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Notice

International Standard-Setting Activities

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AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act, Public Law 103-465, 108 Stat. 4809. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts. This notice, which covers the time periods from June 1, 2003, to May 31, 2004, and June 1, 2004, to May 31, 2005, seeks comments on standards currently under consideration and recommendations for new standards.

ADDRESSES:

Comments may be submitted by any of the following methods:

  • Mail, including floppy disks or CD-ROM's, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 20250.
  • Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions at that site for submitting comments.

All submissions received must include the Agency name and docket number 04-004N. Please state that your comments refer to Codex and, if your comments relate to specific Codex committees, please identify those committees in your comments and submit a copy of your comments to the delegate from that particular committee. All comments submitted will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. The comments also will be posted on the Agency's Web site at http://www.fsis.usda.gov/​OPPDE/​rdad/​FRDockets.htm.

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FOR FURTHER INFORMATION CONTACT:

F. Edward Scarbrough, Ph.D., United States Manager for Codex, U.S. Department of Agriculture, Office of the Undersecretary for Food Safety, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-7760. For information pertaining to particular committees, the delegate of that committee may be contacted. (A complete list of U.S. delegates and alternate delegates can be found in Attachment 2 to this notice.) Documents pertaining to Codex are accessible via the World Wide Web at the following address: http://www.codexalimentarius.net. The U.S. Codex Office also maintains a Web site at http://www.fsis.usda.gov/​Regulations_​&​_​Policies/​Codex_​Alimentarius/​index.asp.

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SUPPLEMENTARY INFORMATION:

Background

The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). U.S. membership in the WTO was approved and the Uruguay Round Agreements Act was signed into law by the President on December 8, 1994. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization, Codex, International Office of Epizootics, and the International Plant Protection Convention. The President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated the U.S. Department of Agriculture as the agency responsible for informing the public of sanitary and phytosanitary standard-setting activities of each international standard-setting organization. The Secretary of Agriculture has delegated to the Administrator, Food Safety and Inspection Service (FSIS), the responsibility to inform the public of the SPS standard-setting activities of Codex. The FSIS Administrator has, in turn, assigned the responsibility for informing the public of the SPS standard-setting activities of Codex to the U.S. Codex Office, FSIS.

Codex was created in 1962 by two U.N. organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for encouraging fair international trade in food and protecting the health and economic interests of consumers. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to ensure that the world's food supply is sound, wholesome, free from adulteration, and correctly labeled. In the United States, the United States Department of Agriculture (USDA); the Food and Drug Administration (FDA), Department of Health and Human Services (HHS); and the Environmental Protection Agency (EPA) manage and carry out U.S. Codex activities.

As the agency responsible for informing the public of the sanitary and phytosanitary standard-setting activities of Codex, FSIS publishes this notice in the Federal Register annually. Attachment 1 (Sanitary and Phytosanitary Activities of Codex) sets forth the following information:

1. The sanitary or phytosanitary standards under consideration or planned for consideration; and

2. For each sanitary or phytosanitary standard specified:

a. A description of the consideration or planned consideration of the standard;

b. Whether the United States is participating or plans to participate in the consideration of the standard;

c. The agenda for United States participation, if any; and Start Printed Page 31943

d. The agency responsible for representing the United States with respect to the standard.

To obtain copies of those standards listed in Attachment 1 that are under consideration by Codex, please contact the Codex delegate or the U.S. Codex office. This notice also solicits public comment on those standards that are under consideration or planned for consideration and recommendations for new standards. The delegate, in conjunction with the responsible agency, will take the comments received into account in participating in the consideration of the standards and in proposing matters to be considered by Codex.

The United States' delegate will facilitate public participation in the United States Government's activities relating to Codex Alimentarius. The United States' delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex committees and will disseminate information regarding United States' delegation activities to interested parties. This information will include the current status of each agenda item; the United States Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its Web page, http://www.fsis.usda.gov/​Regulations_​&​_​Policies/​Codex_​Alimentarius/​index.asp. Please visit the Web page or notify the appropriate U.S. delegate or the Office of U.S. Codex Alimentarius, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700, if you would like to access or receive information about specific committees.

The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2003 to May 31, 2004, and June 1, 2004 to May 31, 2005. In addition, the following attachments are included:

Attachment 2 List of U.S. Codex Officials (includes U.S. delegates and alternate delegates)

Attachment 3 Timetable of Codex Sessions (June 2003 through June 2005)

Attachment 4 Definitions for the Purpose of Codex Alimentarius

Attachment 5 Part 1—Uniform Procedure for the Elaboration of Codex Standards and Related Texts

Part 2—Uniform Accelerated Procedure for the Elaboration of Codex Standards and Related Texts

Attachment 6 Nature of Codex Standards

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that the public and in particular that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov and through the Regulations.gov Web site. The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at http://www.regulations.gov.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

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Done at Washington, DC, on June 1, 2004.

F. Edward Scarbrough,

United States Manager for Codex.

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Attachment 1: Sanitary and Phytosanitary Activities of Codex

Codex Alimentarius Commission and Executive Committee

The Codex Alimentarius Commission will hold its Twenty-Seventh Session June 28-July 3, 2004 in Geneva, Switzerland. At that time it will consider procedural matters, the standards, codes of practice, and related matters brought to its attention by the general subject committees, commodity committees, ad hoc Task Forces and member delegations. It will also consider options or strategies regarding the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards, as well as budgetary and strategic planning issues. The issue of Codex interaction with other international organizations will also be discussed. At this Session, the Commission will elect a Chair and three Vice Chairs.

Prior to the Commission meeting, the Executive Committee will meet at its Fifty-fourth Session on June 24-26, 2004. It is composed of the chairperson, vice-chairpersons and seven members elected from the Commission, one from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific. In addition, regional coordinators from the six regions will attend as observers. It will discuss implementation of the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards, matters arising from reports of Codex Committees, standards management issues, and the Trust Fund for the Participation of Developing Countries and Countries in Transition in the Work of the Codex Alimentarius.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Residues of Veterinary Drugs in Foods

The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. A veterinary drug is defined as any substance applied or administered to a food producing animal, such as meat or dairy animals, poultry, fish or bees, for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behavior.

A Codex Maximum Limit for Veterinary Drugs (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is adopted by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. An MRLVD is based on the Acceptable Daily Intake (ADI) and indicates the amount of residue in food that is considered to be without appreciable toxicological hazard. An MRLVD also takes into account other Start Printed Page 31944relevant public health risks as well as food technological aspects.

When establishing an MRLVD, consideration is also given to residues that occur in food of plant origin and/or the environment. Furthermore, the MRLVD may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.

Acceptable Daily Intake (ADI): An estimate by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk (standard man = 60 kg).

The 15th Session of CCRVDF will take place in the United States on October 25-28, 2004. The following will be discussed by the Committee:

Draft Maximum Residue Limits for:

  • Flumequine.
  • Neomycin.
  • Dicyclanil.
  • Melengestrol acetate.
  • Trichlorfon (metrifonate).

Proposed Draft Maximum Residue Limits for:

  • Cefuroxime.
  • Cypermethrin.
  • Alpha-Cypermethrin.

The Committee continues to work on:

  • Proposed Draft Code of Practice to Minimize and Contain Antimicrobial Resistance.
  • Proposed Draft Revised Guidelines for the Establishment of a Regulatory Program for Control of Veterinary Drug Residues in Foods.
  • Risk Analysis Principles and Methodologies, including Risk Assessment Policies in the Codex Committee on Residues of Veterinary Drugs in Foods.
  • Proposed Draft Appendix on the Prevention and Control of Veterinary Drug Residues in Milk and Milk Products.
  • Priority List of Veterinary Drugs Requiring Evaluation or Reevaluation.
  • Methods of Analysis and Sampling Issues.
  • Performance-based Criteria.
  • Identification of Routine Methods of Analysis.

Responsible Agency: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Additives and Contaminants

The Codex Committee on Food Additives and Contaminants (CCFAC) (a) establishes or endorses permitted maximum or guideline levels for individual food additives, contaminants, and naturally occurring toxicants in food and animal feed; (b) prepares priority lists of food additives and contaminants for toxicological evaluation by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); (c) recommends specifications of identity and purity for food additives for adoption by the Commission; (d) considers methods of analysis for food additives and contaminants; and (e) considers and elaborates standards and codes for related subjects such as labeling of food additives when sold as such and food irradiation. The following matters are under consideration by the Commission at its 27th Session in July 2004. The relevant document is ALINORM 4/27/12.

