01-12938. International Standard-Setting Activities

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice.

SUMMARY:

This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act, Public Law 103-465, 108 Stat. 4809. It 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, 2000, to May 31, 2001, and June 1, 2001, to May 31, 2002, seeks comments on standards currently under consideration and recommendations for new standards.

ADDRESSES:

Submit any written comments to: FSIS Docket Clerk, 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 Docket Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

F. Edward Scarbrough, Ph.D., United States Manager for Codex, U.S. Department of Agriculture, Office of the Undersecretary for Food Safety, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700; [phone]. 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 website at http://www.fsis.usda.gov/​OA/​Codex/​index.htm.

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, 2000 to May 31, 2001, and June 1, 2001 to May 31, 2002. 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 2000 through June 2002)

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 fax to over 300 organizations and individuals. 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 fax list 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 these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, fax your request to the Congressional and Public Affairs Office, at [phone].

Done at Washington, DC on: May 14, 2001.

F. Edward Scarbrough,

United States Manager for Codex.

Attachment 1: Sanitary and Phytosanitary Activities of Codex

Codex Alimentarius Commission and Executive Committee

The Codex Alimentarius Commission will hold its Twenty-fourth Session July 2-July 7, 2001, in Geneva, Switzerland. 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, and member delegations.

Prior to the Commission meeting, the Executive Committee will meet June 28-29, 2001. 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.

The Executive Committee at its June 2000 Session considered 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.

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 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 μg/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 01/31, will be considered by the Codex Alimentarius Commission at its 24th Session.

To be considered at Step 8:

Danofloxacin

Gentamicin

Imodocarb

Sarofloxacin

To be considered at Step 5/8:

Dihydrosteptomycin/Streptomycin

Doramectin

To be considered at Step 5:

Neomycin

Phoxim

Porcine Somatotropin

Thiamphenicol

Priority List of Veterinary Drugs Requiring Evaluation or Reevaluation—Substances for which a firm commitment of data has been provided:

Cefuroxime sodium

Pirlimycin hydrochloride

The Committee is continuing work on:

• Discussion paper on antimicrobial resistance.
• Draft maximum residue limits for veterinary drugs.
• Risk Analysis in the CCRVDF.
• Proposed Draft Guidelines on Residues at Injection Sites.
• Guidelines on Control of Veterinary Drug Residues in Milk and Milk Products.
• Criteria for Methods of Analysis and Sampling Issues.
• Harmonization of MRLs with CCPR, JECFA and JMPR.

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 24th Session in July 2001. The relevant documents are ALINORMS 01/12 and 01/12A.

Risk Analysis. The Discussion Paper entitled “Application of Risk Analysis Principles to the Work of the Codex Committee on Food Additives and Contaminants (CCFAC) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA)” will be revised for circulation and consideration at the next session of the committee.

Food Additives. To be considered at Step 8 by the 24th Session of the Codex Commission (July 2001):

• Guidelines for the Estimation of Appropriate Levels of Use of Food Additives to the Preamble of the General Standard for Food Additives (GSFA)(Annex A).
• Codex General Standard for Food Additives: Draft Food Additive Provisions in Table 1.
• Codex Advisory Specifications for the Identity and Purity of Food Additives.

To be considered at Step 5/8 of the Accelerated Procedure by the 24th Session of the Codex Commission (July 2001):

• Draft Amendments to Table 3 and its Annex of the Codex General Standard for Food Additives.
• Draft Revisions to the Codex International Numbering System for Food Additives.

To be considered at Step 5 by the 24th Session of the Codex Commission (July 2001):

• Proposed Draft Revision to the Codex Standard for Irradiated Foods.
• Proposed Draft Revisions to the Codex General Standard for Food Additives (GSFA).

The Committee is continuing work on:

• General Standard for Food Additives: Food Category System.
• General Standard for Food Additives: Draft Food Additive Provisions (in Table 1).
• Informal Quality Control Work Group—The Committee agreed to reinstate its small informal work group to perform a quality control check on the data submitted to support the food additive provisions in the Draft GSFA for the use of benzoyl peroxide, stearyl tartrate, nitrous oxide, and mineral oil.
• Proposed Draft Revised Codex Recommended International Code of Practice for the Operation of Irradiation Facilities Used for the Treatment of Food.
• International Numbering System.
• Specifications for the Identity and Purity of Food Additives.
• Discussion paper on the relationship between Codex commodity standards and the GSFA's food category system.
• Discussion paper on processing aids and additives used as carriers for other additives.

Contaminants. To be considered at Step 8 by the 24th Session of the Codex Commission (July 2001):

• Maximum Level for Patulin in Apple Juice and Apple Juice Ingredients in Other Beverages.
• Maximum Levels for Lead in fruit; small fruit, berries, grapes, vegetables (except mushrooms, hops and herbs), brassicas, leafy vegetables (except spinach), cereal grains, pulses, legumes; fruit juices, meat (cattle, sheep, pig and poultry), fat (meat and poultry), vegetable oils, edible offal of cattle, pig and poultry, milk, milk fat, wine, and infant formulae.
• Maximum Level for Aflatoxin M₁ in Milk.
• Code of Practice for Source Directed Measures to Reduce Contamination of Food with Chemicals.
• Guideline Level for Cadmium in cereals, pulses and legumes (excluding bran and germ and wheat grain, rice, soybean, and peanuts).
• Revision of the Codex Standard for Food Grade Salt: Packaging, Transportation and Storage.

To be considered at Step 5/8 by the 24th Session of the Codex Commission (July 2001):

• Proposed Draft Revised Sampling Plan for Total Aflatoxins in Peanuts Intended for Further Processing.

