[Federal Register: May 27, 2005 (Volume 70, Number 102)]
[Notices]               
[Page 30675-30690]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my05-31]                         

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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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[[Page 30675]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 05-003N]

 
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, Public Law 103-465, 108 Stat. 4809. This notice also provides a 
list of other standard-setting activities of Codex, including commodity 
standards, guidelines, codes of practice, and revised texts. This 
notice, which covers the time periods from June 1, 2004, to May 31, 
2005, and June 1, 2005, to May 31, 2006, seeks comments on standards 
currently under consideration and recommendations for new standards.

ADDRESSES: Comments may be submitted by any of the following methods:
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
    All submissions received must include the Agency name and docket 
number 05-003N. Please state that your comments refer to Codex and, if 
your comments relate to specific Codex committees, please identify 
those committees in your comments and submit a copy of your comments to 
the delegate from that particular committee. All comments submitted 
will be available for public inspection in the FSIS Docket Room at the 
address listed above between 8:30 a.m. and 4:30 p.m., Monday through 
Friday. The comments also will be posted on the Agency's Web site at 

http://www.fsis.usda.gov/regulations/2005_notices_index/.


FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Ph.D., United 
States Manager for Codex, U.S. Department of Agriculture, Office of the 
Under Secretary 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/current.asp 
The U.S. Codex Office also maintains a Web site at 
http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.

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, World Organization for Animal 
Health, 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 SPS standard-setting activities 
of each international standard-setting organization. The Secretary of 
Agriculture has delegated to the Administrator, Food Safety and 
Inspection Service (FSIS), the responsibility to inform the public of 
the SPS standard-setting activities of Codex. The FSIS Administrator 
has, in turn, assigned the responsibility for informing the public of 
the SPS standard-setting activities of Codex to the U.S. Codex Office, 
FSIS.
    Codex was created in 1962 by two U.N. organizations, the Food and 
Agriculture Organization (FAO) and the World Health Organization (WHO). 
Codex is the principal international organization for encouraging fair 
international trade in food and protecting the health and economic 
interests of consumers. Through adoption of food standards, codes of 
practice, and other guidelines developed by its committees and by 
promoting their adoption and implementation by governments, Codex seeks 
to ensure that the world's food supply is sound, wholesome, free from 
adulteration, and correctly labeled. In the United States, the United 
States Department of Agriculture (USDA); the Food and Drug 
Administration (FDA), Department of Health and Human Services (HHS); 
and the Environmental Protection Agency (EPA) manage and carry out U.S. 
Codex activities.
    As the agency responsible for informing the public of the SPS 
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 SPS standards under consideration or planned for 
consideration; and
    2. For each SPS 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

[[Page 30676]]

consideration by Codex, please contact the Codex delegate or the U.S. 
Codex Office. This notice also solicits public comment on those 
standards that are currently under consideration or planned for 
consideration and recommendations for new standards. The delegate, in 
conjunction with the responsible agency, will take the comments 
received into account in participating in the consideration of the 
standards and in proposing matters to be considered by Codex.
    The United States' delegate will facilitate public participation in 
the United States Government's activities relating to Codex 
Alimentarius. The United States' delegate will maintain a list of 
individuals, groups, and organizations that have expressed an interest 
in the activities of the Codex committees and will disseminate 
information regarding United States' delegation activities to 
interested parties. This information will include the current status of 
each agenda item; the United States Government's position or 
preliminary position on the agenda items; and the time and place of 
planning meetings and debriefing meetings following Codex committee 
sessions. In addition, the U.S. Codex Office makes much of the same 
information available through its web page, 
http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp. 
Please visit the web page or notify the appropriate U.S. delegate or the Office of 
U.S. Codex Alimentarius, Room 4861, South Agriculture Building, 1400 
Independence Avenue, SW., Washington, DC 20250-3700, if you would like 
to access or receive information about specific committees.
    The information provided in Attachment 1 describes the status of 
Codex standard-setting activities by the Codex Committees for the time 
periods from June 1, 2004 to May 31, 2005, and June 1, 2005 to May 31, 
2006. 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 2004 through June 2006)
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 ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS web page located at 
http://www.fsis.usda.gov/regulations/2005_Notices_Index/.

    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at 
http://www.fsis.usda.gov/news_and_events/email_subscription/
 and allows FSIS customers to sign up 
for subscription options across eight categories. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their account.

    Done at Washington, DC on May 24, 2005.
F. Edward Scarbrough,
United States Manager for Codex.

Attachment 1: Sanitary and Phytosanitary Activities of Codex

Codex Alimentarius Commission and Executive Committee

    The Codex Alimentarius Commission will hold its Twenty-Eighth 
Session July 4-9, 2005 in Rome, Italy. At that time it will consider 
procedural matters, and the standards, codes of practice, and related 
matters brought to its attention by the general subject committees, 
commodity committees, ad hoc Task Forces and member delegations. It 
will also consider options to implement recommendations from the review 
of Codex committee structure and mandates of Codex committees and task 
forces, as well as budgetary and strategic planning issues. At this 
Session, the Commission will elect a Chair and three Vice Chairs. The 
issue of Codex interaction with other international organizations will 
be discussed.
    Prior to the Commission meeting, the Executive Committee will have 
met at its Fifty-fifth Session on February 9-11, 2005 and its Fifty-
sixth Session on June 30-July 2, 2005. It is composed of the 
chairperson, vice-chairpersons, seven members elected from the 
Commission, one from each of the following geographic regions: Africa, 
Asia, Europe, Latin America and the Caribbean, Near East, North 
America, and South-West Pacific. In addition, regional coordinators 
from the six regional committees attend as observers. It will consider 
the Codex Strategic Plan 2008-1013; review the Codex committee 
structure and mandate of Codex committees and task forces; review 
matters arising from reports of Codex Committees, proposals for new 
work, and standards management issues; consider the implementation of 
the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO 
and WHO Work on Food Standards; and review the Trust Fund for the 
Participation of Developing Countries and Countries in Transition in 
the Work of the Codex Alimentarius.
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Residues of Veterinary Drugs in Foods

    The Codex Committee on Residues of Veterinary Drugs in Foods 
determines priorities for the consideration of residues of veterinary 
drugs in foods and recommends Maximum Residue Limits (MRLs) for 
veterinary drugs. A veterinary drug is defined as any substance applied 
or administered to a food producing animal, such as meat or dairy 
animals, poultry, fish or bees, for therapeutic, prophylactic or 
diagnostic purposes or for modification of physiological functions or 
behavior.
    A Codex Maximum Limit for Veterinary Drugs (MRLVD) is the maximum 
concentration of residue resulting from the use of a veterinary drug 
(expressed in mg/kg or ug/kg on a fresh weight basis) that is adopted 
by the Codex Alimentarius Commission to be permitted or recognized as 
acceptable in or on a food. An MRLVD is based on the Acceptable Daily 
Intake (ADI) and indicates the amount of residue in food that is 
considered to be without appreciable toxicological hazard. An MRLVD 
also takes into account other

[[Page 30677]]

