[Federal Register: May 27, 2005 (Volume 70, Number 102)]
[Notices]
[Page 30675-30690]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my05-31]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 30675]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 05-003N]
International Standard-Setting Activities
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: This notice informs the public of the sanitary and
phytosanitary standard-setting activities of the Codex Alimentarius
Commission (Codex), in accordance with section 491 of the Trade
Agreements Act of 1979, as amended, and the Uruguay Round Agreements
Act, Public Law 103-465, 108 Stat. 4809. This notice also provides a
list of other standard-setting activities of Codex, including commodity
standards, guidelines, codes of practice, and revised texts. This
notice, which covers the time periods from June 1, 2004, to May 31,
2005, and June 1, 2005, to May 31, 2006, seeks comments on standards
currently under consideration and recommendations for new standards.
ADDRESSES: Comments may be submitted by any of the following methods:
Mail, including floppy disks or CD-ROM's, and hand-or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
All submissions received must include the Agency name and docket
number 05-003N. Please state that your comments refer to Codex and, if
your comments relate to specific Codex committees, please identify
those committees in your comments and submit a copy of your comments to
the delegate from that particular committee. All comments submitted
will be available for public inspection in the FSIS Docket Room at the
address listed above between 8:30 a.m. and 4:30 p.m., Monday through
Friday. The comments also will be posted on the Agency's Web site at
http://www.fsis.usda.gov/regulations/2005_notices_index/.
FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Ph.D., United
States Manager for Codex, U.S. Department of Agriculture, Office of the
Under Secretary for Food Safety, Room 4861, South Agriculture Building,
1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-
7760. For information pertaining to particular committees, the delegate
of that committee may be contacted. (A complete list of U.S. delegates
and alternate delegates can be found in Attachment 2 to this notice.)
Documents pertaining to Codex are accessible via the World Wide Web at
the following address:
http://www.codexalimentarius.net/current.asp
The U.S. Codex Office also maintains a Web site at
http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.
SUPPLEMENTARY INFORMATION:
Background
The World Trade Organization (WTO) was established on January 1,
1995, as the common international institutional framework for the
conduct of trade relations among its members in matters related to the
Uruguay Round Trade Agreements. The WTO is the successor organization
to the General Agreement on Tariffs and Trade (GATT). U.S. membership
in the WTO was approved and the Uruguay Round Agreements Act was signed
into law by the President on December 8, 1994. The Uruguay Round
Agreements became effective, with respect to the United States, on
January 1, 1995. Pursuant to section 491 of the Trade Agreements Act of
1979, as amended, the President is required to designate an agency to
be responsible for informing the public of the sanitary and
phytosanitary (SPS) standard-setting activities of each international
standard-setting organization, Codex, World Organization for Animal
Health, and the International Plant Protection Convention. The
President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR
15845), designated the U.S. Department of Agriculture as the agency
responsible for informing the public of SPS standard-setting activities
of each international standard-setting organization. The Secretary of
Agriculture has delegated to the Administrator, Food Safety and
Inspection Service (FSIS), the responsibility to inform the public of
the SPS standard-setting activities of Codex. The FSIS Administrator
has, in turn, assigned the responsibility for informing the public of
the SPS standard-setting activities of Codex to the U.S. Codex Office,
FSIS.
Codex was created in 1962 by two U.N. organizations, the Food and
Agriculture Organization (FAO) and the World Health Organization (WHO).
Codex is the principal international organization for encouraging fair
international trade in food and protecting the health and economic
interests of consumers. Through adoption of food standards, codes of
practice, and other guidelines developed by its committees and by
promoting their adoption and implementation by governments, Codex seeks
to ensure that the world's food supply is sound, wholesome, free from
adulteration, and correctly labeled. In the United States, the United
States Department of Agriculture (USDA); the Food and Drug
Administration (FDA), Department of Health and Human Services (HHS);
and the Environmental Protection Agency (EPA) manage and carry out U.S.
Codex activities.
As the agency responsible for informing the public of the SPS
standard-setting activities of Codex, FSIS publishes this notice in the
Federal Register annually. Attachment 1 (Sanitary and Phytosanitary
Activities of Codex) sets forth the following information:
1. The SPS standards under consideration or planned for
consideration; and
2. For each SPS standard specified:
a. A description of the consideration or planned consideration of
the standard;
b. Whether the United States is participating or plans to
participate in the consideration of the standard;
c. The agenda for United States participation, if any; and
d. The agency responsible for representing the United States with
respect to the standard.
To obtain Copies of those Standards listed in Attachment 1 that are
under
[[Page 30676]]
consideration by Codex, please contact the Codex delegate or the U.S.
Codex Office. This notice also solicits public comment on those
standards that are currently under consideration or planned for
consideration and recommendations for new standards. The delegate, in
conjunction with the responsible agency, will take the comments
received into account in participating in the consideration of the
standards and in proposing matters to be considered by Codex.
The United States' delegate will facilitate public participation in
the United States Government's activities relating to Codex
Alimentarius. The United States' delegate will maintain a list of
individuals, groups, and organizations that have expressed an interest
in the activities of the Codex committees and will disseminate
information regarding United States' delegation activities to
interested parties. This information will include the current status of
each agenda item; the United States Government's position or
preliminary position on the agenda items; and the time and place of
planning meetings and debriefing meetings following Codex committee
sessions. In addition, the U.S. Codex Office makes much of the same
information available through its web page,
http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.
Please visit the web page or notify the appropriate U.S. delegate or the Office of
U.S. Codex Alimentarius, Room 4861, South Agriculture Building, 1400
Independence Avenue, SW., Washington, DC 20250-3700, if you would like
to access or receive information about specific committees.
The information provided in Attachment 1 describes the status of
Codex standard-setting activities by the Codex Committees for the time
periods from June 1, 2004 to May 31, 2005, and June 1, 2005 to May 31,
2006. In addition, the following attachments are included:
Attachment 2 List of U.S. Codex Officials (includes U.S. delegates and
alternate delegates)
Attachment 3 Timetable of Codex Sessions (June 2004 through June 2006)
Attachment 4 Definitions for the Purpose of Codex Alimentarius
Attachment 5 Part 1--Uniform Procedure for the Elaboration of Codex
Standards and Related Texts
Part 2--Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts
Attachment 6 Nature of Codex Standards
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS web page located at
http://www.fsis.usda.gov/regulations/2005_Notices_Index/.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an e-mail subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at
http://www.fsis.usda.gov/news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
Done at Washington, DC on May 24, 2005.
F. Edward Scarbrough,
United States Manager for Codex.
Attachment 1: Sanitary and Phytosanitary Activities of Codex
Codex Alimentarius Commission and Executive Committee
The Codex Alimentarius Commission will hold its Twenty-Eighth
Session July 4-9, 2005 in Rome, Italy. At that time it will consider
procedural matters, and the standards, codes of practice, and related
matters brought to its attention by the general subject committees,
commodity committees, ad hoc Task Forces and member delegations. It
will also consider options to implement recommendations from the review
of Codex committee structure and mandates of Codex committees and task
forces, as well as budgetary and strategic planning issues. At this
Session, the Commission will elect a Chair and three Vice Chairs. The
issue of Codex interaction with other international organizations will
be discussed.
Prior to the Commission meeting, the Executive Committee will have
met at its Fifty-fifth Session on February 9-11, 2005 and its Fifty-
sixth Session on June 30-July 2, 2005. It is composed of the
chairperson, vice-chairpersons, seven members elected from the
Commission, one from each of the following geographic regions: Africa,
Asia, Europe, Latin America and the Caribbean, Near East, North
America, and South-West Pacific. In addition, regional coordinators
from the six regional committees attend as observers. It will consider
the Codex Strategic Plan 2008-1013; review the Codex committee
structure and mandate of Codex committees and task forces; review
matters arising from reports of Codex Committees, proposals for new
work, and standards management issues; consider the implementation of
the Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO
and WHO Work on Food Standards; and review the Trust Fund for the
Participation of Developing Countries and Countries in Transition in
the Work of the Codex Alimentarius.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Residues of Veterinary Drugs in Foods
The Codex Committee on Residues of Veterinary Drugs in Foods
determines priorities for the consideration of residues of veterinary
drugs in foods and recommends Maximum Residue Limits (MRLs) for
veterinary drugs. A veterinary drug is defined as any substance applied
or administered to a food producing animal, such as meat or dairy
animals, poultry, fish or bees, for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions or
behavior.
A Codex Maximum Limit for Veterinary Drugs (MRLVD) is the maximum
concentration of residue resulting from the use of a veterinary drug
(expressed in mg/kg or ug/kg on a fresh weight basis) that is adopted
by the Codex Alimentarius Commission to be permitted or recognized as
acceptable in or on a food. An MRLVD is based on the Acceptable Daily
Intake (ADI) and indicates the amount of residue in food that is
considered to be without appreciable toxicological hazard. An MRLVD
also takes into account other
[[Page 30677]]
relevant public health risks as well as food technological aspects.
When establishing an MRLVD, consideration is also given to residues
that occur in food of plant origin and/or the environment. Furthermore,
the MRLVD may be reduced to be consistent with good practices in the
use of veterinary drugs and to the extent that practical analytical
methods are available.
Acceptable Daily Intake (ADI): An estimate by the Joint FAO/WHO
Expert Committee on Food Additives (JECFA) of the amount of a
veterinary drug, expressed on a body weight basis, that can be ingested
daily over a lifetime without appreciable health risk (standard man =
60 kg).
The committee met in Arlington, VA (USA), October 25-28, 2004. The
following will be under consideration by the Commission at its 28th
Session in July 2005. The relevant document is ALINORM 5/28/31.
Draft MRLs at Step 8:
Cyhalothrin.
Flumequine.
Neomycin.
Dicyclanil.
Proposed Draft MRLs at Step 5/8:
Imidocarb.
Proposed Draft Code of Practice to Minimize and Contain
Antimicrobial Resistance at Step 5/8.
Proposed Draft MRLs at Step 5:
Flumequine (in black tiger shrimp).
Pirlimycin.
Cypermethrin and alpha-cypermethrin.
Doramectin (in cow's milk).
The Committee continues to work on:
Draft MRLs for Trichlorfon (metrifonate) at step 7.
Proposed Draft MRLs for Ractopamine at step 4.
Proposed Draft Revised Guidelines for the Establishment of
a Regulatory Program for Control of Veterinary Drug Residues in Foods.
