[Federal Register Volume 69, Number 110 (Tuesday, June 8, 2004)]
[Notices]
[Pages 31942-31957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12736]


 ========================================================================
 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.
 
 ========================================================================
 

  Federal Register / Vol. 69, No. 110 / Tuesday, June 8, 2004 / 
Notices  

[[Page 31942]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 04-004N]


International Standard-Setting Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice informs the public of the sanitary and 
phytosanitary standard-setting activities of the Codex Alimentarius 
Commission (Codex), in accordance with section 491 of the Trade 
Agreements Act of 1979, as amended, and the Uruguay Round Agreements 
Act, Public Law 103-465, 108 Stat. 4809. 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, 2003, to May 31, 
2004, and June 1, 2004, to May 31, 2005, 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.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
    All submissions received must include the Agency name and docket 
number 04-004N. 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/OPPDE/rdad/FRDockets.htm.

FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Ph.D., United 
States Manager for Codex, U.S. Department of Agriculture, Office of the 
Undersecretary for Food Safety, Room 4861, South Agriculture Building, 
1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-
7760. For information pertaining to particular committees, the delegate 
of that committee may be contacted. (A complete list of U.S. delegates 
and alternate delegates can be found in Attachment 2 to this notice.) 
Documents pertaining to Codex are accessible via the World Wide Web at 
the following address: http://www.codexalimentarius.net. The U.S. Codex 
Office also maintains a Web site at http://www.fsis.usda.gov/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, International Office of 
Epizootics, and the International Plant Protection Convention. The 
President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 
15845), designated the U.S. Department of Agriculture as the agency 
responsible for informing the public of sanitary and phytosanitary 
standard-setting activities of each international standard-setting 
organization. The Secretary of Agriculture has delegated to the 
Administrator, Food Safety and Inspection Service (FSIS), the 
responsibility to inform the public of the SPS standard-setting 
activities of Codex. The FSIS Administrator has, in turn, assigned the 
responsibility for informing the public of the SPS standard-setting 
activities of Codex to the U.S. Codex Office, FSIS.
    Codex was created in 1962 by two U.N. organizations, the Food and 
Agriculture Organization (FAO) and the World Health Organization (WHO). 
Codex is the principal international organization for encouraging fair 
international trade in food and protecting the health and economic 
interests of consumers. Through adoption of food standards, codes of 
practice, and other guidelines developed by its committees and by 
promoting their adoption and implementation by governments, Codex seeks 
to ensure that the world's food supply is sound, wholesome, free from 
adulteration, and correctly labeled. In the United States, the United 
States Department of Agriculture (USDA); the Food and Drug 
Administration (FDA), Department of Health and Human Services (HHS); 
and the Environmental Protection Agency (EPA) manage and carry out U.S. 
Codex activities.
    As the agency responsible for informing the public of the sanitary 
and phytosanitary standard-setting activities of Codex, FSIS publishes 
this notice in the Federal Register annually. Attachment 1 (Sanitary 
and Phytosanitary Activities of Codex) sets forth the following 
information:
    1. The sanitary or phytosanitary standards under consideration or 
planned for consideration; and
    2. For each sanitary or phytosanitary standard specified:
    a. A description of the consideration or planned consideration of 
the standard;
    b. Whether the United States is participating or plans to 
participate in the consideration of the standard;
    c. The agenda for United States participation, if any; and

[[Page 31943]]

    d. The agency responsible for representing the United States with 
respect to the standard.
    To obtain copies of those standards listed in Attachment 1 that are 
under consideration by Codex, please contact the Codex delegate or the 
U.S. Codex office. This notice also solicits public comment on those 
standards that are under consideration or planned for consideration and 
recommendations for new standards. The delegate, in conjunction with 
the responsible agency, will take the comments received into account in 
participating in the consideration of the standards and in proposing 
matters to be considered by Codex.
    The United States' delegate will facilitate public participation in 
the United States Government's activities relating to Codex 
Alimentarius. The United States' delegate will maintain a list of 
individuals, groups, and organizations that have expressed an interest 
in the activities of the Codex committees and will disseminate 
information regarding United States' delegation activities to 
interested parties. This information will include the current status of 
each agenda item; the United States Government's position or 
preliminary position on the agenda items; and the time and place of 
planning meetings and debriefing meetings following Codex committee 
sessions. In addition, the U.S. Codex Office makes much of the same 
information available through its Web page, http://www.fsis.usda.gov/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, 2003 to May 31, 2004, and June 1, 2004 to May 31, 
2005. 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 2003 through June 2005)
Attachment 4 Definitions for the Purpose of Codex Alimentarius
Attachment 5 Part 1--Uniform Procedure for the Elaboration of Codex 
Standards and Related Texts
    Part 2--Uniform Accelerated Procedure for the Elaboration of Codex 
Standards and Related Texts
Attachment 6 Nature of Codex Standards

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to better ensure 
that the public and in particular that 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 and 
through the Regulations.gov Web site. The Regulations.gov Web site is 
the central online rulemaking portal of the United States government. 
It is being offered as a public service to increase participation in 
the Federal government's regulatory activities. FSIS participates in 
Regulations.gov and will accept comments on documents published on the 
site. The site allows visitors to search by keyword or Department or 
Agency for rulemakings that allow for public comment. Each entry 
provides a quick link to a comment form so that visitors can type in 
their comments and submit them to FSIS. The Web site is located at 
http://www.regulations.gov.
    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.

    Done at Washington, DC, on June 1, 2004.
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-Seventh 
Session June 28-July 3, 2004 in Geneva, Switzerland. At that time it 
will consider procedural matters, the standards, codes of practice, and 
related matters brought to its attention by the general subject 
committees, commodity committees, ad hoc Task Forces and member 
delegations. It will also consider options or strategies regarding the 
Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and 
WHO Work on Food Standards, as well as budgetary and strategic planning 
issues. The issue of Codex interaction with other international 
organizations will also be discussed. At this Session, the Commission 
will elect a Chair and three Vice Chairs.
    Prior to the Commission meeting, the Executive Committee will meet 
at its Fifty-fourth Session on June 24-26, 2004. It is composed of the 
chairperson, vice-chairpersons and seven members elected from the 
Commission, one from each of the following geographic regions: Africa, 
Asia, Europe, Latin America and the Caribbean, Near East, North 
America, and South-West Pacific. In addition, regional coordinators 
from the six regions will attend as observers. It will discuss 
implementation of the Joint FAO/WHO Evaluation of the Codex 
Alimentarius and other FAO and WHO Work on Food Standards, matters 
arising from reports of Codex Committees, standards management issues, 
and 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 
(CCRVDF) 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 31944]]