Risk Analysis

To be considered at Step 8:

  • Draft Risk Analysis Principles applied by the Codex Committee on Food Additives and Contaminants.

Food Additives

To be considered at Step 8:

  • General Standard for Food Additives: Food Category System.
  • General Standard for Food Additives: Draft Food Additive Provisions in Tables 1 and 2.

To be considered at Step 5/8 of the Accelerated Procedure:

  • General Standard for Food Additives: Proposed Draft Food Additive Provisions in Tables 1 and 2.
  • Advisory Specifications for the Identity and Purity of Food Additives.
  • Draft Revisions to the Codex International Numbering System for Food Additives.

The Committee is continuing work on:

  • General Standard for Food Additives: Draft Food Additive Provisions (in Table 1 and Table 3).
  • General Standard for Food Additives: Revisions to the Preamble to clarify relationship between the General Standard and food additive provisions in Codex Commodity Standards and to clarify the principles for establishing food additive provisions in the General Standard.
  • International Numbering System.
  • Specifications for the Identity and Purity of Food Additives.
  • Inventory of processing aids.
  • Discussion paper on food additives used as carriers.
  • Discussion paper on the Harmonization of Terms Used by Codex and JECFA.
  • Terms of reference for a risk assessment of the use of “active chlorine” by a Joint FAO/WHO Expert Consultation.

Contaminants

To be considered at Step 8:

  • General Standard for Contaminants and Toxins: Preamble.
  • General Standard for Contaminants and Toxins: Proposed Draft Principles for Exposure Assessment of Contaminants and Toxins in Foods.
  • CCFAC Policy for Exposure Assessment of Contaminants and Toxins in Foods or Food Groups.
  • Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts.
  • Code of Practice for the Prevention and Reduction of Lead Contamination in Foods.

To be considered at Step 5:

  • Draft Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Tree Nuts.
  • Draft Code of Practice for the Prevention and Reduction of Inorganic Tin Contamination in Canned Foods.
  • Draft Revised Guideline Levels for Radionuclides in Foods Following Accidental Nuclear Contamination for Use in International Trade, Including Guideline Levels for Long-Term Use.

The Committee is continuing work on:

  • Maximum levels for aflatoxin in tree nuts (almonds, hazelnuts, and pistachios).
  • Discussion paper on Aflatoxin Contamination in Brazil Nuts.
  • Maximum level for lead in fish.
  • Maximum levels for cadmium in polished rice, wheat grain, potato, stem and root vegetables, leafy vegetables, other vegetables, and molluscs.
  • Proposed Draft Code of Practice for Source Directed Measures to Reduce Dioxin and Dioxin-like PCB Contamination in Foods.
  • Discussion paper with proposals for maximum levels for 3-monochloropropanediol in acid-hydrolyzed vegetable protein (acid-HVP) and acid-HVP containing foods.
  • Discussion paper on acrylamide.

The Committee is beginning new work on:

  • Sampling plans for aflatoxin in tree nuts (almonds, Brazil nuts, hazelnuts, and pistachios).
  • Discussion paper on options for incorporating the JECFA safety evaluation of flavors into the Codex system.
  • Discussion paper on polyaromatic hydrocarbons.
  • Discussion paper on methylmercury in fish.

General Issues

  • Priority List of Food Additives, Contaminants and Naturally Occurring Start Printed Page 31945Toxicants Proposed for Evaluation by JECFA.

Responsible Agency: HHS/FDA.

U.S. Participation: YES.

Codex Committee on Pesticide Residues

The Codex Committee on Pesticide Residues recommends to the Codex Alimentarius Commission establishment of maximum limits for pesticide residues for specific food items or in groups of food. A Codex Maximum Residue Limit for Pesticide (MRLP) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. Foods derived from commodities that comply with the respective MRLPs are intended to be toxicologically acceptable, that is, consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI, * should indicate that foods complying with Codex MRLPs are safe for human consumption. * Acceptable Daily Intake (ADI) of a chemical is the daily intake which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time of the evaluation of the chemical by the Joint FAO/WHO Meeting on Pesticide Residues. It is expressed in milligrams of the chemical per kilogram of body weight.

Codex MRLPs are primarily intended to apply in international trade and are derived from reviews conducted by the Joint Meeting on Pesticide Residues (JMPR) following:

(a) Review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices (GAP). Data from supervised trials conducted at the highest nationally recommended, authorized, or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLPs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices, and

(b) Toxicological assessment of the pesticide and its residue.

The following items will be considered by the Commission at its 27th Session in July 2004. The relevant document is ALINORM 04/27/24.

To be considered at Step 8:

  • Draft and Draft Revised Maximum Residue Limits.

To be considered at Step 5/8:

  • Proposed Draft and Proposed Draft Revised Maximum Residue Limits.
  • Draft Revision of the Guidelines on Good Laboratory Practice in Pesticide Residue Analysts.

To be considered at Step 5:

  • Proposed Draft and Proposed Draft Revised Maximum Residue Limits.

The committee is continuing work on:

  • Consideration of Draft and Proposed Draft Residue Maximum Limits in Foods and Feeds.
  • Pilot Project for the examination of national MRLs as Interim Codex MRLs for safer replacement pesticides.
  • Proposals for Improvement of Methodology for Point Estimates.
  • Risk Analysis Policies Used in Establishing Codex MRLs.
  • Revision of the List of Recommended Methods on Analysis for Pesticide Residues.
  • Estimation of Uncertainty.
  • Proposals for new Tropical Fruit and Vegetable Commodities.
  • Elaboration of MRLs for Spices.
  • Revision of the Codex Classification of Foods and Animal Feeds.
  • Criteria for Prioritization Process.
  • Revision of Codex Priority Lists of Pesticides for review by JMPR.

Responsible Agency: EPA; USDA/AMS.

U.S. Participation: Yes.

Codex Committee on Methods of Analysis and Sampling

The Codex Committee on Methods of Analysis and Sampling:

(a) Defines the criteria appropriate to Codex Methods of Analysis and Sampling;

(b) Serves as a coordinating body for Codex with other international groups working in methods of analysis and sampling and quality assurance systems for laboratories;

(c) Specifies, on the basis of final recommendations submitted to it by the other bodies referred to in (b) above, Reference Methods of Analysis and Sampling appropriate to Codex Standards which are generally applicable to a number of foods;

(d) Considers, amends, if necessary, and endorses, as appropriate, methods of analysis and sampling proposed by Codex (Commodity) Committees, except that methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives do not fall within the terms of reference of this Committee;

(e) Elaborates sampling plans and procedures, as may be required;

(f) Considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and

(g) Defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.

The 25th Session of the Committee met in Budapest, Hungary, on March 8-12, 2004. The relevant document is ALINORM 04/27/23. The following will be considered by the Commission at its 27th Session in July 2004:

To be considered at Step 8:

  • Draft General Guidelines on Sampling.
  • Draft Guidelines on Measurement Uncertainty.

To be considered at Step 5:

  • Proposed Draft Guidelines for Evaluating Acceptable Methods of Analysis.

The Committee will continue work on:

  • Criteria for Evaluating Acceptable Methods of Analysis.
  • Proposed Draft Guidelines for Settling of Disputes on Analytical (test) Results.
  • Consideration of the Fitness-For-Purpose Approach to Evaluating Methods of Analysis.
  • Further Review of the Analytical Terminology for Codex Use in the Procedural Manual.
  • Endorsement of Methods of Analysis and Sampling Provisions in Codex Standards.
  • Criteria for Methods of Analysis for the Detection and Identification of Foods derived from Biotechnology.
  • Methods of Analysis for the determination of dioxins and PCBs.

Responsible Agency: HHS/FDA; USDA/ARS.

U.S. Participation: Yes.

Codex Committee on Food Import and Export Certification and Inspection Systems

The Codex Committee on Food Import and Export Inspection and Certification Systems is charged with developing principles and guidelines for food import and export inspection and certification systems to protect consumers and to ensure fair practices in international trade in food. Additionally, the Committee develops principles and guidelines for the application of measures by competent authorities to provide assurance that foods comply with essential requirements, especially statutory health requirements. This encompasses work on: equivalence of food inspection systems including equivalence agreements, processes and procedures to ensure that sanitary measures are Start Printed Page 31946implemented; guidelines on food import control systems; and guidelines on food product certification and information exchange. The development of guidelines for the appropriate utilization of quality assurance systems to ensure that foodstuffs conform to requirements and to facilitate trade are also included in the Committee's terms of reference.

