Comments of Public Citizen, Inc. Regarding FDA's Consideration of Codex Alimentarius Standards

Docket No. 97N-0218

? Public Citizen submits these comments regarding the Food and Drug Administration's (FDA's) advance notice of proposed rulemaking to amend regulations governing procedures for the review and evaluation of standards adopted by the Codex Alimentarius Commission (Codex), 62 Fed. Reg. 36248 (July 7, 1997). Our comments are based on three fundamental principles: (1) the paramount goal of FDA's consideration of Codex standards must be to safeguard the public health of the people in the United States, (2) only those Codex standards that would improve (or equally maintain) public health and consumer protection in the United States should be adopted, and (3) our domestic, democratically-accountable policy making process must be maintained. In these comments, we first address the significant problems in the Codex standard-setting process, and then offer specific suggestions to ensure that FDA's consideration of Codex standards does not undermine the public health.

The Interests of Public Citizen

? Public Citizen, founded by Ralph Nader in 1971, is a non-profit consumer advocacy organization with over 120,000 active supporters nationwide. Since its founding, Public Citizen has worked to strengthen the ability 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 ofinternational trade and economic globalization on our nation's health, safety and environmental standards, democratic accountability, and policy-making procedures.
? Public Citizen has a long-standing commitment to assuring the safety of the nation's food supply. We submit these comments to ensure that FDA does not establish procedures for consideration of Codex standards that results in diminishing the quality of our food.

The Codex Alimentarius Commission and Food Safety

? The Codex Alimentarius Commission is an international standard-setting body established jointly in 1962 by the United Nations World Health Organization and the United Nations Food and Agriculture Organization to facilitate international trade of food. At its inception, Codex set identity standards -- that is, descriptive standards for foods -- so that traders around the world would, for example, have a common understanding of what was being bought and sold as "peanut oil." The 158 member countries of Codex are encouraged to accept and implement Codex-approved food standards nationally, but are not obligated to do so. The United States has participated in Codex activities since 1962, but historically, Codex standards were not considered to be safety standards, nor were they accepted as safety standards by FDA. 21 C.F.R. ? 130.6.
? Recent international trade agreements have caused a radical change in the nature of Codex standards. Both the North American Free Trade Agreement (NAFTA) and the Uruguay Round of the GeneralAgreement on Tariffs and Trade (GATT) have changed the status of Codex standards by designating Codex as the international body establishing presumptively trade-legitimate food safety standards. No longer are standards set by Codex purely designed to facilitate smooth trading negotiations, nor are they voluntary. Codex standards -- which traditionally served as a minimum floor of acceptable quality for less developed countries -- have become the presumptive international standards for food safety and labeling. Under the Uruguay Round's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), regulatory requirements that exceed Codex standards may be challenged as trade barriers.See footnote 1 While the SPS Agreement does not require countries to adopt Codex standards as their own national standards, a country must have a scientific justification to establish or maintain a more stringent standard to meet its chosen level of protection.See footnote 2 The burden of proof to show a scientific justification falls on the country witha standard that is more stringent than Codex. Thus, Codex standards now have new significance in the United States and for the FDA's regulatory activities because other countries may challenge an FDA safety standard as a trade barrier if the standard exceeds the requirements set by Codex.
? Despite the heightened status and responsibility that is given to Codex and its standards under the NAFTA and GATT SPS Agreements, significant problems in the way Codex operates have not been addressed:

? 1)?? Codex Was Created to Promote International Trade and Employs Procedures That Jeopardize the Safety of the U.S. Food Supply. Codex is poorly suited to establishing global food safety standards because its mandate to protect public health takes a back seat to its competing mandate to promote international trade. Codex's focus on facilitating international trade contrasts sharply with the domestic mandate in the Federal Food Drug and Cosmetic Act (FDCA) which is to protect and promote the public health, regardless of its impact on trade. Moreover, it threatens to trump United States standards that are based solely on public health, such as the Delaney Clause, which permits no risk of cancer from exposure to carcinogens in food. In contrast to FDA's public health mandate provided by the FDCA, Codex has no over-arching mandate to protect public health and no codified standard that requires precautionary principles to be applied or spells out precisely how to assess whether consumer health is adequately protected.
? Instead, Codex allows health and safety standards to be set by popular votes which may be based on economic factors having nothing to do with public health protection. Codex gives each member country an opportunity to vote on each standard, even when that country has a self-interest in a less-protective standard. Thus, France and other European countries that sell non-pasteurized cheese object to any Codex dairy standards that would require pasteurization, just as pottery-producing nations like Portugal and Spain would object to stringent lead standards. It is not surprising that the United States would be outvoted by countries with less protective safety standards, because if those countries vote to accept higher standards, their products would be banned from international trade. Thus, there is significant pressure to keep Codex standards weak.

