritization screening
process; and
(II) make every effort to
complete the designation of all
active substances as high-
priority substances or low-
priority substances in a timely
manner.
(ii) Decisions on substances subject
to testing for prioritization
purposes.--Not later than 90 days after
the date of receipt of information
regarding a chemical substance
complying with a rule, testing consent
agreement, or order issued under
section 4(a)(2), the Administrator
shall designate the chemical substance
as a high-priority substance or low-
priority substance.
(iii) Consideration.--
(I) In general.--The
Administrator shall screen
substances and designate high-
priority substances taking into
consideration the ability of
the Administrator to schedule
and complete safety assessments
and safety determinations under
section 6 in a timely manner.
(II) Annual goal.--The
Administrator shall publish an
annual goal for the number of
chemical substances to be
subject to the prioritization
screening process.
(C) Screening of categories of substances.--
The Administrator may screen categories of
chemical substances to ensure an efficient
prioritization screening process to allow for
timely and adequate designations of high-
priority substances and low-priority substances
and safety assessments and safety
determinations for high-priority substances.
(D) Publication of list of chemical
substances.--The Administrator shall keep
current and publish a list of chemical
substances that--
(i) are being considered in the
prioritization screening process and
the status of the chemical substances
in the prioritization process,
including those chemical substances for
which prioritization decisions have
been deferred; and
(ii) are designated as high-priority
substances or low-priority substances,
including the bases for such
designations.
(4) Criteria.--The criteria described in paragraph
(1) shall account for--
(A) the recommendation of the Governor of a
State or a State agency with responsibility for
protecting health or the environment from
chemical substances appropriate for
prioritization screening;
(B) the hazard and exposure potential of the
chemical substance (or category of substances),
including persistence, bioaccumulation, and
specific scientific classifications and
designations by authoritative governmental
entities;
(C) the conditions of use or significant
changes in the conditions of use of the
chemical substance;
(D) evidence and indicators of exposure
potential to humans or the environment from the
chemical substance, including potentially
exposed or susceptible populations;
(E) the volume of a chemical substance
manufactured or processed;
(F) whether the volume of a chemical
substance as reported under a rule promulgated
pursuant to section 8(a) has significantly
increased or decreased during the period
beginning on the date of a previous report or
the date on which a notice has been submitted
under section 5(b) for that chemical substance;
(G) the availability of information regarding
potential hazards and exposures required for
conducting a safety assessment or safety
determination, with limited availability of
relevant information to be a sufficient basis
for designating a chemical substance as a high-
priority substance, subject to the condition
that limited availability shall not require
designation as a high-priority substance; and
(H) the extent of Federal or State regulation
of the chemical substance or the extent of the
impact of State regulation of the chemical
substance on the United States, with existing
Federal or State regulation of any uses
evaluated in the prioritization screening
process as a factor in designating a chemical
substance to be a high-priority or a low-
priority substance.
(b) Prioritization Screening Process and Decisions.--
(1) In general.--The prioritization screening process
developed under subsection (a) shall include a
requirement that the Administrator shall--
(A) identify the chemical substances being
considered for prioritization;
(B) request interested persons to supply
information regarding the chemical substances
being considered;
(C) apply the criteria identified in
subsection (a)(4); and
(D) subject to paragraph (5) and using the
information available to the Administrator at
the time of the decision, identify a chemical
substance as a high-priority substance or a
low-priority substance.
(2) Integration of information.--The prioritization
screening decision regarding a chemical substance shall
integrate any hazard and exposure information relating
to the chemical substance that is available to the
Administrator.
(3) Identification of high-priority substances.--The
Administrator--
(A) shall identify as a high-priority
substance a chemical substance that, relative
to other active chemical substances, the
Administrator determines has the potential for
significant hazard and significant exposure;
(B) may identify as a high-priority substance
a chemical substance that, relative to other
active chemical substances, the Administrator
determines has the potential for significant
hazard or significant exposure; and
(C) may identify as a high-priority substance
an inactive substance, as determined under
subsection (a)(3)(A)(ii) and section 8(b), that
the Administrator determines warrants a safety
assessment and safety determination under
section 6.
(4) Identification of low-priority substances.--The
Administrator shall identify as a low-priority
substance a chemical substance that the Administrator
concludes has information sufficient to establish that
the chemical substance is likely to meet the safety
standard.
(5) Deferring a decision.--If the Administrator
determines that additional information is required to
establish the priority of a chemical substance under
this section, the Administrator may defer the
prioritization screening decision for a reasonable
period--
(A) to allow for the submission of additional
information by an interested person and for the
Administrator to evaluate the additional
information; or
(B) to require the development of information
pursuant to a rule, testing consent agreement,
or order issued under section 4(a)(2).
(6) Deadlines for submission of information.--If the
Administrator requests the development or submission of
information under this section, the Administrator shall
establish a deadline for submission of the information.
(7) Notice and comment.--The Administrator shall--
(A) publish, including in the Federal
Register, the proposed decisions made under
paragraphs (3), (4), and (5) and the basis for
the decisions; and
(B) provide 90 days for public comment.
(8) Revisions of prior designations.--
(A) In general.--At any time, and at the
discretion of the Administrator, the
Administrator may revise the designation of a
chemical substance as a high-priority substance
or a low-priority substance based on
information available to the Administrator
after the date of the determination under
paragraph (3) or (4).
(B) Limited availability.--If limited
availability of relevant information was a
basis in the designation of a chemical
substance as a high-priority substance, the
Administrator shall reevaluate the
prioritization screening of the chemical
substance on receiving the relevant
information.
(9) Other information relevant to prioritization.--
(A) In general.--If, after the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, a State
proposes an administrative action or enacts a
statute or takes an administrative action to
prohibit or otherwise restrict the
manufacturing, processing, distribution in
commerce, or use of a chemical substance that
the Administrator has not [as] designated as a
high-priority substance, the Governor or State
agency with responsibility for implementing the
statute or administrative action shall notify
the Administrator.
(B) Requests for information.--Following
receipt of a notification provided under
subparagraph (A), the Administrator may request
any available information from the Governor or
the State agency with respect to--
(i) scientific evidence related to
the hazards, exposures and risks of the
chemical substance under the conditions
of use which the statute or
administrative action is intended to
address;
(ii) any State or local conditions
which warranted the statute or
administrative action;
(iii) the statutory or administrative
authority on which the action is based;
and
(iv) any other available information
relevant to the prohibition or other
restriction, including information on
any alternatives considered and their
hazards, exposures, and risks.
(C) Prioritization screening.--The
Administrator shall conduct a prioritization
screening under this subsection for all
substances that--
(i) are the subject of notifications
received under subparagraph (A); and
(ii) the Administrator determines--
(I) are likely to have
significant health or
environmental impacts;
(II) are likely to have
significant impact on
interstate commerce; or
(III) have been subject to a
prohibition or other
restriction under a statute or
administrative action in 2 or
more States.
(D) Availability to public.--Subject to
section 14 and any applicable State law
regarding the protection of confidential
information provided to the State or to the
Administrator, the Administrator shall make
information received from a Governor or State
agency under subparagraph (A) publicly
available.
(E) Effect of paragraph.--Nothing in this
paragraph shall preempt a State statute or
administrative action, require approval of a
State statute or administrative action, or
apply section 15 to a State.
(10) Review.--Not less frequently than once every 5
years after the date on which the process under this
subsection is established, the Administrator shall--
(A) review the process on the basis of
experience and taking into consideration
resources available to efficiently and
effectively screen and prioritize chemical
substances; and
(B) if necessary, modify the prioritization
screening process.
(11) Effect.--Subject to section 18, a designation by
the Administrator under this section with respect to a
chemical substance shall not affect--
(A) the manufacture, processing, distribution
in commerce, use, or disposal of the chemical
substance; or
(B) the regulation of those activities.
(c) Additional Priorities for Safety Assessments and
Determinations.--
(1) Requirements.--
(A) In general.--The prioritization screening
process developed under subsection (a) shall--
(i) include a process by which a
manufacturer or processor of an active
chemical substance that has not been
designated a high-priority substance or
is not in the process of a
prioritization screening by the
Administrator, may request that the
Administrator designate the substance
as an additional priority for a safety
assessment and safety determination,
subject to the payment of fees pursuant
to section 26(b)(3)(E);
(ii) specify the information to be
provided in such requests; and
(iii) specify the criteria the
Administrator shall use to determine
whether or not to grant such a request,
which shall include whether the
substance is subject to restrictions
imposed by statutes enacted or
administrative actions taken by 1 or
more States on the manufacture,
processing, distribution in commerce,
or use of the substance.
(B) Preference.--Subject to paragraph (2), in
deciding whether to grant requests under this
subsection the Administrator shall give a
preference to requests concerning substances
for which the Administrator determines that
restrictions imposed by 1 or more States have
the potential to have a significant impact on
interstate commerce or health or the
environment.
(C) [Exceptions.--Requests] Exceptions.--
Chemical substances for which requests have
been granted under this subsection shall not be
subject to subsection (a)(3)(A)(iii) or section
18(b).
(2) Limitations.--In considering whether to grant a
request submitted under paragraph (1), the
Administrator shall ensure that--
(A) if a sufficient number of additional
priority requests meet the requirements of
paragraph (1), not less than 25 percent, or
more than 30 percent, of the cumulative number
of substances designated to undergo safety
assessments and safety determinations under
[this section] subsections (a)(2) and (b)(3)
are substances designated under the process and
criteria pursuant to paragraph (1);
(B) the resources allocated to conducting
safety assessments and safety determinations
for additional priorities designated under this
subsection are proportionate to the number of
such substances relative to the total number of
substances designated to undergo safety
assessments and safety determinations under
this section; and
(C) the number of additional priority
requests stipulated under subparagraph (A) is
in addition to the total number of high-
priority [chemicals] substances identified
under [subsection (a)(2)(B)] subsections (a)(2)
and (b)(3).
(3) Additional review of work plan chemicals for
safety assessment and safety determination.--In the
case of a request under paragraph (1) with respect to a
chemical substance identified by the Administrator in
the October 2014 Work Plan--
(A) the 30-percent cap specified in paragraph
(2)(A) shall not apply and the addition of Work
Plan chemicals shall be at the discretion of
the Administrator; and
(B) notwithstanding paragraph [(6)] (1)(C),,
requests for additional Work Plan chemicals
under this subsection shall be considered high-
priority chemicals subject to section 18(b) but
not subsection (a)(3)(A)(iii).
(4) Requirements.--
(A) In general.--The public shall be provided
notice and an opportunity to comment on
requests submitted under this subsection.
(B) Decision by administrator.--Not later
than 180 days after the date on which the
Administrator receives a request under this
subsection, the Administrator shall decide
whether or not to grant the request.
(C) Assessment and determination.--If the
Administrator grants a request under this
subsection, the safety assessment and safety
determination--
(i) shall be conducted in accordance
with the deadlines and other
requirements of sections 3A(i) and 6;
and
(ii) shall not be expedited or
otherwise subject to special treatment
relative to high-priority substances
designated pursuant to subsection
(b)(3) that are undergoing safety
assessments and safety determinations.
[SEC. 5. MANUFACTURING AND PROCESSING NOTICES.]
SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.
[(i)] (a) Definition.--For purposes of this section, the
terms ``manufacture'' and ``process'' mean manufacturing or
processing for commercial purposes.
[(a)] (b) [In General] Notices.--(1) Except as provided in
[subsection (h)] paragraph (3) and subsection (h), no person
may--
(A) manufacture a new chemical substance on or after
the 30th day after the date on which the Administrator
first publishes the list required by section 8(b), or
(B) manufacture or process any chemical substance for
a use which the Administrator has determined, in
accordance with paragraph (2), is a significant new
use,
unless such person submits to the Administrator, at least 90
days before such manufacture or processing, a notice, in
accordance with [subsection (d)] subsection (c), of such
person's intention to manufacture or process such substance
[and such person complies with any applicable requirement of
subsection (b)].
(2) A determination by the Administrator that a use of a
chemical substance is a significant new use with respect to
which notification is required under paragraph (1) shall be
made by a rule promulgated after a consideration of all
relevant factors, including--
(A) the projected volume of manufacturing and
processing of a chemical substance,
(B) the extent to which a use changes the type or
form of exposure of human beings or the environment to
a chemical substance,
(C) the extent to which a use increases the magnitude
and duration of exposure of human beings or the
environment to a chemical substance, and
(D) the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce,
and disposal of a chemical substance.
(3) Article consideration.--The Administrator may
require the notification for the import or processing
of a chemical substance as part of an article or
category of articles under paragraph (1)(B) if the
Administrator makes an affirmative finding in a rule
under paragraph (2) that the reasonable potential for
exposure to the chemical substance through the article
or category of articles subject to the rule warrants
notification.;
[(d)] (c) Content of Notice; Publications in the Federal
Register.--[(1) The notice required by subsection (a)
subsection (b) shall include--
[(A) insofar as known to the person submitting the
notice or insofar as reasonably ascertainable, the
information described in subparagraphs (A), (B), (C),
(D), (F), and (G) of section 8(a)(2), and
[(B) in such form and manner as the Administrator may
prescribe, any test data in the possession or control
of the person giving such notice which are related to
the effect of any manufacture, processing, distribution
in commerce, use, or disposal of such substance or any
article containing such substance, or of any
combination of such activities, on health or the
environment, and
[(C) a description of any other data concerning the
environmental and health effects of such substance,
insofar as known to the person making the notice or
insofar as reasonably ascertainable.
Such a notice shall be made available, subject to section 14,
for examination by interested persons.]
(1) In general.--The notice required by subsection
(b) shall include, with respect to a chemical
substance--
(A) the information required by sections
720.45 and 720.50 of title 40, Code of Federal
Regulations (or successor regulations); and
(B) information regarding conditions of use
and reasonably anticipated exposures.
(2) Subject to section 14, not later than five days
(excluding Saturdays, Sundays and legal holidays) after the
date of the receipt of a notice under [subsection (a)]
subsection (b) [or of data under subsection (b)], the
Administrator shall publish in the Federal Register a notice
which--
(A) identifies the chemical substance for which
notice or data has been received;and
(B) lists the uses or intended uses of such
substance[; and] .
[(C) in the case of the receipt of data under
subsection (b), describes the nature of the tests
performed on such substance and any data which was
developed pursuant to subsection (b) or a rule under
section 4.
A notice under this paragraph respecting a chemical substance
shall identify the chemical substance by generic class unless
the Administrator determines that more specific identification
is required in the public interest.]
(3) At the beginning of each month the Administrator shall
publish a list in the Federal Register of (A) each chemical
substance for which notice has been received under [subsection
(a) and for which the notification period prescribed by
subsection (a), (b), or (c)] subsection (b) and for which the
notification period prescribed by subsection (b) or (d) has not
expired, and (B) each chemical substance for which such
notification period has expired since the last publication in
the Federal Register of such list.
[(b) Submission of Test Data.--(1)(A) If (i) a person is
required by subsection (a)(1) to submit a notice to the
Administrator before beginning the manufacture or processing of
a chemical substance, and (ii) such person is required to
submit test data for such substance pursuant to a rule
promulgated under section 4 before the submission of such
notice, such person shall submit to the Administrator such data
in accordance with such rule at the time notice is submitted in
accordance with subsection (a)(1).
[(B) If--
[(i) a person is required by subsection (a)(1) to
submit a notice to the Administrator, and
[(ii) such person has been granted an exemption under
section 4(c) from the requirements of a rule
promulgated under section 4 before the submission of
such notice,
such person may not, before the expiration of the 90-day period
which begins on the date of the submission in accordance with
such rule of the test data the submission or development of
which was the basis for the exemption, manufacture such
substance if such person is subject to subsection (a)(1)(A) or
manufacture or process such substance for a significant new use
if the person is subject to subsection (a)(1)(B).
[(2)(A) If a person--
[(i) is required by subsection (a)(1) to submit a
notice to the Administrator before beginning the
manufacture or processing of a chemical substance
listed under paragraph (4), and
[(ii) is not required by a rule promulgated under
section 4 before the submission of such notice to
submit test data for such substance,
such person shall submit to the Administrator data prescribed
by subparagraph (B) at the time notice is submitted in
accordance with subsection (a)(1).
[(B) Data submitted pursuant to subparagraph (A) shall be
data which the person submitting the data believes show that--
[(i) in the case of a substance with respect to which
notice is required under subsection (a)(1)(A), the
manufacture, processing, distribution in commerce, use,
and disposal of the chemical substance or any
combination of such activities will not present an
unreasonable risk of injury to health or the
environment, or
[(ii) in the case of a chemical substance with
respect to which notice is required under subsection
(a)(1)(B), the intended significant new use of the
chemical substance will not present an unreasonable
risk of injury to health or the environment.
[(3) Data submitted under paragraph (1) or (2) shall be made
available, subject to section 14, for examination by interested
persons.
[(4)(A)(i) The Administrator may, by rule, compile and keep
current a list of chemical substances with respect to which the
Administrator finds that the manufacture, processing,
distribution in commerce, use, or disposal, or any combination
of such activities, presents or may present an unreasonable
risk of injury to health or the environment.
[(ii) In making a finding under clause (i) that the
manufacture, processing, distribution in commerce, use, or
disposal of a chemical substance or any combination of such
activities presents or may present an unreasonable risk of
injury to health or the environment, the Administrator shall
consider all relevant factors, including--
[(I) the effects of the chemical substance on health
and the magnitude of human exposure to such substance;
and
[(II) the effects of the chemical substance on the
environment and the magnitude of environmental exposure
to such substance.
[(B) The Administrator shall, in prescribing a rule under
subparagraph (A) which lists any chemical substance, identify
those uses, if any, which the Administrator determines, by rule
under subsection (a)(2), would constitute a significant new use
of such substance.
[(C) Any rule under subparagraph (A), and any substantive
amendment or repeal of such a rule, shall be promulgated
pursuant to the procedures specified in section 553 of title 5,
United States Code, except that (i) the Administrator shall
give interested persons an opportunity for the oral
presentation of data, views, or arguments, in addition to an
opportunity to make written submissions, (ii) a transcript
shall be kept of any oral presentation, and (iii) the
Administrator shall make and publish with the rule the finding
described in subparagraph (A)]
[(c)] (d) Extension of Notice Period.--The Administrator may
for good cause extend for additional periods (not to exceed in
the aggregate 90 days) the period, prescribed by subsection (a)
or (b) before which the manufacturing or processing of a
chemical substance subject to such subsection may begin.
Subject to section 14, such an extension and the reasons
therefor shall be published in the Federal Register and shall
constitute a final agency action subject to judicial review.]
(d) Review of Notice.--
(1) Initial review.--
(A) In general.--Subject to subparagraph (B),
not later than 90 days after the date of
receipt of a notice submitted under subsection
(b), the Administrator shall--
(i) conduct an initial review of the
notice;
(ii) as needed, develop a profile of
the relevant chemical substance and the
potential for exposure to humans and
the environment; and
(iii) make any necessary
determination under paragraph (3).
(B) Extension.--Except as provided in
paragraph (5), the Administrator may extend the
period described in subparagraph (A) for good
cause for 1 or more periods, the total of which
shall be not more than 90 days.
(2) Information sources.--In evaluating a notice
under paragraph (1), the Administrator shall take into
consideration--
(A) any relevant information identified in
subsection (c)(1); and
(B) any other relevant additional information
available to the Administrator.
(3) Determinations.--Before the end of the applicable
period for review under paragraph (1), based on the
information described in paragraph (2), and subject to
section 18(g), the Administrator shall determine that--
(A) the relevant chemical substance or
significant new use is not likely to meet the
safety standard, in which case the
Administrator shall take appropriate action
under paragraph (4);
(B) the relevant chemical substance or
significant new use is likely to meet the
safety standard, in which case the
Administrator shall allow the review period to
expire without additional restrictions; or
(C) additional information is necessary in
order to make a determination under
subparagraph (A) or (B), in which case the
Administrator shall take appropriate action
under [paragraph] paragraphs (4) and (5).
(4) Restrictions.--
(A) Determination by administrator.--
(i) In general.--If the Administrator
makes a determination under
subparagraph (A) or (C) of paragraph
(3) with respect to a notice submitted
under subsection (b)--
(I) the Administrator, before
the end of the applicable
period for review under
paragraph (1) and by consent
agreement or order, as
appropriate, shall prohibit or
otherwise restrict the
manufacture, processing, use,
distribution in commerce, or
disposal (as applicable) of the
chemical substance, or of the
chemical substance for a
significant new use, without
compliance with the
restrictions specified in the
consent agreement or order that
the Administrator determines
are sufficient to ensure that
the chemical substance or
significant new use is likely
to meet the safety standard;
and
(II) no person may commence
manufacture of the chemical
substance, or manufacture or
processing of the chemical
substance for a significant new
use, except in compliance with
the restrictions specified in
the consent agreement or order.
(ii) Likely to meet standard.--If the
Administrator makes a determination
under subparagraph (B) of paragraph (3)
with respect to a chemical substance or
significant new use for which a notice
was submitted under subsection (b), at
the end of the applicable period for
review under paragraph (1), the
submitter of the notice may commence
manufacture for commercial purposes of
the chemical substance or manufacture
or processing of the chemical substance
for a significant new use.
(B) Requirements.--Not later than 90 days
after issuing a consent agreement or order
under subparagraph (A), the Administrator
shall--
(i) take into consideration whether
to promulgate a rule pursuant to
subsection (b)(2) that identifies as a
significant new use any manufacturing,
processing, use, distribution in
commerce, or disposal of the chemical
substance, or of the chemical substance
for a new use, that is not in
compliance with the restrictions
imposed by the consent agreement or
order; and
(ii)(I) initiate a rulemaking
described in clause (i); or
(II) publish a statement describing
the reasons of the Administrator for
not initiating a rulemaking.
(C) Inclusions.--A prohibition or other
restriction under subparagraph (A) may include,
as appropriate--
(i) subject to section 18(g), a
requirement that a chemical substance
shall be marked with, or accompanied
by, clear and adequate minimum warnings
and instructions with respect to use,
distribution in commerce, or disposal,
or any combination of those activities,
with the form and content of the
minimum warnings and instructions to be
prescribed by the Administrator
(ii) a requirement that manufacturers
or processors of the chemical substance
shall--
(I) make and retain records
of the processes used to
manufacture or process, as
applicable, the chemical
substance; or
(II) monitor or conduct such
additional tests as are
reasonably necessary to address
potential risks from the
manufacture, processing,
distribution in commerce, use,
or disposal, as applicable, of
the chemical substance, subject
to section 4;
(iii) a restriction on the quantity
of the chemical substance that may be
manufactured, processed, or distributed
in commerce--
(I) in general; or
(II) for a particular use;
(iv) a prohibition or other
restriction of--
(I) the manufacture,
processing, or distribution in
commerce of the chemical
substance for a significant new
use;
(II) any method of commercial
use of the chemical substance;
or
(III) any method of disposal
of the chemical substance; or
(v) a prohibition or other
restriction on the manufacture,
processing, or distribution in commerce
of the chemical substance--
(I) in general; or
(II) for a particular use.
(D) Persistent and bioaccumulative
substances.--For a chemical substance the
Administrator determines ranks high for
persistence and bioaccumulation, the
Administrator shall, in selecting among
prohibitions and other restrictions that the
Administrator determines are sufficient to
ensure that the chemical substance is likely to
meet the safety standard, reduce potential
exposure to the substance to the maximum extent
practicable.
(E) Workplace exposures.--The Administrator
shall consult with the Assistant Secretary of
Labor for Occupational Safety and Health prior
to adopting any prohibition or other
restriction under this subsection to address
workplace exposures.
(F) Definition of requirement.--For purposes
of this Act, the term `requirement' as used in
this section does not displace common law.