Discussion paper on Risk Management Methodologies,
including Risk Assessment Policies in the Codex Committee on Residues
of Veterinary Drugs in Foods.
Proposed Draft Revised Part I, II, III of Guidelines for
the Establishment of a Regulatory Program for the Control of Veterinary
Drug Residues in Foods.
Priority List of Veterinary Drugs Requiring Evaluation or
Reevaluation.
List of Methods of Analysis for Veterinary Drug Residues
and Identification of Routine Methods of Analysis.
Recommendations on Residues of Veterinary Drugs without
ADI/MRL (Prioritization of work).
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Food Additives and Contaminants
The Codex Committee on Food Additives and Contaminants (CCFAC) (a)
establishes or endorses permitted maximum or guideline levels for
individual food additives, contaminants, and naturally occurring
toxicants in food and animal feed; (b) prepares priority lists of food
additives and contaminants for toxicological evaluation by the Joint
FAO/WHO Expert Committee on Food Additives (JECFA); (c) recommends
specifications of identity and purity for food additives for adoption
by the Commission; (d) considers methods of analysis for food additives
and contaminants; and (e) considers and elaborates standards and codes
for related subjects such as labeling of food additives when sold as
such and food irradiation. The committee met in The Hague, The
Netherlands, April 25-29, 2005. The following matters are under
consideration by the Commission at its 28th Session in July 2005. The
relevant document is ALINORM 5/28/12.
Revised Terms of Reference of the Codex Committee on Food
Additives and Contaminants.
Terms of Reference for the FAO/WHO Joint Expert
Consultation to Conduct a Comprehensive Assessment of Use of Active
Chlorine.
Food Additives
To be considered at Step 8:
General Standard for Food Additive (GSFA): Draft Food
Additive Provisions in Tables 1 and 2.
Amendment to Annex B (Food Category System) of the GSFA
(coconut water).
To be considered at Step 5/8:
General Standard for Food Additives: Proposed Draft Food
Additive Provisions in Tables 1, 2 and 3.
Advisory Specifications for the Identity and Purity of
Food Additives.
Proposed Draft Revisions to the Codex International
Numbering System for Food Additives.
To be considered at Step 5:
Proposed Draft Revised Preamble to the GSFA, including
diagram.
To be considered for Revocation and Discontinuation of work:
General Principles for the Use of Food Additives.
Proposed Amendments to the Codex Procedural Manual related
to the revocation of the General Principles for the Use of Food
Additives.
Proposed Draft and Draft Food Additive Provisions in the
GSFA.
To be considered for New Work:
Revision of Class Names and the International Numbering
System for Food Additives.
The Committee is continuing work on:
General Standard for Food Additives: Draft Food Additive
Provisions (in Tables 1, 2 and 3).
General Standard for Food Additives: Revisions to the
Preamble to clarify relationship between the General Standard and
commodity standards.
International Numbering System.
Specifications for the Identity and Purity of Food
Additives.
Inventory of Processing Aids.
Discussion Paper on Flavoring Agents.
Contaminants
To be considered at Step 8:
Draft Code of Practice for the Prevention and Reduction of
Aflatoxin Contamination in Tree Nuts.
Draft Code of Practice for the Prevention and Reduction of
Inorganic Tin Contamination in Canned Foods.
Draft Maximum Levels for Cadmium in wheat grain, potato,
stem and root vegetables, leafy vegetables, and other vegetables.
To be considered at Step 5/8:
Proposed Amendment to the Preamble of the Codex General
Standard for Contaminants and Toxins in Foods (GSCTF).
To be considered at Step 5:
Proposed Draft Maximum Level for Aflatoxin in unprocessed
almonds, hazelnuts and pistachios.
Proposed Draft Maximum Levels for Cadmium in rice,
cephalopod (excluding viscera), and marine bivalve mollusks (excluding
oysters and scallops).
To be considered for Revocation:
List of Maximum Levels for Contaminants and Toxins
Contained in Codex Commodity Standards and Relevant Standards and
Texts.
To be considered for New Work:
Appendix to the Code of Practice for the Prevention and
Reduction of Aflatoxin Contamination in Tree Nuts to address additional
measures for the prevention and reduction of aflatoxins in Brazil nuts.
The Committee is continuing work on:
Maximum levels for aflatoxin in processed almonds,
hazelnuts, and pistachios.
Discussion Paper on Aflatoxin Contamination in Brazil
Nuts.
Proposed draft sampling plan for Aflatoxin contamination
in Almonds, Brazil nuts, Hazelnuts and Pistachios.
[[Page 30678]]
Discussion paper on Deoxynivalenol (DON) Contamination in
Cereals.
Maximum Level for lead in fish.
Proposed Draft Code of Practice for Source Directed
Measures to Reduce Dioxin and Dioxin-like PCB Contamination in Foods.
Discussion paper with proposals for maximum levels for 3-
monochloropropanediol in acid-hydrolyzed vegetable protein (acid-HVP)
and acid-HVP containing foods.
Discussion paper on acrylamide, including a project paper
for new work and an outline of a proposed draft code of practice.
Draft Revised Guideline Levels for Radionuclides in Foods
Following Accidental Nuclear Contamination for Use in International
Trade, Including Guideline Levels for Long-Term Use.
Discussion paper on polyaromatic hydrocarbons, including a
project paper for new work and an outline of a proposed draft code of
practice.
Discussion paper on methylmercury in fish.
Discussion paper on Code of Practice for the Prevention
and Reduction of Ochratoxin A (OTA) Contamination in Coffee and Cocoa.
Discussion paper on Maximum level of Ochratoxin A in Wine.
General Issues
Priority List of Food Additives, Contaminants and
Naturally Occurring Toxicants Proposed for Evaluation by JECFA.
Responsible Agency: HHS/FDA
U.S. Participation: Yes.
Codex Committee on Pesticide Residues
The Codex Committee on Pesticide Residues recommends to the Codex
Alimentarius Commission establishment of maximum limits for pesticide
residues for specific food items or in groups of food. A Codex Maximum
Residue Limit for Pesticide (MRLP) is the maximum concentration of a
pesticide residue (expressed as mg/kg), recommended by the Codex
Alimentarius Commission to be legally permitted in or on food
commodities and animal feeds. Foods derived from commodities that
comply with the respective MRLPs are intended to be toxicologically
acceptable, that is, consideration of the various dietary residue
intake estimates and determinations both at the national and
international level in comparison with the ADI,* should
indicate that foods complying with Codex MRLPs are safe for human
consumption.
Codex MRLPs are primarily intended to apply in international trade
and are derived from reviews conducted by the Joint Meeting on
Pesticide Residues (JMPR) following:
(a) Review of residue data from supervised trials and supervised
uses including those reflecting national good agricultural practices
(GAP). Data from supervised trials conducted at the highest nationally
recommended, authorized, or registered uses are included in the review.
In order to accommodate variations in national pest control
requirements, Codex MRLPs take into account the higher levels shown to
arise in such supervised trials, which are considered to represent
effective pest control practices, and
(b) Toxicological assessment of the pesticide and its residue.
The committee met in The Hague, The Netherlands, April 18-23, 2005.
The following items will be considered by the Commission at its 28th
Session in July 2005. The relevant document is ALINORM 05/28/24.
To be considered at Step 8:
Draft and Draft Revised Maximum Residue Limits.
To be considered at Step 8(I):
Bifenazate.
Fludioxonil.
Trifloxystrobin.
To be considered at Step 5/8:
Proposed Draft and Proposed Draft Revised Maximum Residue
Limits including Proposed Draft MRLs for Spices.
Proposed Draft Guidelines for the Use of Mass Spectrometry
(MS) for Identification, Confirmation and Quantitative Determination of
Residues.
Proposed New Food Classification Codes for Commodities
with Adopted MRLs.
To be considered at Step 5:
Proposed Draft and Proposed Draft Revised Maximum Residue
Limits including Proposed Draft MRLs for Dried Chili Peppers.
Proposed Draft Guidelines on Estimation of Uncertainty of
Results.
Proposed Draft Risk Analysis Principles Applied by the
Codex Committee on Pesticide Residues.
To be considered for Revocation:
Codex CLX-Ds.
The committee is continuing work on:
Pilot Project for the examination of national MRLs as
Interim Codex MRLs for safer replacement pesticides.
Revision of the List of Recommended Methods of Analysis
for Pesticide Residues.
Criteria for Prioritization Process to Recommend Compounds
for Evaluation by JMPR.
Revision of the Codex Priority List of Pesticides for
review by JMPR.
MRLs for Processed or Ready-to-Eat Foods.
*Acceptable Daily Intake (ADI) of a chemical is the daily intake
which, during an entire lifetime, appears to be without appreciable
risk to the health of the consumer on the basis of all the known
facts at the time of the evaluation of the chemical by the Joint
FAO/WHO Meeting on Pesticide Residues. It is expressed in milligrams
of the chemical per kilogram of body weight.
Responsible Agency: EPA, USDA/AMS.
U.S. Participation: Yes.
Codex Committee on Methods of Analysis and Sampling
The Codex Committee on Methods of Analysis and Sampling:
(a) Defines the criteria appropriate to Codex Methods of Analysis
and Sampling;
(b) Serves as a coordinating body for Codex with other
international groups working in methods of analysis and sampling and
quality assurance systems for laboratories;
(c) Specifies, on the basis of final recommendations submitted to
it by the other bodies referred to in (b) above, Reference Methods of
Analysis and Sampling appropriate to Codex Standards which are
generally applicable to a number of foods;
(d) Considers, amends, if necessary, and endorses, as appropriate,
methods of analysis and sampling proposed by Codex (Commodity)
Committees, except that methods of analysis and sampling for residues
of pesticides or veterinary drugs in food, the assessment of
microbiological quality and safety in food, and the assessment of
specifications for food additives do not fall within the terms of
reference of this Committee;
(e) Elaborates sampling plans and procedures, as may be required;
(f) Considers specific sampling and analysis problems submitted to
it by the Commission or any of its Committees; and
(g) Defines procedures, protocols, guidelines or related texts for
the assessment of food laboratory proficiency, as well as quality
assurance systems for laboratories.
The 26th Session of the Committee met in Budapest, Hungary, on
April 4-8, 2005. The relevant document is ALINORM 05/28/23. The
following will be considered by the Commission at its 28th Session in
July 2005.
To be considered at Step 5:
Proposed Draft Guidelines for Evaluating Acceptable
Methods of Analysis.