? 2)?? Lack of Public Participation in Codex Standard-Setting. Codex has operated without adequate mechanisms for obtaining public input or maintaining public accountability. Meetings of the Codex Executive Committee are closed, even when the agenda includes decisions on risk management and other important policy issues. Observers are also excluded from the meetings of the two expert committees that perform the scientific evaluations which support Codex standards -- the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint FAO/WHO Meetings on Pesticide Residues (JMPR). While Non-Governmental Organizations are allowed to attend the Commission's meetings, the needed background documents are rarely provided with adequate lead-times andprocedural rulings by the secretariat have precluded full dissemination of consumer perspectives to Codex participants. Moreover, certain Commission decisions are taken in private sessions. For example, the decision to accept Maximum Residue Limits (MRLs) for growth-promoting hormones in meat production -- a subject of great interest to consumer groups in many countries -- was taken by secret ballot at the Commission's 21st (July 1995) meeting.See footnote 3
? Thus, Codex procedures are completely at odds with the transparent and participatory way in which FDA sets safety standards in the United States. Domestically, the Administrative Procedures Act (APA) and the Federal Advisory Committee Act (FACA) ensure that the public has notice and the opportunity to comment on proposed rules, and that advisory committees are balanced and open to the public. No such democratically-accountable policy making process is followed by Codex.
? In recent years, some consumer and environmental organizations have attended Codex meetings and have sought to make Codex more open and participatory. Consumer and environmental representation, however, has remained sporadic and Codex has not yet significantly reformed its processes to ensure more meaningful publicparticipation.See footnote 4
? The United States delegation to Codex is not headed by FDA -- whose sole mandate is to protect the public health, but by USDA -- an agency with a mandate to promote the sale of U.S. agricultural products abroad.See footnote 5 Not surprisingly, industry has been intimately involved in Codex from the outset. For example, at the most recent Codex meeting in June, representatives from Coca-Cola, Pepsi Cola, Monsato, and Pfizer as well as such trade groups as the International Dairy Federation, the International Council of Grocery Manufacturers Associations, the International Organization of the Flavour Industry, the International Soft Drink Council, and the International Glutamate Technical Committee attended.See footnote 6 In contrast, consumers, public health advocates, and environmental organizations have been relative latecomers, and still comprise a very minor voice. A 1993 study reported that over eighty percent of the non-governmental participants on national delegations to recent Codex committees represented industry, while only onepercent represented public interest organizations.See footnote 7 Of the 37 non-governmental organizations that participated at the most recent Codex meeting this summer, only three represented the public interest community.See footnote 8 And while many of the delegations of member countries included industry advisors, only three countries -- the United States, Germany, and Norway -- had consumer representatives on their delegations.See footnote 9

? 3)?? The Rationale and Process for Codex Decisions Needs Strengthening. According to a report released by the Office of the U.S. Coordinator for Codex Alimentarius ("U.S. Codex") in February 1995, "aspects of the scientific and administrative procedures followed in the elaboration of [Codex health and safety standards] warrant attention for example their transparency, their consistency between and within committees, and their adequacy of data requirements."See footnote 10 U.S. Codex identified three concerns related to the scientific basis for Codex decision:
??? 1.? The basic scientific approaches employed in the expert committees' evaluations need clearer articulation and public review.
??? 2.? The relationships among the technical experts,governments, and non-governmental organizations need to be examined and clarified.
??? 3.? Systematic processes need to be established for continuous reassessment and updating of the scientific approaches and the data evaluations themselves.See footnote 11
U.S. Codex then established a goal that "within five years, with the support of U.S. Codex, Codex Alimentarius decisions will be widely recognized and fully accepted as being based on strong, consistent scientific principles."See footnote 12 In an apparent effort to achieve this goal at the most recent Codex meeting in June 1997, the United States delegation emphasized that the risk analysis process should be transparent and that "it was extremely important that results of risk assessment be published to be available for others to obtain information and/or to confirm their own evaluations."See footnote 13 While Codex is currently developing an action for development and application of risk analysis principles and guidelines in all Codex activities, Codex put off making firm recommendations for adoption of definitions for risk assessment policy and risk profile until the 23rd Session (in 1999).See footnote 14
? The existing problems in the operation of Codex standard-setting -- the inherent conflict posed by Codex's dual mandate to promote international trade while protecting consumer health aswell as the need for Codex to address standard-setting as a democratic policy-making process in which openness, transparency and effective participation are central -- have resulted in standards that are often less protective than FDA standards.
? No comprehensive comparison of FDA and Codex standards has been conducted recently. However, a 1997 report by the Center for Science in the Public Interest pointed to five areas in which the Codex standard falls below existing FDA and USDA regulatory requirements: pasteurization of dairy products, food additives, mineral content of bottled water, meat inspection, and lead contamination.See footnote 15 Moreover, in 1991, the U.S. General Accounting Office conducted a comparison of U.S. pesticide standards to Codex pesticide standards.See footnote 16 While many pesticide tolerances or maximum residue levels (MRLs) could not be directly compared because the standards are defined differently, GAO found that for those that could be compared, among the pesticides that EPA has rated as probable carcinogens, the United States has lower MRLs (a more stringent standard) in 55 percent of the cases.See footnote 17 GAO determined that acceptance of Codex's higher (less stringent) standards could raise health concerns because of possible increased exposure.See footnote 18 Indeed, a 1994 analysis by Public Citizen and the Environmental Working Group found that adopting Codex tolerances for pesticides where they are higher than U.S. tolerances would increase allowable cancer risk 12 times over current U.S. levels.See footnote 19

