Return-Path: jham@concentric.net Errors-To: Date: Thu, 2 Oct 1997 00:04:53 -0400 (EDT) X-Sender: jham@pop3.concentric.net (Unverified) To: cafmr@pnc.com.au From: John Hammell Subject: Codex Comments Due Oct.6 Consideration of Codex Standards [Federal Register: July 7, 1997 (Volume 62, Number 129)] [Proposed Rules] [Page 36243-36248] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07jy97-20] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. 97N-0218] RIN 0910-ZA01 Consideration of Codex Alimentarius Standards AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that it is considering the amendment of its regulations that establish procedures for review and evaluation of standards adopted by the Codex Alimentarius Commission (Codex). Codex is an international body that establishes food standards under the joint auspices of the United Nations World Health Organization (WHO) and Food and Agriculture Organization (FAO). FDA is considering whether to establish procedures for the systematic review of standards and related texts adopted by Codex. This action has the potential to enhance consumer protection with regard to foods, to promote international harmonization, to enable FDA to better meet its public health mission, and to fulfill U.S. obligations under international agreements. The agency is soliciting comments from interested persons about whether to amend agency regulations to provide procedures for consideration of Codex standards, how to best set priorities and evaluate various Codex standards for possible acceptance by FDA, and how evaluation of each such standard could be accomplished in the most transparent, efficient, and resource- effective manner. FDA also invites comments on the agency's preliminary views on these matters. DATES: Written comments by October 6, 1997. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: John W. Jones, Office of Constituent Operations (HFS-550), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4311. SUPPLEMENTARY INFORMATION: I. Background A. FDA's Policy Regarding International Standards Codex is an international food standard-setting organization composed of national Governments that establishes ``standards'' comparable in scope and intent to certain standards established by FDA. For the purpose of this notice, the term ``standard'' refers to any numerical limit, such as a tolerance, maximum residue limit or maximum use level; a commodity or food standard of identity or composition; a code of practice; a procedure; a guideline; a labeling requirement; and a method, general recommendation, or other related text that may be adopted by Codex through its formal eight-step procedure (Ref. 1, Codex Procedural Manual, Ninth ed., FAO/WHO Rome, 1995). In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines. FDA's policy addressed specifically the conditions under which FDA plans to participate in international standard-setting organizations in the development of standards applicable to products regulated by FDA and defined the conditions under which the agency intends to use the resultant standards in fulfilling its statutory mandate to safeguard the public health. The October 11, 1995, notice stated in part: It is the intent of this policy to enable FDA to: (1) Continue to participate in international standards activities that assist it in implementing statutory provisions for safeguarding the public health, (2) increase its efforts to harmonize its regulatory requirements with those of foreign governments, including setting new standards that better serve public health, and (3) respond to laws and policies such as the Trade Agreements Act and OMB Circular No. A-119 that encourage agencies to use international standards that provide the desired degree of protection. The policy statement concluded that the agency's primary goal in participation in such standard-setting activities and use of resultant standards is to preserve and enhance its ability to accomplish FDA's public health mission, with the aim of enhancing regulatory effectiveness, providing more consumer protection with increasingly scarce government resources, and increasing worldwide consumer access to safe, effective, and high quality products. [[Page 36244]] B. International Agreements The U.S. Government is a party to a number of international trade agreements. FDA has participated in a number of recent international trade negotiations to ensure that under such agreements, FDA regulatory practices can remain focused on fulfilling the agency's mission to protect the public health while being supportive of emerging, broader U.S. Government trade obligations and policies. One of the agreements that emerged from the recent General Agreement on Tariffs and Trade (GATT) Uruguay Round of Multilateral Trade Negotiations is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS agreement, Ref. 2). This 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 SPS agreement requires that members of the World Trade Organization (WTO),\1\ when establishing their own SPS measures, consider international standards, guidelines, or recommendations. A country is not required to use an international standard, but must have scientific justification to establish or maintain a more stringent measure to meet the country's chosen level of protection if that measure will impact on trade. As discussed in section II.B of this document, standards established by Codex regarding food and substances in food have a particular status under the SPS agreement. --------------------------------------------------------------------------- \1\ The Final Act of the GATT Uruguay Round in 1993 and the Ministerial Meeting in Marrakesh in 1994 established the WTO. Agreements concluded during the GATT Uruguay Round Negotiations are to be administered by the WTO. --------------------------------------------------------------------------- A second relevant international