To be considered at Step 5 by the 24th Session of the Codex Commission (July 2001):

• Draft Maximum Level for Ochratoxin A in Wheat, Barley, Rye and derived products.
• Proposed Draft Maximum Levels for Cadmium in fruit, wheat grain and rice (including bran and germ), soybeans and peanuts, meat of cattle, poultry, pig and sheep, horse meat, and crustaceans (excluding lobster and brown meat of crab), vegetables (excluding leafy vegetables, fresh herbs, stem and root vegetables, fungi, tomatoes, and peeled potatoes), peeled potatoes, stem and root vegetables (excluding celeriac), and leafy vegetables, fresh herbs, fungi, celeriac.

The Committee is continuing work on:

• Proposed Draft Code of Practice for the Prevention of Mycotoxin Contamination in Cereals, including Annexes on Ochratoxin A, Zearalenone, Fumonisins, and Tricothecenes.
• Proposed Draft Code of Practice for the Prevention of Patulin Contamination in Apple Juice and Apple Juice Ingredients in other Beverages.
• Draft maximum levels for lead in fish, crustaceans, and bivalve mollusks.
• Draft maximum levels for cadmium in liver of cattle, poultry, pig, and sheep, kidney of cattle, poultry, pig, and sheep, and mollusks.
• Discussion paper on dioxins and dioxin like PCBs.
• Proposed Draft Code of Practice for Source Directed Measures to Reduce Dioxin Contamination of Foods.
• Position Paper on Chloropropanols.
• Discussion paper on deoxynivalenol.
• Discussion paper on aflatoxin B₁ in pistachios.
• Discussion paper on use of active chlorine.

New work:

• Elaboration of Principles for the Exposure Assessment of Contaminants and Toxins in Foods (GSCTF).

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.

* 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.

The following items will be considered by the Commission at its 24th Session in July 2001. The relevant documents are ALINORM 01/24 and 01/24A.

To be considered at Steps 5/8 and 8:

• Draft and Draft Revised Maximum Residue Limits.
• Proposed Draft and Proposed Draft Revised Maximum Residue Limits.

To be considered at Step 5:

• Proposed Draft and Proposed Draft Revised Maximum Residue Limits.

The committee is continuing work on:

• Consideration of Draft and Proposed Draft Residue Limits in Foods and Feeds.
• Paper on Trade Vulnerabilities Resulting from the Lengthy Codex MRL Process.
• Paper on Cumulative Risk Assessment Methodology.
• Paper on Acute Dietary Risk Assessment.
• Revision of Regional Diets and Information on Processing.
• Harmonization of MRL Setting for Compounds Used both as Pesticides and as Veterinary Drugs.
• Proposed Draft Amendments to the Guidelines on the Good Laboratory Practice in Pesticide Residue Analysis and the Introduction Section of the Recommended Methods of Analysis for Pesticide Residues.
• Revision of the List of Recommended Methods on Analysis for Pesticide Residues.
• Consideration of Elaboration of MRLs for Spices.
• Discussion paper on the Need for the Revision of the Codex Classification of Foods and Animal Feeds.
• Revision of Codex Priority Lists of Pesticides for review by JMPR.

Responsible Agency: EPA, USDA/AMS

U.S. Participation: Yes

Codex Committee on Methods of Analysis and Sampling

The Codex Committee on Methods of Analysis and Sampling:

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

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

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

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

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

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

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

The relevant document is ALINORM 01/23. The following matters will be considered for adoption by the Commission at its 24th Session in July 2001.

Proposed Amendments to the Procedural Manual:

• General Criteria for the Selection of Methods of Analysis Using the Criteria Approach.
• Relations between Commodity Committees and General Committees—Methods of Analysis and Sampling.
• Guidelines and Working Instructions to Aid the Implementation of the Criteria Approach to the Selection of Methods of Analysis for Codex Purposes.

Guidelines for Adoption by Reference for Codex Purposes:

• Harmonized IUPAC Guidelines for the Use of Recovery Information on Analytical Measurement.

New Work:

• Proposed Draft Guidelines on Measurement Uncertainty.
• Proposed Draft Guidelines for Selection Methods of Analysis directed to governments.

The committee will continue work on:

• Proposed Draft Guidelines on Sampling
• Validation of Methods: Single Laboratory Validation and Use of Proficiency Schemes.
• Endorsement of Methods of Analysis and Sampling Provisions in Codex Standards.

Responsible Agency: HHS/FDA, USDA/ARS

U.S. Participation: Yes

Codex Committee on Food Import and Export Inspection and Certification 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, and the determination of the judgement of equivalence; 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 matters will be considered by the Codex Alimentarius Commission at its 24th Session. The relevant documents are ALINORM 01/30 and 01/30A.

To be considered at Step 8:

• Draft Guidelines for Generic Official Certificate Formats and the Production and Issuance of Certificates.

To be considered at Step 5/8:

• Proposed Draft Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems.

To be considered at Step 5:

• Proposed Draft Guidelines for Food Import Control Systems.

New work:

• Consideration of the concept of “Traceability” in relation to food import and export inspection and certification systems.
• Revised Codex Guidelines for the Exchange of Information in Food Control Emergency Systems.

The Committee is continuing work on:

• Proposed Draft Guidelines for the Utilization and Promotion of Quality Assurance Systems; and
• Proposed Draft Guidelines on the Judgement of Equivalence of Technical Regulations Associated with Food 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 following will be considered by the 24th Session of the Commission when it meets in July 2001. The relevant documents are ALINORMS 01/33 and 01/33A.

