[Federal Register: June 8, 2004 (Volume 69, Number 110)]
[Notices]
[Page 31942-31957]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn04-30]
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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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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 04-004N]
International Standard-Setting Activities
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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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, 2003, to May 31,
2004, and June 1, 2004, to May 31, 2005, seeks comments on standards
currently under consideration and recommendations for new standards.
ADDRESSES: Comments may be submitted by any of the following methods:
Mail, including floppy disks or CD-ROM's, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102 Cotton Annex, Washington, DC 20250.
Federal eRulemaking Portal: Go to http://www.regulations.gov.
Follow the online instructions at that site for
submitting comments.
All submissions received must include the Agency name and docket
number 04-004N. Please state that your comments refer to Codex and, if
your comments relate to specific Codex committees, please identify
those committees in your comments and submit a copy of your comments to
the delegate from that particular committee. All comments submitted
will be available for public inspection in the FSIS Docket Room at the
address listed above between 8:30 a.m. and 4:30 p.m., Monday through
Friday. The comments also will be posted on the Agency's Web site at
http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: F. Edward Scarbrough, Ph.D., United
States Manager for Codex, U.S. Department of Agriculture, Office of the
Undersecretary for Food Safety, Room 4861, South Agriculture Building,
1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-
7760. For information pertaining to particular committees, the delegate
of that committee may be contacted. (A complete list of U.S. delegates
and alternate delegates can be found in Attachment 2 to this notice.)
Documents pertaining to Codex are accessible via the World Wide Web at
the following address: http://www.codexalimentarius.net The U.S. Codex Office also maintains a Web site at http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.
SUPPLEMENTARY INFORMATION:
Background
The World Trade Organization (WTO) was established on January 1,
1995, as the common international institutional framework for the
conduct of trade relations among its members in matters related to the
Uruguay Round Trade Agreements. The WTO is the successor organization
to the General Agreement on Tariffs and Trade (GATT). U.S. membership
in the WTO was approved and the Uruguay Round Agreements Act was signed
into law by the President on December 8, 1994. The Uruguay Round
Agreements became effective, with respect to the United States, on
January 1, 1995. Pursuant to section 491 of the Trade Agreements Act of
1979, as amended, the President is required to designate an agency to
be responsible for informing the public of the sanitary and
phytosanitary (SPS) standard-setting activities of each international
standard-setting organization, Codex, International Office of
Epizootics, and the International Plant Protection Convention. The
President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR
15845), designated the U.S. Department of Agriculture as the agency
responsible for informing the public of sanitary and phytosanitary
standard-setting activities of each international standard-setting
organization. The Secretary of Agriculture has delegated to the
Administrator, Food Safety and Inspection Service (FSIS), the
responsibility to inform the public of the SPS standard-setting
activities of Codex. The FSIS Administrator has, in turn, assigned the
responsibility for informing the public of the SPS standard-setting
activities of Codex to the U.S. Codex Office, FSIS.
Codex was created in 1962 by two U.N. organizations, the Food and
Agriculture Organization (FAO) and the World Health Organization (WHO).
Codex is the principal international organization for encouraging fair
international trade in food and protecting the health and economic
interests of consumers. Through adoption of food standards, codes of
practice, and other guidelines developed by its committees and by
promoting their adoption and implementation by governments, Codex seeks
to ensure that the world's food supply is sound, wholesome, free from
adulteration, and correctly labeled. In the United States, the United
States Department of Agriculture (USDA); the Food and Drug
Administration (FDA), Department of Health and Human Services (HHS);
and the Environmental Protection Agency (EPA) manage and carry out U.S.
Codex activities.
As the agency responsible for informing the public of the sanitary
and phytosanitary standard-setting activities of Codex, FSIS publishes
this notice in the Federal Register annually. Attachment 1 (Sanitary
and Phytosanitary Activities of Codex) sets forth the following
information:
1. The sanitary or phytosanitary standards under consideration or
planned for consideration; and
2. For each sanitary or phytosanitary standard specified:
a. A description of the consideration or planned consideration of
the standard;
b. Whether the United States is participating or plans to
participate in the consideration of the standard;
c. The agenda for United States participation, if any; and
[[Page 31943]]
d. The agency responsible for representing the United States with
respect to the standard.