(5) Additional information.--If the Administrator
determines under paragraph (3)(C) that additional
information is necessary to conduct a review under this
subsection, the Administrator--
(A) shall provide an opportunity for the
submitter of the notice to submit the
additional information;
(B) may, by agreement with the submitter,
extend the review period for a reasonable time
to allow the development and submission of the
additional information;
(C) may promulgate a rule, enter into a
testing consent agreement, or issue an order
under section 4 to require the development of
the information; and
(D) on receipt of information the
Administrator finds supports the determination
under paragraph (3), shall promptly make the
determination.
[(e) Regulation Pending Development of Information.--(1)(A)
If the Administrator determines that--
[(i) the information available to the Administrator
is insufficient to permit a reasoned evaluation of the
health and environmental effects of a chemical
substance with respect to which notice is required by
subsection (a); and
[(ii)(I) in the absence of sufficient information to
permit the Administrator to make such an evaluation,
the manufacture, processing, distribution in commerce,
use, or disposal of such substance, or any combination
of such activities, may present an unreasonable risk of
injury to health or the environment, or
[(II) such substance is or will be produced in
substantial quantities, and such substance either
enters or may reasonably be anticipated to enter the
environment in substantial quantities or there is or
may be significant or substantial human exposure to the
substance,
the Administrator may issue a proposed order, to take effect on
the expiration of the notification period applicable to the
manufacturing or processing of such substance under subsection
(a), (b), or (c), to prohibit or limit the manufacture,
processing, distribution in commerce, use, or disposal of such
substance or to prohibit or limit any combination of such
activities.
[(B) A proposed order may not be issued under subparagraph
(A) respecting a chemical substance (i) later than 45 days
before the expiration of the notification period applicable to
the manufacture or processing of such substance under
subsection (a), (b), or (c), and (ii) unless the Administrator
has, on or before the issuance of the proposed order, notified,
in writing, each manufacturer or processor, as the case may be,
of such substance of the determination which underlies such
order.
[(C) If a manufacturer or processor of a chemical substance
to be subject to a proposed order issued under subparagraph (A)
files with the Administrator (within the 30-day period
beginning on the date such manufacturer or processor received
the notice required by subparagraph (B)(ii)) objections
specifying with particularity the provisions of the order
deemed objectionable and stating the grounds therefor, the
proposed order shall not take effect.
[(2)(A)(i) Except as provided in clause (ii), if with respect
to a chemical substance with respect to which notice is
required by subsection (a), the Administrator makes the
determination described in paragraph (1)(A) and if--
[(I) the Administrator does not issue a proposed
order under paragraph (1) respecting such substance, or
[(II) the Administrator issues such an order
respecting such substance but such order does not take
effect because objections were filed under paragraph
(1)(C) with respect to it,
the Administrator, through attorneys of the Environmental
Protection Agency, shall apply to the United States District
Court for the District of Columbia or the United States
district court for the judicial district in which the
manufacturer or processor, as the case may be, of such
substance is found, resides, or transacts business for an
injunction to prohibit or limit the manufacture, processing,
distribution in commerce, use, or disposal of such substance
(or to prohibit or limit any combination of such activities).
[(ii) If the Administrator issues a proposed order under
paragraph (1)(A) respecting a chemical substance but such order
does not take effect because objections have been filed under
paragraph (1)(C) with respect to it, the Administrator is not
required to apply for an injunction under clause (i) respecting
such substance if the Administrator determines, on the basis of
such objections, that the determinations under paragraph (1)(A)
may not be made.
[(B) A district court of the United States which receives an
application under subparagraph (A)(i) for an injunction
respecting a chemical substance shall issue such injunction if
the court finds that--
(i) the information available to the Administrator is
insufficient to permit a reasoned evaluation of the
health and environmental effects of a chemical
substance with respect to which notice is required by
subsection (a); and
[(ii)(I) in the absence of sufficient information to
permit the Administrator to make such an evaluation,
the manufacture, processing, distribution in commerce,
use, or disposal of such substance, or any combination
of such activities, may present an unreasonable risk of
injury to health or the environment, or
[(II) such substance is or will be produced in
substantial quantities, and such substance either
enters or may reasonably be anticipated to enter the
environment in substantial quantities or there is or
may be significant or substantial human exposure to the
substance.
[(C) Pending the completion of a proceeding for the issuance
of an injunction under subparagraph (B) respecting a chemical
substance, the court may, upon application of the Administrator
made through attorneys of the Environmental Protection Agency,
issue a temporary restraining order or a preliminary injunction
to prohibit the manufacture, processing, distribution in
commerce, use, or disposal of such a substance (or any
combination of such activities) if the court finds that the
notification period applicable under subsection (a), (b), or
(c) to the manufacturing or processing of such substance may
expire before such proceeding can be completed.
[(D) After the submission to the Administrator of test data
sufficient to evaluate the health and environmental effects of
a chemical substance subject to an injunction issued under
subparagraph (B) and the evaluation of such data by the
Administrator, the district court of the United States which
issued such injunction shall, upon petition, dissolve the
injunction unless the Administrator has initiated a proceeding
for the issuance of a rule under section 6(a) respecting the
substance. If such a proceeding has been initiated, such court
shall continue the injunction in effect until the effective
date of the rule promulgated in such proceeding or, if such
proceeding is terminated without the promulgation of a rule,
upon the termination of the proceeding, whichever occurs first.
[(f) Protection Against Unreasonable Risks.--(1) If the
Administrator finds that there is a reasonable basis to
conclude that the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance with respect
to which notice is required by subsection (a), or that any
combination of such activities, presents or will present an
unreasonable risk of injury to health or environment before a
rule promulgated under section 6 can protect against such risk,
the Administrator shall, before the expiration of the
notification period applicable under subsection (a), (b), or
(c) to the manufacturing or processing of such substance, take
the action authorized by paragraph (2) or (3) to the extent
necessary to protect against such risk.
[(2) The Administrator may issue a proposed rule under
section 6(a) to apply to a chemical substance with respect to
which a finding was made under paragraph (1)--
[(A) a requirement limiting the amount of such
substance which may be manufactured, processed, or
distributed in commerce,
[(B) a requirement described in paragraph (2), (3),
(4), (5), (6), or (7) of section 6(a), or
[(C) any combination of the requirements referred to
in subparagraph (B).
Such a proposed rule shall be effective upon its publication in
the Federal Register. Section 6(d)(2)(B) shall apply with
respect to such rule.
[(3)(A) The Administrator may--
[(i) issue a proposed order to prohibit the
manufacture, processing, or distribution in commerce of
a substance with respect to which a finding was made
under paragraph (1), or
[(ii) apply, through attorneys of the Environmental
Protection Agency, to the United States District Court
for the District of Columbia or the United States
district court for the judicial district in which the
manufacturer, or processor, as the case may be, of such
substance, is found, resides, or transacts business for
an injunction to prohibit the manufacture, processing,
or distribution in commerce of such substance.
A proposed order issued under clause (i) respecting a chemical
substance shall take effect on the expiration of the
notification period applicable under subsection (a), (b), or
(c) to the manufacture or processing of such substance.
[(B) If the district court of the United States to which an
application has been made under subparagraph (A)(ii) finds that
there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or disposal of the
chemical substance with respect to which such application was
made, or that any combination of such activities, presents or
will present an unreasonable risk of injury to health or the
environment before a rule promulgated under section 6 can
protect against such risk, the court shall issue an injunction
to prohibit the manufacture, processing or distribution in
commerce of such substance or to prohibit any combination of
such activities.
[(C) The provisions of subparagraphs (B) and (C) of
subsection (e)(1) shall apply with respect to an order issued
under clause (i) of subparagraph (A); and the provisions of
subparagraph (C) of subsection (e)(2) shall apply with respect
to an injunction issued under subparagraph (B).
[(D) If the Administrator issues an order pursuant to
subparagraph (A)(i) respecting a chemical substance and
objections are filed in accordance with subsection (e)(1)(C),
the Administrator shall seek an injunction under subparagraph
(A)(ii) respecting such substance unless the Administrator
determines, on the basis of such objections, that such
substance does not or will not present an unreasonable risk of
injury to health or the environment.
[(g) Statement of Reasons for Not Taking Action.--If the
Administrator has not initiated any action under this section
or section 6 or 7 to prohibit or limit the manufacture,
processing, distribution in commerce, use, or disposal of a
chemical substance, with respect to which notification or data
is required by subsection (a)(1)(B) or (b), before the
expiration of the notification period applicable to the
manufacturing or processing of such substance, the
Administrator shall publish a statement of the Administrator's
reasons for not initiating such action. Such a statement shall
be published in the Federal Register before the expiration of
such period. Publication of such statement in accordance with
the preceding sentence is not a prerequisite to the
manufacturing or processing of the substance with respect to
which the statement is to be published.]
(e) Notice of Commencement.--
(1) In general.--Not later than 30 days after the
date on which a manufacturer that has submitted a
notice under subsection (b) commences nonexempt
commercial manufacture of a chemical substance, the
manufacturer shall submit to the Administrator a notice
of commencement that identifies--
(A) the name of the manufacturer; and
(B) the initial date of nonexempt commercial
manufacture.
(2) Withdrawal.--A manufacturer or processor that has
submitted a notice under subsection (b), but that has
not commenced nonexempt commercial manufacture or
processing of the chemical substance, may withdraw the
notice.
(f) Further Evaluation.--The Administrator may review a
chemical substance under section 4A at any time after the
Administrator receives--
(1) a notice of commencement for a chemical substance
under subsection (c); or
(2) new information regarding the chemical substance.
(g) Transparency.--Subject to section 14, the Administrator
shall make available to the public--
(1) all notices, determinations, consent agreements,
rules, and orders of the Administrator; and
(2) all information submitted or issued under this
section.
(h) Exemptions.--(1) The Administrator may, upon application,
exempt any person from any requirement of subsection [(a) or]
(b) to permit such person to manufacture or process a chemical
substance for test marketing purposes--
(A) upon a showing by such person satisfactory to the
Administrator that the manufacture, processing,
distribution in commerce, use, and disposal of such
substance, and that any combination of such activities,
for such purposes will not present any unreasonable
risk of injury to health or the environment , without
taking into account cost or other nonrisk factors and
(B) under such restrictions as the Administrator
considers appropriate.
[(2)(A) The Administrator may, upon application, exempt any
person from the requirement of subsection (b)(2) to submit data
for a chemical substance. If, upon receipt of an application
under the preceding sentence, the Administrator determines
that--
[(i) the chemical substance with respect to which
such application was submitted is equivalent to a
chemical substance for which data has been submitted to
the Administrator as required by subsection (b)(2), and
[(ii) submission of data by the applicant on such
substance would be duplicative of data which has been
submitted to the Administrator in accordance with such
subsection,
the Administrator shall exempt the applicant from the
requirement to submit such data on such substance. No exemption
which is granted under this subparagraph with respect to the
submission of data for a chemical substance may take effect
before the beginning of the reimbursement period applicable to
such data.
[(B) If the Administrator exempts any person, under
subparagraph (A), from submitting data required under
subsection (b)(2) for a chemical substance because of the
existence of previously submitted data and if such exemption is
granted during the reimbursement period for such data, then
(unless such person and the persons referred to in clauses (i)
and (ii) agree on the amount and method of reimbursement) the
Administrator shall order the person granted the exemption to
provide fair and equitable reimbursement (in an amount
determined under rules of the Administrator)--
[(i) to the person who previously submitted the data
on which the exemption was based, for a portion of the
costs incurred by such person in complying with the
requirement under subsection (b)(2) to submit such
data, and
[(ii) to any other person who has been required under
this subparagraph to contribute with respect to such
costs, for a portion of the amount such person was
required to contribute.
In promulgating rules for the determination of fair and
equitable reimbursement to the persons described in clauses (i)
and (ii) for costs incurred with respect to a chemical
substance, the Administrator shall, after consultation with the
Attorney General and the Federal Trade Commission, consider all
relevant factors, including the effect on the competitive
position of the person required to provide reimbursement in
relation to the persons to be reimbursed and the share of the
market for such substance of the person required to provide
reimbursement in relation to the share of such market of the
persons to be reimbursed. For purposes of judicial review, an
order under this subparagraph shall be considered final agency
action.
[(C) For purposes of this paragraph, the reimbursement period
for any previously submitted data for a chemical substance is a
period--
[(i) beginning on the date of the termination of the
prohibition, imposed under this section, on the
manufacture or processing of such substance by the
person who submitted such data to the Administrator,
and
[(ii) ending--
[(I) five years after the date referred to in
clause (i), or
[(II) at the expiration of a period which
begins on the date referred to in clause (i)
and is equal to the period which the
Administrator determines was necessary to
develop such data,
whichever is later.]
[(3)] (2) The requirements of [subsections (a) and (b)]
subsection (b) do not apply with respect to the manufacturing
or processing of any chemical substance which is manufactured
or processed, or proposed to be manufactured or processed, only
in small quantities (as defined by the Administrator by rule)
solely for purposes of--
(A) scientific experimentation or analysis, or
(B) chemical research on, or analysis of such
substance or another substance, including such research
or analysis for the development of a product,
if all persons engaged in such experimentation, research, or
analysis for a manufacturer or processor are notified (in such
form and manner as the Administrator may prescribe) of any risk
to health which the manufacturer, processor, or the
Administrator has reason to believe may be associated with such
chemical substance.
[(4)] (3) The Administrator may, upon application and by
rule, exempt the manufacturer of any new chemical substance
from all or part of the requirements of this section if the
Administrator determines that the manufacture, processing,
distribution in commerce, use, or disposal of such chemical
substance, or that any combination of such activities, will not
present an unreasonable risk of injury to health or the
environment. A rule promulgated under this paragraph (and any
substantive amendment to, or repeal of, such a rule) shall be
promulgated in accordance with paragraphs (2) and (3) of
section 6(c).
[(5)] (4) The Administrator may, upon application, make the
requirements of subsections (a) and (b) inapplicable with
respect to the manufacturing or processing of any chemical
substance (A) which exists temporarily as a result of a
chemical reaction in the manufacturing or processing of a
mixture or another chemical substance, and (B) to which there
is no, and will not be, human or environmental exposure.
[(6)] (5) Immediately upon receipt of an application under
[paragraph (1) or (5) paragraph (1) or (4) the Administrator
shall publish in the Federal Register notice of the receipt of
such application. The Administrator shall give interested
persons an opportunity to comment upon any such application and
shall, within 45 days of its receipt, either approve or deny
the application. The Administrator shall publish in the Federal
Register notice of the approval or denial of such an
application.
[SEC. 6. REGULATION OF HAZARDOUS CHEMICAL SUBSTANCES AND MIXTURES.]
SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINATIONS.
[(a) Scope of Regulation.--If the Administrator finds that
there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or disposal of a
chemical substance or mixture, or that any combination of such
activities, presents, or will present an unreasonable risk of
injury to health or the environment, the Administrator shall by
rule apply one or more of the following requirements to such
substance or mixture to the extent necessary to protect
adequately against such risk using the least burdensome
requirements:
[(1) A requirement (A) prohibiting the manufacturing,
processing, or distribution in commerce of such
substance or mixture, or (B) limiting the amount of
such substance or mixture which may be manufactured,
processed, or distributed in commerce.
[(2) A requirement--
[(A) prohibiting the manufacture, processing,
or distribution in commerce of such substance
or mixture for (i) a particular use or (ii) a
particular use in a concentration in excess of
a level specified by the Administrator in the
rule imposing the requirement, or
[(B) limiting the amount of such substance or
mixture which may be manufactured, processed,
or distributed in commerce for (i) a particular
use or (ii) a particular use in a concentration
in excess of a level specified by the
Administrator in the rule imposing the
requirement.
[(3) A requirement that such substance or mixture or
any article containing such substance or mixture be
marked with or accompanied by clear and adequate
warnings and instructions with respect to its use,
distribution in commerce, or disposal or with respect
to any combination of such activities. The form and
content of such warnings and instructions shall be
prescribed by the Administrator.
[(4) A requirement that manufacturers and processors
of such substance or mixture make and retain records of
the processes used to manufacture or process such
substance or mixture and monitor or conduct tests which
are reasonable and necessary to assure compliance with
the requirements of any rule applicable under this
subsection.
[(5) A requirement prohibiting or otherwise
regulating any manner or method of commercial use of
such substance or mixture.
[(6)(A) A requirement prohibiting or otherwise
regulating any manner or method of disposal of such
substance or mixture, or of any article containing such
substance or mixture, by its manufacturer or processor
or by any other person who uses, or disposes of, it for
commercial purposes.
[(B) A requirement under subparagraph (A) may not
require any person to take any action which would be in
violation of any law or requirement of, or in effect
for, a State or political subdivision, and shall
require each person subject to it to notify each State
and political subdivision in which a required disposal
may occur of such disposal.
[(7) A requirement directing manufacturers or
processors of such substance or mixture (A) to give
notice of such unreasonable risk of injury to
distributors in commerce of such substance or mixture
and, to the extent reasonably ascertainable, to other
persons in possession of such substance or mixture or
exposed to such substance or mixture, (B) to give
public notice of such risk of injury, and (C) to
replace or repurchase such substance or mixture as
elected by the person to which the requirement is
directed.
Any requirement (or combination of requirements) imposed under
this subsection may be limited in application to specified
geographic areas.
[(b) Quality Control.--If the Administrator has a reasonable
basis to conclude that a particular manufacturer or processor
is manufacturing or processing a chemical substance or mixture
in a manner which unintentionally causes the chemical substance
or mixture to present or which will cause it to present an
unreasonable risk of injury to health or the environment--
[(1) the Administrator may by order require such
manufacturer or processor to submit a description of
the relevant quality control procedures followed in the
manufacturing or processing of such chemical substance
or mixture; and
[(2) if the Administrator determines--
[(A) that such quality control procedures are
inadequate to prevent the chemical substance or
mixture from presenting such risk of injury,
the Administrator may order the manufacturer or
processor to revise such quality control
procedures to the extent necessary to remedy
such inadequacy; or
[(B) that the use of such quality control
procedures has resulted in the distribution in
commerce of chemical substances or mixtures
which present an unreasonable risk of injury to
health or the environment, the Administrator
may order the manufacturer or processor to (i)
give notice of such risk to processors or
distributors in commerce of any such substance
or mixture, or to both, and, to the extent
reasonably ascertainable, to any other person
in possession of or exposed to any such
substance, (ii) to give public notice of such
risk, and (iii) to provide such replacement or
repurchase of any such substance or mixture as
is necessary to adequately protect health or
the environment.
A determination under subparagraph (A) or (B) of paragraph (2)
shall be made on the record after opportunity for hearing in
accordance with section 554 of title 5, United States Code. Any
manufacturer or processor subject to a requirement to replace
or repurchase a chemical substance or mixture may elect either
to replace or repurchase the substance or mixture and shall
take either such action in the manner prescribed by the
Administrator.
[(c) Promulgation of Subsection (a) Rules.--(1) In
promulgating any rule under subsection (a) with respect to a
chemical substance or mixture, the Administrator shall consider
and publish a statement with respect to--
[(A) the effects of such substance or mixture on
health and the magnitude of the exposure of human
beings to such substance or mixture,
[(B) the effects of such substance or mixture on the
environment and the magnitude of the exposure of the
environment to such substance or mixture,
[(C) the benefits of such substance or mixture for
various uses and the availability of substitutes for
such uses, and
[(D) the reasonably ascertainable economic
consequences of the rule, after consideration of the
effect on the national economy, small business,
technological innovation, the environment, and public
health.
If the Administrator determines that a risk of injury to health
or the environment could be eliminated or reduced to a
sufficient extent by actions taken under another Federal law
(or laws) administered in whole or in part by the
Administrator, the Administrator may not promulgate a rule
under subsection (a) to protect against such risk of injury
unless the Administrator finds, in the Administrator's
discretion, that it is in the public interest to protect
against such risk under this Act. In making such a finding the
Administrator shall consider (i) all relevant aspects of the
risk, as determined by the Administrator in the Administrator's
discretion, (ii) a comparison of the estimated costs of
complying with actions taken under this Act and under such law
(or laws), and (iii) the relative efficiency of actions under
this Act and under such law (or laws) to protect against such
risk of injury.
[(2) When prescribing a rule under subsection (a) the
Administrator shall proceed in accordance with section 553 of
title 5, United States Code (without regard to any reference in
such section to sections 556 and 557 of such title), and shall
also (A) publish a notice of proposed rulemaking stating with
particularity the reason for the proposed rule; (B) allow
interested persons to submit written data, views, and
arguments, and make all such submissions publicly available;
(C) provide an opportunity for an informal hearing in
accordance with paragraph (3); (D) promulgate, if appropriate,
a final rule based on the matter in the rulemaking record (as
defined in section 19(a)), and (E) make and publish with the
rule the finding described in subsection (a).
[(3) Informal hearings required by paragraph (2)(C) shall be
conducted by the Administrator in accordance with the following
requirements:
[(A) Subject to subparagraph (B), an interested
person is entitled--
[(i) to present such person's position orally
or by documentary submissions (or both), and
[(ii) if the Administrator determines that
there are disputed issues of material fact it
is necessary to resolve, to present such
rebuttal submissions and to conduct (or have
conducted under subparagraph (B)(ii)) such
cross-examination of persons as the
Administrator determines (I) to be appropriate,
and (II) to be required for a full and true
disclosure with respect to such issues.
[(B) The Administrator may prescribe such rules and
make such rulings concerning procedures in such
hearings to avoid unnecessary costs or delay. Such
rules or rulings may include (i) the imposition of
reasonable time limits on each interested person's oral
presentations, and (ii) requirements that any cross-
examination to which a person may be entitled under
subparagraph (A) be conducted by the Administrator on
behalf of that person in such manner as the
Administrator determines (I) to be appropriate, and
(II) to be required for a full and true disclosure with
respect to disputed issues of material fact.
[(C)(i) Except as provided in clause (ii), if a group
of persons each of whom under subparagraphs (A) and (B)
would be entitled to conduct (or have conducted) cross-
examination and who are determined by the Administrator
to have the same or similar interests in the proceeding
cannot agree upon a single representative of such
interests for purposes of cross-examination, the
Administrator may make rules and rulings (I) limiting
the representation of such interest for such purposes,
and (II) governing the manner in which such cross-
examination shall be limited.
[(ii) When any person who is a member of a group with
respect to which the Administrator has made a
determination under clause (i) is unable to agree upon
group representation with the other members of the
group, then such person shall not be denied under the
authority of clause (i) the opportunity to conduct (or
have conducted) cross-examination as to issues
affecting the person's particular interests if (I) the
person satisfies the Administrator that the person has
made a reasonable and good faith effort to reach
agreement upon group representation with the other
members of the group and (II) the Administrator
determines that there are substantial and relevant
issues which are not adequately presented by the group
representative.
[(D) A verbatim transcript shall be taken of any oral
presentation made, and cross-examination conducted in
any informal hearing under this subsection. Such
transcript shall be available to the public.
[(4)(A) The Administrator may, pursuant to rules prescribed
by the Administrator, provide compensation for reasonable
attorneys' fees, expert witness fees, and other costs of
participating in a rulemaking proceeding for the promulgation
of a rule under subsection (a) to any person--
[(i) who represents an interest which would
substantially contribute to a fair determination of the
issues to be resolved in the proceeding, and
[(ii) if--
[(I) the economic interest of such person is
small in comparison to the costs of effective
participation in the proceeding by such person,
or
[(II) such person demonstrates to the
satisfaction of the Administrator that such
person does not have sufficient resources
adequately to participate in the proceeding
without compensation under this subparagraph.
In determining for purposes of clause (i) if an interest will
substantially contribute to a fair determination of the issues
to be resolved in a proceeding, the Administrator shall take
into account the number and complexity of such issues and the
extent to which representation of such interest will contribute
to widespread public participation in the proceeding and
representation of a fair balance of interests for the
resolution of such issues.
