00-13292. 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, Pub. L. 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, 1999, to May 31, 2000, and June 1, 2000, to May 31, 2001, 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; (202) 205-7760. For information pertaining to particular committees, the delegate of that committee may be contacted. (A complete list of U.S. delegates and alternate delegates can be found in Attachment 2 to this notice.) Documents pertaining to Codex are accessible via the World Wide Web at the following Start Printed Page 34638address: http://www.fao.org/waicent/faoinfo/economic/esn/codex/. 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 on 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. U.S. Codex Alimentarius, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700, if you would like to 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, 1999 to May 31, 2000, and June 1, 2000 to May 31, 2001. 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 1999 through May 2001)

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 (202) 720-5704.

Done at Washington, DC on May 22, 2000.

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 in June 2000 and June 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 will consider matters arising from reports of Codex Committees including review of standards at step 5, requests for new work, and other items brought to its attention.

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 ug/kg on a fresh weight basis) that is adopted by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food.

An MRLVD is based on the type and amount of residue considered to be without any toxicological 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 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; and
Methods of Analysis and Sampling Issues.

Responsible Agency: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

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 32nd Session of CCFAC met on March 20-24, 2000, in Beijing, the Peoples Republic of China. The following matters contained in ALINORM 01/12 are under consideration by the Commission and CCFAC.

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. The Codex Secretariat will report on this activity to the 15th Session of the Codex Committee on General Principles and the 47th Session of the Codex Executive Committee (June 2000).

Food Additives

Annex A (Guidelines for the Estimation of Appropriate Levels of Use of Food Additives) to the Preamble of the General Standard for Food Additives (GSFA) for adoption at Step 8;
Addition of provisions for the use of 15 additives to Table 1 and Table 2 of the Codex General Standard for Food Additives for adoption at Step 8 and Step 5/8;
The Committee agreed to circulate for comment the inclusion of the following additives in Table 3 (Additives Permitted for Use in Food in General, Unless otherwise Specified, in Accordance with GMP) of the Draft GSFA at Step 3 of the accelerated procedure subject to confirmation by the 47th Session of the Codex Executive Committee: Processed Eucheuma seaweed, enzymatically hydrolyzed sodium carboxymethyl cellulose, gamma cyclodextrin, polyglycitol syrup, erythritol, curdlan, and sodium sulfate;
The Committee has requested the Codex Secretariat to prepare a discussion paper on the relationship between Codex Commodity Standards and the further development of the GSFA; and
The 32nd CCFAC agreed to reestablish its ad hoc working group on the GSFA for its 33rd Session under the chairmanship of the U.S.

International Numbering System

The Committee agreed to forward the proposed addition of 4-Start Printed Page 34640hexylresorcinol (INS 586) for use as an antioxidant or color retention agent) and pectins (INS 440) to include its use as an emulsifier to the 24th CAC for final adoption of the accelerated procedure. The Committee also agreed to forward the following proposed revisions (italicized text) to the INS system at Step 3 by the accelerated procedure subject to the approval of the Commission:
acesulfame potassium (INS 950) sweetener and flavor enhancer;
enzymatically hydrolyzed sodium carboxymethyl cellulose (INS 469) as thickener and stabilizer;
monosodium succinate (INS 364i) as acidity regulator and flavor enhancer;
disodium succinate (INS 364ii) as acidity regulator and flavor enhancer;
curdlan (INS 424) as thickener and stabilizer;
erythritol (INS 968) as sweetener, flavor enhancer, and humectant;
sodium L-aspartate (INS 638) as flavor enhancer;
DL-alanine (INS 639) as flavor enhancer;
manasco rubin (INS 130) as color;
gardenia yellow (INS 164) as color;
gamma-cyclodextrin (INS 458) as stabilizer and binder; and
polyglycitol syrup (INS 964) as sweetener.
The Committee also agreed to request comments on the technological functions and functional classes/subclasses in the framework of the INS system, the GSFA, and the Codex General Standard for the Labelling of Prepackaged Foods.

