[Federal Register Volume 67, Number 104 (Thursday, May 30, 2002)]
[Notices]
[Pages 37760-37772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13527]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 02-002N]


International Standard-Setting Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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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, 2001, to May 31, 2002, and June 1, 
2002, to May 31, 2003, 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 address: http://www.codexalimentarius.net. The U.S. Codex 
Office also maintains a web site at http://www.fsis.usda.gov/OA/Codex/index.htm.

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

[[Page 37761]]

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 comments 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, 2001 to May 31, 2002, and June 1, 2002 to May 31, 
2003. 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 2001 through June 2003).
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 make copies of this Federal Register 
publication available through the FSIS Constituent Update. FSIS 
provides a weekly Constituent Update, which is communicated via 
Listserv, a free e-mail subscription service. In addition, the update 
is available on-line through the FSIS web page, located at http://www.fsis.usda.gov. The update is used to provide information regarding 
FSIS policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, recalls, and any other types of information that could 
effect or would be of interest to our constituents/stakeholders. The 
constituent Listserv consists of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals that have requested to be 
included. Through the Listserv and web page, FSIS is able to provide 
information to a much broader, more diverse audience. For more 
information contact the Congressional and Public Affairs Office, at 
(202) 720-9113.
    To be added to the free e-mail subscription service (Listserv) go 
to the ``Constituent Update'' page on the FSIS web site at http://www.fsis.usda.gov/oa/update/update.htm. Click on the ``Subscribe to the 
Constituent Update Listserv'' link, then fill out and submit the form.

    Done at Washington, DC on: May 24, 2002.
F. Edward Scarbrough,
U.S. Manager for Codex Alimentarius.

Attachment 1: Sanitary and Phytosanitary Activities of Codex,

Codex Alimentarius Commission And Executive Committee

    The Codex Alimentarius Commission will hold its Twenty-fifth 
Session June 30-July 5, 2003, in Rome, Italy. At that time it will 
consider the standards, codes of practice, and related matters 
brought to its attention by the general subject committees, 
commodity committees, ad hoc Task Forces, and member delegations.
    Prior to the Commission meeting, the Executive Committee will 
meet in June 2002 and June 2003. It is composed of the chairperson, 
vice-chairpersons and seven members elected from the Commission, one 
from each of the following geographic regions: Africa, Asia, Europe, 
Latin America and the Caribbean, Near East, North America, and 
South-West Pacific.
    The Executive Committee at its Fiftieth Session, June 26-28, 
2002, 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 veterinary drug is defined as any 
substance applied or administered to a food producing animal, such 
as meat or dairy animals, poultry, fish or bees, for therapeutic, 
prophylactic or diagnostic purposes or for modification of 
physiological functions or behavior.
    A Codex Maximum Limit for Veterinary Drugs (MRLVD) is the 
maximum concentration of residue resulting from the use of a 
veterinary drug (expressed in mg/kg or ug/kg on a fresh weight 
basis) that is adopted by the Codex Alimentarius

[[Page 37762]]

Commission to be permitted or recognized as acceptable in or on a 
food. An MRLVD is based on the Acceptable Daily Intake (ADI)* and 
indicates the amount of residue in food that is considered to be 
without appreciable toxicological hazard. An MRLVD also takes into 
account other relevant public health risks as well as food 
technological aspects.
    When establishing an MRLVD, consideration is also given to 
residues that occur in food of plant origin and/or the environment. 
Furthermore, the MRLVD may be reduced to be consistent with good 
practices in the use of veterinary drugs and to the extent that 
practical analytical methods are available.
    * Acceptable Daily Intake (ADI): An estimate by the Joint FAO/
WHO Expert Committee on Food Additives (JECFA) of the amount of a 
veterinary drug, expressed on a body weight basis, that can be 
ingested daily over a lifetime without appreciable health risk 
(standard man = 60 kg).
    The following matters, contained in ALINORM 03/31, will be 
considered by the Codex Alimentarius Commission at its 25th Session 
in July 2003 or the Executive Committee at its 50th Session in June 
2002.
    To be considered at Step 8 by the 25th Session of the 
Commission:
    [sbull] Abemectin
    [sbull] Carazolol
    [sbull] Chlortetracycline/oxytetracycline/tetracycline
    [sbull] Clenbuterol
    [sbull] Cyfluthrin
    [sbull] Eprinomectrin
    [sbull] Phoxim
    [sbull] Porcine somatotropin
    To be considered at Step 5/8 by the 25th Session of the 
Commission:
    [sbull] Cyhalothrin
    [sbull] Ivermectin
    [sbull] Lincomycin
    To be considered at Step 5 Accelerated Procedure by the 25th 
Session of the Commission:
    [sbull] Draft amendments to the Glossary of Terms and 
Definitions
    To be considered at Step 5 by the 50th Session of the Executive 
Committee:
    [sbull] Clenbuterol
    [sbull] Deltamethrin
    [sbull] Dicyclanil
    [sbull] Melengestrol acetate
    [sbull] Trichlorfon (metrifinate)
    The Committee will continue to work on:
    [sbull] Proposed Draft Code of Practice to Minimize and Contain 
Antimicrobial Resistance
    [sbull] Proposed Draft Revised Guidelines for the Establishment 
of a Regulatory Programme for Control of Veterinary Drug Residues in 
Foods
    [sbull] Revised Discussion Paper on Residue Issues for the Codex 
Committee on Residues of Veterinary Drugs in Foods
    [sbull] Risk Analysis Principles and Methodologies, including 
Risk Assessment Policies, in the Codex Committee on Residues of 
Veterinary Drugs in Foods
    [sbull] Proposed Draft Appendix on the Prevention and Control of 
Veterinary Drug Residues in Milk and Milk Products
    [sbull] Priority List of Veterinary Drugs Requiring Evaluation 
or Reevaluation
    [sbull] Methods of Analysis and Sampling Issues
    [sbull] Performance-based Criteria
    [sbull] Identification of Routine Methods of Analysis
    Responsible Agency: HHS/FDA, USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Food Additives and Contaminants

    The Codex Committee on Food Additives and Contaminants (CCFAC) 
(a) establishes or endorses permitted maximum or guideline levels 
for individual food additives, contaminants, and naturally occurring 
toxicants in food and animal feed; (b) prepares priority lists of 
food additives and contaminants for toxicological evaluation by the 
Joint FAO/WHO Expert Committee on Food Additives (JECFA); (c) 
recommends specifications of identity and purity for food additives 
for adoption by the Commission; (d) considers methods of analysis 
for food additives and contaminants; and (e) considers and 
elaborates standards and codes for related subjects such as labeling 
of food additives when sold as such and food irradiation. The 
following matters are under consideration by the Commission at its 
25th Session in July 2003 or the Executive Committee at its 50th 
Session in June 2002. The relevant document is ALINORM 03/12.

