|COMMENTS OF PUBLIC CITIZEN, INC.
REGARDING FDA'S DRAFT GUIDANCE ON
EQUIVALENCE CRITERIA FOR FOOD
Docket No. 97D-0202
Public Citizen submits these comments regarding the Food and Drug Administration ("FDA") draft guidance on equivalence criteria for food, published in the Federal Register on June 4, 1997. We strongly support FDA's decision to publish the draft guidance for notice and comment. As the pressure on federal agencies to move toward uniform global standards through international standard-setting mounts, it is imperative that our domestic, democratically-accountable policy making process be maintained. If United States citizens are to continue to have control over the safety of the foods they eat, they must be notified and offered opportunity to comment on policy proposals as they are being developed, not after the fact. In these comments, we not only address FDA's equivalence criteria, but also offer specific suggestions for how FDA should continue to involve the public in all of its international harmonization activities.
The Interests of Public Citizen
Public Citizen, founded by Ralph Nader in 1971, is a non-profit research, litigation and advocacy organization dedicated to consumer rights in the market place, safe products, a healthy environment, worker safety and labor rights, fair trade, government and corporate accountability, and clean and safe energy sources through education, research, public outreach, and litigation. Public Citizen has over 120,000 active supporters nationwide. Since its founding, Public Citizen has worked to strengthen theability of citizens to participate in the domestic policy-making process and has actively monitored the activities of the FDA. For the past six years, Public Citizen has worked to educate the American public about the enormous impact of international trade and economic globalization on our nation's health, safety and environmental standards, democratic accountability, and policy-making procedures.
Food Imports and Consumer Safety
Public Citizen has a long-standing commitment to assuring the safety of the nation's food supply. We submit these comments to ensure that "equivalence" determinations do not diminish the quality of our food or increase the risk of food-borne illnesses.
Food imports have increased dramatically in recent years, with estimates that as much as 70 percent of produce sold in this country in some seasons is grown elsewhere. The growing number of imports and the dramatic changes in the way food is produced, distributed, and consumed, have significant implications for food safety:
* Studies by the General Accounting Office ("GAO") have consistently found that adulterated imported foods are reaching U.S. grocery shelves, noting a long-term trend of importers' disregarding U.S. laws prohibiting the distributionof adulterated foods. Just this spring, GAO released a report documenting the inability of current inspection systems to keep up with growing imports.
* In 1996, there was a large outbreak of cyclosporiasis -- a food-borne illness characterized by severe, prolonged diarrhea, considerable weight loss, vomiting, chills and fatigue -- in North America. Before 1996, most documented cases of the illness here were in overseas travelers. The domestic outbreak was associated with the consumption of Guatemalan raspberries. Again this year, more than 1300 cases of cyclospora infection have been reported so far; most appear to be caused by Guatemalan raspberries.
* In March 1997, 150 school children were affected by an outbreak of hepatitis A after consuming frozen strawberries imported from Mexico.
While the international food industry may claim benefits frominternational equivalence determinations, equivalence determinations that exclude the public and fail to undertake exacting review of both the substance of foreign standards and how foreign regulatory systems are implemented pose a significant risk of harm to public health and safety. "Equivalence" between U.S. and foreign standards should be found only in those circumstances in which a foreign standard or procedure meets or exceeds the level of public health protection, enforceability, and effectiveness of the U.S. standard. An erroneous determination of equivalence will lower the safety and quality of our food supply and expose the public to an increased risk of harm, as demonstrated by the experience with USDA's determination of equivalence for Canadian meat inspection procedures, discussed below.
A Case Study of an "Equivalence" Failure: Canadian Meat Inspection
FDA's Equivalence Criteria for Food
In 1995, the United States imported 2.4 billion pounds of meat and poultry from 34 countries. Canada is the largest exporter of meat and poultry to the United States, responsible for almost 40 percent of this total.
Prior to the 1988 U.S.-Canada Free Trade Agreement, USDA conducted random inspections of meat imported to the United States from Canada. To implement the U.S.-Canada Free Trade Agreement, USDA made an equivalence determination regarding Canadian meat inspection procedures. USDA's equivalence determination did not require Canada to have an inspection system identical to ours, nordid it involve examinations of individual foreign plants. Instead, it employed a vague risk analysis to determine whether the Canadian system achieved the same results overall, and concluded that it did, despite the absence of many of the safeguards that exist in the United States. There was no opportunity for public input into the equivalence determination.