To obtain copies of those standards listed in Attachment 1 that are
under consideration by Codex, please contact the Codex delegate or the
U.S. Codex office. This notice also solicits public comment on those
standards that are under consideration or planned for consideration and
recommendations for new standards. The delegate, in conjunction with
the responsible agency, will take the comments received into account in
participating in the consideration of the standards and in proposing
matters to be considered by Codex.
The United States' delegate will facilitate public participation in
the United States Government's activities relating to Codex
Alimentarius. The United States' delegate will maintain a list of
individuals, groups, and organizations that have expressed an interest
in the activities of the Codex committees and will disseminate
information regarding United States' delegation activities to
interested parties. This information will include the current status of
each agenda item; the United States Government's position or
preliminary position on the agenda items; and the time and place of
planning meetings and debriefing meetings following Codex committee
sessions. In addition, the U.S. Codex Office makes much of the same
information available through its Web page, http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.
Please visit
the Web page or notify the appropriate U.S. delegate or the Office of
U.S. Codex Alimentarius, Room 4861, South Agriculture Building, 1400
Independence Avenue, SW., Washington, DC 20250-3700, if you would like
to access or receive information about specific committees.
The information provided in Attachment 1 describes the status of
Codex standard-setting activities by the Codex Committees for the time
periods from June 1, 2003 to May 31, 2004, and June 1, 2004 to May 31,
2005. In addition, the following attachments are included:
Attachment 2 List of U.S. Codex Officials (includes U.S. delegates and
alternate delegates)
Attachment 3 Timetable of Codex Sessions (June 2003 through June 2005)
Attachment 4 Definitions for the Purpose of Codex Alimentarius
Attachment 5 Part 1--Uniform Procedure for the Elaboration of Codex
Standards and Related Texts
Part 2--Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts
Attachment 6 Nature of Codex Standards
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that the public and in particular that minorities, women, and persons
with disabilities are aware of this notice, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov and
through the Regulations.gov Web site. The Regulations.gov Web site is
the central online rulemaking portal of the United States government.
It is being offered as a public service to increase participation in
the Federal government's regulatory activities. FSIS participates in
Regulations.gov and will accept comments on documents published on the
site. The site allows visitors to search by keyword or Department or
Agency for rulemakings that allow for public comment. Each entry
provides a quick link to a comment form so that visitors can type in
their comments and submit them to FSIS. The Web site is located at
http://www.regulations.gov.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
Done at Washington, DC, on June 1, 2004.
F. Edward Scarbrough,
United States Manager for Codex.
Attachment 1: Sanitary and Phytosanitary Activities of Codex
Codex Alimentarius Commission and Executive Committee
The Codex Alimentarius Commission will hold its Twenty-Seventh
Session June 28-July 3, 2004 in Geneva, Switzerland. At that time it
will consider procedural matters, the standards, codes of practice, and
related matters brought to its attention by the general subject
committees, commodity committees, ad hoc Task Forces and member
delegations. It will also consider options or strategies regarding the
Joint FAO/WHO Evaluation of the Codex Alimentarius and other FAO and
WHO Work on Food Standards, as well as budgetary and strategic planning
issues. The issue of Codex interaction with other international
organizations will also be discussed. At this Session, the Commission
will elect a Chair and three Vice Chairs.
Prior to the Commission meeting, the Executive Committee will meet
at its Fifty-fourth Session on June 24-26, 2004. It is composed of the
chairperson, vice-chairpersons and seven members elected from the
Commission, one from each of the following geographic regions: Africa,
Asia, Europe, Latin America and the Caribbean, Near East, North
America, and South-West Pacific. In addition, regional coordinators
from the six regions will attend as observers. It will discuss
implementation of the Joint FAO/WHO Evaluation of the Codex
Alimentarius and other FAO and WHO Work on Food Standards, matters
arising from reports of Codex Committees, standards management issues,
and the Trust Fund for the Participation of Developing Countries and
Countries in Transition in the Work of the Codex Alimentarius.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Residues of Veterinary Drugs in Foods
The Codex Committee on Residues of Veterinary Drugs in Foods
(CCRVDF) determines priorities for the consideration of residues of
veterinary drugs in foods and recommends Maximum Residue Limits (MRLs)
for veterinary drugs. A veterinary drug is defined as any substance
applied or administered to a food producing animal, such as meat or
dairy animals, poultry, fish or bees, for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions or
behavior.
