Left to right: Sharon Smith Holston, Andrew McKenzie, Arthur Liang, Marjorie Davidson, Donald Kautter
Auckland, New Zealand
Meeting Highlights
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Left to right: Sharon Smith Holston, Andrew McKenzie, Arthur Liang, Marjorie Davidson, Donald Kautter |
Andrew McKenzie |
Andrew McKenzie, Group Director, Food Assurance Authority, Ministry of Agriculture and Forestry, New Zealand
Her Excellency Carol Moseley-Braun, U.S. Ambassador to New Zealand
Sharon Smith Holston, Deputy Commissioner, International and Constituent Relations, U.S. Food and Drug Administration (Delegation Leader)
John Cherry, Director, Eastern Regional Research Center, Agricultural Research Service, U.S. Department of Agriculture
Camille Brewer, the Conference Coordinator for the US Food and Drug Administration, welcomed delegates and outlined the objectives of the Conference. These were primarily outreach - sharing information about the U.S. policies on food safety - particularly the key U.S. food safety initiatives and programs, these include the National Food Safety and Produce Initiatives; seafood, meat, poultry and juice HACCP and low acid canned foods. Andrew McKenzie welcomed guests and expressed his pleasure at the opportunities for sharing information that the conference presented. He was also pleased that the conference was extended to enable New Zealand’s need to run a conference where a broad update on contemporary issues in food safety. Dr. McKenzie also outlined the importance of food safety to the region.
Her Excellency Carol Moseley-Braun, the U.S. Ambassador to New Zealand welcomed participants and especially acknowledged the cooperative efforts of the Governments of New Zealand and the United States to bring the meeting together.
Ambassador Moseley-Braun described American consumer demands for safe food and President Clinton’s keen interest in food safety. She commented that the U.S. is also committed to the principles of the World Trade Organization Agreement – free trade, sound science and transparency of decision making and recognizes the benefits consumers gain from access to a wide variety of foods year round.
Food safety is not just a trade issue, but also an important public health issue. Each link in the food chain – from farm to table – has a responsibility to use safe practices. Among all the countries in the region Ambassador Moseley-Braun welcomed the opportunity for dialogue the conference provided.
John Cherry outlined the objectives of the Conference from the point of view of the U.S. Department of Agriculture. He described the international taste for quality and safe food and the value in sharing information and learning from each other. There is no single solution to "food safety" problems and much to be gained from working together to solve problems.
Keynote speaker, Sharon Smith Holston outlined the role of the U.S. FDA in food safety and the long history of American consumer demands for safe, plentiful, varied and readily available food. This has resulted in major increases in trade from fewer than one million shipments of imported food in 1984 to more than 3.5 million shipments last year. Nearly $US600 billion of food is consumed each year in the United States and total imports of agricultural, fish and seafood products from Oceania and the Association of Southeast Asian Nations – the area represented at the Conference – reached almost $US7.7 billion dollars last year.
Relationships with trading partners, based on Memoranda of Understanding, are particularly important to U.S. FDA. There is no evidence that imported food poses a greater risk to consumers, but there is a need to ensure that all food consumed in the U.S. – both domestic and imported – is safe. Last year, nearly 76 million cases of foodborne illness were recorded in the U.S., some 5000 of which were fatal. Productivity and economic losses were estimated at $6-$37US billion per year. New pathogens are emerging and public concern about all food is very high.
Food Imports currently account for 10% of all food consumed in the US. That is expected to rise to nearly 30% by the year 2002. The FDA’s role is to make sure that all food that reaches consumers’ tables is as safe as it can be.
The goal of the Food Safety Initiative is to protecting public health, and FDA will continue doing this in the same spirit of international cooperation that has been its hallmark for the last half century.
The Conference was welcomed as an opportunity to familiarize regulatory officials, producers and exporters with the facts and implications of the U.S. food safety program for the benefit of all involved.