Risk Analysis

    The 34th CCFAC agreed to circulate the ``Proposed Risk 
Assessment Policy Statement for the Application of Risk Analysis 
Principles to the Standard Setting Activities of the Codex Committee 
on Food Additives and Contaminants (CCFAC) in Conjunction with Risk 
Assessments Performed by the Joint FAO/WHO Expert Committee on Food 
Additives (JECFA)'' for comments at Step 3 and further consideration 
at its next meeting. The CCFAC also agreed to inform the Codex 
Executive Committee and the Codex Committee on General Principles of 
this document. 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 and forwarded 
to the 59th Meeting of the JECFA (Geneva, June 2002) for review and 
comment.

Food Additives

    To be considered at Step 8 by the 25th Session of the Codex 
Commission (July 2003):
    [sbull] Codex General Standard for Food Additives: Draft Food 
Additive Provisions in Table 1
    [sbull] Codex Advisory Specifications for the Identity and 
Purity of Food Additives
    To be considered at Step 5/8 of the Accelerated Procedure by the 
25th Session of the Codex Commission (July 2003):
    [sbull] Draft Revisions to the Codex International Numbering 
System for Food Additives
    [sbull] Proposed Draft Revisions to the Codex General Standard 
for Food Additives
    [sbull] Proposed Draft Revision to the Recommended International 
Code of Practice for Radiation processing of Food
    The Committee is continuing work on:
    [sbull] General Standard for Food Additives: Food Category 
System
    [sbull] General Standard for Food Additives: Draft Food Additive 
Provisions (in Table 1 and Table 3)
    [sbull] General Standard for Food Additives: Revisions to the 
Preamble to the clarify relationship between the General Standard 
and food additive provisions in Codex Commodity Standards and to 
clarify the principles for establishing food additive provisions in 
the General Standard
    [sbull] Proposed Draft Revision to the Codex Standard for 
Irradiated Foods
    [sbull] International Numbering System
    [sbull] Specifications for the Identity and Purity of Food 
Additives
    [sbull] Discussion Paper on Processing Aids and Additives Used 
as Carriers for Other Additives
    [sbull] Discussion Paper on the Use of Active Chlorine Compounds 
in Food Processing

Contaminants

    To be considered at Step 8 by the 25th Session of the Codex 
Commission (July 2003):
    [sbull] Codex General Standard for Contaminants and Toxins: 
Maximum Level for Patulin in Apple Juice and Apple Juice Ingredients 
in Other Beverages
    [sbull] Codex General Standard for Contaminants and Toxins: 
Maximum Level for Ochratoxin A in Wheat, Barley, Rye and derived 
products
    To be considered at Step 5 by the 50th Session of the Codex 
Executive Committee (June 2002):
    [sbull] Proposed Draft Code of Practice for the Prevention of 
Mycotoxin Contamination in Cereals, including Annexes on Ochratoxin 
A, Zearalenone, Fumonisins, and Tricothecenes
    [sbull] Proposed Draft Code of Practice for the Reduction of 
Patulin Contamination in Apple Juice and Apple Juice Ingredients
    The Committee is continuing work on:
    [sbull] Codex General Standard for Contaminants and Toxins: 
Proposed Draft Principles for Exposure Assessment of Contaminants 
and Toxins in Foods
    [sbull] Codex General Standard for Contaminants and Toxins: 
Draft maximum levels for lead in fish
    [sbull] Codex General Standard for Contaminants and Toxins: 
Maximum levels for lead in milk and milkfat
    [sbull] Codex General Standard for Contaminants and Toxins: 
Proposed Draft Maximum Levels for Cadmium in fruit, wheat grain, 
milled rice, soybean and peanuts, meat of cattle, poultry, pig and 
sheep, horse meat, vegetables, peeled potatoes, stem and root 
vegetables, leafy vegetables, fresh herbs, fungi, celeriac, and 
mollusks
    [sbull] Codex General Standard for Contaminants and Toxins: 
Proposed Draft Maximum Levels for Tin in liquid canned foods and 
solid canned foods
    [sbull] Proposed Draft Code of Practice for Source Directed 
Measures to Reduce Dioxin and Dioxin-like PCB Contamination of Foods
    [sbull] Discussion paper on Dioxins and Dioxin-like PCBs
    [sbull] Position Paper on Chloropropanols

[[Page 37763]]

    [sbull] Position Paper on Aflatoxin in Tree Nuts
    [sbull] Discussion Paper on Deoxynivalenol
    New Work:
    [sbull] Proposed Draft Code of Practice for the Reduction of 
Aflatoxin Contamination in Tree Nuts
    [sbull] Proposed Draft Code of Practice for the Prevention and 
Reduction of Lead in Food
    [sbull] Discussion Paper on the Development of a Code of 
Practice for the Reduction of Aflatoxin Contamination in Peanuts
    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 groups of food 
commodities. A Codex Maximum Residue 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. Foods derived from commodities that comply with the 
respective MRLPs are intended to be toxicologically acceptable, that 
is, consideration of the various dietary residue intake estimates 
and determinations both at the national and international level in 
comparison with the ADI*, should indicate that foods complying with 
Codex MRLPs are safe for human consumption.
    Codex MRLPs are primarily intended to apply in international 
trade and are derived from reviews conducted by the Joint Meeting on 
Pesticide Residues (JMPR) following:
    (a) Review of residue data from supervised trials and supervised 
uses including those reflecting national good agricultural practices 
(GAP). Data from supervised trials conducted at the highest 
nationally recommended, authorized, or registered uses are included 
in the review. In order to accommodate variations in national pest 
control requirements, Codex MRLPs take into account the higher 
levels shown to arise in such supervised trials, which are 
considered to represent effective pest control practices, and
    (b) Toxicological assessment of the pesticide and its residue.
    The following items will be considered by the Codex Commission 
at its 25th Session in July 2003. The relevant document is ALINORM 
03/24.
    To be considered at Step 8:
    [sbull] Proposed Draft Amendments to the ``Guidelines on Good 
Laboratory Practice in Pesticide Residue Analysis and the 
Introduction Section of the Recommended Methods of Analysis for 
Pesticide Residues''
    [sbull] Draft and Draft Revised Maximum Residue Limits
    To be considered at Step 5/8:
    [sbull] Proposed Draft and Proposed Draft Revised Maximum 
Residue Limits
    To be considered at Step 5 by the Executive Committee at its 
50th Session June 2002:
    [sbull] Proposed Draft and Proposed Draft Revised Maximum 
Residue Limits
    The committee is continuing work on:
    [sbull] Consideration of Draft and Proposed Draft Residue Limits 
in Foods and Feeds
    [sbull] Paper on Trade Vulnerabilities Resulting from the 
Lengthy Codex MRL Process
    [sbull] Paper on Cumulative Risk Assessment Methodology
    [sbull] Paper on Acute Dietary Risk Assessment
    [sbull] Revision of Regional Diets and Information on Processing
    [sbull] Revision of the List of Recommended Methods of Analysis 
for Pesticide Residues
    [sbull] Revision of the Codex Classification of Foods and Animal 
Feeds
    [sbull] Revision of Codex Priority Lists of Pesticides for 
review by JMPR
    * Acceptable Daily Intake (ADI) of a chemical is the daily 
intake which, during an entire lifetime, appears to be without 
appreciable risk to the health of the consumer on the basis of all 
the known facts at the time of the evaluation of the chemical by the 
Joint FAO/WHO Meeting on Pesticide Residues. It is expressed in 
milligrams of the chemical per kilogram of body weight.
    Responsible Agency: EPA, USDA/AMS.
    U.S. Participation: Yes.