Draft Revisions to the Codex General Standard for Irradiated Foods

The 32nd CCFAC agreed to ask WHO, IAEA and FAO to further revise the Codex General Standard for Irradiated Foods for circulation, comment and further consideration by the 33rd CCFAC; and
The Committee also agreed to request the Codex Executive Committee to consider as new work the revision of the companion Codex Recommended International Code of Practice for the Operation of Irradiation Facilities Used for the Treatment of Foods (CAC/RCP 19-1979).

Food Additive Specifications

The 32nd CCFAC agreed to forward specifications for 34 food additives and 58 flavoring agents, and specifications for 2 food additives after editorial changes including technical revisions to the 24th CAC for adoption as Codex Advisory Specifications; and
The 32nd CCFAC agreed to reestablish its ad hoc working group for food additive specifications for its 33rd Session under the chairmanship of the U.S.

The Committee is continuing work on a discussion paper on processing aids.

The 32nd CCFAC agreed to discontinue further work on its discussion paper on the use of colors in food.

Contaminants

The Committee agreed to forward the following for final adoption:

Draft Maximum Level of 50ug/kg in apple juice and apple juice ingredient in ready made soft drinks for adoption at Step 8; and
Draft Maximum Levels for Lead (except for fish, crustaceans, bivalve mollusks and fruit juices) at Step 8.

The Committee is continuing work on:

Methodology and Principles for Exposure Assessment in the Codex General Standard for Contaminants and Toxins in Food;
Draft Maximum Level for Aflatoxin M1 in Milk at Step 6;
Proposed Draft Maximum Levels for Ochratoxin A in Cereals and Cereal Products at Step 3;
The Committee discussed two draft codes of practice for the prevention of mycotoxin contamination of cereals (ochratoxin A, zearalenone) and a position paper on fumonisins. Given the similarity of the various draft Codes of Practice, the Committee agreed that a General Code of Practice for the prevention of mycotoxin contamination in cereals with annexes containing guidance on practices to prevent cereal grain contamination by specific mycotoxins. Currently, the General Code of Practice is expected to contain annexes for ochratoxin A, zearalenone and fumonisins;
Draft Code of Practice for Source Directed Measures to Reduce Contamination of Foodstuffs (paper to be revised for consideration at Step 3 by the 32nd CCFAC);
Draft Maximum Levels for Lead for fish, crustaceans, bivalve mollusks and fruit juices to be circulated for comment and consideration at Step 6 by the 33rd CCFAC);
Draft Maximum Levels for Cadmium for Cereals, Pulses and Legumes to be circulated for comment at Step 6. (Proposed draft maximum levels for Cadmium in other foods to be circulated at Step 3);
Discussion Paper on Dioxins (Paper to be revised for circulation and comment by the 33rd CCFAC); and
The 32nd CCFAC agreed to reestablish the ad hoc working group for contaminants for its 33rd Session under the chairmanship of Denmark.

Other Issues

Position Paper on Chloropropanols: The Committee agreed that a discussion paper should be prepared to address the levels of 3-monochloropropane-1,2-diol and 1,3-dichloro-2-propanol in foods subject to approval by the 47th CCEXEC.

The 33rd Session of the CCFAC is tentatively scheduled for March 12-16, 2001 in The Hague, The Netherlands.

Responsible AGENCY: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Pesticide Residues

The Codex Committee on Pesticide Residues recommends to the Codex Alimentarius Commission establishment of maximum limits for pesticide residues for specific food items or in groups of food. A Codex Maximum Residue Limit for Pesticide (MRLP) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. Foods derived from commodities that comply with the respective MRLPs are intended to be toxicologically acceptable, that is, consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI*, should indicate that foods complying with Codex MRLPs are safe for human consumption.

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

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

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

The following items will have been considered by 32nd Session of the Codex Committee on Pesticide Residues at the Hague, the Netherlands, May 1-8, 2000. The final results will be in ALINORM 01/24.

Consideration of Intake of Pesticide Residues:
Acute Dietary Exposure Assessment; Start Printed Page 34641
Report on Pesticide Residue Intake Studies; and
Report on the Revision of Regional Diets and Information on Processing
Consideration of Draft and Proposed Draft Residue Limits in Foods and Feeds at Steps 7 and 4:
Harmonization of MRL setting for compounds used both as pesticides and as veterinary drugs;
Which uses to support when chronic dietary intake estimate(s) exceed the ADI;
Feasibility of establishing MRLs for genetically modified crops and for metabolite residues;
Feasibility of establishing specific MRLs for cereal-based foods and infant formula; and
Need for EMRL for camphechlor in fish.
Recommendations for Methods of Analysis and Sampling;
Establishment of Codex Priority Lists of Pesticides; and
Problems Relative to Pesticide Residues in Food in Developing Countries.