[(B) In determining whether compensation should be provided
to a person under subparagraph (A) and the amount of such
compensation, the Administrator shall take into account the
financial burden which will be incurred by such person in
participating in the rulemaking proceeding. The Administrator
shall take such action as may be necessary to ensure that the
aggregate amount of compensation paid under this paragraph in
any fiscal year to all persons who, in rulemaking proceedings
in which they receive compensation, are persons who either--
[(i) would be regulated by the proposed rule, or
[(ii) represent persons who would be so regulated,
may not exceed 25 per centum of the aggregate amount paid as
compensation under this paragraph to all persons in such fiscal
year.
[(5) Paragraphs (1), (2), (3), and (4) of this subsection
apply to the promulgation of a rule repealing, or making a
substantive amendment to, a rule promulgated under subsection
(a).
[(d) Effective Date.--(1) The Administrator shall specify in
any rule under subsection (a) the date on which it shall take
effect, which date shall be as soon as feasible.
[(2)(A) The Administrator may declare a proposed rule under
subsection (a) to be effective upon its publication in the
Federal Register and until the effective date of final action
taken, in accordance with subparagraph (B), respecting such
rule if--
[(i) the Administrator determines that--
[(I) the manufacture, processing,
distribution in commerce, use, or disposal of
the chemical substance or mixture subject to
such proposed rule or any combination of such
activities is likely to result in an
unreasonable risk of serious or widespread
injury to health or the environment before such
effective date; and
[(II) making such proposed rule so effective
is necessary to protect the public interest;
and
[(ii) in the case of a proposed rule to prohibit the
manufacture, processing, or distribution of a chemical
substance or mixture because of the risk determined
under clause (i)(I), a court has in an action under
section 7 granted relief with respect to such risk
associated with such substance or mixture.
Such a proposed rule which is made so effective shall not, for
purposes of judicial review, be considered final agency action.
[(B) If the Administrator makes a proposed rule effective
upon its publication in the Federal Register, the Administrator
shall, as expeditiously as possible, give interested persons
prompt notice of such action, provide reasonable opportunity,
in accordance with paragraphs (2) and (3) of subsection (c),
for a hearing on such rule, and either promulgate such rule (as
proposed or with modifications) or revoke it; and if such a
hearing is requested, the Administrator shall commence the
hearing within five days from the date such request is made
unless the Administrator and the person making the request
agree upon a later date for the hearing to begin, and after the
hearing is concluded the Administrator shall, within ten days
of the conclusion of the hearing, either promulgate such rule
(as proposed or with modifications) or revoke it.]
(a) In General.--The Administrator--
(1) shall conduct a safety assessment and make a
safety determination of each high-priority substance in
accordance with subsections (b) and (c);
(2) shall, as soon as practicable and not later than
6 months after the date on which a chemical substance
is designated as a high-priority substance, define and
publish the scope of the safety assessment and safety
determination to be conducted pursuant to this section,
including the hazards, exposures, conditions of use,
and potentially exposed or susceptible populations that
the Administrator expects to consider;
(3) as appropriate based on the results of a safety
determination, shall establish restrictions pursuant to
subsection (d);
(4) shall complete a safety assessment and safety
determination not later than 3 years after the date on
which a chemical substance is designated as a high-
priority substance;
(5) shall promulgate a final rule pursuant to
subsection (d) by not later than 2 years after the date
on which the safety determination is completed; and
(6) may extend any deadline under [this subsection]
paragraph (4) or (5) for a reasonable period of time
after an adequate public justification, subject to the
condition that the aggregate length of all extensions
of deadlines under [paragraphs (4) and (5) and] this
subsection, plus any deferral under subsection (c)(2)
does not exceed 2 years.
(b) Prior Actions and Notice of Existing Information.--
(1) Prior-initiated assessments.--
(A) In general.--Nothing in this Act prevents
the Administrator from initiating a safety
assessment or safety determination regarding a
chemical substance, or from continuing or
completing such a safety assessment or safety
determination that was initiated before the
date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, prior
to the effective date of the policies and
procedures required to be established by the
Administrator under section 3A or 4A.
(B) Integration of prior policies and
procedures.--As policies and procedures under
section 3A and 4A are established, to the
maximum extent practicable, the Administrator
shall integrate the policies and procedures
into ongoing safety assessments and safety
determinations.
(2) Actions completed prior to completion of policies
and procedures.--Nothing in this Act requires the
Administrator to revise or withdraw a completed safety
assessment, safety determination, or rule solely
because the action was completed prior to the
completion of a policy or procedure established under
section 3A or 4A, and the validity of a completed
assessment, determination, or rule shall not be
determined based on the content of such a policy or
procedure.
(3) Notice of existing information.--
(A) In general.--The Administrator shall,
where such information is available, take
notice of existing information regarding hazard
and exposure published by other Federal
agencies and the National Academies and
incorporate the information in safety
assessments and safety determinations with the
objective of increasing the efficiency of the
safety assessments and safety determinations.
(B) Inclusion of information.--Existing
information described in subparagraph (A)
should be included to the extent practicable
and where the Administrator determines the
information is relevant and scientifically
reliable.
(c) Safety Determinations.--
(1) In general.--Based on a review of the information
available to the Administrator, including draft safety
assessments submitted by interested persons, and
subject to section 18, the Administrator shall
determine that--
(A) the relevant chemical substance meets the
safety standard;
(B) the relevant chemical substance does not
meet the safety standard, in which case the
Administrator shall, by rule under subsection
(d)--
(i) impose restrictions necessary to
ensure that the chemical substance
meets the safety standard under the
conditions of use; or
(ii) if the safety standard cannot be
met with the application of
restrictions, ban or phase out the
chemical substance, as appropriate; or
(C) additional information is necessary in
order to make a determination under
subparagraph (A) or (B), in which case the
Administrator shall take appropriate action
under paragraph (2).
(2) Additional information.--If the Administrator
determines that additional information is necessary to
make a safety assessment or safety determination for a
high-priority substance, the Administrator--
(A) shall provide an opportunity for
interested persons to submit the additional
information;
(B) may promulgate a rule, enter into a
testing consent agreement, or issue an order
under section 4 to require the development of
the information;
(C) may defer, for a reasonable period
consistent with the deadlines described in
subsection (a), a safety assessment and safety
determination until after receipt of the
information; and
(D) consistent with the deadlines described
in subsection (a), on receipt of information
the Administrator finds supports the safety
assessment and safety determination, shall make
a determination under paragraph (1).
(3) Establishment of deadline.--In requesting the
development or submission of information under this
section, the Administrator shall establish a deadline
for the submission of the information.
(d) Rule.--
(1) Implementation.--If the Administrator makes a
determination under subsection (c)(1)(B) with respect
to a chemical substance, the Administrator shall
promulgate a rule establishing restrictions necessary
to ensure that the chemical substance meets the safety
standard.
(2) Scope.--
(A) In general.--The rule promulgated
pursuant to this subsection--
(i) may apply to mixtures containing
the chemical substance, as appropriate;
(ii) shall include dates by which
compliance is mandatory, which--
(I) shall be as soon as
practicable;
(II) in the case of a ban or
phase-out of the chemical
substance, shall implement the
ban or phase-out in as short a
period as practicable; and
(III) as determined by the
Administrator, may vary for
different affected persons; and
(iii) shall exempt replacement parts
that are manufactured prior to the
effective date of the rule for articles
that are first manufactured prior to
the effective date of the rule unless
the Administrator finds the replacement
parts contribute significantly to the
identified risk; and
(iv) shall, in selecting among
prohibitions and other restrictions,
apply such prohibitions or other
restrictions to articles containing the
chemical substance only to the extent
necessary to address the identified
risks in order to determine that the
chemical substance meets the safety
standard.
(B) Persistent and bioaccumulative
substances.--For a chemical substance the
Administrator determines ranks high for
persistence and bioaccumulation, the
Administrator shall, in selecting among
prohibitions and other restrictions that the
Administrator determines are sufficient to
ensure that the chemical substance meets the
safety standard, reduce exposure to the
substance to the maximum extent practicable.
(C) Workplace exposures.--The Administrator
shall consult with the Assistant Secretary of
Labor for Occupational Safety and Health before
adopting any prohibition or other restriction
under this subsection to address workplace
exposures.
(D) Definition of requirement.--For the
purposes of this Act, the term `requirement' as
used in this section does not displace common
law.
(3) Restrictions.--A restriction under paragraph (1)
may include, as appropriate--
(A) subject to section 18, a requirement that
a chemical substance shall be marked with, or
accompanied by, clear and adequate minimum
warnings and instructions with respect to use,
distribution in commerce, or disposal, or any
combination of those activities, with the form
and content of the minimum warnings and
instructions to be prescribed by the
Administrator;
(B) a requirement that manufacturers or
processors of the chemical substance shall--
(i) make and retain records of the
processes used to manufacture or
process the chemical substance;
(ii) describe and apply the relevant
quality control procedures followed in
the manufacturing or processing of the
substance; or
(iii) monitor or conduct tests that
are reasonably necessary to ensure
compliance with the requirements of any
rule under this subsection;
(C) a restriction on the quantity of the
chemical substance that may be manufactured,
processed, or distributed in commerce;
(D) a requirement to ban or phase out, or any
other rule regarding, the manufacture,
processing, or distribution in commerce of the
chemical substance for--
(i) a particular use;
(ii) a particular use at a
concentration in excess of a level
specified by the Administrator; or
(iii) all uses;
(E) a restriction on the quantity of the
chemical substance that may be manufactured,
processed, or distributed in commerce for--
(i) a particular use; or
(ii) a particular use at a
concentration in excess of a level
specified by the Administrator;
(F) a requirement to ban, phase out, or
otherwise restrict any method of commercial use
of the chemical substance;
(G) a requirement to ban, phase out, or
otherwise restrict any method of disposal of
the chemical substance or any article
containing the chemical substance; and
(H) a requirement directing manufacturers or
processors of the chemical substance to give
notice of the Administrator's determination
under subsection (c)(1)(B) to distributors in
commerce of the chemical substance and, to the
extent reasonably ascertainable, to other
persons in the chain of commerce in possession
of the chemical substance.
(4) Analysis for rulemaking.--
(A) Considerations.--In deciding which
restrictions to impose under paragraph (3) as
part of developing a rule under paragraph (1),
the Administrator shall take into
consideration, to the extent practicable based
on reasonably available information, the
quantifiable and nonquantifiable costs and
benefits of the proposed regulatory action and
of the 1 or more primary alternative regulatory
actions considered by the Administrator.
(B) Alternatives.--As part of the analysis,
the Administrator shall review any 1 or more
technically and economically feasible
alternatives to the chemical substance that the
Administrator determines are relevant to the
rulemaking.
(C) Public availability.--In proposing a rule
under paragraph (1), the Administrator shall
make publicly available any analysis conducted
under this paragraph.
(D) Statement required.--In making final a
rule under paragraph (1), the Administrator
shall include a statement describing how the
analysis considered under subparagraph (A) was
taken into account.
(5) Exemptions.--
(A) In general.--The Administrator may exempt
1 or more uses of a chemical substance from any
restriction in a rule promulgated under
paragraph (1) if the Administrator determines
that--
(i) the rule cannot be complied with,
without--
(I) harming national
security;
(II) causing significant
disruption in the national
economy due to the lack of
availability of a chemical
substance; or
(III) interfering with a
critical or essential use for
which no technically and
economically feasible safer
alternative is available,
taking into consideration
hazard and exposure; or
(ii) the use of the chemical
substance, as compared to reasonably
available alternatives, provides a
substantial benefit to health, the
environment, or public safety.
(B) Exemption analysis.--In proposing a rule
under paragraph (1) that includes an exemption
under this paragraph, the Administrator shall
make publicly available any analysis conducted
under this paragraph to assess the need for the
exemption.
(C) Statement required.--In making final a
rule under paragraph (1) that includes an
exemption under this paragraph, the
Administrator shall include a statement
describing how the analysis considered under
subparagraph (B) was taken into account.
(D) Analysis in case of ban or phase-out.--In
determining whether an exemption should be
granted under this paragraph for a chemical
substance for which a ban or phase-out is
proposed, the Administrator shall take into
consideration, to the extent practicable based
on reasonably available information, the
quantifiable and nonquantifiable costs and
benefits of the 1 or more technically and
economically feasible alternatives to the
chemical substance most likely to be used in
place of the chemical substance under the
conditions of use if the rule is promulgated.
(E) Conditions.--As part of a rule
promulgated under paragraph (1), the
Administrator shall include conditions in any
exemption established under this paragraph,
including reasonable recordkeeping, monitoring,
and reporting requirements, to the extent that
the Administrator determines the conditions are
necessary to protect health and the environment
while achieving the purposes of the exemption.
(F) Duration.--
(i) In general.--The Administrator
shall establish, as part of a rule
under paragraph (1) that contains an
exemption under this paragraph, a time
limit on any exemption for a time to be
determined by the Administrator as
reasonable on a case-by-case basis.
(ii) Authority of administrator.--The
Administrator, by rule, may extend,
modify, or eliminate the exemption if
the Administrator determines, on the
basis of reasonably available
information and after adequate public
justification, the exemption warrants
extension or is no longer necessary.
(iii) Considerations.--
(I) In general.--Subject to
subclause (II), the
Administrator shall issue
exemptions and establish time
periods by considering factors
determined by the Administrator
to be relevant to the goals of
fostering innovation and the
development of alternatives
that meet the safety standard.
(II) Limitation.--Any renewal
of an exemption in the case of
a rule requiring the ban or
phase-out of a chemical
substance shall not exceed 5
years.
(e) Immediate Effect.--The Administrator may declare a
proposed rule under subsection (d)(1) to be effective on
publication of the rule in the Federal Register and until the
effective date of final action taken respecting the rule, if--
(1) the Administrator determines that--
(A) the manufacture, processing, distribution
in commerce, use, or disposal of the chemical
substance or mixture subject to the proposed
rule or any combination of those activities is
likely to result in a risk of serious or
widespread injury to health or the environment
before the effective date; and
(B) making the proposed rule so effective is
necessary to protect the public interest; and
(2) in the case of a proposed rule to prohibit the
manufacture, processing, or distribution in commerce of
a chemical substance or mixture because of the risk
determined under paragraph (1)(A), a court has granted
relief in an action under section 7 with respect to
that risk associated with the chemical substance or
mixture.
(f) Final Agency Action.--Under this section and subject to
section 18--
(1) a safety determination, and the associated safety
assessment, for a chemical substance that the
Administrator determines under subsection (c) meets the
safety standard, shall be considered to be a final
agency action, effective beginning on the date of
issuance of the final safety determination; and
(2) a final rule promulgated under subsection (d)(1),
and the associated safety assessment and safety
determination that a chemical substance does not meet
the safety standard, shall be considered to be a final
agency action, effective beginning on the date of
promulgation of the final rule.
[(e)] (g) Polychlorinated Biphenyls.--(1) Within six months
after the effective date of this Act the Administrator shall
promulgate rules to--
(A) prescribe methods for the disposal of
polychlorinated biphenyls, and
(B) require polychlorinated biphenyls to be marked
with clear and adequate warnings, and instructions with
respect to their processing, distribution in commerce,
use, or disposal or with respect to any combination of
such activities.
Requirements prescribed by rules under this paragraph shall be
consistent with the requirements of paragraphs (2) and (3).
(2)(A) Except as provided under subparagraph (B), effective
one year after the effective date of this Act no person may
manufacture, process, or distribute in commerce or use any
polychlorinated biphenyl in any manner other than in a totally
enclosed manner.
(B) The Administrator may by rule authorize the manufacture,
processing, distribution in commerce or use (or any combination
of such activities) of any polychlorinated biphenyl in a manner
other than in a totally enclosed manner if the Administrator
finds that such manufacture, processing, distribution in
commerce, or use (or combination of such activities) will not
present an unreasonable risk of injury to health or the
environment.
(C) For the purposes of this paragraph, the term ``totally
enclosed manner'' means any manner which will ensure that any
exposure of human beings or the environment by the
polychlorinated biphenyl will be insignificant as determined by
the Administrator by rule.
(3)(A) Except as provided in subparagraphs (B), (C), and
(D)--
(i) no person may manufacture any polychlorinated
biphenyl after two years after the effective date of
this Act, and
(ii) no person may process or distribute in commerce
any polychlorinated biphenyl after two and one-half
years after such date.
(B) Any person may petition the Administrator for an
exemption from the requirements of subparagraph (A), and the
Administrator may grant by rule such an exemption if the
Administrator finds that--
(i) an unreasonable risk of injury to health or
environment would not result, and
(ii) good faith efforts have been made to develop a
chemical substance which does not present an
unreasonable risk of injury to health or the
environment and which may be substituted for such
polychlorinated biphenyl.
An exemption granted under this subparagraph shall be subject
to such terms and conditions as the Administrator may prescribe
and shall be in effect for such period (but not more than 1
year from the date it is granted, except as provided in
subparagraph (D)) as the Administrator may prescribe.
(C) Subparagraph (A) shall not apply to the distribution in
commerce of any polychlorinated biphenyl if such
polychlorinated biphenyl was sold for purposes other than
resale before two and one-half years after the date of
enactment of this Act.
(D)\4\ The Administrator may extend an exemption granted
pursuant to subparagraph (B) that has not yet expired for a
period not to exceed 60 days for the purpose of authorizing the
Secretary of Defense and the Secretaries of the military
departments to provide for the transportation into the customs
territory of the United States of polychlorinated biphenyls
generated by or under the control of the Department of Defense
for purposes of their disposal, treatment, or storage in the
customs territory of the United States if those polychlorinated
biphenyls are already in transit from their storage locations
but the Administrator determines, in the sole discretion of the
Administrator, they would not otherwise arrive in the customs
territory of the United States within the period of the
original exemption. The Administrator shall promptly publish
notice of such extension in the Federal Register.]
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\4\Section 317(a) of Public Law 109-364 (120 Stat. 2142) amends
paragraph (3) of section 6(e). Subsection (b) of section 317 of such
Public Law provides as follows:
(b) Sunset Date.--The amendments made by subsection (a) shall cease
to have effect on September 30, 2012. The termination of the authority
to grant exemptions pursuant to such amendments shall not effect the
validity of any exemption granted prior to such date.
---------------------------------------------------------------------------
[(4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be
promulgated in accordance with paragraphs (2), (3), and (4) of
subsection (c).]
[(5)] (4) This subsection does not limit the authority of the
Administrator, under any other provision of this Act or any
other Federal law, to take action respecting any
polychlorinated biphenyl.
[(f)] (h) Mercury.--
(1) Prohibition on sale, distribution, or transfer of
elemental mercury by federal agencies.--Except as
provided in paragraph (2), effective beginning on the
date of enactment of this subsection, no Federal agency
shall convey, sell, or distribute to any other Federal
agency, any State or local government agency, or any
private individual or entity any elemental mercury
under the control or jurisdiction of the Federal
agency.
(2) Exceptions.--Paragraph (1) shall not apply to--
(A) a transfer between Federal agencies of
elemental mercury for the sole purpose of
facilitating storage of mercury to carry out
this Act; or
(B) a conveyance, sale, distribution, or
transfer of coal.
(3) Leases of federal coal.--Nothing in this
subsection prohibits the leasing of coal.
SEC. 7. IMMINENT HAZARDS.
[(a) Actions Authorized and Required.--(1) The Administrator
may commence a civil action in an appropriate district court of
the United States--
[(A) for seizure of an imminently hazardous chemical
substance or mixture or any article containing such a
substance or mixture,
[(B) for relief (as authorized by subsection (b))
against any person who manufactures, processes,
distributes in commerce, or uses, or disposes of, an
imminent hazardous chemical substance or mixture or any
article containing such a substance or mixture, or
[(C) for both such seizure and relief.
A civil action may be commenced under this paragraph
notwithstanding the existence of a rule under section 4, 5, 6,
or title IV or an order under section 5 or title IV, and
notwithstanding the pendency of any administrative or judicial
proceeding under any provision of this Act.
[(2) If the Administrator has not made a rule under section
6(a) immediately effective (as authorized by subsection
6(d)(2)(A)(i)) with respect to an imminently hazardous chemical
substance or mixture, the Administrator shall commence in a
district court of the United States with respect to such
substance or mixture or article containing such substance or
mixture a civil action described in subparagraph (A), (B), or
(C) of paragraph (1).]
(a) Civil Actions.--
(1) In general.--The Administrator may commence a
civil action in an appropriate United States district
court for--
(A) seizure of an imminently hazardous
chemical substance or mixture or any article
containing the chemical substance or mixture;
(B) relief (as authorized by subsection (b))
against any person that manufactures,
processes, distributes in commerce, uses, or
disposes of, an imminently hazardous chemical
substance or mixture or any article containing
the chemical substance or mixture; or
(C) both seizure described in subparagraph
(A) and relief described in subparagraph (B).
(2) Rule, order, or other proceeding.--A civil action
may be commenced under this paragraph,
notwithstanding--
(A) the existence of a decision, rule,
consent agreement, or order by the
Administrator under section 4, 4A, 5, or 6 or
title IV or VI; or
(B) the pendency of any administrative or
judicial proceeding under any provision of this
Act.
(b) Relief Authorized.--(1) The district court of the United
States in which an action under subsection (a) is brought shall
have jurisdiction to grant such temporary or permanent relief
as may be necessary to protect health or the environment from
the [unreasonable] risk associated with the chemical substance,
mixture, or article involved in such action.
(2) In the case of an action under subsection (a) brought
against a person who manufactures, processes, or distributes in
commerce a chemical substance or mixture or an article
containing a chemical substance or mixture, the relief
authorized by paragraph (1) may include the issuance of a
mandatory order requiring (A) in the case of purchasers of such
substance, mixture, or article known to the defendant,
notification to such purchasers of the risk associated with it;
(B) public notice of such risk; (C) recall; (D) the replacement
or repurchase of such substance, mixture, or article; or (E)
any combination of the actions described in the preceding
clauses.
(3) In the case of an action under subsection (a) against a
chemical substance, mixture, or article, such substance,
mixture, or article may be proceeded against by process of
libel for its seizure and condemnation. Proceedings in such an
action shall conform as nearly as possible to proceedings in
rem in admiralty.
(c) Venue and Consolidation.--(1)(A) An action under
subsection (a) against a person who manufactures, processes, or
distributes a chemical substance or mixture or an article
containing a chemical substance or mixture may be brought in
the United States District Court for the District of Columbia
or for any judicial district in which any of the defendants is
found, resides, or transacts business; and process in such an
action may be served on a defendant in any other district in
which such defendant resides or may be found. An action under
subsection (a) against a chemical substance, mixture, or
article may be brought in any United States district court
within the jurisdiction of which the substance, mixture, or
article is found.
(B) In determining the judicial district in which an action
may be brought under subsection (a) in instances in which such
action may be brought in more than one judicial district, the
Administrator shall take into account the convenience of the
parties.
(C) Subpoenas\5\ requiring attendance of witnesses in an
action brought under subsection (a) may be served in any
judicial district.
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\5\In Public Law 94-469, the word ``subpoenas'' is spelled
``subpeonas''. The spelling is corrected in this print to reflect the
probable intent of Congress.
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(2) Whenever proceedings under subsection (a) involving
identical chemical substances, mixtures, or articles are
pending in courts in two or more judicial districts, they shall
be consolidated for trial by order of any such court upon
application reasonably made by any party in interest, upon
notice to all parties in interest.
(d) Action Under Section 6.--Where appropriate, concurrently
with the filing of an action under subsection (a) or as soon
thereafter as may be practicable, the Administrator shall
initiate a proceeding for the promulgation of a rule under
[section 6(a)] section [6(c)] 6(d).