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 15th Session of CCRVDF will take place in the United States on 
October 25-28, 2004. The following will be discussed by the Committee:
    Draft Maximum Residue Limits for:
     Flumequine.
     Neomycin.
     Dicyclanil.
     Melengestrol acetate.
     Trichlorfon (metrifonate).
    Proposed Draft Maximum Residue Limits for:
     Cefuroxime.
     Cypermethrin.
     Alpha-Cypermethrin.
    The Committee continues to work on:
     Proposed Draft Code of Practice to Minimize and Contain 
Antimicrobial Resistance.
     Proposed Draft Revised Guidelines for the Establishment of 
a Regulatory Program for Control of Veterinary Drug Residues in Foods.
     Risk Analysis Principles and Methodologies, including Risk 
Assessment Policies in the Codex Committee on Residues of Veterinary 
Drugs in Foods.
     Proposed Draft Appendix on the Prevention and Control of 
Veterinary Drug Residues in Milk and Milk Products.
     Priority List of Veterinary Drugs Requiring Evaluation or 
Reevaluation.
     Methods of Analysis and Sampling Issues.
     Performance-based Criteria.
     Identification of Routine Methods of Analysis.
    Responsible Agency: HHS/FDA; USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Food Additives and Contaminants

    The Codex Committee on Food Additives and Contaminants (CCFAC) (a) 
establishes or endorses permitted maximum or guideline levels for 
individual food additives, contaminants, and naturally occurring 
toxicants in food and animal feed; (b) prepares priority lists of food 
additives and contaminants for toxicological evaluation by the Joint 
FAO/WHO Expert Committee on Food Additives (JECFA); (c) recommends 
specifications of identity and purity for food additives for adoption 
by the Commission; (d) considers methods of analysis for food additives 
and contaminants; and (e) considers and elaborates standards and codes 
for related subjects such as labeling of food additives when sold as 
such and food irradiation. The following matters are under 
consideration by the Commission at its 27th Session in July 2004. The 
relevant document is ALINORM 4/27/12.
Risk Analysis
    To be considered at Step 8:
     Draft Risk Analysis Principles applied by the Codex 
Committee on Food Additives and Contaminants.
Food Additives
    To be considered at Step 8:
     General Standard for Food Additives: Food Category System.
     General Standard for Food Additives: Draft Food Additive 
Provisions in Tables 1 and 2.
    To be considered at Step 5/8 of the Accelerated Procedure:
     General Standard for Food Additives: Proposed Draft Food 
Additive Provisions in Tables 1 and 2.
     Advisory Specifications for the Identity and Purity of 
Food Additives.
     Draft Revisions to the Codex International Numbering 
System for Food Additives.
    The Committee is continuing work on:
     General Standard for Food Additives: Draft Food Additive 
Provisions (in Table 1 and Table 3).
     General Standard for Food Additives: Revisions to the 
Preamble to clarify relationship between the General Standard and food 
additive provisions in Codex Commodity Standards and to clarify the 
principles for establishing food additive provisions in the General 
Standard.
     International Numbering System.
     Specifications for the Identity and Purity of Food 
Additives.
     Inventory of processing aids.
     Discussion paper on food additives used as carriers.
     Discussion paper on the Harmonization of Terms Used by 
Codex and JECFA.
     Terms of reference for a risk assessment of the use of 
``active chlorine'' by a Joint FAO/WHO Expert Consultation.
Contaminants
    To be considered at Step 8:
     General Standard for Contaminants and Toxins: Preamble.
     General Standard for Contaminants and Toxins: Proposed 
Draft Principles for Exposure Assessment of Contaminants and Toxins in 
Foods.
     CCFAC Policy for Exposure Assessment of Contaminants and 
Toxins in Foods or Food Groups.
     Code of Practice for the Prevention and Reduction of 
Aflatoxin Contamination in Peanuts.
     Code of Practice for the Prevention and Reduction of Lead 
Contamination in Foods.
    To be considered at Step 5:
     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 Revised Guideline Levels for Radionuclides in Foods 
Following Accidental Nuclear Contamination for Use in International 
Trade, Including Guideline Levels for Long-Term Use.
    The Committee is continuing work on:
     Maximum levels for aflatoxin in tree nuts (almonds, 
hazelnuts, and pistachios).
     Discussion paper on Aflatoxin Contamination in Brazil 
Nuts.
     Maximum level for lead in fish.
     Maximum levels for cadmium in polished rice, wheat grain, 
potato, stem and root vegetables, leafy vegetables, other vegetables, 
and molluscs.
     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.
    The Committee is beginning new work on:
     Sampling plans for aflatoxin in tree nuts (almonds, Brazil 
nuts, hazelnuts, and pistachios).
     Discussion paper on options for incorporating the JECFA 
safety evaluation of flavors into the Codex system.
     Discussion paper on polyaromatic hydrocarbons.
     Discussion paper on methylmercury in fish.
General Issues
     Priority List of Food Additives, Contaminants and 
Naturally Occurring

[[Page 31945]]

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. * 
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.
    Codex MRLPs are primarily intended to apply in international trade 
and are derived from reviews conducted by the Joint Meeting on 
Pesticide Residues (JMPR) following:
    (a) Review of residue data from supervised trials and supervised 
uses including those reflecting national good agricultural practices 
(GAP). Data from supervised trials conducted at the highest nationally 
recommended, authorized, or registered uses are included in the review. 
In order to accommodate variations in national pest control 
requirements, Codex MRLPs take into account the higher levels shown to 
arise in such supervised trials, which are considered to represent 
effective pest control practices, and
    (b) Toxicological assessment of the pesticide and its residue.
    The following items will be considered by the Commission at its 
27th Session in July 2004. The relevant document is ALINORM 04/27/24.
    To be considered at Step 8:
     Draft and Draft Revised Maximum Residue Limits.
    To be considered at Step 5/8:
     Proposed Draft and Proposed Draft Revised Maximum Residue 
Limits.
     Draft Revision of the Guidelines on Good Laboratory 
Practice in Pesticide Residue Analysts.
    To be considered at Step 5:
     Proposed Draft and Proposed Draft Revised Maximum Residue 
Limits.
    The committee is continuing work on:
     Consideration of Draft and Proposed Draft Residue Maximum 
Limits in Foods and Feeds.
     Pilot Project for the examination of national MRLs as 
Interim Codex MRLs for safer replacement pesticides.
     Proposals for Improvement of Methodology for Point 
Estimates.
     Risk Analysis Policies Used in Establishing Codex MRLs.
     Revision of the List of Recommended Methods on Analysis 
for Pesticide Residues.
     Estimation of Uncertainty.
     Proposals for new Tropical Fruit and Vegetable 
Commodities.
     Elaboration of MRLs for Spices.
     Revision of the Codex Classification of Foods and Animal 
Feeds.
     Criteria for Prioritization Process.
     Revision of Codex Priority Lists of Pesticides for review 
by JMPR.
    Responsible Agency: EPA; USDA/AMS.
    U.S. Participation: Yes.