The Committee will continue work on:
Criteria for Evaluating Acceptable Methods of Analysis.
[[Page 30679]]
Proposed Draft Guidelines for Settling of Disputes on
Analytical (test) Results.
Consideration of the Fitness-For-Purpose Approach to
Evaluating Methods of Analysis.
Further Review of the Analytical Terminology for Codex Use
in the Procedural Manual.
Endorsement of Methods of Analysis and Sampling Provisions
in Codex Standards.
Criteria for Methods of Analysis for the Detection and
Identification of Foods derived from Biotechnology
Methods of Analysis for the determination of dioxins and
PCBs.
Responsible Agency: HHS/FDA; USDA/MRP.
U.S. Participation: Yes.
Codex Committee on Food Import and Export Inspection and Certification
Systems
The Codex Committee on Food Import and Export Inspection and
Certification Systems is charged with developing principles and
guidelines for food import and export inspection and certification
systems to protect consumers and to facilitate trade. Additionally, the
Committee develops principles and guidelines for the application of
measures by competent authorities to provide assurance that foods
comply with essential requirements, especially statutory health
requirements. This encompasses work on: Equivalence of food inspection
systems including equivalence agreements, processes and procedures to
ensure that sanitary measures are implemented; guidelines on food
import control systems; and guidelines on food product certification
and information exchange. The development of guidelines for the
appropriate utilization of quality assurance systems to ensure that
foodstuffs conform to requirements and to facilitate trade also are
included in the Committee's terms of reference. The reference document
is ALINORM 05/28/30. The committee met in Melbourne, Australia, on
December 6-10, 2004. The following will be considered for adoption by
the Commission at its 28thSession in July 2005.
To be considered at step 5/8:
Draft Principles for Electronic Certification.
The committee is continuing work on:
Proposed Draft Appendices to the Guidelines on the
Judgment of Equivalence of Sanitary Measures Associated with Food
Inspection and Certification.
(a) Determining an ``objective basis of comparison''
(b) Details on the process of determining equivalence.
(c) Documentation for evaluation of submissions of requests for
equivalence determinations.
Proposed Draft Guidelines for Risk-based Inspection of
Imported Foods.
New work:
Develop principles for product tracing/traceability within
the context of food inspection and certification systems.
Revise the Codex Guidelines for Generic Official
Certificate Formats and the Production and Issuance of Certification.
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on General Principles
The Codex Committee on General Principles deals with procedure and
general matters as are referred to it by the Codex Alimentarius
Commission. The 21st Session addressed issues related to decisions made
by the Commission regarding the FAO/WHO Codex Evaluation. The 22nd
Session which met on April 11-15, 2005 in Paris, France, considered the
regular work of the Committee. The relevant documents are ALINORM 05/
28/33 and ALINORM 05/28/33A. Matters to be considered for adoption by
the 28th Commission in July 2005:
To be considered at Step 8:
Draft Risk Analysis Principles Applied by the Committee on
Food Additives and Contaminants (CCFAC).
Draft CCFAC Policy for Exposure Assessment.
For consideration by the Commission:
Amendments to the Rules of Procedure:
Proposed amendments concerning the enlargement of the
Executive Committee, the functions of the Executive Committee and
matters related to budget and expenses.
Proposed Amendments to Rule VIII.5--Observers.
Proposed Amendment on the Right to Address the Chair.
Amendments to the Procedure Manual:
Draft Revised Criteria for the Establishment of Work
Priorities.
Draft Guidelines on Physical Working Groups.
Draft Guidelines on Electronic Working Groups.
Draft Revised Principles concerning the Participation of
International Non-Governmental Organizations in the Work of the Codex
Alimentarius Commission.
Proposed Amendments to the Procedural Manual to eliminate
the acceptance procedures for Codex Standards.
Draft Guidelines for Cooperation with International
Intergovernmental Organizations.
The Committee continued work on:
Proposed Draft Working Principles for Risk Analysis for
Food Safety (Guidance to National Governments).
Proposed amendments to the Rules of Procedure: Duration of
the terms of the Members of the Executive Committee.
Possible reorganization of the structure, content and
presentation of the Procedural Manual.
Changes in the Elaboration Procedures.
Clarification of the term ``interim'' as used for the
adoption of Codex standards at Step 8.
Possible definitions of ``science-based'' and ``risk-
based''.
Management of the work in the Codex Committee on Food
Hygiene.
Responsible Agency: USDA/FSIS, FDA/CFSAN.
U.S. Participation: Yes.
Codex Committee on Food Labelling
The Codex Committee on Food Labelling is responsible for drafting
provisions on labelling issues assigned by the Codex Alimentarius
Commission. The reference document is ALINORM 04/27/22. The Committee
held its Thirty-third Session in Kota Kinabalu, Malaysia, on May 9-13,
2005. It considered the following items:
Guidelines for the Production, Processing, Labelling and
Marketing of Organically Produced Foods Proposed Revised Sections:
Annex 2--Tables 3 and 4, Revision to Table 1 (Natural Sodium Nitrate).
Draft Amendment to the General Standard for the Labelling
of Prepackaged Foods--(Draft Recommendations for the Labelling of Foods
Obtained through Certain Techniques of Genetic Modification/Genetic
Engineering) Section 2. (Definitions).
Proposed Draft Guidelines for the Labelling of Food and
food Ingredients obtained through certain Techniques of Genetic
Modification/Genetic Engineering: Labelling Provisions.
Proposed Draft Amendment to the General Standard for the
Labelling of Prepackaged Foods: Quantitative Declaration of
Ingredients.
Country of Origin Labelling.
Discussion paper on Advertising.
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
[[Page 30680]]
Codex Committee on Food Hygiene
The Codex Committee on Food Hygiene has four primary
responsibilities. First, to draft basic provisions on food hygiene
applicable to all food. These provisions normally take the form of
Codes of Hygienic Practice for a specific commodity (e.g. bottled
water) or group of commodities (e.g., milk and milk products). Second,
to suggest and prioritize areas where there is a need for
microbiological risk assessment at the international level and to
consider microbiological risk management matters in relation to food
hygiene and in relation to the risk assessment activities of FAO and
WHO. Third, to consider, amend if necessary, and endorse food hygiene
provisions that are incorporated into specific Codex commodity
standards by the Codex commodity committees. Fourth, to provide such
other general guidance to the Commission on matters relating to food
hygiene as may be necessary. The following items will be considered by
the Codex Alimentarius Commission at its 28th Session in Rome, Italy,
July 4-9, 2005. The relevant document is ALINORM 05/28/13.
To be considered at Step 5:
Proposed Draft Guidelines on the Application of the
General Principles of Food Hygiene to the Control of Listeria
monocytogenes in Ready-to-Eat Foods.
Proposed Draft Code of Hygienic Practice for Eggs and Egg
Products.
Proposed Draft Principles and Guidelines for the Conduct
of Microbiological Risk Management.
The committee continues to work on:
Proposed Draft Guidelines for Validation of Food Hygienic
Control Measures.
Proposed Draft Code of Hygienic Practice for Powdered
Formulae for Infants and Children.
Endorsement of Hygiene Provisions in Codex Standards and
Codes of Practice.
Annexes to the step 5 documents.
Proposals/risk profiles:
Guidelines for the Application of the General Principles
of Food Hygiene to the Risk-Based Control of Enterohemorrhagic E. coli
in Ground Beef and Fermented Sausages.
Guidelines for the Application of the General Principles
of Food Hygiene to the Risk-Based Control of Salmonella spp. in Broiler
Chickens.
Guidelines for Risk Management Options for Campylobacter
in Broiler Chickens.
Vibrio spp. in Seafood.
Viruses in Food.
Responsible Agency: HHS/FDA; FSIS/USDA.
U.S. Participation: Yes.
Codex Committee on Fresh Fruits and Vegetables
The Codex Committee on Fresh Fruits and Vegetables is responsible
for elaborating world-wide standards and codes of practice for fresh
fruits and vegetables. The Committee met in Mexico City, Mexico, on May
16-20, 2005. At the session they discussed the following items:
Draft Standard for Tomatoes at Step 7.
Draft Standard for Table Grapes retained at Step 7.
Proposed Draft Standard for Rambutan at Step 3.
Proposed Draft Standard for Apples at Step 3.
Section 2.1.1 (Maturity Requirements) and Annex on Small-
berry Varieties (Section 3.1) (draft Codex Standard for Table Grapes).
Guidelines for the Quality Control of Fresh Fruits and
Vegetables.
Standard Layout for Codex Standards for Fresh Fruits and
Vegetables.
Priority List.
Responsible Agency: USDA/AMS.
U.S. Participation: Yes.
Codex Committee on Nutrition and Foods for Special Dietary Uses
The Codex Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU) is responsible for studying nutritional problems referred by
the Codex Alimentarius Commission. The Committee also drafts general
provisions, as appropriate, on nutritional aspects of all foods and
develops standards, guidelines, or related texts for foods for special
dietary uses. The committee met in Bonn, Germany, November 1-4, 2004.
The relevant document is ALINORM 05/28/26. The following items will be
considered by the 28th Session of the Commission in June 2005.
To be adopted at Step 8:
Draft Guidelines for Vitamin and Mineral Food Supplements.
The Committee continues work on:
Draft Revised Standard for Gluten-Free Foods at Step 7.
Draft Revised Standard for Processed Cereal-Based.Foods
for Infants and Young Children at Step 6.
Draft Revised Standard for Infant Formula and Formulas for
Special Medical Purposes Intended for Infants at Steps 3 (Section A)
and 6 (Section B).
Guidelines for Use of Nutrition Claims Draft Table of
Conditions for Nutrient Content Claims (Part B containing Provisions on
Dietary Fibre) at Step 6.
Proposed Draft Revision of the Advisory Lists of Nutrient
Compounds for Use in Foods for Special Dietary Uses Intended for Use by
Infants and Young Children.
Proposed Draft Recommendations on the Scientific Basis of
Health Claims.
Discussion Paper on the Application of Risk Analysis to
the Work of the CCNFSDU.
Discussion Paper on Proposals for Additional or Revised
Nutrient Reference Values (NRVs).
Responsible Agency: HHS/FDA; FNS/USDA.
U.S. Participation: Yes.