Codex Committee on Methods of Analysis and Sampling

    The Codex Committee on Methods of Analysis and Sampling:
    (a) Defines the criteria appropriate to Codex Methods of 
Analysis and Sampling;
    (b) Serves as a coordinating body for Codex with other 
international groups working in methods of analysis and sampling and 
quality assurance systems for laboratories;
    (c) Specifies, on the basis of final recommendations submitted 
to it by the other bodies referred to in (b) above, Reference 
Methods of Analysis and Sampling appropriate to Codex Standards 
which are generally applicable to a number of foods;
    (d) Considers, amends, if necessary, and endorses, as 
appropriate, methods of analysis and sampling proposed by Codex 
(Commodity) Committees, except that methods of analysis and sampling 
for residues of pesticides or veterinary drugs in food, the 
assessment of microbiological quality and safety in food, and the 
assessment of specifications for food additives do not fall within 
the terms of reference of this Committee;
    (e) Elaborates sampling plans and procedures, as may be 
required;
    (f) Considers specific sampling and analysis problems submitted 
to it by the Commission or any of its Committees; and
    (g) Defines procedures, protocols, guidelines or related texts 
for the assessment of food laboratory proficiency, as well as 
quality assurance systems for laboratories.
    The next session of the Committee will take place in Budapest, 
Hungary on November 18-22, 2002. The Committee will continue work 
on:
    [sbull] Proposed Draft Guidelines on Measurement Uncertainly
    [sbull] Proposed Draft Guidelines for Evaluating Acceptable 
Methods of Analysis
    [sbull] Proposed Draft General Guidelines on Sampling
    [sbull] Validation of Methods
    [sbull] Single Laboratory Validation
    [sbull] Use of Proficiency Testing Schemes
    [sbull] 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 Certification and 
Inspection Systems

    The Codex Committee on Food Import and Export Inspection and 
Certification Systems is charged with developing principles and 
guidelines for food import and export inspection and certification 
systems to protect consumers and to facilitate trade. Additionally, 
the Committee develops principles and guidelines for the application 
of measures by competent authorities to provide assurance that foods 
comply with requirements, especially statutory health requirements. 
This encompasses work on: equivalence of food inspection systems 
including equivalence agreements, processes and procedures to ensure 
that sanitary measures are implemented; guidelines on food import 
control systems; and guidelines on food product certification and 
information exchange. The development of guidelines for the 
appropriate utilization of quality assurance systems to ensure that 
foodstuffs conform to requirements and to facilitate trade also are 
included in the Committee's terms of reference.
    The following guidelines, found in ALINORM 03/30, will be 
considered for adoption by the Codex Alimentarius Commission at its 
25th Session in July 2003.
    To be considered at Step 8:
    [sbull] Draft Guidelines for Food Import Control Systems
    The committee is continuing work on:
    [sbull] Draft Guidelines on the Judgement of Equivalence of 
Sanitary Measures Associated with Food Inspection and Certification 
Systems
    [sbull] Proposed Draft Guidelines for the Utilization and 
Promotion of Quality Assurance Systems to Meet Requirements in 
Relation to Food.
    [sbull] Proposed Revised Draft Guidelines for the Exchange of 
Information in Food Control Emergency Systems
    [sbull] Discussion paper to examine the need for elaboration of 
Proposed Draft Guidelines on the Judgement of Equivalence of 
Technical Regulations Associated with Food Inspection and 
Certification Systems
    [sbull] Discussion paper on traceability in the context of 
inspection and certification systems
    Responsible Agency: HHS/FDA, USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on General Principles

    The Codex Committee on General Principles deals with procedure 
and general matters as are referred to it by the Codex Alimentarius 
Commission. The 17th Session of the Committee met in Paris, France, 
on April 15-19, 2002. The following will be considered by the 50th 
Session of the Executive Committee in June 2002. The relevant 
document is ALINORM 03/33, Appendix II.
    To be considered at Step 5 by the 50th Session of the Executive 
Committee:

[[Page 37764]]

    [sbull] Proposed Draft Working Principles for Risk Analysis for 
Application within the Framework of Codex, at Step 5
    The Committee continues to work on:
    [sbull] Proposed Draft Working Principles for Risk Analysis as 
Guidance to National Governments, with consideration of traceability 
as a risk management option
    [sbull] Proposed Draft Revised Code of Ethics for International 
Trade in Foods
    [sbull] Guidelines for Cooperation with International 
Intergovernmental Organizations
    [sbull] Membership in the Codex Alimentarius Commission of 
Regional Economic Integration Organizations
    Responsible Agency: USDA/FSIS, HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Food Labelling