Panel 2: The U.S. National Food Safety Initiative
Arthur Miller, Andrew McKenzie, Camille Brewer, Michelle Smith |
Arthur Miller, Lead Scientist, Food Safety Initiative, US Food and Drug Administration
Michelle Smith, Center for Food Safety and Applied Nutrition, US Food and Drug Administration
Food Safety Research
Arthur Miller gave an update on research on the safety of fresh produce. He also outlined some of the myths and new information on the safety of fruits and vegetables and commented on the research needs and information gaps that exist. Finally, he emphasized that the FSI research activities were focused on preventing problems from occurring between sectors.
U.S. Produce Initiative
Michelle Smith spoke about the U.S. Produce Initiative and gave an overview and report on several projects. There are strong incentives for producers and suppliers to meet the requirements of the initiative and to ensure adequate traceback mechanisms. Risk reduction has to be the goal as risk elimination is not always possible. Education, evaluation and monitoring are important and the National Agricultural Statistical Survey is being developed to track changes in practices.
A delegate from Indonesia asked how it was anticipated to look at the system in future, for example, co-operating with exporting country governments. Mary Ayling responded that the U.S. FDA is working on equivalence, HACCP, needs assessments, traceback, and other systems issues and will be focusing particularly on high risk foods.
A delegate from Samoa asked whether the U.S. was promoting organic farming as a way to reduce use of pesticides on foods. Michelle Smith responded that there was no evidence that organic is safer, particularly from the point of view of micro-organisms. There is an ongoing push for reduced use of pesticides, with the recognition however, that the main risks in food are from bacterial contamination. The panel was asked as to whether the U.S. had identified organic as the best way to go for U.S. production and John Cherry responded that there is currently some ongoing research in this area but the key focus has been on specific aspects of agriculture.
Steve Hathaway was the discussant for the session and raised a number of key points relating to the New Zealand approach.
Panel 3: USDA Update
John Cherry |
Industry is seeking fast detection methods for identifying problems in production or during processing so that products do not have to be recalled if it is sent out before results are received. John’s group is also getting out onto farms and looking at the interconnections between farm, process, harvest and all potential vectors and crossovers.
Debbie Morris was the discussant for the session and made the point that comparing New Zealand and the U.S. approach is difficult as the logistics are very different. However, the risks, issues and challenges that face us all are the same and the collaborative approach is recognized as the best way to progress.
Concurrent sessions A and B held on day 1 are summarized at the end of this document.
Plenary Session
Marjorie Davidson |
HACCP Systems
Donald Kautter discussed HACCP - what it is and its applications, advantages, misconceptions and limitations. He considered emerging issues, management control philosophy and systems, the basis for sanitary and phytosanitary regulations, levels of risk, the problems of information gaps and determining what is acceptable and the need to develop HACCP systems in full consultation with all stakeholders. He also discussed U.S. experience with pilot HACCP programs and questions of on-farm HACCP.
Food Safety Education
Marjorie Davidson outlined the U.S. Fight Bac! Campaign and the Partnership for Food Safety Education. Food choices are increasing rapidly and people are eating outside the home in increasing numbers. The number of young, old and immuno-compromised people is increasing and making it more and more important that people know how to manage food risks for themselves.
Partnerships are key in food safety education. The Fight Bac! Campaign and US retail education campaign are making an important contribution to managing food related risks.
Discussant Bob Boyd outlined the New Zealand antibiotic resistance monitoring program and the New Zealand Foodsafe Partnership and other consumer education efforts. Tony Zohrab described the New Zealand interpretation of HACCP and the need to harmonize internationally while taking care that HACCP did not become an issue for trading partners. The underpinning programs for HACCP have led to a better awareness within industry of food safety but regulators must be careful not to oversell HACCP – it is not a "silver bullet".