agreement is the Agreement on Technical Barriers to Trade (TBT agreement, Ref. 3). The TBT agreement is intended to promote use by countries of standards, technical regulations, and conformity assessment procedures that are based on work done by international standard-setting bodies. In the TBT agreement, the term ``standard'' is defined as follows: A document approved by a recognized body that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labeling requirements as they apply to a product, process or production method. Thus, FDA's stated policy on international standards and the nation's obligations under the WTO provide compelling impetus for FDA to consider whether to revise its existing system for review and evaluation of international food standards, and if so, how such a revised system might be designed. II. Codex Alimentarius Commission A. Codex Committees and U.S. Codex Codex was created in 1962 by two United Nations organizations, FAO and WHO. The dual purpose of Codex is to protect the health of consumers and to ensure fair international trade in food. Codex currently has over 150 members. Codex elaborates numerical standards, codes of practice, and other guidelines through its committees (which include committees related to specific commodities and committees dealing with cross-cutting general subject areas) and promotes acceptance\2\ and implementation of its standards by national Governments. Each committee is chaired by a host member country. --------------------------------------------------------------------------- \2\ Standards adopted by Codex are currently subject to various degrees of ``acceptance'' by national Governments using terms defined by Codex. Such terms as ``full acceptance'', ``non- acceptance'', and ``free distribution'' are currently employed to describe an importing country's intent to accept or reject an import shipment based on its compliance or noncompliance with applicable Codex standards. These terms of acceptance are currently under review by the Codex Committee on General Principles in order to update and refine them relative to the recent SPS and TBT agreements. The terms, per se, are not considered in this notice. Thus, the terms ``accept'' and ``acceptance'', as used in this document, are not intended to adhere to existing Codex definitions, practices, or procedures. --------------------------------------------------------------------------- Codex currently has 8 general subject and 15 commodity committees. The general subject committees and their host countries are: (1) Food Labelling (Canada), (2) Food Additives and Contaminants (The Netherlands), (3) Food Hygiene (The United States), (4) Pesticide Residues (The Netherlands), (5) Residues of Veterinary Drugs in Foods (The United States), (6) Methods of Analysis and Sampling (Hungary), (7) Food Import and Export Inspection and Certification Systems (Australia), and (8) General Principles (France). The General Principles Committee oversees, maintains, and manages the Codex procedural rules. The general subject committees work closely with scientific bodies established by FAO and WHO in developing Codex recommendations and standards. For example, the Joint Expert Committee on Food Additives (JECFA) and the Joint Meeting on Pesticide Residues (JMPR) are comprised of experts selected from member countries. JECFA and JMPR provide scientific advice and consultation on matters relevant to Codex's standard-setting activities. Specifically, JECFA advises the Codex Committee on Food Additives and Contaminants and the Codex Committee on Residues of Veterinary Drugs in Foods; JMPR advises the Codex Committee on Pesticide Residues. These scientific advisory bodies do not themselves establish Codex standards, but they provide the independent scientific review and scientific judgment necessary to assist the Codex committees with development of such standards. In addition to the 8 general subject committees, there are 15 commodity committees,\3\ of which 8 are still active. The active commodity committees and their host countries are: (1) Fish and Fishery Products (Norway), (2) Nutrition and Foods for Special Dietary Uses (Germany), (3) Fresh Fruits and Vegetables (Mexico), (4) Milk and Milk Products (New Zealand), (5) Fats and Oils (The United Kingdom), (6) Cocoa Products and Chocolate (Switzerland), (7) Natural Mineral Waters (Switzerland),\4\ and (8) Processed Fruits and Vegetables (The United States). --------------------------------------------------------------------------- \3\ Seven Codex commodity committees, having completed their current program of work, have been adjourned for the time being. One former committee, the Codex Committee on Meat, has been dissolved. The Codex commodity committees that have adjourned are: (1) Meat Hygiene; (2) Sugars; (3) Soups and Broths; (4) Edible Ices; (5) Vegetable Proteins; (6) Processed Meat and Poultry Products; and (7) Cereals, Pulses, and Legumes. \4\ This Committee was established by Codex as a Regional (European) Committee, but has since been allocated the task of elaborating world-wide standards for natural mineral waters. --------------------------------------------------------------------------- The Codex commodity committees and general subject committees work cooperatively in that they consult one another on issues and defer particular issues to the committee with most appropriate authority and technical expertise.