* Acceptable Daily Intake (ADI) of a chemical is the daily intake which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time of the evaluation of the chemical by the Joint FAO/WHO Meeting on Pesticide Residues. It is expressed in milligrams of the chemical per kilogram of body weight.

Responsible Agency: EPA; USDA/ARS.

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 Committee will hold its 23rd Session in Budapest, Hungary, February 26-March 2, 2001. At that time the committee will consider the following:

Principles for the Establishment of Codex Methods of Analysis and Sampling;
Relations between Commodity Committees and General Committees;
Proposed Draft General Guidelines on Sampling;
Criteria for Evaluating Acceptable Methods of Analysis for Codex Purposes;
Harmonization of Analytical Terminology “Measurement Limits”;
Harmonization of Reporting of Test Results Corrected for Recovery Factors;
Measurement Uncertainty;
In-House Method Validation; and
Endorsement of Methods of Analysis and Sampling Provisions in Codex Standards.

Responsible Agency: HHS/FDA; USDA/AMS.

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 Committee held its 8th Session at Adelaide, Australia, on February 21-25, 2000. The following matters will be considered by the Codex Alimentarius Commission at its 24th Session. The relevant document is ALINORM 01/30.

To be considered at Step 5:

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

The Committee is continuing work on:

Proposed Draft Guidelines/Recommendations for Food Import Control Systems;
Proposed Draft Guidelines for the Utilization and Promotion of Quality Assurance Systems; and
Discussion Paper on the adequacy of existing Codex texts in food emergency control situations (including an existing CCFICS developed set of Guidelines for the Exchange of Information in Food Control Emergency Situations).

New Work:

Proposed Draft Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification Systems; and
Proposed draft Guidelines on the Judgement of Equivalence of Technical Regulations Associated with Food Import and Export 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 15th Session of the Committee met in Paris on April 10-14, 2000. The relevant ALINORM is 01/33.

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; and
Practical measures intended to facilitate consensus.

The Committee continues to work on:

Working Principles for Risk Analysis;
Food Safety Objectives;
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;
Composition of the Executive Committee and related matters; Start Printed Page 34642
Revision of the Code of Ethics for International Trade in Foods; and
Consumer Participation in Codex Work and related matters.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Labeling

The Codex Committee on Food Labeling is responsible for drafting provisions on labeling issues assigned by the Codex Alimentarius Commission. The Committee will have held its 28th Session in Ottawa on May 9-12, 2000. The following items will have been discussed. The documents will be in ALINORM 01/22.

Considered at Step 7:

Draft Guidelines for the Production, Processing, Labeling and Marketing of Organically Produced Foods (Animal Production);
Proposed Draft Amendment to the General Standard for the Labeling of Prepackaged Foods (Class Names) (milk protein/milk protein products);
Proposed Draft Recommendations for the Labeling of Foods Obtained Through Biotechnology (Definitions); and
Draft Amendment to the Standard for Quick Frozen Fish Sticks (Fish Fingers), Fish Portions and Fish Fillets, Breaded and in Batter (Declaration of Fish Core).

Considered at Step 4:

Proposed Draft Recommendations for the Use of Health Claims;
Proposed Draft Recommendations for the Labeling of Foods Obtained Through Biotechnology (Mandatory Labeling);
Proposed Draft Recommendations to the Guidelines on Nutrition Labeling; and
Proposed Draft Recommendations for the Use of the Term “Vegetarian”.

Also considered:

Discussion paper on Quantitative Ingredient Labeling.