SESSION A: RISK MANAGEMENT WORKSHOP (Day 1)
Steve Hathaway, Director Program Development, Food Assurance Authority, Ministry of Agriculture and Forestry
Art Liang, Director, Food Safety Initiative, National Center for Infectious Diseases, Division of Bacterial and Mycotic Disease, Centers for Disease Control and Prevention
John Cherry, Director, Eastern Regional Research Center, Agricultural Research Service, USDA
Linda Tollefson, Center for Veterinary Medicine, U.S. Food and Drug Administration
John Reeve, National Manager, Toxicology and Residues, Agriculture Compounds and Veterinary Medicines Group, Food Assurance Authority, Ministry of Agriculture and Forestry
Marjorie Davidson, Director, Food Safety Education, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Risk assessment is a quantitative process, part science and part art, to determine the likelihood that exposure to a hazard will result in harm or disease. Most importantly, risk assessment allows distillation of available data into a form that enables policy-makers to rapidly identify where:
The four steps of risk assessment-hazard identification, exposure assessment, dose response assessment/hazard characterization and risk characterization were discussed, using Listeria monocytogenes as an example. Risk assessment is an iterative process with initially "simple" assessments being continually refined as new data becomes available, with the assessment- verified against observed human health rates.
Steve Hathaway then followed up on his broad introduction by describing how New Zealand has expanded the risk analysis paradigm, and how risk assessment forms the basis of international policy-making and determination of acceptable levels of protection (ALOP) for a hazard.
New Zealand has developed a Risk Management Framework (RMF) that enables resource-limited risk managers to plug in exogenous assessments to make cost-effective policy decisions. The RMF includes four steps: risk evaluation, assessment of management options, implementation of risk management decisions, and monitoring and review.
Central to the risk management approach is the setting of the ALOP prior to selection of the sanitary measures, and he described alternative means for determining ALOPs, one resulting from the need to solve a problem, the other dictated by policy.
Current FAO/WHO cutting edge risk assessment initiatives had identified a number of issues:
There is a need to capture appropriate epidemiological and microbiological data from any outbreak. Outbreak investigation must be refocused to provide the most appropriate data for exposure characterization. The need for clearly defining the objective and scope of a risk assessment prior to commencing any risk assessment activities was emphasized, along with involving risk managers and risk communicators at all stages of the assessment.
Arthur Liang briefly described how epidemiology figures into risk assessment, and the sources of epidemiological information that is available in the United States through the CDC initiatives.
Epidemiology figures into
John Cherry briefly described the usefulness of predictive microbiological models for risk assessment in that they can provide answers that would be cost-prohibitive using classical microbiological case-control experiments.
Models are useful for developing HACCP, determining of shelf life and reformulation consequences, and assessing of the effects of process failures, and for training and education.
Models for microbial growth, survival and inactivation have been developed by the USDA (PMPWin v5.1), and are available at no cost on the USDA web-site.
Notwithstanding savings in costs to the risk assessors, Dr. Cherry described the costs involved in validating the models (US$1.8 million to validate predicted listeria prevalence in hot dogs).
Future modelling to account for food validation, competitive exclusion, host defense/virulence potential, MAP, lag phase effectors (irradiation) and validation of new technologies were described.
Linda Tollefson then described an example of risk assessment in action – Impact of resistant campylobacteriosis in humans due to fluoroquinolone use in chickens. The assessment was broad-based and used a suitable multi-pronged approach.
Flexibility of design was emphasized with the approach used not following the classical farm- to-fork scenarios but applied to just part of the continuum. Sources of data were described, and how assumptions were required, again due to lack, or incompleteness, of data. Dr. Tollefson introduced the concept of uncertainty into risk assessment discussions, and how that can be quantified and built into risk assessments.
Finally, Dr. Tollefson indicated that the risk assessment indicated a high impact of fluoroquinolone use in chicken husbandry to resistant campylobacter in humans.
John Reeve then described how risk assessment is used in New Zealand for the development of new MRLs for chemical pesticides, and described the new legislation being developed for the Food Safety Protection Act.