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 committee met in Arlington, VA (USA), October 25-28, 2004. The 
following will be under consideration by the Commission at its 28th 
Session in July 2005. The relevant document is ALINORM 5/28/31.
    Draft MRLs at Step 8:
     Cyhalothrin.
     Flumequine.
     Neomycin.
     Dicyclanil.
    Proposed Draft MRLs at Step 5/8:
     Imidocarb.
    Proposed Draft Code of Practice to Minimize and Contain 
Antimicrobial Resistance at Step 5/8.
    Proposed Draft MRLs at Step 5:
     Flumequine (in black tiger shrimp).
     Pirlimycin.
     Cypermethrin and alpha-cypermethrin.
     Doramectin (in cow's milk).
    The Committee continues to work on:
     Draft MRLs for Trichlorfon (metrifonate) at step 7.
     Proposed Draft MRLs for Ractopamine at step 4.
     Proposed Draft Revised Guidelines for the Establishment of 
a Regulatory Program for Control of Veterinary Drug Residues in Foods.
     Discussion paper on Risk Management Methodologies, 
including Risk Assessment Policies in the Codex Committee on Residues 
of Veterinary Drugs in Foods.
     Proposed Draft Revised Part I, II, III of Guidelines for 
the Establishment of a Regulatory Program for the Control of Veterinary 
Drug Residues in Foods.
     Priority List of Veterinary Drugs Requiring Evaluation or 
Reevaluation.
     List of Methods of Analysis for Veterinary Drug Residues 
and Identification of Routine Methods of Analysis.
     Recommendations on Residues of Veterinary Drugs without 
ADI/MRL (Prioritization of work).
    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 committee met in The Hague, The 
Netherlands, April 25-29, 2005. The following matters are under 
consideration by the Commission at its 28th Session in July 2005. The 
relevant document is ALINORM 5/28/12.
     Revised Terms of Reference of the Codex Committee on Food 
Additives and Contaminants.
     Terms of Reference for the FAO/WHO Joint Expert 
Consultation to Conduct a Comprehensive Assessment of Use of Active 
Chlorine.
Food Additives
    To be considered at Step 8:
     General Standard for Food Additive (GSFA): Draft Food 
Additive Provisions in Tables 1 and 2.
     Amendment to Annex B (Food Category System) of the GSFA 
(coconut water).
    To be considered at Step 5/8:
     General Standard for Food Additives: Proposed Draft Food 
Additive Provisions in Tables 1, 2 and 3.
     Advisory Specifications for the Identity and Purity of 
Food Additives.
     Proposed Draft Revisions to the Codex International 
Numbering System for Food Additives.
    To be considered at Step 5:
     Proposed Draft Revised Preamble to the GSFA, including 
diagram.
    To be considered for Revocation and Discontinuation of work:
     General Principles for the Use of Food Additives.
     Proposed Amendments to the Codex Procedural Manual related 
to the revocation of the General Principles for the Use of Food 
Additives.
     Proposed Draft and Draft Food Additive Provisions in the 
GSFA.
    To be considered for New Work:
     Revision of Class Names and the International Numbering 
System for Food Additives.
    The Committee is continuing work on:
     General Standard for Food Additives: Draft Food Additive 
Provisions (in Tables 1, 2 and 3).
     General Standard for Food Additives: Revisions to the 
Preamble to clarify relationship between the General Standard and 
commodity standards.
     International Numbering System.
     Specifications for the Identity and Purity of Food 
Additives.
     Inventory of Processing Aids.
     Discussion Paper on Flavoring Agents.
Contaminants
    To be considered at Step 8:
     Draft Code of Practice for the Prevention and Reduction of 
Aflatoxin Contamination in Tree Nuts.
     Draft Code of Practice for the Prevention and Reduction of 
Inorganic Tin Contamination in Canned Foods.
     Draft Maximum Levels for Cadmium in wheat grain, potato, 
stem and root vegetables, leafy vegetables, and other vegetables.
    To be considered at Step 5/8:
     Proposed Amendment to the Preamble of the Codex General 
Standard for Contaminants and Toxins in Foods (GSCTF).
    To be considered at Step 5:
     Proposed Draft Maximum Level for Aflatoxin in unprocessed 
almonds, hazelnuts and pistachios.
     Proposed Draft Maximum Levels for Cadmium in rice, 
cephalopod (excluding viscera), and marine bivalve mollusks (excluding 
oysters and scallops).
    To be considered for Revocation:
     List of Maximum Levels for Contaminants and Toxins 
Contained in Codex Commodity Standards and Relevant Standards and 
Texts.
    To be considered for New Work:
     Appendix to the Code of Practice for the Prevention and 
Reduction of Aflatoxin Contamination in Tree Nuts to address additional 
measures for the prevention and reduction of aflatoxins in Brazil nuts.
    The Committee is continuing work on:
     Maximum levels for aflatoxin in processed almonds, 
hazelnuts, and pistachios.
     Discussion Paper on Aflatoxin Contamination in Brazil 
Nuts.
     Proposed draft sampling plan for Aflatoxin contamination 
in Almonds, Brazil nuts, Hazelnuts and Pistachios.

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     Discussion paper on Deoxynivalenol (DON) Contamination in 
Cereals.
     Maximum Level for lead in fish.
     Proposed Draft Code of Practice for Source Directed 
Measures to Reduce Dioxin and Dioxin-like PCB Contamination in Foods.
     Discussion paper with proposals for maximum levels for 3-
monochloropropanediol in acid-hydrolyzed vegetable protein (acid-HVP) 
and acid-HVP containing foods.
     Discussion paper on acrylamide, including a project paper 
for new work and an outline of a proposed draft code of practice.
     Draft Revised Guideline Levels for Radionuclides in Foods 
Following Accidental Nuclear Contamination for Use in International 
Trade, Including Guideline Levels for Long-Term Use.
     Discussion paper on polyaromatic hydrocarbons, including a 
project paper for new work and an outline of a proposed draft code of 
practice.
     Discussion paper on methylmercury in fish.
     Discussion paper on Code of Practice for the Prevention 
and Reduction of Ochratoxin A (OTA) Contamination in Coffee and Cocoa.
     Discussion paper on Maximum level of Ochratoxin A in Wine.
General Issues
     Priority List of Food Additives, Contaminants and 
Naturally Occurring Toxicants Proposed for Evaluation by JECFA.
    Responsible Agency: HHS/FDA
    U.S. Participation: Yes.

Codex Committee on Pesticide Residues

    The Codex Committee on Pesticide Residues recommends to the Codex 
Alimentarius Commission establishment of maximum limits for pesticide 
residues for specific food items or in groups of food. A Codex Maximum 
Residue Limit for Pesticide (MRLP) is the maximum concentration of a 
pesticide residue (expressed as mg/kg), recommended by the Codex 
Alimentarius Commission to be legally permitted in or on food 
commodities and animal feeds. Foods derived from commodities that 
comply with the respective MRLPs are intended to be toxicologically 
acceptable, that is, consideration of the various dietary residue 
intake estimates and determinations both at the national and 
international level in comparison with the ADI,* should 
indicate that foods complying with Codex MRLPs are safe for human 
consumption.
    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 committee met in The Hague, The Netherlands, April 18-23, 2005. 
The following items will be considered by the Commission at its 28th 
Session in July 2005. The relevant document is ALINORM 05/28/24.
    To be considered at Step 8:
     Draft and Draft Revised Maximum Residue Limits.
    To be considered at Step 8(I):
    Bifenazate.
    Fludioxonil.
    Trifloxystrobin.
    To be considered at Step 5/8:
     Proposed Draft and Proposed Draft Revised Maximum Residue 
Limits including Proposed Draft MRLs for Spices.
     Proposed Draft Guidelines for the Use of Mass Spectrometry 
(MS) for Identification, Confirmation and Quantitative Determination of 
Residues.
     Proposed New Food Classification Codes for Commodities 
with Adopted MRLs.
    To be considered at Step 5:
     Proposed Draft and Proposed Draft Revised Maximum Residue 
Limits including Proposed Draft MRLs for Dried Chili Peppers.
     Proposed Draft Guidelines on Estimation of Uncertainty of 
Results.
     Proposed Draft Risk Analysis Principles Applied by the 
Codex Committee on Pesticide Residues.
    To be considered for Revocation:
     Codex CLX-Ds.
    The committee is continuing work on:
     Pilot Project for the examination of national MRLs as 
Interim Codex MRLs for safer replacement pesticides.
     Revision of the List of Recommended Methods of Analysis 
for Pesticide Residues.
     Criteria for Prioritization Process to Recommend Compounds 
for Evaluation by JMPR.
     Revision of the Codex Priority List of Pesticides for 
review by JMPR.
     MRLs for Processed or Ready-to-Eat Foods.