To be considered by the Commission:

• Adoption of an amendment to Rule VI.2 to the Rules of Procedure to clarify members' rights with respect to voting.
• Practical measures intended to facilitate consensus.
• Review of the Statement of Principles on the Role of Science and the Extent to which Other Factors are taken into account: Role of science and other factors in relation to risk analysis.
• Membership in the Codex Alimentarius Commission of Regional Economic Integration Organizations.

The Committee continues to work on:

• Proposed Draft Working Principles for Risk Analysis.
• Composition of the Executive Committee and related matters.
• Proposed Draft Revised Code of Ethics for International Trade in Foods.

Responsible Agency: USDA/FSIS, FDA/OC

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 following items will be considered by the Commission at its 24th Session in July 2001. The relevant documents are ALINORM 01/22 and 01/22A.

To be considered at Step 8:

• Draft Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (Animal Production including bees and substances for use in soil and fertilizing and conditioning).
• 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).

The Committee is continuing work on:

• Proposed Draft Amendment to the General Standard for the Labelling of Prepackaged Foods (Class Names)(milk protein/milk protein products).
• Proposed Draft Guidelines for the Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering.
• 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.

Proposed new work:

• Proposed Draft Amendment to the General Standard for the Labelling of Prepackaged Foods: Country of Origin Labelling.
• Review of the Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (Section 5 and Annex 2).

Responsible Agency: HHS/FDA, USDA/FSIS

U.S. Participation: Yes

Codex Committee on Food Hygiene

The Codex Committee on Food Hygiene has three primary responsibilities. First, to draft 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, to consider, amend if necessary, and endorse 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. Third, to provide general guidance to the Commission on matters relating to food hygiene. This often takes the form of providing general guidance documents such as the Draft Principles and Guidelines for the Conduct of Microbiological Risk Assessment and Draft Proposed Principles and Guidelines for the Conduct of Microbiological Risk Management. The following items will be considered by the Codex Alimentarius Commission at its 24th Session in July 2001. The relevant documents are ALINORM 01/13 and 01/13A:

To be considered at Step 8:

• Draft Code of Hygienic Practice for Bottled/Packaged Drinking Waters (other than Natural Mineral Water).
• Draft Code of Hygienic Practice for the Transport of Food in Bulk and Semi-Packed Food.

To be considered at Step 5:

• Code of Hygienic Practice for the Primary Production, Harvesting and Packing of Fresh Fruits and Vegetables (including the sprout annex).
• Code of Hygienic Practice for Ready-to-Eat Fresh Pre-Cut Fruits and Vegetables as an Annex to the Code of Hygienic Practice for the Primary Production, Harvesting and Packing of Fresh Fruits and Vegetables.

New work:

• Revision of the Code of Hygienic Practice for Eggs and Egg Products.

The committee continues to work on:

• Proposed Draft Code of Hygienic Practice for Milk and Milk Products.
• Proposed Draft Principles and Guidelines for the Conduct of Microbiological Risk Management.
• Proposed Draft Guidelines for the Control of Listeria monocytogenes in Foods.
• Proposed Draft Guidelines for the Hygienic Reuse of Processing Water in Food Plants.
• Proposed Draft Application of HACCP in Small and/or Less Developed Businesses.
• Discussion paper on Risk Profile of Antibiotic Resistance in Bacteria in Food.
• Discussion paper on Guidelines for Validation of Food Hygienic Control Measures.
• Discussion paper on Proposed Guidelines for Evaluating the Presence of Objectionable Matter in Food.

Responsible Agency: HHS/FDA

U.S. Participation: Yes

Codex Committee on Fresh Fruits and Vegetables

The Codex Committee on Fresh Fruits and Vegetables is responsible for elaborating worldwide standards and codes of practice for fresh fruits and vegetables. The following will be considered by the Commission at its 24th Session in July 2001. The relevant document is ALINORM 01/35.

To be considered at Step 8:

• Draft Standard for Tannia.
• Draft Standard for Papaya.
• Draft Standard for Asparagus.
• Draft Standard for Cape Gooseberry.
• Draft Minimum Juice Content Provision in the Codex Standard for Limes.

To be considered at Step 5:

• Proposed Draft Standard for Cassava.

The committee is continuing work on:

• Draft Standard for Yellow Pitahaya.
• Draft Standard for Oranges, including Guide for Use in Scoring Freezing Injury.
• Sizing sections of the Grapefruit, Lime, and Pummelo standards.
• Proposed Draft Standard for Apples.
• Proposed Draft Standard for Tomatoes.
• Proposed Draft Standard for Table Grapes.
• Proposed Draft Guide for the Quality Control of Fresh Fruits and Vegetables.
• Discussion paper on definitions of terms.

Responsible Agency: USDA/AMS

U.S. Participation: Yes

Codex Committee on Nutrition and Foods for Special Dietary Uses

The Codex Committee on Nutrition and Foods for Special Dietary Uses is responsible for studying nutritional problems referred by the Codex Alimentarius Commission. The Committee also drafts provisions on nutritional aspects for all foods and develops guidelines, general principles, and standards for foods for special dietary uses. The following will be considered by the Commission at its 24th Session in July 2001. The relevant document is ALINORM 01/26.

To be considered at Step 8:

• Guidelines for Use of Nutrition Claims—Draft Table of Conditions for Nutrient Contents (Part B containing provisions on Protein and Vitamin and Minerals).