The following will be considered for adoption by the Commission at its 27th Session in July 2004.

To be considered at Step 5/8:

  • Proposed Draft Principles and Guidelines for the Exchange of Information in Food Safety Emergency Situations.

New Work:

  • Proposed Draft Appendices to the Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification.
  • Proposed Draft Principles for Electronic Certification.
  • Proposed Draft Guidelines for Risk-based Inspection of Imported Foods.

The committee is continuing work on:

  • Discussion paper on the Revision of the Guidelines for the Exchange of Information Between Countries on Rejections of Imported Foods.
  • Discussion paper on “traceability/product tracing” in the context of Food Inspection and Certification Systems.
  • Discussion paper on the Revision of the Guidelines for Generic Official Certificate Formats and the Production and Issuance of Certificates.
  • Discussion paper on clarification of the reference “a reasonable interval” in the Guidelines for Food Import Control Systems.

Responsible Agency: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on General Principles

The Codex Committee on General Principles deals with procedure and general matters as are referred to it by the Codex Alimentarius Commission. The 19th (Extraordinary) Session addressed issues related to decisions made by the Commission regarding the FAO/WHO Codex Evaluation. The 20th Session which met on May 3-7, 2004 in Paris, France, considered the regular work of the Committee. The relevant documents are ALINORM 04/27/33 and ALINORM 04/27/33A. Matters from the 19th Session to be considered for adoption by the 27th Commission in July 2004 are:

  • Procedural Amendments to the Rules of Procedure.
  • Proposed Amendments to the Procedures for the Elaboration of Codex Standards and Related Texts.
  • Draft Criteria for the Appointment of Chairpersons.
  • Draft Guidelines to Host Governments of Codex Committees and ad hoc Intergovernmental Task Forces.
  • Draft Guidelines on the Conduct of Meetings of Codex Committees and ad hoc Intergovernmental Task Forces.
  • Draft Guidelines to Chairpersons of Codex Committees and ad hoc Intergovernmental Task Forces.

At its 20th (regular) Session, the Committee continued work on:

  • Proposed Draft Working Principles for Risk Analysis for Food Safety (Guidance to National Governments).
  • Proposed Draft Revised Code of Ethics for International Trade in Foods.
  • Guidelines for Cooperation with International Intergovernmental Organizations.
  • Definition of traceability/product tracing.
  • Proposed Amendment to Rule VII.5 (Observers) of the Rules of Procedure.
  • Review of the Principles concerning the Participation of International Non-Governmental Organizations in the work of the Commission.
  • Matters arising from the 19th (Extraordinary) Session:.

(a) Clarification of the respective roles of Members of the Executive Committee elected on a geographic basis and of Coordinators.

(b) Clarification of the duration of the terms of the Coordinators and other Members of the Executive Committee.

(c) Relevance of the current acceptance and notification procedures for Codex standards.

(d) Possible reorganization of the structure and presentation of the Procedural Manual.

(e) Particular situation of the North America Region in the context of Rule IV.1.

(f) Implication of the exclusive use of electronic distribution of Codex documents to Members and Observers.

(g) Criteria applicable for the participation of developing country members in the Executive Committee in the light of the proposed Rule XII.3 and the Codex budget available. At its 21st (Extraordinary) Session the Committee will continue work on:

  • Consideration of the Status of Observers in the Executive Committee.
  • Revision of the Criteria for the Establishment of Work Priorities.
  • Draft Guidelines on Physical Working Groups and Draft Guidelines on Electronic Working Groups.

Responsible Agency: USDA/FSIS; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Food Labelling

The Codex Committee on Food Labelling is responsible for drafting provisions on labelling issues assigned by the Codex Alimentarius Commission. The reference document is ALINORM 04/27/22. The Committee held its thirty-second Session in Montreal, Quebec, Canada, on May 10-14, 2004. It considered the following items:

  • Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods: Draft Revised Annex 2—Permitted Substances.
  • Report of the Working Group on the Management of the Agenda Items on Labelling of Foods and Food Ingredients Obtained through Certain Techniques of Genetic Modification/Genetic Engineering.
  • Draft Amendment to the General Standard for the Labelling of Prepackaged Foods—(Draft Recommendations for the Labelling of Foods Obtained through Certain Techniques of Genetic Modification/Genetic Engineering) (Definitions).
  • Proposed Draft Guidelines for the Labelling of Food and food Ingredients obtained through certain Techniques of Genetic Modification/Genetic Engineering: Labelling Provisions.
  • Draft Guidelines for the Use of Health and Nutrition Claims.
  • Proposed Draft Amendment to the General Standard for the Labelling of Prepackaged Foods: Quantitative Declaration of Ingredients.
  • Discussion paper on Misleading Claims.
  • Discussion paper on Country of Origin Labelling.
  • Discussion on Food Labelling and Traceability/Product Tracing.

Responsible Agency: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Hygiene

The Codex Committee on Food Hygiene has four primary responsibilities. First, the Committee drafts basic provisions on food hygiene applicable to all food. These provisions normally take the form of Codes of Hygienic Practice for a specific commodity (e.g., bottled water) or group of commodities (e.g., milk and milk products). Second, it suggests and prioritizes areas where there is a need for microbiological risk assessment at the international level and considers microbiological risk management matters in relation to food hygiene and in relation to the risk assessment activities of FAO and WHO. Third, it considers, amends, if necessary, and Start Printed Page 31947endorses food hygiene provisions that are incorporated into specific Codex commodity standards by the Codex commodity committees. Fourth, the Committee provides such other general guidance to the Commission on matters relating to food hygiene as may be necessary. The following items will be considered by the Codex Alimentarius Commission at its 27th Session in July 2004. The relevant document is ALINORM 04/27/13.

To be considered at Step 8:

  • Draft Code of Hygienic Practice for Milk and Milk Products.
  • Definitions of Food Safety Objective, Performance Objective, and Performance Criterion.

The committee continues to work on:

  • Discussion papers on the management of the work of the Committee.
  • Work on Microbiological Risk Assessment/Risk Management.
  • Criteria to Establish Work Priorities.
  • Options for Cross-Committee Interaction Process.
  • Proposed Draft Guidelines on the Application of the General Principles of Food Hygiene to the [management] of Listeria monocytogenes in Foods.
  • Proposed Draft Revision of the Code of Hygienic Practice for Eggs and Egg Products.
  • Proposed Draft Guidelines for the Validation of Food Hygienic Control Measures.
  • Endorsement of Hygiene Provisions in Codex Standards and Codes of Practice.
  • Reports of ad hoc Expert Consultations.
  • Risk Management Strategies for Salmonella spp. in Poultry.
  • Risk Management Strategies for Campylobacter spp. in Poultry.
  • Risk Profile for Enterohemorrhagic E. coli, including the Identification of Commodities of Concern, including Sprouts, Ground Beef and Pork.
  • Discussion paper on the Proposed Draft Revision of the Recommended International Code of Practice for Foods for Infants and Children; Risk Profile on E. sakazakii.
  • Discussion paper on Proposed Draft Guidelines for Evaluating Objectionable Matter in Food.

Responsible Agency: HHS/FDA; FSIS/USDA.

U.S. Participation: Yes.

Codex Committee on Fresh Fruits and Vegetables

The Codex Committee on Fresh Fruits and Vegetables is responsible for elaborating world-wide standards and codes of practice for fresh fruits and vegetables. The following standards will be considered by the 27th Session of the Commission in July 2004. The relevant document is ALINORM 04/27/35.

To be considered at Step 8:

  • Draft Standard for Oranges.

To be considered at Step 5:

  • Proposed Draft Standard for Tomatoes.

The Committee continues work on:

  • Draft Standard for Table Grapes retained at Step 7.
  • Proposed Draft Standard for Rambutan.
  • Proposed Draft Standard for Apples.
  • Section 2.1.1 (Maturity Requirements) and Annex on Small-berry Varieties (Section 3.1) (draft Codex Standard for Table Grapes).
  • Proposed Draft Guide for the Quality Control of Fresh Fruits and Vegetables.
  • Standard Layout for Codex Standards for Fresh Fruits and Vegetables.

Responsible Agency: USDA/AMS.

U.S. Participation: Yes.

Codex Committee on Nutrition and Foods for Special Dietary Uses

The Codex Committee on Nutrition and Foods for Special Dietary Uses is responsible for studying nutritional problems referred by the Codex Alimentarius Commission. The Committee also drafts general provisions, as appropriate, on nutritional aspects of all foods and develops standards, guidelines, or related texts for foods for special dietary uses. The relevant document is ALINORM 03/27/26. The following items will be considered by the 27th Session of the Commission in July 2004.