    The Codex Committee on Food Labelling is responsible for 
drafting provisions on labelling issues assigned by the Codex 
Alimentarius Commission. The Committee held its Thirtieth Session in 
Halifax, Canada on May 6-10, 2001. It considered the following 
items:
    [sbull] Draft Guidelines for the Production, Processing, 
Labelling and Marketing of Organically Produced Foods Proposed 
Revised Sections: Section 5--Criteria and Annex 2--Permitted 
Substances
    [sbull] 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)
    [sbull] Proposed Draft Amendment to the General Standard for the 
Labelling of Prepackaged Foods (Class Names) (milk protein/milk 
protein products)
    [sbull] Proposed Draft Amendment to the Guidelines on Nutrition 
Labelling
    [sbull] Proposed Draft Recommendations for the Use of Health 
Claims: Proposed Draft Guidelines for the use of Nutrition and 
Health Claims
    [sbull] Proposed Draft Amendment to the General Standard for the 
Labelling of Prepackaged Foods: Quantitative Declaration of 
Ingredients
    [sbull] Discussion paper on Misleading Claims
    [sbull] Discussion paper on Country of Origin Labelling
    Responsible Agency: HHS/FDA, USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Food Hygiene

    The Codex Committee on Food Hygiene drafts basic provisions on 
food hygiene applicable to all food. The Committee suggests and 
prioritizes areas where there is a need for microbiological risk 
assessment at the international level and considers microbiological 
risk management matters in relation to food hygiene and in relation 
to the risk assessment activities of FAO and WHO. The Committee 
considers, amends if necessary, and endorses food hygiene provisions 
that are incorporated into specific Codex commodity standards by the 
Codex commodity committees. The Committee provides such other 
general guidance to the Commission on matters relating to food 
hygiene as may be necessary.
    The following item will be considered by the Codex Alimentarius 
Commission at its 25th Session in July 2003. The relevant document 
is ALINORM 03/13.
    To be considered at Step 8:
    [sbull] Draft Code of Hygienic Practice for Fresh Fruits and 
Vegetables
    The following will be considered at Step 5 by the Executive 
Committee
    [sbull] Proposed Draft Revised Guidelines for the Application of 
HACCP System
    The committee continues to work on:
    [sbull] Proposed Draft Code of Hygienic Practice for Milk and 
Milk Products
    [sbull] Proposed Draft Principles and Guidelines for the Conduct 
of Microbiological Risk Management
    [sbull] Proposed Draft Guidelines for the Control of Listeria 
monocytogenes in Foods
    [sbull] Proposed Draft Guidelines for Validation of Food 
Hygienic Control Measures
    [sbull] Proposed Draft Revision of the Code of Hygienic Practice 
for Eggs and Egg Products
    [sbull] Discussion paper on Risk Management Strategies for 
Salmonella spp. in Poultry
    [sbull] Discussion paper on Risk Management Strategies for 
Campylobacter spp. in Poultry
    [sbull] Discussion paper on Risk Management Strategies for 
Vibrio spp. in finfish and shellfish.
    [sbull] Risk Profile for Enterohemorrhagic E. coli Including the 
Identification of Commodities of Concern, including Sprouts, Ground 
Beef and Pork
    Responsible Agency: HHS/FDA, FSIS/USDA.
    U.S. Participation: Yes.

Codex Committee on Fresh Fruits And Vegetables

    The Codex Committee on Fresh Fruits and Vegetables is 
responsible for elaborating world-wide standards and codes of 
practice for fresh fruits and vegetables. The next session of the 
Committee will be held June 10-14, 2002 in Mexico City, Mexico.
    The committee is continuing work on:
    [sbull] Draft Standard for Cassava
    [sbull] Draft Standard for Yellow Pitahaya
    [sbull] Draft Standard for Oranges including Guide for Use in 
Scoring Freezing Injury
    [sbull] Sizing sections of the grapefruit, lime and pummelo 
standards.
    [sbull] Proposed Draft Standard for Tomatoes
    [sbull] Proposed Draft Standard for Table Grapes
    [sbull] Proposed Draft Standard for Apples
    [sbull] Proposed Draft Guide for the Quality Control of Fresh 
Fruits and Vegetables
    [sbull] 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 general 
provisions, as appropriate, on nutritional aspects of all foods and 
develops standards, guidelines, or related texts for foods for 
special dietary uses.
    The committee continues work on:
    [sbull] Proposed Draft Revised Standard for Processed Cereal-
Based Foods for Infants and Young Children
    [sbull] Proposed Draft Revised Standard for Infant Formula
    [sbull] Proposed Draft Guidelines for Vitamin and Mineral 
Supplements
    [sbull] Proposed Draft Revision of the Advisory List(s) of 
Mineral Salts and Vitamin Compounds for the Use in Foods for Infants 
and Children
    When new scientific information becomes available, the committee 
plans to resume work on:
    [sbull] Discussion Paper on Energy Conversion Factors
    [sbull] Guidelines for Use of Nutrition Claims--Draft Table of 
Conditions for Nutrient Contents Claims (Part B containing 
Provisions on Dietary Fibre)
    [sbull] Proposed Draft Revised Standards for Gluten-Free 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, frozen and otherwise processed 
fish, crustaceans and mollusks. The Committee will hold its 25th 
Session on June 3-7, 2002 in Alesund, Norway. The Committee is 
working on these standards and codes of practice:
    [sbull] Inclusion of additional species (Proposed Draft 
Amendment to the Canned Sardines Standard)
    [sbull] Proposed Draft Standard for Salted Atlantic Herring and 
Salted Sprats
    [sbull] Proposed Draft Code of Practice for Fish and Fishery 
Products
    [sbull] Draft Standard for Dried Salted Anchovies
    [sbull] Proposed Draft Standard for Smoked Fish
    [sbull] Proposed Draft Standard for Molluscan Shellfish
    [sbull] Proposed Draft Model Certificate for Fish and Fishery 
Products
    [sbull] Proposed Draft Standard for Live, Quick Frozen and 
Canned Bivalve Molluscs
    [sbull] Proposed Draft Amendment to the Standard for Quick 
Frozen Lobsters
    [sbull] Fish Content Definition and its Method of Determination
    [sbull] 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 by the 25th Session of 
the Commission when it meets in June 2003. The relevant document is 
ALINORM 03/11.
    To be considered at Step 8:
    [sbull] Proposed Draft Revised Standard for Cream and Prepared 
Creams
    [sbull] Proposed Draft Revised Standard for Fermented Milks
    [sbull] Proposed Draft Revised Standard for Whey Powders

[[Page 37765]]