(e) Representation.--Notwithstanding any other provision of
law, in any action under subsection (a), the Administrator may
direct attorneys of the Environmental Protection Agency to
appear and represent the Administrator in such an action.
(f) Definition.--For the purposes of subsection (a), the term
``imminently hazardous chemical substance or mixture'' means a
chemical substance or mixture which presents an imminent [and
unreasonable] risk of serious or widespread injury to health or
the environment. Such a risk to health or the environment shall
be considered imminent if it is shown that the manufacture,
processing, distribution in commerce, use, or disposal of the
chemical substance or mixture, or that any combination of such
activities, is likely to result in such injury to health or the
environment before a final rule under section 6 can protect
against such risk.
SEC. 8. REPORTING AND RETENTION OF INFORMATION.
(a) Reports.--(1) The Administrator shall promulgate rules
under which--
(A) each person (other than a small manufacturer or
processor) who manufactures or processes or proposes to
manufacture or process a chemical substance (other than
a chemical substance described in subparagraph (B)(ii)
shall maintain such records, and shall submit to the
Administrator such reports, as the Administrator may
reasonably require, and
(B) each person (other than a small manufacturer or
processor) who manufactures or processes or proposes to
manufacture or process--
(i) a mixture, or
(ii) a chemical substance in small quantities
(as defined by the Administrator by rule)
solely for purposes of scientific
experimentation or analysis or chemical
research on, or analysis of, such substance or
another substance, including any such research
or analysis for the development of a product,
shall maintain records and submit to the Administrator
reports but only to the extent the Administrator
determines the maintenance of records or submission of
reports, or both, is necessary for the effective
enforcement of this Act.
The Administrator may not require in a rule promulgated under
this paragraph the maintenance of records or the submission of
reports with respect to changes in the proportions of the
components of a mixture unless the Administrator finds that the
maintenance of such records or the submission of such reports,
or both, is necessary for the effective enforcement of this
Act. For purposes of the compilation of the list of chemical
substances required under subsection (b), the Administrator
shall promulgate rules pursuant to this subsection not later
than 180 days after the effective date of this Act.
(2) The Administrator may require under paragraph (1)
maintenance of records and reporting with respect to the
following insofar as known to the person making the report or
insofar as reasonably ascertainable:
(A) The common or trade name, the chemical identity,
and molecular structure of each chemical substance or
mixture for which such a report is required.
(B) The categories or proposed categories of use of
each such substance or mixture.
(C) The total amount of each substance and mixture
manufactured or processed, reasonable estimates of the
total amount to be manufactured or processed, the
amount manufactured or processed for each of its
categories of use, and reasonable estimates of the
amount to be manufactured or processed for each of its
categories of use or proposed categories of use.
(D) A description of the byproducts resulting from
the manufacture, processing, use, or disposal of each
such substance or mixture.
(E) All existing data concerning the environmental
and health effects of such substance or mixture.
(F) The number of individuals exposed, and reasonable
estimates of the number who will be exposed, to such
substance or mixture in their places of employment and
the duration of such exposure.
(G) In the initial report under paragraph (1) on such
substance or mixture, the manner or method of its
disposal, and in any subsequent report on such
substance or mixture, any change in such manner or
method.
To the extent feasible, the Administrator shall not require
under paragraph (1), any reporting which is unnecessary or
duplicative.
(3)(A)(i) The Administrator may by rule require a small
manufacturer or processor of a chemical substance to submit to
the Administrator such information respecting the chemical
substance as the Administrator may require for publication of
the first list of chemical substances required by subsection
(b).
(ii) The Administrator may by rule require a small
manufacturer or processor of a chemical substance or mixture--
(I) subject to a rule proposed or promulgated under
section 4, [5(b)(4)] 5, or 6, or an order in effect
under section 4 or section [5(e),] 5(d)(4) or
(II) with respect to which relief has been granted
pursuant to a civil action brought under section 5 or
7,
to maintain such records on such substance or mixture, and to
submit to the Administrator such reports on such substance or
mixture, as the Administrator may reasonably require. A rule
under this clause requiring reporting may require reporting
with respect to the matters referred to in paragraph (2).
(B) The Administrator, after consultation with the
Administrator of the Small Business Administration, shall by
rule prescribe standards for determining the manufacturers and
processors which qualify as small manufacturers and processors
for purposes of this paragraph and paragraph (1).
(4) Rules.--
(A) Deadline.--
(i) In general.--Not later than 2
years after the date of enactment of
the Frank R. Lautenberg Chemical Safety
for the 21st Century Act, the
Administrator shall promulgate rules
requiring the maintenance of records
and the reporting of information known
or reasonably ascertainable by the
person making the report, including
rules requiring processors to report
information, so that the Administrator
has the information necessary to carry
out sections 4 and 6.
(ii) Modification of prior rules.--In
carrying out this subparagraph, the
Administrator may modify, as
appropriate, rules promulgated before
the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st
Century Act.
(B) Contents.--The rules promulgated pursuant
to subparagraph (A)--
(i) may impose different reporting
and recordkeeping requirements on
manufacturers and processors; and
(ii) shall include the level of
detail necessary to be reported,
including the manner by which use and
exposure information may be reported.
(C) Administration.--In implementing the
reporting and recordkeeping requirements under
this paragraph, the Administrator shall take
measures--
(i) to limit the potential for
duplication in reporting requirements;
(ii) to minimize the impact of the
rules on small manufacturers and
processors; and
(iii) to apply any reporting
obligations to those persons likely to
have information relevant to the
effective implementation of this title.
(5) Guidance.--The Administrator shall develop
guidance relating to the information required to be
reported under the rules promulgated under this
subsection.
(b) Inventory.--(1) The Administrator shall compile, keep
current, and publish a list of each chemical substance which is
manufactured or processed in the United States. Such list shall
at least include each chemical substance which any person
reports, under section 5 or subsection (a) of this section, is
manufactured or processed in the United States. Such list may
not include any chemical substance which was not manufactured
or processed in the United States within three years before the
effective date of the rules promulgated pursuant to the last
sentence of subsection (a)(1). In the case of a chemical
substance for which a notice is submitted in accordance with
section 5, such chemical substance shall be included in such
list as of the earliest date (as determined by the
Administrator) on which such substance was manufactured or
processed in the United States. The Administrator shall first
publish such a list not later than 315 days after the effective
date of this Act. The Administrator shall not include in such
list any chemical substance which is manufactured or processed
only in small quantities (as defined by the Administrator by
rule) solely for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such
substance or another substance, including such research or
analysis for the development of a product.
(2) To the extent consistent with the purposes of this Act,
the Administrator may, in lieu of listing, pursuant to
paragraph (1), a chemical substance individually, list a
category of chemical substances in which such substance is
included.
(3) Nomenclature.--
(A) In general.--In carrying out paragraph
(1), the Administrator shall--
(i) maintain the use of Class 2
nomenclature in use on the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act;
(ii) maintain the use of the Soap and
Detergent Association Nomenclature
System, published in March 1978 by the
Administrator in section 1 of addendum
III of the document entitled `Candidate
List of Chemical Substances', and
further described in the appendix A of
volume I of the 1985 edition of the
Toxic Substances Control Act Substances
Inventory (EPA Document No. EPA-560/7-
85-002a); and
(iii) treat all components of
categories that are considered to be
statutory mixtures under this Act as
being included on the list published
under paragraph (1) under the Chemical
Abstracts Service numbers for the
respective categories, including,
without limitation--
(I) cement, Portland,
chemicals, CAS No. 65997-15-1;
(II) cement, alumina,
chemicals, CAS No. 65997-16-2;
(III) glass, oxide,
chemicals, CAS No. 65997-17-3;
(IV) frits, chemicals, CAS
No. 65997-18-4;
(V) steel manufacture,
chemicals, CAS No. 65997-19-5;
and
(VI) ceramic materials and
wares, chemicals, CAS No.
66402-68-4.
(B) Multiple nomenclature conventions.--
(i) In general.--If an existing
guidance allows for multiple
nomenclature conventions, the
Administrator shall--
(I) maintain the nomenclature
conventions for substances; and
(II) develop new guidance
that--
(aa) establishes
equivalency between the
nomenclature
conventions for
chemical substances on
the list published
under paragraph (1);
and
(bb) permits persons
to rely on the new
guidance for purposes
of determining whether
a chemical substance is
on the list published
under paragraph (1).
(ii) Multiple cas numbers.--For any
chemical substance appearing multiple
times on the list under different
Chemical Abstracts Service numbers, the
Administrator shall develop guidance
recognizing the multiple listings as a
single chemical substance.
(4) Chemical substances in commerce.--
(A) Rules.--
(i) In general.--Not later than 1
year after the date of enactment of the
Frank R. Lautenberg Chemical Safety for
the 21st Century Act, the
Administrator, by rule, shall require
manufacturers and processors to notify
the Administrator, by not later than
180 days after the date of promulgation
of the rule, of each chemical substance
on the list published under paragraph
(1) that the manufacturer or processor,
as applicable, has manufactured or
processed for a nonexempt commercial
purpose during the 10-year period
ending on the day before the date of
enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act.
(ii) Active substances.--The
Administrator shall, pursuant to
paragraph (5)(A), designate chemical
substances for which notices are
received under clause (i) to be active
substances on the list published under
paragraph (1).
(B) Confidential chemical substances.--The
rule promulgated by the Administrator pursuant
to subparagraph (A) shall require--
(i) the Administrator to maintain the
list under paragraph (1), which shall
include a confidential portion and a
nonconfidential portion consistent with
this section and section 14;
(ii) a manufacturer or processor that
is submitting a notice pursuant to
subparagraph (A) for a chemical
substance on the confidential portion
of the list published under paragraph
(1) to indicate in the notice whether
the manufacturer or processor seeks to
maintain any existing claim for
protection against disclosure of the
specific identity of the substance as
confidential pursuant to section 14;
and
(iii) the substantiation of those
claims pursuant to section 14 and in
accordance with the review plan
described in subparagraph (C).
(C) Review plan.--Not later than 1 year after
the date on which the Administrator compiles
the initial list of active substances pursuant
to subparagraph (A), the Administrator shall
promulgate a rule that establishes a plan to
review all claims to protect the specific
identities of chemical substances on the
confidential portion of the list published
under paragraph (1) that are notified pursuant
to subparagraph (A) or identified as active
substances under subsection (f)(1).
(D) Requirements of review plan.--The review
plan under subparagraph (C) shall--
(i) require, at the time requested by
the Administrator, all manufacturers or
processors asserting claims under
subparagraph (B) to substantiate the
claim unless the manufacturer or
processor has substantiated the claim
in a submission made to the
Administrator during the 5-year period
ending on the date of the request by
the Administrator;
(ii) require the Administrator, in
accordance with section 14--
(I) to review each
substantiation--
(aa) submitted
pursuant to clause (i)
to determine if the
claim warrants
protection from
disclosure; and
(bb) submitted
previously by a
manufacturer or
processor and relied on
in lieu of the
substantiation required
pursuant to clause (i),
if the substantiation
has not been previously
reviewed by the
Administrator, to
determine if the claim
warrants protection
from disclosure;
(II) approve, modify, or deny
each claim; and
(III) except as provided in
this section and section 14,
protect from disclosure
information for which the
Administrator approves such a
claim for a period of 10 years,
unless, prior to the expiration
of the period--
(aa) the person
notifies the
Administrator that the
person is withdrawing
the confidentiality
claim, in which case
the Administrator shall
promptly make the
information available
to the public; or
(bb) the
Administrator otherwise
becomes aware that the
need for protection
from disclosure can no
longer be
substantiated, in which
case the Administrator
shall take the actions
described in section
14(g)(2); and
(iii) encourage manufacturers or
processors that have previously made
claims to protect the specific
identities of chemical substances
identified as inactive pursuant to
subsection (f)(2) to review and either
withdraw or substantiate the claims.
(E) Timeline for completion of reviews.--
(i) In general.--The Administrator
shall implement the review plan so as
to complete reviews of all claims
specified in subparagraph (C) not later
than 5 years after the date on which
the Administrator compiles the initial
list of active substances pursuant to
subparagraph (A).
(ii) Considerations.--
(I) In general.--The
Administrator may extend the
deadline for completion of the
reviews for not more than 2
additional years, after an
adequate public justification,
if the Administrator determines
that the extension is necessary
based on the number of
applicable claims needing
review and the available
resources.
(II) Annual goal.--The
Administrator shall publish an
annual goal for the number of
reviews to be completed over
the course of implementation of
the plan.
(5) Active and inactive substances.--
(A) In general.--The Administrator shall
maintain and keep current designations of
active substances and inactive substances on
the list published under paragraph (1).
(B) Update.--The Administrator shall update
the list of chemical substances designated as
active substances as soon as practicable after
the date of publication of the most recent data
reported under--
(i) part 711 of title 40, Code of
Federal Regulations (or successor
regulations); and
(ii) the rules promulgated pursuant
to subsection (a)(4).
(C) Change to active status.--
(i) In general.--Any person that
intends to manufacture or process for a
nonexempt commercial purpose a chemical
substance that is designated as an
inactive substance shall notify the
Administrator before the date on which
the inactive substance is manufactured
or processed.
(ii) Confidential chemical identity
claims.--If a person submitting a
notice under clause (i) for an inactive
substance on the confidential portion
of the list published under paragraph
(1) seeks to maintain an existing claim
for protection against disclosure of
the specific identity of the inactive
substance as confidential, the person
shall--
(I) in the notice submitted
under clause (i), assert the
claim; and
(II) by not later than 30
days after providing the notice
under clause (i), substantiate
the claim.
(iii) Active status.--On receiving a
notification under clause (i), the
Administrator shall--
(I) designate the applicable
chemical substance as an active
substance;
(II) pursuant to section 14,
promptly review any claim and
associated substantiation
submitted pursuant to clause
(ii) for protection against
disclosure of the specific
identity of the chemical
substance and approve, modify,
or deny the claim;
(III) except as provided in
this section and section 14,
protect from disclosure the
specific identity of the
chemical substance for which
the Administrator approves a
claim under subclause (II) for
a period of not less than 10
years, unless, prior to the
expiration of the period--
(aa) the person
notifies the
Administrator that the
person is withdrawing
the confidentiality
claim, in which case
the Administrator shall
promptly make the
information available
to the public; or
(bb) the
Administrator otherwise
becomes aware that the
need for protection
from disclosure can no
longer be
substantiated, in which
case the Administrator
shall take the actions
described in section
14(g)(2); and
(IV) pursuant to section 4A,
review the priority of the
chemical substance as the
Administrator determines to be
necessary.
(D) Category status.--The list of inactive
substances shall not be considered to be a
category for purposes of section 26(c).
(6) Interim list of active substances.--Prior to the
promulgation of the rule required under [this
subsection] paragraph (4)(A), the Administrator shall
designate the chemical substances reported under part
711 of title 40, Code of Federal Regulations (or
successor regulations), during the reporting period
that most closely preceded the date of enactment of the
Frank R. Lautenberg Chemical Safety for the 21st
Century Act, as the interim list of active substances
for the purposes of section 4A.
(7) Public participation.--Subject to this
subsection, the Administrator shall make available to
the public--
(A) the specific identity of each chemical
substance on the nonconfidential portion of the
list published under paragraph (1) that the
Administrator has designated as--
(i) an active substance; or
(ii) an inactive substance;
(B) the accession number, generic name, and,
if applicable, premanufacture notice case
number for each chemical substance on the
confidential portion of the list published
under paragraph (1) for which a claim of
confidentiality was received and approved by
the Administrator pursuant to section 14; and
(C) subject to section 14(g), the specific
identity of any active substance for which--
(i) no claim of protection against
disclosure of the specific identity of
the active substance pursuant to this
subsection was received;
(ii) a claim for protection against
disclosure of the specific identity of
the active substance has been denied by
the Administrator; or
(iii) the time period for protection
against disclosure of the specific
identity of the active substance has
expired.
(8) Limitation.--No person may assert a new claim
under this subsection for protection from disclosure of
a specific identity of any active or inactive chemical
substance for which a notice is received under
paragraph (4)(A)(i) or (5)(C)(i) that is not on the
confidential portion of the list published under
paragraph (1).
(9) Certification.--Under the [rule] rules
promulgated under this subsection, manufacturers and
processors shall be required--
(A) to certify that each report the
manufacturer or processor submits complies with
the requirements of the rule, and that any
confidentiality claims are true and correct;
and
(B) to retain a record supporting the
certification for a period of 5 years beginning
on the last day of the submission period.
* * * * * * *
(e) Notice to Administrator of Substantial Risks.--[Any
person]
(1) In general.--Any person who manufactures,
processes, or distributes in commerce a chemical
substance or mixture and who obtains information which
reasonably supports the conclusion that such substance
or mixture presents a substantial risk of injury to
health or the environment shall immediately inform the
Administrator of such information unless such person
has actual knowledge that the Administrator has been
adequately informed of such information.
(2) Applicability.--Any person may submit to the
Administrator information reasonably supporting the
conclusion that a chemical substance or mixture
presents, will present, or does not present a
substantial risk of injury to health and the
environment.
(f) Definitions.--[For purposes of this section, the] In this
section:
(1) Active substance.--The term `active substance'
means a chemical substance--
(A) that has been manufactured or processed
for a nonexempt commercial purpose at any point
during the 10-year period ending on the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act;
(B) that is added to the list published under
subsection (b)(1) after that date of enactment;
or
(C) for which a notice is received under
subsection (b)(5)(C).
(2) Inactive substance.--The term `inactive
substance' means a chemical substance on the list
published under subsection (b)(1) that does not meet
any of the criteria described in paragraph (1).
(3) Manufacture; process.--Theterms ``manufacture''
and ``process'' mean manufacture or process for
commercial purposes.
SEC. 9. RELATIONSHIP TO OTHER FEDERAL LAWS.
(a) Laws Not Administered by the Administrator.--(1) If the
Administrator has reasonable basis to conclude that the
manufacture, processing, distribution in commerce, use, or
disposal of a chemical substance or mixture, or that any
combination of such activities, [presents or will present an
unreasonable risk of injury to health or the environment] does
not meet the safety standard and determines, in the
Administrator's discretion, that [such risk] the risk posed by
the substance or mixture may be prevented or reduced to a
sufficient extent by action taken under a Federal law not
administered by the Administrator, the Administrator shall
submit to the agency which administers such law a report which
describes such risk and includes in such description a
specification of the activity or combination of activities
which the Administrator has reason to believe so presents such
risk. Such report shall also request such agency--
(A)(i) to determine if the risk described in such
report may be prevented or reduced to a sufficient
extent by action taken under such law, and
(ii) if the agency determines that such risk may be
so prevented or reduced, to issue an order declaring
whether or not the activity or combination of
activities specified in the description of such risk
presents such risk; and
(B) to respond to the Administrator with respect to
the matters described in subparagraph (A).
Any report of the Administrator shall include a detailed
statement of the information on which it is based and shall be
published in the Federal Register. The agency receiving a
request under such a report shall make the requested
determination, issue the requested order, and make the
requested response within such time as the Administrator
specifies in the request, but such time specified may not be
less than 90 days from the date the request was made. The
response of an agency shall be accompanied by a detailed
statement of the findings and conclusions of the agency and
shall be published in the Federal Register.
(2) If the Administrator makes a report under paragraph (1)
with respect to a chemical substance or mixture and the agency
to which such report was made either--
(A) issues an order declaring that the activity or
combination of activities specified in the description
of the risk described in the report does not present
the risk described in the report, or
(B) initiates, within 90 days of the publication in
the Federal Register of the response of the agency
under paragraph (1), action under the law (or laws)
administered by such agency to protect against such
risk associated with such activity or combination of
activities,
the Administrator may not take any action under [section 6 or
7] section 6(d) or section 7 with respect to such risk.
(3) If the Administrator has initiated action under [section
6 or 7] section 6(d) or 7 with respect to a risk associated
with a chemical substance or mixture which was the subject of a
report made to an agency under paragraph (1), such agency shall
before taking action under the law (or laws) administered by it
to protect against such risk consult with the Administrator for
the purpose of avoiding duplication of Federal action against
such risk.
(b) Laws Administered by the Administrator.--The
Administrator shall coordinate actions taken under this Act
with actions taken under other Federal laws administered in
whole or in part by the Administrator. If the Administrator
determines that a risk to health or the environment associated
with a chemical substance or mixture could be eliminated or
reduced to a sufficient extent by actions taken under the
authorities contained in such other Federal laws, the
Administrator shall use such authorities to protect against
such risk unless the Administrator determines, in the
Administrator's discretion, that it is in the public interest
to protect against such risk by actions taken under this Act.
This subsection shall not be construed to relieve the
Administrator of any requirement imposed on the Administrator
by such other Federal laws.
(c) Occupational Safety and Health.--In exercising any
authority under this Act, the Administrator shall not, for
purposes of section 4(b)(1) of the Occupational Safety and
Health Act of 1970, be deemed to be exercising statutory
authority to prescribe or enforce standards or regulations
affecting occupational safety and health.
(d) Coordination.--In administering this Act, the
Administrator shall consult and coordinate with the Secretary
of [Health, Education, and Welfare] Health and Human Services
and the heads of any other appropriate Federal executive
department or agency, any relevant independent regulatory
agency, and any other appropriate instrumentality of the
Federal Government for the purpose of achieving the maximum
enforcement of this Act while imposing the least burdens of
duplicative requirements on those subject to the Act and for
other purposes. The Administrator shall, in the report required
by section 30, report annually to the Congress on actions taken
to coordinate with such other Federal departments, agencies, or
instrumentalities, and on actions taken to coordinate the
authority under this Act with the authority granted under other
Acts referred to in subsection (b).
(e) Exposure Information.--If the Administrator obtains
information related to exposures or releases of a chemical
substance that may be prevented or reduced under another
Federal law, including laws not administered by the
Administrator, the Administrator shall make such information
available to the relevant Federal agency or office of the
Environmental Protection Agency.
SEC. 10. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMINATION AND
UTILIZATION OF DATA.
(a) Authority.--The Administrator shall, in consultation and
cooperation with the Secretary of [Health, Education, and
Welfare] Health and Human Services and with other heads of
appropriate departments and agencies, conduct such research,
development, and monitoring as is necessary to carry out the
purposes of this Act. The Administrator may enter into
contracts and may make grants for research, development, and
monitoring under this subsection. Contracts may be entered into
under this subsection without regard to sections 3648 and 3709
of the Revised Statutes (31 U.S.C. 529, 14 U.S.C. 5).
(b) Data Systems.--(1) The Administrator shall establish,
administer, and be responsible for the continuing activities of
an interagency committee which shall design, establish, and
coordinate an efficient and effective system, within the
Environmental Protection Agency, for the collection,
dissemination to other Federal departments and agencies, and
use of data submitted to the Administrator under this Act.
(2)(A) The Administrator shall, in consultation and
cooperation with the Secretary of [Health, Education, and
Welfare] Health and Human Services and other heads of
appropriate departments and agencies design, establish, and
coordinate an efficient and effective system for the retrieval
of toxicological and other scientific data which could be
useful to the Administrator in carrying out the purposes of
this Act. Systematized retrieval shall be developed for use by
all Federal and other departments and agencies with
responsibilities in the area of regulation or study of chemical
substances and mixtures and their effect on health or the
environment.
(B) The Administrator, in consultation and cooperation with
the Secretary of [Health, Education, and Welfare] Health and
Human Services, may make grants and enter into contracts for
the development of a data retrieval system described in
subparagraph (A). Contracts may be entered into under this
subparagraph without regard to sections 3648 and 3709 of the
Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5).