Risk assessment is useful not only for considering the effects on human health but also for the risk to international trade. Risk assessments used worst-case scenarios and multiple assumptions ("risk cup") for exposure data because of lack of data, but warned how such levels of assumption can result in policy decisions/trade barriers that are distant from any food safety consequence.
Finally, Marjorie Davidson defined Risk Communication and the need for risk communicators to be involved at all stages of the risk management and risk assessment processes. The process is "interactive" and designed to ensure accountability and trust and confidence in the process, and hence in the food safety system.
There are different "publics" and that each segment of the public may have specific communication needs. For example, scientists may not be able to communicate with consumers at a level that engenders understanding and trust. Different messages are needed for different audiences. Risk communicators are often aware of information that is not in the peer review of scientific literature, and can bring that information to the table.
Consumers need practical "what to do" advice as an output from risk assessments, and risk communicators are the most appropriate ones to provide that advice.
What happens when risk assessments are wrong? [Kaye Weir, Pacific Institute of Resource Management, New Zealand]
Remember that risk assessments are based on all the information and understanding available at the time of development. Remember also that the risk assessments are iterative, and can be changed at any stage in response to new information and verification. Continuous improvement is the answer. [Art Miller]
How does one account for mild, perhaps unreported, illness in risk assessments? [Sally Hassell, ANZFA, New Zealand]
This is difficult to answer, as it is a problem for all diseases. There have been attempts to quantify the level of unreported/mild illnesses. The UK data may be useful. [Art Liang]
How do inappropriate sampling plans affect the data and hence risk assessment? [Sally Hassell, ANZFA, New Zealand]
This is always a problem. ICMSF are re-evaluating sampling plans to try to standardize the data. [Art Miller]
Given the CODEX one-size-fits-all philosophy, what is the likelihood that resource- limited countries can take standards to a higher level if they wish? [Wendy Johnson, Friends of the Earth, New Zealand]
CODEX only provides benchmarks. Any country can go to a higher level, if that need is fully transparent and justified. Remember that the development of CODEX standards is an eight- stage process with ample time for countries to question the proposed standards. In addition, all WTO countries must provide technical assistance to countries without that technical competence. Safeguards are built in to make sure that the needs of developing countries are met. [Steve Hathaway]
Why is it necessary to irradiate meat rather than clean up processing? [Wendy Johnson, Friends of the Earth, New Zealand]
The panel were not able to answer the question specifically, but noted that irradiation had been fully investigated and was approved for use in the United States. [John Cherry, Art Miller]
How could consumers agree on an acceptable level of risk, given media hype, etc? [Celia Murphy, Consumers Institute, New Zealand]
Consumers should be engaged in the risk assessment process at all stages. Hence, there should be no surprises. In addition, a better term would be "tolerable" risk. These are set on the current state of processing, knowledge and overseas requirements, hence are not "new systems". They are simply a reflection of the status quo. [Marjorie Davidson, Steve Hathaway]
Are there international bodies co-ordinating the work of predictive modellers? [Dave Lowry, EcoLab, New Zealand]
No, but there is a close network and yearly national and international conferences occur, at which researchers in the fields of predictive modelling and risk assessment get together to discuss their developments. A meeting is being planned for next Spring in England between U.S. and European scientists. [John Cherry, Art Miller]
In resource-limited countries, could the risk manager and risk assessor be the same person? [Jamal Khair, Ministry of Health, Malaysia]
This issue has been hotly debated in FAO/WHO and while separation is recommended, it is recognized that they may be the same person as long as decisions, etc. are transparent and well documented such that the two levels can be clearly seen. [Steve Hathaway]
Would it not be appropriate to divert money from the huge amount going into risk assessment to educate the food sector and consumers? [Bruce Sutherland, Ministry of Health, New Zealand]
Totally agree! [Margaret Davidson]
Comment: Devastated by the fluoroquinalone use in chickens and campylobacteriosis resistance in chickens. [Kaye Weir, Pacific Institute of Resource Management, New Zealand]
All we can say is that this is very well recognized by the poultry industry and they are currently working very hard to find alternative husbandry practices.
