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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, Pub. L. 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, 2002, to May 31, 2003, and June 1, 2003, to May 31, 2004, seeks comments on standards currently under consideration and recommendations for new standards.

ADDRESSES:

Submit any written comments to: FSIS Docket Room, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102, Cotton Annex, Washington, DC 20250-3700. 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 between 8:30 a.m. and 4:30 p.m., Monday through Friday.

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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 Start Printed Page 33445Independence 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/​OA/​Codex/​index.htm.

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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

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/​OA/​Codex. 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, 2002 to May 31, 2003, and June 1, 2003 to May 31, 2004. 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 2002 through June 2004)

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 minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and provide copies of this Federal Register publication in the FSIS Constituent Update. FSIS provides a weekly FSIS Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on line through the FSIS web page, located at http://www.fsis.usda.gov. The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience. Start Printed Page 33446

For more information, contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv), go to the “Constituent Update” page on the Internet at http://www.fsis.usda.gov/​oa/​update/​update.htm. Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

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Done at Washington, DC on: May 28, 2003.

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-sixth Session June 30-July 7, 2003, in Rome, Italy. At that time it will consider 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 recent Joint FAO/WHO Evaluation of the Codex Alimentarius and Other FAO and WHO Work on Food Standards. At this Session, the Commission will elect a Chair, three Vice Chairs, and Regional Members of the Executive Committee as well as appoint Regional Coordinators.

Prior to the Commission meeting, the Executive Committee will meet at its Fifty-second Session on June 26-27, 2003. 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. It will consider matters arising from reports of Codex Committees including review of standards at step 5, requests for new work, and other items brought to its attention. It will also hear a report on, and make recommendations concerning, 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 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 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 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 following matters, contained in ALINORM 03/31 and ALINORM 03/31A, will be considered by the Codex Alimentarius Commission at its 26th Session:

To be considered at Step 8:

  • Abemectin
  • Carazolol
  • Chlortetracycline/oxytetracycline/tetracycline
  • Clenbuterol
  • Cyfluthrin
  • Deltamethrin
  • Eprinomectrin
  • Phoxim
  • Porcine somatotropin

To be considered at Step 5/8:

  • Cyhalothrin
  • Dihydrostreptomycin/Streptomycin
  • Ivermectin
  • Lincomycin

To be considered for final adoption at Step 5 Accelerated Procedure:

  • Draft amendments to the Glossary of Terms and Definitions

To be considered at Step 5:

  • Cefuroxime

Other Work of the Committee:

  • 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 26th Session in July 2003. The relevant documents are ALINORM 03/12 and ALINORM 03/12A.

Risk Analysis

To be considered at Step 5:

  • Proposed Draft Risk Analysis Principles Applied by the Codex Committee on Food Additives and Contaminants

Food Additives

To be considered at Step 8:

  • Codex General Standard for Food Additives: Draft Food Additive Provisions in Table 1 and Table 2
  • General Standard for Food Additives: Draft Revisions to the Annex to Table 3
  • Draft Revised Codex General Standard for Irradiated Foods Start Printed Page 33447
  • Codex Advisory Specifications for the Identity and Purity of Food Additives arising from the 57th and 59th meetings of the Joint FAO/WHO Expert Committee on Food Additives (JECFA)
  • Draft Revisions to the INS for Food Additives

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

  • Proposed Draft Revised Recommended International Code of Practice for Radiation Processing of Food
  • Draft Revisions to the Codex International Numbering System for Food Additives
  • Codex General Standard for Food Additives: Proposed Draft Food Additive Provisions in Table 1 and Table 2

To be considered at Step 5:

  • Proposed Draft Revised Food Category System of the Codex General Standard for Food Additives

Proposed New Work:

  • Proposed Draft Revised Preamble to the Codex General Standard for Food Additives
  • Proposed Draft Code of Practice for the Safe Use of Active Chlorine

The Committee is continuing work on:

  • General Standard for Food Additives: Draft Food Additive Provisions (in Tables 1, 2 and 3)
  • International Numbering System
  • Specifications for the Identity and Purity of Food Additives
  • Discussion paper on Processing Aids and Carriers
  • Discussion paper on the Harmonization of Terms Used by Codex and JECFA for Sub-Classes and Technological Functions

Contaminants

To be considered at Step 8:

  • Codex General Standard for Contaminants and Toxins: Maximum Level for Patulin in Apple Juice and Apple Juice Ingredients in Other Beverages
  • Codex General Standard for Contaminants and Toxins: Maximum Level for Ochratoxin A in Wheat, Barley, Rye and Derived Products
  • Draft Code of Practice for the Prevention and Reduction of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages
  • Draft Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals, Including Annexes on Ochratoxin A, Zearalenone, Fumonisins, and Trichothecenes
  • Codex General Standard for Contaminants and Toxins: Revocation of maximum level for lead in milkfat.