Discontinuation of work:

• Discussion paper on Provisions of Fortification on Iodine, Iron and Vitamin A in the Guidelines of Nutrition Claims.

The committee continues work on:

• Guidelines for Use of Nutrition Claims—Draft Table of Dietary Conditions for Nutrient Claims (Part B containing Provisions on Dietary Fibre).
• Proposed Draft Revised Standards for Gluten-Free Foods.
• 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 List(s) of Mineral Salts and Vitamin Compounds for the Use in Foods for Infants and Children.
• Discussion Paper on Review of Provisions for Vitamins and Minerals in Codex Standards: Vitamins and Minerals in Foods for Special Medical Purposes.
• Discussion Paper on Energy Conversion Factors.
• Discussion Paper on the Consideration of the Use of the Recommendations of the FAO/WHO Expert Consultation on Food Consumption and Exposure Assessment of Chemicals.
• Sports and Energy Drinks.

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 and frozen fish, crustaceans and mollusks. The following will be considered by the 24th Session of the Commission in July 2001. The relevant document is ALINORM 01/18.

To be considered at Step 8:

• Draft Standard for Crackers from Marine and Freshwater Fish, Crustacean and Molluscan Shellfish.

To be considered at Step 5 of the Accelerated Procedure:

• Inclusion of additional species (Proposed Draft Amendment to the Canned Sardines Standard).

To be considered at Step 5:

• Proposed Draft Standard for Salted Atlantic Herring and Salted Sprats.
• Proposed Draft Code of Practice for Fish and Fishery Products (sections 1, 2.1, 2.2, 2.9, 3 to 6 and 9).

The committee continues or begins work on:

• Draft Standard for Dried Salted Anchovies.
• Proposed Draft Amendment to the Standard for Canned Sardines and Sardine-Type Products (Inclusion of an additional species).
• Proposed Draft Code of Practice for Fish and Fishery Products (other sections).
• Proposed Draft Standard for Smoked Fish.
• Proposed Draft Standard for Molluscan Shellfish.
• Proposed Draft Model Certificate for Fish and Fishery Products.
• Proposed Draft Standard for Live, Quick Frozen and Canned Bivalve Molluscs.
• Proposed Draft Amendment to the Standard for Quick Frozen Lobsters.
• Fish Content Definition and its Method of Determination.
• Proposed Draft Standard for Scallops.

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 at the 24th Session of the Codex Alimentarius Commission in July 2001. The reference document is ALINORM 01/11.

To be considered at Step 8:

• Draft Group Standard for Unripened Cheese Including Fresh Cheese.
• Proposed Draft Revised Standard for Edible Casein Products at Step 5/8.
• Proposed Draft Amendment to the Codex General Standard for Cheese (Description) at Step 5/8.
• Proposed Draft Amendment to the Codex Group Standard for Cheeses in Brine (Sampling) at Step 5/8.

The committee is continuing work on:

• Proposed Draft Revised Standard for Creams, Whipped Creams, and Fermented Creams.
• Proposed Draft Revised Standard for Fermented Milks.
• Proposed Draft Revised Standard for Whey Powders.
• Proposed Draft Amendment to the Codex General Standard for Cheese (Composition).
• Proposed Draft Amendment to the Codex General Standard for Cheese (Composition).
• Proposed Draft Amendment to the Codex General Standard for Cheese (Appendix on cheese rind, surface, and coating).
• Proposed Draft Revised Standard for Processed Cheese (minimum cheese content).
• Proposed Draft Revised Individual Standards for Cheese (including a new Standard for Mozzarella).
• Proposed Draft Standard for Dairy Spreads.
• Model Export Certificates for Milk Products.

New work:

• 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.

Responsible Agency: USDA/AMS, HHS/FDA

U.S. Participation: Yes

Codex Committee on Fats and Oils

The Codex Committee on Fats and Oils is responsible for elaborating standards for fats and oils of animal, vegetable, and marine origin. The Committee held its 17th Session in London in February 2001. The relevant document is ALINORM 01/17. The following matters will be considered by the Codex Alimentarius Commission at its 24th Session in July 2001:

To be considered at Steps 5/8:

• Amendments to the Draft Standard for Named Vegetable Oils:
• High Oleic Acid Sunflower Oil.
• High Oleic Acid Safflower Oil.
• Code of Practice for Storage and Transport of Fats & Oils in Bulk: List of Acceptable Previous Cargoes and of Banned Immediate Previous Cargoes.

To be considered at Step 5:

• Proposed Draft Standard for Fat Spreads and Blended Spreads.

To be considered by the Committee at its next session:

• Draft Standard for Olive Oils and Olive-Pomace Oils.
• Proposed Draft Amendments to the Standard for Named Vegetable Oils:
• Super Palm Olein.
• Mid-oleic Sunflower Oil.
• Inclusion of New Desmethysterol Data and Tocopherol and Tocotrienol Data for Palm Olein, Palm Stearin, Rapeseed Oil (High Erucic Acid) and Mustard Oil.
• Draft Standard for Fat Spreads.
• Proposed Draft Amendments to the List of Acceptable Previous Cargoes and of Banned Immediate 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 worldwide standards for cocoa products and chocolate. The 21st Session of the Commission endorsed the recommendation of the forty-second session of the Executive Committee to initiate the revision of the Cocoa Products and Chocolate Standards. The following standards will be considered by the 24th Session of the Commission in July 2001. The relevant document is ALINORM 01/14.