FDA's Consideration of Codex Standards

? Congress has made clear that FDA's obligations to protect the public from adulterated and misbranded food under the Federal Food Drug and Cosmetic Act (FDCA) have not been reduced or modified by the United States's participation in international trade agreements. In approving and implementing the Uruguay Round trade agreements, Congress explicitly provided that "[n]othing in this Act shall be construed (A) to amend or modify any law of the United States, including any law relating to (i) the protection of human, animal, or plant life or health."See footnote 20 Moreover, the Statement of Administrative Action written by the Administration and approved by Congress when it implemented the Uruguay Round agreements specifically lists the FDCA as a federal environmental and health measure that is not amended or modified by the agreements.See footnote 21 Accordingly, FDA may not adopt Codex standards that do not comply with the statutory requirements set forth in the FDCA.
? FDA's primary goal in consideration of Codex standards, as inall of its international harmonization activities, must be to preserve and enhance its ability to accomplish its public health mission. With this goal in mind, we make the following suggestions:
? 1)? FDA procedures for review of Codex standards must ensure that the agency is exercising its own independent judgment (uninfluenced by international trade pressures) when it considers whether a particular Codex standard will improve public health in the United States. The review should ensure that the relevant science on which the Codex standard was based is independent from industry influence and has not changed; that the Codex standard reflects the newest science and consumer protection concerns, including precautionary principles; that the factual and scientific bases for the Codex standard are part of the record made available to the public; and that the standard maintains the flexibility to respond to emerging health hazards and other new information.
? 2)? FDA should only consider for adoption Codex standards that provide a greater level of protection than current U.S. standards, or address concerns not yet regulated by FDA. For example, in 1991, GAO determined that Codex standards had lower (more stringent) MRLs for certain carcinogenic pesticides than United States MRLs in 27 percent of the comparable cases.See footnote 22 Codex standards like these that would increase the level of consumer protection should be reviewed first and adopted. Codex standards that are adopted domestically should be reviewed at least onceevery three to five years to ensure that the standard still offers the highest level of health and consumer protection.
? 3)? In order to identify other Codex standards for review, FDA should look to those FDA regulations that need updating and revision and consider any relevant Codex standards in conjunction with a review of FDA regulations. For example, FDA intends to review its regulations pertaining to identity, quality, and fill of container for standardized food in order to simplify the regulations where practicable and to take into account the impact of the 1990 NLEA amendments. 60 Fed. Reg. 67492 (Dec. 29, 1995). As part of this review, FDA should consider any relevant Codex standards. Whenever FDA plans to issue a new FDA regulation (or revise an existing regulation), the agency should also review any relevant Codex standards.
? 4)? FDA should not give priority to standards adopted since 1993, because there is no basis for assuming that post-1993 standards are "better" than those adopted previously. It is true that Codex standards adopted from 1993 forward are intended to reflect the new role of Codex standards under the SPS and TBT agreements, while those adopted previously were intended to provide product standardization and guidance to developing nations. However, the significant problems in the way Codex sets standards continues and thus, there is no merit to any assumption that post-1993 standards are more likely to be deserving of adoption as standards than those adopted previously.See footnote 23
? However, post-1993 Codex standards are more likely to be upheld by WTO in a trade challenge, and are, therefore, much more worrisome from the public health perspective. FDA must make sufficient resources available so that it can conduct necessary scientific studies and defend its position at the WTO.
? In future Codex proceedings, FDA should strongly object to any Codex standards that are weaker than FDA standards. Indeed, the new U.S. strategic plan calls for FDA employees who participate in Codex proceedings to determine whether acceptance of a Codex standard would affect the health and safety of American consumers.See footnote 24 FDA should not only ascertain when Codex standards fall below U.S. requirements, but also object to the approval of such standards by Codex and place on the record its reasons for contesting the soundness of Codex's proposed standard. If theUnited States cannot successfully block the development of weaker Codex standards, then it should record its position in the minutes and reports of Codex proceedings to establish a record that clearly demonstrates why the Codex standard does not sufficiently protect consumers. This record will help discourage potential trade complaints and serve as a basis for a defense before the WTO if necessary.See footnote 25