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, found in ALINORM 01/13, will be considered by the Codex Alimentarius Commission at its 24th Session in June 2001:

To be considered at Step 8:

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

Codex texts to be considered by the Committee at its 33rd Session to be held October 23-27, 2000 are the following:

To be considered at Step 4:

Proposed Draft Code of Hygienic Practice for Milk and Milk Products;
Proposed Draft Code of Hygienic Practice for the Primary Production, Harvesting and Packaging of Fresh Fruits and Vegetables;
Proposed Draft Code of Hygienic Practice for Pre-cut Vegetable Products Ready for Human Consumption;
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; and
Discussion on Risk Assessment of Certain Pathogens in Specific Commodities.

Other committee work:

Discussion paper on the Application of HACCP in Small and/or Less Developed Businesses;
Discussion paper on Priorities for the Revision of the Codes of Hygienic Practice;
Discussion paper on Antibiotic Resistance in Bacteria in Food;
Discussion paper on Guidelines for Validation of Food Hygienic Control Measures; and
Discussion paper on Proposed Guidelines for Evaluating the Presence of Objectionable Matter

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 Committee will hold its Ninth Session in Mexico City, Mexico, on October 9-13, 2000 and consider the following:

To be considered at Step 7:

Draft Standard for Grapefruit, Pummelos, Limes (sizing provisions);
Draft Standard for Tisquisque (White and Lilac);
Draft Standard for Yellow Pitahayas;
Draft Standard for Papaya;
Draft Standard for Asparagus;
Draft Standard for Oranges; and
Draft Standard for Cape Gooseberry;

To be considered at Step 4:

Proposed Draft Standard for Cassava;
Proposed Draft Standard for Apples;
Proposed Draft Standard for Tomatoes;
Proposed Draft Standard for Table Grapes;
Discussion paper on size tolerances, including sizing provisions of the Draft Standards for Grapefruits, Limes, Pummelos, and Oranges;
Code of Practice for the Quality Inspection and Certification of Fresh Fruits and Vegetables;
Inspection Site Requisites (Annex II of the Draft Code of Practice for the Quality Inspection and Certification of Fresh Fruits and Vegetables);
Discussion paper on definitions of terms; and
Brix levels in Codex Standard for Pineapples;

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 Committee holds its 22nd Session in Berlin, Germany, on June 19-23, 2000. At that Session, it will consider the following:

To be considered at Step 7:

Draft Table of Conditions for Nutrient Contents (Part B), (Guidelines for Nutrient Claims) Fibre and Serving Size; andStart Printed Page 34643
Proposed Draft Revised Standards for Gluten-Free Foods.

To be considered at Step 4:

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 and Discussion Paper to Facilitate Consideration of the Draft Guidelines; and
Proposed Draft Revision of the Advisory List(s) of Mineral Salts and Vitamin Compounds for the Use in Foods for Infants and Children.

Other work:

Discussion Paper on Criteria for Scientific Evidence Relative to Health Claims;
Discussion Paper on Provisions of Fortification on Iodine, Iron and Vitamin A in the Guidelines of Nutrition Claims;
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 Proposal to Design the Basis for Derivation of Energy Conversion Factors in the Codex Guidelines on Nutrition Labelling;
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; and
Consideration of the Need to Review the General Principles for the Addition of Essential Nutrients to Foods.

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 24th Session of the Committee will be held on June 5-9, 2000, in Alesund, Norway. At that Session, the following items will be discussed:

To be considered at Step 7:

Draft Standard for Dried Anchovies; and
Draft Standard for Crackers from Marine and Freshwater Fish, Crustacean and Molluscan Shellfish.

To be considered at Step 4:

Proposed Draft Amendment to the Standard for Canned Sardines and Sardine-Type Products (Inclusion of an additional species);
Proposed Draft Standard for Salted Atlantic Herring and Salted Sprats;
Proposed Draft Code of Practice for Fish and Fishery Products;
Model Certificate for Fish and Fishery Products;
Proposed Draft Standard for Smoked Fish; and
Proposed Draft Standard for Molluscan Shellfish.

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 June 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; and ( Proposed Draft Amendment to the Codex Group Standard for Cheeses in Brine (Sampling) at Step 5/8.

To be considered at Step 5:

Proposed Draft Revised Standard for Cream, Whipped Creams, and Fermented Creams;
Proposed Draft Revised Standard for Fermented Milks; and
Proposed Draft Revised Standard for Whey Powders.