Codex Committee on Fish and Fishery Products
The Fish and Fishery Products Committee is responsible for
elaborating standards for fresh, frozen and otherwise processed fish,
crustaceans and mollusks. The committee met in Capetown, South Africa,
February 28-March 4, 2005. The following will be considered by the 28th
Session of the Commission when it meets in July 2005. The relevant
document is ALINORM 05/28/18.
To be considered at Step 8:
Draft Code of Practice for Fish and Fishery Products
(Aquaculture).
Draft Amendment to the Standard for Salted Fish and Dried
Salted Fish.
To be considered at Step 5/8:
Proposed Draft Code of Practice for Fish and Fishery
Products (Shrimps and Prawns; Cephalopods; Transport; Retail; and
relevant Definitions).
To be considered at Step 5:
Proposed Draft Standard for Sturgeon Caviar New work:
Revision of the Procedure for the Inclusion of Species.
Amendment of the Standard for Canned Sardines and Sardine-
Type Products.
The Committee continues work on the following:
Proposed Draft Standard for Live and Processed Bivalve
Mollusks.
Proposed Draft Standard for Smoked Fish.
Proposed Draft Standard for Quick Frozen Scallop Adductor
Muscle Meat.
Proposed Draft Code of Practice on the Processing of
Scallop Meat.
Proposed Draft Code of Practice for Fish and Fishery
Products (other sections).
Proposed Draft Amendment of the Standard for Canned
Sardines and Sardine-Type Products (Clupea bentincki).
Responsible Agency: HHS/FDA; USDC/NOAA/NMFS.
U.S. Participation: Yes.
[[Page 30681]]
Codex Committee on Milk and Milk Products
The Codex Committee on Milk and Milk Products is responsible for
establishing international codes and standards for milk and milk
products. The Committee held its 6th Session in Auckland, NZ on April
26-30, 2004. The relevant document is ALINORM 04/27/11.
For discussion at the 28th Session of the Codex Alimentarius
Commission in July 2005.
Proposal for a new standard for Parmesan Cheese At its 7th
Session, the Committee will continue work on the following:
At Step 6:
Draft Standard for a Blend of Evaporated Skimmed Milk and
Vegetable Fat.
Draft Standard for a Blend of Skimmed Milk and Vegetable
Fat in Powdered Form.
Draft Standard for a Blend of Sweetened Condensed Skimmed
Milk and Vegetable Fat.
Draft Revised Standard for Whey Cheese.
Draft Revised Standards for Cheddar (C-1) and Danbo (C-3).
Other work of the committee:
Proposed Draft Revised Standards for Individual Cheeses at
Step 4.
Proposed Template for Fermented Milk Drinks Provisions.
Proposed Draft Model Export Certificate for Milk and Milk
Products.
Methods of Analysis and Sampling for Milk Products.
Proposed Draft Revised Standard for Processed Cheese.
Proposed Draft Revised Standard for Dairy Spreads.
Discussion paper on Proposed Revision of the Codex
Standard for Extra Hard Grating Cheese.
Discussion paper on the Issue of Naming Non-standardized
Dairy Products.
Responsible Agency: USDA/AMS; HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Fats and Oils
The Codex Committee on Fats and Oils is responsible for elaborating
standards for fats and oils of animal, vegetable, and marine origin.
The committee met in London, U.K., February 21-25, 2005. The relevant
document is 05/28/17. The following will be considered by the
Commission at its July 2005 session.
To be considered at Step 5/8:
Proposed Draft Amendments to the Standard for Named
Vegetable Oils: Sesameseed Oil.
To be considered at Step 5:
Proposed Draft Amendments to the Standard for Named
Vegetable Oils: Rice Bran Oil.
To be considered at Step 5 of the Accelerated Procedure:
Proposed Draft Revised Table 1 of the Recommended
International Code of Practice for the Storage and Transport of Edible
Fats and Oils in Bulk.
New Work:
Amendment of the Standard for Named Vegetable Oils.
Mid-oleic sunflowerseed oil.
Mid-oleic acid soya bean oil.
Low linolenic acid soya bean oil.
Unbleached palm oil: total carotenoids.
The Committee continues work on:
Draft Standard for Fat Spreads and Blended Spreads: Food
additives.
Draft List and Proposed Draft List of Acceptable Previous
Cargoes.
Proposed Draft Amendment to the Standard for Olive Oil:
Linolenic Acid content.
Criteria for the Revision of Named Vegetable oils.
Consideration of ISO proposal to amend the nomenclature of
oils.
Responsible Agency: HHS/FDA; USDA/ARS.
U.S. Participation: Yes.
Codex Committee on Processed Fruits and Vegetables
The Codex Committee on Processed Fruits and Vegetables is
responsible for elaborating standards for Processed Fruits and
Vegetables. After having been adjourned sine die, the Committee
reconvened in Washington, DC, in March 1998 to begin work revising the
standards. The Committee held its most recent session on September 27
October 1, 2004. The relevant document is ALINORM 05/28/27.
To be considered at Step 5:
Processed Tomato Concentrates.
Preserved (Canned) Tomatoes.
Certain Canned Citrus Fruits.
The committee is continuing work on:
Draft Codex Standard for Pickled Fruits and Vegetables.
Proposed Draft Codex Standards for:
Jams, Jellies and Marmalades.
Certain Canned Vegetables and Guidelines for Packing Media
for Canned Vegetables.
Other work:
Methods of Analysis for Processed Fruits and Vegetables.
Priority List for the Standardization of Processed Fruits
and Vegetables.
Discontinued work in this committee:
Proposed Draft Standard for Soy Sauce.
Responsible Agency: USDA/AMS; HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Meat Hygiene
The 24th Session of the Commission decided to reactivate the Codex
Committee on Meat Hygiene with New Zealand as Host Government. The
Terms of Reference were amended to reflect the inclusion of poultry in
its mandate. The Committee completed its work at its 11th Session and
requested the Commission that it be adjourned sine die. The relevant
document is ALINORM 05/28/16.
To be considered at Step 8:
Draft Code of Hygienic Practice for Meat.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Cereals, Pulses, and Legumes
The 26th Session of the Codex Alimentarius Commission adopted the
Proposed Draft Standard for Instant Noodles at Step 5, on the
recommendation of the Coordinating Committee for Asia, and advanced it
to Step 6 for consideration by the Committee on Cereals, Pulses and
Legumes by correspondence. The United States, as host government, has
circulated the Draft Standard for two rounds of comments. Consideration
of the additives provisions will take place in the Codex Committee on
Food Additives and Contaminants.
Responsible Agency: HHS/FDA; USDA/GIPSA.
U.S. Participation: Yes.
Certain Codex Commodity Committees
Several Codex Alimentarius Commodity Committees have adjourned sine
die. The following Committees fall into this category:
Cocoa Products and Chocolate.
Responsible Agency: HHS/FDA.
U.S. Participation: Yes.
Natural Mineral Water.
Responsible Agency: HHS/FDA.
U.S. Participation: Yes.
Sugars.
Responsible Agency: USDA/ARS; HHS/FDA.
U.S. Participation: Yes.
Vegetable Proteins.
Responsible Agency: USDA/ARS; HHS/FDA.
U.S. Participation: Yes.
Ad Hoc Intergovernmental Task Force on Animal Feeding
The Commission at its 23rd Session established the Ad Hoc
Intergovernmental Task Force on Animal Feeding to develop guidelines or
standards as appropriate on good animal feeding practices. The Revised
[[Page 30682]]
Draft Code of Practice for Good Animal Feeding was held at Step 8 by
the Commission at its 26th Session in June 2003, with the exception
that the definition of ``feed additive'' and paragraphs 11, 12, and 13
were advanced to step 6. The Task Force held its 5th Session on May 17-
19, 2004 and discussed:
Revised Draft Code of Practice for Good Animal Feeding
(definition of ``feed additive'' and paragraphs 11, 12, and 13).
Responsible Agency: HHS/FDA; USDA/APHIS.
U.S. Participation: Yes.
Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices
The Commission at its 23rd Session established this Task Force to
revise and consolidate the existing Codex standards and guidelines for
fruit and vegetable juices and related products, giving preference to
general standards. These standards were originally developed by the
Joint UNECE/Codex Group of Experts on the Standardization of Fruit
Juices which had been abolished by its parent organizations. The Task
Force held its fourth and final session in Fortaleza, Brazil, on
October 11-15, 2004. The Task Force completed the work assigned to the
Task Force in its Terms of Reference.
For Adoption at Step 8:
Draft Codex General Standard for Fruit Juices and Nectars.
Draft Minimum Brix Level for Reconstituted Juice and
Reconstituted Pure and Minimum Juice and/or Pure Content for Fruit
Nectars (%v/v)--grapes, guava, mandarine/tangerine, mango, passion
fruit and tamarind (Indian date) juices/nectars.
For Adoption at Step 5/8:
Proposed Draft Minimum Brix Level for Reconstituted Juice
and Reconstituted Pure and Minimum Juice and/or Pur[eacute]e Content
for Fruit nectars (%v/v)--orange, lemon, lime, and pineapple juices/
nectars.
Responsible Agency: HHS/FDA; USDA/AMS.
U.S. Participation: Yes.
FAO/WHO Regional Coordinating Committees
The Codex Alimentarius Commission is made up of an Executive
Committee, as well as approximately 30 subsidiary bodies. Included in
these subsidiary bodies are coordinating committees for groups of
countries located in proximity to each other who share common concerns.
There are currently six Regional Coordinating Committees:
Coordinating Committee for Africa.
Coordinating Committee for Asia.
Coordinating Committee for Europe.
Coordinating Committee for Latin America and the
Caribbean.
Coordinating Committee for the Near East.
Coordinating Committee for North America and the South-
West Pacific.
The United States participates as an active member of the
Coordinating Committee for North America and the South-West Pacific,
and is informed of the other coordinating committees through meeting
documents, final reports, and representation at meetings. Each regional
committee:
Defines the problems and needs of the region concerning
food standards and food control;
Promotes within the committee contacts for the mutual
exchange of information on proposed regulatory initiatives and problems
arising from food control and stimulates the strengthening of food
control infrastructures;
Recommends to the Commission the development of world-wide
standards for products of interest to the region, including products
considered by the committee to have an international market potential
in the future; and
Serves a general coordinating role for the region and
performs such other functions as may be entrusted to it by the
Commission.
Codex Coordinating Committee for North America and the South-West
Pacific
The Coordinating Committee is responsible for defining problems and
needs concerning food standards and food control of all Codex member
countries of the region. Items coming before the Commission in July
include the following. The committee met in Apia, Samoa, on October 19-
22, 2004. The relevant document is ALINORM 05/28/32.