(c) Screening Techniques.--The Administrator shall
coordinate, with the Assistant Secretary for Health of the
Department of [Health, Education, and Welfare] Health and Human
Services, research undertaken by the Administrator and directed
toward the development of rapid, reliable, and economical
screening techniques for carcinogenic, mutagenic, teratogenic,
and ecological effects of chemical substances and mixtures.
(d) Monitoring.--The Administrator shall, in consultation and
cooperation with the Secretary of [Health, Education, and
Welfare] Health and Human Services, establish and be
responsible for research aimed at the development, in
cooperation with local, State, and Federal agencies, of
monitoring techniques and instruments which may be used in the
detection of toxic chemical substances and mixtures and which
are reliable, economical, and capable of being implemented
under a wide variety of conditions.
(e) Basic Research.--The Administrator shall, in consultation
and cooperation with the Secretary of [Health, Education, and
Welfare] Health and Human Services, establish research programs
to develop the fundamental scientific basis of the screening
and monitoring techniques described in subsections (c) and (d),
the bounds of the reliability of such techniques, and the
opportunities for their improvement.
(f) Training.--The Administrator shall establish and promote
programs and workshops to train or facilitate the training of
Federal laboratory and technical personnel in existing or newly
developed screening and monitoring techniques.
(g) Exchange of Research and Development Results.--The
Administrator shall, in consultation with the Secretary of
[Health, Education, and Welfare] Health and Human Services and
other heads of appropriate departments and agencies, establish
and coordinate a system for exchange among Federal, State, and
local authorities of research and development results
respecting toxic chemical substances and mixtures, including a
system to facilitate and promote the development of standard
data format and analysis and consistent testing procedures.
* * * * * * *
SEC. 12. EXPORTS.
(a) In General.--(1) Except as provided in paragraph (2) and
subsections (b) and (c), this Act (other than section 8) shall
not apply to any chemical substance, mixture, or to an article
containing a chemical substance or mixture, if--
(A) it can be shown that such substance, mixture, or
article is being manufactured, processed, or
distributed in commerce for export from the United
States, unless such substance, mixture, or article was,
in fact, manufactured, processed, or distributed in
commerce, for use in the United States, and
(B) such substance, mixture, or article (when
distributed in commerce), or any container in which it
is enclosed (when so distributed), bears a stamp or
label stating that such substance, mixture, or article
is intended for export.
[(2) Paragraph (1) shall not apply to any chemical substance,
mixture, or article if the Administrator finds that the
substance, mixture, or article will present an unreasonable
risk of injury to health within the United States or to the
environment of the United States. The Administrator may
require, under section 4, testing of any chemical substance or
mixture exempted from this Act by paragraph (1) for the purpose
of determining whether or not such substance or mixture
presents an unreasonable risk of injury to health within the
United States or to the environment of the United States.]
(2) Exception.--Paragraph (1) shall not apply to any
chemical substance that the Administrator determines--
(A) under section 5 is not likely to meet the
safety standard; or
(B) under section 6 does not meet the safety
standard.
(3) Waivers.--For a mixture or article containing a
chemical substance described in paragraph (2), the
Administrator may--
(A) determine that paragraph (1) shall not
apply to the mixture or article; or
(B) establish a threshold concentration in a
mixture or article at which paragraph (1) shall
not apply.
(4) Testing.--The Administrator may require testing
under section 4 of any chemical substance or mixture
exempted from this Act under paragraph (1) for the
purpose of determining whether the chemical substance
or mixture meets the safety standard within the United
States.
[(b) Notice.--[(1) If any person exports or intends to export
to a foreign country a chemical substance or mixture for which
the submission of data is required under section 4 or 5(b),
such person shall notify the Administrator of such exportation
or intent to export and the Administrator shall furnish to the
government of such country notice of the availability of the
data submitted to the Administrator under such section for such
substance or mixture.
[(2) If any person exports or intends to export to a foreign
country a chemical substance or mixture for which an order has
been issued under section 5 or a rule has been proposed or
promulgated under section 5 or 6, or with respect to which an
action is pending, or relief has been granted under section 5
or 7, such person shall notify the Administrator of such
exportation or intent to export and the Administrator shall
furnish to the government of such country notice of such rule,
order, action, or relief.]
(b) Notice.--
(1) In general.--A person shall notify the
Administrator that the person is exporting or intends
to export to a foreign country--
(A) a chemical substance or a mixture
containing a chemical substance that the
Administrator has determined under section 5 is
not likely to meet the safety standard and for
which a prohibition or other restriction has
been proposed or established under that
section;
(B) a chemical substance or a mixture
containing a chemical substance that the
Administrator has determined under section 6
does not meet the safety standard and for which
a prohibition or other restriction has been
proposed or established under that section;
(C) a chemical substance for which the United
States is obligated by treaty to provide export
notification;
(D) a chemical substance or mixture subject
to a significant new use rule, or a prohibition
or other restriction pursuant to a rule, order,
or consent agreement in effect under this Act;
or
(E) a chemical substance or mixture for which
the submission of information is required under
section 4.
(2) Rules.--
(A) In general.--The Administrator shall
promulgate rules to carry out paragraph (1).
(B) Contents.--The rules promulgated pursuant
to subparagraph (A) shall--
(i) include such exemptions as the
Administrator determines to be
appropriate, which may include
exemptions identified under section
5(h); and
(ii) indicate whether, or to what
extent, the rules apply to articles
containing a chemical substance or
mixture described in paragraph (1).
(3) Notification.--The Administrator shall submit to
the government of each country to which a chemical
substance or mixture is exported--
(A) for a chemical substance or mixture
described in subparagraph (A), (B), or (D) of
paragraph (1), a notice of the determination,
rule, order, consent agreement, requirement, or
designation;
(B) for a chemical substance described in
paragraph (1)(C), a notice that satisfies the
obligation of the United States under the
applicable treaty; and
(C) for a chemical substance or mixture
described in paragraph (1)(E), a notice of
availability of the information on the chemical
substance or mixture submitted to the
Administrator.
(c) Prohibition on Export of Elemental Mercury.--
(1) Prohibition.--Effective January 1, 2013, the
export of elemental mercury from the United States is
prohibited.
(2) Inapplicability of subsection (a).--Subsection
(a) shall not apply to this subsection.
[(3) Report to congress on mercury compounds.--
[(A) Report.--Not later than one year after
the date of enactment of the Mercury Export Ban
Act of 2008, the Administrator shall publish
and submit to Congress a report on mercuric
chloride, mercurous chloride or calomel,
mercuric oxide, and other mercury compounds, if
any, that may currently be used in significant
quantities in products or processes. Such
report shall include an analysis of--
[(i) the sources and amounts of each
of the mercury compounds imported into
the United States or manufactured in
the United States annually;
[(ii) the purposes for which each of
these compounds are used domestically,
the amount of these compounds currently
consumed annually for each purpose, and
the estimated amounts to be consumed
for each purpose in 2010 and beyond;
[(iii) the sources and amounts of
each mercury compound exported from the
United States annually in each of the
last three years;
[(iv) the potential for these
compounds to be processed into
elemental mercury after export from the
United States; and
[(v) other relevant information that
Congress should consider in determining
whether to extend the export
prohibition to include one or more of
these mercury compounds.
[(B) Procedure.--For the purpose of preparing
the report under this paragraph, the
Administrator may utilize the information
gathering authorities of this title, including
sections 10 and 11.]
[(4)] (3) Essential use exemption.--(A) Any person
residing in the United States may petition the
Administrator for an exemption from the prohibition in
paragraph (1), and the Administrator may grant by rule,
after notice and opportunity for comment, an exemption
for a specified use at an identified foreign facility
if the Administrator finds that--
(i) nonmercury alternatives for the specified
use are not available in the country where the
facility is located;
(ii) there is no other source of elemental
mercury available from domestic supplies (not
including new mercury mines) in the country
where the elemental mercury will be used;
(iii) the country where the elemental mercury
will be used certifies its support for the
exemption;
(iv) the export will be conducted in such a
manner as to ensure the elemental mercury will
be used at the identified facility as described
in the petition, and not otherwise diverted for
other uses for any reason;
(v) the elemental mercury will be used in a
manner that will protect human health and the
environment, taking into account local,
regional, and global human health and
environmental impacts;
(vi) the elemental mercury will be handled
and managed in a manner that will protect human
health and the environment, taking into account
local, regional, and global human health and
environmental impacts; and
(vii) the export of elemental mercury for the
specified use is consistent with international
obligations of the United States intended to
reduce global mercury supply, use, and
pollution.
(B) Each exemption issued by the Administrator
pursuant to this paragraph shall contain such terms and
conditions as are necessary to minimize the export of
elemental mercury and ensure that the conditions for
granting the exemption will be fully met, and shall
contain such other terms and conditions as the
Administrator may prescribe. No exemption granted
pursuant to this paragraph shall exceed three years in
duration and no such exemption shall exceed 10 metric
tons of elemental mercury.
(C) The Administrator may by order suspend or cancel
an exemption under this paragraph in the case of a
violation described in subparagraph (D).
(D) A violation of this subsection or the terms and
conditions of an exemption, or the submission of false
information in connection therewith, shall be
considered a prohibited act under section 15, and shall
be subject to penalties under section 16, injunctive
relief under section 17, and citizen suits under
section 20.
[(5)] (4) Consistency with trade obligations.--
Nothing in this subsection affects, replaces, or amends
prior law relating to the need for consistency with
international trade obligations.
[(6)] (5) Export of coal.--Nothing in this subsection
shall be construed to prohibit the export of coal.
* * * * * * *
[SEC. 14. DISCLOSURE OF DATA.
[(a) In General.--Except as provided by subsection (b), any
information reported to, or otherwise obtained by, the
Administrator (or any representative of the Administrator)
under this Act, which is exempt from disclosure pursuant to
subsection (a) of section 552 of title 5, United States Code,
by reason of subsection (b)(4) of such section, shall,
notwithstanding the provisions of any other section of this
Act, not be disclosed by the Administrator or by any officer or
employee of the United States, except that such information--
[(1) shall be disclosed to any officer or employee of
the United States--
[(A) in connection with the official duties
of such officer or employee under any law for
the protection of health or the environment, or
[(B) for specific law enforcement purposes;
[(2) shall be disclosed to contractors with the
United States and employees of such contractors if in
the opinion of the Administrator such disclosure is
necessary for the satisfactory performance by the
contractor of a contract with the United States entered
into on or after the date of enactment of this Act for
the performance of work in connection with this Act and
under such conditions as the Administrator may specify;
[(3) shall be disclosed if the Administrator
determines it necessary to protect health or the
environment against an unreasonable risk of injury to
health or the environment; or
[(4) may be disclosed when relevant in any proceeding
under this Act, except that disclosure in such a
proceeding shall be made in such manner as to preserve
confidentiality to the extent practicable without
impairing the proceeding.
[In any proceeding under section 552(a) of title 5, United
States Code, to obtain information the disclosure of which has
been denied because of the provisions of this subsection, the
Administrator may not rely on section 552(b)(3) of such title
to sustain the Administrator's action.
[(b) Data From Health and Safety Studies.--(1) Subsection (a)
does not prohibit the disclosure of--
[(A) any health and safety study which is submitted
under this Act with respect to--
[(i) any chemical substance or mixture which,
on the date on which such study is to be
disclosed has been offered for commercial
distribution, or
[(ii) any chemical substance or mixture for
which testing is required under section 4 or
for which notification is required under
section 5, and
[(B) any data reported to, or otherwise obtained by,
the Administrator from a health and safety study which
relates to a chemical substance or mixture described in
clause (i) or (ii) of subparagraph (A).
This paragraph does not authorize the release of any data which
discloses processes used in the manufacturing or processing of
a chemical substance or mixture or, in the case of a mixture,
the release of data disclosing the portion of the mixture
comprised by any of the chemical substances in the mixture.
[(2) If a request is made to the Administrator under
subsection (a) of section 552 of title 5, United States Code,
for information which is described in the first sentence of
paragraph (1) and which is not information described in the
second sentence of such paragraph, the Administrator may not
deny such request on the basis of subsection (b)(4) of such
section.
[(c) Designation and Release of Confidential Data.--[(1) In
submitting data under this Act, a manufacturer, processor, or
distributor in commerce may (A) designate the data which such
person believes is entitled to confidential treatment under
subsection (a), and (B) submit such designated data separately
from other data submitted under this Act. A designation under
this paragraph shall be made in writing and in such manner as
the Administrator may prescribe.
[(2)(A) Except as provided by subparagraph (B), if the
Administrator proposes to release for inspection data which has
been designated under paragraph (1)(A), the Administrator shall
notify, in writing and by certified mail, the manufacturer,
processor, or distributor in commerce who submitted such data
of the intent to release such data. If the release of such data
is to be made pursuant to a request made under section 552(a)
of title 5, United States Code, such notice shall be given
immediately upon approval of such request by the Administrator.
The Administrator may not release such data until the
expiration of 30 days after the manufacturer, processor, or
distributor in commerce submitting such data has received the
notice required by this subparagraph.
[(B)(i) Subparagraph (A) shall not apply to the release of
information under paragraph (1), (2), (3), or (4) of subsection
(a), except that the Administrator may not release data under
paragraph (3) of subsection (a) unless the Administrator has
notified each manufacturer, processor, and distributor in
commerce who submitted such data of such release. Such notice
shall be made in writing by certified mail at least 15 days
before the release of such data, except that if the
Administrator determines that the release of such data is
necessary to protect against an imminent, unreasonable risk of
injury to health or the environment, such notice may be made by
such means as the Administrator determines will provide notice
at least 24 hours before such release is made.
[(ii) Subparagraph (A) shall not apply to the release of
information described in subsection (b)(1) other than
information described in the second sentence of such
subsection.
[(d) Criminal Penalty for Wrongful Disclosure.--[(1) Any
officer or employee of the United States or former officer or
employee of the United States, who by virtue of such employment
or official position has obtained possession of, or has access
to, material the disclosure of which is prohibited by
subsection (a), and who knowing that disclosure of such
material is prohibited by such subsection, willfully
disclosures the material in any manner to any person not
entitled to receive it, shall be guilty of a misdemeanor and
fined not more than $5,000 or imprisoned for not more than one
year, or both. Section 1905 of title 18, United States Code,
does not apply with respect to the publishing, divulging,
disclosure, or making known of, or making available,
information reported or otherwise obtained under this Act.
[(2) For the purposes of paragraph (1), any contractor with
the United States who is furnished information as authorized by
subsection (a)(2), and any employee of any such contractor,
shall be considered to be an employee of the United States.
[(e) Access by Congress.--Notwithstanding any limitation
contained in this section or any other provision of law, all
information reported to or otherwise obtained by the
Administrator (or any representative of the Administrator)
under this Act shall be made available, upon written request of
any duly authorized committee of the Congress, to such
committee.]
SEC. 14. CONFIDENTIAL INFORMATION.
(a) In General.--Except as otherwise provided in this
section, the Administrator shall not disclose information that
is exempt from disclosure pursuant to subsection (a) of section
552 of title 5, United States Code, under subsection (b)(4) of
that section--
(1) that is reported to, or otherwise obtained by,
the Administrator under this Act; and
(2) for which the requirements of subsection (d) are
met.
(b) Information Generally Protected From Disclosure.--The
following information specific to, and submitted by, a
manufacturer, processor, or distributor that meets the
requirements of subsections (a) and (d) shall be presumed to be
protected from disclosure, subject to the condition that
nothing in this Act prohibits the disclosure of any such
information, or information that is the subject of subsection
(g)(3), through discovery, subpoena, other court order, or any
other judicial process otherwise allowed under applicable
Federal or State law:
(1) Specific information describing the processes
used in manufacture or processing of a chemical
substance, mixture, or article.
(2) Marketing and sales information.
(3) Information identifying a supplier or customer.
(4) Details of the full composition of a mixture and
the respective percentages of constituents.
(5) Specific information regarding the use, function,
or application of a chemical substance or mixture in a
process, mixture, or product.
(6) Specific production or import volumes of the
manufacturer and specific aggregated volumes across
manufacturers, if the Administrator determines that
disclosure of the specific aggregated volumes would
reveal confidential information.
(7) Except as otherwise provided in this section, the
specific identity of a chemical substance prior to the
date on which the chemical substance is first offered
for commercial distribution, including the chemical
name, molecular formula, Chemical Abstracts Service
number, and other information that would identify a
specific chemical substance, if--
(A) the specific identity was claimed as
confidential information at the time it was
submitted in a notice under section 5; and
(B) the claim--
(i) is not subject to an exception
under subsection (e); or
(ii) has not subsequently been
withdrawn or found by the Administrator
not to warrant protection as
confidential information under
subsection (f)(2) or (g).
(c) Information Not Protected From Disclosure.--
Notwithstanding subsections (a) and (b), the following
information shall not be protected from disclosure:
(1) Information from health and safety studies.--
(A) In general.--Subject to subparagraph (B),
subsection (a) does not prohibit the disclosure
of--
(i) any health and safety study that
is submitted under this Act with
respect to--
(I) any chemical substance or
mixture that, on the date on
which the study is to be
disclosed, has been offered for
commercial distribution; or
(II) any chemical substance
or mixture for which--
(aa) testing is
required under section
4; or
(bb) a notification
is required under
section 5; or
(ii) any information reported to, or
otherwise obtained by, the
Administrator from a health and safety
study relating to a chemical substance
or mixture described in subclause (I)
or (II) of clause (i).
(B) Effect of paragraph.--Nothing in this
paragraph authorizes the release of any
information that discloses--
(i) a process used in the
manufacturing or processing of a
chemical substance or mixture; or
(ii) in the case of a mixture, the
portion of the mixture comprised by any
chemical substance in the mixture.
(2) Certain requests.--If a request is made to the
Administrator under section 552(a) of title 5, United
States Code, for information that is described in
paragraph (1) that is not described in paragraph
(1)(B), the Administrator may not deny the request on
the basis of section 552(b)(4) of title 5, United
States Code.
(3) Other information not protected from
disclosure.--The following information is not protected
from disclosure under this section:
``(A) For information submitted after the
date of enactment of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, the
specific identity of a chemical substance as of
the date on which the chemical substance is
first offered for commercial distribution, if
the person submitting the information does not
meet the requirements of subsection (d).
(B) A safety assessment developed, or a
safety determination made, under section 6.
(C) Any general information describing the
manufacturing volumes, expressed as specific
aggregated volumes or, if the Administrator
determines that disclosure of specific
aggregated volumes would reveal confidential
information, expressed in ranges.
(D) A general description of a process used
in the manufacture or processing and
industrial, commercial, or consumer functions
and uses of a chemical substance, mixture, or
article containing a chemical substance or
mixture, including information specific to an
industry or industry sector that customarily
would be shared with the general public or
within an industry or industry sector.
(4) Mixed confidential and nonconfidential
information .--Any information that is otherwise
eligible for protection under this section and
contained in a submission of information described in
this subsection shall be protected from disclosure, if
the submitter complies with subsection (d), subject to
the condition that information in the submission that
is not eligible for protection against disclosure shall
be disclosed.
(5) Ban or phase-out.--If the Administrator
promulgates a rule pursuant to section 6(d) that
establishes a ban or phase-out of the manufacture,
processing, or distribution in commerce of a chemical
substance, subject to paragraphs (2), (3), and (4) of
subsection (g), any protection from disclosure provided
under this section with respect to the specific
identity of the chemical substance and other
information relating to the chemical substance shall no
longer apply.
(d) Requirements for Confidentiality Claims.--
(1) Assertion of claims.--
(A) In general.--A person seeking to protect
any information submitted under this Act from
disclosure (including information described in
subsection (b)) shall assert to the
Administrator a claim for protection concurrent
with submission of the information, in
accordance with such rules regarding a claim
for protection from disclosure as the
Administrator has promulgated or may promulgate
pursuant to this title.
(B) Inclusion.--An assertion of a claim under
subparagraph (A) shall include a statement that
the person has--
(i) taken reasonable measures to
protect the confidentiality of the
information;
(ii) determined that the information
is not required to be disclosed or
otherwise made available to the public
under any other Federal law;
(iii) a reasonable basis to conclude
that disclosure of the information is
likely to cause substantial harm to the
competitive position of the person; and
(iv) a reasonable basis to believe
that the information is not readily
discoverable through reverse
engineering.
(C) Specific chemical identity.--In the case
of a claim under subparagraph (A) for
protection against disclosure of a specific
chemical identity, the claim shall include a
structurally descriptive generic name for the
chemical substance that the Administrator may
disclose to the public, subject to the
condition that the generic name shall--
(i) conform with guidance prescribed
by the Administrator under paragraph
(3)(A); and
(ii) describe the chemical structure
of the substance as specifically as
practicable while protecting those
features of the chemical structure--
(I) that are considered to be
confidential; and
(II) the disclosure of which
would be likely to harm the
competitive position of the
person.
(D) Public information.--No person may assert
a claim under this section for protection from
disclosure of information that is already
publicly available.
(2) Additional requirements for confidentiality
claims.--Except for information described in paragraphs
(1) through (7) of subsection (b), a person asserting a
claim to protect information from disclosure under this
Act shall substantiate the claim, in accordance with
the rules promulgated and guidance issued by the
Administrator.
(3) Guidance.--The Administrator shall develop
guidance regarding--
(A) the determination of structurally
descriptive generic names, in the case of
claims for the protection against disclosure of
specific chemical identity; and
(B) the content and form of the statements of
need and agreements required under paragraphs
(4), (5), and (6) of subsection (e).
(4) Certification.--An authorized official of a
person described in paragraph (1)(A) shall certify that
the information that has been submitted is true and
correct.
(e) Exceptions to Protection From Disclosure.--Information
described in subsection (a)--
(1) shall be disclosed if the information is to be
disclosed to an officer or employee of the United
States in connection with the official duties of the
officer or employee--
(A) under any law for the protection of
health or the environment; or
(B) for a specific law enforcement purpose;
(2) shall be disclosed if the information is to be
disclosed to a contractor of the United States and
employees of that contractor--
(A) if, in the opinion of the Administrator,
the disclosure is necessary for the
satisfactory performance by the contractor of a
contract with the United States for the
performance of work in connection with this
Act; and
(B) subject to such conditions as the
Administrator may specify;
(3) shall be disclosed if the Administrator
determines that disclosure is necessary to protect
health or the environment;
(4) shall be disclosed if the information is to be
disclosed to a State or political subdivision of a
State, on written request, for the purpose of
development, administration, or enforcement of a law,
if--
(A) 1 or more applicable agreements with the
Administrator that conform with the guidance
issued under subsection (d)(3)(B) ensure that
the recipient will take appropriate measures,
and has adequate authority, to maintain the
confidentiality of the information in
accordance with procedures comparable to the
procedures used by the Administrator to
safeguard the information; and
(B) the Administrator notifies the person
that submitted the information that the
information has been disclosed to the State or
political subdivision of a State;
(5) shall be disclosed if a health or environmental
professional employed by a Federal or State agency or a
treating physician or nurse in a nonemergency situation
provides a written statement of need and agrees to sign
a written confidentiality agreement with the
Administrator, subject to the conditions that--
(A) the statement of need and confidentiality
agreement shall conform with the guidance
issued under subsection (d)(3)(B);
(B) the written statement of need shall be a
statement that the person has a reasonable
basis to suspect that--
(i) the information is necessary for,
or will assist in--
(I) the diagnosis or
treatment of 1 or more
individuals; or
(II) responding to an
environmental release or
exposure; and
(ii) 1 or more individuals being
diagnosed or treated have been exposed
to the chemical substance concerned, or
an environmental release or exposure
has occurred; and
(C) the confidentiality agreement shall
provide that the person will not use the
information for any purpose other than the
health or environmental needs asserted in the
statement of need, except as otherwise may be
authorized by the terms of the agreement or by
the person submitting the information to the
Administrator, except that nothing in this Act
prohibits the disclosure of any such
information through discovery, subpoena, other
court order, or any other judicial process
otherwise allowed under applicable Federal or
State law;
(6) shall be disclosed if in the event of an
emergency, a treating physician, nurse, agent of a
poison control center, public health or environmental
official of a State or political subdivision of a
State, or first responder (including any individual
duly authorized by a Federal agency, State, or
political subdivision of a State who is trained in
urgent medical care or other emergency procedures,
including a police officer, firefighter, or emergency
medical technician) requests the information, subject
to the conditions that--
(A) the treating physician, nurse, agent,
public health or environmental official of a
State or a political subdivision of a State, or
first responder shall have a reasonable basis
to suspect that--
(i) a medical or public health or
environmental emergency exists;
(ii) the information is necessary
for, or will assist in, emergency or
first-aid diagnosis or treatment; or
(iii) 1 or more individuals being
diagnosed or treated have likely been
exposed to the chemical substance
concerned, or a serious environmental
release of or exposure to the chemical
substance concerned has occurred;
(B) if requested by the person submitting the
information to the Administrator, the treating
physician, nurse, agent, public health or
environmental official of a State or a
political subdivision of a State, or first
responder shall, as described in paragraph
(5)--
(i) provide a written statement of
need; and
(ii) agree to sign a confidentiality
agreement; and
(C) the written confidentiality agreement or
statement of need shall be submitted as soon as
practicable, but not necessarily before the
information is disclosed;
(7) may be disclosed if the Administrator determines
that disclosure is relevant in a proceeding under this
Act, subject to the condition that the disclosure shall
be made in such a manner as to preserve confidentiality
to the maximum extent practicable without impairing the
proceeding;
(8) shall be disclosed if the information is to be
disclosed, on written request of any duly authorized
congressional committee, to that committee; or
(9) shall be disclosed if the information is required
to be disclosed or otherwise made public under any
other provision of Federal law.