The Committee is continuing work on:

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; and
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 will hold its 17th Session in London, England, in March 2001 and consider the following:

To be considered at Step 7:

Draft Standard for Olive Oils and Olive-Pomace Oils.

To be considered at Step 4:

Proposed Draft Standard for Fat Spreads and Blended Spreads.

New Work:

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.

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 Committee will hold its 18th Session in Switzerland in November 2000 and consider the following:

To be considered at Step 7:

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; and
Draft Revised Standard for Cocoa Powders (Cocoas) and Dry Cocoa-Sugar Mixture.

To be considered at Step 4:

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 Start Printed Page 34644reconvened in Washington, DC, in March 1998 to begin work revising the standards. The 20th Session of the Committee will be held in Washington, DC on September 11-15, 2000. The Committee will consider the following:

To be considered at step 7:

Draft Standard for Canned Bamboo Shoots;
Draft Standard for Pickles;
Draft Standard for Kimchee;
Draft Revised Standard for Canned Applesauce;
Draft Revised Standard for Canned Pears; and
Draft Standard for Aqueous Coconut Products.

To be considered at step 4:

Proposed Draft Standard for Canned Stone Fruits;
Proposed Draft Standard for Canned Citrus Fruits;
Proposed Draft Standard for Canned Berry Fruits;
Proposed Draft Standard for Jams, Jellies and Marmalades;
Proposed Standard for Canned Vegetables;
Proposed Draft Guidelines for Packing Media in Canned Fruits;
Proposed Draft Guidelines for Packing Media in Canned Vegetables;
Proposed Draft Revised Standard for Canned Mangoes;
Proposed Draft Revised Standard for Canned Pineapple;
Proposed Draft Revised Standard for Canned Fruit Cocktails;
Proposed Draft Revised Standard for Canned Tropical Fruit Salad;
Proposed Draft Revised Standard for Canned Chestnuts and Chestnut Puree;
Proposed Draft Revised Standard for Canned Tomatoes;
Proposed Draft Revised Standard for Canned Mushrooms;
Proposed Draft Revised Standard for Mango Chutney;
Proposed Draft Revised Standard for Pickled Cucumbers (Cucumber Pickles);
Proposed Draft Revised Standard for Table Olives;
Proposed Draft Revised Standard for Processed Tomato Concentrates;
Proposed Draft Revised Standard for Dried Apricots;
Proposed Draft Revised Standard for Dates;
Proposed Draft Revised Standard for Raisins;
Proposed Draft Revised Standard for Grated Desiccated Coconuts;
Proposed Draft Revised Standard for Unshelled Pistachio Nuts;
Proposed Draft Revised Standard for Dried Edible Fungi;
Proposed Draft Revised Standard for Edible Fungi and Fungus Products;
Proposed Draft Standard for Soy Sauce; and
Proposed Draft Standard for Dried Figs.

Other Work:

Methods of Analysis for Processed Fruits and Vegetables.

The committee has been tasked with considering the revision of the Standards for Quick Frozen Fruits and Vegetables including: Peas, Strawberries, Raspberries, Peaches, Bilberries, Spinach, Blueberries, Leek, Broccoli, Cauliflower, Brussels Sprouts, Green and Wax Beans, French Fried Potatoes, Whole Kernel Corn, Corn-on-the-Cob, Carrots.

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 7th Session of the Committee will meet October 30-November 1, 2000. The Committee will consider the following:

To be considered at Step 4:

Proposed Draft General Standard for Bottled/Packaged Drinking Waters Other Than Natural Mineral Waters.

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 June 2001. The relevant document is ALINORM 01/25.

To be considered at Step 8:

Draft Revised Standard for Honey; and
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; and
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

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.

U.S. Participation: Yes.

*There is no planned activity for these Committees in the next year.

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

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 Proposed Draft Revised Standard for Bouillons and Consommes was prepared by the Secretariat and has been circulated to member countries for comment at Step 3.

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 Start Printed Page 34645Alimentarius 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 has been circulated to member countries and other interested parties for comment at Step 3. The Proposed Draft will be revised and should be forwarded to the Executive Committee for adoption at Step 5.

Responsible Agency: USDA/ARS.

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 of consumers and the promotion of fair trade practices. The Task Force met in Tokyo, Japan on March 20-24, 2000. The relevant document is ALINORM 01/34.