To be adopted at Step 5:

  • Proposed Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children.
  • Proposed Draft Revised Standard for Infant Formula.
  • Proposed Draft Guidelines for Vitamin and Mineral Supplements.

The Committee continues work on:

  • Proposed Draft Revision of the Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses intended for use by Infants and Young Children.
  • Guidelines for Use of Nutrition Claims—Draft Table of Conditions for Nutrient Contents Claims (Part B containing Provisions on Dietary Fibre) at Step 6.
  • Draft Revised Standards for Gluten-Free Foods at Step 7.
  • Proposed Draft Recommendations on the Scientific Basis of Health Claims.
  • Guidelines on the Application of Risk Analysis to the Work of the CCNFSDU.
  • Discussion paper on the FAO Technical Workshop on Energy Conversion Factors.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Fish and Fishery Products

The Fish and Fishery Products Committee is responsible for elaborating standards for fresh, frozen and otherwise processed fish, crustaceans and mollusks. The following will be considered by the 27th Session of the Commission when it meets in June 2004. The relevant document is ALINORM 04/27/18.

To be considered at Step 8:

  • Draft Standard for Salt Atlantic Herring and Salted Sprat.
  • Draft Model Certificate for Fish and Fishery Products (Sanitary Certificate).
  • Draft Amendment to the Standard for Quick Frozen Lobsters.

To be considered at Step 5/8:

  • Proposed Draft Code of Practice for Fish and Fishery Products (aquaculture and quick frozen coated fish products).

To be considered at Step 5:

  • Proposed Draft Amendment to the Standard for Salted Fish and Dried Salted Fish.

The Committee continues work on the following:

  • Proposed Draft Code of Practice for Fish and Fishery Products (other sections).
  • Proposed Draft Standard for Live and Raw Bivalve Mollusks.
  • Proposed Draft Standard for Smoked Fish.
  • Proposed Draft Standard for Granular Sturgeon Caviar.
  • Proposed Draft Standard for Quick Frozen Scallop Adductor Muscle Meat.
  • Revision of the procedure for the Inclusion of Species.
  • Proposed Draft Amendment of the Labelling Section in the Standard for Canned Sardines and Sardine-Type Products (Clupea bentincki).

Responsible Agency: HHS/FDA; USDC/NOAA/NMFS.

U.S. Participation: Yes.

Codex Committee on Milk and Milk Products

The Codex Committee on Milk and Milk Products is responsible for establishing international codes and standards for milk and milk products. The Committee held its 6th Session in Auckland, NZ on April 26-30, 2004. The relevant document is ALINORM 04/27/11.

The Committee worked on the following:

  • Proposed Draft Amendment to Section 3.3 (Composition) of the Codex General Standard for Cheese. Start Printed Page 31948
  • Proposed Draft Standard for Products in Which Milk Components are Substituted by Non-Milk Components.
  • Evaporated Skimmed Milk with Vegetable Fat.
  • Sweetened Condensed Skimmed Milk with Vegetable Fat.
  • Skimmed Milk Powder with Vegetable Fat.
  • Proposed Draft Model Export Certificate for Milk and Milk Products.
  • Methods of Analysis and Sampling for Milk Products.
  • Draft Revised Standards for Individual Cheeses.
  • Draft Revised Standard for Processed Cheese.
  • Draft Revised Standard for Dairy Spreads.
  • Proposed Draft Revised Standard for Whey Cheese.
  • Proposed Standard for Parmesan Cheese.
  • Discussion paper on Proposed Revision of the Codex Standard for Extra Hard Grating Cheese.

Responsible Agency: USDA/AMS; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Fats and Oils

The Codex Committee on Fats and Oils is responsible for elaborating standards for fats and oils of animal, vegetable, and marine origin. The Committee will hold its next session on February 21-25, 2005, in London, England.

The Committee continues work on:

  • Draft Standard for Fat Spreads and Blended Spreads.
  • Proposed Draft Amendments to the Standard for Named Vegetable Oils:
  • Amendment to Sesame Seed Oil.
  • Rice Bran Oil.
  • Draft List of Acceptable Previous Cargoes.
  • Proposed Draft List of Acceptable Previous Cargoes.
  • Proposed Draft Amendment to the Standard for Olive Oil: Linolenic Acid content.
  • Proposed Draft Amendments to the Recommended International Code of Practice for the Storage and Transport of Edible Fats and Oils in Bulk:
  • Amendments to Table 1.

Responsible Agency: HHS/FDA; USDA/ARS.

U.S. Participation: Yes.

Codex Committee on Processed Fruits and Vegetables

The Codex Committee on Processed Fruits and Vegetables is responsible for elaborating standards for Processed Fruits and Vegetables. After having been adjourned sine die, the Committee reconvened in Washington, DC, in March 1998 to begin work revising the standards. The Committee will hold its next session on September 27-October 1, 2004.

The committee is continuing work on:

  • Draft Codex Standard for Pickled Products.
  • Proposed Draft Revised Standards for:
  • Processed Tomato Concentrates.
  • Canned Tomatoes.
  • Canned Vegetables including Guidelines for Packing Media for Canned Vegetables.
  • Jams, Jellies and Marmalades.
  • Soy Sauce.
  • Canned Citrus Fruits.

Other work:

  • Methods of Analysis for Processed Fruits and Vegetables.
  • Priority List for the Standardization of Processed Fruits and Vegetables.

Responsible Agency: USDA/AMS; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Meat Hygiene

The 24th Session of the Commission decided to reactivate the Codex Committee on Meat Hygiene with New Zealand as Host Government. The Terms of Reference were amended to reflect the inclusion of poultry in its mandate. The relevant document is ALINORM 04/27/16.

The Committee continues to work on:

  • Proposed Draft Code of Hygienic Practice for Meat at Step 5.
  • Incorporating the Hygiene Provisions for Processed Meat in the Draft Code of Hygienic Practice for Meat for discussion.
  • Attaching the Proposed Draft Annex on Risk-Based Post-Mortem Examination Procedures for Meat and the Proposed Draft Annex on Microbiological Verification of Process Control of Meat Hygiene as Annex I and II, respectively.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Cereals, Pulses, and Legumes

The 26th Session of the Codex Alimentarius Commission adopted the Proposed Draft Standard for Instant Noodles at Step 5, on the recommendation of the Coordinating Committee for Asia, and advanced it to Step 6 for consideration by the Committee on Cereals, Pulses and Legumes by correspondence. The United States, as host government, has circulated the Draft Standard for comments and will circulate the revised version for another round of comments following discussion in CCFAC regarding additives and peroxide values.

Responsible Agency: HHS/FDA; USDA/GIPSA.

U.S. Participation: Yes.

Certain Codex Commodity Committees 1

Several Codex Alimentarius Commodity Committees have adjourned sine die. The following Committees fall into this category:

  • Cocoa Products and Chocolate.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

  • Natural Mineral Water.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

  • Sugars.

Responsible Agency: USDA/ARS; HHS/FDA.

U.S. Participation: Yes.

  • Vegetable Proteins.

Responsible Agency: USDA/ARS; HHS/FDA.

U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Animal Feeding

The Commission at its 23rd Session established the Ad Hoc Intergovernmental Task Force on Animal Feeding to develop guidelines or standards as appropriate on good animal feeding practices. The Revised Draft Code of Practice for Good Animal Feeding was held at Step 8 by the Commission at its 26th Session in June 2003, with the exception that the definition of “feed additive” and paragraphs 11, 12, and 13 were advanced to step 6. The Task Force held its 5th Session on May 17-19, 2004 and discussed:

  • Revised Draft Code of Practice for Good Animal Feeding (definition of “feed additive” and paragraphs 11, 12, and 13)

Responsible Agency: HHS/FDA; USDA/APHIS.

U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices

The Commission at its 23rd Session established this Task Force to revise and consolidate the existing Codex standards and guidelines for fruit and vegetable juices and related products, giving preference to general standards. These standards were originally developed by the Joint UNECE/Codex Group of Experts on the Standardization of Fruit Juices which had been abolished by its parent organizations. The Task Force will hold its fourth session in Brazil, on October 11-15, 2004.