A Codex Maximum Limit for Veterinary Drugs (MRLVD) is the maximum
concentration of residue resulting from the use of a veterinary drug
(expressed in mg/kg or ug/kg on a fresh weight basis) that is adopted
by the Codex Alimentarius Commission to be permitted or recognized as
acceptable in or on a food. An MRLVD is based on the Acceptable Daily
Intake (ADI) and indicates the amount of residue in food that is
considered to be without appreciable toxicological hazard. An MRLVD
also takes into account other
[[Page 31944]]
relevant public health risks as well as food technological aspects.
When establishing an MRLVD, consideration is also given to residues
that occur in food of plant origin and/or the environment. Furthermore,
the MRLVD may be reduced to be consistent with good practices in the
use of veterinary drugs and to the extent that practical analytical
methods are available.
Acceptable Daily Intake (ADI): An estimate by the Joint FAO/WHO
Expert Committee on Food Additives (JECFA) of the amount of a
veterinary drug, expressed on a body weight basis, that can be ingested
daily over a lifetime without appreciable health risk (standard man =
60 kg).
The 15th Session of CCRVDF will take place in the United States on
October 25-28, 2004. The following will be discussed by the Committee:
Draft Maximum Residue Limits for:
Flumequine.
Neomycin.
Dicyclanil.
Melengestrol acetate.
Trichlorfon (metrifonate).
Proposed Draft Maximum Residue Limits for:
Cefuroxime.
Cypermethrin.
Alpha-Cypermethrin.
The Committee continues to work on:
Proposed Draft Code of Practice to Minimize and Contain
Antimicrobial Resistance.
Proposed Draft Revised Guidelines for the Establishment of
a Regulatory Program for Control of Veterinary Drug Residues in Foods.
Risk Analysis Principles and Methodologies, including Risk
Assessment Policies in the Codex Committee on Residues of Veterinary
Drugs in Foods.
Proposed Draft Appendix on the Prevention and Control of
Veterinary Drug Residues in Milk and Milk Products.
Priority List of Veterinary Drugs Requiring Evaluation or
Reevaluation.
Methods of Analysis and Sampling Issues.
Performance-based Criteria.
Identification of Routine Methods of Analysis.
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Food Additives and Contaminants
The Codex Committee on Food Additives and Contaminants (CCFAC) (a)
establishes or endorses permitted maximum or guideline levels for
individual food additives, contaminants, and naturally occurring
toxicants in food and animal feed; (b) prepares priority lists of food
additives and contaminants for toxicological evaluation by the Joint
FAO/WHO Expert Committee on Food Additives (JECFA); (c) recommends
specifications of identity and purity for food additives for adoption
by the Commission; (d) considers methods of analysis for food additives
and contaminants; and (e) considers and elaborates standards and codes
for related subjects such as labeling of food additives when sold as
such and food irradiation. The following matters are under
consideration by the Commission at its 27th Session in July 2004. The
relevant document is ALINORM 4/27/12.
Risk Analysis
To be considered at Step 8:
Draft Risk Analysis Principles applied by the Codex
Committee on Food Additives and Contaminants.
Food Additives
To be considered at Step 8:
General Standard for Food Additives: Food Category System.
General Standard for Food Additives: Draft Food Additive
Provisions in Tables 1 and 2.
To be considered at Step 5/8 of the Accelerated Procedure:
General Standard for Food Additives: Proposed Draft Food
Additive Provisions in Tables 1 and 2.
Advisory Specifications for the Identity and Purity of
Food Additives.
Draft Revisions to the Codex International Numbering
System for Food Additives.
The Committee is continuing work on:
General Standard for Food Additives: Draft Food Additive
Provisions (in Table 1 and Table 3).
General Standard for Food Additives: Revisions to the
Preamble to clarify relationship between the General Standard and food
additive provisions in Codex Commodity Standards and to clarify the
principles for establishing food additive provisions in the General
Standard.
International Numbering System.
Specifications for the Identity and Purity of Food
Additives.
Inventory of processing aids.
Discussion paper on food additives used as carriers.