Matters under discussion by the task force at its next meeting:

Consideration of proposed draft general principles of an over-arching nature for the application of risk analysis to foods derived from biotechnology;
Consideration of proposed draft guidelines for risk assessment with reference to food safety and nutrition of foods derived from biotechnology;
Consideration of transparency and involvement of stakeholders in the proposed draft principles/guidelines;
Consideration of analytical methods;
A Discussion Paper on Traceability; and
An Information Paper on Familiarity.

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 task force will meet in Copenhagen, Denmark, on June 13-15, 2000. It will discuss the following items:

Draft Code of Practice for Good Animal Feeding; and
Other items that are important for food safety, such as problems related to toxic substances, pathogens, microbial resistance, new technologies, storage, control measures, traceability, etc.

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 will meet in Brasilia, Brazil, September 18-22, 2000.

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 will be held in December 2000, in Brisbane, Australia. Agenda topics will include the following:

Review of acceptance and promotion of Codex standards by countries in the region;
National reports on food control, food safety, and food standards in the region;
National reports on the application of risk analysis;
Promotion of Codex activities in the Region; and
Report on activities of national Codex contact points and national Codex committees in the region

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Attachment 2

U.S. Codex Alimentarius Officials

Codex Committee Chairpersons

Codex Committee on Food Hygiene

Dr. 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 #: (202) 720-2644, Fax # (202) 690-2980, E-mail: kaye.wachsmuth@usda.gov

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 #: (202) 720-2185, Fax #: (202) 720-8871, E-mail: david.priester@usda.gov

Codex Committee on Residues of Veterinary Drugs in Foods

Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, Phone #: (301) 594-1740, Start Printed Page 34646Fax #: (301) 594-1830, E-mail: ssundlof@cvm.fda.gov

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

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

Listing of U.S. Delegates and Alternate Delegates

Worldwide General Subject Codex Committees

Codex Committee on Residues of Veterinary Drugs in Foods

(Host Government—United States)

U.S. Delegate

Dr. Robert C. Livingston, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, Phone #: (301) 594-5903, Fax #: (301) 594-1830, E-mail: rlivings@bangate.fda.gov

Alternate Delegate VACANT

Codex Committee on Food Additives and Contaminants

(Host Government—The Netherlands)

U.S. Delegate

Dr. Alan Rulis, Director, Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 418-3100, Fax #: (202) 418-3131, E-mail: arulis@bangate.fda.gov

Alternate 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, (HFS-456), Washington, DC 20204, Phone #: (202) 205-4064, Fax #: (202) 205-4422, E-mail: ttroxell@bangate.fda.gov

Codex Committee on Pesticide Residues

(Host Government—The Netherlands)

U.S. Delegate

Mr. Fred Ives, Health Effects Division (7509C), Office of Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460, Phone #: (703) 305-6378, Fax #: (703) 305-5147, E-mail: ives.fred@epamail.epa.gov

Alternate Delegate

Dr. Richard Parry, Jr., Assistant Administrator, Cooperative Interactions, Agricultural Research Service, U.S. Department of Agriculture, Room 358-A, Jamie L. Whitten Federal Building, Washington, DC 20250-3700, Phone #: (202) 720-3973, Fax #: (202) 720-5427, E-mail: rparry@ars.usda.gov

Codex Committee on Methods of Analysis and Sampling

(Host Government—Hungary)

U.S. Delegate

Dr. William Horwitz, Scientific Advisor (HFS-500), Center for Food Safety and Applied Nutrition, Food and Drug Administration, Room 3832, 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-4346, Fax #: (202) 401-7740, E-mail: whorwitz@bangate.fda.gov

Alternate Delegate

Mr. William Franks, Deputy Administrator, Science and Technology, Agricultural Marketing Service, U.S. Department of Agriculture, Room 3507, South Agriculture Building, 1400 Independence Avenue, SW, Washington, DC 20250, Phone #: (202) 720-5231, Fax #: (202) 720-6496, E-mail: william.franks@usda.gov

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 #: (202) 205-4160, Fax #: (202) 401-7739, E-mail: rlake@bangate.fda.gov