(f) Duration of Protection From Disclosure.--
(1) In general.--
(A) Information protected from disclosure.--
Subject to paragraph (2), the Administrator
shall protect from disclosure information that
meets the requirements of subsection (d) for a
period of 10 years, unless, prior to the
expiration of the period--
(i) an affected person notifies the
Administrator that the person is
withdrawing the confidentiality claim,
in which case the Administrator shall
promptly make the information available
to the public; or
(ii) the Administrator otherwise
becomes aware that the need for
protection from disclosure can no
longer be substantiated, in which case
the Administrator shall take the
actions described in subsection (g)(2).
(B) Extensions.--
(i) In general.--Not later than the
date that is 60 days before the
expiration of the period described in
subparagraph (A), the Administrator
shall provide to the person that
asserted the claim a notice of the
impending expiration of the period.
(ii) Statement.--
(I) In general.--Not later
than the date that is 30 days
before the expiration of the
period described in
subparagraph (A), a person
reasserting the relevant claim
shall submit to the
Administrator a statement
substantiating, in accordance
with subsection (d)(2), the
need to extend the period.
(II) Action by
administrator.--Not later than
the date that is 30 days after
the date of receipt of a
statement under subclause (I),
the Administrator shall--
(aa) review the
request;
(bb) make a
determination regarding
whether the information
for which the request
is made continues to
meet the relevant
criteria established
under this section; and
(cc)(AA) grant an
extension of not more
than 10 years; or
(BB) deny the claim.
(C) No limit on number of extensions.--There
shall be no limit on the number of extensions
granted under subparagraph (B), if the
Administrator determines that the relevant
statement under subparagraph (B)(ii)(I)--
(i) establishes the need to extend
the period; and
(ii) meets the requirements
established by the Administrator.
(2) Review and resubstantiation.--
(A) Discretion of administrator.--The
Administrator may review, at any time, a claim
for protection against disclosure under
subsection (a) for information submitted to the
Administrator regarding a chemical substance
and require any person that has claimed
protection for that information, whether
before, on, or after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the
21st Century Act, to withdraw or reassert and
substantiate or resubstantiate the claim in
accordance with this section--
(i) after the chemical substance is
identified as a high-priority substance
under section 4A;
(ii) for any chemical substance for
which the Administrator has made a
determination under section 6(c)(1)(C);
(iii) for any inactive chemical
substance identified under section
8(b)(5); or
(iv) in limited circumstances, if the
Administrator determines that
disclosure of certain information
currently protected from disclosure
would assist the Administrator in
conducting safety assessments and
safety determinations under subsections
(b) and (c) of section 6 or
promulgating rules pursuant to section
6(d), subject to the condition that the
information shall not be disclosed
unless the claimant withdraws the claim
or the Administrator determines that
the information does not meet the
requirements of subsection (d).
(B) Review required.--The Administrator shall
review a claim for protection from disclosure
under subsection (a) for information submitted
to the Administrator regarding a chemical
substance and require any person that has
claimed protection for that information,
whether before, on, or after the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, to withdraw or
reassert and substantiate or resubstantiate the
claim in accordance with this section--
(i) as necessary to comply with a
request for information received by the
Administrator under section 552 of
title 5, United States Code;
(ii) if information available to the
Administrator provides a basis that the
requirements of section 552(b)(4) of
title 5, United States Code, are no
longer met; or
(iii) for any substance for which the
Administrator has made a determination
under section 6(c)(1)(B).
(C) Action by recipient.--If the
Administrator makes a request under
subparagraph (A) or (B), the recipient of the
request shall--
(i) reassert and substantiate or
resubstantiate the claim; or
(ii) withdraw the claim.
(D) Period of protection.--Protection from
disclosure of information subject to a claim
that is reviewed and approved by the
Administrator under this paragraph shall be
extended for a period of 10 years from the date
of approval, subject to any subsequent request
by the Administrator under this paragraph.
(3) Unique identifier.--The Administrator shall--
(A)(i) develop a system to assign a unique
identifier to each specific chemical identity
for which the Administrator approves a request
for protection from disclosure, other than a
specific chemical identity or structurally
descriptive generic term; and
(ii) apply that identifier consistently to
all information relevant to the applicable
chemical substance;
(B) annually publish and update a list of
chemical substances, referred to by unique
identifier, for which claims to protect the
specific chemical identity from disclosure have
been approved, including the expiration date
for each such claim;
(C) ensure that any nonconfidential
information received by the Administrator with
respect to such a chemical substance during the
period of protection from disclosure--
(i) is made public; and
(ii) identifies the chemical
substance using the unique identifier;
and
(D) for each claim for protection of specific
chemical identity that has been denied by the
Administrator on expiration of the period for
appeal under subsection (g)(4), that has
expired, or that has been withdrawn by the
submitter, provide public access to the
specific chemical identity clearly linked to
all nonconfidential information received by the
Administrator with respect to the chemical
substance.
(g) Duties of Administrator.--
(1) Determination.--
(A) In general.--Except as provided in
subsection (b), the Administrator shall,
subject to subparagraph (C), not later than 90
days after the receipt of a claim under
subsection (d), and not later than 30 days
after the receipt of a request for extension of
a claim under subsection (f), review and
approve, modify, or deny the claim or request.
(B) Denial or modification.--
(i) In general.--Except as provided
in subsections (c) and (f), the
Administrator shall deny a claim to
protect a chemical identity from
disclosure only if the person that has
submitted the claim fails to meet the
requirements of subsections (a) and
(d).
(ii) Reasons for denial or
modification.--The Administrator shall
provide to a person that has submitted
a claim described in clause (i) a
written statement of the reasons for
the denial or modification of the
claim.
(C) Subsets.--The Administrator shall--
(i) except for claims described in
subsection (b)(7), review all claims
under this section for the protection
against disclosure of the specific
identity of a chemical substance; and
(ii) review a representative subset,
comprising at least 25 percent, of all
other claims for protection against
disclosure.
(D) Effect of failure to act.--The failure of
the Administrator to make a decision regarding
a claim for protection against disclosure or
extension under this section shall not be the
basis for denial or elimination of a claim for
protection against disclosure.
(2) Notification.--
(A) In general.--Except as provided in
subparagraph (B) and subsections (c), (e), and
(f), if the Administrator denies or modifies a
claim under paragraph (1), or promulgates a
rule under section 6(d) establishing a ban or
phase-out of a chemical substance, the
Administrator shall notify, in writing and by
certified mail, the person that submitted the
claim of the intent of the Administrator to
release the information.
(B) Release of information.--
(i) In general.--Except as provided
in clause (ii), the Administrator shall
not release information under this
subsection until the date that is 30
days after the date on which the person
that submitted the request receives
notification under subparagraph (A).
(ii) Exceptions.--
(I) In general.--For
information under paragraph (3)
or (8) of subsection (e), the
Administrator shall not release
that information until the date
that is 15 days after the date
on which the person that
submitted the claim receives a
notification, unless the
Administrator determines that
release of the information is
necessary to protect against an
imminent and substantial harm
to health or the environment,
in which case no prior
notification shall be
necessary.
(II) No notification.--For
information under paragraph
(1), (2), (6), (7), or (9) of
subsection (e), no prior
notification shall be
necessary.
(3) Rebuttable presumption.--
(A) In general.--With respect to
notifications provided by the Administrator
pursuant to subsection (c)(5), there shall be a
rebuttable presumption that the public interest
in disclosing confidential information related
to a chemical substance subject to a rule
promulgated under section 6(d) that establishes
a ban or phase-out of the manufacture,
processing, or distribution in commerce of the
substance outweighs the proprietary interest in
maintaining the protection from disclosure of
that information.
(B) Request for nondisclosure.--A person that
receives a notification under paragraph (2)
with respect to the information described in
subparagraph (A) may submit to the
Administrator, before the date on which the
information is to be released, a request with
supporting documentation describing why the
person believes some or all of that information
should not be disclosed.
(C) Determination by administrator.--
(i) In general.--Not later than 30
days after the Administrator receives a
request under subparagraph (B), the
Administrator shall determine, at the
discretion of the Administrator,
whether the documentation provided by
the person making the request rebuts or
does not rebut the presumption
described in subparagraph (A), for all
or a portion of the information that
the person has requested not be
disclosed.
(ii) Objective.--The Administrator
shall make the determination with the
objective of ensuring that information
relevant to protection of health and
the environment is disclosed to the
maximum extent practicable.
(D) Timing.--Not later than 30 days after
making the determination described in
subparagraph (C), the Administrator shall make
public the information the Administrator has
determined is not to be protected from
disclosure.
(E) No timely request received.--If the
Administrator does not receive, before the date
on which the information described in
subparagraph (A) is to be released, a request
pursuant to subparagraph (B), the Administrator
shall promptly make public all of the
information.
(4) Appeals.--
(A) In general.--If a person receives a
notification under paragraph (2) and believes
disclosure of the information is prohibited
under subsection (a), before the date on which
the information is to be released, the person
may bring an action to restrain disclosure of
the information in--
(i) the United States district court
of the district in which the
complainant resides or has the
principal place of business; or
(ii) the United States District Court
for the District of Columbia.
(B) No disclosure.--The Administrator shall
not disclose any information that is the
subject of an appeal under this section before
the date on which the applicable court rules on
an action under subparagraph (A).
(5) Administration.--In carrying out this subsection,
the Administrator shall use the procedures described in
part 2 of title 40, Code of Federal Regulations (or
successor regulations).
(h) Criminal Penalty for Wrongful Disclosure.--
(1) Officers and employees of united states.--
(A) In general.--Subject to paragraph (2), a
current or former officer or employee of the
United States described in subparagraph (B)
shall be guilty of a misdemeanor and fined
under title 18, United States Code, or
imprisoned for not more than 1 year, or both.
(B) Description.--A current or former officer
or employee of the United States referred to in
subparagraph (A) is a current or former officer
or employee of the United States who--
(i) by virtue of that employment or
official position has obtained
possession of, or has access to,
material the disclosure of which is
prohibited by subsection (a); and
(ii) knowing that disclosure of that
material is prohibited by subsection
(a), willfully discloses the material
in any manner to any person not
entitled to receive that material.
(2) Other laws.--Section 1905 of title 18, United
States Code, shall not apply with respect to the
publishing, divulging, disclosure, making known of, or
making available, information reported or otherwise
obtained under this Act.
(3) Contractors.--For purposes of this subsection,
any contractor of the United States that is provided
information in accordance with subsection (e)(2),
including any employee of that contractor, shall be
considered to be an employee of the United States.
(i) Applicability.--
(1) In general.--Except as otherwise provided in this
section, section 8, or any other applicable Federal
law, the Administrator shall have no authority--
(A) to require the substantiation or
resubstantiation of a claim for the protection
from disclosure of information submitted to the
Administrator under this Act before the date of
enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act; or
(B) to impose substantiation or
resubstantiation requirements under this Act
that are more extensive than those required
under this section.
(2) Prior actions.--Nothing in this Act prevents the
Administrator from reviewing, requiring substantiation
or resubstantiation for, or approving, modifying or
denying any claim for the protection from disclosure of
information before the effective date of such rules
applicable to those claims as the Administrator may
promulgate after the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act.
SEC. 15. PROHIBITED ACTS.
It shall be unlawful for any person to--
[(1) fail or refuse to comply with (A) any rule
promulgated or order issued under section 4, (B) any
requirement prescribed by section 5 or 6, (C) any rule
promulgated or order issued under section 5 or 6, or
(D) any requirement of title II or any rule promulgated
or order issued under title II;]
(1) fail or refuse to comply with--
(A) any rule promulgated, consent agreement
entered into, or order issued under section 4;
(B) any requirement under section 5 or 6;
(C) any rule promulgated, consent agreement
entered into, or order issued under section 5
or 6; or
(D) any requirement of, or any rule
promulgated or order issued pursuant to title
II;
(2) use for commercial purposes a chemical substance
or mixture which such person knew or had reason to know
was manufactured, processed, or distributed in commerce
in violation of section 5 or 6, a rule or order under
section 5 or 6, or an order issued in action brought
under section 5 or 7;
(3) fail or refuse to (A) establish or maintain
records, (B) submit reports, notices, or other
information, or (C) permit access to or copying of
records, as required by this Act or a rule thereunder;
or
(4) fail or refuse to permit entry or inspection as
required by section 11.
SEC. 16. PENALTIES.
(a) Civil.--(1) Any person who violates a provision of this
Act or a rule or order promulgated or issued pursuant to this
Act, including section 15 or 409 shall be liable to the United
States for a civil penalty in an amount not to exceed [$25,000]
$37,500 for each such violation. Each day such a violation
continues shall, for purposes of this subsection, constitute a
separate [violation of section 15 or 409] violation of this
Act.
(2)(A) A civil penalty for a violation of section 15 or 409
shall be assessed by the Administrator by an order made on the
record after opportunity (provided in accordance with this
subparagraph) for a hearing in accordance with section 554 of
title 5, United States Code. Before issuing such an order, the
Administrator shall give written notice to the person to be
assessed a civil penalty under such order of the
Administrator's proposal to issue such order and provide such
person an opportunity to request, within 15 days of the date
the notice is received by such person, such a hearing on the
order.
(B) In determining the amount of a civil penalty, the
Administrator shall take into account the nature,
circumstances, extent, and gravity of the violation or
violations and, with respect to the violator, ability to pay,
effect on ability to continue to do business, any history of
prior such violations, the degree of culpability, and such
other matters as justice may require.
(C) The Administrator may compromise, modify, or remit, with
or without conditions, any civil penalty which may be imposed
under this subsection. The amount of such penalty, when finally
determined, or the amount agreed upon in compromise, may be
deducted from any sums owing by the United States to the person
charged.
(3) Any person who requested in accordance with paragraph
(2)(A) a hearing respecting the assessment of a civil penalty
and who is aggrieved by an order assessing a civil penalty may
file a petition for judicial review of such order with the
United States Court of Appeals for the District of Columbia
Circuit or for any other circuit in which such person resides
or transacts business. Such a petition may only be filed within
the 30-day period beginning on the date the order making such
assessment was issued.
(4) If any person fails to pay an assessment of a civil
penalty--
(A) after the order making the assessment has become
a final order and if such person does not file a
petition for judicial review of the order in accordance
with paragraph (3), or
(B) after a court in an action brought under
paragraph (3) has entered a final judgment in favor of
the Administrator,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 30-day period referred to in paragraph (3) or
the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
(b) Criminal.--[Any person who]
(1) In general.--Any person that; knowingly or
willfully violates any provision of [section 15 or 409]
this Act shall, in addition to or in lieu of any civil
penalty which may be imposed under subsection (a) of
this section for such violation, be subject, upon
conviction, to a fine of not more than [$25,000]
$50,000 for each day of violation, or to imprisonment
for not more than one year, or both.
(2) Imminent danger of death or serious bodily
injury.--
(A) In general.--Any person that knowingly or
willfully violates any provision of this Act,
and that knows at the time of the violation
that the violation places an individual in
imminent danger of death or serious bodily
injury, shall be subject on conviction to a
fine of not more than $250,000, or imprisonment
for not more than 15 years, or both.
(B) Organizations.--An organization that
commits a violation described in subparagraph
(A) shall be subject on conviction to a fine of
not more than $1,000,000 for each violation.
(3) Knowledge of imminent danger or injury.--For
purposes of determining whether a defendant knew that
the violation placed another individual in imminent
danger of death or serious bodily injury--
(A) the defendant shall be responsible only
for actual awareness or actual belief
possessed; and
(B) knowledge possessed by an individual may
not be attributed to the defendant.
* * * * * * *
SEC. 18. PREEMPTION.
[(a) Effect on State Law.--(1) Except as provided in
paragraph (2), nothing in this Act shall affect the authority
of any State or political subdivision of a State to establish
or continue in effect regulation of any chemical substance,
mixture, or article containing a chemical substance or mixture.
[(2) Except as provided in subsection (b)--
[(A) if the Administrator requires by a rule
promulgated under section 4 the testing of a chemical
substance or mixture, no State or political subdivision
may, after the effective date of such rule, establish
or continue in effect a requirement for the testing of
such substance or mixture for purposes similar to those
for which testing is required under such rule; and
[(B) if the Administrator prescribes a rule or order
under section 5 or 6 (other than a rule imposing a
requirement described in subsection (a)(6) of section
6) which is applicable to a chemical substance or
mixture, and which is designed to protect against a
risk of injury to health or the environment associated
with such substance or mixture, no State or political
subdivision of a State may, after the effective date of
such requirement, establish or continue in effect, any
requirement which is applicable to such substance or
mixture, or an article containing such substance or
mixture, and which is designed to protect against such
risk unless such requirement (i) is identical to the
requirement prescribed by the Administrator, (ii) is
adopted under the authority of the Clean Air Act or any
other Federal law, or (iii) prohibits the use of such
substance or mixture in such State or political
subdivision (other than its use in the manufacture or
processing of other substances or mixtures).
[(b) Exemption.--Upon application of a State or political
subdivision of a State the Administrator may by rule exempt
from subsection (a)(2), under such conditions as may be
prescribed in such rule, a requirement of such State or
political subdivision designed to protect against a risk of
injury to health or the environment associated with a chemical
substance, mixture, or article containing a chemical substance
or mixture if--
[(1) compliance with the requirement would not cause
the manufacturing, processing, distribution in
commerce, or use of the substance, mixture, or article
to be in violation of the applicable requirement under
this Act described in subsection (a)(2), and
[(2) the State or political subdivision requirement
(A) provides a significantly higher degree of
protection from such risk than the requirement under
this Act described in subsection (a)(2) and (B) does
not, through difficulties in marketing, distribution,
or other factors, unduly burden interstate commerce.]
(a) In General.--
(1) Establishment or enforcement.--Except as provided
in subsections (c), (d), (e), (f), and (g), and subject
to paragraph (2), no State or political subdivision of
a State may establish or continue to enforce any of the
following:
(A) Testing and information collection.--A
statute or administrative action to require the
development of information on a chemical
substance or category of substances that is
reasonably likely to produce the same
information required under section 4, 5, or 6
in--
(i) a rule promulgated by the
Administrator;
(ii) a testing consent agreement
entered into by the Administrator; or
(iii) an order issued by the
Administrator.
(B) Chemical substances found to meet the
safety standard or restricted.--A statute or
administrative action to prohibit or otherwise
restrict the manufacture, processing, or
distribution in commerce or use of a chemical
substance--
(i) found to meet the safety standard
and consistent with the scope of the
determination made under section 6; or
(ii) found not to meet the safety
standard, after the effective date of
the rule issued under section 6(d) for
the substance, consistent with the
scope of the determination made by the
Administrator.
(C) Significant new use.--A statute or
administrative action requiring the
notification of a use of a chemical substance
that the Administrator has specified as a
significant new use and for which the
Administrator has required notification
pursuant to a rule promulgated under section 5.
(2) Effective date of preemption.--Under this
subsection, Federal preemption of State statutes and
administrative actions applicable to specific
substances shall not occur until the effective date of
the applicable action described in paragraph (1) taken
by the Administrator.
(b) New Statutes or Administrative Actions Creating
Prohibitions or Other Restrictions.--
(1) In general.--Except as provided in subsections
(c), (d), and (e), beginning on the date on which the
Administrator defines the scope of a safety assessment
and safety determination under section 6(a)(2) and
ending on the date on which the Administrator publishes
the safety determination, no State or political
subdivision of a State may establish a statute or
administrative action prohibiting or restricting the
manufacture, processing, distribution in commerce or
use of a chemical substance that is a high-priority
substance designated under section 4A.
(2) Effect of subsection.--
(A) In general.--This subsection does not
restrict the authority of a State or political
subdivision of a State to continue to enforce
any State statute enacted, or administrative
action taken, prior to the date on which the
Administrator defines the scope of a safety
assessment and safety determination under
section 6(a)(2).
(B) Limitation.--Subparagraph (A) does not
allow a State or political subdivision of a
State to enforce any new prohibition or
restriction under a State statute or
administrative action described in that
subparagraph, if the prohibition or restriction
is established after the date described in that
subparagraph.
(c) Scope of Preemption.--Federal preemption under
subsections (a) and (b) of State statutes and administrative
actions applicable to specific substances shall apply only to--
(1) the chemical substances or category of substances
subject to a rule, order, or consent agreement under
section 4;
(2) the uses or conditions of use of such substances
that are identified by the Administrator as subject to
review in a safety assessment and included in the scope
of the safety determination made by the Administrator
for the substance, or of any rule the Administrator
promulgates pursuant to section 6(d); or
(3) the uses of such substances that the
Administrator has specified as significant new uses and
for which the Administrator has required notification
pursuant to a rule promulgated under section 5.
(d) Exceptions.--
(1) No preemption of state statutes and
administrative actions.--
(A) In general.--Nothing in this Act, nor any
amendment made by this Act, nor any rule,
standard of performance, safety determination,
or scientific assessment implemented pursuant
to this Act, shall affect the right of a State
or a political subdivision of a State to adopt
or enforce any rule, standard of performance,
safety determination, scientific assessment, or
any protection for public health or the
environment that--
(i) is adopted or authorized under
the authority of any other Federal law
or adopted to satisfy or obtain
authorization or approval under any
other Federal law;
(ii) implements a reporting,
monitoring, disclosure, or other
information obligation for the chemical
substance not otherwise required by the
Administrator under this Act or
required under any other Federal law;
(iii) is adopted pursuant to
authority under a law of the State or
political subdivision of the State
related to water quality, air quality,
or waste treatment or disposal, except
to the extent that the action--
(I) imposes a restriction on
the manufacture, processing,
distribution in commerce, or
use of a chemical substance;
and
(II)(aa) addresses the same
hazards and exposures, with
respect to the same conditions
of use as are included in the
scope of the safety
determination pursuant to
section 6, but is inconsistent
with the action of the
Administrator; or
(bb) would cause a violation
of the applicable action by the
Administrator under section 5
or 6; or
(iv) subject to subparagraph (B), is
identical to a requirement prescribed
by the Administrator.