? (5)? Public participation in the review of Codex standards is critical. FDA's proposal to publish a Federal Register notice of newly adopted Codex standards is a sensible way to get preliminary public input on the priority to attach to review and evaluation of particular standards.See footnote 26 Not only should this notice also be posted on the FDA's Web page, but FDA should take affirmative steps to ensure that consumer, health, and interested academics receive this information. Moreover, this notice should not be either the first or last step in providing the public with the opportunity to participate. At the front end, FDA should strive to improve public participation in the Codex standard-setting process itself, so that the public has input into the Codex standards before they arefinalized. Moreover, in those situations in which FDA decides to pursue adoption of a Codex standard, a separate notice should be published in the Federal Register and the public should be given the opportunity to comment.
? Currently, FDA reviews Codex standards for adoption in the United States in one of the following three ways: (1) an individual files a petition for adoption of a Codex standard, and if reasonable grounds are provided in the petition, FDA publishes the petition in the Federal Register for comment; (2) on the FDA's own initiative, a proposal for adoption of a Codex standard is published in the Federal Register; or (3) after publication in the Federal Register, the public submits comments on whether a Codex standard should be adopted; and after reviewing the comments, FDA either publishes a proposal to establish a food standard or publishes a notice terminating consideration of the standard. 21 C.F.R. ?? 130.6, 564.6.
? These regulations should be clarified in three ways. First, the regulation should provide guidance to the petitioner by setting forth the criteria FDA will use to decide whether to publish the petition for comment. In light of FDA's public health mandate, FDA should require a petitioner to make a prima facie case that the adoption of a Codex standard would not lower current FDA standards or otherwise raise public health concerns. Only in such circumstances would the petition be published for comment. Second, the regulation should provide that FDA would, on its own initiative, consider adoption of a Codex standard (1) when theCodex standard provides a greater level of protection than a current FDA standard, or addresses concerns not yet regulated by FDA; (2) when a Codex standard is relevant to new or revised FDA regulations; or (3) when a Codex standard would improve the public health or consumer protection. Third, the Federal Register notice provided for in ? 130.6(b)(3) should, at a minimum, (1) describe the Codex standard and its comparability to an FDA standard; (2) provide FDA's preliminary views on the Codex standard including its potential for acceptance by FDA and whether rulemaking would be necessary; (3) describe information the agency would need for adequate evaluation of the standard; (4) invite information on relative importance of the standard to public health protection; and (5) state the agency's preliminary plans to perform substantive review of the standard. Based on the comments received, FDA would either decide to proceed with review of the Codex standard, and publish a notice to that effect in the Federal Register for additional comment, or decide against further review of the standard.


? FDA's statutory mandate is to ensure public health and consumer protection. Codex standards should only be adopted when they will improve food safety and labeling in the United States. Given FDA's limited resources, FDA should focus on review of Codex standards (1) when the Codex standard provides a greater level of protection than a current FDA standard, or addresses concerns not yet regulated by FDA and (2) when a Codex standard is relevant tonew or revised FDA regulations. FDA should strive to improve public participation in the Codex standard-setting process itself, and should provide the public with notice-and-comment opportunities when the agency considers adoption of a Codex standard.
????????????? Respectfully submitted,

????????????? Lucinda Sikes
????????????? Staff Attorney
????????????? Public Citizen Litigation Group
????????????? 1600 20th Street, N.W.
????????????? Washington, D.C. 20009

Footnote: 1The SPS Agreement governs among other things, measures intended: (1) to protect human or animal life or health within a territory from risks arising from additives, contaminants, toxins, or disease-causing organisms in foods, beverages, or feedstuffs; and (2) to protect human life or health within a territory from risks arising from diseases carried by animals, plants, or products thereof. The NAFTA, involving Mexico, Canada, and the United States, contains provisions that are substantively similar to the Uruguay Round's SPS Agreement.?