    [sbull] Proposed Draft Amendment to the Codex General Standard 
for Cheese (Appendix on cheese rind, surface, and coating)
    The following will be considered by the 50th Session of the 
Executive Committee when it meets in June 2002:
    To be considered at Step 5:
    [sbull] Proposed Draft Standard for Products in Which Milk 
Components are Substituted by Non-Milk Components
    [sbull] Evaporated Skimmed Milk with Vegetable Fat
    [sbull] Sweetened Condensed Skimmed Milk with Vegetable Fat
    [sbull] Skimmed Milk Powder with Vegetable Fat
    [sbull] Proposed Draft Amendment to Section 3.3 (Composition) of 
the Codex General Standard for Cheese
    To be considered as new work:
    [sbull] Proposed Draft Model Export Certificate for Milk and 
Milk Products
    The Committee continues work on:
    [sbull] Methods of Analysis and Sampling for Milk Products
    [sbull] Draft Revised Standards for Individual Cheeses
    [sbull] Draft Revised Standard for Processed Cheese
    [sbull] Draft Revised Standard for Dairy Spreads
    [sbull] Proposals for new standards: Parmesan, Cheese 
Specialties
    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 18th Session in London in 
February 2003.
    To be considered by the Committee at its next session:
    [sbull] Draft Standard for Olive Oils and Olive-Pomace Oils
    [sbull] Proposed Draft Amendments to the Standard for Named 
Vegetable Oils
    [sbull] Super palm olein
    [sbull] Mid-oleic sunflower oil
    [sbull] Inclusion of new desmethysterol data and tocopherol and 
tocotrienol data for palm olien, palm stearin, rapeseed oil (high 
erucic acid) and mustard oil
    [sbull] Inclusion of new data on Table 3 expressed in mg/kg
    [sbull] Draft Standard for Fat Spreads
    [sbull] 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 world-wide standards for cocoa products 
and chocolate. The following standard will be considered by the 25th 
Session of the Commission in June 2003. The relevant document is 
ALINORM 03/14.
    To be considered at Step 8:
    [sbull] Draft Revised Standard for Chocolate and Chocolate 
Products
    The Committee agreed to adjourn sine die as it had completed its 
program of work.
    Responsible Agency: HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Processed Fruits and Vegetables

    The Codex Committee on Processed Fruits and Vegetables is 
responsible for elaborating standards for processed fruits and 
vegetables. The Twenty-first Session of the Committee will be hosted 
by the United States in September 2002.
    To be considered at step 7:
    [sbull] Draft Standard for Canned Stone Fruit
    [sbull] Draft Standard for Canned Pickled Products
    [sbull] Draft Standard for Canned Bamboo Shoots
    [sbull] Draft Standard for Aqueous Coconut Products
    [sbull] Draft Codex Guidelines for Packing Media for Canned 
Fruits
    To be considered at step 4:
    [sbull] Proposed Draft Standard for Canned Citrus Fruits
    [sbull] Proposed Draft Revised Standard for Canned Tomatoes
    [sbull] Proposed Draft Revised Standard for Processed Tomato 
Concentrates
    [sbull] Proposed Draft Standard for Canned Vegetables
    [sbull] Proposed Draft Standard for Jams, Jellies, and 
Marmalades
    [sbull] Proposed Draft Standard for Soy Sauce
    [sbull] Proposed Draft Standard for Ginseng
    [sbull] Proposed Draft Guidelines for Packing Media for Canned 
Vegetables.
    The Committee will also discuss:
    [sbull] Proposed Draft Codex Guidelines for the Processing and 
Handling of Quick Frozen Foods
    Responsible Agency: USDA/AMS, HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Meat and Poultry Hygiene

    The 24th Session of the Commission decided to reactivate the 
Codex Committee on Meat Hygiene and agreed to rename it the Codex 
Committee on Meat and Poultry Hygiene with New Zealand as Host 
Government. The Terms of Reference were amended to reflect the 
inclusion of poultry in its mandate. The reconstituted committee 
held its 8th Session in Wellington, New Zealand on February 18-22, 
2002. The following, contained in ALINORM 03/16, will be considered 
by the Executive Committee at its 50th Session in June 2002.
    To be considered at Step 5:
    [sbull] Proposed Draft General Principles of Meat Hygiene
    Requested the Commission to change the name back to the Codex 
Committee on Meat Hygiene.
    The Committee continues to work on:
    [sbull] Proposed Draft Code of Hygienic Practice for Fresh Meat
    [sbull] Discussion paper on hygiene provisions for processed 
meat
    [sbull] Discussion paper on principles and guidelines for 
establishing risk based ante- and post-mortem inspection systems for 
particular slaughter populations
    [sbull] Discussion paper on principles and guidelines on systems 
for microbiological process control for meat
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Certain Codex Commodity Committees \1\
---------------------------------------------------------------------------

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

    Several Codex Alimentarius Commodity Committees have adjourned 
sine die. The following Committees fall into this category:
    [sbull] Cereals, Pulses and Legumes
    Responsible Agency: HHS/FDA, USDA/GIPSA.
    U.S. Participation: Yes.
    [sbull] Natural Mineral Water
    Responsible Agency: HHS/FDA.
    U.S. Participation: Yes.
    [sbull] Sugars
    Responsible Agency: USDA/ARS; HHS/FDA.
    U.S. Participation: Yes.
    [sbull] Vegetable Proteins
    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 of consumers and the 
promotion of fair trade practices.
    The following, contained in ALINORM 03/34, will be considered by 
the Codex Alimentarius Commission at its 25th Session in June 2003.
    To be considered at Step 8:
    [sbull] Draft General Principles for the Risk Analysis of Foods 
Derived from Modern Biotechnology
    [sbull] Draft Guideline for the Conduct of Safety Assessment of 
Foods Derived from Recombinant-DNA Plants
    To be considered by the Executive Committee in June 2002 at Step 
5:
    [sbull] Proposed Draft Guidelines for the Conduct of Food Safety 
Assessment of Recombinant-DNA Microorganisms
    The Task Force will continue to:
    [sbull] Discuss traceback/traceability
    Responsible Agency: HHS/FDA, USDA/APHIS.
    U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Animal Feeding

    The Commission at its 23rd Session established the ad hoc 
Intergovernmental Task Force on Animal Feeding to develop guidelines 
or standards as appropriate on good animal feeding practices. An 
Interim Report of the work of the Task Force, as required under its 
Terms of Reference, was presented to the 24th Commission by Denmark, 
the host government. The Task Force will hold its 3rd Session on 
June 17-20, 2002 and continue discussing:

[[Page 37766]]

    [sbull] Revised Draft Code of Practice for Good Animal Feeding
    Responsible Agency: HHS/FDA, USDA/APHIS.
    U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices

    The Commission at its 23rd Session established this Task Force 
to revise and consolidate the existing Codex standards and 
guidelines for fruit and vegetable juices and related products, 
giving preference to general standards. These standards were 
originally developed by the Joint UNECE/Codex Group of Experts on 
the Standardization of Fruit Juices, which had been abolished by its 
parent organizations. The Task Force held its second session in Rio 
de Janeiro, Brazil, on April 23-26, 2002. The reference document is 
ALINORM 03/39.
    The committee is discussing:
    [sbull] Proposed Draft Codex General Standard for Fruit Juices 
and Nectars
    [sbull] Proposed Draft Revised Codex General Standard for 
Vegetable Juices
    [sbull] 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:
    [sbull] Coordinating Committee for Africa
    [sbull] Coordinating Committee for Asia
    [sbull] Coordinating Committee for Europe
    [sbull] Coordinating Committee for Latin America and the 
Caribbean
    [sbull] Coordinating Committee for the Near East
    [sbull] 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:
    [sbull] Defines the problems and needs of the region concerning 
food standards and food control;
    [sbull] 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;
    [sbull] 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
    [sbull] Exercises a general coordinating role for the region and 
such other functions as may be entrusted to it by the Commission.