To be considered at Step 8:

• Draft Revised Standard for Cocoa Butters.
• Draft Revised Standard for Cocoa (Cacao) Mass (Cocoa/Chocolate Liquor) and Cocoa Cake, for Use in the Manufacture of Cocoa and Chocolate Products.
• Draft Revised Standard for Cocoa Powders (Cocoas) and Dry Cocoa-Sugar Mixture.

To be considered at Step 5:

• Proposed Draft Standard for Chocolate and Chocolate Products.

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 24th Session of the Commission in July 2001. The relevant document is ALINORM 01/27.

To be considered at step 8:

• Draft Standard for Kimchi.
• Draft Revised Standard for Canned Applesauce.
• Draft Revised Standard for Canned Pears.

To be considered at step 5:

• Proposed Draft Standard for Canned Stone Fruits.
• Proposed Draft Guidelines for Packing Media in Canned Fruits.

The Committee is continuing work on:

• Draft Codex Standard for Pickled Products.
• Draft Codex Standard for Canned Bamboo Shoots.
• Draft Codex Standard for Aqueous Coconut Products.
• Proposed Draft Revised Standards.
• Canned Tomatoes.
• Processed Tomato Concentrates.
• Soy Sauce.
• Canned Vegetables.
• Citrus Fruits.
• Insam (Ginseng).
• Guidelines for Packing Media for Canned Fruits.

Other work:

• Methods of Analysis for Processed Fruits and Vegetables.

Responsible Agency: USDA/AMS, HHS/FDA

U.S. Participation: Yes

Codex Committee for Natural Mineral Waters

The Codex Committee for Natural Mineral Waters (CCNMW) is responsible for elaborating standards for natural mineral waters. The Codex Alimentarius Commission at its 22nd meeting approved the development of a standard for bottled/packaged water other than natural mineral waters. The following standards will be considered by the 24th Session of the Commission in July 2001. The relevant document is ALINORM 01/20.

To be considered at Step 5/8:

• Proposed Draft Standard for Bottled/Packaged Drinking Waters (Other Than Natural Mineral Waters).
• An amendment to the levels of Health Related Limits for Certain Substances in the Revised Codex Standard for Natural Mineral Waters (Codex STAN 108-1981:Rev. 1-1977) so that they would be consistent with the WHO Guidelines on Drinking Water.

Other matters for the Commission:

• Committee adjourned sine die.

Responsible Agency: HHS/FDA

U.S. Participation: Yes

Codex Committee on Sugars

The Codex Committee on Sugars elaborated standards for all types of sugars and sugar products. The Committee was adjourned sine die, but was asked to revise the standards for sugar and honey. The Committee prepared the revised standard for sugar by correspondence. At its 23rd Session, the Codex Alimentarius Commission adopted the Draft Revised Standard for Sugar with the exception of the levels of arsenic and lead that will be reviewed by CCFAC. However, the Committee decided that it could not prepare a Draft Revised Standard for Honey by correspondence. The United Kingdom convened a Session of the Committee in London, England, on February 9-11, 2000 to discuss the Draft Revised Standard for Honey. The following standard will be considered by the 24th Session of the Commission in July 2001. The relevant document is ALINORM 01/25.

To be considered at Step 8:

• Draft Revised Standard for Honey.
• Proposed Amendments to the Revised Codex Standard for Sugars:

(1) Definition of Raw Cane Sugar and Soft Sugars.

(2) Food Additives and Contaminants.

(3) Methods of Analysis for inclusion in the Standard.

New work:

• Amendment to the Codex Standard for Sugar.
• Development of a Standard for Unifloral Honey.
• Completion of an addendum to the Standard for Honey covering industrial uses.

Responsible Agency: USDA/ARS, HHS/FDA

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

Meat Hygiene

Responsible Agency: USDA/FSIS

U.S. Participation: Yes

• Soups and Broths

Responsible Agency: USDA/FSIS

U.S. Participation: Yes

• Vegetable Proteins

Responsible Agency: USDA/ARS, HHS/FDA

U.S. Participation: Yes

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

* There is no planned activity for this Committee in the next year.

Brief reports on activities of the Codex Committees on Meat Hygiene, Soups and Broths, and Vegetable Proteins follows:

Codex Committee on Meat Hygiene

As a result of several years of work, the Codex Committee on Meat Hygiene elaborated worldwide standards and/or codes of practice as were appropriate for meat hygiene. The Committee adjourned sine die in 1993. The 47th Session of the Executive Committee welcomed a proposal from New Zealand that the Committee be reactivated and recommended that the work and terms of reference of the Committee be expanded to include reference to poultry, as a Codex committee had never addressed poultry hygiene. It was proposed that the next session be held in late 2001 or early 2002. The Commission will consider this recommendation when it meets in July 2001.

Responsible Agency: USDA/FSIS

U.S. Participation: Yes

Codex Committee on Soups and Broths

The Codex Committee on Soups and Broths elaborated worldwide standards for soups, broths, bouillons and consommes. The Committee adjourned sine die. The main tasks of the Committee were completed. However, at its June 1997 meeting, the Codex Alimentarius Commission requested that the Committee commence work revising the Standard for Bouillons and Consommes. A Draft Revised Standard for Bouillons and Consommes was approved at Step 5 by the Executive Committee at its 47th Session and was circulated at Step 6 for consideration in advance of the next Commission session. The relevant document is ALINORM 01/29.

Responsible Agency: USDA/FSIS

U.S. Participation: Yes

Codex Committee on Vegetable Proteins

The Codex Committee on Vegetable Proteins elaborated worldwide standards for vegetable protein products deriving from any member of the plant kingdom. The Committee was adjourned sine die in 1989. The Codex Alimentarius Commission at its 23rd Session requested that the Committee undertake a revision of the Codex Standard for Wheat Gluten. A Proposed Draft Standard for Wheat Protein Products was circulated to member countries and other interested parties for comment at Step 3. It was adopted by the 47th Session of the Executive Committee at Step 5 and was circulated at Step 6 for consideration in advance of the next Commission session.