Discussion paper on the Harmonization of Terms Used by
Codex and JECFA.
Terms of reference for a risk assessment of the use of
``active chlorine'' by a Joint FAO/WHO Expert Consultation.
Contaminants
To be considered at Step 8:
General Standard for Contaminants and Toxins: Preamble.
General Standard for Contaminants and Toxins: Proposed
Draft Principles for Exposure Assessment of Contaminants and Toxins in
Foods.
CCFAC Policy for Exposure Assessment of Contaminants and
Toxins in Foods or Food Groups.
Code of Practice for the Prevention and Reduction of
Aflatoxin Contamination in Peanuts.
Code of Practice for the Prevention and Reduction of Lead
Contamination in Foods.
To be considered at Step 5:
Draft Code of Practice for the Prevention and Reduction of
Aflatoxin Contamination in Tree Nuts.
Draft Code of Practice for the Prevention and Reduction of
Inorganic Tin Contamination in Canned Foods.
Draft Revised Guideline Levels for Radionuclides in Foods
Following Accidental Nuclear Contamination for Use in International
Trade, Including Guideline Levels for Long-Term Use.
The Committee is continuing work on:
Maximum levels for aflatoxin in tree nuts (almonds,
hazelnuts, and pistachios).
Discussion paper on Aflatoxin Contamination in Brazil
Nuts.
Maximum level for lead in fish.
Maximum levels for cadmium in polished rice, wheat grain,
potato, stem and root vegetables, leafy vegetables, other vegetables,
and molluscs.
Proposed Draft Code of Practice for Source Directed
Measures to Reduce Dioxin and Dioxin-like PCB Contamination in Foods.
Discussion paper with proposals for maximum levels for 3-
monochloropropanediol in acid-hydrolyzed vegetable protein (acid-HVP)
and acid-HVP containing foods.
Discussion paper on acrylamide.
The Committee is beginning new work on:
Sampling plans for aflatoxin in tree nuts (almonds, Brazil
nuts, hazelnuts, and pistachios).
Discussion paper on options for incorporating the JECFA
safety evaluation of flavors into the Codex system.
Discussion paper on polyaromatic hydrocarbons.
Discussion paper on methylmercury in fish.
General Issues
Priority List of Food Additives, Contaminants and
Naturally Occurring
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Toxicants Proposed for Evaluation by JECFA.
Responsible Agency: HHS/FDA.
U.S. Participation: YES.
Codex Committee on Pesticide Residues
The Codex Committee on Pesticide Residues recommends to the Codex
Alimentarius Commission establishment of maximum limits for pesticide
residues for specific food items or in groups of food. A Codex Maximum
Residue Limit for Pesticide (MRLP) is the maximum concentration of a
pesticide residue (expressed as mg/kg), recommended by the Codex
Alimentarius Commission to be legally permitted in or on food
commodities and animal feeds. Foods derived from commodities that
comply with the respective MRLPs are intended to be toxicologically
acceptable, that is, consideration of the various dietary residue
intake estimates and determinations both at the national and
international level in comparison with the ADI, * should indicate that
foods complying with Codex MRLPs are safe for human consumption. *
Acceptable Daily Intake (ADI) of a chemical is the daily intake which,
during an entire lifetime, appears to be without appreciable risk to
the health of the consumer on the basis of all the known facts at the
time of the evaluation of the chemical by the Joint FAO/WHO Meeting on
Pesticide Residues. It is expressed in milligrams of the chemical per
kilogram of body weight.
Codex MRLPs are primarily intended to apply in international trade
and are derived from reviews conducted by the Joint Meeting on
Pesticide Residues (JMPR) following:
(a) Review of residue data from supervised trials and supervised
uses including those reflecting national good agricultural practices
(GAP). Data from supervised trials conducted at the highest nationally
recommended, authorized, or registered uses are included in the review.
In order to accommodate variations in national pest control
requirements, Codex MRLPs take into account the higher levels shown to
arise in such supervised trials, which are considered to represent
effective pest control practices, and
(b) Toxicological assessment of the pesticide and its residue.
The following items will be considered by the Commission at its
27th Session in July 2004. The relevant document is ALINORM 04/27/24.
To be considered at Step 8:
Draft and Draft Revised Maximum Residue Limits.