The committee is discussing:

  • Proposed Draft Minimum Brix Level for Reconstituted Juice and Reconstituted Puree and Minimum Juice Start Printed Page 31949and/or Puree Content for Fruit Nectars (%v/v).
  • Grape, Guava, Mandarin/Tangerine, Mango, Passion Fruit and Tamarind (Indian date) juice at step 7.
  • Orange, Lemon, Lime and Pineapple Juice at step 4.

Responsible Agency: HHS/FDA; USDA/AMS.

U.S. Participation: Yes.

FAO/WHO Regional Coordinating Committees

The Codex Alimentarius Commission is made up of an Executive Committee, as well as approximately 30 subsidiary bodies. Included in these subsidiary bodies are coordinating committees for groups of countries located in proximity to each other who share common concerns. There are currently six Regional Coordinating Committees:

  • Coordinating Committee for Africa.
  • Coordinating Committee for Asia.
  • Coordinating Committee for Europe.
  • Coordinating Committee for Latin America and the Caribbean.
  • Coordinating Committee for the Near East.
  • Coordinating Committee for North America and the South-West Pacific.

The United States participates as an active member of the Coordinating Committee for North America and the South-West Pacific, and is informed of the other coordinating committees through meeting documents, final reports, and representation at meetings. Each regional committee:

  • Defines the problems and needs of the region concerning food standards and food control;
  • Promotes within the committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulates the strengthening of food control infrastructures;
  • Recommends to the Commission the development of world-wide standards for products of interest to the region, including products considered by the committee to have an international market potential in the future; and
  • Serves a general coordinating role for the region and performs such other functions as may be entrusted to it by the Commission.

Codex Coordinating Committee for North America and the South-West Pacific

The Coordinating Committee is responsible for defining problems and needs concerning food standards and food control of all Codex member countries of the region. The Eighth Session of the Committee will take place in Apia, Samoa on October 19-22, 2004. Items on the agenda may include:

  • Trust Fund for the Participation of Developing Countries in Codex Standard Setting Procedures.
  • Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and WHO Work on Food Standards.
  • Consideration of Traceability/Product Tracing.
  • Strategic Plan for the Coordinating Committee for North America and the Southwest Pacific.
  • Cooperation between Codex and the International Office of Epizootics.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Attachment 2: U.S. Codex Alimentarius Officials

Codex Committee Chairpersons

Codex Committee on Food Hygiene

Dr. Karen Hulebak, Assistant Administrator, Office of Public Health Science, Food Safety and Inspection Service, U.S. Department of Agriculture, 1400 Independence Avenue, SW., Room 3130, South Building, Washington, DC 20250-3700, Phone: (202) 720-8609, Fax: (202) 720-9893, E-mail: karen.hulebak@fsis.usda.gov.

Codex Committee on Processed Fruits and Vegetables

Mr. David L. Priester, International Standards Coordinator, Fruit & Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2049, South Building, Stop 0140, 1400 Independence Avenue, SW., Washington, DC 20250-0240, Phone: (202) 720-2185, Fax: (202) 720-8871, E-mail: david.priester@usda.gov.

Codex Committee on Residues of Veterinary Drugs in Foods

Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, Phone: (301) 827-2950, Fax: (301) 827-4401, E-mail: ssundlof@cvm.fda.gov.

Codex Committee on Cereals, Pulses and Legumes (adjourned sine die)

Mr. Steven N. Tanner, Director, Technical Services Division, Grain Inspection, Packers & Stockyards, Administration, U.S. Department of Agriculture, 10383 N. Executive Hills Boulevard, Kansas City, MO 64153-1394, Phone: (816) 891-0401, Fax: (816) 891-0478, E-mail: stanner@tsd.fgiskc.usda.gov.

Listing of U.S. Delegates and Alternates; Worldwide General Subject Codex Committees

Codex Committee on Residues of Veterinary Drugs in Foods (Host Government—United States)

U.S. Delegate

Dr. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, Phone: (301) 827-1796, Fax: (301) 594-2297, E-mail: SVaughn@cvm.fda.gov.

Alternate Delegate

Dr. Alice Thaler, Staff Director, Animal and Egg Production Food Safety Staff, Food Safety and Inspection Service, U.S. Department of Agriculture, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) 690-2683, Fax: (202) 720-8213, E-mail: alice.thaler@fsis.usda.gov.

Codex Committee on Food Additives and Contaminants (Host Government—The Netherlands)

U.S. Delegate

Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700, Fax: (301) 436-2632, E-mail: Terry.Troxell@cfsan.fda.gov.

Alternate Delegate

Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-255), Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202) 418-3131, E-mail: dennis.keefe@cfsan.fda.gov.

Codex Committee on Pesticide Residues (Host Government—The Netherlands)

U.S. Delegate

Ms. Lois Rossi, Director of Registration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Phone: (703) 305-5035, Fax: (703) 305-5147, E-mail: Rossi.Lois@epamail.epa.gov.

Alternate Delegate

Dr. Robert Epstein, Associate Deputy Administrator, Science and Technology, Agricultural Marketing Service, U.S. Start Printed Page 31950Department of Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 1400 Independence Ave., SW., Washington, DC 20090, Phone: (202) 720-2158, Fax: (202) 720-1484, E-mail: Robert.Epstein@usda.gov.

Codex Committee on Methods of Analysis and Sampling (Host Government—Hungary)

U.S. Delegate

Dr. Gregory Diachenko, Director, Division of Chemistry Research and Environmental Review, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (HFS-245), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1898, Fax: (301) 436-2634, E-mail: Gregory.Diachenko@cfsan.fda.gov.

Alternate Delegate

Mr. Donald C. Kendall, Technical Services Division, Grain, Inspection, Packers & Stockyards Administration, U.S. Department of Agriculture, 10383 N. Ambassador Drive, Kansas City, MO 64153-1394, Phone: (816) 891-0463, Fax: (816) 891-0478, E-mail: Donnald.C.Kendall@usda.gov.

Codex Committee on Food Import and Export Certification and Inspection Systems (Host Government—Australia)

U.S. Delegate

Dr. Catherine Carnevale, Director, Office of Constituent Operations, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2380, Fax: (301) 436-2618, E-mail: Catherine.Carnevale@cfsan.fda.gov.

Alternate Delegate

Ms. Karen Stuck, Assistant Administrator, Office of International Policy, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 2137, South Building, 1400 Independence Ave., SW., Washington, DC 20250-3700, Phone: (202) 720-3470, Fax: (202) 720-7990, E-mail: Karen.Stuck@fsis.usda.gov.

Codex Committee on General Principles (Host Government—France)

U.S. Delegate

Note:

A member of the Steering Committee heads the delegation to meetings of the General Principles Committee.

Codex Committee on Food Labeling (Host Government—Canada)

Interim U.S. Delegate

Mr. L. Robert Lake, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition (HFS-4), Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2379, Fax: (301) 436-2637, E-mail: RLake@cfsan.fda.gov.

Alternate Delegate

Mary K. Cutshall, Acting Director, Strategic Initiatives, Partnerships and Outreach Staff, Food Safety and Inspection Service, U.S. Department of Agriculture, 405 Aerospace Building, Washington, DC 20250-3700, Phone: (202) 690-6520, Fax: (202) 690-6519, E-mail: Mary.Cutshall@fsis.usda.gov.

Codex Committee on Food Hygiene (Host Government—United States)

U.S. Delegate

Dr. Robert L. Buchanan, Director, Office of Science, Center for Food Safety and Applied Nutrition (HFS-006), Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2369, Fax: (301) 436-2642, E-mail: Robert.Buchanan@cfsan.fda.gov.

Alternate Delegate

Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of Policy, Program and Employee Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th St., SW. Washington, DC 20250, Phone: (202) 205-0699, Fax: (202) 401-1760, E-mail: Perfecto.Santiago@fsis.usda.gov.

Codex Committee on Nutrition and Food for Special Dietary Uses (Host Government—Germany)

U.S. Delegate

Vacant.

Alternate Delegate

Vacant.

Worldwide Commodity Codex Committees

Codex Committee on Fresh Fruits and Vegetables (Host Government—Mexico)

U.S. Delegate

Mr. Dorian LaFond, International Standards Coordinator, Fruit and Vegetables Program, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2086, South Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-4722, E-mail: dorian.lafond@usda.gov,

Alternate Delegate

Vacant.

Codex Committee on Fish and Fishery Products (Host Government—Norway)

U.S. Delegate

Mr. Philip C. Spiller, Director, Office of Seafood (HFS-400), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2300, Fax: (301) 436-2599, E-mail: Philip.Spiller@cfsan.fda.gov.