Recommendation that Samoa be reappointed as Regional
Coordinator.
Support the development of a new Standard for Parmesan
cheese and adopt the amendment of the Codex Standard for Canned
Sardines and Sardine-Type Products.
Items on the agenda for the next meeting may include:
Codex working documents of special interest to regional
member states.
Joint FAO/WHO Evaluation of the Codex Alimentarius and
other FAO and WHO Work on Food Standards.
Strategic Plan for the Coordinating Committee for North
America and the Southwest Pacific.
Trust Fund for the participation of Developing Countries
in Codex.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Codex Coordinating Committee for Asia
The Coordinating Committee met in Jeju-Do, Republic of Korea on
September 7-10, 2004. The relevant document is ALINORM--5/15.
To be considered at Step 5:
Proposed Draft Standard for Ginseng Products.
New work:
Refrigerated, Non-fermented Soybean Products.
Attachment 2--U.S. Codex Alimentarius Officials Codex Committee
Chairpersons
Codex Committee on Food Hygiene
Dr. Karen Hulebak, Chief Scientist, Office of Public Health
Science, Food Safety and Inspection Service, U.S. Department of
Agriculture, 1400 Independence Avenue, SW., Room 3130, South Building,
Washington, DC 20250-3700, Phone: (202) 720-5735, Fax: (202) 720-2980.
E-mail: karen.hulebak@fsis.usda.gov.
Codex Committee on Processed Fruits and Vegetables
Mr. David L. Priester, Head, Standardization Section, AMS Fruit &
Vegetable Programs, Fresh Products Branch, U.S. Department of
Agriculture, Room 1661, South Building, 1400 Independence Avenue, SW.,
Washington, DC 20250-0240. Phone: (202) 720-2185. Fax: (202) 720-8871.
E-mail: david.priester@usda.gov.
Codex Committee on Residues of Veterinary Drugs in Foods
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville,
MD 20855, Phone: (301) 827-2950, Fax: (301) 827-8401, E-mail:
ssundlof@cvm.fda.gov.
Codex Committee on Cereals, Pulses and Legumes (Adjourned sine die)
Mr. Steven N. Tanner, Director, Technical Services Division, Grain
Inspection, Packers & Stockyards Administration, U.S. Department of
Agriculture, 10383 N. Executive Hills Boulevard, Kansas City, MO 64153-
1394, Phone: (816) 891-0401, Fax: (816) 891-0478, E-mail:
stanner@tsd.fgiskc.usda.gov.
[[Page 30683]]
Listing of U.S. Delegates and Alternates Worldwide General Subject
Codex Committees
Codex Committee on Residues of Veterinary Drugs in Foods (Host
Government--United States)
U.S. Delegate
Dr. Steven D. Vaughn, Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine, Food and Drug
Administration, 7500 Standish Place, Rockville, MD 20855, Phone: (301)
827-1796, Fax: (301) 594-2297, E-mail: SVaughn@cvm.fda.gov.
Alternate Delegate
Dr. Alice Thaler, Staff Director, Animal and Egg Production Food
Safety Staff, Food Safety and Inspection Service, 1400 Independence
Avenue, SW., Washington, DC 20250, Phone: (202) 690-2683, Fax: (202)
720-8213, E-mail: alice.thaler@fsis.usda.gov.
Codex Committee on Food Additives and Contaminants (Host Government--
The Netherlands)
U.S. Delegate
Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and
Beverages, Center for Food Safety and Applied Nutrition (HFS-300), Food
and Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700,
Fax: (301) 436-2632, E-mail: Terry.Troxell@cfsan.fda.gov.
Alternate Delegate
Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for
Food Safety and Applied Nutrition (HFS-265), Food and Drug
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch
Parkway, College Park, MD 20740-3835, Phone: (301) 436-1284, Fax: (301)
436-2972, E-mail: dennis.keefe@cfsan.fda.gov.
Codex Committee on Pesticide Residues (Host Government--The
Netherlands)
U.S. Delegate
Lois Rossi, Director of Registration Division, Office of Pesticide
Programs, U.S. Environmental Protection Agency, Ariel Rios Building,
1200 Pennsylvania Avenue, NW., Washington, DC 20460, Phone: (703) 305-
5035, Fax: (703) 305-5147, E-mail: Rossi.Lois@epamail.epa,gov.
Alternate Delegate
Dr. Robert Epstein, Associate Deputy Administrator, Science and
Technology, Agricultural Marketing Service, U.S. Department of
Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222, 1400
Independence Avenue, SW., Washington, DC 20090, Phone (202) 720-2158,
Fax: (202) 720-1484, E-mail: Robert.Epstein@usda.gov.
Codex Committee on Methods of Analysis and Sampling (Host Government--
Hungary)
U.S. Delegate
Dr. Gregory Diachenko, Director, Division of Chemistry Research and
Environmental Review, Office of Food Additive Safety, Center for Food
Safety and Applied Nutrition (CFSAN), Food and Drug Administration
(HFS-245), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway,
College Park, MD 20740-3835, Phone (301) 436-1898, Fax: (301) 436-2364,
E-mail: Gregory.Diachenko@cfsan.fda.gov.
Alternate Delegate
Mr. Donald C. Kendall, Technical Services Division, Grain,
Inspection, Packers & Stockyards Administration, U.S. Department of
Agriculture, 10383 N. Ambassador Drive, Kansas City, MO 64153-1394,
Phone: (816) 891-0463, Fax: (816) 891-0478, E-mail:
Donald.C.Kendall@usda.gov.
Codex Committee on Food Import and Export Inspection and Certification
Systems (Host Government--Australia)
U.S. Delegate
Dr. Catherine Carnevale, Director, Office of Constituent
Operations, Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2380,
Fax: (301) 436-2612, E-mail: Catherine.Carnevale@cfsan.fda.gov.
Alternate Delegate
Karen Stuck, Chief, International Policy Staff, Food Safety and
Inspection Service, U.S. Department of Agriculture, Room 2137, South
Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700,
Phone: (202) 720-3470, Fax: (202) 720-7990, E-mail:
Karen.Stuck@fsis.usda.gov.
Codex Committee on General Principles (Host Government--France)
U.S.Delegate
Note: A member of the Steering Committee heads the delegation to
meetings of the General Principles Committee.
Codex Committee on Food Labeling (Host Government--Canada)
U.S. Delegate
Leslye Fraser, J.D., Director, Office of Regulations and Policy,
Center for Food Safety and Applied Nutrition, FDA, 5100 Paint Branch
Parkway (HFS-004), College Park, MD 20740, Phone: (301) 436-2378, Fax:
(301) 436-2637, E-mail: leslye.fraser@fda.hhs.gov.
Alternate Delegate
Ms. Danielle Schor, Chief of Staff, Office of the Administrator,
Food Safety and Inspection Service, U.S. Department of Agriculture,
1400 Independence Avenue, SW., Washington, DC 20250-1400, Phone: (202)
720-6618, Fax: (202) 720-7771, E-mail: danielle.schor@fsis.usda.gov.
Codex Committee on Food Hygiene (Host Government--United States)
U.S. Delegate
Dr. Robert L. Buchanan, Director, Office of Science, Center for
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
006), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway,
College Park, MD 20740-3835, Phone: (301) 436-2369, Fax: (301) 436-
2642, E-mail: Robert.Buchanan@cfsan.fda.gov.
Alternate Delegates
Dr. Daniel Engeljohn, Deputy Assistant Administrator, Office of
Policy, Program, and Employee Development, Room 3149, South Building,
U.S. Department of Agriculture, 1400 Independence Avenue, SW.,
Washington, DC 20250, Phone: (202) 205-0495, Fax: (202) 401-1760, E-
mail: Daniel.engeljohn@fsis.usda.gov.
Dr. Rebecca Buckner, Consumer Safety Officer, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, Room 3B-
0033 Harvey Wiley Building, 5100 Paint Branch Parkway, College Park, MD
20740, Phone: (301) 436-1486, Fax: (301) 436-2632, E-mail:
Rebecca.Buckner@cfsan.fda.gov.
Codex Committee on Nutrition and Food for Special Dietary Uses (Host
Government--Germany) U.S. Delegate
Barbara O. Schneeman, PhD, Director, Office of Nutritional
Products, Labeling and Dietary Supplements, Center for Food Safety and
Applied Nutrition, FDA, 5100 Paint Branch Highway, College Park, MD
20740, Tel: (301) 436-2373, Fax: (301) 436-2636, E-mail:
Barbara.Schneeman@cfsan.fda.gov.
[[Page 30684]]
Alternate Delegate
Patricia McKinney, Senior Program Analyst, Office of Analysis,
Nutrition Service, Food and Nutrition Service, USDA, 3101 Park Center
Drive, Room 1014, Alexandria, VA 22302, Tel: (703) 305-2126, Fax: (703)
305-2576, E-mail: Pat.Mckinney@fns.usda.gov.
Worldwide Commodity Codex Committees Codex Committee on Fresh Fruits
and Vegetables (Host Government--Mexico)
U.S. Delegate
Dorian LaFond, International Standards Coordinator, Fruit and
Vegetables Program, Agricultural Marketing Service, Room 2086, South
Building, 1400 Independence Avenue, SW., Washington, DC 20250, Phone
(202) 690-4944, Fax: (202) 720-4722, E-mail: dorian.lafond@usda.gov.
Alternate Delegate
Vacant.
Codex Committee on Fish and Fishery Products (Host Government--Norway)
U.S. Delegate
Mr. Philip C. Spiller, Director, Office of Seafood, Center for Food
Safety and Applied Nutrition, Food and Drug Administration (HFS-400),
Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College
Park, MD 20740-3835, Phone: (301) 436-2300, Fax: (301) 436-2599, E-
mail: Philip.Spiller@cfsan.fda.gov.
Alternate Delegate
Mr. Richard V. Cano, Acting Director, National Seafood Inspection
Program, NOAA, U.S. Department of Commerce, 1315 East-West Highway,
Silver Spring, MD 20910, Phone: (301) 713-2355, Fax: (301) 713-1081, E-
mail: richard.cano@noaa.gov.
Codex Committee on Cereals, Pulses and Legumes (Host Government--United
States)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Activities Staff,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714,
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
Mr. David Shipman, Deputy Administrator, Federal Grain Inspection
Division, Grain Inspection, Packers and Stockyards Administration, U.S.