Footnote: 2The Uruguay Round's Agreement on Technical Barriers to Trade (TBT Agreement) encourages the harmonization of technical regulations, including packaging, marking and labeling requirements. While the TBT Agreement does not specifically refer to Codex standards, Codex does qualify as an international standard-setting body under the TBT agreement when Codex elaborates and adopts international standards not related to SPS food safety matters. Thus, some Codex standards fall within the terms of the TBT agreement.?

Footnote: 3See Position Paper, "Position of Consumers International for the Twenty-Second Session of the Codex Alimentarius Commission re: involvement of non-governmental organizations in the work of Codex Alimentarius Commission," June 1997 (discussing significant barriers to consumer participation in Codex proceedings and making recommendations for improvements).?

Footnote: 4At the most recent Codex meeting on June 23-28, 1997, the Commission considered the involvement of non-governmental organizations in its work and concluded that the Secretariat should prepare a paper in consultation with independent non-governmental consumers' organizations on enhancing the role of such organizations in the Codex process for consideration at the next session of the Commission (in 1999). See Codex Alimentarius: Report of the 22nd Session ("22nd Session Report") ?? 155-159 (1997).?

Footnote: 5Indeed, USDA recently stated that "[t]he makeup of U.S. Codex should reflect a balance between trade and regulatory perspectives." 62 Fed. Reg. 23,746, 23,752 (May 1, 1997).?

Footnote: 622nd Session Report, List of Participants 75-82 (1997).?

Footnote: 7Natalie Avery et al., National Food Alliance, Cracking the Codex: An Analysis of Who Sets World Food Standards 1 (1993).?

Footnote: 822nd Session Report, List of Participants, 75-82.?

Footnote: 9Id. at 32-73. Norway even paid for a consumer representative -- from the Consumer Council of Norway -- to attend.?

Footnote: 10Office of the U.S. Coordinator for Codex Alimentarius, U.S. Codex Strategic Plan, 8 (February 1995).?

Footnote: 11Id. at 8-9.?

Footnote: 12Id at 11.?

Footnote: 1322nd Session Report, ? 166?

Footnote: 14Id. at ?? 162-167.?

Footnote: 15Center for Science in the Public Interest, International Harmonization of Food Safety and Labeling Standards 10-28 (June 1997).?

Footnote: 16United States General Accounting Office, International Food Safety: Comparison of U.S. and Codex Pesticide Standards (GAO/PEMD-91-22) (Aug. 1991).?

Footnote: 17Id. at 4.?

Footnote: 18Id. at 35.?

Footnote: 19Public Citizen and Environmental Working Group, Trading Away U.S. Food Safety, 70 (April 1994).?

Footnote: 20Uruguay Round Agreements Act, P.L. 103-465, ? 102; 19 U.S.C. 3512.?

Footnote: 21The Uruguay Round Agreements Act, Statement of Administrative Action, reprinted in 1994 U.S. Code Cong. & Ad. News 4040, 4063.?

Footnote: 22GAO, Comparison of U.S. and Codex Pesticide Standards at 4.?

Footnote: 23As U.S. Codex recognized in 1995, routine acceptance of Codex standards is not likely to be appropriate until at least the year 2000:
??? Ideally, within the next five to ten years, . . . Codex standards would be
??????? - established through a more transparent and fully participatory process;
??????? - based on stronger, more consistent scientific principles, and
????? -fully protective of health in all countries.
Office of the U.S. Coordinator for Codex Alimentarius, U.S. Codex Strategic Plan, 7 (February 1995). Thus, it may be that, at some point in the future, FDA could give priority to consideration of Codex standards adopted after a certain date because those standards would reflect a Codex standard-setting process that is more transparent and participatory, based on stronger science, less tainted by purely economic considerations, and fully protective of health. However, at this time, it is premature for FDA to focus review on post-1993 standards.?

Footnote: 2462 Fed. Reg. 23,750 (May 1, 1997).?

Footnote: 25See CSPI, International Harmonization of Food Safety and Labeling Standards 34-35 (June 1997).?

Footnote: 26The notice would (1) describe the Codex standard and its comparability to an FDA standard; (2) provide FDA's preliminary views on the Codex standard including its potential for acceptance by FDA and whether rulemaking would be necessary; (3) describe information the agency would need for adequate evaluation of the standard; (4) invite information on relative importance of the standard to public health protection and international trade; and (5) state the agency's preliminary plans to perform substantive review of the standard.