Alternate Delegate

Mr. Mark Manis, Director, International Policy Development Division, 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 #: (202) 720-6400, Fax #: (202) 720-7990, E-mail: mark.manis@usda.gov

Codex Committee on General Principles

(Host Government—France)

Mr. James Rodeheaver, Chief, Processed Products Branch, Fruits and Vegetables Program, Agricultural Marketing Service, U.S. Department of Agriculture, P.O. Box 96456, Room 0709, South Agriculture Building, Washington, DC 20090-6456, Phone: (202) 720-4693, Fax: (202) 690-1527, E-mail: james.rodeheaver@usda.gov

Alternate Delegate

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 20250-3700, Phone #: (202) 205-7760, Fax #: (202) 720-3157, E-mail: patrick.clerkin@usda.gov

Attachment 3

**Timetable of Codex Sessions**
[June 1999 through June 2001]
1999:
CX 702-46	Executive Committee of the Codex Alimentarius Commission (46th Session)	24-25 June	Rome.
CX 701-23	Codex Alimentarius Commission (23rd Session)	28 June-3 July	Rome.
Start Printed Page 34649
CX 727-12	Codex Regional Coordinating Committee for Asia (12th Session)	23-26 November	Chaing Mai.
CX 712-32	Codex Committee of Food Hygiene (32nd Session)	29 November-4 December	Washington, DC.
2000:
CX 710-07	Codex Committee on Sugars (7th Session)	9-11 February	London.
CX 733-08	Codex Committee on Food Import and Export Certification and Inspection (8th Session)	21-25 February	Adelaide.
CX 703-04	Codex Committee on Milk and Milk Products (4th Session)	28 February-3 March	Wellington.
CX 802-01	ad hoc Intergovernmental Task Force on Biotechnology	14-17 March	Tokyo.
CX 711-32	Codex Committee on Food Additives and Contaminants (32nd Session)	20-24 March	Beijing.
CX 730-12	Codex Committee on Residues of Veterinary Drugs in Foods (12th Session)	28-31 March	Washington, DC.
CX 716-15	Codex Committee on General Principles (15th Session)	10-14 April	Paris.
CX 718-32	Codex Committee on Pesticide Residues (32nd Session)	1-8 May	The Hague.
CX 714-28	Codex Committee on Food Labelling (28th Session)	8-12 May	Ottawa.
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	TBA.
CX 719-07	Codex Committee on Natural Mineral Waters (7th Session)	30 October-1 November	TBA.
CX 708-18	Codex Committee on Cocoa Products and Chocolate (18th Session)	2-4 November	TBA.
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 711-33	Codex Committee on Food Additives and Contaminants (33rd Session)	12-16 March	The Hague.
CX 715-23	Codex Committee on Methods of Analysis and Sampling (23rd Session)	26 February-2 March	Budapest.
CX 803-02	ad hoc Intergovernmental Task Force on Animal Feeding	19-21 March	Copenhagen.
CX 709-17	Codex Committee on Fats and Oils (17th Session)	26-30 March	London.
CX 718-33	Codex Committee on Pesticide Residues (33rd Session)	2-6 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.

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 Start Printed Page 34650environmental 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 ug/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.

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 Start Printed Page 34651effects 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 ^[1]

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.

(3) The proposed draft standard is sent to Members of the Commission and interested international organizations Start Printed Page 34652for 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 Start Printed Page 34653endorsed] 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 Anaylsis 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.”

Footnotes

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

Back to Citation

1. Without prejudice to any decision that may be taken by the Commission at Step 5, the proposed draft standard may be sent by the Secretariat for government comment prior to its consideration at Step 5, when, in the opinion of the subsidiary body or other body concerned, the time between the relevant session of the Commission and the subsequent session of the subsidiary or other body concerned requires such actions in order to advance the work.

Back to Citation

[FR Doc. 00-13292 Filed 5-30-00; 8:45 am]

BILLING CODE 3410-DM-P

Visit the Official Version

Document Information

Published:: 05/31/2000
Department:: Food Safety and Inspection Service
Entry Type:: Notice
Action:: Notice.
Document Number:: 00-13292
Pages:: 34637-34653 (17 pages)
Docket Numbers:: Docket No. 00-005N
PDF File:: 00-13292.pdf