To be considered at Step 5:

  • Proposed Draft Principles for Exposure Assessment of Contaminants and Toxins in Foods
  • Proposed Draft Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts
  • Proposed Draft Code of Practice for the Prevention and Reduction of Lead Contamination in Foods
  • Proposed Draft Maximum Levels for Cadmium

Proposed New Work:

  • Proposed Draft Maximum Levels for Aflatoxins in Tree Nuts (Almonds, Hazelnuts and Pistachios)
  • Proposed Draft Code of Practice for the Prevention and Reduction of Tin Contamination in Foods
  • Proposed Draft Maximum Levels for Deoxynivalenol
  • Proposed Draft Revised Guideline Levels for Radionuclides in Foods following Accidental Nuclear Contamination for Use in International Trade (CAC/GL 5-1989), including Guideline Levels for Long-Term Use
  • Discussion Paper on Acrylamide

The Committee is continuing work on:

  • Proposed Draft Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Tree Nuts (Almonds, Hazelnuts and Pistachios)
  • Proposed Draft Code of Practice for Source Directed Measures to Reduce Dioxin and Dioxin-like PCB Contamination of Foods
  • Codex General Standard for Contaminants and Toxins: Draft Maximum Levels for Lead in Fish
  • Codex General Standard for Contaminants and Toxins: Proposed Draft Maximum Levels for Cadmium in Rice, Soybeans, Peanuts, and Mollusks (including cephalopods)
  • Codex General Standard for Contaminants and Toxins: Proposed Draft Maximum Levels for Tin in Liquid Canned Foods Other Than Beverages and in Canned Beverages
  • Schedule 1 of the Proposed Draft Codex General Standard for Contaminants and Toxins in Foods
  • Codex General Standard for Contaminants and Toxins: Maximum Level for Patulin in Apple Juice Ingredients in other beverages. The CCFAC is collecting data on the level of patulin in apple juice and apple juice ingredients for other beverages with the intent of reconsidering the maximum level once the Code of Practice had been implemented (i.e., after four years)
  • Position Paper on Dioxins and Dioxin-like PCBs
  • Position Paper on Chloropropanols
  • Position Paper on Aflatoxin in Tree Nuts
  • Mycotoxin Contamination in Sorghum

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.

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 26th Session in July 2003. The relevant documents are ALINORM 03/24 and ALINORM 03/24A.

To be considered at Step 8:

  • Draft Amendments to the Guidelines on Good Laboratory Practice in Pesticide Residue Analysis and the Introduction Section of the Recommended Methods of Analysis for Pesticide Residues
  • Draft and Draft Revised Maximum Residue Limits

To be considered at Step 5/8:

  • Proposed Draft and Proposed Draft Revised Maximum Residue Limits

To be considered at Step 5: Start Printed Page 33448

  • Proposed Draft and Proposed Draft Revised Maximum Residue Limits

The committee is continuing work on:

  • Consideration of Draft and Proposed Draft Residue Limits in Foods and Feeds
  • Paper on Pilot Project for the Examination of National MRLs as Interim Codex MRLs for Safer Alternative Pesticides
  • Paper on Acute Dietary Risk Assessment
  • Revision of Regional Diets and Information on Processing
  • Revision of the List of Recommended Methods of Analysis for Pesticide Residues
  • Revision of the Codex Classification of Foods and Animal Feeds
  • Consideration of Elaboration of MRLs for Spices
  • Revision of Codex Priority Lists of Pesticides for review by JMPR
  • Paper on the establishment of MRLs for processed commodities.
  • Paper on the elimination of environmental fate data review from the work of JMPR

*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.