Modelling is a very dynamic science. Will we ever get to the stage where one model fits all? [Dave Lowry, Ecolab, New Zealand]
The advantage of risk assessment is that it allows us to rank inputs and outputs, and decide what is important and unimportant. If we can get to the right scenario that gets balance between complexity and simplicity, then we may get to that "one model". But currently we are right at the start of this process but will get smarter with time and experience. [Art Miller].
SESSION B: EXPORTING FOOD TO THE US (Day 1)
Mary Ayling, Arthur Liang |
Mary Ayling, Food Inspections Team Leader, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Virginia Olson, International policy Division, Food Safety Inspection Service, U.S. Department of Agriculture
Donald Kautter Jr., Consumer Safety Officer, Division of HACCP Programs, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Brett Koonse, Chief, Programs and Enforcement, U.S. Food and Drug Administration
Camille Brewer, International Activities Coordinator, Food Safety Initiative, Center for Food Safety and Applied Nutrtion, U.S. Food and Drug Administration
Julia Ho, Associate Director for Asia and the Pacific, Office of International Programs, U.S. Food and Drug Administration
Bill Jolly, New Zealand Embassy (D.C)
Mary Ayling presented "Understanding the legal requirements for exporting food to the U.S.". She noted that domestic and imported foods must meet the same standards although regulatory options may differ. She discussed how firms are selected for inspection, what happens when foods arrive at the border, what FDA looks for, and how to assure food meets FDA requirements. In the question session, there was some discussion about the fate of goods refused entry into the U.S. and how other countries might avoid becoming the recipient of such goods.
Virginia Olson presented "Process for evaluating the equivalence of foreign meat and poultry food regulatory systems." She noted that food safety equivalence determinations are based on provisions of the SPS agreement. Equivalency determinations consist of a series of cooperative steps between the importing and exporting countries. Because of time and cost involved, most countries adopt US requirements. Questions included equivalence determinations for other (non-FSIS) products and reasons for the differences in approach between FDA and USDA.
Donald Kautter Jr. presented "Future importation of juice into the U.S.". He discussed the U.S. Juice HACCP proposal and steps that an importer might take to ensure compliance with requirements once they become final.
Brett Koonse presented "Importing seafood into the US". He discussed the seafood HACCP requirements and verification options for importers. He noted that all current agreements are compliance agreements, not equivalence determinations, although the US is working to develop equivalence agreements with four countries. Questions included how FDA would work with third party verification and the differences between verifying the practices of a firm compared to verifying the system within a country.
Camille Brewer presented "Overview of food labeling requirements". She discussed basic food labeling requirements, placement, and Nutrition Facts labeling and format options. Discussion topics included country of origin labeling, shelf-life labeling, dietary supplements, and the role of FDA in advertising.
Julia Ho presented information about FDA’s authority, structure, and how to interact with the agency.
Bill Jolly recapped high points of the session presentations. He questioned if there was a better way to get assurance of equivalency and improve verification systems. He argued for flexibility and focus on outcome. He noted that the seafood HACCP approach is as much about outreach as enforcement. He maintained that significant efficiencies could be gained by MOUs with countries. He stated that transparency is a significant strength of the U.S. system. Limitations include old statutes and politicians.
SESSION C: SEAFOOD SAFETY AND HACCP SYSTEMS (Day 2)
John Lee, National Manager, Seafood, Food Assurance Authority, Ministry of Agriculture and Forestry.
Brett Koonse hosted an interactive audience discussion on seafood regulatory policy. The discussion focused on how the United States and New Zealand regulate seafood, both domestically and for imported products. It focused on the regulatory framework in the U.S. and New Zealand but several other countries discussed pieces of their regulatory strategies as well.
Why doesn't FDA do more foreign inspections?
How does a firm get off of Detention Without Physical Exam?
What is our regulatory policy on vacuum packaged raw products?