Codex Committee on Methods of Analysis and Sampling

    The Codex Committee on Methods of Analysis and Sampling:
    (a) Defines the criteria appropriate to Codex Methods of Analysis 
and Sampling;
    (b) Serves as a coordinating body for Codex with other 
international groups working in methods of analysis and sampling and 
quality assurance systems for laboratories;
    (c) Specifies, on the basis of final recommendations submitted to 
it by the other bodies referred to in (b) above, Reference Methods of 
Analysis and Sampling appropriate to Codex Standards which are 
generally applicable to a number of foods;
    (d) Considers, amends, if necessary, and endorses, as appropriate, 
methods of analysis and sampling proposed by Codex (Commodity) 
Committees, except that methods of analysis and sampling for residues 
of pesticides or veterinary drugs in food, the assessment of 
microbiological quality and safety in food, and the assessment of 
specifications for food additives do not fall within the terms of 
reference of this Committee;
    (e) Elaborates sampling plans and procedures, as may be required;
    (f) Considers specific sampling and analysis problems submitted to 
it by the Commission or any of its Committees; and
    (g) Defines procedures, protocols, guidelines or related texts for 
the assessment of food laboratory proficiency, as well as quality 
assurance systems for laboratories.
    The 25th Session of the Committee met in Budapest, Hungary, on 
March 8-12, 2004. The relevant document is ALINORM 04/27/23. The 
following will be considered by the Commission at its 27th Session in 
July 2004:
    To be considered at Step 8:
     Draft General Guidelines on Sampling.
     Draft Guidelines on Measurement Uncertainty.
    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.
     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/ARS.
    U.S. Participation: Yes.

Codex Committee on Food Import and Export Certification and Inspection 
Systems

    The Codex Committee on Food Import and Export Inspection and 
Certification Systems is charged with developing principles and 
guidelines for food import and export inspection and certification 
systems to protect consumers and to ensure fair practices in 
international trade in food. 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

[[Page 31946]]

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 are also included in the Committee's terms of 
reference.
    The following will be considered for adoption by the Commission at 
its 27th Session in July 2004.
    To be considered at Step 5/8:
     Proposed Draft Principles and Guidelines for the Exchange 
of Information in Food Safety Emergency Situations.
    New Work:
     Proposed Draft Appendices to the Guidelines on the 
Judgement of Equivalence of Sanitary Measures Associated with Food 
Inspection and Certification.
     Proposed Draft Principles for Electronic Certification.
     Proposed Draft Guidelines for Risk-based Inspection of 
Imported Foods.
    The committee is continuing work on:
     Discussion paper on the Revision of the Guidelines for the 
Exchange of Information Between Countries on Rejections of Imported 
Foods.
     Discussion paper on ``traceability/product tracing'' in 
the context of Food Inspection and Certification Systems.
     Discussion paper on the Revision of the Guidelines for 
Generic Official Certificate Formats and the Production and Issuance of 
Certificates.
     Discussion paper on clarification of the reference ``a 
reasonable interval'' in the Guidelines for Food Import Control 
Systems.
    Responsible Agency: HHS/FDA; USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on General Principles

    The Codex Committee on General Principles deals with procedure and 
general matters as are referred to it by the Codex Alimentarius 
Commission. The 19th (Extraordinary) Session addressed issues related 
to decisions made by the Commission regarding the FAO/WHO Codex 
Evaluation. The 20th Session which met on May 3-7, 2004 in Paris, 
France, considered the regular work of the Committee. The relevant 
documents are ALINORM 04/27/33 and ALINORM 04/27/33A. Matters from the 
19th Session to be considered for adoption by the 27th Commission in 
July 2004 are:
     Procedural Amendments to the Rules of Procedure.
     Proposed Amendments to the Procedures for the Elaboration 
of Codex Standards and Related Texts.
     Draft Criteria for the Appointment of Chairpersons.
     Draft Guidelines to Host Governments of Codex Committees 
and ad hoc Intergovernmental Task Forces.
     Draft Guidelines on the Conduct of Meetings of Codex 
Committees and ad hoc Intergovernmental Task Forces.
     Draft Guidelines to Chairpersons of Codex Committees and 
ad hoc Intergovernmental Task Forces.
    At its 20th (regular) Session, the Committee continued work on:
     Proposed Draft Working Principles for Risk Analysis for 
Food Safety (Guidance to National Governments).
     Proposed Draft Revised Code of Ethics for International 
Trade in Foods.
     Guidelines for Cooperation with International 
Intergovernmental Organizations.
     Definition of traceability/product tracing.
     Proposed Amendment to Rule VII.5 (Observers) of the Rules 
of Procedure.
     Review of the Principles concerning the Participation of 
International Non-Governmental Organizations in the work of the 
Commission.
     Matters arising from the 19th (Extraordinary) Session:.
    (a) Clarification of the respective roles of Members of the 
Executive Committee elected on a geographic basis and of Coordinators.
    (b) Clarification of the duration of the terms of the Coordinators 
and other Members of the Executive Committee.
    (c) Relevance of the current acceptance and notification procedures 
for Codex standards.
    (d) Possible reorganization of the structure and presentation of 
the Procedural Manual.
    (e) Particular situation of the North America Region in the context 
of Rule IV.1.
    (f) Implication of the exclusive use of electronic distribution of 
Codex documents to Members and Observers.
    (g) Criteria applicable for the participation of developing country 
members in the Executive Committee in the light of the proposed Rule 
XII.3 and the Codex budget available. At its 21st (Extraordinary) 
Session the Committee will continue work on:
     Consideration of the Status of Observers in the Executive 
Committee.
     Revision of the Criteria for the Establishment of Work 
Priorities.
     Draft Guidelines on Physical Working Groups and Draft 
Guidelines on Electronic Working Groups.
    Responsible Agency: USDA/FSIS; HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Food Labelling

    The Codex Committee on Food Labelling is responsible for drafting 
provisions on labelling issues assigned by the Codex Alimentarius 
Commission. The reference document is ALINORM 04/27/22. The Committee 
held its thirty-second Session in Montreal, Quebec, Canada, on May 10-
14, 2004. It considered the following items:
     Guidelines for the Production, Processing, Labelling and 
Marketing of Organically Produced Foods: Draft Revised Annex 2--
Permitted Substances.
     Report of the Working Group on the Management of the 
Agenda Items on Labelling of Foods and Food Ingredients Obtained 
through Certain Techniques of Genetic Modification/Genetic Engineering.
     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) (Definitions).
     Proposed Draft Guidelines for the Labelling of Food and 
food Ingredients obtained through certain Techniques of Genetic 
Modification/Genetic Engineering: Labelling Provisions.
     Draft Guidelines for the Use of Health and Nutrition 
Claims.
     Proposed Draft Amendment to the General Standard for the 
Labelling of Prepackaged Foods: Quantitative Declaration of 
Ingredients.
     Discussion paper on Misleading Claims.
     Discussion paper on Country of Origin Labelling.
     Discussion on Food Labelling and Traceability/Product 
Tracing.
    Responsible Agency: HHS/FDA; USDA/FSIS.
    U.S. Participation: Yes.