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

    The Coordinating Committee is responsible for defining problems 
and needs concerning food standards and food control of all Codex 
member countries of the region. The Seventh Session of the Committee 
will be hosted by Canada October 29-November 1, 2002. Work 
priorities include the following ongoing and new areas of work:
    [sbull] Changes to food regulatory systems and food laws;
    [sbull] Policy-related issues including the areas of 
biotechnology, anti-microbial resistance, animal feeding and 
improving the effectiveness of Codex responses in meeting the needs 
of its members;
    [sbull] Issues facing small and less developed businesses;
    [sbull] Ongoing capacity building and monitoring compliance 
within developing countries;
    [sbull] The responses by relevant Codex Committees to the public 
health and trade vulnerability issues resulting from the lengthy 
Codex MRL setting process.
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Attachment 2

U.S. Codex Alimentarius Officials

Codex Committee Chairpersons

Codex Committee on Food Hygiene

    Dr. Karen Hulebak, Senior Advisor for Scientific Affairs, Office 
of the Administrator, U.S. Department of Agriculture, Food Safety 
and Inspection Service, 1400 Independence Ave., SW., Room 3130-South 
Building, Washington, DC 20250. Phone: 202-720-8609; Fax: 202-720-
9893; E-mail: [email protected]

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: [email protected]

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; Fax : 
(301) 594-1830; E-mail: [email protected]

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: [email protected]

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

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

U.S. Delegate

    Dr. Pamela L. Chamberlain, Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Place HFV-130, Rockville, MD 
20855. Phone (301) 827-0121; FAX: (301) 594-2298; E-mail: 
[email protected]

Alternate Delegate

    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition (HFS-200), Food and Drug 
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835. Phone: (202) 418-3113; Fax: 
(202) 418-3131. E-mail: [email protected].

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

U.S. Delegate

    Edward Zager, Associate Director, Health Effects Division, 
Office of Pesticide Programs, U.S. Environmental Protection Agency, 
Ariel Rios Building, 1200 Pennsylvania Ave., NW, Washington, DC 
20460, Phone: (703) 305-5035; Fax: (703) 305-5147. E-mail: 
[email protected].

Alternate Delegate

    Dr. Robert Epstein, Associate Deputy Administrator, Science and 
Technology, Agricultural Marketing Service, U.S. Department of 
Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 1400 
Independence Ave., SW, Washington, DC 20090. Phone (202) 720-2158; 
Fax: (202) 720-1484. E-mail: [email protected].

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

U.S. Delegate

    Dr. Gregory Diachenko, Director, Division of Chemistry Research 
and Environmental Review, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition (CFSAN), Food and Drug 
Administration (HFS-245), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835. Phone 301-436-
2387; Fax: (301) 436-2364. E-mail: [email protected].

Alternate Delegate

    Dr. Thomas B. Whitaker, Senior Scientist, Agricultural Research 
Service, U.S. Department of Agriculture, 124 Weaver Laboratory, 
North Carolina State University, Raleigh, North Carolina, Phone: 
(919) 515-6731; Fax: (919) 515-7760. E-mail: [email protected].

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

U.S. Delegate

     Dr. Catherine Carnevale, Director, Office of Constituent 
Operations, Center for Food Safety and Applied Nutrition, Food and 
Drug

[[Page 37767]]

Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
2380; Fax: (301) 436-2618. E-mail: 
[email protected].

Alternate Delegate

    Karen Stuck, Chief, International Policy Staff, Food Safety and 
Inspection Service, U.S. Dept. of Agriculture, Room 2137 South 
Bldg., 1400 Independence Ave., SW, Washington, DC 20250-3700, Phone: 
202-720-3470; Fax: 202-720-7990. E-mail: [email protected].

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 Labeling, (Host Government--Canada),

U.S. Delegate

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

Alternate Delegate

    Dr. Robert Post, Director, Labeling & Compounds Review Division, 
OPPDE, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 602, 300 12th Street, SW, Washington, DC 20250. 
Phone: (202) 205-0279; Fax: (202) 205-3625. E-mail: 
[email protected].

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

U.S. Delegate

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

Alternate Delegate

    Dr. H. Michael Wehr, U.S. Food and Drug Administration, Office 
of Constituent Operations, Food and Drug Administration (HFS-550), 
Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College 
Park, MD 20740-3835. Phone: (301) 436-1725; Fax: (301) 436-2618. E-
mail: [email protected].

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

U.S. Delegate

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

Alternate Delegate

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

Worldwide Commodity Codex Committees,

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

U.S. Delegate

    Mr. David Priester, Head, Standardization Branch, International 
Standards Coordinator, Fruit & Vegetable Division, Agricultural 
Marketing Service, U.S. Department of Agriculture, Room 2069, South 
Building, 1400 Independence Ave., SW, Washington, DC 20250. Phone: 
(202) 720-2184; Fax: (202) 720-0016. E-mail: 
[email protected].

Alternate Delegate

    VACANT,

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

U.S. Delegate,

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

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: (301) 
713-2351; Fax: (301) 713-1081. E-mail: [email protected].

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

U.S. Delegate

    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835. Phone: (301) 436-
1714; Fax: (301) 436-2612. E-mail: [email protected].

Alternate Delegate

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

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

U.S. Delegate

    Mr. Duane Spomer, Chief, Dairy Standardization Branch, U.S. 
Department of Agriculture, Agricultural Marketing Service, Room 
2750-South Building, 1400 Independence Ave., SW, Washington, DC 
20250. Phone: (202) 720-9382; Fax: (202) 720-2643. E-mail: 
[email protected].