(B) Identical requirements.--
(i) In general.--The penalties and
other sanctions applicable under State
law in the event of noncompliance with
the identical requirement shall be no
more stringent than the penalties and
other sanctions available to the
Administrator under section 16 of this
Act.
(ii) Penalties.--In the case of an
identical requirement, no State may
assess a penalty for a specific
violation for which the Administrator
has already assessed a penalty under
section 16, and the Administrator may
not assess a penalty under section 16
for a specific violation for which a
State has already assessed a penalty.
(2) Applicability to certain rules or orders.--
Notwithstanding subsection (e)--
(A) nothing in this section shall be
construed as modifying the effect under this
section, as in effect on the day before the
effective date of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act, of
any rule or order promulgated or issued under
this Act prior to that effective date; and
(B) with respect to a chemical substance or
mixture for which any rule or order was
promulgated or issued under section 6 prior to
the effective date of the Frank R. Lautenberg
Chemical Safety for the 21st Century Act with
regards to manufacturing, processing,
distribution in commerce, use, or disposal of a
chemical substance, this section (as in effect
on the day before the effective date of the
Frank R. Lautenberg Chemical Safety for the
21st Century Act) shall govern the preemptive
effect of any rule or order that is promulgated
or issued respecting such chemical substance or
mixture under section 6 of this Act after that
effective date, unless the latter rule or order
is with respect to a chemical substance or
mixture containing a chemical substance and
follows a designation of that chemical
substance as a high-priority substance under
[subsection (b) or (c) of] section 4A (b) or as
an additional priority for safety assessment
and safety determination under section [4A(d)]
4A(c).
(e) Preservation of Certain State Law.--
(1) In general.--Nothing in this Act, subject to
subsection (g) of this section, shall--
(A) be construed to preempt or otherwise
affect the authority of a State or political
subdivision of a State to continue to enforce
any action taken before August 1, 2015, under
the authority of a State law that prohibits or
otherwise restricts manufacturing, processing,
distribution in commerce, use, or disposal of a
chemical substance; or
(B) be construed to preempt or otherwise
affect any action taken pursuant to a State law
that was in effect on August 31, 2003.
(2) Effect of subsection.--This subsection does not
affect, modify, or alter the relationship between State
and Federal law pursuant to any other Federal law.
(f) State Waivers.--
(1) Discretionary exemptions.--Upon application of a
State or political subdivision of a State, the
Administrator may by rule, exempt from subsection (a),
under such conditions as may be prescribed in the rule,
a statute or administrative action of that State or
political subdivision of the State that relates to the
effects of, or exposure to, a chemical substance under
the conditions of use if the Administrator determines
that--
(A) compelling State or local conditions
warrant granting the waiver to protect health
or the environment;
(B) compliance with the proposed requirement
of the State or political subdivision of the
State would not unduly burden interstate
commerce in the manufacture, processing,
distribution in commerce, or use of a chemical
substance;
(C) compliance with the proposed requirement
of the State or political subdivision of the
State would not cause a violation of any
applicable Federal law, rule, or order; and
(D) based on the judgment of the
Administrator, the proposed requirement of the
State or political subdivision of the State is
consistent with sound objective scientific
practices, the weight of the evidence, and the
best available science.
(2) Required exemptions.--Upon application of a State
or political subdivision of a State, the Administrator
shall exempt from subsection (b) a statute or
administrative action of a State or political
subdivision of a State that relates to the effects of
exposure to a chemical substance under the conditions
of use if the Administrator determines that--
(A) compliance with the proposed requirement
of the State will not unduly burden interstate
commerce in the manufacture, processing,
distribution in commerce, or use of a chemical
substance;
(B) compliance with the proposed requirement
would not cause a violation of any applicable
Federal law, rule, or order; and
(C) the State or political subdivision of a
State has a concern about the chemical
substance or use of the chemical substance
based in peer-reviewed science.
(3) Determination of a state waiver request.--The
duty of the Administrator to grant or deny a waiver
application shall be nondelegable and shall be
exercised--
(A) not later than 180 days after the date on
which an application under paragraph (1) is
submitted; and
(B) not later than 90 days after the date on
which an application under paragraph (2) is
submitted.
(4) Failure to make determination.--If the
Administrator fails to make a determination under
paragraph (3)(B) during the 90-day period beginning on
the date on which an application under paragraph (2) is
submitted, the State statute or administrative action
that was the subject of the application shall not be
considered to be an existing statute or administrative
action for purposes of subsection [(a)] (b) by reason
of the failure of the Administrator to make a
determination.
(5) Notice and comment.--Except in the case of an
application approved under paragraph (9), the
application of a State or political subdivision of the
State shall be subject to public notice and comment.
(6) Final agency action.--The decision of the
Administrator on the application of a State or
political subdivision of the State shall be--
(A) considered to be a final agency action;
and
(B) subject to judicial review.
(7) Duration of waivers.--
(A) In general.--Except as provided in
subparagraph (B), a waiver granted under
paragraph (2) or approved under paragraph (9)
shall remain in effect--
(i) until such time as the safety
assessment and safety determination is
completed; or
(ii) subject to subparagraph (B),
until judicial review of the failure of
the Administrator to make a
determination under paragraph (3) is
sought under paragraph (8).
(B) Reinstatement of waiver.--A waiver
described in subparagraph (A)(ii) shall again
take effect upon the earlier of--
(i) the date of approval by the
Administrator of the waiver
application;
(ii) the effective date of a court
order directing the Administrator to
approve the waiver application; or
(iii) 90 days after the date on which
judicial review under paragraph (8) is
sought.
(8) Judicial review of waivers.--Not later than 60
days after the date on which the Administrator makes a
determination on an application of a State or political
subdivision of the State under paragraph (1) or (2), or
not later than 60 days after the date on which the
Administrator fails to make a determination under
paragraph (3), any person may file a petition for
judicial review in the United States Court of Appeals
for the District of Columbia Circuit, which shall have
exclusive jurisdiction over the determination.
(9) Approval.--
(A) In general.--If the Administrator fails
to meet the deadline under section 6(a)(4)
(including an extension granted under section
6(a)(6)), or the deadline established under
paragraph (3)(B), the application of a State or
political subdivision of a State under
paragraph (2) shall be automatically approved.
(B) Requirements.--Notwithstanding paragraph
(6), approval of a waiver application under
subparagraph (A) for failure to meet the
deadlines under section 6(a)(4) (including an
extension granted under section 6(a)(6)) shall
not be considered final agency action or be
subject to judicial review or public notice and
comment.
(10) Judicial review of low-priority decisions.--
(A) In general.--Not later than 60 days after
the publication of a designation under section
4A(b)(4), any person may commence a civil
action to challenge the designation.
(B) Jurisdiction.--The United States Court of
Appeals for the District of Columbia Circuit
shall have exclusive jurisdiction over a civil
action filed under this paragraph.
(g) Savings.--
(1) No preemption of common law or statutory causes
of action for civil relief or criminal conduct.--
(A) In general.--Nothing in this Act, nor any
amendment made by this Act, nor any safety
standard, rule, requirement, standard of
performance, safety determination, or
scientific assessment implemented pursuant to
this Act, shall be construed to preempt,
displace, or supplant any state or Federal
common law rights or any state or Federal
statute creating a remedy for civil relief,
including those for civil damage, or a penalty
for a criminal conduct.
(B) Clarification of no preemption.--
Notwithstanding any other provision of this
Act, nothing in this Act, nor any amendments
made by this Act, shall preempt or preclude any
cause of action for personal injury, wrongful
death, property damage, or other injury based
on negligence, strict liability, products
liability, failure to warn, or any other legal
theory of liability under any State law,
maritime law, or Federal common law or
statutory theory.
(2) No effect on private remedies.--
(A) In general.--Nothing in this Act, nor any
amendments made by this Act, nor any rules,
regulations, requirements, safety assessments,
safety determinations, scientific assessments,
or orders issued pursuant to this Act shall be
interpreted as, in either the plaintiff's or
defendant's favor, dispositive in any civil
action.
(B) Authority of courts.--This Act does not
affect the authority of any court to make a
determination in an adjudicatory proceeding
under applicable State or Federal law with
respect to the admission into evidence or any
other use of this Act or rules, regulations,
requirements, standards of performance, safety
assessments, scientific assessments, or orders
issued pursuant to this Act.
SEC. 19. JUDICIAL REVIEW.
(a) In General.--(1)(A) Not later than 60 days after the date
of the promulgation of a rule under [section 4(a), 5(a)(2),
5(b)(4), 6(a), 6(e), or 8, or under title II or IV] section
4(a), 5(d), 6(c), 6(d), 6(g), or 8, or title II or IV, any
person may file a petition for judicial review of such rule
with the United States Court of Appeals for the District of
Columbia Circuit or for the circuit in which such person
resides or in which such person's principal place of business
is located. Courts of appeals of the United States shall have
exclusive jurisdiction of any action to obtain judicial review
(other than in an enforcement proceeding) of such a rule if any
district court of the United States would have had jurisdiction
of such action but for this subparagraph.
(B) Courts of appeals of the United States shall have
exclusive jurisdiction of any action to obtain judicial review
(other than in an enforcement proceeding) of [an order issued
under subparagraph (A) or (B) of section 6(b)(1)] an order
issued under this title if any district court of the United
States would have had jurisdiction of such action but for this
subparagraph.
(2) Copies of any petition filed under [paragraph (1)(A)]
paragraph (1) shall be transmitted forthwith to the
Administrator and to the Attorney General by the clerk of the
court with which such petition was filed. The provisions of
section 2112 of title 28, United States Code, shall apply to
the filing of the rulemaking record of proceedings on which the
Administrator based the rule being reviewed under this section
and to the transfer of proceedings between United States courts
of appeals.
[(3) For purposes of this section, the term ``rulemaking
record'' means--
[(A) the rule being reviewed under this section;
[(B) in the case of a rule under section 4(a), the
finding required by such section, in the case of a rule
under section 5(b)(4), the finding required by such
section, in the case of a rule under section 6(a) the
finding required by section 5(f) or 6(a), as the case
may be, in the case of a rule under section 6(a), the
statement required by section 6(c)(1), and in the case
of a rule under section 6(e), the findings required by
paragraph (2)(B) or (3)(B) of such section, as the case
may be\6\ and in the case of a rule under title IV, the
finding required for the issuance of such a rule;
---------------------------------------------------------------------------
\6\So in law. Probably should be followed by a comma.
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[(C) any transcript required to be made of oral
presentations made in proceedings for the promulgation
of such rule;
[(D) any written submission of interested parties
respecting the promulgation of such rule; and
[(E) any other information which the Administrator
considers to be relevant to such rule and which the
Administrator identified, on or before the date of the
promulgation of such rule, in a notice published in the
Federal Register.]
(b) Additional Submissions and Presentations;
Modifications.--If in an action under this section to review a
rule the petitioner or the Administrator applies to the court
for leave to make additional oral submissions or written
presentations respecting such rule and shows to the
satisfaction of the court that such submissions and
presentations would be material and that there were reasonable
grounds for the submissions and failure to make such
submissions and presentations in the proceeding before the
Administrator, the court may order the Administrator to provide
additional opportunity to make such submissions and
presentations. The Administrator may modify or set aside the
rule being reviewed or make a new rule by reason of the
additional submissions and presentations and shall file such
modified or new rule with the return of such submissions and
presentations. The court shall thereafter review such new or
modified rule.
(c) Standard of Review.--(1)(A) Upon the filing of a petition
under subsection (a)(1) for judicial review of a rule, the
court shall have jurisdiction (i) to grant appropriate relief,
including interim relief, as provided in chapter 7 of title 5,
United States Code, and (ii) except as otherwise provided in
subparagraph (B), to review such rule in accordance with
chapter 7 of title 5, United States Code.
(B) Section 706 of title 5, United States Code, shall apply
to review of a rule under this section, except that--
(i) in the case of review of a rule under [section
4(a), 5(b)(4), 6(a), or 6(e)] section 4(a), 5(d), 6(d),
or 6(g), the standard for review prescribed by
paragraph (2)(E) of such section 706 shall not apply
and the court shall hold unlawful and set aside such
rule if the court finds that the rule is not supported
by substantial [evidence in the rulemaking record (as
defined in subsection (a)(3)) taken as a whole;]
[(ii) in the case of review of a rule under section
6(a), the court shall hold unlawful and set aside such
rule if it finds that--
[(I) a determination by the Administrator
under section 6(c)(3) that the petitioner
seeking review of such rule is not entitled to
conduct (or have conducted) cross-examination
or to present rebuttal submissions, or
[(II) a rule of, or ruling by, the
Administrator under section 6(c)(3) limiting
such petitioner's cross-examination or oral
presentations,
has precluded disclosure of disputed material facts
which was necessary to a fair determination by the
Administrator of the rulemaking proceeding taken as a
whole; and section 706(2)(D) shall not apply with
respect to a determination, rule, or ruling referred to
in subclause (I) or (II); and
[(iii) the court may not review the contents and
adequacy of--
[(I) any statement required to be made
pursuant to section 6(c)(1), or
[(II) any statement of basis and purpose
required by section 553(c) of title 5, United
States Code, to be incorporated in the rule]
[except as part of a review of the rulemaking record
taken as a whole.
[The term ``evidence'' as used in clause (i) means any matter
in the rulemaking record.]
(ii) the court may not review the
contents and adequacy of any statement
of basis and purpose required by
section 553(c) of title 5, United
States Code, to be incorporated in the
rule, except as part of the rulemaking
record, taken as a whole.
(C) A determination, rule, or ruling of the Administrator
described in subparagraph (B)(ii) may be reviewed only in an
action under this section and only in accordance with such
subparagraph.
(2) The judgment of the court affirming or setting aside, in
whole or in part, any rule reviewed in accordance with this
section shall be final, subject to review by the Supreme Court
of the United States upon certiorari or certification, as
provided in section 1254 of title 28, United States Code.
(d) Fees and Costs.--The decision of the court in an action
commenced under subsection (a), or of the Supreme Court of the
United States on review of such a decision, may include an
award of costs of suit and reasonable fees for attorneys and
expert witnesses if the court determines that such an award is
appropriate.
(e) Other Remedies.--The remedies as provided in this section
shall be in addition to and not in lieu of any other remedies
provided by law.
* * * * * * *
SEC. 21. CITIZENS' PETITIONS.
(a) In General.--Any person may petition the Administrator to
initiate a proceeding for the issuance, amendment, or repeal of
a rule under section 4, 6, or 8 or [an order under section 5(e)
or (6)(b)(2)] an order under section 4 or 5(d).
(b) Procedures.--(1) Such petition shall be filed in the
principal office of the Administrator and shall set forth the
facts which it is claimed establish that it is necessary to
issue, amend, or repeal a rule under section 4, 6, or 8 or [an
order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)] an order
under section 4 or 5(d).
(2) The Administrator may hold a public hearing or may
conduct such investigation or proceeding as the Administrator
deems appropriate in order to determine whether or not such
petition should be granted.
(3) Within 90 days after filing of a petition described in
paragraph (1), the Administrator shall either grant or deny the
petition. If the Administrator grants such petition, the
Administrator shall promptly commence an appropriate proceeding
in accordance with section 4, 5, 6, or 8. If the Administrator
denies such petition, the Administrator shall publish in the
Federal Register the Administrator's reasons for such denial.
(4)(A) If the Administrator denies a petition filed under
this section (or if the Administrator fails to grant or deny
such petition within the 90-day period) the petitioner may
commence a civil action in a district court of the United
States to compel the Administrator to initiate a rulemaking
proceeding as requested in the petition. Any such action shall
be filed within 60 days after the Administrator's denial of the
petition or, if the Administrator fails to grant or deny the
petition within 90 days after filing the petition, within 60
days after the expiration of the 90-day period.
[(B) In an action under subparagraph (A) respecting a
petition to initiate a proceeding to issue a rule under section
4, 6, or 8 or an order under section 5(e) or 6(b)(2), the
petitioner shall be provided an opportunity to have such
petition considered by the court in a de novo proceeding. If
the petitioner demonstrates to the satisfaction of the court by
a preponderance of the evidence that--]
(B) De novo proceeding.--
(i) In general.--In an action under
subparagraph (A) to initiate a
proceeding to promulgate a rule
pursuant to section 4, 5, 6, or 8 or
issue an order [issued] under section 4
or 5 (d), the petitioner shall be
provided an opportunity to have the
petition considered by the court in a
de novo proceeding.
(ii) Demonstration.--
(I) In general.--The court in
a de novo proceeding under this
subparagraph shall order the
Administrator to initiate the
action requested by the
petitioner if the petitioner
demonstrates to the
satisfaction of the court by a
preponderance of the evidence
that--
(aa) in the case of a
petition to initiate a
proceeding for the
issuance of a rule or
order under section 4,
the information
available to the
Administrator is
insufficient for the
Administrator to
perform an action
described in section 4,
4A, 5, or 6(d);
(bb) in the case of a
petition to issue an
order under section
5(d), there is a
reasonable basis to
conclude that the
chemical substance is
not likely to meet the
safety standard;
(cc) in the case of a
petition to initiate a
proceeding for the
issuance of a rule
under section 6(d),
there is a reasonable
basis to conclude that
the chemical substance
will not meet the
safety standard; or
(dd) in the case of a
petition to initiate a
proceeding for the
issuance of a rule
under section 8, there
is a reasonable basis
to conclude that the
rule is necessary to
protect health or the
environment or ensure
that the chemical
substance meets the
safety standard.
(II) Deferment.--The court in
a de novo proceeding under this
subparagraph may permit the
Administrator to defer
initiating the action requested
by the petitioner until such
time as the court prescribes,
if the court finds that--
(aa) the extent of
the risk to health or
the environment alleged
by the petitioner is
less than the extent of
risks to health or the
environment with
respect to which the
Administrator is taking
action under this Act;
and
(bb) there are
insufficient resources
available to the
Administrator to take
the action requested by
the petitioner.
* * * * * * *
SEC. 24. EMPLOYMENT EFFECTS.
(a) In General.--The Administrator shall evaluate on a
continuing basis the potential effects on employment (including
reductions in employment or loss of employment from threatened
plant closures) of--
(1) the issuance of a rule or order under section 4,
5, or 6, or
(2) a requirement of section 5 or 6.
(b)(1) Investigations.--Any employee (or any representative
of an employee) may request the Administrator to make an
investigation of--
(A) a discharge or layoff or threatened discharge or
layoff of the employee, or
(B) adverse or threatened adverse effects on the
employee's employment,
allegedly resulting from a rule or order under section 4, 5, or
6 or a requirement of section 5 or 6. Any such request shall be
made in writing, shall set forth with reasonable particularity
the grounds for the request, and shall be signed by the
employee, or representative of such employee, making the
request.
(2)(A) Upon receipt of a request made in accordance with
paragraph (1) the Administrator shall (i) conduct the
investigation requested, and (ii) if requested by any
interested person, hold public hearings on any matter involved
in the investigation unless the Administrator, by order issued
within 45 days of the date such hearings are requested, denies
the request for the hearings because the Administrator
determines there are no reasonable grounds for holding such
hearings. If the Administrator makes such a determination, the
Administrator shall notify in writing the person requesting the
hearing of the determination and the reasons therefor and shall
publish the determination and the reasons therefor in the
Federal Register.
(B) If public hearings are to be held on any matter involved
in an investigation conducted under this subsection--
(i) at least five days' notice shall be provided the
person making the request for the investigation and any
person identified in such request,
(ii) such hearings shall be held in accordance with
[section 6(c)(3),] the applicable requirements of this
Act; and
(iii) each employee who made or for whom was made a
request for such hearings and the employer of such
employee shall be required to present information
respecting the applicable matter referred to in
paragraph (1)(A) or (1)(B) together with the basis for
such information.
(3) Upon completion of an investigation under paragraph (2),
the Administrator shall make findings of fact, shall make such
recommendations as the Administrator deems appropriate, and
shall make available to the public such findings and
recommendations.
(4) This section shall not be construed to require the
Administrator to amend or repeal any rule or order in effect
under this Act.
SEC. 25. STUDIES.
[(a) Indemnification Study.--The Administrator shall conduct
a study of all Federal laws administered by the Administrator
for the purpose of determining whether and under what
conditions, if any, indemnification should be accorded any
person as a result of any action taken by the Administrator
under any such law. The study shall--
[(1) include an estimate of the probable cost of any
indemnification programs which may be recommended;
[(2) include an examination of all viable means of
financing the cost of any recommended indemnification;
and
[(3) be completed and submitted to Congress within
two years from the effective date of enactment of this
Act.
[The General Accounting Office shall review the adequacy of the
study submitted to Congress pursuant to paragraph (3) and shall
report the results of its review to the Congress within six
months of the date such study is submitted to Congress.
[(b) Classification, Storage, and Retrieval Study.--The
Council on Environmental Quality, in consultation with the
Administrator, the Secretary of Health, Education, and Welfare,
the Secretary of Commerce, and the heads of other appropriate
Federal departments or agencies, shall coordinate a study of
the feasibility of establishing (1) a standard classification
system for chemical substances and related substances, and (2)
a standard means for storing and for obtaining rapid access to
information respecting such substances. A report on such study
shall be completed and submitted to Congress not later than 18
months after the effective date of enactment of this Act.]
SEC. 26. ADMINISTRATION OF THE ACT.
(a) Cooperation of Federal Agencies.--Upon request by the
Administrator, each Federal department and agency is
authorized--
(1) to make its services, personnel, and facilities
available (with or without reimbursement) to the
Administrator to assist the Administrator in the
administration of this Act; and
(2) to furnish to the Administrator such information,
data, estimates, and statistics, and to allow the
Administrator access to all information in its
possession as the Administrator may reasonably
determine to be necessary for the administration of
this Act.
[(b) Fees.--[(1) The Administrator may, by rule, require the
payment of a reasonable fee from any person required to submit
data under section 4 or 5 to defray the cost of administering
this Act. Such rules shall not provide for any fee in excess of
$2,500 or, in the case of a small business concern, any fee in
excess of $100. In setting a fee under this paragraph, the
Administrator shall take into account the ability to pay of the
person required to submit the data and the cost to the
Administrator of reviewing such data. Such rules may provide
for sharing such a fee in any case in which the expenses of
testing are shared under section 4 or 5.
[(2) The Administrator, after consultation with the
Administrator of the Small Business Administration, shall by
rule prescribe standards for determining the persons which
qualify as small business concerns for purposes of paragraph
(1).]
(b) Fees.--
(1) In general.--The Administrator shall establish,
not later than 1 year after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, by rule--
(A) the payment of 1 or more reasonable fees
as a condition of submitting a notice or
requesting an exemption under section 5;
(B) the payment of 1 or more reasonable fees
by a manufacturer or processor that--
(i) is required to submit a notice
pursuant to the rule promulgated under
section 8(b)(4)(A)(i) identifying a
chemical substance as active;
(ii) is required to submit a notice
pursuant to section 8(b)(5)(B)(i)
changing the status of a chemical
substance from inactive to active;
(iii) is required to report
information pursuant to the rules
promulgated under section 8(a)(4); and
(iv) manufactures or processes a
chemical substance subject to a safety
assessment and safety determination
pursuant to section 6.
(2) Utilization and collection of fees.--The
Administrator shall--
(A) utilize the fees collected under
paragraph (1) only to defray costs associated
with the actions of the Administrator--
(i) to collect, process, review,
provide access to, and protect from
disclosure (where appropriate)
information on chemical substances
under this Act;
(ii) to review notices and make
determinations for chemical substances
under paragraphs (1) and (3) of section
5(d) and impose any necessary
restrictions under section 5(d)(4);
(iii) to make prioritization
decisions under section 4A;
(iv) to conduct and complete safety
assessments and determinations under
section 6; and
(v) to conduct any necessary
rulemaking pursuant to section 6(d);
(B) insofar as possible, collect the fees
described in paragraph (1) in advance of
conducting any fee-supported activity;
(C) deposit the fees in the Fund established
by paragraph (4)(A); and
(D) not collect excess fees or retain a
significant amount of unused fees.