Responsible Agency: USDA/ARS, HHS/FDA

U.S.Participation: Yes

Ad Hoc Intergovernmental Task Force on Foods Derived From Biotechnology

The Commission, at its 23rd Session, 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 protection of consumers and the promotion of fair trade practices. The relevant documents are ALINORMS 01/34 and 01/34A. The following items have been forwarded to the Commission for its consideration at its 24th Session in July 2001.

To be considered at Step 5:

• Proposed Draft General Principles for the Risk Analysis of Foods Derived from Modern Biotechnology.
• Proposed Draft Guideline for the Conduct of Safety Assessment of Foods Derived from Recombinant DNA Plants.

New work:

• Proposed Draft Guidelines for the Conduct of Food Safety Assessment of Recombinant DNA Microorganisms.

The Task Force will continue work on:

• Discussion Paper on Traceability.
• Consideration of Analytical Methods.

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 Task Force to develop guidelines or standards as appropriate on Good Animal Feeding practices. The relevant documents are ALINORMS 01/38 and 01/38A. The task force discussed the following items:

• Revised Draft Code of Practice for Good Animal Feeding.
• Information paper compiling a list of internationally available standards and validated methods for the examination of feeding stuffs.
• Information paper on lists established by different governments to control the use of prohibited and undesirable substances in animal feeding stuffs or other approaches.

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 first session in Brasilia, Brazil, September 18-22, 2000. It will hold a second session in Rio de Janeiro, date to be announced. The reference document is ALINORM 01/39.

The committee will be working on:

• 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, as well as approximately 30 subsidiary bodies. Included in these subsidiary bodies are coordinating committees for groups of countries located in proximity to each other who share common concerns. There are currently six Regional Coordinating Committees:

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

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

• Defines the problems and needs of the region concerning food standards and food control;
• Promotes within the committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulates the strengthening of food control infrastructures;
• Recommends to the Commission the development of world-wide standards for products of interest to the region, including products considered by the committee to have an international market potential in the future; and
• 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 Sixth Session of the Committee was held in December 2000, in Perth, Australia. The relevant document is ALINORM 01/32. Agenda topics included the following:

• Review of acceptance and promotion of Codex standards by countries in the region;
• Activities related to economic integration and harmonization of food legislation in the region;
• Activities related to the application of risk analysis;
• Promotion of Codex activities in the Region;
• Activities of national Codex contact points and national Codex committees in the region;
• Consumer participation in the work of Codex;
• Report on activities related to biotechnology;
• Codex Strategic Vision and Medium Term Plan 2003-2007;
• Trade vulnerabilities resulting from the lengthy Codex MRL process; and
• Codex Ad hoc Intergovernmental Task Force on Animal Feeding.

Responsible Agency: USDA/FSIS

U.S. Participation: Yes

Attachment 2

U.S. Codex Alimentarius Officials

Codex Committee Chairpersons

Codex Committee on Food Hygiene

Dr. I. Kaye Wachsmuth, Deputy Administrator, Office of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 341-E, Jamie L. Whitten Federal Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: [phone], Fax # [phone], E-mail: [e-mail]

Codex Committee on Processed Fruits and Vegetables

Mr. David L. Priester, Head, Standardization Section, AMS Fruit & Vegetable Programs, Fresh Products Branch, USDA Stop 0140, Room 2049-S, 1400 Independence Avenue, SW, Washington, DC 20250-0240, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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 #: [phone], Fax #: [phone], E-mail: [e-mail]

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 Blvd., Kansas City, MO 64153-1394, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Listing of U.S. Delegates and Alternate Delegates—Worldwide General Subject Codex Committees

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

U.S. Delegate: Dr. Steven D. Vaughn, Director, Division of Therapeutic Drugs for Food Animals, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place HFV-130, Rockville, MD 20855, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Richard Ellis, Special Assistant, Office of the Deputy Administrator, Office of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 322 Aerospace Center, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Dennis M. Keefe, Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

U.S. Delegate: Mr. Edward Zager, Associate Director, Health Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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, Washington, DC 20090, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

U.S. Delegate: Dr. Gregory Diachenko, Director, Division of Product Manufacture and Use, Office of Premarket Approval, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Thomas Whitaker, Senior Scientist, Agricultural Research Service, U.S. Department of Agriculture, 124 Weaver Laboratory, North Carolina State University, Raleigh, NC, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. L. Robert Lake, Director, Office of Regulations and Policy (HFS-4), U.S. Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. Mark Manis, Director, International Policy Staff, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 4434, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Codex Committee on General Principles (Host Government—France)

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

Codex Committee on Food Labelling (Host Government—Canada)

Delegate: Dr. Christine Lewis, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW (HFS-800), Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 602, 300 12th Street, SW, Washington, DC 20250-3700, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Dr. Robert Buchanan, Director, Office of Science, Center for Food Science and Applied Nutrition, Food and Drug Administration 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. H. Michael Wehr (acting), Office of Constituent Operations, U.S. Food and Drug Administration, Room 5826 (HFS-550), 200 C St. SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Dr. Elizabeth Yetley, FDA Lead Scientist for Nutrition (HFS-450), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Christine Lewis, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW (HFS-800), Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Worldwide Commodity Codex Committees