Alternate Delegate

    Mr. John C. Mowbray, Division of Dairy and Egg Safety, Center 
for Food Safety and Applied Nutrition, Food and Drug Administration 
(HFS-306), Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835. Phone: 301-436-1490; Fax: 301-
436-2632. E-mail: [email protected]

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

U.S. Delegate

    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714; Fax: (301) 436-2618, E-mail: [email protected].

Alternate Delegate

    Kathleen Warner (Acting), U.S. Department of Agriculture, 1815 
N. University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax: 
(309) 681-6668, E-mail: [email protected]

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

U.S. Delegate

    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2612, E-mail: [email protected]

Alternate Delegate

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

Codex Committee on Sugars (Host Government--United Kingdom)

U.S. Delegate

    Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit, 
Agricultural Research, USDA--FSIS 5883 USDA Road, Houma, LA 70360, 
Phone: (504) 872-5042, Fax: (504) 868-8369, E-mail: 
[email protected]

Alternate Delegate

    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and

[[Page 37768]]

Applied Nutrition, Food and Drug Administration (HFS-200), Harvey W. 
Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 
20740-3835, Phone: (202) 418-3113, Fax: (202) 418-3131, E-mail: 
[email protected]

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

U.S. Delegate

    Mr. James Rodeheaver, Chief, Processed Products Branch, Fruit 
and Vegetable Division, Agricultural Marketing Service, U.S. 
Department of Agriculture, Room 0709 South Building, 1400 
Independence Ave. SW, Washington, DC 20250, Phone: 202-720-4693, 
Fax: 202-690-1527, E-mail: [email protected]

Alternate Delegate

    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: [email protected]

Codex Committee on Vegetable Proteins (Host Government--Canada)

U.S. Delegate

    Dr. Wilda H. Martinez, Area Director, ARS North Atlantic Area, 
Agricultural Research Service, USDA 600 E. Mermaid Lane, Wyndmoor, 
PA 19038, Phone: (215) 233-6593, Fax: (215) 233-6719, E-mail: 
[email protected]

Alternate Delegate

    Dr. Jeanne Rader, Director, Division of Research and Applied 
Technology, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2377, 
Fax: (301) 436-2640, E-mail: [email protected]

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

U.S. Delegate, Dr. Perfecto Santiago, Assistant Deputy Administrator, 
Office of Policy, Program Development, and Evaluation, Food Safety and 
Inspection Service, USDA 402 Cotton Annex 300 12th St. SW, Washington, 
DC 20025, Phone: (202) 205-0699, Fax: (202) 401-1760, E-mail: 
[email protected]

Alternate Delegate

    Dr. William James, Director, Food Animal Sciences Division, 
Office of Public Health and Science, Food Safety and Inspection 
Service, USDA, Mail Drop 343, 900 D Street, SW, Washington, DC 
20024. Phone: (202) 690-6572; Fax: (202) 690-6565; E-mail: 
[email protected].

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

U.S. Delegate

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

Alternate Delegate

    Ms. Shellee Anderson, Division of Dairy and Egg Safety, Center 
for Food Safety and Applied Nutrition, Food and Drug Administration 
(HFS-306), Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835. Phone: (301) 436-1491; Fax: 
(301) 436-2632; E-mail: [email protected].

Ad Hoc Intergovernmental Task Forces

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices 
(Host government--Brazil)

U.S. Delegate

    Mr. Martin Stutsman, Office of Plant and Dairy Foods and 
Beverages, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 
5100 Paint Branch Parkway, College Park, MD 20740-3835. Phone: (301) 
436-1642; Fax: (301) 436-2651; E-mail: [email protected].

Alternate Delegate

    Mr. David Priester, International Standards Coordinator, Fruit & 
Vegetable Division, Agricultural Marketing Service, U.S. Department 
of Agriculture, Room 2069, South Building, 1400 Independence Ave., 
SW., Washington, DC 20250. Phone: (202) 720-2184; Fax: (202) 720-
0016; E-mail: [email protected].

Ad Hoc Intergovernmental Task Force on Foods Derived from 
Biotechnology (Host government--Japan)

U.S. Delegate

    L. Robert Lake, Director, Office of Regulations and Policy, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-004), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835. Phone: (301) 436-
2379; Fax: (301) 436-2637; E-mail: [email protected].

Alternate Delegate

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

Ad Hoc Intergovernmental Task Group on Animal Feeding (Host 
government--Denmark)

U.S. Delegate

    Dr. Stephen F. Sundlof, Director, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Place (HFV-1), 
Metro Park N. 4, Rockville, MD 20855. Phone: (301) 827-2950; Fax: 
(301) 827-4401; E-mail: [email protected].

Alternate Delegate

    Dr. Lawrence E. Miller, Senior Staff Veterinarian, Veterinary 
Services, Marketing and Regulatory Programs, Animal and Plant Health 
Inspection Service, U.S. Department of Agriculture, 4700 River Road, 
Unit 46, Riverdale, MD 20737. Phone: 301 734 7718; Fax: 301-734 
7964; E-mail: [email protected].

There are six regional coordinating committees:

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

Contact

    Dr. F. Edward Scarbrough, Manager, U.S. Codex Office, Food 
Safety and Inspection Service, Room 4861 South Bldg, 1400 
Independence Ave., SW, Washington, DC 20250-3700. Phone (202) 205-
7760; Fax (202) 720-3157; E-mail: [email protected].

Attachment 3

Timetable of Codex Sessions

(June 2001 through June 2003)

----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
2001:
    CX 702-48.....................  Executive Committee of the      28-29 June...........  Geneva.
                                     Codex Alimentarius Commission
                                     (48th Session).
    CX 701-24.....................  Codex Alimentarius Committee    2-7 July.............  Geneva.
                                     (24th Session).
    CX 702-49.....................  Executive Committee of the      26-27 September......  Geneva.
                                     Codex Alimentarius Commission
                                     (49th Extraordinary Session).
    CX 708-19.....................  Codex Committee on Cocoa        3-5 October..........  Fribourg.
                                     Products and Chocolate (19th
                                     Session).
    CX 712-34.....................  Codex Committee on Food         15-20 October........  Bangkok.
                                     Hygiene (34th Session).