Codex Committee on Food Hygiene

    The Codex Committee on Food Hygiene has four primary 
responsibilities. First, the Committee drafts basic provisions on food 
hygiene applicable to all food. These provisions normally take the form 
of Codes of Hygienic Practice for a specific commodity (e.g., bottled 
water) or group of commodities (e.g., milk and milk products). Second, 
it suggests and prioritizes areas where there is a need for 
microbiological risk assessment at the international level and 
considers microbiological risk management matters in relation to food 
hygiene and in relation to the risk assessment activities of FAO and 
WHO. Third, it considers, amends, if necessary, and

[[Page 31947]]

endorses food hygiene provisions that are incorporated into specific 
Codex commodity standards by the Codex commodity committees. Fourth, 
the Committee provides 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 
27th Session in July 2004. The relevant document is ALINORM 04/27/13.
    To be considered at Step 8:
     Draft Code of Hygienic Practice for Milk and Milk 
Products.
     Definitions of Food Safety Objective, Performance 
Objective, and Performance Criterion.
    The committee continues to work on:
     Discussion papers on the management of the work of the 
Committee.
     Work on Microbiological Risk Assessment/Risk Management.
     Criteria to Establish Work Priorities.
     Options for Cross-Committee Interaction Process.
     Proposed Draft Guidelines on the Application of the 
General Principles of Food Hygiene to the [management] of Listeria 
monocytogenes in Foods.
     Proposed Draft Revision of the Code of Hygienic Practice 
for Eggs and Egg Products.
     Proposed Draft Guidelines for the Validation of Food 
Hygienic Control Measures.
     Endorsement of Hygiene Provisions in Codex Standards and 
Codes of Practice.
     Reports of ad hoc Expert Consultations.
     Risk Management Strategies for Salmonella spp. in Poultry.
     Risk Management Strategies for Campylobacter spp. in 
Poultry.
     Risk Profile for Enterohemorrhagic E. coli, including the 
Identification of Commodities of Concern, including Sprouts, Ground 
Beef and Pork.
     Discussion paper on the Proposed Draft Revision of the 
Recommended International Code of Practice for Foods for Infants and 
Children; Risk Profile on E. sakazakii.
     Discussion paper on Proposed Draft Guidelines for 
Evaluating Objectionable Matter 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 following standards will be considered by 
the 27th Session of the Commission in July 2004. The relevant document 
is ALINORM 04/27/35.
    To be considered at Step 8:
     Draft Standard for Oranges.
    To be considered at Step 5:
     Proposed Draft Standard for Tomatoes.
    The Committee continues work on:
     Draft Standard for Table Grapes retained at Step 7.
     Proposed Draft Standard for Rambutan.
     Proposed Draft Standard for Apples.
     Section 2.1.1 (Maturity Requirements) and Annex on Small-
berry Varieties (Section 3.1) (draft Codex Standard for Table Grapes).
     Proposed Draft Guide for the Quality Control of Fresh 
Fruits and Vegetables.
     Standard Layout for Codex Standards for Fresh Fruits and 
Vegetables.
    Responsible Agency: USDA/AMS.
    U.S. Participation: Yes.

Codex Committee on Nutrition and Foods for Special Dietary Uses

    The Codex Committee on Nutrition and Foods for Special Dietary Uses 
is responsible for studying nutritional problems referred by the Codex 
Alimentarius Commission. The Committee also drafts general provisions, 
as appropriate, on nutritional aspects of all foods and develops 
standards, guidelines, or related texts for foods for special dietary 
uses. The relevant document is ALINORM 03/27/26. The following items 
will be considered by the 27th Session of the Commission in July 2004.
    To be adopted at Step 5:
     Proposed Draft Revised Standard for Processed Cereal-Based 
Foods for Infants and Young Children.
     Proposed Draft Revised Standard for Infant Formula.
     Proposed Draft Guidelines for Vitamin and Mineral 
Supplements.
    The Committee continues work on:
     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.
     Guidelines for Use of Nutrition Claims--Draft Table of 
Conditions for Nutrient Contents Claims (Part B containing Provisions 
on Dietary Fibre) at Step 6.
     Draft Revised Standards for Gluten-Free Foods at Step 7.
     Proposed Draft Recommendations on the Scientific Basis of 
Health Claims.
     Guidelines on the Application of Risk Analysis to the Work 
of the CCNFSDU.
     Discussion paper on the FAO Technical Workshop on Energy 
Conversion Factors.
    Responsible Agency: HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Fish and Fishery Products

    The Fish and Fishery Products Committee is responsible for 
elaborating standards for fresh, frozen and otherwise processed fish, 
crustaceans and mollusks. The following will be considered by the 27th 
Session of the Commission when it meets in June 2004. The relevant 
document is ALINORM 04/27/18.
    To be considered at Step 8:
     Draft Standard for Salt Atlantic Herring and Salted Sprat.
     Draft Model Certificate for Fish and Fishery Products 
(Sanitary Certificate).
     Draft Amendment to the Standard for Quick Frozen Lobsters.
    To be considered at Step 5/8:
     Proposed Draft Code of Practice for Fish and Fishery 
Products (aquaculture and quick frozen coated fish products).
    To be considered at Step 5:
     Proposed Draft Amendment to the Standard for Salted Fish 
and Dried Salted Fish.
    The Committee continues work on the following:
     Proposed Draft Code of Practice for Fish and Fishery 
Products (other sections).
     Proposed Draft Standard for Live and Raw Bivalve Mollusks.
     Proposed Draft Standard for Smoked Fish.
     Proposed Draft Standard for Granular Sturgeon Caviar.
     Proposed Draft Standard for Quick Frozen Scallop Adductor 
Muscle Meat.
     Revision of the procedure for the Inclusion of Species.
     Proposed Draft Amendment of the Labelling Section in the 
Standard for Canned Sardines and Sardine-Type Products (Clupea 
bentincki).
    Responsible Agency: HHS/FDA; USDC/NOAA/NMFS.
    U.S. Participation: Yes.