Department of Agriculture, Room 1661, South Building, 1400 Independence
Avenue, SW., Washington, DC 20250, Phone: (202) 720-9170, Fax: (202)
205-9237, E-mail: dshipman@gipsadc.usda.gov.
Codex Committee on Milk and Milk Products (Host Government--New
Zealand)
U.S. Delegate
Mr. Duane Spomer, Associate Deputy Administrator for Standards and
Grading, Dairy Programs, Agricultural Marketing Service, U.S.
Department of Agriculture, Room 2746, South Building, 1400 Independence
Avenue, SW., Washington, DC 20250, Phone: (202) 720-3171, Fax: (202)
720-2643, E-mail: duane.spomer@usda.gov.
Alternate Delegate
John F. Sheehan, Director, Division of Dairy and Egg Safety, Office
of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition
(HFS-306), Food and Drug Administration, Harvey W. Wiley Federal
Building, 5100 Paint Branch Parkway, College Park, MD 20740, Phone:
(301) 436-1488, Fax: (301) 436-2632, E-mail:
john.sheehan@cfsan.fda.gov.
Codex Committee on Fats and Oils (Host Government--United Kingdom)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Activities Staff,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714,
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
Ms. Kathleen Warner, U.S. Department of Agriculture, 1815 N.
University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax: (309)
681-6668, E-mail: warnerk@ncaur.usda.gov.
Codex Committee on Cocoa Products and Chocolate (Host Government--
Switzerland)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Activities Staff,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714,
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
Dr. Michelle Smith, Food Technologist, Office of Plant and Dairy
Foods and Beverages, Center for Food Safety and Applied Nutrition, Food
and Drug Administration (HFS-306), Harvey W. Wiley Federal Building,
5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: 301-436-
2024, Fax: 301-436-2651, E-mail: Michelle.Smith@cfsan.fda.gov.
Codex Committee on Sugars (Host Government--United Kingdom)
U.S. Delegate
Dr. Thomas L. Tew, Research Geneticist, Sugarcane Research Unit,
Agricultural Research, USDA--FSIS, 5883 USDA Road, Houma, LA 70360,
Phone: (504) 872-5042, Fax: (504) 868-8369, E-mail:
ttew@nola.srrc.usda.gov.
Alternate Delegate
Dr. Dennis M. Keefe, Office of Food Additive Safety, Center for
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
265), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway,
College Park, MD 20740-3835, Phone: (301) 436-1284, Fax: (301) 436-
2972, E-mail: dennis.keefe@cfsan.fda.gov.
Codex Committee on Processed Fruits and Vegetables (Host Government--
United States)
U.S. Delegate
Dorian Lafond, International Standards Coordinator, Fruit and
Vegetable Division, Agricultural Marketing Service, U.S. Department of
Agriculture, Room 2086, South Building, 1400 Independence Avenue, SW.,
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-0016, E-
mail: Dorian.Lafond@usda.gov.
Alternate Delegate
Mr. Charles W. Cooper, Director, International Activities Staff,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-585), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1714,
Fax: (301) 436-2612, E-mail: Charles.Cooper@cfsan.fda.gov.
Codex Committee on Vegetable Proteins (Host Government--Canada)
U.S. Delegate
Dr. Wilda H. Martinez, Area Director, ARS North Atlantic Area,
Agricultural Research Service, USDA, 600 E. Mermaid Lane, Wyndmoor, PA
19038, Phone: (215) 233-6593, Fax: (215) 233-6719, E-mail:
wmartinez@ars.usda.gov.
[[Page 30685]]
Alternate Delegate
Dr. Jeanne Rader, Director, Division of Research and Applied
Technology, Office of Nutritional Products, Labeling and Dietary
Supplements, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1786,
Fax: (301) 436-2640, E-mail: Jeanne.Rader@cfsan.fda.gov.
Codex Committee on Meat Hygiene (Host Government--New Zealand)
U.S. Delegate
Dr. Perfecto Santiago, Deputy Assistant Administrator, Office of
Food Security and Emergency Preparedness, Room 3130, South Building,
U.S. Department of Agriculture, 1400 Independence Avenue, SW.,
Washington, DC 20250, Phone: (202) 205-0452, Fax: (202) 690-5634.
Perfecto.Santiago@fsis.usda.gov.
Alternate Delegate
Dr. William O. James, Deputy Assistant Administrator, Office of
International Affairs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Room 3143, South Building, Washington, DC
20250-3700, Phone: (202) 720-5362, Fax: (202) 690-3856, E-mail:
william.james@fsis.usda.gov.
Codex Committee on Natural Mineral Waters (Host Government--
Switzerland)
U.S. Delegate
Dr. Terry C. Troxell, Director, Office of Plant and Dairy Foods and
Beverages, Center for Food Safety & Applied Nutrition, Food and Drug
Administration (HFS-300), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700,
Fax: (301) 436-2632, E-mail: Terry.troxell@cfsan.fda.gov.
Alternate Delegate
Ms. Shellee Anderson, Office of Nutritional Products, Labeling and
Dietary Supplements, Center for Food Safety and Applied Nutrition, Food
and Drug Administration (HFS-830), Harvey W. Wiley Federal Building,
5100 Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301)
436-1491, Fax: (301) 436-2636, E-mail: Shellee.Anderson@cfsan.fda.gov.
Ad Hoc Intergovernmental Task Forces; Ad Hoc Intergovernmental Task
Force on Fruit and Vegetable Juices (Host Government--Brazil)
U.S. Delegate
Mr. Martin Stutsman, Office of Plant and Dairy Foods, Center for
Food Safety and Applied Nutrition, Food and Drug Administration (HFS-
306), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway,
College Park, MD 20740-3835, Phone: (301) 436-1642, Fax: (301) 436-
2651, E-mail: Martin.Stutsman@cfsan.fda.gov.
Alternate Delegate
Vacant.
Ad Hoc Intergovernmental Task Force on Foods Derived From Modern
Biotechnology (Host Government--Japan)
U.S. Delegate
Bernice Slutsky, Ph.D., Special Assistant to the Secretary for
Biotechnology, Office of the Secretary, U.S. Department of Agriculture,
1400 Independence Avenue, SW., Washington, DC 20250, Phone: (202) 720-
3631, Fax: (202) 720-6314, E-mail: Bernice.Slutsky@usda.gov.
Alternate Delegate
Eric Flamm, Ph.D., Senior Advisor, Office of the Commissioner, Food
and Drug Administration, Room 1561 Parklawn Building, Rockville, MD
20857, Phone: (301) 827-0591, FAX: (301) 827-4774, E-mail:
EFLAMM@OC.FDA.GOV.
There are six regional coordinating committees:
Coordinating Committee for Africa
Coordinating Committee for Asia
Coordinating Committee for Europe
Coordinating Committee for Latin America and the Caribbean
Coordinating Committee for the Near East
Coordinating Committee for North America and the South-West
Pacific
Contact: Paulo Almeida, Office Manager, U.S. Codex Office, Food
Safety and Inspection Service, Room 4861, South Building, 1400
Independence Avenue, SW., Washington, DC 20250-3700, Phone (202) 205-
7760, Fax (202) 720-3157, E-mail: Paulo.Almeida@fsis.usda.gov.
Attachment 3.--Timetable of Codex Sessions
[June 2004 through June 2006]
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
2004:
CX 702-54.................. Executive Committee (54th 24-26 June................................. Geneva (Switzerland).
session).
CX 701-27.................. Codex Alimentarius 28 June-2 July............................. Geneva (Switzerland).
Commission (27th Session).
CX 727-14.................. Regional Coordinating 7-10 September............................. JeJu (City) Republic of Korea.
Committee for Asia (14th
Session).
CX 706-24.................. Regional Coordinating 20-23 September............................ Bratislava (Slovak Republic).
Committee for Europe (24th
Session).
CX 713-22.................. Codex Committee on 27 September-1 October..................... Arlington, VA (USA).
Processed Fruits and
Vegetables (22nd Session).
CX 801-03.................. Ad Hoc Intergovernmental 11-15 October.............................. Fortaleza (Brazil).
Task Force on Fruit and
Vegetable Juices (3rd
Session).
CX 732-08.................. Regional Coordinating 19-22 October.............................. Apia (Samoa).
Committee for North
America and South West
Pacific (8th Session).
CX 730-15.................. Codex Committee on Residue 25-28 October.............................. Arlington, VA (USA).
of Veterinary Drugs in
Foods (15th Session).
CX 720-26.................. Codex Committee on 1-5 November............................... Bonn (Germany).
Nutrition and Foods for
Special Dietary Uses (26th
Session).
CX 716-21.................. Codex Committee on General 15-19 November............................. Paris (France).
Principles (21st Session).
CX 725-14.................. Regional Coordinating 29 November-3 December..................... Buenos Aires (Argentina).
Committee for Latin
America and the Caribbean
(14th Session).
CX 733-13.................. Codex Committee on Food 6-10 December.............................. Melbourne (Australia).
Import and Export
Certification Systems
(13th Session).
[[Page 30686]]
2005:
CX 707-16.................. Regional Coordinating 25-28 January.............................. Rome (FAO) (Italy).
Committee for Africa (16th
Session).
CX 702-55.................. Executive Committee (55th 9-11 February.............................. Rome (FAO) (Italy).
Session).
CX 723-11.................. Codex Committee on Meat and 14-18 February............................. Christchurch (New Zealand).
Poultry Hygiene (11th
Session).
CX 709-19.................. Codex Committee on Fats and 21-25 February............................. London (United Kingdom).
Oils (19th Session).
CX 722-27.................. Codex Committee on Fish and 28 February-4 March........................ Capetown (South Africa).
Fishery Products (27th
Session).
CX 734-03.................. Regional Coordinating 7-10 March................................. Amman (Jordan).
Committee for Near East
(3rd Session).
CX 712-37.................. Codex Committee on Food 14-19 April................................ Buenos Aires (Argentina).
Hygiene (37th Session).
CX 715-26.................. Codex Committee on Methods 4-8 April.................................. Budapest (Hungary).
of Analysis and Sampling
(26th Session).
CX 716-22.................. Codex Committee on General 11-15 April................................ Paris (France).
Principles (22nd Session).
CX 718-37.................. Codex Committee on 18-23 April................................ The Hague (The Netherlands).
Pesticide Residues (37th
Session).