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

Delegate: Mr. David L. Priester, Head, Standardization Section, International Standards Coordinator, Fruit & Vegetable Programs, Agricultural Marketing Service, Room 2069, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. Larry B. Lace, Branch Chief, Fresh Products Branch, Fruit & Vegetable Program, Agricultural Marketing Service, U.S. Department of Agriculture, Room 2049, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. Philip C. Spiller, Director, Office of Seafood, (HFS-400) VERB, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. Samuel W. McKeen, Director, Office of Trade and Industry Services, National Oceanic and Atmospheric Administration, NMFS, 1335 East-West Highway, Room 6490, Silver Spring, MD 20910, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. David Shipman, Deputy Administrator, Federal Grain Inspection Division, Grain Inspection Packers and Stockyards Administration, U.S. Department of Agriculture, Room 1661, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. Duane Spomer, Chief, Dairy Standardization Branch, U.S. Department of Agriculture, Agricultural Marketing Service, Room 2750, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. John C. Mowbray, Division of Programs and Policy Enforcement, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. Charles W. Cooper, Director, International Activities Staff (HFS-585), Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Ms. Kathleen Warner (Acting), U.S. Department of Agriculture, 1815 N. University Street, Peoria, IL 61604, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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, Room 5823 (HFS-585), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Michelle Smith, Food Technologist, Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition (HFS-306), 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Codex Committee on Sugars (Host Government—United Kingdom)

Delegate: Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit, Agricultural Research Service, USDA, 5883 USDA Road, Houma, LA 70360, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Dennis M. Keefe, Office of Premarket Approval, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Mr. James Rodeheaver, Chief, Processed Products Branch, Fruit & Vegetable Programs, Agricultural Marketing Service, U.S. Department of Agriculture, Room 0709, South Agriculture Building, Washington, DC 20250, Phone: [phone], Fax: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. Charles W. Cooper, Director, International Activities Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-585) Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Codex Committee on Soups and Broths (Host Government—Switzerland)

Delegate: Mr. Charles Edwards, Director, Technology Program Development Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 405, 300 12th Street, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 602, 300 12th Street, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Codex Committee on Vegetable Proteins (Host Government—Canada)

U.S. Delegate: Dr. Wilda H. Martinez, Area Director, ARS North Atlantic Area Sciences, Agricultural Research Service, USDA, 600 E. Mermaid Lane, Wynwood, PA 19038, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

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

Delegate: Dr. John Prucha, Assistant Deputy Administrator, Program Coordination and Evaluation, Office of Policy, Program Development, and Evaluation, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 4866, South Agriculture Building, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Bonnie Buntain, Acting Assistant Deputy Administrator, Office of Public Health and Safety, Food Safety and Inspection Service, U.S. Department of Agriculture, Mail drop 343 Aerospace Building, 3rd Floor, Room 333, 1400 Independence Avenue, SW, Washington, DC 20250, Phone: [phone], Fax: [phone], E-mail: [e-mail]

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

Delegate: Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and Beverages (HFS-300), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Alternate Delegate: Ms. Shellee Anderson, Division of Programs and Policy Enforcement (HFS-306), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

Ad Hoc Intergovernmental Task Forces

AD HOC Intergovernmental Task Force on Fruit and Vegetable Juices (Host government—Brazil)

Delegate: Mr. Martin Stutsman, Office of Plant and Dairy Foods and Beverages (HFS-306), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW, Washington, DC 20204, Phone: [phone], Fax: [phone], E-mail: [e-mail]

Alternate Delegate: Mr. David Priester, Head, Standardization Section, International Standards Coordinator, Fruit & Vegetable Programs, Agricultural Marketing Service, Room 2069, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone], E-mail: [e-mail]

AD HOC Intergovernmental Task Force on Foods, Derived From Biotechnology (Host government—Japan)

Delegate: L. Robert Lake, Director, Office of Regulations and Policy, Center for Food Safety and Applied Nutrition (HFS-4), Food and Drug Administration, 200 C St. SW, Washington, DC 20204, Phone: [phone], Fax: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Sally L. McCammon, Science Advisor to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, 4700 River Road (Unit 98), Riverdale, MD 20737, Phone [phone], Fax: [phone], E-mail: [e-mail]

AD HOC Intergovernmental Task Group On Animal Feeding (Host government—Denmark)

Delegate: Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Metro Park N. 4, Rockville, MD 20855, Phone: [phone], Fax: [phone], E-mail: [e-mail]

Alternate Delegate: Dr. Alejandro B. Thiermann, Regional Director for Europe, Africa and the Middle East, FAS/USEU, US Department of Agriculture, PSC 82, Box 002, APO AE 09710, Phone: [phone], Fax: [phone], E-mail: [e-mail]

Subsidiary Bodies of The Codex Alimentarius

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: Mr. Patrick Clerkin, Associate Manager, U.S. Codex Office, Food Safety and Inspection Service, U.S. Department of Agriculture, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: [phone], Fax #: [phone],E-mail: [e-mail]

Attachment 3

Timetable of Codex Sessions (June 2000 through June 2002)