Alternate Delegate

Richard V. Cano, Acting Director, National Seafood Inspection Program, NOAA, U.S. Department of Commerce, 1315 East-West Highway, Silver Spring, MD 20910, Phone: (301) 713-2355, Fax: (301) 713-1081, Email: richard.cano@noaa.gov.

Codex Committee on Cereals, Pulses and Legumes (Host Government—United States)

U.S. Delegate

Mr. Charles W. Cooper, Director, International Policy and Industry Outreach Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, Fax: (301) 436-2618, E-mail Charles.Cooper@cfsan.fda.gov.

Alternate Delegate

Mr. David Shipman, Deputy Administrator, Federal Grain Inspection Division, Grain Inspection, Packers and Stockyards Administration, U.S. Department of Agriculture, Room 1661, South Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) 720-9170, Fax: (202) 205-9237, E-mail: dshipman@gipsadc.usda.gov.

Codex Committee on Milk and Milk Products (Host Government—New Zealand)

U.S. Delegate

Mr. Duane Spomer, Chief, Dairy Standardization Branch, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2750, South Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) Start Printed Page 31951720-9382, Fax: (202) 720-2643, E-mail: duane.spomer@usda.gov.

Alternate Delegate

John F. Sheehan, Director, Division of Dairy and Egg Safety, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-365), Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: (301) 436-1488, Fax: (301) 436-2632, E-mail: john.sheehan@cfsan.fda.gov.

Codex Committee on Fats and Oils (Host Government—United Kingdom)

U.S. Delegate

Mr. Charles W. Cooper, Director, International Policy and Industry Outreach Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, Fax: (301) 436-2618, E-mail: Charles.Cooper@cfsan.fda.gov.

Alternate Delegate

Ms. Kathleen Warner (Acting), U.S. Department of Agriculture, 1815 N. University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax: (309) 681-6668, E-mail: warnerk@ncaur.usda.gov.

Codex Committee on Cocoa Products and Chocolate (Host Government—Switzerland)

U.S. Delegate

Mr. Charles W. Cooper, Director, International Policy and Industry Outreach Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, Fax: (301) 436-2618, E-mail: Charles.Cooper@cfsan.fda.gov.

Alternate Delegate

Dr. Michelle Smith, Food Technologist, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2024, Fax: (301) 436-2651, E-mail: Michelle.Smith@cfsan.fda.gov.

Codex Committee on Sugars (Host Government—United Kingdom)

U.S. Delegate

Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit, Agricultural Research, U.S. Department of Agriculture, 5883 USDA Road, Houma, LA 70360, Phone: (504) 872-5042, Fax: (504) 868-8369, E-mail: ttew@nola.srrc.usda.gov.

Alternate Delegate

Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-255), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202) 418-3131, E-mail: dennis.keefe@cfsan.fda.gov.

Codex Committee on Processed Fruits and Vegetables (Host Government—United States)

U.S. Delegate

Mr. Dorian Lafond, International Standards Coordinator, Fruit and Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2086, South Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-0016, E-mail: Dorian.Lafond@usda.gov.

Alternate Delegate

Mr. Charles W. Cooper, Director, International Policy and Industry Outreach Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, Fax: (301) 436-2618, E-mail: Charles.Cooper@cfsan.fda.gov.

Codex Committee on Vegetable Proteins (Host Government—Canada)

U.S. Delegate

Dr. Wilda H. Martinez, Area Director, ARS North Atlantic Area, Agricultural Research Service, U.S. Department of Agriculture, 600 E. Mermaid Lane, Wyndmoor, PA 19038, Phone: (215) 233-6593, Fax: (215) 233-6719, E-mail: wmartinez@ars.usda.gov.

Alternate Delegate

Dr. Jeanne Rader, Director, Division of Research and Applied Technology, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-840), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1786, Fax: (301) 436-2640, E-mail: Jeanne.Rader@cfsan.fda.gov.

Codex Committee on Meat Hygiene (Host Government—New Zealand)

U.S. Delegate

Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of Policy, Program and Employee Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th Street, SW., Washington, DC 20250, Phone: (202) 205-0699, Fax: (202) 401-1760, E-mail: Perfecto.Santiago@fsis.usda.gov.

Alternate Delegate

Dr. William James, Deputy Assistant Administrator, Office of International Affairs, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 3143, South Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: (202) 720-8601, Fax: (202) 690-3856, E-mail: william.james@fsis.usda.gov.

Codex Committee on Natural Mineral Waters (Host Government—Switzerland)

U.S. Delegate

Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700, Fax: (301) 436-2632, E-mail: terry.troxell@cfsan.fda.gov.

Alternate Delegate

Ms. Shellee Anderson, Food Technologist, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-800), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1491, Fax: (301) 436-2636, E-mail: Shellee.Anderson@cfsan.fda.gov.

Ad Hoc Intergovernmental Task Forces

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices (Host Government—Brazil)

U.S. Delegate

Mr. Martin Stutsman, Consumer Safety Officer, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 5100 Paint Start Printed Page 31952Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1642, Fax: (301) 436-2651, E-mail: Martin.Stutsman@cfsan.fda.gov.

Alternate Delegate

Vacant.

Ad Hoc Intergovernmental Task Group on Animal Feeding (Host Government—Denmark)

U.S. Delegate

Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place (HFV-1), Metro Park N. 4, Rockville, MD 20855, Phone: (301) 827-2950, Fax: (301) 827-4401, E-mail: ssundlof@cvm.fda.gov.

Alternate Delegate

Dr. Lawrence E. Miller, Program Manager, Veterinary Regulatory Support, Plant Protection and Quarantine, Animal and Plant Health Inspection Service, Unit 129, Room 4D79, 4700 River Road, Riverdale, MD 20737, Phone: (301) 734-7633, Fax: (301) 734-8538, E-mail: Lawrence.E.Miller@usda.gov.

There are six regional coordinating committees:

Coordinating Committee for Africa.

Coordinating Committee for Asia.

Coordinating Committee for Europe.

Coordinating Committee for Latin America and the Caribbean.

Coordinating Committee for the Near East.

Coordinating Committee for North American and the South-West Pacific.

Contact

Paulo Almeida, Office Manager, U.S. Codex Office, Food Safety and Inspection Service, Room 4861, South Building, 1400 Independence Ave., SW., Washington, DC 20250-3700, Phone: (202) 205-7760, Fax: (202) 720-3157, E-mail: Paulo.Almeida@fsis.usda.gov.

Attachment 3: Timetable of Codex Sessions

[June 2003 through June 2005]