\5\ --------------------------------------------------------------------------- \5\ In addition to the committees, there are five regional coordinating committees (Africa, Asia, Europe, Latin America and the Caribbean, and North America and the Southwest Pacific). The purpose of the regional coordinating committees is to ensure that the Codex's work is responsive to regional interests, particularly to developing countries within each geographic region. --------------------------------------------------------------------------- Since 1962, Codex has produced numerous standards, guidelines, codes of practice, and recommendations, including food commodity standards and general subject food standards. In the course of its work, Codex has evaluated the safety of over 500 food additives and contaminants and set maximum residue limits for [[Page 36245]] approximately 2,500 pesticide/commodity combinations. Codex has adopted maximum residue limits for 15 veterinary drugs. The United States participates in Codex through U.S. Codex. U.S. Codex consists of Federal Government officials representing several Federal agencies, including FDA, and is assisted by representatives of industry and consumer non-government organizations (NGO's). Representatives of the United States have participated in deliberations of Codex since its inception in 1962. The United States sends delegations to participate in all Codex commodity and general subject committee meetings. FDA, through its participation on most Codex committees, provides scientific and regulatory expertise and conveys agency views on various matters concerning Codex standards, from elaboration to adoption. FDA officials also participate as independent experts on JECFA. In a notice published in the Federal Register of June 4, 1996 (61 FR 28132), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), the lead Federal agency for coordination of U.S. Codex activities,\6\ published the most recent annual summary of standards under consideration or planned for consideration by Codex to solicit input from persons and organizations on these standards. This annual notice is required by the Trade Agreements Act, as amended by the Uruguay Round Agreements Act, 108 Stat. 4809 (1994). --------------------------------------------------------------------------- \6\ Section 491 of the Trade Agreements Act of 1979, as amended by the Uruguay Round Agreements Act, Public L. 103-465, 108 Stat. 4809 (1994) requires an annual notice of Codex activities. Presidential Proclamation No. 6780 (60 FR 15845, March 23, 1995) designates USDA/FSIS as the agency responsible for coordinating U.S. Codex activities. --------------------------------------------------------------------------- Future annual notices by USDA/FSIS will continue to inform interested parties of matters before the various Codex committees. This mechanism provides the public with comprehensive and current information, in one place, on all Codex activities and facilitates public participation in the Codex standard-setting process. Thus, through various U.S. Codex outreach activities such as pre- and post- session briefings for the public, mailings, and the opportunity for direct participation by NGO's on U.S. Codex delegations, interested persons and organizations can contribute substantively to the elaboration and eventual adoption of Codex standards. B. Role of Codex Standards Under the SPS and TBT Agreements of the WTO For the past 6 years, Codex has been engaged in a process of revising a large proportion of its standards. In March 1991, in anticipation of the changing status of Codex standards under the SPS and TBT agreements then being negotiated in the GATT Uruguay Round, WHO and FAO, in cooperation with GATT, sponsored the FAO/WHO Conference on Food Standards and Chemicals in Food and Food Trade. This 1991 Conference in Rome (Ref. 4, ALICOM 91/22, FAO, WHO, GATT, Rome 1991) made a number of recommendations on how the then-existing Codex standard-setting process could be improved to better meet the anticipated role of Codex standards under the SPS and TBT agreements. The Rome meeting anticipated the SPS agreement's reference to, and reliance upon, international standards, guidelines, and recommendations, specifically those elaborated by Codex (SPS agreement introductory statements, Art. 3.4, and Annex A, 3.a). Although 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, the provisions of some Codex standards fall within the terms of the TBT agreement. Among the Conference's more significant recommendations intended to position Codex to meet its anticipated role were several that addressed streamlining existing Codex standards and the process by which new standards are developed. Specifically, the Conference recommended that Codex move toward a more horizontal approach to standard-setting, i.e., away from detailed, commodity-specific standards and toward more broadly applicable, general subject standards. The Conference also recommended that standards adopted include only those provisions necessary for consumer protection, particularly those related to health and food safety. Most recommendations made by the Conference were subsequently adopted by Codex at its 19th session in 1991. At its 20th session in 1993, Codex adopted a Medium Term Program of Work for 1993 to 1998 (Medium Term Plan, Ref. 5, ALINORM 93/38 and Addenda) which outlines the anticipated standard-setting activities of Codex (including numerical standards and related texts) over the next 5 years and incorporates the 1991 Conference recommendations. III. Possible FDA Strategy for Review of Codex Standards In 1973, FDA established a regulation describing the process for the review of commodity standards adopted by Codex (Secs. 130.6 and 564.6 (21 CFR 130.6 and 564.5)).