    *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 26th Session of the Committee met in Budapest, Hungary, on 
April 4-8, 2005. The relevant document is ALINORM 05/28/23. The 
following will be considered by the Commission at its 28th Session in 
July 2005.
    To be considered at Step 5:
     Proposed Draft Guidelines for Evaluating Acceptable 
Methods of Analysis.
    The Committee will continue work on:
     Criteria for Evaluating Acceptable Methods of Analysis.

[[Page 30679]]

     Proposed Draft Guidelines for Settling of Disputes on 
Analytical (test) Results.
     Consideration of the Fitness-For-Purpose Approach to 
Evaluating Methods of Analysis.
     Further Review of the Analytical Terminology for Codex Use 
in the Procedural Manual.
     Endorsement of Methods of Analysis and Sampling Provisions 
in Codex Standards.
     Criteria for Methods of Analysis for the Detection and 
Identification of Foods derived from Biotechnology
     Methods of Analysis for the determination of dioxins and 
PCBs.
    Responsible Agency: HHS/FDA; USDA/MRP.
    U.S. Participation: Yes.

Codex Committee on Food Import and Export Inspection and Certification 
Systems

    The Codex Committee on Food Import and Export Inspection and 
Certification Systems is charged with developing principles and 
guidelines for food import and export inspection and certification 
systems to protect consumers and to facilitate trade. Additionally, the 
Committee develops principles and guidelines for the application of 
measures by competent authorities to provide assurance that foods 
comply with essential requirements, especially statutory health 
requirements. This encompasses work on: Equivalence of food inspection 
systems including equivalence agreements, processes and procedures to 
ensure that sanitary measures are implemented; 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 reference document 
is ALINORM 05/28/30. The committee met in Melbourne, Australia, on 
December 6-10, 2004. The following will be considered for adoption by 
the Commission at its 28thSession in July 2005.
    To be considered at step 5/8:
     Draft Principles for Electronic Certification.
    The committee is continuing work on:
     Proposed Draft Appendices to the Guidelines on the 
Judgment of Equivalence of Sanitary Measures Associated with Food 
Inspection and Certification.
    (a) Determining an ``objective basis of comparison''
    (b) Details on the process of determining equivalence.
    (c) Documentation for evaluation of submissions of requests for 
equivalence determinations.
     Proposed Draft Guidelines for Risk-based Inspection of 
Imported Foods.
    New work:
     Develop principles for product tracing/traceability within 
the context of food inspection and certification systems.
     Revise the Codex Guidelines for Generic Official 
Certificate Formats and the Production and Issuance of Certification.
    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 21st Session addressed issues related to decisions made 
by the Commission regarding the FAO/WHO Codex Evaluation. The 22nd 
Session which met on April 11-15, 2005 in Paris, France, considered the 
regular work of the Committee. The relevant documents are ALINORM 05/
28/33 and ALINORM 05/28/33A. Matters to be considered for adoption by 
the 28th Commission in July 2005:
    To be considered at Step 8:
     Draft Risk Analysis Principles Applied by the Committee on 
Food Additives and Contaminants (CCFAC).
     Draft CCFAC Policy for Exposure Assessment.
    For consideration by the Commission:
    Amendments to the Rules of Procedure:
     Proposed amendments concerning the enlargement of the 
Executive Committee, the functions of the Executive Committee and 
matters related to budget and expenses.
     Proposed Amendments to Rule VIII.5--Observers.
     Proposed Amendment on the Right to Address the Chair.
    Amendments to the Procedure Manual:
     Draft Revised Criteria for the Establishment of Work 
Priorities.
     Draft Guidelines on Physical Working Groups.
     Draft Guidelines on Electronic Working Groups.
     Draft Revised Principles concerning the Participation of 
International Non-Governmental Organizations in the Work of the Codex 
Alimentarius Commission.
     Proposed Amendments to the Procedural Manual to eliminate 
the acceptance procedures for Codex Standards.
     Draft Guidelines for Cooperation with International 
Intergovernmental Organizations.
    The Committee continued work on:
     Proposed Draft Working Principles for Risk Analysis for 
Food Safety (Guidance to National Governments).
     Proposed amendments to the Rules of Procedure: Duration of 
the terms of the Members of the Executive Committee.
     Possible reorganization of the structure, content and 
presentation of the Procedural Manual.
     Changes in the Elaboration Procedures.
     Clarification of the term ``interim'' as used for the 
adoption of Codex standards at Step 8.
     Possible definitions of ``science-based'' and ``risk-
based''.
     Management of the work in the Codex Committee on Food 
Hygiene.
    Responsible Agency: USDA/FSIS, FDA/CFSAN.
    U.S. Participation: Yes.

Codex Committee on Food Labelling

    The Codex Committee on Food Labelling is responsible for drafting 
provisions on labelling issues assigned by the Codex Alimentarius 
Commission. The reference document is ALINORM 04/27/22. The Committee 
held its Thirty-third Session in Kota Kinabalu, Malaysia, on May 9-13, 
2005. It considered the following items:
     Guidelines for the Production, Processing, Labelling and 
Marketing of Organically Produced Foods Proposed Revised Sections: 
Annex 2--Tables 3 and 4, Revision to Table 1 (Natural Sodium Nitrate).
     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 2. (Definitions).
     Proposed Draft Guidelines for the Labelling of Food and 
food Ingredients obtained through certain Techniques of Genetic 
Modification/Genetic Engineering: Labelling Provisions.
     Proposed Draft Amendment to the General Standard for the 
Labelling of Prepackaged Foods: Quantitative Declaration of 
Ingredients.
     Country of Origin Labelling.
     Discussion paper on Advertising.
    Responsible Agency: HHS/FDA; USDA/FSIS.
    U.S. Participation: Yes.

[[Page 30680]]

Codex Committee on Food Hygiene

    The Codex Committee on Food Hygiene has four primary 
responsibilities. First, to draft basic provisions on food hygiene 
applicable to all food. These provisions normally take the form of 
Codes of Hygienic Practice for a specific commodity (e.g. bottled 
water) or group of commodities (e.g., milk and milk products). Second, 
to suggest and prioritize areas where there is a need for 
microbiological risk assessment at the international level and to 
consider microbiological risk management matters in relation to food 
hygiene and in relation to the risk assessment activities of FAO and 
WHO. Third, to consider, amend if necessary, and endorse food hygiene 
provisions that are incorporated into specific Codex commodity 
standards by the Codex commodity committees. Fourth, to provide such 
other general guidance to the Commission on matters relating to food 
hygiene as may be necessary. The following items will be considered by 
the Codex Alimentarius Commission at its 28th Session in Rome, Italy, 
July 4-9, 2005. The relevant document is ALINORM 05/28/13.
    To be considered at Step 5:
     Proposed Draft Guidelines on the Application of the 
General Principles of Food Hygiene to the Control of Listeria 
monocytogenes in Ready-to-Eat Foods.
     Proposed Draft Code of Hygienic Practice for Eggs and Egg 
Products.
     Proposed Draft Principles and Guidelines for the Conduct 
of Microbiological Risk Management.
    The committee continues to work on:
     Proposed Draft Guidelines for Validation of Food Hygienic 
Control Measures.
     Proposed Draft Code of Hygienic Practice for Powdered 
Formulae for Infants and Children.
     Endorsement of Hygiene Provisions in Codex Standards and 
Codes of Practice.
     Annexes to the step 5 documents.
     Proposals/risk profiles:
     Guidelines for the Application of the General Principles 
of Food Hygiene to the Risk-Based Control of Enterohemorrhagic E. coli 
in Ground Beef and Fermented Sausages.
     Guidelines for the Application of the General Principles 
of Food Hygiene to the Risk-Based Control of Salmonella spp. in Broiler 
Chickens.
     Guidelines for Risk Management Options for Campylobacter 
in Broiler Chickens.
     Vibrio spp. in Seafood.
     Viruses in Food.
    Responsible Agency: HHS/FDA; FSIS/USDA.
    U.S. Participation: Yes.