SESSION D: PRODUCE SAFETY (Day 2)
Arthur Miller, Lead Scientist, Food Safety Initiative, U.S. Food and Drug Administration
Michelle Smith, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Jeff Oberman, United Fruits and Vegetable Association
Arthur Miller, FDA
Q: What decision-making process initiates a traceback?
A: Having a greater than expected number of cases of foodborne illness, as judged by CDC.
Michelle Smith, FDA
Q: Were there any other driving forces, e.g. commercial drivers, quality drivers, for this document besides the food safety initiative?
A: No. However, food safety practices have benefits in other areas and the plan is to examine these areas.
Q: Can processing facilities use recycled water?
A: Key criterion is that water must be fit for its intended purpose.
Q: Buyers are requesting that their suppliers following Guide – are growers being audited against this practices?
A: Third party audits are taking place.
Jeff Oberman, United Fruits And Vegetable Association
SESSION E: PROCESSED FOODS (Day 2)
Ms. Ayling discussed various legal requirements on importing dairy products into the U.S. and provided an update on FDA’s HACCP Pilots for dairy products. The grade A Options and Grade A Program for dairy products were discussed. She also provided an update on the Egg Safety Initiative.
Ms. Ayling gave a detailed description of FDA’s pesticide residue monitoring program and provided the 1998 monitoring results. She explained the total diet study program and provided the result of the study.
She also provided an overview of the agency’s efforts on the monitoring of toxic contaminants in foods, such as lead in candy and foodware. She discussed the agency’s efforts on testing and monitoring mycotoxins in foods in the U.S.
The participants were interested in learning about the FDA’s review of process filing data of acidified and LACF products. The discussion focused on what the agency looks for in a review.
The issue of whether unpasteurized dairy products could be imported into the U.S. was raised. A comment was made on the U.S. - New Zealand MOU on dry milk -whether the current requirements under the MOU were too strict or necessary.
There was a discussion on whether the USDA will require mandatory pasteurization of juice products. The issue whether the government identifies all the pathogens in juice products or whether that is the responsibility of the industry was discussed.
Any testing of mycotoxins for products export out of the U.S.? No. FDA does not conduct testing for export purpose since the agency is not an export agency.
Does FDA test for allergens in foods? The challenge of developing testing for allergens was discussed.
There was considerable discussion on the pros/cons of third-party auditors. It is the trend in Australia and New Zealand. What is the U.S. government's view of such approach? The issues of consumer confidence and ethics/conflicts of interest were discussed.
SESSION F: MEAT, POULTRY, DAIRY AND EGG SAFETY (Day 2)
Virginia Olson, Linda Tollefson |
Marjorie Davidson, Director, Food Safety Education, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
Linda Tollefson, Center for Veterinary Medicine, U.S. Food and Drug Administration
Marjorie Davidson presented the Egg Safety Action Plan, which is a joint initiative of FDA and USDA. She described each agency's responsibilities at every point in the process.
Linda Tollefson described FDA’s regulatory response to antibiotic resistance among foodborne bacteria. She also described in detail the U.S. National Antimicrobial Resistance Monitoring System (NARMS), which is a collaborative effort of FDA, CDC and USDA to monitor changes in susceptibility of foodborne pathogens in humans and animals.
Also, surveillance of human health is necessary to measure impact. Questions arose as to the ability of breeder lines to remain SE free in the United States
The issue of drug use in food animals and the concomitant threat of antibiotic resistant pathogens indicates a need to control drug use. However, animal welfare issues should be considered. Also, the perceived conflict of interest among veterinarians benefiting from drug sales may become an issue in the future.
Jonathon Taylor of NZ MAF was asked to describe the current processes within MAF to address the issue of antibiotic resistance associated with animal drugs. He presented a schematic diagram of how animal drugs are reviewed prior to approval with respect to minimizing the human health impact. The MAF rationale includes an assessment of human health significance of the drug under review, the veterinary use hazard, and the veterinary health significance.
Hypertext updated by bap 2000-OCT-30