(3) Amount and adjustment of fees; refunds.--In
setting fees under this section, the Administrator
shall--
(A) take into account the cost to the
Administrator of conducting the activities
described in paragraph (2);
(B) prescribe lower fees for small business
concerns, after consultation with the
Administrator of the Small Business
Administration;
(C) set the fees established under paragraph
(1) at levels such that the fees will, in
aggregate, provide a sustainable source of
funds to defray approximately 25 percent of the
costs of conducting the activities identified
in paragraph (2)(A), not to exceed $18,000,000,
not including fees under subparagraph (E) of
this paragraph;
(D) reflect an appropriate balance in the
assessment of fees between manufacturers and
processors, and allow the payment of fees by
consortia of manufacturers or processors;
(E) for substances designated as additional
priorities pursuant to section 4A(c), establish
the fee at a level sufficient to defray the
full costs to the Administrator of conducting
the safety assessment and safety determination
under section 6, except that for substances
subject to section 4A(c)(3), the Administrator
shall establish the fee at a level sufficient
to defray 50 percent of those costs;
(F) prior to the establishment or amendment
of any fees under paragraph (1), consult and
meet with parties potentially subject to the
fees or their representatives, subject to the
condition that no obligation under the Federal
Advisory Committee Act (5 U.S.C. App.) or
subchapter III of chapter 5 of title 5, United
States Code, is applicable with respect to such
meetings;
(G) beginning with the fiscal year that is 3
years after the date of enactment of the Frank
R. Lautenberg Chemical Safety for the 21st
Century Act, and every 3 years thereafter,
after consultation with parties potentially
subject to the fees and their representatives,
increase or decrease the fees established under
paragraph (1) as necessary--
(i) to ensure that funds deposited in
the Fund are sufficient to conduct the
activities identified in paragraph
(2)(A) and the full cost or 50-percent
portion of the costs of safety
assessments and safety determinations
pursuant to subparagraph (E); and
(ii) to account for inflation;
(H) adjust fees established under paragraph
(1) as necessary to vary on account of
differing circumstances, including reduced fees
or waivers in appropriate circumstances, to
reduce the burden on manufacturing or
processing, remove barriers to innovation, or
where the costs to the Administrator of
collecting the fees exceed the fee revenue
anticipated to be collected; and
(I) if a notice submitted under section 5 is
refused or subsequently withdrawn, refund the
fee or a portion of the fee if no substantial
work was performed on the notice.
(4) TSCA implementation fund.--
(A) Establishment.--There is established in
the Treasury of the United States a fund, to be
known as the `TSCA Implementation Fund'
(referred to in this subsection as the `Fund'),
consisting of--
(i) such amounts as are deposited in
the Fund under paragraph (2)(C); and
(ii) any interest earned on the
investment of amounts in the Fund; and
(iii) any proceeds from the sale or
redemption of investments held in the
Fund.
(B) Crediting and availability of fees.--
(i) In general.--Fees authorized
under this section shall be collected
and available for obligation only to
the extent and in the amount provided
in advance in appropriations Acts, and
shall be available without fiscal year
limitation.
(ii) Requirements.--Fees collected
under this section shall not--
(I) be made available or
obligated for any purpose other
than to defray the costs of
conducting the activities
identified in paragraph (2)(A);
(II) otherwise be available
for any purpose other than
implementation of this Act; and
(III) so long as amounts in
the Fund remain available, be
subject to restrictions on
expenditures applicable to the
Federal government as a whole.
(C) Unused funds.--Amounts in the Fund not
currently needed to carry out this subsection
shall be--
(i) maintained readily available or
on deposit;
(ii) invested in obligations of the
United States or guaranteed by the
United States; or
(iii) invested in obligations,
participations, or other instruments
that are lawful investments for
fiduciary, trust, or public funds.
(D) Minimum amount of appropriations.--Fees
may not be assessed for a fiscal year under
this section unless the amount of
appropriations for salaries, contracts, and
expenses for the functions (as in existence in
fiscal year 2015) of the Office of Pollution
Prevention and Toxics of the Environmental
Protection Agency for the fiscal year
(excluding the amount of any fees appropriated
for the fiscal year) are equal to or greater
than the amount of appropriations for covered
functions for fiscal year 2015 (excluding the
amount of any fees appropriated for the fiscal
year).
(5) Auditing.--
(A) Financial statements of agencies.--For
the purpose of section 3515(c) of title 31,
United States Code, the Fund shall be
considered a component of an executive agency.
(B) Components.--The annual audit required
under sections 3515(b) and 3521 of that title
of the financial statements of activities under
this subsection shall include an analysis of--
(i) the fees collected under
paragraph (1) and disbursed;
(ii) compliance with the deadlines
established in section 6 of this Act;
(iii) the amounts budgeted,
appropriated, collected from fees, and
disbursed to meet the requirements of
sections 4, 4A, 5, 6, 8, and 14,
including the allocation of full time
equivalent employees to each such
section or activity; and
(iv) the reasonableness of the
allocation of the overhead associated
with the conduct of the activities
described in paragraph (2)(A).
(C) Inspector general.--The Inspector General
of the Environmental Protection Agency shall--
(i) conduct the annual audit required
under this subsection; and
(ii) report the findings and
recommendations of the audit to the
Administrator and to the appropriate
committees of Congress.
(6) Termination.--The authority provided by this
section shall terminate at the conclusion of the fiscal
year that is 10 years after the date of enactment of
the Frank R. Lautenberg Chemical Safety for the 21st
Century Act, unless otherwise reauthorized or modified
by Congress.
(c) Action With Respect to Categories.--(1) Any action
authorized or required to be taken by the Administrator under
any provision of this Act with respect to a chemical substance
or mixture may be taken by the Administrator in accordance with
that provision with respect to a category of chemical
substances or mixtures. Whenever the Administrator takes action
under a provision of this Act with respect to a category of
chemical substances or mixtures, any reference in this Act to a
chemical substance or mixture (insofar as it relates to such
action) shall be deemed to be a reference to each chemical
substance or mixture in such category.
(2) For purposes of paragraph (1):
(A) The term ``category of chemical substances''
means a group of chemical substances the members of
which are similar in molecular structure, in physical,
chemical, or biological properties, in use, or in mode
of entrance into the human body or into the
environment, or the members of which are in some other
way suitable for classification as such for purposes of
this Act, except that such term does not mean a group
of chemical substances which are grouped together
solely on the basis of their being new chemical
substances.
(B) The term ``category of mixtures'' means a group
of mixtures the members of which are similar in
molecular structure, in physical, chemical, or
biological 1properties, in use, or in the mode of
entrance into the human body or into the environment,
or the members of which are in some other way suitable
for classification as such for purposes of this Act.
(d) Assistance Office.--The Administrator shall establish in
the Environmental Protection Agency an identifiable office to
provide technical and other nonfinancial assistance to
manufacturers and processors of chemical substances and
mixtures respecting the requirements of this Act applicable to
such manufacturers and processors, the policy of the Agency
respecting the application of such requirements to such
manufacturers and processors, and the means and methods by
which such manufacturers and processors may comply with such
requirements.
(e) Financial Disclosures.--(1) Except as provided under
paragraph (3), each officer or employee of the Environmental
Protection Agency and the Department of [Health, Education, and
Welfare] Health and Human Services who--
(A) performs any function or duty under this Act, and
(B) has any known financial interest (i) in any
person subject to this Act or any rule or order in
effect under this Act, or (ii) in any person who
applies for or receives any grant or contract under
this Act,
shall, on February 1, 1978, and on February 1 of each year
thereafter, file with the Administrator or the Secretary of
[Health, Education, and Welfare] Health and Human Services
(hereinafter in this subsection referred to as the
``Secretary''), as appropriate, a written statement concerning
all such interests held by such officer or employee during the
preceding calendar year. Such statement shall be made available
to the public.
(2) The Administrator and the Secretary shall--
(A) act within 90 days of the effective date of this
Act--
(i) to define the term ``known financial
interests'' for purposes of paragraph (1), and
(ii) to establish the methods by which the
requirement to file written statements
specified in paragraph (1) will be monitored
and enforced, including appropriate provisions
for review by the Administrator and the
Secretary of such statements; and
(B) report to the Congress on June 1, 1978, and on
June 1 of each year thereafter with respect to such
statements and the actions taken in regard thereto
during the preceding calendar year.
(3) The Administrator may by rule identify specific positions
with the Environmental Protection Agency, and the Secretary may
by rule identify specific positions with the Department of
[Health, Education, and Welfare] Health and Human Services,
which are of a nonregulatory or nonpolicy-making nature, and
the Administrator and the Secretary may by rule provide that
officers or employees occupying such positions shall be exempt
from the requirements of paragraph (1).
(4) This subsection does not supersede any requirement of
chapter 11 of title 18, United States Code.
(5) Any officer or employee who is subject to, and knowingly
violates, this subsection or any rule issued thereunder, shall
be fined not more than $2,500 or imprisoned not more than one
year, or both.
(f) Statement of Basis and Purpose.--Any final order issued
under this Act shall be accompanied by a statement of its basis
and purpose. The contents and adequacy of any such statement
shall not be subject to judicial review in any respect.
(g) Assistant Administrator.--(1) The President, by and with
the advice and consent of the Senate, shall appoint an
Assistant Administrator for Toxic Substances of the
Environmental Protection Agency. Such Assistant Administrator
shall be a qualified individual who is, by reason of background
and experience, especially qualified to direct a program
concerning the effects of chemicals on human health and the
environment. Such Assistant Administrator shall be responsible
for (A) the collection of data, (B) the preparation of studies,
(C) the making of recommendations to the Administrator for
regulatory and other actions to carry out the purposes and to
facilitate the administration of this Act, and (D) such other
functions as the Administrator may assign or delegate.
(2) The Assistant Administrator to be appointed under
paragraph (1) shall be in addition to the Assistant
Administrators of the Environmental Protection Agency
authorized by section 1(d) of Reorganization Plan No. 3 of
1970.
(h) Prior Actions.--Nothing in this Act eliminates, modifies,
or withdraws any rule promulgated, order issued, or exemption
established pursuant to this Act before the date of enactment
of the Frank R. Lautenberg Chemical Safety for the 21st Century
Act.
SEC. 27. DEVELOPMENT AND EVALUATION OF TEST METHODS.
(a) In General.--The Secretary of [Health, Education, and
Welfare] Health and Human Services in consultation with the
Administrator and acting through the Assistant Secretary for
Health, may conduct, and make grants to public and nonprofit
private entities and enter into contracts with public and
private entities for, projects for the development and
evaluation of inexpensive and efficient methods (1) for
determining and evaluating the health and environmental effects
of chemical substances and mixtures, and their toxicity,
persistence, and other characteristics which affect health and
the environment, and (2) which may be used for the development
of test data to meet the requirements of rules promulgated
under section 4. The Administrator shall consider such methods
in prescribing under section 4 standards for the development of
test data.
(b) Approval by Secretary.--No grant may be made or contract
entered into under subsection (a) unless an application
therefor has been submitted to and approved by the Secretary.
Such an application shall be submitted in such form and manner
and contain such information as the Secretary may require. The
Secretary may apply such conditions to grants and contracts
under subsection (a) as the Secretary determines are necessary
to carry out the purposes of such subsection. Contracts may be
entered into under such subsection without regard to sections
3648 and 3709 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C.
5).
(c) Sustainable Chemistry Program.--The President shall
establish an interagency Sustainable Chemistry Program to
promote and coordinate Federal sustainable chemistry research,
development, demonstration, technology transfer,
commercialization, education, and training activities.
(d) Program Activities.--The activities of the Program shall
be designed to--
(1) provide sustained support for sustainable
chemistry research, development, demonstration,
technology transfer, commercialization, education, and
training through--
(A) coordination of sustainable chemistry
research, development, demonstration, and
technology transfer conducted at Federal
laboratories and agencies; and
(B) to the extent practicable, encouragement
of consideration of sustainable chemistry in,
as appropriate--
(i) the conduct of Federal and State
science and engineering research and
development; and
(ii) the solicitation and evaluation
of applicable proposals for science and
engineering research and development;
(2) examine methods by which the Federal Government
can create incentives for consideration and use of
sustainable chemistry processes and products, including
innovative financing mechanisms;
(3) expand the education and training of
undergraduate and graduate students and professional
scientists and engineers, including through
partnerships with industry, in sustainable chemistry
science and engineering;
(4) collect and disseminate information on
sustainable chemistry research, development, and
technology transfer including information on--
(A) incentives and impediments to
development, manufacturing, and
commercialization;
(B) accomplishments;
(C) best practices; and
(D) costs and benefits;
(5) support (including through technical assistance,
participation, financial support, or other forms of
support) economic, legal, and other appropriate social
science research to identify barriers to
commercialization and methods to advance
commercialization of sustainable chemistry.
(e) Interagency Working Group.--
(1) Establishment.--Not later than 180 days after the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the President, in
consultation with the Office of Science and Technology
Policy, shall establish an Interagency Working Group
that shall include representatives from the National
Science Foundation, the National Institute of Standards
and Technology, the Department of Energy, the
Environmental Protection Agency, the Department of
Agriculture, the Department of Defense, the National
Institutes of Health, and any other agency that the
President may designate to oversee the planning,
management, and coordination of the Program.
(2) Governance.--The Director of the National Science
Foundation and the Assistant Administrator for Research
and Development of the Environmental Protection Agency,
or their designees, shall serve as co-chairs of the
Interagency Working Group.
(3) Responsibilities.--In overseeing the planning,
management, and coordination of the Program, the
Interagency Working Group shall--
(A) establish goals and priorities for the
Program, in consultation with the Advisory
Council;
(B) provide for interagency coordination,
including budget coordination, of activities
under the Program;
(C) meet not later than 90 days from its
establishment and periodically thereafter; and
(D) establish and consult with an Advisory
Council on a regular basis.
(4) Membership.--The Advisory Council members shall
not be employees of the Federal Government and shall
include a diverse representation of knowledgeable
individuals from the private sector (including small-
and medium-sized enterprises from across the value
chain), academia, State and tribal governments, and
nongovernmental organizations and others who are in a
position to provide expertise.
(f) Agency Budget Requests.--
(1) In general.--Each Federal agency and department
participating in the Program shall, as part of its
annual request for appropriations to the Office of
Management and Budget, submit a report to the Office of
Management and Budget that--
(A) identifies the activities of the agency
or department that contribute directly to the
Program; and
(B) states the portion of the agency or
department's request for appropriations that is
allocated to those activities.
(2) Annual budget request to congress.--The President
shall include in the annual budget request to Congress
a statement of the portion of the annual budget request
for each agency or department that will be allocated to
activities undertaken pursuant to the Program.
(g) Report to Congress.--
(1) In general.--Not later than 2 years after the
date of enactment of the Frank R. Lautenberg Chemical
Safety for the 21st Century Act, the Interagency
Working Group shall submit a report to the Committee on
Science, Space, and Technology and Committee on Energy
and Commerce of the House of Representatives and the
Committee on Environment and Public Works and the
Committee on Commerce, Science, and Transportation of
the Senate that shall include--
(A) a summary of federally funded sustainable
chemistry research, development, demonstration,
technology transfer, commercialization,
education, and training activities;
(B) a summary of the financial resources
allocated to sustainable chemistry initiatives;
(C) an analysis of the progress made toward
achieving the goals and priorities of this Act
the program established pursuant to subsection
(c), and recommendations for future program
activities;
(D) an assessment of the benefits of
expanding existing, federally-supported
regional innovation and manufacturing hubs to
include sustainable chemistry and the value of
directing the creation of 1 or more dedicated
sustainable chemistry centers of excellence or
hubs; and
(E) an evaluation of steps taken and future
strategies to avoid duplication of efforts,
streamline interagency coordination, facilitate
information sharing, and spread best practices
between participating agencies in the Program.
(2) Submission to gao.--The Interagency Working Group
shall also submit the report described in paragraph (1)
to the Government Accountability Office for
consideration in future Congressional inquiries.
SEC. 28. STATE PROGRAMS.
(a) In General.--For the purpose of complementing (but not
reducing) the authority of, or actions taken by, the
Administrator under this Act, the Administrator may make grants
to States for the establishment and operation of programs to
prevent or eliminate unreasonable risks within the States to
health or the environment which are associated with a chemical
substance or mixture and with respect to which the
Administrator is unable or is not likely to take action under
this Act for their prevention or elimination. The amount of a
grant under this subsection shall be determined by the
Administrator, except that no grant for any State program may
exceed 75 per centum of the establishment and operation costs
(as determined by the Administrator) of such program during the
period for which the grant is made.
(b) Approval by Administrator.--(1) No grant may be made
under subsection (a) unless an application therefor is
submitted to and approved by the Administrator. Such an
application shall be submitted in such form and manner as the
Administrator may require and shall--
(A) set forth the need of the applicant for a grant
under subsection (a)[,] ;
(B) identify the agency or agencies of the State
which shall establish or operate, or both, the program
for which the application is submitted[,] ;
(C) describe the actions proposed to be taken under
such program[,] ;
(D) contain or be supported by assurances
satisfactory to the Administrator that such program
shall, to the extent feasible, be integrated with other
programs of the applicant for environmental and public
health protection[,] ;
(E) provide for the making of such reports and
evaluations as the Administrator may require[, and]
(F) contain such other information as the
Administrator may prescribe.
(2) The Administrator may approve an application submitted in
accordance with paragraph (1) only if the applicant has
established to the satisfaction of the Administrator a priority
need, as determined under rules of the Administrator, for the
grant for which the application has been submitted. Such rules
shall take into consideration the seriousness of the health
effects in a State which are associated with chemical
substances or mixtures, including cancer, birth defects, and
gene mutations, the extent of the exposure in a state of human
beings and the environment to chemical substances and mixtures,
and the extent to which chemical substances and mixtures are
manufactured, processed, used, and disposed of in a State.
[(c) Annual Reports.--Not later than six months after the end
of each of the fiscal years 1979, 1980, and 1981, the
Administrator shall submit to the Congress a report respecting
the programs assisted by grants under subsection (a) in the
preceding fiscal year and the extent to which the Administrator
has disseminated information respecting such programs.
[(d) Authorization.--For the purpose of making grants under
subsection (a), there are authorized to be appropriated
$1,500,000 for each of the fiscal years 1982 and 1983. Sums
appropriated under this subsection shall remain available until
expended.]
[SEC. 29. AUTHORIZATION FOR APPROPRIATIONS.
[There are authorized to be appropriated to the Administrator
for purposes of carrying out this Act (other than sections 27
and 28 and subsections (a) and (c) through (g) of section 10
thereof) $10,100,000 for the fiscal year ending September 30,
1977, $58,646,000 for the fiscal year 1982 and $62,000,000 for
the fiscal year 1983. No part of the funds appropriated under
this section may be used to construct any research
laboratories.]
SEC. 30. ANNUAL REPORT.
The Administrator shall prepare and submit to the President
and the Congress on or before January 1, 1978, and on or before
January 1 of each succeeding year a comprehensive report on the
administration of this Act during the preceding fiscal year.
Such report shall include--
(1) a list of the testing required under section 4
during the year for which the report is made and an
estimate of the costs incurred during such year by the
persons required to perform such tests;
[(2) the number of notices received during such year
under section 5, the number of such notices received
during such year under such section for chemical
substances subject to a section 4 rule, and a summary
of any action taken during such year under section
5(g);]
(2)(A) the number of notices received during each
year under section 5; and
(B) the number of the notices described in
subparagraph (A) for chemical substances subject to a
rule, testing consent agreement, or order under section
4;
(3) a list of rules issued during such year under
section 6;
(4) a list, with a brief statement of the issues, of
completed or pending judicial actions under this Act
and administrative actions under section 16 during such
year;
(5) a summary of major problems encountered in the
administration of this Act; and
(6) such recommendations for additional legislation
as the Administrator deems necessary to carry out the
purposes of this Act.
SEC. 31. EFFECTIVE DATE.
[Except as provided in section 4(f), this]
(a) In General.--ThisAct shall take effect on January 1,
1977.
(b) Retroactive Applicability.--Nothing in this Act shall be
interpreted to apply retroactively to any State, Federal, or
maritime legal action commenced prior to the effective date of
the Frank R. Lautenberg Chemical Safety for the 21st Century
Act.
COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION, AND LIABILITY ACT
OF 1980
* * * * * * *
Sec. 101. For purpose of this title--
(1)* * *
* * * * * * *
Sec. 104. (a)(1) Whenever (A) any hazardous substance is
released or there is a substantial threat of such a release
into the environment, or (B) there is a release or substantial
threat of release into the environment of any pollutant or
contaminant which may present an imminent and substantial
danger to the public health or welfare, the President is
authorized to act, consistent with the national contingency
plan, to remove or arrange for the removal of, and provide for
remedial action relating to such hazardous substance,
pollutant, or contaminant at any time (including its removal
from any contaminated natural resource), or take any other
response measure consistent with the national contingency plan
which the President deems necessary to protect the public
health or welfare or the environment. When the President
determines that such action will be done properly and promptly
by the owner or operator of the facility or vessel or by any
other responsible party, the President may allow such person to
carry out the action, conduct the remedial investigation, or
conduct the feasibility study in accordance with section 122.
No remedial investigation or feasibility study (RI/FS) shall be
authorized except on a determination by the President that the
party is qualified to conduct the RI/FS and only if the
President contracts with or arranges for a qualified person to
assist the President in overseeing and reviewing the conduct of
such RI/FS and if the responsible party agrees to reimburse the
Fund for any cost incurred by the President under, or in
connection with, the oversight contract or arrangement. In no
event shall a potentially responsible party be subject to a
lesser standard of liability, receive preferential treatment,
or in any other way, whether direct or indirect, benefit from
any such arrangements as a response action contractor, or as a
person hired or retained by such a response action contractor,
with respect to the release or facility in question. The
President shall give primary attention to those releases which
the President deems may present a public health threat.
* * * * * * *
(i)(1) There is hereby established within the Public
Health Service an agency, to be known as the Agency for Toxic
Substances and Disease Registry, which shall report directly to
the Surgeon General of the United States. The Administrator of
said Agency shall, with the cooperation of the Administrator of
the Environmental Protection Agency, the Commissioner of the
Food and Drug Administration, the Directors of the National
Institute of Medicine, National Institute of Environmental
Health Sciences, National Institute of Occupational Safety and
Health, Centers for Disease Control and Prevention, the
Administrator of the Occupational Safety and Health
Administration, the Administrator of the Social Security
Administration, the Secretary of Transportation, and
appropriate State and local health officials, effectuate and
implement the health related authorities of this Act. In
addition, said Administrator shall--
* * * * * * *
(5)(A) For each hazardous substance listed pursuant to
paragraph (2), the Administrator of ATSDR (in consultation with
the Administrator of EPA and other agencies and programs of the
Public Health Service) shall assess whether adequate
information on the health effects of such substance is
available. For any such substance for which adequate
information is not available (or under development), the
Administrator of ATSDR, in cooperation with the Director of the
National Toxicology Program, shall assure the initiation of a
program of research designed to determine the health effects
(and techniques for development of methods to determine such
health effects) of such substance. Where feasible, such program
shall seek to develop methods to determine the health effects
of such substance in combination with other substances with
which it is commonly found. Before assuring the initiation of
such program, the Administrator of ATSDR shall consider
recommendations of the Interagency Testing Committee
established under [section 4(e)] section 4(f) of the Toxic
Substances Control Act on the types of research that should be
done.
* * * * * * *
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