2003:
CX 702-52Executive Committee (52nd Session)26-27 JuneRome.
CX 701-26Codex Alimentarius Commission (26th Session)30 June-5 JulyRome.
CX 731-11Codex Committee on Fresh Fruits and Vegetables (11th Session)8-12 SeptemberMexico City.
CX 722-26Codex Committee on Fish and Fishery Products (26th Session)13-17 OctoberAalesund (Norway).
CX 720-25Codex Committee on Nutrition and Foods for Special Dietary Uses (25th Session)3-7 NovemberBerlin.
CX 716-19Codex Committee on General Principles (19th Session)17-21 NovemberParis.
CX-733-12Codex Committee on Food Import and Export Inspection and Certification (12th Session)1-5 DecemberBrisbane.
2004:
CX 702-53Executive Committee (53rd Session)4-6 FebruaryGeneva.
CX 723-10Codex Committee on Meat and Poultry Hygiene (10th Session)16-20 FebruaryAuckland.
CX 715-25Codex Committee on Methods of Analysis and Sampling (25th Session)8-12 MarchBudapest.
CX 711-36Codex Committee on Food Additives and Contaminants (36th Session)22-26 MarchRotterdam.
CX 712-36Codex Committee on Food Hygiene (36th Session)29 March-3 AprilWashington, DC.
CX 718-36Codex Committee on Pesticide Residues (36th Session)19-24 AprilNew Delhi.
CX-703-06Codex Committee on Milk and Milk Products (6th Session)26-30 AprilAuckland.
CX 716-19Codex Committee on General Principles (19th Session)3-7 MayParis.
CX 714-32Codex Committee on Food Labelling (32nd Session)10-14 MayMontreal.
CX 803-05Ad Hoc Intergovernmental Task Force on Animal Feeding (5th Session)17-19 MayCopenhagen.
CX 702-54Executive Committee (54th Session)24-26 JuneGeneva.
CX 701-27Codex Alimentarius Commission (27th Session)28 June-3 JulyGeneva.
CX 727-14Regional Coordinating Committee for Asia (14th Session)7-10 SeptemberJeJu (City) Republic of Korea.
CX 706-24Regional Coordinating Committee for Europe (24th Session)20-23 SeptemberBratislava (Slovak Republic).
CX 713-22Codex Committee on Processed Fruits and Vegetables (22nd Session)27 September-1 OctoberAlexandria, VA.
CX 801-03Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices (3rd Session)11-15 OctoberTBA (Brazil).
CX 732-08Regional Coordinating Committee for North America and South West Pacific (8th Session)19-22 OctoberApia (Samoa).
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CX 730-15Codex Committee on Residue of Veterinary Drugs in Foods (15th Session)25-28 OctoberTBA, USA.
CX 720-26Codex Committee on Nutrition and Foods for Special Dietary Uses (26th Session)1-5 NovemberBonn (Germany).
CX 716-21Codex Committee on General Principles (21st Session)15-19 NovemberParis.
CX 701-55Executive Committee (55th Session)22-24 NovemberRome.
CX 725-14Regional Coordinating Committee for Latin America and the Caribbean (14th Session)29 November-3 DecemberBuenos Aires.
CX 733-13Codex Committee on Food Import and Export Inspection and Certification Systems (13th Session)6-10 DecemberTBA, (Australia).
2005:
CX 707-16Regional Coordinating Committee for Africa (16th Session)14-17 DecemberRabat (Morocco).
CX 723-11Codex Committee on Meat and Poultry Hygiene (11th Session)14-18 FebruaryTBA, (New Zealand).
CX 709-19Codex Committee on Fats and Oils (19th Session)21-25 FebruaryLondon.
CX 722-27Codex Committee on Fish and Fishery Products (27th Session)28 February-4 MarchTBA (South Africa).
CX 734-03Regional Coordinating Committee for Near East (3rd Session)7-10 MarchAmman (Jordan).
CX 712-37Codex Committee on Food Hygiene (37th Session)14-19 MarchTBA, USA.
CX 711-37Codex Committee on Food Additives and Contaminants (37th Session)21-25 MarchRotterdam.
CX 715-26Codex Committee on Methods of Analysis and Sampling (26th Session)4-8 AprilBudapest.
CX 716-22Codex Committee on General Principles (22nd Session)11-15 AprilParis.
CX 718-37Codex Committee on Pesticide Residues (37th Session)18-23 AprilThe Hague.
CX 714-33Codex Committee on Food Labelling (33rd Session)9-13 MayTBA.
CX 731-12Codex Committee on Fresh Fruits and Vegetables (12th Session)16-20 MayMexico City.
CX 702-56Executive Committee (56th Session)23-24 JuneRome.
CX 701-28Codex Alimentarius Commission (28th Session)27 June-1 JulyRome.

Attachment 4: Definitions for the Purpose of Codex Alimentarius

Words and phrases have specific meanings when used by the Codex Alimentarius. For the purposes of Codex, the following definitions apply:

1. Food means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drink, chewing gum, and any substance which has been used in the manufacture, preparation or treatment of “food” but does not include cosmetics or tobacco or substances used only as drugs.

2. Food hygiene comprises conditions and measures necessary for the production, processing, storage and distribution of food designed to ensure a safe, sound, wholesome product fit for human consumption.

3. Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport, or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The food additive term does not include “contaminants” or substances added to food for maintaining or improving nutritional qualities.

4. Contaminant means any substance not intentionally added to food, which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry, and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food or as a result of environmental contamination. The term does not include insect fragments, rodent hairs and other extraneous matters.

5. Pesticide means any substance intended for preventing, destroying, attracting, repelling, or controlling any pest including unwanted species of plants or animals during the production, storage, transport, distribution and processing of food, agricultural commodities, or animal feeds or which may be administered to animals for the control of ectoparasites. The term includes substances intended for use as a plant-growth regulator, defoliant, desiccant, fruit thinning agent, or sprouting inhibitor and substances applied to crops either before of after harvest to protect the commodity from Start Printed Page 31954deterioration during storage and transport. The term pesticides excludes fertilizers, plant and animal nutrients, food additives, and animal drugs.

6. Pesticide residue means any specified substance in food, agricultural commodities, or animal feed resulting from the use of a pesticide. The term includes any derivatives of a pesticide, such as conversion products, metabolites, reaction products, and impurities considered to be of toxological significance.

7. Good Agricultural Practice in the Use of Pesticides (GAP) includes the nationally authorized safe uses of pesticides under actual conditions necessary for effective and reliable pest control. It encompasses a range of levels of pesticide applications up to the highest authorized use, applied in a manner that leaves a residue, which is the smallest amount practicable.

Authorized safe uses are determined at the national level and include nationally registered or recommended uses, which take into account public and occupational health and environmental safety considerations.

Actual conditions include any stage in the production, storage, transport, distribution and processing of food commodities and animal feed.

8. Codex Maximum Limit for Pesticide Residues (MRLP) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. MRLPs are based on their toxological affects and on GAP data and foods derived from commodities that comply with the respective MRLPs are intended to be toxologically acceptable.

Codex MRLPs, which are primarily intended to apply in international trade, are derived from reviews conducted by the JMPR following:

(a) toxological assessment of the pesticide and its residue, and

(b) review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices. Data from supervised trials conducted at the highest nationally recommended, authorized, or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLPs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices.

Consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI, should indicate that foods complying with Codex MRLPs are safe for human consumption.

9. Veterinary Drug means any substance applied or administered to any food-producing animal, such as meat or milk-producing animals, poultry, fish or bees, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiological functions or behavior.

10. Residues of Veterinary Drugs include the parent compounds and/or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned.

11. Codex Maximum Limit for Residues of Veterinary Drugs (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or μg/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be legally permitted or recognized as acceptable in or on food.

An MRLVD is based on the type and amount of residue considered to be without any toxological hazard for human health as expressed by the Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that utilizes an additional safety factor. An MRLVD also takes into account other relevant public health risks as well as food technological aspects.

When establishing an MRLVD, consideration is also given to residues that occur in food of plant origin and/or the environment. Furthermore, the MRLVD may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical and analytical methods are available.

12. Good Practice in the Use of Veterinary Drugs (GPVD) is the official recommended or authorized usage including withdrawal periods approved by national authorities, of veterinary drugs under practicable conditions.

13. Processing Aid means any substance or material, not including apparatus or utensils, not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product.

Definitions of Risk Analysis Terms Related to Food Safety

Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.

Hazard Identification: The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food or group of foods.

Hazard Characterization: The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents that may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable.

Dose-Response Assessment: The determination of the relationship between the magnitude of exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency of associated adverse health effects (response).

Exposure Assessment: The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant.

Risk: A function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard(s) in food.

Risk Analysis: A process consisting of three components: risk assessment, risk management and risk communication.

Risk Assessment: A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization.

Risk Assessment Policy: Documented guidelines on the choice of options and associated judgments for their application at appropriate decision points in the risk assessment such that the scientific integrity of the process is maintained.

Risk Characterization: The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment.

Risk Communication: The interactive exchange of information and opinions throughout the risk analysis process concerning risk, related risk factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the Start Printed Page 31955explanation of risk assessment findings and the basis of risk management decisions.

Risk Estimate: The quantitative estimation of risk resulting from risk characterization.

Risk Management: The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options.

Risk Profile: The description of the food safety problem and its context.

Attachment 5

Part 1—Uniform Procedure for the Elaboration of Codex Standards and Related Texts

Steps 1, 2 and 3

(1) The Commission decides, taking into account the “Criteria for the Establishment of Work Priorities and for the Establishment of Subsidiary Bodies,” to elaborate a Worldwide Codex Standard and also decides which subsidiary body or other body should undertake the work. A decision to elaborate a Worldwide Codex Standard may also be taken by subsidiary bodies of the Commission in accordance with the above-mentioned criteria, subject to subsequent approval by the Commission or its Executive Committee at the earliest possible opportunity. In the case of Codex Regional Standards, the Commission shall base its decision on the proposal of the majority of members belonging to a given region or group of countries submitted at a session of the Codex Alimentarius Commission.

(2) The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Panel of Experts on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF).

(3) The proposed draft standard is sent to members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests.

Step 4

The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard.