[[Page 37769]]

 
    CX 720-23.....................  Codex Committee for Nutrition   26-30 November.......  Berlin.
                                     and Foods for Special Dietary
                                     Uses (23rd Session).
    CX 730-13.....................  Codex Committee on Residue of   4-7 December.........  Charleston, SC.
                                     Veterinary Drugs in Foods
                                     (13th Session).
2002:
    CX 723-8......................  Codex Committee on Meat         18-22 February.......  Wellington.
                                     Hygiene (8th Session).
    CX 733-10.....................  Codex Committee on Food Import  25 February-1 March..  Brisbane.
                                     and Export Certification and
                                     Inspection Systems (10th
                                     Session).
    CX 802-03.....................  ad hoc Intergovernmental Task   4-8 February.........  Yokohama.
                                     Force on Biotechnology (3rd
                                     Session).
    CX 711-34.....................  Codex Committee on Food         11-15 March..........  Rotterdam.
                                     Additives and Contaminants
                                     (34th Session).
    CX 703-5......................  Codex Committee on Milk and     8-12 April...........  Wellington.
                                     Milk Products (5th Session).
    CX 716-17.....................  Codex Committee on General      15-19 April..........  Paris.
                                     Principles (17th Session).
    CX 801-2......................  ad hoc Intergovernmental Task   23-26 April..........  Rio de Janeiro.
                                     Force on Fruit Juice (2nd
                                     Session).
    CX 714-30.....................  Codex Committee on Food         6-10 May.............  Halifax.
                                     Labelling (30th Session).
    CX 718-34.....................  Codex Committee on Pesticide    13-18 May............  The Hague.
                                     Residues (34th Session).
    CX 722-25.....................  Codex Committee on Fish and     3-7 June.............  Alesund.
                                     Fishery Products (25th
                                     Session).
    CX 731-10.....................  Codex Committee on Fresh        10-14 June...........  Mexico City.
                                     Fruits and Vegetables (10th
                                     Session).
    CX 803-03.....................  ad hoc Intergovernmental Task   17-20 June...........  Copenhagen.
                                     Force on Animal Feeding (3rd
                                     Session).
    CX 702-50.....................  Executive Commission of the     26-28 June...........  Rome.
                                     Codex Alimentarius Commission
                                     (50th Session).
    CX 706-23.....................  FAO/WHO (Codex) Regional        10-13 September......  Bratislava.
                                     Coordinating Committee for
                                     Europe (23rd Session).
    CX 727-13.....................  FAO/WHO (Codex) Regional        17-20 September......  Kuala Lumpur.
                                     Coordinating Committee for
                                     Asia (13th Session).
    CX 713-21.....................  Codex Committee on Processed    23-27 September......  San Antonio, TX.
                                     Fruits and Vegetables (21st
                                     Session).
    CX 712-35.....................  Codex Committee on Food         21-26 October........  Washington, DC.
                                     Hygiene (35th Session).
    CX 732-7......................  FAO/WHO (Codex) Regional        29 October-1 November  Canada.
                                     Coordinating Committee for
                                     North America and the South-
                                     West Pacific (7th Session).
    CX 720-24.....................  Codex Committee on Nutrition    4-8 November.........  Berlin.
                                     and Foods for Special Dietary
                                     Uses (24th Session).
2003:
    CX 734-3......................  FAO/WHO (Codex) Regional        20-23 January........  Cairo.
                                     Coordinating Committee for
                                     the Near East (2nd Session).
    CX 709-18.....................  Codex Committee on Fats and     3-7 February.........  London.
                                     Oils (18th Session).
    CX 723-9......................  Codex Committee on Meat         17-21 February.......  Wellington.
                                     Hygiene (9th Session).
    CX 730-14.....................  Codex Committee on Residues of  4-7 March............  TBA.
                                     Veterinary Drugs in Foods
                                     (14th Session).
    CX 802-4......................  ad hoc Intergovernmental Task   10-14 March..........  Yokohama.
                                     Force on Biotechnology (4th
                                     Session).
    CX 711-35.....................  Codex Committee on Food         17-21 March..........  The Hague.
                                     Additives and Contaminants
                                     (35th Session).
    CX 803-4......................  ad hoc Intergovernmental Task   24-26 March..........  Copenhagen.
                                     Force on Animal Feeding (4th
                                     Session).
    CX 718-35.....................  Codex Committee on Pesticide    31 March-4 April.....  The Hague.
                                     Residues (35th Session).
    CX 716-18.....................  Codex Committee on General      7-11 April...........  Paris.
                                     Principles (18th Session).
    CX 714-31.....................  Codex Committee on Food         28 April-2 May.......  Ottawa.
                                     Labelling (31st Session).
    CX 801-3......................  ad hoc Intergovernmental Task   6-9 May..............  Brasilia.
                                     Force on Fruit and Vegetable
                                     Juices (3rd Session).
    CX 702-51.....................  Executive Committee of the      26-27 June...........  Rome.
                                     Codex Alimentarius Commission
                                     (51st Session).
    CX 701-25.....................  Codex Alimentarius Commission   30 June-5 July.......  Rome.
                                     (25th Session).
----------------------------------------------------------------------------------------------------------------


[[Page 37770]]

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 ([mu]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

[[Page 37771]]

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

[[Page 37772]]

indicates the statements which should be included in standards as 
appropriate under the relevant headings of the standard. The 
sections of the format required to be completed for a standard are 
only those provisions that are appropriate to an international 
standard for the food in question.

Name of the Standard
Scope
Description
Essential Composition and Quality Factors
Food Additives
Contaminants
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling

Format for Codex Standards

Name of the Standard

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

Scope

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

Description

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

Essential Composition and Quality Factors

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

Food Additives

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

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

    A tabulation should then follow, viz.:
    ``Name of additive, maximum level (in percentage or mg/kg).''

Contaminants

    (a) Pesticide Residues: This section should include, by 
reference, any levels for pesticide residues that have been 
established by the Codex Committee on Pesticide Residues for the 
product concerned.
    (b) Other Contaminants: In addition, this section should contain 
the names of other contaminants and where appropriate the maximum 
level permitted in the food, and the text to appear in the standard 
may take the following form:

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

    A tabulation should then follow, viz.:
    ``Name of contaminant, maximum level (in percentage or mg/kg).''

Hygiene

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

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

Weights and Measures

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

Labelling

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

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

Methods of Analysis and Sampling

    This section should include, either specifically or by 
reference, all methods of analysis and sampling considered necessary 
and should be prepared in accordance with the guidance given in the 
Codex Procedural Manual. If two or more methods have been proved to 
be equivalent by the Codex Committee on Methods of Analysis and 
Sampling, these could be regarded as alternatives and included in 
this section either specifically or by reference. The following 
statement should also appear:
    ``The methods of analysis and sampling described hereunder are 
to be endorsed [have been endorsed] by the Codex Committee on 
Methods of Analysis and Sampling.''
[FR Doc. 02-13527 Filed 5-29-02; 8:45 am]
BILLING CODE 3410-DM-P