To be considered at Step 5/8:
Proposed Draft and Proposed Draft Revised Maximum Residue
Limits.
Draft Revision of the Guidelines on Good Laboratory
Practice in Pesticide Residue Analysts.
To be considered at Step 5:
Proposed Draft and Proposed Draft Revised Maximum Residue
Limits.
The committee is continuing work on:
Consideration of Draft and Proposed Draft Residue Maximum
Limits in Foods and Feeds.
Pilot Project for the examination of national MRLs as
Interim Codex MRLs for safer replacement pesticides.
Proposals for Improvement of Methodology for Point
Estimates.
Risk Analysis Policies Used in Establishing Codex MRLs.
Revision of the List of Recommended Methods on Analysis
for Pesticide Residues.
Estimation of Uncertainty.
Proposals for new Tropical Fruit and Vegetable
Commodities.
Elaboration of MRLs for Spices.
Revision of the Codex Classification of Foods and Animal
Feeds.
Criteria for Prioritization Process.
Revision of Codex Priority Lists of Pesticides for review
by JMPR.
Responsible Agency: EPA; USDA/AMS.
U.S. Participation: Yes.
Codex Committee on Methods of Analysis and Sampling
The Codex Committee on Methods of Analysis and Sampling:
(a) Defines the criteria appropriate to Codex Methods of Analysis
and Sampling;
(b) Serves as a coordinating body for Codex with other
international groups working in methods of analysis and sampling and
quality assurance systems for laboratories;
(c) Specifies, on the basis of final recommendations submitted to
it by the other bodies referred to in (b) above, Reference Methods of
Analysis and Sampling appropriate to Codex Standards which are
generally applicable to a number of foods;
(d) Considers, amends, if necessary, and endorses, as appropriate,
methods of analysis and sampling proposed by Codex (Commodity)
Committees, except that methods of analysis and sampling for residues
of pesticides or veterinary drugs in food, the assessment of
microbiological quality and safety in food, and the assessment of
specifications for food additives do not fall within the terms of
reference of this Committee;
(e) Elaborates sampling plans and procedures, as may be required;
(f) Considers specific sampling and analysis problems submitted to
it by the Commission or any of its Committees; and
(g) Defines procedures, protocols, guidelines or related texts for
the assessment of food laboratory proficiency, as well as quality
assurance systems for laboratories.
The 25th Session of the Committee met in Budapest, Hungary, on
March 8-12, 2004. The relevant document is ALINORM 04/27/23. The
following will be considered by the Commission at its 27th Session in
July 2004:
To be considered at Step 8:
Draft General Guidelines on Sampling.
Draft Guidelines on Measurement Uncertainty.
To be considered at Step 5:
Proposed Draft Guidelines for Evaluating Acceptable
Methods of Analysis.
The Committee will continue work on:
Criteria for Evaluating Acceptable Methods of Analysis.
Proposed Draft Guidelines for Settling of Disputes on
Analytical (test) Results.
Consideration of the Fitness-For-Purpose Approach to
Evaluating Methods of Analysis.
Further Review of the Analytical Terminology for Codex Use
in the Procedural Manual.
Endorsement of Methods of Analysis and Sampling Provisions
in Codex Standards.
Criteria for Methods of Analysis for the Detection and
Identification of Foods derived from Biotechnology.
Methods of Analysis for the determination of dioxins and
PCBs.
Responsible Agency: HHS/FDA; USDA/ARS.
U.S. Participation: Yes.
Codex Committee on Food Import and Export Certification and Inspection
Systems
The Codex Committee on Food Import and Export Inspection and
Certification Systems is charged with developing principles and
guidelines for food import and export inspection and certification
systems to protect consumers and to ensure fair practices in
international trade in food. Additionally, the Committee develops
principles and guidelines for the application of measures by competent
authorities to provide assurance that foods comply with essential
requirements, especially statutory health requirements. This
encompasses work on: equivalence of food inspection systems including
equivalence agreements, processes and procedures to ensure that
sanitary measures are
[[Page 31946]]
implemented; guidelines on food import control systems; and guidelines
on food product certification and information exchange. The development
of guidelines for the appropriate utilization of quality assurance
systems to ensure that foodstuffs conform to requirements and to
facilitate trade are also included in the Committee's terms of
reference.