Codex Committee on Milk and Milk Products

    The Codex Committee on Milk and Milk Products is responsible for 
establishing international codes and standards for milk and milk 
products. The Committee held its 6th Session in Auckland, NZ on April 
26-30, 2004. The relevant document is ALINORM 04/27/11.
    The Committee worked on the following:
     Proposed Draft Amendment to Section 3.3 (Composition) of 
the Codex General Standard for Cheese.

[[Page 31948]]

     Proposed Draft Standard for Products in Which Milk 
Components are Substituted by Non-Milk Components.
     Evaporated Skimmed Milk with Vegetable Fat.
     Sweetened Condensed Skimmed Milk with Vegetable Fat.
     Skimmed Milk Powder with Vegetable Fat.
     Proposed Draft Model Export Certificate for Milk and Milk 
Products.
     Methods of Analysis and Sampling for Milk Products.
     Draft Revised Standards for Individual Cheeses.
     Draft Revised Standard for Processed Cheese.
     Draft Revised Standard for Dairy Spreads.
     Proposed Draft Revised Standard for Whey Cheese.
     Proposed Standard for Parmesan Cheese.
     Discussion paper on Proposed Revision of the Codex 
Standard for Extra Hard Grating Cheese.
    Responsible Agency: USDA/AMS; HHS/FDA.
    U.S. Participation: Yes.

Codex Committee on Fats and Oils

    The Codex Committee on Fats and Oils is responsible for elaborating 
standards for fats and oils of animal, vegetable, and marine origin. 
The Committee will hold its next session on February 21-25, 2005, in 
London, England.
    The Committee continues work on:
     Draft Standard for Fat Spreads and Blended Spreads.
     Proposed Draft Amendments to the Standard for Named 
Vegetable Oils:
     Amendment to Sesame Seed Oil.
     Rice Bran Oil.
     Draft List of Acceptable Previous Cargoes.
     Proposed Draft List of Acceptable Previous Cargoes.
     Proposed Draft Amendment to the Standard for Olive Oil: 
Linolenic Acid content.
     Proposed Draft Amendments to the Recommended International 
Code of Practice for the Storage and Transport of Edible Fats and Oils 
in Bulk:
     Amendments to Table 1.
    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 will hold its next session on September 27-
October 1, 2004.
    The committee is continuing work on:
     Draft Codex Standard for Pickled Products.
     Proposed Draft Revised Standards for:
     Processed Tomato Concentrates.
     Canned Tomatoes.
     Canned Vegetables including Guidelines for Packing Media 
for Canned Vegetables.
     Jams, Jellies and Marmalades.
     Soy Sauce.
     Canned Citrus Fruits.
    Other work:
     Methods of Analysis for Processed Fruits and Vegetables.
     Priority List for the Standardization of Processed Fruits 
and Vegetables.
    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 relevant document is ALINORM 04/27/16.
    The Committee continues to work on:
     Proposed Draft Code of Hygienic Practice for Meat at Step 
5.
     Incorporating the Hygiene Provisions for Processed Meat in 
the Draft Code of Hygienic Practice for Meat for discussion.
     Attaching the Proposed Draft Annex on Risk-Based Post-
Mortem Examination Procedures for Meat and the Proposed Draft Annex on 
Microbiological Verification of Process Control of Meat Hygiene as 
Annex I and II, respectively.
    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 comments and will circulate the 
revised version for another round of comments following discussion in 
CCFAC regarding additives and peroxide values.
    Responsible Agency: HHS/FDA; USDA/GIPSA.
    U.S. Participation: Yes.

Certain Codex Commodity Committees \1\

    Several Codex Alimentarius Commodity Committees have adjourned sine 
die. The following Committees fall into this category:

 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 
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 will hold its fourth session in Brazil, on October 11-15, 2004.
    The committee is discussing:
     Proposed Draft Minimum Brix Level for Reconstituted Juice 
and Reconstituted Puree and Minimum Juice

[[Page 31949]]

and/or Puree Content for Fruit Nectars (%v/v).
     Grape, Guava, Mandarin/Tangerine, Mango, Passion Fruit and 
Tamarind (Indian date) juice at step 7.
     Orange, Lemon, Lime and Pineapple Juice at step 4.
    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. The Eighth Session of the Committee will take 
place in Apia, Samoa on October 19-22, 2004. Items on the agenda may 
include:
     Trust Fund for the Participation of Developing Countries 
in Codex Standard Setting Procedures.
     Joint FAO/WHO Evaluation of the Codex Alimentarius and 
other FAO and WHO Work on Food Standards.
     Consideration of Traceability/Product Tracing.
     Strategic Plan for the Coordinating Committee for North 
America and the Southwest Pacific.
     Cooperation between Codex and the International Office of 
Epizootics.
    Responsible Agency: USDA/FSIS.
    U.S. Participation: Yes.

Attachment 2: U.S. Codex Alimentarius Officials

Codex Committee Chairpersons

Codex Committee on Food Hygiene
    Dr. Karen Hulebak, Assistant Administrator, 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) 720-8609, Fax: (202) 720-9893, 
E-mail: [email protected].
Codex Committee on Processed Fruits and Vegetables
    Mr. David L. Priester, International Standards Coordinator, Fruit & 
Vegetable Division, Agricultural Marketing Service, U.S. Department of 
Agriculture, Room 2049, South Building, Stop 0140, 1400 Independence 
Avenue, SW., Washington, DC 20250-0240, Phone: (202) 720-2185, Fax: 
(202) 720-8871, E-mail: [email protected].
Codex Committee on Residues of Veterinary Drugs in Foods
    Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, 
MD 20855, Phone: (301) 827-2950, Fax: (301) 827-4401, E-mail: 
[email protected].
Codex Committee on Cereals, Pulses and Legumes (adjourned sine die)
    Mr. Steven N. Tanner, Director, Technical Services Division, Grain 
Inspection, Packers & Stockyards, Administration, U.S. Department of 
Agriculture, 10383 N. Executive Hills Boulevard, Kansas City, MO 64153-
1394, Phone: (816) 891-0401, Fax: (816) 891-0478, E-mail: 
[email protected].

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

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

U.S. Delegate
    Dr. 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: [email protected].
Alternate Delegate
    Dr. Alice Thaler, Staff Director, Animal and Egg Production Food 
Safety Staff, Food Safety and Inspection Service, U.S. Department of 
Agriculture, 1400 Independence Ave., SW., Washington, DC 20250, Phone: 
(202) 690-2683, Fax: (202) 720-8213, E-mail: 
[email protected].

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: [email protected].
Alternate Delegate
    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition (HFS-255), Food and Drug 
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202) 
418-3131, E-mail: [email protected].

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

U.S. Delegate
    Ms. Lois Rossi, Director of Registration Division, Office of 
Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios 
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Phone: 
(703) 305-5035, Fax: (703) 305-5147, E-mail: 
[email protected].
Alternate Delegate
    Dr. Robert Epstein, Associate Deputy Administrator, Science and 
Technology, Agricultural Marketing Service, U.S.