\7\ These regulations apply only to Codex commodity standards for human and animal foods, respectively, and not to Codex general subject standards such as numerical standards for chemical contaminants in foods or codes of practice for employing food hygiene procedures. Currently, the agency has no process defined by regulation for the consideration of general subject, also known as horizontal, standards. FDA is considering revising its regulations to accommodate agency review and acceptance of Codex general subject standards. It is important to note that the Codex Committee on General Principles at its November 1996 session recognized that all Codex standards and related texts, including maximum residue limits, codes of practice, and guidelines fall under the SPS rubric of international standards, guidelines, and recommendations. Therefore, FDA has tentatively concluded that the agency should have a procedure for review of all Codex standards falling within its purview. --------------------------------------------------------------------------- \7\ This regulation was originally issued as 21 CFR 10.8 and was redesignated subsequently as Secs. 130.6 (Part 130--Food Standards: General) and 564.6 (Part 564--Definitions and Standards for Animal Food). --------------------------------------------------------------------------- The agency is considering devoting substantial effort toward the review and evaluation of Codex standards, perhaps focusing on those standards adopted since 1993 and presented in the Medium Term Plan. It may, however, be appropriate to consider the review of some pre-1993 Codex standards, for example, when: (1) An interested party petitions the agency to accept a pre-1993 Codex standard and provides information to enable a review, (2) the agency plans to issue a new FDA regulation (or revise an existing regulation) and an existing Codex standard is relevant to the new regulation,\8\ or (3) the United States is [[Page 36246]] challenged in an international trade situation where another country cites as supporting information an existing Codex standard. --------------------------------------------------------------------------- \8\ As an example of this type of situation, current FDA standards of identity regulations are often very specific for particular foods. Virtually all of these standards of identity regulations were established prior to the passage of the Nutrition Labeling and Education Act of 1990 (Pub. L. 101-535, November 8, 1990) (the 1990 NLEA amendments) and thus, were developed without reference to the significant informational function that a food label can play. For example, prior to the 1990 amendments, standarized foods were not required to bear complete ingredient labeling. In light of this and other factors, FDA published an Advance Notice of Proposed Rulemaking (60 FR 67492, December 29, 1995) announcing that the agency intends to review its regulations pertaining to identity, quality, and fill of container for standardized foods with the intent of simplifying the regulations where practicable and taking into account the impact of the 1990 NLEA amendments. As part of any rulemaking growing out of the December 1995 ANPR, and in keeping with FDA's obligations under international trade agreements to consider Codex standards whenever the agency develops or revises regulations, FDA intends to review corresponding Codex commodity standards (including those adopted before 1993) concurrently with its planned review and evaluation of FDA standards pertaining to identity, quality, and fill of container and to determine whether the corresponding provisions in the Codex standard should be incorporated entirely or partially into any revised FDA standard. In this context, it should be noted that FDA has not yet determined the best means for streamlining domestic commodity standards and the eventual approach chosen for evaluation of relevant Codex standards will depend significantly on this determination. --------------------------------------------------------------------------- IV. Request for Information A. FDA's Possible Strategy for Consideration of Codex Standards FDA notes that, faced with competing food safety priorities, it may not be able to devote the resources necessary to fulfill all of its responsibilities in an efficient and timely manner. In light of this, FDA invites general comment on the relative importance of its Codex activities in comparison to its other food safety and regulatory responsibilities. In particular, FDA requests comments on the following questions: 1. What is the appropriate priority of the agency's activities in Codex in light of U.S. obligations under the WTO? 2. How might FDA enhance its ability to fulfill its broad public health mandate through judicious acceptance and use of Codex standards? 3. Are there reasons that the agency should not expend resources in the review and consideration of Codex standards? 4. If there are reasons that FDA should not expend resources on the review of Codex standards, are these reasons compelling considering U.S. obligations under the WTO? 5. How can review of Codex standards be incorporated efficiently into current FDA standard setting processes? 6. Can resource savings be achieved without compromising consumer protection? If the agency concludes that it is appropriate to propose to revise its regulations to accommodate consideration of Codex standards, FDA plans to develop and publish a proposal outlining specific revisions. To facilitate the agency's consideration of possible alternative approaches, FDA requests comments on the following questions: 1. What revisions to existing FDA regulations or what new regulations are appropriate? 2. If the agency eventually does undertake systematic review of Codex standards, FDA is faced with deciding on how best to proceed with review and evaluation of many newly adopted and some existing Codex standards with regard to the acceptability of such standards relative to existing FDA standards. What factors should the agency consider to guide its priority setting and the efficient review and evaluation of these Codex standards during any such review? Codex standards adopted since 1993 reflect strengthening of the standard setting process to enhance consumer protection and to accommodate the more prominent role of Codex standards under the SPS and TBT agreements. Because Codex standards adopted from 1993 forward are intended to reflect the new role of Codex standards under the WTO trade agreements, FDA is considering focusing its resources for review of Codex standards on those standards adopted since 1993 as articulated in the Codex Medium Term Plan and in its future updates. In this context, FDA requests comments on the following questions: 1. Should FDA give priority to those Codex standards adopted since 1993? 