The following will be considered for adoption by the Commission at
its 27th Session in July 2004.
To be considered at Step 5/8:
Proposed Draft Principles and Guidelines for the Exchange
of Information in Food Safety Emergency Situations.
New Work:
Proposed Draft Appendices to the Guidelines on the
Judgement of Equivalence of Sanitary Measures Associated with Food
Inspection and Certification.
Proposed Draft Principles for Electronic Certification.
Proposed Draft Guidelines for Risk-based Inspection of
Imported Foods.
The committee is continuing work on:
Discussion paper on the Revision of the Guidelines for the
Exchange of Information Between Countries on Rejections of Imported
Foods.
Discussion paper on ``traceability/product tracing'' in
the context of Food Inspection and Certification Systems.
Discussion paper on the Revision of the Guidelines for
Generic Official Certificate Formats and the Production and Issuance of
Certificates.
Discussion paper on clarification of the reference ``a
reasonable interval'' in the Guidelines for Food Import Control
Systems.
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on General Principles
The Codex Committee on General Principles deals with procedure and
general matters as are referred to it by the Codex Alimentarius
Commission. The 19th (Extraordinary) Session addressed issues related
to decisions made by the Commission regarding the FAO/WHO Codex
Evaluation. The 20th Session which met on May 3-7, 2004 in Paris,
France, considered the regular work of the Committee. The relevant
documents are ALINORM 04/27/33 and ALINORM 04/27/33A. Matters from the
19th Session to be considered for adoption by the 27th Commission in
July 2004 are:
Procedural Amendments to the Rules of Procedure.
Proposed Amendments to the Procedures for the Elaboration
of Codex Standards and Related Texts.
Draft Criteria for the Appointment of Chairpersons.
Draft Guidelines to Host Governments of Codex Committees
and ad hoc Intergovernmental Task Forces.
Draft Guidelines on the Conduct of Meetings of Codex
Committees and ad hoc Intergovernmental Task Forces.
Draft Guidelines to Chairpersons of Codex Committees and
ad hoc Intergovernmental Task Forces.
At its 20th (regular) Session, the Committee continued work on:
Proposed Draft Working Principles for Risk Analysis for
Food Safety (Guidance to National Governments).
Proposed Draft Revised Code of Ethics for International
Trade in Foods.
Guidelines for Cooperation with International
Intergovernmental Organizations.
Definition of traceability/product tracing.
Proposed Amendment to Rule VII.5 (Observers) of the Rules
of Procedure.
Review of the Principles concerning the Participation of
International Non-Governmental Organizations in the work of the
Commission.
Matters arising from the 19th (Extraordinary) Session:.
(a) Clarification of the respective roles of Members of the
Executive Committee elected on a geographic basis and of Coordinators.
(b) Clarification of the duration of the terms of the Coordinators
and other Members of the Executive Committee.
(c) Relevance of the current acceptance and notification procedures
for Codex standards.
(d) Possible reorganization of the structure and presentation of
the Procedural Manual.
(e) Particular situation of the North America Region in the context
of Rule IV.1.
(f) Implication of the exclusive use of electronic distribution of
Codex documents to Members and Observers.
(g) Criteria applicable for the participation of developing country
members in the Executive Committee in the light of the proposed Rule
XII.3 and the Codex budget available. At its 21st (Extraordinary)
Session the Committee will continue work on:
Consideration of the Status of Observers in the Executive
Committee.
Revision of the Criteria for the Establishment of Work
Priorities.
Draft Guidelines on Physical Working Groups and Draft
Guidelines on Electronic Working Groups.
Responsible Agency: USDA/FSIS; HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Food Labelling
The Codex Committee on Food Labelling is responsible for drafting
provisions on labelling issues assigned by the Codex Alimentarius
Commission. The reference document is ALINORM 04/27/22. The Committee
held its thirty-second Session in Montreal, Quebec, Canada, on May 10-
14, 2004. It considered the following items:
Guidelines for the Production, Processing, Labelling and
Marketing of Organically Produced Foods: Draft Revised Annex 2--
Permitted Substances.
Report of the Working Group on the Management of the
Agenda Items on Labelling of Foods and Food Ingredients Obtained
through Certain Techniques of Genetic Modification/Genetic Engineering.