[[Page 31950]]

Department of Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 
1400 Independence Ave., SW., Washington, DC 20090, Phone: (202) 720-
2158, Fax: (202) 720-1484, E-mail: [email protected].

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

U.S. Delegate
    Dr. Gregory Diachenko, Director, Division of Chemistry Research and 
Environmental Review, Office of Food Additive Safety, Center for Food 
Safety and Applied Nutrition (CFSAN), Food and Drug Administration 
(HFS-245), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, 
College Park, MD 20740-3835, Phone: (301) 436-1898, Fax: (301) 436-
2634, E-mail: [email protected].
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: 
[email protected].

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

U.S. Delegate
    Dr. Catherine Carnevale, Director, Office of Constituent 
Operations, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2380, 
Fax: (301) 436-2618, E-mail: [email protected].
Alternate Delegate
    Ms. Karen Stuck, Assistant Administrator, Office of International 
Policy, Food Safety and Inspection Service, U.S. Department of 
Agriculture, Room 2137, South Building, 1400 Independence Ave., SW., 
Washington, DC 20250-3700, Phone: (202) 720-3470, Fax: (202) 720-7990, 
E-mail: [email protected].

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

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)

Interim U.S. Delegate
    Mr. L. Robert Lake, Director, Office of Regulations and Policy, 
Center for Food Safety and Applied Nutrition (HFS-4), Food and Drug 
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835, Phone: (301) 436-2379, Fax: (301) 
436-2637, E-mail: [email protected].
Alternate Delegate
    Mary K. Cutshall, Acting Director, Strategic Initiatives, 
Partnerships and Outreach Staff, Food Safety and Inspection Service, 
U.S. Department of Agriculture, 405 Aerospace Building, Washington, DC 
20250-3700, Phone: (202) 690-6520, Fax: (202) 690-6519, E-mail: 
[email protected].

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

U.S. Delegate
    Dr. Robert L. Buchanan, Director, Office of Science, Center for 
Food Safety and Applied Nutrition (HFS-006), Food and Drug 
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch 
Parkway, College Park, MD 20740-3835, Phone: (301) 436-2369, Fax: (301) 
436-2642, E-mail: [email protected].
Alternate Delegate
    Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of 
Policy, Program and Employee Development, Food Safety and Inspection 
Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th 
St., SW. Washington, DC 20250, Phone: (202) 205-0699, Fax: (202) 401-
1760, E-mail: [email protected].

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

U.S. Delegate
    Vacant.
Alternate Delegate
    Vacant.

Worldwide Commodity Codex Committees

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

U.S. Delegate
    Mr. Dorian LaFond, International Standards Coordinator, Fruit and 
Vegetables Program, Agricultural Marketing Service, U.S. Department of 
Agriculture, Room 2086, South Building, 1400 Independence Ave., SW., 
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-4722, E-
mail: [email protected],
Alternate Delegate
    Vacant.

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

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

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

U.S. Delegate
    Mr. Charles W. Cooper, Director, International Policy and Industry 
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail [email protected].
Alternate Delegate
    Mr. David Shipman, Deputy Administrator, Federal Grain Inspection 
Division, Grain Inspection, Packers and Stockyards Administration, U.S. 
Department of Agriculture, Room 1661, South Building, 1400 Independence 
Ave., SW., Washington, DC 20250, Phone: (202) 720-9170, Fax: (202) 205-
9237, E-mail: [email protected].

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

U.S. Delegate
    Mr. Duane Spomer, Chief, Dairy Standardization Branch, Agricultural 
Marketing Service, U.S. Department of Agriculture, Room 2750, South 
Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone: 
(202)

[[Page 31951]]

720-9382, Fax: (202) 720-2643, E-mail: [email protected].
Alternate Delegate
    John F. Sheehan, Director, Division of Dairy and Egg Safety, Office 
of Plant and Dairy Foods and Beverages, Center for Food Safety and 
Applied Nutrition (HFS-365), 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: 
[email protected].

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

U.S. Delegate
    Mr. Charles W. Cooper, Director, International Policy and Industry 
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: [email protected].
Alternate Delegate
    Ms. Kathleen Warner (Acting), U.S. Department of Agriculture, 1815 
N. University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax: 
(309) 681-6668, E-mail: [email protected].

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

U.S. Delegate
    Mr. Charles W. Cooper, Director, International Policy and Industry 
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: [email protected].
Alternate Delegate
    Dr. Michelle Smith, Food Technologist, Office of Plant and Dairy 
Foods and Beverages, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration (HFS-306), Harvey W. Wiley Federal Building, 
5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 
436-2024, Fax: (301) 436-2651, E-mail: [email protected].

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

U.S. Delegate
    Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit, 
Agricultural Research, U.S. Department of Agriculture, 5883 USDA Road, 
Houma, LA 70360, Phone: (504) 872-5042, Fax: (504) 868-8369, E-mail: 
[email protected].
Alternate Delegate
    Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
255), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, 
College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202) 418-
3131, E-mail: [email protected].

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

U.S. Delegate
    Mr. Dorian Lafond, International Standards Coordinator, Fruit and 
Vegetable Division, Agricultural Marketing Service, U.S. Department of 
Agriculture, Room 2086, South Building, 1400 Independence Ave., SW., 
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-0016, E-
mail: [email protected].
Alternate Delegate
    Mr. Charles W. Cooper, Director, International Policy and Industry 
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: [email protected].

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

U.S. Delegate
    Dr. Wilda H. Martinez, Area Director, ARS North Atlantic Area, 
Agricultural Research Service, U.S. Department of Agriculture, 600 E. 
Mermaid Lane, Wyndmoor, PA 19038, Phone: (215) 233-6593, Fax: (215) 
233-6719, E-mail: [email protected].
Alternate Delegate
    Dr. Jeanne Rader, Director, Division of Research and Applied 
Technology, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition, Food and 
Drug Administration (HFS-840), Harvey W. Wiley Federal Building, 5100 
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1786, Fax: (301) 436-2640, E-mail: [email protected].

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

U.S. Delegate
    Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of 
Policy, Program and Employee Development, Food Safety and Inspection 
Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th 
Street, SW., Washington, DC 20250, Phone: (202) 205-0699, Fax: (202) 
401-1760, E-mail: [email protected].
Alternate Delegate
    Dr. William James, Deputy Assistant Administrator, Office of 
International Affairs, Food Safety and Inspection Service, U.S. 
Department of Agriculture, Room 3143, South Building, 1400 Independence 
Ave., SW., Washington, DC 20250, Phone: (202) 720-8601, Fax: (202) 690-
3856, E-mail: [email protected].