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 following guidelines and proposed amendments to the procedural manual will be considered by the 26th Commission in July 2003. The relevant document is ALINORM 03/23.

To be considered at Step 5:

  • Proposed Draft General Guidelines on Sampling
  • Proposed Draft Guidelines on Measurement Uncertainly

For consideration by the Commission:

  • IUPAC Guidelines for Single-Laboratory Validation of Methods of Analysis (for adoption by reference)
  • Proposed amendments to the Procedural Manual:
  • Amendment to the General Criteria for the Selection of Methods of Analysis Using the Criteria Approach
  • New section on Working Instructions for the Implementation of the Criteria Approach in Codex New Work:
  • Review current Analytical Terminology for Codex

The Committee will continue work on:

  • Proposed Draft Guidelines for Evaluating Acceptable Methods of Analysis
  • Validation of methods
  • Single Laboratory Validation
  • Use of Proficiency Testing Schemes
  • Endorsement of Methods of Analysis and Sampling Provisions in Codex Standards
  • Proposed Draft Guidelines for Settling of Disputes on Analytical (test) Results
  • Criteria for Methods of Analysis for Foods derived from Biotechnology

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 facilitate trade. 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 implemented; 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 also are included in the Committee's terms of reference.

The following guidelines, found in ALINORM 03/30 and 03/30A, will be considered for adoption by the Codex Alimentarius Commission at its 26th Session in July 2003:

To be considered at Step 8:

  • Draft Guidelines for Food Import Control Systems
  • Draft Guidelines on the Judgement of Equivalence on Sanitary Measures Associated with Food Inspection and Certification Systems

The committee is continuing work on:

  • Proposed Revised Draft Guidelines for the Exchange of Information in Food Control Emergency Situations
  • Discussion paper on the Judgement of Equivalence of Technical Regulations Associated with Food Inspection and Certification Systems
  • Discussion paper on “traceability/product tracing” in the context of inspection and certification 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 relevant documents are ALINORM 03/33 and ALINORM 03/33A. The following items will be considered at the 26th Session of the Commission in July 2003:

To be considered at Step 8:

  • Draft Working Principles for Risk Analysis for Application within the Framework of Codex

The Committee continues to work on:

  • Proposed Draft Working Principles for Risk Analysis as Guidance to National Governments
  • Proposed Draft Revised Code of Ethics for International Trade in Foods Start Printed Page 33449
  • Guidelines for Cooperation with International Intergovernmental Organizations
  • Membership in the Codex Alimentarius Commission of Regional Economic Integration Organizations
  • Consideration of a Definition for “Traceability”/product tracing
  • The role of the Committee in implementation of recommendations from the Joint FAO/WHO Evaluation of Codex Alimentarius and Other FAO and WHO Work on Food Standards

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 documents are ALINORM 03/22 and ALINORM 03/22A. The Committee held its Thirty-First Session in Ottawa, Canada, on April 28-May 2, 2003. It considered the following items:

  • Draft Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods Proposed Revised Sections: Section 5—Criteria and Annex 2—Permitted Substances
  • 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) Section 4.2.2 (allergenicity) and Section 2. (Definitions)
  • Proposed Draft Amendment to the General Standard for the Labelling of Prepackaged Foods (Class Names) (Milk Protein/Milk Protein Products)
  • Proposed Draft Amendment to the Guidelines on Nutrition Labelling
  • Proposed Draft Recommendations for the Use of Health Claims: Proposed Draft Guidelines for the use of Nutrition and Health 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 paper on “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, the Committee 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. This often takes the form of developing general guidance documents such as the Principles and Guidelines for the Conduct of Microbiological Risk Assessment and the proposed draft Principles and Guidelines for the Conduct of Microbiological Risk Management, but can also take the form of developing microbiological risk management guidance documents for the control of specific microbial pathogens in food. Third, the Committee considers, amends if necessary, and endorses food hygiene provisions that are incorporated into specific Codex commodity standards by the Codex commodity committees. These provisions normally contain generic wording referencing the Recommended Code of Hygienic Practice: General Principles for Food Hygiene (ref: CAC/RCP 1-1969, Rev. 3-1997) and the Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1997), but may also include other provisions. Fourth, the Committee provides such other general guidance to the Commission on matters relating to food hygiene as is necessary. The following items will be considered by the Codex Alimentarius Commission at its 26th Session in July 2003. The relevant documents are ALINORM 03/13 and ALINORM 03/13A.