Draft Amendment to the General Standard for the Labelling
of Prepackaged Foods--(Draft Recommendations for the Labelling of Foods
Obtained through Certain Techniques of Genetic Modification/Genetic
Engineering) (Definitions).
Proposed Draft Guidelines for the Labelling of Food and
food Ingredients obtained through certain Techniques of Genetic
Modification/Genetic Engineering: Labelling Provisions.
Draft Guidelines for the Use of Health and Nutrition
Claims.
Proposed Draft Amendment to the General Standard for the
Labelling of Prepackaged Foods: Quantitative Declaration of
Ingredients.
Discussion paper on Misleading Claims.
Discussion paper on Country of Origin Labelling.
Discussion on Food Labelling and Traceability/Product
Tracing.
Responsible Agency: HHS/FDA; USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Food Hygiene
The Codex Committee on Food Hygiene has four primary
responsibilities. First, the Committee drafts basic provisions on food
hygiene applicable to all food. These provisions normally take the form
of Codes of Hygienic Practice for a specific commodity (e.g., bottled
water) or group of commodities (e.g., milk and milk products). Second,
it suggests and prioritizes areas where there is a need for
microbiological risk assessment at the international level and
considers microbiological risk management matters in relation to food
hygiene and in relation to the risk assessment activities of FAO and
WHO. Third, it considers, amends, if necessary, and
[[Page 31947]]
endorses food hygiene provisions that are incorporated into specific
Codex commodity standards by the Codex commodity committees. Fourth,
the Committee provides such other general guidance to the Commission on
matters relating to food hygiene as may be necessary. The following
items will be considered by the Codex Alimentarius Commission at its
27th Session in July 2004. The relevant document is ALINORM 04/27/13.
To be considered at Step 8:
Draft Code of Hygienic Practice for Milk and Milk
Products.
Definitions of Food Safety Objective, Performance
Objective, and Performance Criterion.
The committee continues to work on:
Discussion papers on the management of the work of the
Committee.
Work on Microbiological Risk Assessment/Risk Management.
Criteria to Establish Work Priorities.
Options for Cross-Committee Interaction Process.
Proposed Draft Guidelines on the Application of the
General Principles of Food Hygiene to the [management] of Listeria
monocytogenes in Foods.
Proposed Draft Revision of the Code of Hygienic Practice
for Eggs and Egg Products.
Proposed Draft Guidelines for the Validation of Food
Hygienic Control Measures.
Endorsement of Hygiene Provisions in Codex Standards and
Codes of Practice.
Reports of ad hoc Expert Consultations.
Risk Management Strategies for Salmonella spp. in Poultry.
Risk Management Strategies for Campylobacter spp. in
Poultry.
Risk Profile for Enterohemorrhagic E. coli, including the
Identification of Commodities of Concern, including Sprouts, Ground
Beef and Pork.
Discussion paper on the Proposed Draft Revision of the
Recommended International Code of Practice for Foods for Infants and
Children; Risk Profile on E. sakazakii.
Discussion paper on Proposed Draft Guidelines for
Evaluating Objectionable Matter in Food.
Responsible Agency: HHS/FDA; FSIS/USDA.
U.S. Participation: Yes.
Codex Committee on Fresh Fruits and Vegetables
The Codex Committee on Fresh Fruits and Vegetables is responsible
for elaborating world-wide standards and codes of practice for fresh
fruits and vegetables. The following standards will be considered by
the 27th Session of the Commission in July 2004. The relevant document
is ALINORM 04/27/35.
To be considered at Step 8:
Draft Standard for Oranges.
To be considered at Step 5:
Proposed Draft Standard for Tomatoes.
The Committee continues work on:
Draft Standard for Table Grapes retained at Step 7.
Proposed Draft Standard for Rambutan.
Proposed Draft Standard for Apples.
Section 2.1.1 (Maturity Requirements) and Annex on Small-
berry Varieties (Section 3.1) (draft Codex Standard for Table Grapes).
Proposed Draft Guide for the Quality Control of Fresh
Fruits and Vegetables.
Standard Layout for Codex Standards for Fresh Fruits and
Vegetables.
Responsible Agency: USDA/AMS.
U.S. Participation: Yes.