The GAO criticized the Canadian meat equivalence determination for reaching certain conclusions without outside peer review and for overlooking important considerations. For instance, the United States tests end products for the presence of listeria, a dangerous and sometimes fatal bacteria related to salmonella. In contrast, Canada does not test end products, but only inspects workers and the work environment in which food is processed. Nonetheless, USDA determined that Canada's weaker, more cursory meat inspection system was equivalent to the U.S. system, and did not subject that determination to peer review.
Moreover, the equivalence study did not assess the Canadian system's control of or testing for residues of drugs approved for use in Canada, but not in the United States. Because USDA's testing program is driven by domestic concerns, border inspectors did not test meat products for the presence of unapproved drugs intheir reinspections of Canadian meat.
Pursuant to this equivalence determination, USDA ceased inspecting all Canadian meat imports in 1989. Instead, USDA instituted a cursory reinspection system designed not to ensure that the meat imports met U.S. standards, but rather to ensure that Canada maintained its "equivalent" inspection system.
GAO criticized the relaxed border inspections, contending that USDA documentation did not support the conclusion that the Canadian meat inspection was equivalent to the U.S. system. USDA meat inspectors complained that Canadian producers were taking advantage of the cursory reinspections and shipping contaminated meat. As a result of GAO's criticisms and numerous Congressional hearings on the issue, USDA discontinued its lax reinspection procedures in July 1992 and recently instituted new verification procedures to check on the decisions of Canadian inspectors.
FDA's decision to publish for public comment its draft guidance on equivalence criteria for food is a positive step toward avoiding the mistakes that USDA made in its equivalence determination for Canadian meat. Whenever a federal agency seeks to determine that the regulatory system used by a foreign countryis "equivalent" to the regulatory system of the United States, public participation is crucial. A federal agency should take steps to involve the public and consumer, health and environmental organizations in any aspects of trade agreements and international standards activities affecting food safety and other health, safety, and environmental matters. Thus, as FDA has done here, the United States should use notice and comment rulemaking procedures in formulating U.S. positions on equivalence determinations, harmonization activities, dispute resolution proceedings, and Codex activities. The agencies should also establish other mechanisms and provide funding for consumer monitoring of and participation in these activities.
We urge FDA to communicate early and often with the public not simply because it is better public policy, but also because public participation is in keeping with the spirit of the Administrative Procedures Act ("APA"). Congress did not envision an international policy-making forum when the APA was enacted. Thus, accommodating APA procedures with the bilateral or multilateral negotiations that lead to the formulation of international standards or equivalence determinations presents new challenges for agencies. The APA prohibits agencies from prejudging policy determinations and requires a full and thorough public airing of policy issues prior to the agency's making a final decision. At the same time, the exigencies of international standard-setting require the agency to engage in good faith discussions with counterpart officials from other countries that can and often do shape, if not determine, theoutcome of domestic agency rulemakings.
In our view, the overall process proposed by FDA (with certain modifications to improve public participation) is the right way to accommodate both the purpose and the spirit of the APA while meeting the demands of international standard-setting. FDA's proposal is one premised on significant public involvement in the determination process and, as such, bridges the gap between APA-style rulemaking and the challenges of policy-making in the international arena.
Public involvement must also extend beyond situations in which the United States is determining its position in harmonization talks, or when the United States is formulating the mechanism for equivalence determinations. Public involvement through notice and comment opportunities must be offered before such initial standards or equivalence determinations are given affect in United States law. Public participation is vital before the adoption of any final standard or determination because the final outcome may differ from the initial U.S. position.
Our comments on the specific provisions in FDA's draft guidance on equivalence criteria for food follow.
The Equivalence Agreement Process
FDA contemplates a process that will involve a paper review, an on-site verification review, and public notice and comment in making a determination that a foreign country's regulatory system is equivalent to that of the United States. According to the draft guidance, FDA does not plan to publish a notice until it hasalready made a preliminary determination of whether equivalence exists.