2000:
CX 722-24	Codex Committee on Fish and Fishery Products (24th Session)	5-9 June	Alesund
CX 803-01	ad hoc Intergovernmental Codex Task Force on Animal Feeding	13-15 June	Copenhagen
CX 720-22	Codex Committee on Nutrition and Foods for Special Dietary Uses (22nd Session)	19-23 June	Berlin
CX 702-47	Executive Committee of the Codex Alimentarius Commission (47th Session)	28-30 June	Geneva
CX 713-20	Codex Committee on Processed Fruits and Vegetables (20th Session)	11-15 September	Washington, DC
CX 801-01	ad hoc Intergovernmental Codex Task Force on Fruit Juices (1st Session)	18-22 September	Brasilia
CX 706-22	Codex Regional Coordinating Committee for Europe	3-6 October	Madrid
CX 731-09	Codex Committee on Fresh Fruits and Vegetables (9th Session)	9-13 October	Mexico City
CX 712-33	Codex Committee on Food Hygiene (33rd Session)	23-27 October	Washington, DC
CX 719-07	Codex Committee on Natural Mineral Waters (7th Session)	30 October-  1 November	Fribourg
CX 708-18	Codex Committee on Cocoa Products and Chocolate (18th Session)	2-4 November	Fribourg
CX 707-14	Codex Regional Coordinating Committee for Africa (14th Session)	27-30 November	Entebbe
CX 732-06	Codex Regional Coordinating Committee for North America and the South-West Pacific (6th Session)	5-8 December	Perth
2001:
CX 734-01	Codex Regional Coordinating Committee for the Near East	29 January-  1 February	Cairo
CX 725-12	Codex Regional Committee for Latin America and the Caribbean (12th Session)	13-16 February	Santo Domingo
CX 709-17	Codex Committee of Fats and Oils (17th Session)	19-23 February	London
CX 715-23	Codex Committee on Methods of Analysis and Sampling (23rd Session)	26 February-  2 March	Budapest
CX 711-33	Codex Committee on Food Additives and Contaminants (33rd Session)	12-16 March	The Hague
CX 803-02	ad hoc Intergovernmental Task Force on Animal Feeding	19-21 March	Copenhagen
CX 718-33	Codex Committee on Pesticide Residues (33rd Session)	2-7 April	The Hague
CX 716-16	Codex Committee on General Principles (16th Session)	23-27 April	Paris
CX 714-29	Codex Committee on Food Labelling (29th Session)	30 April-4 May	Ottawa
CX 702-48	Executive Committee of the Codex Alimentarius Commission (48th Session)	28-29 June	Geneva
CX 701-24	Codex Alimentarius Committee (24th Session)	2-7 July	Geneva
CX 708-19	Codex Committee on Cocoa Products and Chocolate (19th Session)	3-5 October	Fribourg
CX 712-23	Codex Committee on Food Hygiene (34th Session)	8-13 October	Bangkok
CX 720-23	Codex Committee for Nutrition and Foods for Special Dietary uses (23rd Session)	26-30 November	Berlin
CX 730-13	Codex Committee on Residues of Veterinary Drugs in Foods (13th Session)	4-7 December	Charleston, SC
2002:
CX 731-10	Codex Committee on Fresh Fruits and Vegetables (10th Session)	28 January-  1 February	Mexico City
CX 723-8	Codex Committee on Meat Hygiene (8th Session)	18-22 February	Wellington
CX 733-10	Codex Committee on Food Import and Export Certification and Inspection Systems (10th Session)	25 February-  1 March	Canberra
CX 802-03	ad hoc Intergovernmental Task Force on Biotechnology (3rd Session)	4-8 March	Kyoto
CX 711-34	Codex Committee on Food Additives and Contaminants (34th Session)	11-15 March	The Hague
CX 803-03	ad hoc Intergovernmental Task Force on Animal Feeding (3rd Session)	18-20 March	Copenhagen
CX 703-05	Codex Committee on Milk and Milk Products (5th Session)	8-12 April	Wellington
CX 716-17	Codex Committee on General Principles (17th Session)	15-19 April	Paris
CX 801-02	ad hoc Intergovernmental Task Force on Fruit Juice (2nd Session)	23-26 April	Brasilia
CX 714-30	Codex Committee on Food Labelling (30th Session)	6-10 May	Ottawa
CX 718-34	Codex Committee on Pesticide Residues (34th Session)	13-18 May	The Hague
CX 722-25	Codex Committee on Fish and Fishery Products (25th Session)	3-7 June	Bergen
CX 702-49	Executive Committee of the Codex Alimentarius Commission (49th Session)	26-28 June	Rome

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 highest authorized use, applied in a manner that leaves a residue which is the smallest amount practicable.

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

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

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

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

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

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

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

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

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

11. Codex Maximum Limit for Residues of Veterinary Drugs (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or (g/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 subsidiary body or other body should undertake the work. A decision to elaborate a Worldwide Codex Standard may also be taken by subsidiary bodies of the Commission in accordance with the above-mentioned criteria, subject to subsequent approval by the Commission or its Executive Committee at the earliest possible opportunity. In the case of Codex Regional Standards, the Commission shall base its decision on the proposal of the majority of members belonging to a given region or group of countries submitted at a session of the Codex Alimentarius Commission.

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

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

Step 4

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

Step 5

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

Step 6

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

Step 7

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

Step 8

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

Part 2

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

Steps 1, 2 and 3

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

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

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

Step 4

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

Step 5

In the case of standards identified as being subject to an accelerated 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.

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 definition 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 93 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 on page 95 of 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 on page 92 of the Codex Procedural Manual. Provisions should be included by reference to the General Standard for the Labelling of Prepackaged Foods. The section may also contain provisions which are exemptions from, additions to, or which are necessary for the interpretation of the General Standard in respect of the product concerned provided that these can be justified fully. The following statement should also appear:

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

Methods of Analysis and Sampling

This section should include, either specifically or by reference, all methods of analysis and sampling considered necessary and should be prepared in accordance with the guidance given on page 95 of 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 alternative 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.”