To be considered at Step 8:

  • Draft Code of Hygienic Practice for Fresh Fruits and Vegetables
  • Draft Revised Guidelines for the Application of HACCP System

To be considered at Step 5:

  • Proposed Draft Code of Hygienic Practice for Milk and Milk Products

The committee continues to work on:

  • Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management
  • Proposed Draft Guidelines on the Application of the General Principles of Food Hygiene to the [management] of Listeria monocytogenes in Foods
  • Proposed Draft Guidelines for Validation of Food Hygienic Control Measures
  • Proposed Draft Revision of the Code of Hygienic Practice for Egg Products
  • Discussion paper on Risk Management Strategies for Salmonella spp. in Poultry
  • Discussion paper on 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
  • Proposed Draft Process by Which the Committee on Food Hygiene Could Undertake its Work in Microbiological Risk Assessment/Risk Management
  • Discussion Paper on the Proposed Draft Revision of the Recommended International Code of Practice for Foods for Infants and Children
  • Discussion Paper on Development of Process, Procedures and Criteria to Establish Priorities for the Work of the Codex Committee on Food Hygiene
  • Discussion Paper on the Development of Options for a Cross-Committee Interaction Process

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 26th Session of the Commission in July 2003. The relevant document is ALINORM 03/35.

To be considered at Step 8:

  • Draft Standard for Sweet Cassava
  • Draft Standard for Pitahayas
  • Section 3—Provisions concerning sizing and Section 6.2.4—Commercial Identification in the grapefruit, lime and pummelo standards.

To be considered at Step 5:

  • Proposed Draft Standard for Table Grapes

The Committee continues work on:

  • Draft Standard for Oranges retained at Step 7
  • Proposed Draft Standard for Tomatoes
  • Proposed Draft Standard for Apples
  • Proposed Draft Guide for the Quality Control of Fresh Fruits and Vegetables

New work subject to approval by 26th CAC:

  • Proposed Draft Standard for Rambutan

Responsible Agency: USDA/AMS.

U.S. Participation: Yes. Start Printed Page 33450

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. A request for new work will be made to the 26th Session of the Commission in July 2003. The relevant documents are ALINORM 03/26 and ALINORM 03/26A.

The committee continues work on:

  • 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
  • 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

New Work:

  • Proposed Draft Recommendations on the Scientific Basis of Health Claims

When new scientific information becomes available, the committee plans to resume work on:

  • Guidelines for Use of Nutrition Claims—Draft Table of Conditions for Nutrient Contents Claims (Part B containing Provisions on Dietary Fibre)
  • Proposed Draft Revised Standards for Gluten-Free Foods
  • Discussion Paper 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 26th Session of the Commission when it meets in July 2003. The relevant document is ALINORM 03/18.

To be considered at Step 8:

  • Draft Standard for Dried Salted Anchovies
  • Draft Code of Practice for Fish and Fishery Products (specific sections 1, 2, 3, 4, 5, 8, and 16)

To be considered at Step 5/8:

  • Draft Code of Practice for Fish and Fishery Products (section 9, Surimi)

To be considered at Step 5:

  • Proposed Draft Model Certificate for Fish and Fishery Products (sanitary certificate)
  • Proposed Draft Amendment to the Standard for Quick Frozen Lobsters (inclusion of the species Pleurooncondes monodon and Cervimundia johni)

New Work:

  • Proposed Draft Standard for Sturgeon Caviar
  • Proposed Draft Amendment to the Standard for Salted Fish and Dried Salted Fish of the Gadidae family (Determination of water and salt by selecting certain sections of the fish)

The Committee continues work on the following:

  • Proposed Draft Standard for Salted Atlantic Herring and Salted Sprats at Step 6
  • Proposed Draft Code of Practice for Fish and Fishery Products (other sections 2, 6, 7, 10, 11, 12, 13, 14, 15, 17, and 18) at Step 3
  • Proposed Draft Standard for Live and Processed Bivalve Mollusks
  • Proposed Draft Standard for Smoked Fish
  • Proposed Draft Standard for Quick Frozen Scallop Adductor Muscle Meat
  • Fish Content Definition and its Method of Determination in Fish Sticks
  • Revision of the Procedure for the Inclusion of Species
  • Proposed Draft Model Certificate for Fish and Fishery Products (other than sanitary)

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 following will be considered by the 26th Session of the Commission when it meets in July 2003. The relevant document is ALINORM 03/11.