This is too late in the process. FDA should publish a notice for comment when the first contacts are made about initiating a future equivalence determination process. Public input at the initial stages of the review process must inform FDA's design of its review to ensure that the concerns of public health and safety experts and consumers are taken into account before the review process moves forward. For example, public comments may suggest that the design for a proposed equivalence determination for a particular food category exclude particular products or particular processors, or may offer guidance on particular regulatory practices of a foreign country that must be considered. An initial notice should include, at a minimum, the foreign country involved, the food categories to be considered, a detailed description of the other country's regulatory process and a proposed design for the determination, including the elements of the foreign country's regulatory system to be considered.
In conducting its equivalence determination, FDA should not limit the paper review to the foreign country's food safety regulatory system, but should also consider the country's sanitation conditions, environmental factors, climate, the state of the transportation infrastructure, and its compliance with OSHA-type requirements. All of these factors contribute to the quality of food produced in a country. For example, a country with a tropical climate would have to follow particular procedures toensure that its food was not contaminated with certain pathogens that might not even exist in other countries with less humate climates.
If FDA determines from a paper review that the foreign system meets or exceeds the level of public health protection, enforceability and effectiveness of the U.S. system and plans to conduct one or more on-site visits to verify the results, notice should again be published in the Federal Register. The notice should include, at a minimum, both the results of the paper review (including a side-by-side comparison of the elements of the U.S. system and the elements of the foreign system) and an explanation of how FDA plans to verify that the foreign regulatory system, including its plant inspection system, is functioning as indicated in the paper review.
The on-site visit, at a minimum, should include looking at the conditions under which the food is produced. For example, if the product concerned is raspberries, FDA's on-site visit should include a visit to see where and under what conditions the raspberries are being grown.
Not only should the initial notices be published as FDA conducts its equivalency review, but, as FDA recognizes, notice of FDA's preliminary equivalence determination must be published for public comment. This notice should include, at a minimum, both the results of the paper review and a summary of the on-site visit. FDA states that the final determination will take into account the comments received. When the final determination is published, FDAmust also explain publicly why it has accepted or rejected the comments.
An equivalence determination should have an expiration date that is no more than five years following the initial determination. As the expiration date approaches, FDA should publish a notice in the Federal Register for public comment on whether the equivalence determination should be renewed. Before renewing an equivalence determination, FDA should verify that the foreign country's standard or procedure continues to meet or exceed the level of public health protection, enforceability, and effectiveness of the U.S. standard.
FDA sets forth four fundamental principles that will guide its determinations of whether equivalence exists: transparency of process and reasoning, no loosening of standards, fundamental fairness and consistency, and adequate verification. In addition to these basic principles, we suggest the following:
* Not only must the factual basis for a determination of equivalence be publicly available and clearly understood, but the public must have the opportunity to participate in the process. Public input should be solicited as soon as FDA is contacted by a private party or government about the possibility of reviewing whether a foreign regulatory system is equivalent to ours.
* If FDA has entered into an equivalence agreement, the agency must engage in adequate ongoing verification and theverification process must be transparent. The public must have access to information about what FDA is doing to verify equivalence and to information about the results of FDA's verification activities. To be subject to an equivalency determination, the foreign system must allow public access to information about its regulatory activities so that the public can conduct an independent verification of on-going equivalence.
What is Equivalence?
1. Outcome and Processing Controls: As FDA recognizes, in order for a foreign regulatory system to be equivalent to the United States system, it must address both outcome (as in maximum residue levels for food contaminants or residues of pesticides or veterinary drugs) and processing (as in how a product is prepared, packed, or held). Both the maximum residue level ("MRL") requirement and the processing control requirements of a foreign regulatory system must meet or exceed the level of public health protection and effectiveness of the U.S. requirements before equivalence may be found.
FDA cites two possible situations in which a country with a less stringent MRL might be found to have an equivalent system. Both situations are fraught with unacceptable risks, and FDA should not support claims of equivalence in either case. First, FDA states that a foreign system with a less stringent MRL, or no MRL at all, may achieve equivalence if the country can demonstrate that conditions do not exist whereby the food would contain levels inexcess of the U.S. MRL. This situation might occur in those limited circumstances in which the foreign system prevents the U.S. MRL from occurring by, for example, banning the use of a particular pesticide. However, a showing that a particular pesticide is not currently being used in a country should not suffice for an equivalence determination unless there is a regulatory requirement that guarantees that the pesticide will not be used there in the future, as well as oversight to ensure that such a ban is not evaded by producers. Moreover, FDA should not allow a country to argue that its processing controls prevent contamination as that would not assure the dual protections of outcome and processing offered by the U.S. system.