Codex Committee on Fresh Fruits and Vegetables

    The Codex Committee on Fresh Fruits and Vegetables is responsible 
for elaborating world-wide standards and codes of practice for fresh 
fruits and vegetables. The Committee met in Mexico City, Mexico, on May 
16-20, 2005. At the session they discussed the following items:
     Draft Standard for Tomatoes at Step 7.
     Draft Standard for Table Grapes retained at Step 7.
     Proposed Draft Standard for Rambutan at Step 3.
     Proposed Draft Standard for Apples at Step 3.
     Section 2.1.1 (Maturity Requirements) and Annex on Small-
berry Varieties (Section 3.1) (draft Codex Standard for Table Grapes).
     Guidelines for the Quality Control of Fresh Fruits and 
Vegetables.
     Standard Layout for Codex Standards for Fresh Fruits and 
Vegetables.
     Priority List.
    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 
(CCNFSDU) 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 met in Bonn, Germany, November 1-4, 2004. 
The relevant document is ALINORM 05/28/26. The following items will be 
considered by the 28th Session of the Commission in June 2005.
    To be adopted at Step 8:
     Draft Guidelines for Vitamin and Mineral Food Supplements.
    The Committee continues work on:
     Draft Revised Standard for Gluten-Free Foods at Step 7.
     Draft Revised Standard for Processed Cereal-Based.Foods 
for Infants and Young Children at Step 6.
     Draft Revised Standard for Infant Formula and Formulas for 
Special Medical Purposes Intended for Infants at Steps 3 (Section A) 
and 6 (Section B).
     Guidelines for Use of Nutrition Claims Draft Table of 
Conditions for Nutrient Content Claims (Part B containing Provisions on 
Dietary Fibre) at Step 6.
     Proposed Draft Revision of the Advisory Lists of Nutrient 
Compounds for Use in Foods for Special Dietary Uses Intended for Use by 
Infants and Young Children.
     Proposed Draft Recommendations on the Scientific Basis of 
Health Claims.
     Discussion Paper on the Application of Risk Analysis to 
the Work of the CCNFSDU.
     Discussion Paper on Proposals for Additional or Revised 
Nutrient Reference Values (NRVs).
    Responsible Agency: HHS/FDA; FNS/USDA.
    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 met in Capetown, South Africa, 
February 28-March 4, 2005. The following will be considered by the 28th 
Session of the Commission when it meets in July 2005. The relevant 
document is ALINORM 05/28/18.
    To be considered at Step 8:
     Draft Code of Practice for Fish and Fishery Products 
(Aquaculture).
     Draft Amendment to the Standard for Salted Fish and Dried 
Salted Fish.
    To be considered at Step 5/8:
     Proposed Draft Code of Practice for Fish and Fishery 
Products (Shrimps and Prawns; Cephalopods; Transport; Retail; and 
relevant Definitions).
    To be considered at Step 5:
     Proposed Draft Standard for Sturgeon Caviar New work:
     Revision of the Procedure for the Inclusion of Species.
     Amendment of the Standard for Canned Sardines and Sardine-
Type Products.
    The Committee continues work on the following:
     Proposed Draft Standard for Live and Processed Bivalve 
Mollusks.
     Proposed Draft Standard for Smoked Fish.
     Proposed Draft Standard for Quick Frozen Scallop Adductor 
Muscle Meat.
     Proposed Draft Code of Practice on the Processing of 
Scallop Meat.
     Proposed Draft Code of Practice for Fish and Fishery 
Products (other sections).
     Proposed Draft Amendment of the Standard for Canned 
Sardines and Sardine-Type Products (Clupea bentincki).
    Responsible Agency: HHS/FDA; USDC/NOAA/NMFS.
    U.S. Participation: Yes.

[[Page 30681]]

Codex Committee on Milk and Milk Products

    The Codex Committee on Milk and Milk Products is responsible for 
establishing international codes and standards for milk and milk 
products. The Committee held its 6th Session in Auckland, NZ on April 
26-30, 2004. The relevant document is ALINORM 04/27/11.
    For discussion at the 28th Session of the Codex Alimentarius 
Commission in July 2005.
     Proposal for a new standard for Parmesan Cheese At its 7th 
Session, the Committee will continue work on the following:
    At Step 6:
     Draft Standard for a Blend of Evaporated Skimmed Milk and 
Vegetable Fat.
     Draft Standard for a Blend of Skimmed Milk and Vegetable 
Fat in Powdered Form.
     Draft Standard for a Blend of Sweetened Condensed Skimmed 
Milk and Vegetable Fat.
     Draft Revised Standard for Whey Cheese.
     Draft Revised Standards for Cheddar (C-1) and Danbo (C-3).
    Other work of the committee:
     Proposed Draft Revised Standards for Individual Cheeses at 
Step 4.
     Proposed Template for Fermented Milk Drinks Provisions.
     Proposed Draft Model Export Certificate for Milk and Milk 
Products.
     Methods of Analysis and Sampling for Milk Products.
     Proposed Draft Revised Standard for Processed Cheese.
     Proposed Draft Revised Standard for Dairy Spreads.
     Discussion paper on Proposed Revision of the Codex 
Standard for Extra Hard Grating Cheese.
     Discussion paper on the Issue of Naming Non-standardized 
Dairy Products.
    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 met in London, U.K., February 21-25, 2005. The relevant 
document is 05/28/17. The following will be considered by the 
Commission at its July 2005 session.
    To be considered at Step 5/8:
     Proposed Draft Amendments to the Standard for Named 
Vegetable Oils: Sesameseed Oil.
    To be considered at Step 5:
     Proposed Draft Amendments to the Standard for Named 
Vegetable Oils: Rice Bran Oil.
    To be considered at Step 5 of the Accelerated Procedure:
     Proposed Draft Revised Table 1 of the Recommended 
International Code of Practice for the Storage and Transport of Edible 
Fats and Oils in Bulk.
    New Work:
     Amendment of the Standard for Named Vegetable Oils.
     Mid-oleic sunflowerseed oil.
     Mid-oleic acid soya bean oil.
     Low linolenic acid soya bean oil.
     Unbleached palm oil: total carotenoids.
    The Committee continues work on:
     Draft Standard for Fat Spreads and Blended Spreads: Food 
additives.
     Draft List and Proposed Draft List of Acceptable Previous 
Cargoes.
     Proposed Draft Amendment to the Standard for Olive Oil: 
Linolenic Acid content.
     Criteria for the Revision of Named Vegetable oils.
     Consideration of ISO proposal to amend the nomenclature of 
oils.
    Responsible Agency: HHS/FDA; USDA/ARS.
    U.S. Participation: Yes.