To be considered at Step 8:

  • Proposed Draft Revised Standard for Cream and Prepared Creams
  • Proposed Draft Revised Standard for Fermented Milk Products
  • Proposed Draft Revised Standard for Whey Powders

To be considered at Steps 5/8:

  • Proposed Draft Amendment to the Codex General Standard for Cheese (Appendix on cheese rind, surface, and coating)

The Committee continues work on:

  • 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 Amendment to Section 3.3 (Composition) of the Codex General Standard for Cheese
  • 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

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 relevant document is ALINORM 03/17. The following will be considered by the Commission at its 26th Session in July 2003.

To be considered at Step 8:

  • Draft Revised Standard for Olive Oils and Olive Pomace Oils
  • Draft Amendment to the Standard for Named Vegetable Oils
  • Palm superolein
  • Mid-oleic sunflower oil
  • Inclusion of new desmethysterol data and tocopherol and tocotrienol data for palm olien, palm stearin

New Work:

  • Amendment to the Standard for Named Vegetable Oils: Rice Bran Oil

The Committee continues work on:

  • Draft Standard for Fat Spreads and Blended Spreads
  • Proposed Draft Amendments to the List of Acceptable Previous Cargoes

Responsible Agency: HHS/FDA; USDA/ARS.

U.S. Participation: Yes.

Codex Committee on Cocoa Products and Chocolate

The Codex Committee on Cocoa Products and Chocolate is responsible for elaborating world-wide standards for cocoa products and chocolate. The following standard will be considered by the 26th Session of the Commission in July 2003. The relevant document is ALINORM 03/14.

To be considered at Step 8:

  • Draft Revised Standard for Chocolate and Chocolate Products Start Printed Page 33451

The Committee agreed to adjourn sine die as it had completed its program of work.

Responsible Agency: HHS/FDA.

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 following standards will be considered by the 26th Session of the Commission in July 2003. The relevant document is ALINORM 03/27.

To be considered at step 8:

  • Draft Standard for Bamboo Shoots
  • Draft Revised Standard for Canned Stone Fruits
  • Draft Codex Guidelines for Packing Media for Canned Fruit
  • Draft Codex Standard for Aqueous Coconut Products—Coconut Milk and Coconut Cream

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
  • Proposed Draft Code of Practice for the Processing and Handling of Quick Frozen Foods
  • Priority List for the Standardization of Processed Fruits and Vegetables

Responsible Agency: USDA/AMS; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Meat and Poultry Hygiene

The 24th Session of the Commission decided to reactivate the Codex Committee on Meat Hygiene and agreed to rename it the Codex Committee on Meat and Poultry Hygiene, with New Zealand as Host Government. The Terms of Reference were amended to reflect the inclusion of poultry in its mandate. The following, contained in ALINORM 03/16 and ALINORM 03/16A, will be considered by the Codex Alimentarius Commission at its 26th Session in July 2003.

To be considered at Step 8:

  • Draft General Principles of Meat Hygiene

Other:

  • Request to change the name back to the Codex Committee on Meat Hygiene

To be considered at Step 5:

  • Proposed Draft Code of Hygienic Practice for Meat
  • Requested the Commission to change the name back to the Codex Committee on Meat Hygiene

The Committee continues to work on:

  • Proposed Draft Annex on Risk-Based Post-Mortem Examination Procedures for Meat
  • Proposed Draft Annex on Microbiological Verification of Process Control of Meat Hygiene
  • Discussion paper on Hygiene Provisions for Processed Meat

Responsible Agency: USDA/FSIS.

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:

  • Cereals, Pulses and Legumes

Responsible Agency: HHS/FDA, USDA/GIPSA

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 Foods Derived from Biotechnology

The Commission established this task force to develop standards, guidelines, or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology, on the basis of scientific evidence, risk analysis and having regard, where appropriate, to other legitimate factors relevant to the health of consumers and the promotion of fair trade practices. The Task Force, established by the 23rd (1999) Session of the Codex Alimentarius Commission for a four year period of time, has completed its work. The following, contained in ALINORM 03/34 and ALINORM 03/34A, will be considered by the Codex Alimentarius Commission at its 26th Session in July 2003.