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

U.S. Delegate
    Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and 
Beverages, Center for Food Safety and Applied Nutrition, Food and Drug 
Administration (HFS-300), Harvey W. Wiley Federal Building, 5100 Paint 
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700, 
Fax: (301) 436-2632, E-mail: [email protected].
Alternate Delegate
    Ms. Shellee Anderson, Food Technologist, Office of Nutritional 
Products, Labeling and Dietary Supplements, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration (HFS-800), Harvey W. 
Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD 
20740-3835, Phone: (301) 436-1491, Fax: (301) 436-2636, E-mail: 
[email protected].

Ad Hoc Intergovernmental Task Forces

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

U.S. Delegate
    Mr. Martin Stutsman, Consumer Safety Officer, 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

[[Page 31952]]

Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1642, 
Fax: (301) 436-2651, E-mail: [email protected].
Alternate Delegate
    Vacant.

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

U.S. Delegate
    Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Place (HFV-1), Metro Park 
N. 4, Rockville, MD 20855, Phone: (301) 827-2950, Fax: (301) 827-4401, 
E-mail: [email protected].
Alternate Delegate
    Dr. Lawrence E. Miller, Program Manager, Veterinary Regulatory 
Support, Plant Protection and Quarantine, Animal and Plant Health 
Inspection Service, Unit 129, Room 4D79, 4700 River Road, Riverdale, MD 
20737, Phone: (301) 734-7633, Fax: (301) 734-8538, E-mail: 
[email protected].
    There are six regional coordinating committees:
    Coordinating Committee for Africa.
    Coordinating Committee for Asia.
    Coordinating Committee for Europe.
    Coordinating Committee for Latin America and the Caribbean.
    Coordinating Committee for the Near East.
    Coordinating Committee for North American and the South-West 
Pacific.
Contact
    Paulo Almeida, Office Manager, U.S. Codex Office, Food Safety and 
Inspection Service, Room 4861, South Building, 1400 Independence Ave., 
SW., Washington, DC 20250-3700, Phone: (202) 205-7760, Fax: (202) 720-
3157, E-mail: [email protected].

                                                        Attachment 3: Timetable of Codex Sessions
                                                              [June 2003 through June 2005]
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
2003:
    CX 702-52.....................  Executive Committee     26-27 June............................  Rome.
                                     (52nd Session).
    CX 701-26.....................  Codex Alimentarius      30 June-5 July........................  Rome.
                                     Commission (26th
                                     Session).
    CX 731-11.....................  Codex Committee on      8-12 September........................  Mexico City.
                                     Fresh Fruits and
                                     Vegetables (11th
                                     Session).
    CX 722-26.....................  Codex Committee on      13-17 October.........................  Aalesund (Norway).
                                     Fish and Fishery
                                     Products (26th
                                     Session).
    CX 720-25.....................  Codex Committee on      3-7 November..........................  Berlin.
                                     Nutrition and Foods
                                     for Special Dietary
                                     Uses (25th Session).
    CX 716-19.....................  Codex Committee on      17-21 November........................  Paris.
                                     General Principles
                                     (19th Session).
    CX-733-12.....................  Codex Committee on      1-5 December..........................  Brisbane.
                                     Food Import and
                                     Export Inspection and
                                     Certification (12th
                                     Session).
2004:
    CX 702-53.....................  Executive Committee     4-6 February..........................  Geneva.
                                     (53rd Session).
    CX 723-10.....................  Codex Committee on      16-20 February........................  Auckland.
                                     Meat and Poultry
                                     Hygiene (10th
                                     Session).
    CX 715-25.....................  Codex Committee on      8-12 March............................  Budapest.
                                     Methods of Analysis
                                     and Sampling (25th
                                     Session).
    CX 711-36.....................  Codex Committee on      22-26 March...........................  Rotterdam.
                                     Food Additives and
                                     Contaminants (36th
                                     Session).
    CX 712-36.....................  Codex Committee on      29 March-3 April......................  Washington, DC.
                                     Food Hygiene (36th
                                     Session).
    CX 718-36.....................  Codex Committee on      19-24 April...........................  New Delhi.
                                     Pesticide Residues
                                     (36th Session).
    CX-703-06.....................  Codex Committee on      26-30 April...........................  Auckland.
                                     Milk and Milk
                                     Products (6th
                                     Session).
    CX 716-19.....................  Codex Committee on      3-7 May...............................  Paris.
                                     General Principles
                                     (19th Session).
    CX 714-32.....................  Codex Committee on      10-14 May.............................  Montreal.
                                     Food Labelling (32nd
                                     Session).
    CX 803-05.....................  Ad Hoc                  17-19 May.............................  Copenhagen.
                                     Intergovernmental
                                     Task Force on Animal
                                     Feeding (5th Session).
    CX 702-54.....................  Executive Committee     24-26 June............................  Geneva.
                                     (54th Session).
    CX 701-27.....................  Codex Alimentarius      28 June-3 July........................  Geneva.
                                     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................  Alexandria, VA.
                                     Processed Fruits and
                                     Vegetables (22nd
                                     Session).
    CX 801-03.....................  Ad Hoc                  11-15 October.........................  TBA (Brazil).
                                     Intergovernmental
                                     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).

[[Page 31953]]

 
    CX 730-15.....................  Codex Committee on      25-28 October.........................  TBA, USA.
                                     Residue 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      15-19 November........................  Paris.
                                     General Principles
                                     (21st Session).
    CX 701-55.....................  Executive Committee     22-24 November........................  Rome.
                                     (55th Session).
    CX 725-14.....................  Regional Coordinating   29 November-3 December................  Buenos Aires.
                                     Committee for Latin
                                     America and the
                                     Caribbean (14th
                                     Session).
    CX 733-13.....................  Codex Committee on      6-10 December.........................  TBA, (Australia).
                                     Food Import and
                                     Export Inspection and
                                     Certification Systems
                                     (13th Session).
2005:
    CX 707-16.....................  Regional Coordinating   14-17 December........................  Rabat (Morocco).
                                     Committee for Africa
                                     (16th Session).
    CX 723-11.....................  Codex Committee on      14-18 February........................  TBA, (New Zealand).
                                     Meat and Poultry
                                     Hygiene (11th
                                     Session).
    CX 709-19.....................  Codex Committee on      21-25 February........................  London.
                                     Fats and Oils (19th
                                     Session).
    CX 722-27.....................  Codex Committee on      28 February-4 March...................  TBA (South Africa).
                                     Fish and 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      14-19 March...........................  TBA, USA.
                                     Food Hygiene (37th
                                     Session).
    CX 711-37.....................  Codex Committee on      21-25 March...........................  Rotterdam.
                                     Food Additives and
                                     Contaminants (37th
                                     Session).
    CX 715-26.....................  Codex Committee on      4-8 April.............................  Budapest.
                                     Methods of Analysis
                                     and Sampling (26th
                                     Session).
    CX 716-22.....................  Codex Committee on      11-15 April...........................  Paris.
                                     General Principles
                                     (22nd Session).
    CX 718-37.....................  Codex Committee on      18-23 April...........................  The Hague.
                                     Pesticide Residues
                                     (37th Session).
    CX 714-33.....................  Codex Committee on      9-13 May..............................  TBA.
                                     Food Labelling (33rd
                                     Session).
    CX 731-12.....................  Codex Committee on      16-20 May.............................  Mexico City.
                                     Fresh Fruits and
                                     Vegetables (12th
                                     Session).
    CX 702-56.....................  Executive Committee     23-24 June............................  Rome.
                                     (56th Session).
    CX 701-28.....................  Codex Alimentarius      27 June-1 July........................  Rome.
                                     Commission (28th
                                     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, 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

[[Page 31954]]

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 
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

[[Page 31955]]

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.