Second, FDA suggests that a country may be able to demonstrate with scientific evidence that the United States could meet its own level of protection with a less stringent MRL. This notion is inherently perilous to public health and safety, particularly given the recent example in the WTO beef hormone case of how such "scientific" evidence is malleable to political and trade considerations. The equivalence determination process is not the appropriate forum for FDA to reconsider its MRLs. Consumer confidence in the safety of food will suffer tremendously if FDA begins to lower its own MRL requirements at the behest of foreign countries.
Moreover, while end product testing by itself is not a good vehicle for ensuring food safety, it is critically important as a verification tool for process control systems for raw products. FDA should require that countries utilizing HACCP systems for raw products include laboratory verification to demonstrate that the system controls or reduces food-borne pathogens.
2. Labeling and Other Special Considerations: We agree with FDA's assessment that labeling which fails to meet U.S. requirements could not be found to be equivalent to those requirements. The same is true for particular types of foods, like infant formula and medical foods, which are subject to special statutory requirements.
3. Elements of the U.S. Regulatory System: As FDA recognizes, it is not enough for a foreign country to have a law that meets or exceeds the U.S. level of protection. The foreign country must also have the authority to implement the law and must, in fact, be doing so. In order to make this assessment, FDA must consider the performance of the country's regulatoryinfrastructure. Historical data from FDA monitoring of products that are exported to the United States from the foreign country is a good source of information for this assessment, as are the budget and actual infrastructure of the country under review. And, after an equivalence agreement is reached, on-going verification must be used to ensure that the country is continuing to implement and enforce the law. The current import inspection frequency -- one to two percent -- is not adequate to verify equivalence of systems. Border inspections should be significantly increased; equivalence agreements should periodically be renegotiated; and on-site visits and evaluation of the program should occur yearly.
FDA neglects to mention a key element of the U.S. regulatory system that ensures consumer confidence in the safety of our food: public access to information about FDA's enforcement activities. FDA cannot rely only on the agency's ongoing verification after entering into an equivalence agreement. The foreign system must also allow public access to information about its regulatory activities -- either through mechanisms readily accessible to U.S. consumers through the foreign government or through FDA -- so that U.S. consumers can verify that the foreign government's activities prevent adulterated products from being exported into the United States. The Freedom of Information Act ("FOIA") is an important safeguard to assuring that our food supply is safe because it allows the American public to find out what FDA is up to and to hold our public officials accountable for their actions. No equivalence determination should be reached unless the foreignsystem allows the public independently to verify adequacy through a FOIA-type procedure.
FDA's draft guidance allows for the possibility of finding that third-party inspections systems are equivalent to ours. Yet third-party inspections are not equivalent to government inspections because company-hired inspectors face a serious conflict of interest between protecting food safety and promoting the business interests of the company that hired them. Food inspectors routinely make judgment calls that are essential to protect the public health, but that also may have a negative impact on company production and profitability by, for example, slowing or stopping a production line or by prohibiting food from being sold. Government inspectors have a mandate to put the public's safety above all else, while company-hired inspectors' food safety role can be compromised by their dependence on the company for continuing employment. For this reason, FDA should not find that third-party inspection systems are equivalent to government inspection.
If FDA nonetheless believes that recent CODEX negotiations obligate the agency to at least consider equivalence when third-party inspectors are involved, FDA should assure that the following circumstances are satisfied before determining equivalency:
(1) Inspection companies are government-certified;
(2) Food companies do not have the authority to hire or fire the inspection firms or individual inspectors;
(3) Payment for the inspection service are made to a separateentity like the government; and
(4) Whistleblower protection is in place both for the third-party inspectors and for the private plant workers.
These four factors will help counter the conflicts of interest inherent in third-party investigations.