To be considered at Step 8:

  • Draft General Principles for the Risk Analysis of Foods Derived from Modern Biotechnology
  • Draft Guidelines for the Conduct of Safety Assessment of Foods Derived from Recombinant-DNA Plants
  • Draft Guidelines for the Conduct of Food Safety Assessment of Recombinant-DNA Microorganisms

Responsible Agency: HHS/FDA; USDA/APHIS.

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. An Interim Report of the work of the Task Force, as required under its Terms of Reference, was presented to the 24th Commission by Denmark, the host government. The Task Force held its 4th Session on March 25-28, 2003. The following will be considered by the Commission at its 26th Session in July 2003:

To be considered at Step 5/8:

  • Revised Draft Code of Practice for Good Animal Feeding

Responsible Agency: HHS/FDA/CVM; 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 held its third session in Brasilia, Brazil, on May 6-9, 2003. The reference documents are ALINORM 03/39 and 03/39A.

The committee is discussing:

  • Proposed Draft Codex General Standard for Fruit Juices and Nectars
  • Proposed Draft Revised Codex General Standard for Vegetable Juices
  • Methods of Analysis and Sampling for Fruit and Vegetable Juices and Nectars

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, Start Printed Page 33452as 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
  • Exercises a general coordinating role for the region and 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 Seventh Session of the Committee was hosted by Canada October 29-November 1, 2002. Items on the agenda included:

  • 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 the Draft Medium-Term Plan 2003-2007
  • Consideration of Traceability/Product Tracing
  • Strategic Plan for the Coordinating Committee for North America and the Southwest Pacific
  • Nomination of Samoa as the next Coordinator for the Region

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, Senior Advisor for Scientific Affairs, Office of the Administrator, U.S. Department of Agriculture, Food Safety and Inspection Service, 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) 827-8401, 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. Pamela L. Chamberlain, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place HFV-130, Rockville, MD 20855, Phone #: (301) 827-8566, FAX #: (301) 827-4299, E-mail: pchambe1@cvm.fda.gov

Alternate Delegate

Dr. Alice Thaler, Staff Director, Animal and Egg Production Food Safety Staff, Food Safety and Inspection Service, 1400 Independence Avenue, SW., Washington, DC 20250-3700, 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

Edward Zager, Associate Director, Health Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, Phone #: (703) 305-5035, Fax #: (703) 305-5147, E-mail: Zager.Ed@epamail.epa.gov

Alternate Delegate

Dr. Robert Epstein, Associate Deputy Administrator, Science and Technology, Agricultural Marketing Service, U.S. Department of Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 1400 Independence Avenue, 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 Start Printed Page 33453

Dr. Gregory Diachenko, Director, Division of Chemistry, 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) 436-2364, E-mail: Gregory.Diachenko@cfsan.fda.gov

Alternate Delegate

Dr. Thomas B. Whitaker, Senior Scientist, Agricultural Research Service, U.S. Department of Agriculture, 124 Weaver Laboratory, North Carolina State University, Raleigh, NC 27695-7625, Phone #: (919) 515-6731, Fax #: (919) 515-7760, E-mail: Thomas_whitaker@ncsu.edu

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, Chief, International Policy Staff, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 2137, South Building, 1400 Independence Avenue, 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)

U.S. Delegate

Dr. Christine Taylor, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Harvey E. Wiley Federal Building, 5100 Paint Branch Parkway (HFS-800), College Park, MD 20740-3835, Phone #: (301) 436-2373, Fax #: (301) 436-2636, E-mail: Christine.Taylor@cfsan.fda.gov

Alternate Delegate

Dr. Robert Post, Director, Labeling & Consumer Protection Staff, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street, SW., Room 602, Cotton Annex, Washington, DC 20250-3700, Phone #: (202) 205-0279, Fax #: (202) 205-3625, E-mail: Robert.Post@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, Food and Drug Administration (HFS-006), 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 Delegates

Mr. John Mowbray, Food Technologist, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, Room 1B064, College Park, MD 20740, Phone #: (301) 436-1490, Fax #: (301) 436-2632 E-mail: John.Mowbray@cfsan.fda.gov