Codex Committee on Processed Fruits and Vegetables

    The Codex Committee on Processed Fruits and Vegetables is 
responsible for elaborating standards for Processed Fruits and 
Vegetables. After having been adjourned sine die, the Committee 
reconvened in Washington, DC, in March 1998 to begin work revising the 
standards. The Committee held its most recent session on September 27 
October 1, 2004. The relevant document is ALINORM 05/28/27.
    To be considered at Step 5:
     Processed Tomato Concentrates.
     Preserved (Canned) Tomatoes.
     Certain Canned Citrus Fruits.
    The committee is continuing work on:
     Draft Codex Standard for Pickled Fruits and Vegetables.
     Proposed Draft Codex Standards for:
     Jams, Jellies and Marmalades.
     Certain Canned Vegetables and Guidelines for Packing Media 
for Canned Vegetables.
    Other work:
     Methods of Analysis for Processed Fruits and Vegetables.
     Priority List for the Standardization of Processed Fruits 
and Vegetables.
    Discontinued work in this committee:
     Proposed Draft Standard for Soy Sauce.
    Responsible Agency: USDA/AMS; HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Meat Hygiene

    The 24th Session of the Commission decided to reactivate the Codex 
Committee on Meat Hygiene with New Zealand as Host Government. The 
Terms of Reference were amended to reflect the inclusion of poultry in 
its mandate. The Committee completed its work at its 11th Session and 
requested the Commission that it be adjourned sine die. The relevant 
document is ALINORM 05/28/16.
    To be considered at Step 8:
     Draft Code of Hygienic Practice for Meat.
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Cereals, Pulses, and Legumes

    The 26th Session of the Codex Alimentarius Commission adopted the 
Proposed Draft Standard for Instant Noodles at Step 5, on the 
recommendation of the Coordinating Committee for Asia, and advanced it 
to Step 6 for consideration by the Committee on Cereals, Pulses and 
Legumes by correspondence. The United States, as host government, has 
circulated the Draft Standard for two rounds of comments. Consideration 
of the additives provisions will take place in the Codex Committee on 
Food Additives and Contaminants.
    Responsible Agency: HHS/FDA; USDA/GIPSA.
    U.S. Participation: Yes.

Certain Codex Commodity Committees

    Several Codex Alimentarius Commodity Committees have adjourned sine 
die. The following Committees fall into this category:
     Cocoa Products and Chocolate.
    Responsible Agency: HHS/FDA.
    U.S. Participation: Yes.
     Natural Mineral Water.
    Responsible Agency: HHS/FDA.
    U.S. Participation: Yes.
     Sugars.
    Responsible Agency: USDA/ARS; HHS/FDA.
    U.S. Participation: Yes.
     Vegetable Proteins.
    Responsible Agency: USDA/ARS; HHS/FDA.
    U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Animal Feeding

    The Commission at its 23rd Session established the Ad Hoc 
Intergovernmental Task Force on Animal Feeding to develop guidelines or 
standards as appropriate on good animal feeding practices. The Revised

[[Page 30682]]

Draft Code of Practice for Good Animal Feeding was held at Step 8 by 
the Commission at its 26th Session in June 2003, with the exception 
that the definition of ``feed additive'' and paragraphs 11, 12, and 13 
were advanced to step 6. The Task Force held its 5th Session on May 17-
19, 2004 and discussed:
     Revised Draft Code of Practice for Good Animal Feeding 
(definition of ``feed additive'' and paragraphs 11, 12, and 13).
    Responsible Agency: HHS/FDA; USDA/APHIS.
    U.S. Participation: Yes.

Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices

    The Commission at its 23rd Session established this Task Force to 
revise and consolidate the existing Codex standards and guidelines for 
fruit and vegetable juices and related products, giving preference to 
general standards. These standards were originally developed by the 
Joint UNECE/Codex Group of Experts on the Standardization of Fruit 
Juices which had been abolished by its parent organizations. The Task 
Force held its fourth and final session in Fortaleza, Brazil, on 
October 11-15, 2004. The Task Force completed the work assigned to the 
Task Force in its Terms of Reference.
    For Adoption at Step 8:
     Draft Codex General Standard for Fruit Juices and Nectars.
     Draft Minimum Brix Level for Reconstituted Juice and 
Reconstituted Pure and Minimum Juice and/or Pure Content for Fruit 
Nectars (%v/v)--grapes, guava, mandarine/tangerine, mango, passion 
fruit and tamarind (Indian date) juices/nectars.
    For Adoption at Step 5/8:
     Proposed Draft Minimum Brix Level for Reconstituted Juice 
and Reconstituted Pure and Minimum Juice and/or Pur[eacute]e Content 
for Fruit nectars (%v/v)--orange, lemon, lime, and pineapple juices/
nectars.
    Responsible Agency: HHS/FDA; USDA/AMS.
    U.S. Participation: Yes.

FAO/WHO Regional Coordinating Committees

    The Codex Alimentarius Commission is made up of an Executive 
Committee, as well as approximately 30 subsidiary bodies. Included in 
these subsidiary bodies are coordinating committees for groups of 
countries located in proximity to each other who share common concerns. 
There are currently six Regional Coordinating Committees:
     Coordinating Committee for Africa.
     Coordinating Committee for Asia.
     Coordinating Committee for Europe.
     Coordinating Committee for Latin America and the 
Caribbean.
     Coordinating Committee for the Near East.
     Coordinating Committee for North America and the South-
West Pacific.
    The United States participates as an active member of the 
Coordinating Committee for North America and the South-West Pacific, 
and is informed of the other coordinating committees through meeting 
documents, final reports, and representation at meetings. Each regional 
committee:
     Defines the problems and needs of the region concerning 
food standards and food control;
     Promotes within the committee contacts for the mutual 
exchange of information on proposed regulatory initiatives and problems 
arising from food control and stimulates the strengthening of food 
control infrastructures;
     Recommends to the Commission the development of world-wide 
standards for products of interest to the region, including products 
considered by the committee to have an international market potential 
in the future; and
     Serves a general coordinating role for the region and 
performs such other functions as may be entrusted to it by the 
Commission.

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

    The Coordinating Committee is responsible for defining problems and 
needs concerning food standards and food control of all Codex member 
countries of the region. Items coming before the Commission in July 
include the following. The committee met in Apia, Samoa, on October 19-
22, 2004. The relevant document is ALINORM 05/28/32.
     Recommendation that Samoa be reappointed as Regional 
Coordinator.
     Support the development of a new Standard for Parmesan 
cheese and adopt the amendment of the Codex Standard for Canned 
Sardines and Sardine-Type Products.
    Items on the agenda for the next meeting may include:
     Codex working documents of special interest to regional 
member states.
     Joint FAO/WHO Evaluation of the Codex Alimentarius and 
other FAO and WHO Work on Food Standards.
     Strategic Plan for the Coordinating Committee for North 
America and the Southwest Pacific.
     Trust Fund for the participation of Developing Countries 
in Codex.
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Codex Coordinating Committee for Asia

    The Coordinating Committee met in Jeju-Do, Republic of Korea on 
September 7-10, 2004. The relevant document is ALINORM--5/15.
    To be considered at Step 5:
     Proposed Draft Standard for Ginseng Products.
    New work:
     Refrigerated, Non-fermented Soybean Products.

Attachment 2--U.S. Codex Alimentarius Officials Codex Committee 
Chairpersons

Codex Committee on Food Hygiene

    Dr. Karen Hulebak, Chief Scientist, Office of Public Health 
Science, Food Safety and Inspection Service, U.S. Department of 
Agriculture, 1400 Independence Avenue, SW., Room 3130, South Building, 
Washington, DC 20250-3700, Phone: (202) 720-5735, Fax: (202) 720-2980. 
E-mail: karen.hulebak@fsis.usda.gov.

Codex Committee on Processed Fruits and Vegetables

    Mr. David L. Priester, Head, Standardization Section, AMS Fruit & 
Vegetable Programs, Fresh Products Branch, U.S. Department of 
Agriculture, Room 1661, South Building, 1400 Independence Avenue, SW., 
Washington, DC 20250-0240. Phone: (202) 720-2185. Fax: (202) 720-8871. 
E-mail: david.priester@usda.gov.