Moreover, we are concerned that FDA's standard for approving a foreign system as equivalent is too lenient. According to FDA's proposal, a foreign government's regulatory system is equivalent when the foreign authority is implementing its law in a manner that provides "reasonable assurance" that the products being offered for import meet current U.S. standards. FDA's "reasonable assurance" standard would appear to permit approval of a system even if its implementation creates more than de minimis risks. Instead, FDA should adopt the following standard for determining equivalent implementation:
Equivalent implementation is achieved when the foreign regulatory infrastructure is carrying out its functions in a manner that produces at least the same level of protection as the implementation of domestic standards by the Food and Drug Administration.
Forms of Equivalence Agreements
We strongly oppose the concept of "piggy back" equivalence agreements, in which the United States would agree that additional agreements between one country and any third country would be recognized by the United States. Such agreements would take away the ability of the American public to participate in theequivalence determination process and could saddle the United States with agreements that do not provide sufficient safeguards.
Problem Solving Agreements vs. Equivalence Agreements
We support FDA's current policy of focusing its bilateral agreements with trading partners on assuring compliance with U.S. requirements by the foreign regulatory authority for foods that present high risks or that have had persistent compliance problems, rather than on whether the regulatory systems are equivalent. From the public health standpoint, a higher priority should be given to solving specific food safety problems than to recognizing foreign food control systems as equivalent to the United States system. Should the agency decide to revise its Criteria for Memoranda of Understanding, we support FDA's decision to issue a separate notice to that effect for public comment.
For the reasons stated above, Public Citizen commends FDA for recognizing the importance of public participation in equivalence determinations by publishing the draft guidance for equivalence criteria for food. However, we urge FDA to incorporate additional public participation mechanisms in the draft guidance as suggested in these comments. We plan to submit additional comments as FDA receives requests for equivalence determinations and if FDA moves forward on negotiating equivalence agreements with foreign countries.
Public Citizen Litigation Group
1600 20th Street, N.W.
Washington, D.C. 20009
See S. Boodman, "Forbidden Fruit, How Safe is Our Produce?," The Washington Post, Health Section, July 8, 1997.
General Accounting Office, Pesticides: Adulterated Imported Foods Are Reaching U.S. Grocery Shelves at 3 (Sept. 24, 1992) [GAO/RCED-92-205], citing GAO studies conducted in 1979 and 1986.
General Accounting Office, Agricultural Inspection, Improvements Needed to Minimize Threat of Foreign Pests and Diseases at 1 (May 1997) [GAO/RCED-97-102].
B. Herwaldt, M. Ackers, and the Cyclospora Working Group, "An Outbreak in 1996 of Cyclosporiasis Associated with Imported Raspberries," The New England Journal of Medicine, May 29, 1997.
S. Boodman, "Forbidden Fruit, How Safe is Our Produce?," The Washington Post, Health Section, July 8, 1997.
See Subcommittee on Early Childhood, Youth and Families of the U.S. House of Representatives Committee on Economic and Educational Opportunities, "Hearing on Food Safety in the School Lunch Program," April 17, 1997.
USDA Food Safety and Inspection Service, Key Facts: Import Reinspection Between USDA and Agriculture Canada, February 1997.
General Accounting Office, Food Safety & Quality: USDA Improves Inspection Program for Canadian Meat, but Some Concerns Remain at 1-2, 4, 14 (Aug. 1992).
Id. at 5, 18.
Id. at 2, 7.
Id. at 5, 6.
Id. at 6.
Id. at 1.
Id. at 2.
General Accounting Office, Food Safety: Procedures for Inspecting Canadian Meat Imports at 4-5 (April 2, 1997).
On June 30, 1997, the World Trade Organization issued a ruling against the European Union's ten-year ban on beef produced with growth hormones. The EU has accused WTO of ignoring scientific evidence and plans to appeal the ruling.
See, e.g., "Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Final Rule," 61 Fed. Reg. 38806 (July 25, 1996); Subcommittee on Microbial Criteria, Committee on Food Protection, Food and Nutrition Board, National Research Council, An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients at 227 (1985); General Accounting Office, Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry at 13 (May 1994); Committee on the Scientific Basis of the Nation's Meat and Poultry Inspection Program, Food and Nutrition Board, National Research Council Meat and Poultry Inspection: The Scientific Basis of the Nation's Program at 127-28 (1985); Committee on the Public Health Risk Assessment of Poultry Inspection Programs, Food and Nutrition Board, National Research Council, Poultry Inspection: The Basis for a Risk-Assessment Approach at 3 (1987).