Step 5

The proposed draft standard is submitted through the Secretariat to the Commission or to the Executive Committee with a view to its adoption as a draft standard. When making any decision at this step, the Commission or the Executive Committee will give due consideration to any comments that may be submitted by any of its members regarding the implications which the proposed draft standard or any provisions of the standard may have for their economic interests. In the case of Regional Standards, all members of the Commission may present their comments, take part in the debate and propose amendments, but only the majority of the Members of the region or group of countries concerned attending the session can decide to amend or adopt the draft. When making any decisions at this step, the members of the region or group of countries concerned will give due consideration to any comments that may be submitted by any of the members of the Commission regarding the implications which the proposed draft standard or any provisions of the proposed draft standard may have for their economic interests.

Step 6

The draft standard is sent by the Secretariat to all members and interested international organizations for comment on all aspects, including possible implications of the draft standard for their economic interests.

Step 7

The comments received are sent by the Secretariat to the subsidiary body or other body concerned, which has the power to consider such comments and amend the draft standard.

Step 8

The draft standard is submitted through the Secretariat to the Commission together with any written proposals received from members and interested international organizations for amendments at Step 8 with a view to its adoption as a Codex Standard. In the case of Regional standards, all members and interested international organizations may present their comments, take part in the debate and propose amendments but only the majority of members of the region or group of countries concerned attending the session can decide to amend and adopt the draft.

Part 2—Uniform Accelerated Procedure for the Elaboration of Codex Standards and Related Texts

Steps 1, 2 and 3

(1) The Commission or the Executive Committee between Commission sessions, on the basis of a two-thirds majority of votes cast, taking into account the “Criteria for the Establishment of Work Priorities and for the Establishment of Subsidiary Bodies”, shall identify those standards which shall be the subject of an accelerated elaboration process. The identification of such standards may also be made by subsidiary bodies of the Commission, on the basis of a two-thirds majority of votes cast, subject to confirmation at the earliest opportunity by the Commission or its Executive Committee by a two-thirds majority of votes cast.

(2) The Secretariat arranges for the preparation of a proposed draft standard. In the case of Maximum Limits for Residues of Pesticides or Veterinary Drugs, the Secretariat distributes the recommendations for maximum limits, when available from the Joint Meetings of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Panel of Experts on Pesticide Residues (JMPR), or the Joint FAO/WHO Expert Committee on Food Additives (JECFA). In the cases of milk and milk products or individual standards for cheeses, the Secretariat distributes the recommendations of the International Dairy Federation (IDF).

(3) The proposed draft standard is sent to Members of the Commission and interested international organizations for comment on all aspects including possible implications of the proposed draft standard for their economic interests. When standards are subject to an accelerated procedure, this fact shall be notified to the Members of the Commission and the interested international organizations.

Step 4

The comments received are sent by the Secretariat to the subsidiary body or other body concerned which has the power to consider such comments and to amend the proposed draft standard.

Step 5

In the case of standards identified as being subject to an accelerated Start Printed Page 31956elaboration procedure, the draft standard is submitted through the Secretariat to the Commission together with any written proposals received from Members and interested international organizations for amendments with a view to its adoption as a Codex standard. In taking any decision at this step, the Commission will give due consideration to any comments that may be submitted by any of its Members regarding the implications which the proposed draft standard or any provisions thereof may have for their economic interests.

Attachment 6: Nature of Codex Standards

Codex standards contain requirements for food aimed at ensuring for the consumer a sound, wholesome food product free from adulteration, and correctly labelled. A Codex standard for any food or foods should be drawn up in accordance with the Format for Codex Commodity Standards and contain, as appropriate, the criteria listed therein.

Format for Codex Commodity Standards Including Standards Elaborated Under the Code of Principles Concerning Milk and Milk Products

Introduction

The format is also intended for use as a guide by the subsidiary bodies of the Codex Alimentarius Commission in presenting their standards, with the object of achieving, as far as possible, a uniform presentation of commodity standards. The format also indicates the statements which should be included in standards as appropriate under the relevant headings of the standard. The sections of the format required to be completed for a standard are only those provisions that are appropriate to an international standard for the food in question.

Name of the Standard

Scope

Description

Essential Composition and Quality Factors

Food Additives

Contaminants

Hygiene

Weights and Measures

Labelling

Methods of Analysis and Sampling

Format for Codex Standards

Name of the Standard

The name of the standard should be clear and as concise as possible. It should usually be the common name by which the food covered by the standard is known or, if more than one food is dealt with in the standard, by a generic name covering them all. If a fully informative title is inordinately long, a subtitle could be added.

Scope

This section should contain a clear, concise statement as to the food or foods to which the standard is applicable unless the name of the standard clearly and concisely identifies the food or foods. A generic standard covering more than one specific product should clearly identify the specific products to which the standard applies.

Description

This section should contain a definition of the product or products with an indication, where appropriate, of the raw materials from which the product or products are derived and any necessary references to processes of manufacture. The description may also include references to types and styles of product and to type of pack. The description may also include additional definitions when these additional definitions are required to clarify the meaning of the standard.

Essential Composition and Quality Factors

This section should contain all quantitative and other requirements as to composition including, where necessary, identity characteristics, provisions on packing media and requirements as to compulsory and optional ingredients. It should also include quality factors that are essential for the designation, definition, or composition of the product concerned. Such factors could include the quality of the raw material, with the object of protecting the health of the consumer, provisions on taste, odor, color, and texture which may be apprehended by the senses, and basic quality criteria for the finished products, with the object of preventing fraud. This section may refer to tolerances for defects, such as blemishes or imperfect material, but this information should be contained in appendix to the standard or in another advisory text.

Food Additives

This section should contain the names of the additives permitted and, where appropriate, the maximum amount permitted in the food. It should be prepared in accordance with guidance given on page 84 of the Codex Procedural Manual and may take the following form:

“The following provisions in respect of food additives and their specifications as contained in section * * * of the Codex Alimentarius are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.”

A tabulation should then follow, viz.:

Name of additive, maximum level (in percentage or mg/kg).”

Contaminants

(a) Pesticide Residues: This section should include, by reference, any levels for pesticide residues that have been established by the Codex Committee on Pesticide Residues for the product concerned.

(b) Other Contaminants: In addition, this section should contain the names of other contaminants and where appropriate the maximum level permitted in the food, and the text to appear in the standard may take the following form:

“The following provisions in respect of contaminants, other than pesticide residues, are subject to endorsement [have been endorsed] by the Codex Committee on Food Additives and Contaminants.”

A tabulation should then follow, viz.:

Name of contaminant, maximum level (in percentage or mg/kg).”

Hygiene

Any specific mandatory hygiene provisions considered necessary should be included in this section. They should be prepared in accordance with the guidance given in the Codex Procedural Manual. Reference should also be made to applicable codes of hygienic practice. Any parts of such codes, including in particular any end-product specifications, should be set out in the standard, if it is considered necessary that they should be made mandatory. The following statement should also appear:

“The following provisions in respect of the food hygiene of the product are subject to endorsement [have been endorsed] by the Codex Committee on Food Hygiene.”

Weights and Measures

This section should include all provisions, other than labelling provisions, relating to weights and measures, e.g., where appropriate, fill of container, weight, measure or count of units determined by an appropriate method of sampling and analysis. Weights and measures should be expressed in S.I. units. In the case of standards which include provisions for the sale of products in standardized amounts, e.g. multiples of 100 grams, S.I. units should be used, but this would not preclude additional statements in the standards of these standardized amounts in approximately similar amounts in other systems of weights and measures. Start Printed Page 31957

Labelling

This section should include all the labelling provisions contained in the standard and should be prepared in accordance with the guidance given in the Codex Procedural Manual. Provisions should be included by reference to the General Standard for the Labelling of Prepackaged Foods. The section may also contain provisions which are exemptions from, additions to, or which are necessary for the interpretation of the General Standard in respect of the product concerned provided that these can be justified fully. The following statement should also appear:

“The following provisions in respect of the labelling of this product are subject to endorsement [have been endorsed] by the Codex Committee on Food Labelling.”

Methods of Analysis and Sampling

This section should include, either specifically or by reference, all methods of analysis and sampling considered necessary and should be prepared in accordance with the guidance given in the Codex Procedural Manual. If two or more methods have been proved to be equivalent by the Codex Committee on Methods of Analysis and Sampling, these could be regarded as alternatives and included in this section either specifically or by reference. The following statement should also appear:

“The methods of analysis and sampling described hereunder are to be endorsed [have been endorsed] by the Codex Committee on Methods of Analysis and Sampling.”

End Supplemental Information

[FR Doc. 04-12736 Filed 6-7-04; 8:45 am]

BILLING CODE 3410-DM-P