Dr. Barbara Masters, Acting Associate Deputy Administrator, Field Operations, Food Safety and Inspection Service, 1400 Independence Avenue, SW., Washington, DC 20250-3700, Phone #: (202) 720-3697, Fax #: (202) 720-5439, E-mail: Barbara.Masters@fsis.usda.gov

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

U.S. Delegate

Dr. Elizabeth Yetley, FDA Lead Scientist for Nutrition, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-006), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone #: (301) 436-1671, Fax #: (301) 436-2641, E-mail: Elizabeth.Yetley@cfsan.fda.gov

Alternate Delegate

Dr. Christine Taylor, Director, Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway (HFS-800), College Park, MD 20740-3835, Phone #: (301) 436-2373, Fax #: (301) 436-2636, E-mail: Christine.Taylor@cfsan.fda.gov

Worldwide Commodity Codex Committees

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

U.S. Delegate

Mr. David Priester, International Standards Coordinator, Fruit & Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2069, South Building 1400 Independence Avenue, SW., Washington, DC 20250 Phone #: (202) 720-2184, Fax #: (202) 720-0016, E-mail: david.priester@usda.gov

Alternate Delegate

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

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

U.S. Delegate

Mr. Philip C. Spiller, Director, Office of Seafood, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-400), 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

Vacant

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

U.S. Delegate

Mr. Charles W. Cooper, Director, International Activities Staff, 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 Start Printed Page 33454Administrator, Federal Grain Inspection Division, Grain Inspection, Packers and Stockyards Administration, U.S. Department of Agriculture, Room 1661, South Building, 1400 Independence Avenue, 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, U.S. Department of Agriculture, Agricultural Marketing Service, Room 2750, South Building, 1400 Independence Avenue, SW., Washington, DC 20250, Phone #: (202) 720-9382, 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, Food and Drug Administration (HFS-306), 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 Activities Staff, 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, 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 Activities Staff, 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, USDA—FSIS, 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 Activities Staff, 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, 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 and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 300 12th Street, SW., Room 402, Cotton Annex, Washington, DC 20250-3700, Phone #: (202) 205-0699, Fax #: (202) 401-1760, E-mail: Perfecto.Santiago@fsis.usda.gov

Alternate Delegate

Dr. William James, Director, Food Animal Sciences Division, Office of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Agriculture, Mail Drop 343, 900 D Street, SW., Washington, DC 20024, Phone #: (202) 690-6572, Fax #: (202) 690-6565, 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 & 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, Division of Nutritional Products, Labeling, and Start Printed Page 33455Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-820), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone #: (301) 436-1491, Fax #: (301) 436-2637, 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, 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) 436-1642, Fax #: (301) 436-2651, E-mail: Martin.Stutsman@cfsan.fda.gov

Alternate Delegate

Mr. David Priester, International Standards Coordinator, Fruit & Vegetable Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2069, South Building, 1400 Independence Avenue, SW., Washington, DC 20250, Phone: (202) 720-2184, Fax: (202) 720-0016, E-mail: david.priester@usda.gov

Ad Hoc Intergovernmental Task Force on Foods Derived From Biotechnology (Host government—Japan)

U.S. Delegate

L. Robert Lake, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-004), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone #: (301) 436-2379, Fax #: (301) 436-2668, E-mail: RLake@cfsan.fda.gov

Alternate Delegate

Dr. Sally L. McCammon, Science Advisor to the Administrator, Animal Plant Health Inspection Service, U.S. Department of Agriculture, 4700 River Road (Unit 98), Riverdale, MD 20737, Phone #: (301) 734-5761, Fax #: (301) 734-5992, E-mail: Sally.L.Mccammon@usda.gov

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 America and the South-West Pacific

Contact

Dr. F. Edward Scarbrough, Manager, U.S. Codex Office, Food Safety and Inspection Service, Room 4861, South Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700, Phone #: (202) 205-7760, Fax #: (202) 720-3157, E-mail: ed.scarbrough@fsis.usda.gov

Attachment 3.—Timetable of Codex Sessions

[June 2002 through June 2004]