CX 711-37.................. Codex Committee on Food 25-29 April................................ The Hague (The Netherlands).
Additives and Contaminants
(37th Session).
CX 714-33.................. Codex Committee on Food 9-13 May................................... Kota Kinabalu (Malaysia).
Labelling (33rd Session).
CX 731-12.................. Codex Committee on Fresh 16-20 May.................................. Mexico City Mexico).
Fruits and Vegetables
(12th Session).
CX 702-56.................. Executive Committee (56th 6 June-2 July.............................. Rome (Italy).
Session).
CX 701-28.................. Codex Alimentarius 4-9 July................................... Rome (Italy).
Commission (28th Session).
CX 804-1................... Ad Hoc Task Force on 19-23 September............................ TBA (Japan).
Biotechnology.
CX 720-14.................. Codex Committee on 21-25 November............................. Bonn (Germany).
Nutrition and Foods for
Special Dietary Uses (27th
Session).
CX 733-14.................. Codex Committee on Food 28 November-2 December..................... TBA (Australia).
Import and Export
Inspection and
Certification Systems
(14th Session).
CX 702-57.................. Executive Committee (57th 30 November-2 December..................... Geneva (Switzerland).
Session).
2006:
CX 703-7................... Codex Committee on Milk and 27-31 March................................ TBA (New Zealand).
Milk Products (7th
Session).
CX 718-38.................. Codex Committee on 3-8 April.................................. TBA (Brazil).
Pesticide Residues (38th
Session).
CX 716-23.................. Codex Committee on General 9-13 April................................. Paris (France).
Principles (23rd Session).
CX 711-38.................. Codex Committee on Food 24-28 April................................ The Hague (The Netherlands).
Additives and Contaminants
(38th Session).
CX 714-34.................. Codex Committee on Food 1-5 May.................................... Ottawa (Canada).
Labelling (34th Session).
CX 730-16.................. Codex Committee on Residue 8-12 May................................... Washington, DC (USA).
of Veterinary Drugs in
Food (16th Session).
CX 715-27.................. Codex Committee on Methods 15-19 May.................................. Budapest (Hungary).
of Analysis and Sampling
(27th Session).
CX 702-58.................. Executive Committee (58th 28-30 June................................. Geneva (Switzerland).
Session).
CX 201-29.................. Codex Alimentarius 3-8 July................................... Geneva (Switzerland).
Commission (29th Session).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 4--Definitions for the Purpose of Codex Alimentarius
Words and phrases have specific meanings when used by the Codex
Alimentarius.
For the purposes of Codex, the following definitions apply:
1. Food means any substance, whether processed, semi-processed or
raw, which is intended for human consumption, and includes drink,
chewing gum, and any substance which has been used in the manufacture,
preparation or treatment of ``food'' but does not include cosmetics or
tobacco or substances used only as drugs.
2. Food hygiene comprises conditions and measures necessary for the
production, processing, storage and distribution of food designed to
ensure a safe, sound, wholesome product fit for human consumption.
3. Food additive means any substance not normally consumed as a
food by itself and not normally used as a typical ingredient of the
food, whether or not it has nutritive value, the intentional addition
of which to food for a technological (including organoleptic) purpose
in the manufacture, processing, preparation, treatment, packing,
packaging, transport, or holding of such food results, or may be
reasonably expected to result, (directly or indirectly) in it or its
by-products becoming a component of or otherwise affecting the
characteristics of such foods. The food additive term does not include
``contaminants'' or substances added to food for maintaining or
improving nutritional qualities.
4. Contaminant means any substance not intentionally added to food,
which is present in such food as a result of the production (including
operations carried out in crop husbandry, animal husbandry, and
veterinary medicine), manufacture, processing, preparation, treatment,
packing, packaging, transport or holding of such food or as a result of
environmental contamination. The term does not include insect
fragments, rodent hairs and other extraneous matters.
5. Pesticide means any substance intended for preventing,
destroying, attracting, repelling, or controlling any pest including
unwanted species of plants or animals during the production,
[[Page 30687]]
storage, transport, distribution and processing of food, agricultural
commodities, or animal feeds or which may be administered to animals
for the control of ectoparasites. The term includes substances intended
for use as a plant-growth regulator, defoliant, desiccant, fruit
thinning agent, or sprouting inhibitor and substances applied to crops
either before of after harvest to protect the commodity from
deterioration during storage and transport. The term pesticides
excludes fertilizers, plant and animal nutrients, food additives, and
animal drugs.
6. Pesticide residue means any specified substance in food,
agricultural commodities, or animal feed resulting from the use of a
pesticide. The term includes any derivatives of a pesticide, such as
conversion products, metabolites, reaction products, and impurities
considered to be of toxological significance.
7. Good Agricultural Practice in the Use of Pesticides (GAP)
includes the nationally authorized safe uses of pesticides under actual
conditions necessary for effective and reliable pest control. It
encompasses a range of levels of pesticide applications up to the
highest authorized use, applied in a manner that leaves a residue,
which is the smallest amount practicable.
Authorized safe uses are determined at the national level and
include nationally registered or recommended uses, which take into
account public and occupational health and environmental safety
considerations.
Actual conditions include any stage in the production, storage,
transport, distribution and processing of food commodities and animal
feed.
8. Codex Maximum Limit for Pesticide Residues (MRLP) is the maximum
concentration of a pesticide residue (expressed as mg/kg), recommended
by the Codex Alimentarius Commission to be legally permitted in or on
food commodities and animal feeds. MRLPs are based on their toxological
affects and on GAP data and foods derived from commodities that comply
with the respective MRLPs are intended to be toxologically acceptable.
Codex MRLPs, which are primarily intended to apply in international
trade, are derived from reviews conducted by the JMPR following:
(a) Toxological assessment of the pesticide and its residue, and
(b) Review of residue data from supervised trials and supervised
uses including those reflecting national good agricultural practices.
Data from supervised trials conducted at the highest nationally
recommended, authorized, or registered uses are included in the review.
In order to accommodate variations in national pest control
requirements, Codex MRLPs take into account the higher levels shown to
arise in such supervised trials, which are considered to represent
effective pest control practices.
Consideration of the various dietary residue intake estimates and
determinations both at the national and international level in
comparison with the ADI, should indicate that foods complying with
Codex MRLPs are safe for human consumption.
9. Veterinary Drug means any substance applied or administered to
any food-producing animal, such as meat or milk-producing animals,
poultry, fish or bees, whether used for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions or
behavior.
10. Residues of Veterinary Drugs include the parent compounds and/
or their metabolites in any edible portion of the animal product, and
include residues of associated impurities of the veterinary drug
concerned.
11. Codex Maximum Limit for Residues of Veterinary Drugs (MRLVD) is
the maximum concentration of residue resulting from the use of a
veterinary drug (expressed in mg/kg or [mu]g/kg on a fresh weight
basis) that is recommended by the Codex Alimentarius Commission to be
legally permitted or recognized as acceptable in or on food.
An MRLVD is based on the type and amount of residue considered to
be without any toxological hazard for human health as expressed by the
Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that
utilizes an additional safety factor. An MRLVD also takes into account
other relevant public health risks as well as food technological
aspects.
When establishing an MRLVD, consideration is also given to residues
that occur in food of plant origin and/or the environment. Furthermore,
the MRLVD may be reduced to be consistent with good practices in the
use of veterinary drugs and to the extent that practical and analytical
methods are available.
12. Good Practice in the Use of Veterinary Drugs (GPVD) is the
official recommended or authorized usage including withdrawal periods
approved by national authorities, of veterinary drugs under practicable
conditions.
13. Processing Aid means any substance or material, not including
apparatus or utensils, not consumed as a food ingredient by itself,
intentionally used in the processing of raw materials, foods or its
ingredients, to fulfill a certain technological purpose during
treatment or processing and which may result in the non-intentional but
unavoidable presence of residues or derivatives in the final product.
Definitions of Risk Analysis Terms Related to Food Safety Hazard: A
biological, chemical or physical agent in, or condition of, food with
the potential to cause an adverse health effect.
Hazard Identification: The identification of biological, chemical,
and physical agents capable of causing adverse health effects and which
may be present in a particular food or group of foods.
Hazard Characterization: The qualitative and/or quantitative
evaluation of the nature of the adverse health effects associated with
biological, chemical and physical agents that may be present in food.
For chemical agents, a dose-response assessment should be performed.
For biological or physical agents, a dose-response assessment should be
performed if the data are obtainable.
Dose-Response Assessment: The determination of the relationship
between the magnitude of exposure (dose) to a chemical, biological or
physical agent and the severity and/or frequency of associated adverse
health effects (response).
Exposure Assessment: The qualitative and/or quantitative evaluation
of the likely intake of biological, chemical, and physical agents via
food as well as exposures from other sources if relevant.
Risk: A function of the probability of an adverse health effect and
the severity of that effect, consequential to a hazard(s) in food.
Risk Analysis: A process consisting of three components: Risk
assessment, risk management and risk communication.
Risk Assessment: A scientifically based process consisting of the
following steps: (i) Hazard identification, (ii) hazard
characterization, (iii) exposure assessment, and (iv) risk
characterization.
Risk Assessment Policy: Documented guidelines on the choice of
options and associated judgments for their application at appropriate
decision points in the risk assessment such that the scientific
integrity of the process is maintained.
Risk Characterization: The qualitative and/or quantitative
estimation, including attendant uncertainties, of the probability of
occurrence and severity of known or potential adverse health effects in
a given population based on hazard identification, hazard
[[Page 30688]]
characterization and exposure assessment.
Risk Communication: The interactive exchange of information and
opinions throughout the risk analysis process concerning risk, related
risk factors and risk perceptions, among risk assessors, risk managers,
consumers, industry, the academic community and other interested
parties, including the explanation of risk assessment findings and the
basis of risk management decisions.
Risk Estimate: The quantitative estimation of risk resulting from
risk characterization.
Risk Management: The process, distinct from risk assessment, of
weighing policy alternatives, in consultation with all interested
parties, considering risk assessment and other factors relevant for the
health protection of consumers and for the promotion of fair trade
practices, and, if needed, selecting appropriate prevention and control
options.
Risk Profile: The description of the food safety problem and its
context.
Food Safety Objective (FSO): The maximum frequency and/or
concentration of a hazard in a food at the time of consumption that
provides or contributes to the appropriate level of protection (ALOP).
Performance Criterion (PC): The effect in frequency and/or
concentration of a hazard in a food that must be achieved by the
application of one or more control measures to provide or contribute to
a PO or an FSO.