Codex Committee on Residues of Veterinary Drugs in Foods

    Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, 
MD 20855, Phone: (301) 827-2950, Fax: (301) 827-8401, E-mail: 
ssundlof@cvm.fda.gov.

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

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

[[Page 30683]]

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

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

U.S. Delegate
    Dr. Steven D. Vaughn, Director, Office of New Animal Drug 
Evaluation, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Place, Rockville, MD 20855, Phone: (301) 
827-1796, Fax: (301) 594-2297, E-mail: SVaughn@cvm.fda.gov.
Alternate Delegate
    Dr. Alice Thaler, Staff Director, Animal and Egg Production Food 
Safety Staff, Food Safety and Inspection Service, 1400 Independence 
Avenue, SW., Washington, DC 20250, Phone: (202) 690-2683, Fax: (202) 
720-8213, E-mail: alice.thaler@fsis.usda.gov.

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

U.S. Delegate
    Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and 
Beverages, Center for Food Safety and Applied Nutrition (HFS-300), Food 
and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700, 
Fax: (301) 436-2632, E-mail: Terry.Troxell@cfsan.fda.gov.
Alternate Delegate
    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition (HFS-265), Food and Drug 
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835, Phone: (301) 436-1284, Fax: (301) 
436-2972, E-mail: dennis.keefe@cfsan.fda.gov.

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

U.S. Delegate
    Lois Rossi, Director of Registration Division, Office of Pesticide 
Programs, U.S. Environmental Protection Agency, Ariel Rios Building, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460, Phone: (703) 305-
5035, Fax: (703) 305-5147, E-mail: Rossi.Lois@epamail.epa,gov.
Alternate Delegate
    Dr. Robert Epstein, Associate Deputy Administrator, Science and 
Technology, Agricultural Marketing Service, U.S. Department of 
Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 1400 
Independence Avenue, SW., Washington, DC 20090, Phone (202) 720-2158, 
Fax: (202) 720-1484, E-mail: Robert.Epstein@usda.gov.

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

U.S. Delegate
    Dr. Gregory Diachenko, Director, Division of Chemistry Research and 
Environmental Review, Office of Food Additive Safety, Center for Food 
Safety and Applied Nutrition (CFSAN), Food and Drug Administration 
(HFS-245), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, 
College Park, MD 20740-3835, Phone (301) 436-1898, Fax: (301) 436-2364, 
E-mail: Gregory.Diachenko@cfsan.fda.gov.
Alternate Delegate
    Mr. Donald C. Kendall, Technical Services Division, Grain, 
Inspection, Packers & Stockyards Administration, U.S. Department of 
Agriculture, 10383 N. Ambassador Drive, Kansas City, MO 64153-1394, 
Phone: (816) 891-0463, Fax: (816) 891-0478, E-mail: 
Donald.C.Kendall@usda.gov.

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

U.S. Delegate
    Dr. Catherine Carnevale, Director, Office of Constituent 
Operations, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2380, 
Fax: (301) 436-2612, E-mail: Catherine.Carnevale@cfsan.fda.gov.
Alternate Delegate
    Karen Stuck, Chief, International Policy Staff, Food Safety and 
Inspection Service, U.S. Department of Agriculture, Room 2137, South 
Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700, 
Phone: (202) 720-3470, Fax: (202) 720-7990, E-mail: 
Karen.Stuck@fsis.usda.gov.

Codex Committee on General Principles (Host Government--France)

U.S.Delegate

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

Codex Committee on Food Labeling (Host Government--Canada)

U.S. Delegate
    Leslye Fraser, J.D., Director, Office of Regulations and Policy, 
Center for Food Safety and Applied Nutrition, FDA, 5100 Paint Branch 
Parkway (HFS-004), College Park, MD 20740, Phone: (301) 436-2378, Fax: 
(301) 436-2637, E-mail: leslye.fraser@fda.hhs.gov.
Alternate Delegate
    Ms. Danielle Schor, Chief of Staff, Office of the Administrator, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
1400 Independence Avenue, SW., Washington, DC 20250-1400, Phone: (202) 
720-6618, Fax: (202) 720-7771, E-mail: danielle.schor@fsis.usda.gov.

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

U.S. Delegate
    Dr. Robert L. Buchanan, Director, Office of Science, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
006), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, 
College Park, MD 20740-3835, Phone: (301) 436-2369, Fax: (301) 436-
2642, E-mail: Robert.Buchanan@cfsan.fda.gov.
Alternate Delegates
    Dr. Daniel Engeljohn, Deputy Assistant Administrator, Office of 
Policy, Program, and Employee Development, Room 3149, South Building, 
U.S. Department of Agriculture, 1400 Independence Avenue, SW., 
Washington, DC 20250, Phone: (202) 205-0495, Fax: (202) 401-1760, E-
mail: Daniel.engeljohn@fsis.usda.gov.
    Dr. Rebecca Buckner, Consumer Safety Officer, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, Room 3B-
0033 Harvey Wiley Building, 5100 Paint Branch Parkway, College Park, MD 
20740, Phone: (301) 436-1486, Fax: (301) 436-2632, E-mail: 
Rebecca.Buckner@cfsan.fda.gov.

Codex Committee on Nutrition and Food for Special Dietary Uses (Host 
Government--Germany) U.S. Delegate

    Barbara O. Schneeman, PhD, Director, Office of Nutritional 
Products, Labeling and Dietary Supplements, Center for Food Safety and 
Applied Nutrition, FDA, 5100 Paint Branch Highway, College Park, MD 
20740, Tel: (301) 436-2373, Fax: (301) 436-2636, E-mail: 
Barbara.Schneeman@cfsan.fda.gov.

[[Page 30684]]

Alternate Delegate
    Patricia McKinney, Senior Program Analyst, Office of Analysis, 
Nutrition Service, Food and Nutrition Service, USDA, 3101 Park Center 
Drive, Room 1014, Alexandria, VA 22302, Tel: (703) 305-2126, Fax: (703) 
305-2576, E-mail: Pat.Mckinney@fns.usda.gov.

Worldwide Commodity Codex Committees Codex Committee on Fresh Fruits 
and Vegetables (Host Government--Mexico)

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

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

U.S. Delegate
    Mr. Philip C. Spiller, Director, Office of Seafood, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration (HFS-400), 
Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College 
Park, MD 20740-3835, Phone: (301) 436-2300, Fax: (301) 436-2599, E-
mail: Philip.Spiller@cfsan.fda.gov.
Alternate Delegate
    Mr. Richard V. Cano, Acting Director, National Seafood Inspection 
Program, NOAA, U.S. Department of Commerce, 1315 East-West Highway, 
Silver Spring, MD 20910, Phone: (301) 713-2355, Fax: (301) 713-1081, E-
mail: richard.cano@noaa.gov.

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

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

U.S. Delegate
    Mr. Duane Spomer, Associate Deputy Administrator for Standards and 
Grading, Dairy Programs, Agricultural Marketing Service, U.S. 
Department of Agriculture, Room 2746, South Building, 1400 Independence 
Avenue, SW., Washington, DC 20250, Phone: (202) 720-3171, Fax: (202) 
720-2643, E-mail: duane.spomer@usda.gov.
Alternate Delegate
    John F. Sheehan, Director, Division of Dairy and Egg Safety, Office 
of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition 
(HFS-306), Food and Drug Administration, Harvey W. Wiley Federal 
Building, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 
(301) 436-1488, Fax: (301) 436-2632, E-mail: 
john.sheehan@cfsan.fda.gov.

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

U.S. Delegate
    Mr. Charles W. Cooper, Director, International 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: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
    Ms. Kathleen Warner, U.S. Department of Agriculture, 1815 N. 
University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax: (309) 
681-6668, E-mail: warnerk@ncaur.usda.gov.