2. Alternatively, should FDA attempt systematic review of all existing Codex standards? 3. What are the resource implications of an approach requiring review of all existing Codex standards? 4. Are there cost-efficient means for FDA to review all Codex standards? 5. If only certain pre-1993 Codex standards merit consideration for review by FDA, what circumstances would warrant FDA consideration of a pre-1993 Codex standard? 6. How do existing Codex standards currently affect U.S. imports and exports? 7. Are there specific Codex standards that have significant trade impacts? 8. Are there specific Codex standards that are of particular importance due to safety or other concerns? 9. In the case of a person or organization that specifically petitions FDA to review a particular Codex standard, how might FDA best guide the petitioner to submit appropriate background information? Should FDA encourage the submission of draft language that could be used as a basis for a proposed FDA regulation governing the particular issue? 10. What are the potential benefits and costs to U.S. consumers and businesses of FDA consideration, acceptance and use of some specific Codex standards? 11. What costs are associated with researching and summarizing information necessary to compare a Codex standard with an FDA standard? How do these costs vary according to the complexity of the standard? Upon consideration of a Codex standard, FDA believes that it will be faced with the following four situations with regard to standards that the agency believes to be suitable for FDA acceptance: (1) The standard is substantively identical to FDA's regulations; (2) the standard is similar but not identical to FDA's regulations; (3) although the standard is not identical or similar to FDA's regulations, FDA wishes to propose to accept the Codex standard to further its public health mission and such acceptance will require rulemaking under the Federal Food, Drug, and Cosmetic Act (the act); (4) or the standard is not identical to or similar to any FDA regulation, and the adoption of the Codex standard is not subject to rulemaking under the act. In addition to these four situations where the agency might wish to accept a Codex standard, FDA might wish, instead, to reject a particular Codex standard because the standard fails to provide the appropriate level of protection for U.S. consumers. There are various procedural approaches that the agency might use to address these situations. In a case where a Codex standard is essentially identical to an FDA regulation, the agency might elect only to publish a Federal Register notice recognizing the substantive equivalence of the Codex standard to FDA's standard. Where a Codex standard is very similar, but not identical, to an FDA standard, the agency might publish a proposal for comment to amend FDA's regulations slightly to bring the agency's regulations into conformity with the Codex standard. More complex proposals and associated rulemaking would likely be required when FDA wishes to accept a Codex standard that is substantively different from an FDA regulation, but that the agency believes would provide a greater degree of public health protection than an existing FDA standard. Such a situation would likely entail significant revision to the existing FDA regulation with corresponding greater opportunities for public comment on the proposed, substantive revisions. In light of the need for FDA to accomplish any review, consideration, and determination of acceptability of Codex standards in as efficient a manner as possible, and recognizing that there [[Page 36247]] are a large number of Codex standards that may vary greatly in their complexity and their actual impact on U.S. public health protection, FDA invites comments on approaches the agency might employ to achieve the most resource-efficient reviews. FDA is considering amending its current regulations by removing Secs. 130.6 and 564.6 and establishing a new section to describe procedures that the agency would use when it considers Codex standards for acceptance. To date, FDA has identified the following goals for the proposed amendments it is considering: (1) To be certain that any process used by FDA for reviewing standards adopted by Codex ensures that food conforming to a Codex standard is safe within the meaning of the act, (2) to ensure that FDA's review and consideration of Codex standards is transparent and science-based, (3) to clarify the procedures for FDA's consideration of commodity and general subject standards adopted by Codex, (4) to clarify when rulemaking is necessary as part of the agency's consideration of a standard adopted by Codex, and (5) to ensure that FDA's regulations for consideration of Codex standards are appropriate for all Codex standards and related texts. The agency seeks comment on whether to proceed with a proposal to establish new regulations governing agency consideration of Codex standards. What goals, in addition to those listed previously, should be considered by the agency in developing any new regulations governing consideration of Codex standards? B. Public Participation 1. FDA Notice of Newly Adopted Codex Standards In the event that FDA proposes to establish a systematic review and ****************************************** Donations Needed- Am One Person Working Alone International Advocates for Health Freedom John C. Hammell, Legislative Advocate 2411 Monroe St.#2 Hollywood, FL 33020 USA 800-333-2553, 954-929-2905, FAX 954-929-0507, FAX ON DEMAND 954-927-8795,jham@concentric.net http://www.pnc.com.au/~cafmr/hammell/index.html