Attachment 5

Part 1--Uniform Procedure for the Elaboration of Codex Standards and 
Related Texts

Steps 1, 2 and 3
    (1) The Commission decides, taking into account the ``Criteria for 
the Establishment of Work Priorities and for the Establishment of 
Subsidiary Bodies,'' to elaborate a Worldwide Codex Standard and also 
decides which subsidiary body or other body should undertake the work. 
A decision to elaborate a Worldwide Codex Standard may also be taken by 
subsidiary bodies of the Commission in accordance with the above-
mentioned criteria, subject to subsequent approval by the Commission or 
its Executive Committee at the earliest possible opportunity. In the 
case of Codex Regional Standards, the Commission shall base its 
decision on the proposal of the majority of members belonging to a 
given region or group of countries submitted at a session of the Codex 
Alimentarius Commission.
    (2) The Secretariat arranges for the preparation of a proposed 
draft standard. In the case of Maximum Limits for Residues of 
Pesticides or Veterinary Drugs, the Secretariat distributes the 
recommendations for maximum limits, when available from the Joint 
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and 
the Environment and the WHO Panel of Experts on Pesticide Residues 
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA). In the cases of milk and milk products or individual standards 
for cheeses, the Secretariat distributes the recommendations of the 
International Dairy Federation (IDF).
    (3) The proposed draft standard is sent to members of the 
Commission and interested international organizations for comment on 
all aspects including possible implications of the proposed draft 
standard for their economic interests.
Step 4
    The comments received are sent by the Secretariat to the subsidiary 
body or other body concerned which has the power to consider such 
comments and to amend the proposed draft standard.
Step 5
    The proposed draft standard is submitted through the Secretariat to 
the Commission or to the Executive Committee with a view to its 
adoption as a draft standard. When making any decision at this step, 
the Commission or the Executive Committee will give due consideration 
to any comments that may be submitted by any of its members regarding 
the implications which the proposed draft standard or any provisions of 
the standard may have for their economic interests. In the case of 
Regional Standards, all members of the Commission may present their 
comments, take part in the debate and propose amendments, but only the 
majority of the Members of the region or group of countries concerned 
attending the session can decide to amend or adopt the draft. When 
making any decisions at this step, the members of the region or group 
of countries concerned will give due consideration to any comments that 
may be submitted by any of the members of the Commission regarding the 
implications which the proposed draft standard or any provisions of the 
proposed draft standard may have for their economic interests.
Step 6
    The draft standard is sent by the Secretariat to all members and 
interested international organizations for comment on all aspects, 
including possible implications of the draft standard for their 
economic interests.
Step 7
    The comments received are sent by the Secretariat to the subsidiary 
body or other body concerned, which has the power to consider such 
comments and amend the draft standard.
Step 8
    The draft standard is submitted through the Secretariat to the 
Commission together with any written proposals received from members 
and interested international organizations for amendments at Step 8 
with a view to its adoption as a Codex Standard. In the case of 
Regional standards, all members and interested international 
organizations may present their comments, take part in the debate and 
propose amendments but only the majority of members of the region or 
group of countries concerned attending the session can decide to amend 
and adopt the draft.

Part 2--Uniform Accelerated Procedure for the Elaboration of Codex 
Standards and Related Texts

Steps 1, 2 and 3
    (1) The Commission or the Executive Committee between Commission 
sessions, on the basis of a two-thirds majority of votes cast, taking 
into account the ``Criteria for the Establishment of Work Priorities 
and for the Establishment of Subsidiary Bodies'', shall identify those 
standards which shall be the subject of an accelerated elaboration 
process. The identification of such standards may also be made by 
subsidiary bodies of the Commission, on the basis of a two-thirds 
majority of votes cast, subject to confirmation at the earliest 
opportunity by the Commission or its Executive Committee by a two-
thirds majority of votes cast.
    (2) The Secretariat arranges for the preparation of a proposed 
draft standard. In the case of Maximum Limits for Residues of 
Pesticides or Veterinary Drugs, the Secretariat distributes the 
recommendations for maximum limits, when available from the Joint 
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and 
the Environment and the WHO Panel of Experts on Pesticide Residues 
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives 
(JECFA). In the cases of milk and milk products or individual standards 
for cheeses, the Secretariat distributes the recommendations of the 
International Dairy Federation (IDF).
    (3) The proposed draft standard is sent to Members of the 
Commission and interested international organizations for comment on 
all aspects including possible implications of the proposed draft 
standard for their economic interests. When standards are subject to an 
accelerated procedure, this fact shall be notified to the Members of 
the Commission and the interested international organizations.
Step 4
    The comments received are sent by the Secretariat to the subsidiary 
body or other body concerned which has the power to consider such 
comments and to amend the proposed draft standard.
Step 5
    In the case of standards identified as being subject to an 
accelerated

[[Page 31956]]

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 84 of the 
Codex Procedural Manual and may take the following form:

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

    A tabulation should then follow, viz.:

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

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

    A tabulation should then follow, viz.:

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

    ``The following provisions in respect of the food hygiene of the 
product are subject to endorsement [have been endorsed] by the Codex 
Committee on Food Hygiene.''
Weights and Measures
    This section should include all provisions, other than labelling 
provisions, relating to weights and measures, e.g., where appropriate, 
fill of container, weight, measure or count of units determined by an 
appropriate method of sampling and analysis. Weights and measures 
should be expressed in S.I. units. In the case of standards which 
include provisions for the sale of products in standardized amounts, 
e.g. multiples of 100 grams, S.I. units should be used, but this would 
not preclude additional statements in the standards of these 
standardized amounts in approximately similar amounts in other systems 
of weights and measures.

[[Page 31957]]

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. 04-12736 Filed 6-7-04; 8:45 am]
BILLING CODE 3410-DM-P