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

U.S. Delegate
    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, 
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
    Dr. Michelle Smith, Food Technologist, Office of Plant and Dairy 
Foods and Beverages, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 
5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: 301-436-
2024, Fax: 301-436-2651, E-mail: Michelle.Smith@cfsan.fda.gov.

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

U.S. Delegate
    Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit, 
Agricultural Research, USDA--FSIS, 5883 USDA Road, Houma, LA 70360, 
Phone: (504) 872-5042, Fax: (504) 868-8369, E-mail: 
ttew@nola.srrc.usda.gov.
Alternate Delegate
    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
265), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, 
College Park, MD 20740-3835, Phone: (301) 436-1284, Fax: (301) 436-
2972, E-mail: dennis.keefe@cfsan.fda.gov.

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

U.S. Delegate
    Dorian Lafond, International Standards Coordinator, Fruit and 
Vegetable Division, Agricultural Marketing Service, U.S. Department of 
Agriculture, Room 2086, South Building, 1400 Independence Avenue, SW., 
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-0016, E-
mail: Dorian.Lafond@usda.gov.
Alternate Delegate
    Mr. Charles W. Cooper, Director, International Activities Staff, 
Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714, 
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.

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

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

[[Page 30685]]

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

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

U.S. Delegate
    Dr. Perfecto Santiago, Deputy Assistant Administrator, Office of 
Food Security and Emergency Preparedness, Room 3130, South Building, 
U.S. Department of Agriculture, 1400 Independence Avenue, SW., 
Washington, DC 20250, Phone: (202) 205-0452, Fax: (202) 690-5634. 
Perfecto.Santiago@fsis.usda.gov.

Alternate Delegate
    Dr. William O. James, Deputy Assistant Administrator, Office of 
International Affairs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Room 3143, South Building, Washington, DC 
20250-3700, Phone: (202) 720-5362, Fax: (202) 690-3856, E-mail: 
william.james@fsis.usda.gov.

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

U.S. Delegate
    Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and 
Beverages, Center for Food Safety & Applied Nutrition, Food and Drug 
Administration (HFS-300), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700, 
Fax: (301) 436-2632, E-mail: Terry.troxell@cfsan.fda.gov.
Alternate Delegate
    Ms. Shellee Anderson, Office of Nutritional Products, Labeling and 
Dietary Supplements, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration (HFS-830), Harvey W. Wiley Federal Building, 
5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 
436-1491, Fax: (301) 436-2636, E-mail: Shellee.Anderson@cfsan.fda.gov.

Ad Hoc Intergovernmental Task Forces; Ad Hoc Intergovernmental Task 
Force on Fruit and Vegetable Juices (Host Government--Brazil)

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

Ad Hoc Intergovernmental Task Force on Foods Derived From Modern 
Biotechnology (Host Government--Japan)

U.S. Delegate
    Bernice Slutsky, Ph.D., Special Assistant to the Secretary for 
Biotechnology, Office of the Secretary, U.S. Department of Agriculture, 
1400 Independence Avenue, SW., Washington, DC 20250, Phone: (202) 720-
3631, Fax: (202) 720-6314, E-mail: Bernice.Slutsky@usda.gov.
Alternate Delegate
    Eric Flamm, Ph.D., Senior Advisor, Office of the Commissioner, Food 
and Drug Administration, Room 1561 Parklawn Building, Rockville, MD 
20857, Phone: (301) 827-0591, FAX: (301) 827-4774, E-mail: 
EFLAMM@OC.FDA.GOV.
    There are six regional coordinating committees:

Coordinating Committee for Africa
Coordinating Committee for Asia
Coordinating Committee for Europe
Coordinating Committee for Latin America and the Caribbean
Coordinating Committee for the Near East
Coordinating Committee for North America and the South-West
Pacific
    Contact: Paulo Almeida, Office Manager, U.S. Codex Office, Food 
Safety and Inspection Service, Room 4861, South Building, 1400 
Independence Avenue, SW., Washington, DC 20250-3700, Phone (202) 205-
7760, Fax (202) 720-3157, E-mail: Paulo.Almeida@fsis.usda.gov.

                                                       Attachment 3.--Timetable of Codex Sessions
                                                              [June 2004 through June 2006]
--------------------------------------------------------------------------------------------------------------------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
2004:
    CX 702-54..................  Executive Committee (54th    24-26 June.................................  Geneva (Switzerland).
                                  session).
    CX 701-27..................  Codex Alimentarius           28 June-2 July.............................  Geneva (Switzerland).
                                  Commission (27th Session).
    CX 727-14..................  Regional Coordinating        7-10 September.............................  JeJu (City) Republic of Korea.
                                  Committee for Asia (14th
                                  Session).
    CX 706-24..................  Regional Coordinating        20-23 September............................  Bratislava (Slovak Republic).
                                  Committee for Europe (24th
                                  Session).
    CX 713-22..................  Codex Committee on           27 September-1 October.....................  Arlington, VA (USA).
                                  Processed Fruits and
                                  Vegetables (22nd Session).
    CX 801-03..................  Ad Hoc Intergovernmental     11-15 October..............................  Fortaleza (Brazil).
                                  Task Force on Fruit and
                                  Vegetable Juices (3rd
                                  Session).
    CX 732-08..................  Regional Coordinating        19-22 October..............................  Apia (Samoa).
                                  Committee for North
                                  America and South West
                                  Pacific (8th Session).
    CX 730-15..................  Codex Committee on Residue   25-28 October..............................  Arlington, VA (USA).
                                  of Veterinary Drugs in
                                  Foods (15th Session).
    CX 720-26..................  Codex Committee on           1-5 November...............................  Bonn (Germany).
                                  Nutrition and Foods for
                                  Special Dietary Uses (26th
                                  Session).
    CX 716-21..................  Codex Committee on General   15-19 November.............................  Paris (France).
                                  Principles (21st Session).
    CX 725-14..................  Regional Coordinating        29 November-3 December.....................  Buenos Aires (Argentina).
                                  Committee for Latin
                                  America and the Caribbean
                                  (14th Session).
    CX 733-13..................  Codex Committee on Food      6-10 December..............................  Melbourne (Australia).
                                  Import and Export
                                  Certification Systems
                                  (13th Session).

[[Page 30686]]