2002:
CX 702-50Executive Committee of the Codex Alimentarius Commission (50th Session)26-28 JuneRome.
CX 706-23FAO/WHO (Codex) Regional Coordinating Committee for Europe (23th Session)10-13 SeptemberBratislava.
CX 727-13FAO/WHO (Codex) Regional Coordinating Committee for Asia (13th Session)17-20 SeptemberKuala Lumpur.
CX 713-21Codex Committee on Processed Fruits and Vegetables (21st Session)23-27 SeptemberSan Antonio, TX.
CX 732-7FAO/WHO (Codex) Regional Coordinating Committee for North America and the South-West Pacific (7th Session)29 October-1 NovemberVancouver, BC.
CX 720-24Codex Committee on Nutrition and Foods for Special Dietary Uses (24th Session)4-8 NovemberBerlin.
CX 715-24Codex Committee on Methods of Analysis and Sampling (24th Session)18-22 NovemberBudapest.
CX-707-15FAO/WHO (Codex) Regional Coordinating Committee for Africa (15th Session)25-29 NovemberKampala.
CX 725-13FAO/WHO (Codex) Regional Committee for Latin America and the Caribbean (13th Session)3-6 DecemberSanto Domingo.
2003:
CX-734-2FAO/WHO (Codex) Regional Coordinating Committee for the Near East (2nd Session)20-23 JanuaryCairo.
CX 712-35Codex Committee on Food Hygiene (35th Session)27 January-1 FebruaryOrlando, FL.
CX 709-18Codex Committee on Fats and Oils (18th Session)3-7 FebruaryLondon.
CX-702-51Executive Committee of the Codex Alimentarius Commission (51st [Extraordinary] Session)10-11 FebruaryGeneva.
CX-701-25Codex Alimentarius Commission (25th [Extraordinary] Session)12-15 FebruaryGeneva.
CX 723-9Codex Committee on Meat Hygiene (9th Session)17-21 FebruaryWellington.
CX 730-14Codex Committee on Residues of Veterinary Drugs in Foods (14th Session)4-7 MarchArlington, VA.
Start Printed Page 33456
CX 802-4Ad hoc Intergovernmental Task Force on Biotechnology (4th Session)10-14 MarchYokohama.
CX 711-35Codex Committee on Food Additives and Contaminants (35th Session)17-21 MarchArusha.
CX 803-4Ad hoc Intergovernmental Task Force on Animal Feeding (4th Session)24-26 MarchCopenhagen.
CX 718-35Codex Committee on Pesticide Residues (35th Session)31 March-4 AprilRotterdam.
CX 716-18Codex Committee on General Principles (18th Session)7-11 AprilParis.
CX 714-31Codex Committee on Food Labelling (31st Session)28 April-2 MayOttawa.
CX 801-3Ad hoc Intergovernmental Task Force on Fruit and Vegetable Juices (3rd Session)6-9 MayBrasilia.
CX 702-52Executive Committee of the Codex Alimentarius Commission (52st Session)26-27 JuneRome.
CX 701-26Codex Alimentarius Commission (26th Session)30 June-5 JulyRome.
CX 731-11Codex Committee on Fresh Fruits and Vegetables8-12 SeptemberMexico City.
CX 722-26Codex Committee on Fish and Fishery products13-17 OctoberAalesund, Norway.
CX-720-25Codex Committee on Nutrition and Foods for Special Dietary Uses3-7 NovemberBerlin.
CX-733-123Codex Committee on Food Import and Export Inspection and Certification1-5 DecemberTBA.
2004:
CX 702-53Executive Committee of the Codex Alimentarius Commission (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)7-14 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 MayOttawa.
CX-702-54Executive Committee (54th Session)24-26 JuneGeneva.
CX-701-27Codex Alimentarius Commission (27th Session)28 June-2 JulyGeneva.

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 deterioration 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 Start Printed Page 33457highest 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 effects 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.

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.

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 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 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 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 explanation of risk assessment findings and the basis of risk management decisions.

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 Start Printed Page 33458subsidiary 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 elaboration 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.Start Printed Page 33459

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.

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.”Start Printed Page 33460

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

Footnotes

1.  Adjourned sine die. The main tasks of these Committees are completed. However, the committees may be called to meet again if required.

Back to Citation

[FR Doc. 03-13771 Filed 6-3-03; 8:45 am]

BILLING CODE 3410-DM-P