Performance Objective (PO): The maximum frequency and/or
concentration of a hazard in a food at a specified step in the food
chain before the time of consumption that provides or contributes to an
FSO or ALOP, as applicable.
Attachment 5
Part 1--Uniform Procedure for the Elaboration of Codex Standards and
Related Texts
Steps 1, 2 and 3
(1) The Commission decides, taking into account the ``Criteria for
the Establishment of Work Priorities and for the Establishment of
Subsidiary Bodies,'' to elaborate a Worldwide Codex Standard and also
decides which subsidiary body or other body should undertake the work.
A decision to elaborate a Worldwide Codex Standard may also be taken by
subsidiary bodies of the Commission in accordance with the above-
mentioned criteria, subject to subsequent approval by the Commission or
its Executive Committee at the earliest possible opportunity. In the
case of Codex Regional Standards, the Commission shall base its
decision on the proposal of the majority of members belonging to a
given region or group of countries submitted at a session of the Codex
Alimentarius Commission.
(2) The Secretariat arranges for the preparation of a proposed
draft standard. In the case of Maximum Limits for Residues of
Pesticides or Veterinary Drugs, the Secretariat distributes the
recommendations for maximum limits, when available from the Joint
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Panel of Experts on Pesticide Residues
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives
(JECFA). In the cases of milk and milk products or individual standards
for cheeses, the Secretariat distributes the recommendations of the
International Dairy Federation (IDF).
(3) The proposed draft standard is sent to members of the
Commission and interested international organizations for comment on
all aspects including possible implications of the proposed draft
standard for their economic interests.
Step 4
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned which has the power to consider such
comments and to amend the proposed draft standard.
Step 5
The proposed draft standard is submitted through the Secretariat to
the Commission or to the Executive Committee with a view to its
adoption as a draft standard. When making any decision at this step,
the Commission or the Executive Committee will give due consideration
to any comments that may be submitted by any of its members regarding
the implications which the proposed draft standard or any provisions of
the standard may have for their economic interests. In the case of
Regional Standards, all members of the Commission may present their
comments, take part in the debate and propose amendments, but only the
majority of the Members of the region or group of countries concerned
attending the session can decide to amend or adopt the draft. When
making any decisions at this step, the members of the region or group
of countries concerned will give due consideration to any comments that
may be submitted by any of the members of the Commission regarding the
implications which the proposed draft standard or any provisions of the
proposed draft standard may have for their economic interests.
Step 6
The draft standard is sent by the Secretariat to all members and
interested international organizations for comment on all aspects,
including possible implications of the draft standard for their
economic interests.
Step 7
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned, which has the power to consider such
comments and amend the draft standard.
Step 8
The draft standard is submitted through the Secretariat to the
Commission together with any written proposals received from members
and interested international organizations for amendments at Step 8
with a view to its adoption as a Codex Standard. In the case of
Regional standards, all members and interested international
organizations may present their comments, take part in the debate and
propose amendments but only the majority of members of the region or
group of countries concerned attending the session can decide to amend
and adopt the draft.
Part 2--Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts
Steps 1, 2 and 3
(1) The Commission or the Executive Committee between Commission
sessions, on the basis of a two-thirds majority of votes cast, taking
into account the ``Criteria for the Establishment of Work Priorities
and for the Establishment of Subsidiary Bodies'', shall identify those
standards which shall be the subject of an accelerated elaboration
process. The identification of such standards may also be made by
subsidiary bodies of the Commission, on the basis of a two-thirds
majority of votes cast, subject to confirmation at the earliest
opportunity by the Commission or its Executive Committee by a two-
thirds majority of votes cast.
(2) The Secretariat arranges for the preparation of a proposed
draft standard. In the case of Maximum Limits for Residues of
Pesticides or Veterinary Drugs, the Secretariat distributes the
recommendations for maximum limits, when available from the Joint
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Panel of Experts on Pesticide Residues
[[Page 30689]]
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives
(JECFA). In the cases of milk and milk products or individual standards
for cheeses, the Secretariat distributes the recommendations of the
International Dairy Federation (IDF).
(3) The proposed draft standard is sent to Members of the
Commission and interested international organizations for comment on
all aspects including possible implications of the proposed draft
standard for their economic interests. When standards are subject to an
accelerated procedure, this fact shall be notified to the Members of
the Commission and the interested international organizations.
Step 4
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned which has the power to consider such
comments and to amend the proposed draft standard.
Step 5
In the case of standards identified as being subject to an
accelerated elaboration procedure, the draft standard is submitted
through the Secretariat to the Commission together with any written
proposals received from Members and interested international
organizations for amendments with a view to its adoption as a Codex
standard. In taking any decision at this step, the Commission will give
due consideration to any comments that may be submitted by any of its
Members regarding the implications which the proposed draft standard or
any provisions thereof may have for their economic interests.
Attachment 6--Nature of Codex Standards
Codex standards contain requirements for food aimed at ensuring for
the consumer a sound, wholesome food product free from adulteration,
and correctly labelled. A Codex standard for any food or foods should
be drawn up in accordance with the Format for Codex Commodity Standards
and contain, as appropriate, the criteria listed therein.
Format for Codex Commodity Standards Including Standards Elaborated
Under the Code of Principles Concerning Milk and Milk Products
Introduction
The format is also intended for use as a guide by the subsidiary bodies
of the Codex Alimentarius Commission in presenting their standards,
with the object of achieving, as far as possible, a uniform
presentation of commodity standards. The format also indicates the
statements which should be included in standards as appropriate under
the relevant headings of the standard. The sections of the format
required to be completed for a standard are only those provisions that
are appropriate to an international standard for the food in question.
Name of the Standard
Scope
Description
Essential Composition and Quality Factors
Food Additives
Contaminants
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling
Format for Codex Standards
Name of the Standard
The name of the standard should be clear and as concise as
possible. It should usually be the common name by which the food
covered by the standard is known or, if more than one food is dealt
with in the standard, by a generic name covering them all. If a fully
informative title is inordinately long, a subtitle could be added.
Scope
This section should contain a clear, concise statement as to the
food or foods to which the standard is applicable unless the name of
the standard clearly and concisely identifies the food or foods. A
generic standard covering more than one specific product should clearly
identify the specific products to which the standard applies.
Description
This section should contain a definition of the product or products
with an indication, where appropriate, of the raw materials from which
the product or products are derived and any necessary references to
processes of manufacture. The description may also include references
to types and styles of product and to type of pack. The description may
also include additional definitions when these additional definitions
are required to clarify the meaning of the standard.
Essential Composition and Quality Factors
This section should contain all quantitative and other requirements
as to composition including, where necessary, identity characteristics,
provisions on packing media and requirements as to compulsory and
optional ingredients. It should also include quality factors that are
essential for the designation, definition, or composition of the
product concerned. Such factors could include the quality of the raw
material, with the object of protecting the health of the consumer,
provisions on taste, odor, color, and texture which may be apprehended
by the senses, and basic quality criteria for the finished products,
with the object of preventing fraud. This section may refer to
tolerances for defects, such as blemishes or imperfect material, but
this information should be contained in appendix to the standard or in
another advisory text.
Food Additives
This section should contain the names of the additives permitted
and, where appropriate, the maximum amount permitted in the food. It
should be prepared in accordance with guidance given on page of the
Codex Procedural Manual and may take the following form:
``The following provisions in respect of food additives and their
specifications as contained in section * * * of the Codex Alimentarius
are subject to endorsement [have been endorsed] by the Codex Committee
on Food Additives and Contaminants.''
A tabulation should then follow, viz.:
``Name of additive, maximum level (in percentage or mg/kg).''
Contaminants
(a) Pesticide Residues: This section should include, by reference,
any levels for pesticide residues that have been established by the
Codex Committee on Pesticide Residues for the product concerned.
(b) Other Contaminants: In addition, this section should contain
the names of other contaminants and where appropriate the maximum level
permitted in the food, and the text to appear in the standard may take
the following form:
``The following provisions in respect of contaminants, other than
pesticide residues, are subject to endorsement [have been endorsed] by
the Codex Committee on Food Additives and Contaminants.''
A tabulation should then follow, viz.:
``Name of contaminant, maximum level (in percentage or mg/kg).''
Hygiene
Any specific mandatory hygiene provisions considered necessary
should be included in this section. They should be prepared in
accordance with the guidance given in the Codex Procedural Manual.
Reference should also be made to applicable codes of hygienic practice.
Any parts of such codes, including in
[[Page 30690]]
particular any end-product specifications, should be set out in the
standard, if it is considered necessary that they should be made
mandatory. The following statement should also appear:
``The following provisions in respect of the food hygiene of the
product are subject to endorsement [have been endorsed] by the Codex
Committee on Food Hygiene.''
Weights and Measures
This section should include all provisions, other than labelling
provisions, relating to weights and measures, e.g., where appropriate,
fill of container, weight, measure or count of units determined by an
appropriate method of sampling and analysis. Weights and measures
should be expressed in S.I. units. In the case of standards which
include provisions for the sale of products in standardized amounts,
e.g. multiples of 100 grams, S.I. units should be used, but this would
not preclude additional statements in the standards of these
standardized amounts in approximately similar amounts in other systems
of weights and measures.
Labelling
This section should include all the labelling provisions contained
in the standard and should be prepared in accordance with the guidance
given in the Codex Procedural Manual. Provisions should be included by
reference to the General Standard for the Labelling of Prepackaged
Foods. The section may also contain provisions which are exemptions
from, additions to, or which are necessary for the interpretation of
the General Standard in respect of the product concerned provided that
these can be justified fully. The following statement should also
appear:
``The following provisions in respect of the labelling of this
product are subject to endorsement [have been endorsed] by the Codex
Committee on Food Labelling.''
Methods of Analysis and Sampling
This section should include, either specifically or by reference,
all methods of analysis and sampling considered necessary and should be
prepared in accordance with the guidance given in the Codex Procedural
Manual. If two or more methods have been proved to be equivalent by the
Codex Committee on Methods of Analysis and Sampling, these could be
regarded as alternatives and included in this section either
specifically or by reference. The following statement should also
appear:
``The methods of analysis and sampling described hereunder are to be
endorsed [have been endorsed] by the Codex Committee on Methods of
Analysis and Sampling.''
[FR Doc. 05-10636 Filed 5-26-05; 8:45 am]