2005:
    CX 707-16..................  Regional Coordinating        25-28 January..............................  Rome (FAO) (Italy).
                                  Committee for Africa (16th
                                  Session).
    CX 702-55..................  Executive Committee (55th    9-11 February..............................  Rome (FAO) (Italy).
                                  Session).
    CX 723-11..................  Codex Committee on Meat and  14-18 February.............................  Christchurch (New Zealand).
                                  Poultry Hygiene (11th
                                  Session).
    CX 709-19..................  Codex Committee on Fats and  21-25 February.............................  London (United Kingdom).
                                  Oils (19th Session).
    CX 722-27..................  Codex Committee on Fish and  28 February-4 March........................  Capetown (South Africa).
                                  Fishery Products (27th
                                  Session).
    CX 734-03..................  Regional Coordinating        7-10 March.................................  Amman (Jordan).
                                  Committee for Near East
                                  (3rd Session).
    CX 712-37..................  Codex Committee on Food      14-19 April................................  Buenos Aires (Argentina).
                                  Hygiene (37th Session).
    CX 715-26..................  Codex Committee on Methods   4-8 April..................................  Budapest (Hungary).
                                  of Analysis and Sampling
                                  (26th Session).
    CX 716-22..................  Codex Committee on General   11-15 April................................  Paris (France).
                                  Principles (22nd Session).
    CX 718-37..................  Codex Committee on           18-23 April................................  The Hague (The Netherlands).
                                  Pesticide Residues (37th
                                  Session).
    CX 711-37..................  Codex Committee on Food      25-29 April................................  The Hague (The Netherlands).
                                  Additives and Contaminants
                                  (37th Session).
    CX 714-33..................  Codex Committee on Food      9-13 May...................................  Kota Kinabalu (Malaysia).
                                  Labelling (33rd Session).
    CX 731-12..................  Codex Committee on Fresh     16-20 May..................................  Mexico City Mexico).
                                  Fruits and Vegetables
                                  (12th Session).
    CX 702-56..................  Executive Committee (56th    6 June-2 July..............................  Rome (Italy).
                                  Session).
    CX 701-28..................  Codex Alimentarius           4-9 July...................................  Rome (Italy).
                                  Commission (28th Session).
    CX 804-1...................  Ad Hoc Task Force on         19-23 September............................  TBA (Japan).
                                  Biotechnology.
    CX 720-14..................  Codex Committee on           21-25 November.............................  Bonn (Germany).
                                  Nutrition and Foods for
                                  Special Dietary Uses (27th
                                  Session).
    CX 733-14..................  Codex Committee on Food      28 November-2 December.....................  TBA (Australia).
                                  Import and Export
                                  Inspection and
                                  Certification Systems
                                  (14th Session).
    CX 702-57..................  Executive Committee (57th    30 November-2 December.....................  Geneva (Switzerland).
                                  Session).
2006:
    CX 703-7...................  Codex Committee on Milk and  27-31 March................................  TBA (New Zealand).
                                  Milk Products (7th
                                  Session).
    CX 718-38..................  Codex Committee on           3-8 April..................................  TBA (Brazil).
                                  Pesticide Residues (38th
                                  Session).
    CX 716-23..................  Codex Committee on General   9-13 April.................................  Paris (France).
                                  Principles (23rd Session).
    CX 711-38..................  Codex Committee on Food      24-28 April................................  The Hague (The Netherlands).
                                  Additives and Contaminants
                                  (38th Session).
    CX 714-34..................  Codex Committee on Food      1-5 May....................................  Ottawa (Canada).
                                  Labelling (34th Session).
    CX 730-16..................  Codex Committee on Residue   8-12 May...................................  Washington, DC (USA).
                                  of Veterinary Drugs in
                                  Food (16th Session).
    CX 715-27..................  Codex Committee on Methods   15-19 May..................................  Budapest (Hungary).
                                  of Analysis and Sampling
                                  (27th Session).
    CX 702-58..................  Executive Committee (58th    28-30 June.................................  Geneva (Switzerland).
                                  Session).
    CX 201-29..................  Codex Alimentarius           3-8 July...................................  Geneva (Switzerland).
                                  Commission (29th Session).
--------------------------------------------------------------------------------------------------------------------------------------------------------

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,

[[Page 30687]]

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.
    Hazard Identification: The identification of biological, chemical, 
and physical agents capable of causing adverse health effects and which 
may be present in a particular food or group of foods.
    Hazard Characterization: The qualitative and/or quantitative 
evaluation of the nature of the adverse health effects associated with 
biological, chemical and physical agents that may be present in food. 
For chemical agents, a dose-response assessment should be performed. 
For biological or physical agents, a dose-response assessment should be 
performed if the data are obtainable.
    Dose-Response Assessment: The determination of the relationship 
between the magnitude of exposure (dose) to a chemical, biological or 
physical agent and the severity and/or frequency of associated adverse 
health effects (response).
    Exposure Assessment: The qualitative and/or quantitative evaluation 
of the likely intake of biological, chemical, and physical agents via 
food as well as exposures from other sources if relevant.
    Risk: A function of the probability of an adverse health effect and 
the severity of that effect, consequential to a hazard(s) in food.
    Risk Analysis: A process consisting of three components: Risk 
assessment, risk management and risk communication.
    Risk Assessment: A scientifically based process consisting of the 
following steps: (i) Hazard identification, (ii) hazard 
characterization, (iii) exposure assessment, and (iv) risk 
characterization.
    Risk Assessment Policy: Documented guidelines on the choice of 
options and associated judgments for their application at appropriate 
decision points in the risk assessment such that the scientific 
integrity of the process is maintained.
    Risk Characterization: The qualitative and/or quantitative 
estimation, including attendant uncertainties, of the probability of 
occurrence and severity of known or potential adverse health effects in 
a given population based on hazard identification, hazard

[[Page 30688]]

characterization and exposure assessment.
    Risk Communication: The interactive exchange of information and 
opinions throughout the risk analysis process concerning risk, related 
risk factors and risk perceptions, among risk assessors, risk managers, 
consumers, industry, the academic community and other interested 
parties, including the explanation of risk assessment findings and the 
basis of risk management decisions.
    Risk Estimate: The quantitative estimation of risk resulting from 
risk characterization.
    Risk Management: The process, distinct from risk assessment, of 
weighing policy alternatives, in consultation with all interested 
parties, considering risk assessment and other factors relevant for the 
health protection of consumers and for the promotion of fair trade 
practices, and, if needed, selecting appropriate prevention and control 
options.
    Risk Profile: The description of the food safety problem and its 
context.
    Food Safety Objective (FSO): The maximum frequency and/or 
concentration of a hazard in a food at the time of consumption that 
provides or contributes to the appropriate level of protection (ALOP).
    Performance Criterion (PC): The effect in frequency and/or 
concentration of a hazard in a food that must be achieved by the 
application of one or more control measures to provide or contribute to 
a PO or an FSO.
    Performance Objective (PO): The maximum frequency and/or 
concentration of a hazard in a food at a specified step in the food 
chain before the time of consumption that provides or contributes to an 
FSO or ALOP, as applicable.

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

[[Page 30689]]

(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA). In the cases of milk and milk products or individual standards 
for cheeses, the Secretariat distributes the recommendations of the 
International Dairy Federation (IDF).
    (3) The proposed draft standard is sent to Members of the 
Commission and interested international organizations for comment on 
all aspects including possible implications of the proposed draft 
standard for their economic interests. When standards are subject to an 
accelerated procedure, this fact shall be notified to the Members of 
the Commission and the interested international organizations.
Step 4
    The comments received are sent by the Secretariat to the subsidiary 
body or other body concerned which has the power to consider such 
comments and to amend the proposed draft standard.
Step 5
    In the case of standards identified as being subject to an 
accelerated elaboration procedure, the draft standard is submitted 
through the Secretariat to the Commission together with any written 
proposals received from Members and interested international 
organizations for amendments with a view to its adoption as a Codex 
standard. In taking any decision at this step, the Commission will give 
due consideration to any comments that may be submitted by any of its 
Members regarding the implications which the proposed draft standard or 
any provisions thereof may have for their economic interests.

Attachment 6--Nature of Codex Standards

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

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

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

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

Format for Codex Standards

Name of the Standard
    The name of the standard should be clear and as concise as 
possible. It should usually be the common name by which the food 
covered by the standard is known or, if more than one food is dealt 
with in the standard, by a generic name covering them all. If a fully 
informative title is inordinately long, a subtitle could be added.
Scope
    This section should contain a clear, concise statement as to the 
food or foods to which the standard is applicable unless the name of 
the standard clearly and concisely identifies the food or foods. A 
generic standard covering more than one specific product should clearly 
identify the specific products to which the standard applies.
Description
    This section should contain a definition of the product or products 
with an indication, where appropriate, of the raw materials from which 
the product or products are derived and any necessary references to 
processes of manufacture. The description may also include references 
to types and styles of product and to type of pack. The description may 
also include additional definitions when these additional 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 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

[[Page 30690]]

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. 05-10636 Filed 5-26-05; 8:45 am]