Codex Committee on Nutrition and Foods for Special Dietary Uses
The Codex Committee on Nutrition and Foods for Special Dietary Uses
is responsible for studying nutritional problems referred by the Codex
Alimentarius Commission. The Committee also drafts general provisions,
as appropriate, on nutritional aspects of all foods and develops
standards, guidelines, or related texts for foods for special dietary
uses. The relevant document is ALINORM 03/27/26. The following items
will be considered by the 27th Session of the Commission in July 2004.
To be adopted at Step 5:
Proposed Draft Revised Standard for Processed Cereal-Based
Foods for Infants and Young Children.
Proposed Draft Revised Standard for Infant Formula.
Proposed Draft Guidelines for Vitamin and Mineral
Supplements.
The Committee continues work on:
Proposed Draft Revision of the Advisory Lists of Nutrient
Compounds for Use in Foods for Special Dietary Uses intended for use by
Infants and Young Children.
Guidelines for Use of Nutrition Claims--Draft Table of
Conditions for Nutrient Contents Claims (Part B containing Provisions
on Dietary Fibre) at Step 6.
Draft Revised Standards for Gluten-Free Foods at Step 7.
Proposed Draft Recommendations on the Scientific Basis of
Health Claims.
Guidelines on the Application of Risk Analysis to the Work
of the CCNFSDU.
Discussion paper on the FAO Technical Workshop on Energy
Conversion Factors.
Responsible Agency: HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Fish and Fishery Products
The Fish and Fishery Products Committee is responsible for
elaborating standards for fresh, frozen and otherwise processed fish,
crustaceans and mollusks. The following will be considered by the 27th
Session of the Commission when it meets in June 2004. The relevant
document is ALINORM 04/27/18.
To be considered at Step 8:
Draft Standard for Salt Atlantic Herring and Salted Sprat.
Draft Model Certificate for Fish and Fishery Products
(Sanitary Certificate).
Draft Amendment to the Standard for Quick Frozen Lobsters.
To be considered at Step 5/8:
Proposed Draft Code of Practice for Fish and Fishery
Products (aquaculture and quick frozen coated fish products).
To be considered at Step 5:
Proposed Draft Amendment to the Standard for Salted Fish
and Dried Salted Fish.
The Committee continues work on the following:
Proposed Draft Code of Practice for Fish and Fishery
Products (other sections).
Proposed Draft Standard for Live and Raw Bivalve Mollusks.
Proposed Draft Standard for Smoked Fish.
Proposed Draft Standard for Granular Sturgeon Caviar.
Proposed Draft Standard for Quick Frozen Scallop Adductor
Muscle Meat.
Revision of the procedure for the Inclusion of Species.
Proposed Draft Amendment of the Labelling Section in the
Standard for Canned Sardines and Sardine-Type Products (Clupea
bentincki).
Responsible Agency: HHS/FDA; USDC/NOAA/NMFS.
U.S. Participation: Yes.
Codex Committee on Milk and Milk Products
The Codex Committee on Milk and Milk Products is responsible for
establishing international codes and standards for milk and milk
products. The Committee held its 6th Session in Auckland, NZ on April
26-30, 2004. The relevant document is ALINORM 04/27/11.
The Committee worked on the following:
Proposed Draft Amendment to Section 3.3 (Composition) of
the Codex General Standard for Cheese.
[[Page 31948]]
Proposed Draft Standard for Products in Which Milk
Components are Substituted by Non-Milk Components.
Evaporated Skimmed Milk with Vegetable Fat.
Sweetened Condensed Skimmed Milk with Vegetable Fat.
Skimmed Milk Powder with Vegetable Fat.
Proposed Draft Model Export Certificate for Milk and Milk
Products.
Methods of Analysis and Sampling for Milk Products.
Draft Revised Standards for Individual Cheeses.
Draft Revised Standard for Processed Cheese.
Draft Revised Standard for Dairy Spreads.
Proposed Draft Revised Standard for Whey Cheese.
Proposed Standard for Parmesan Cheese.
Discussion paper on Proposed Revision of the Codex
Standard for Extra Hard Grating Cheese.
Responsible Agency: USDA/AMS; HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Fats and Oils
The Codex Committee on Fats and Oils is responsible for elaborating
standards for fats and oils of animal, vegetable, and marine origin.
The Committee will hold its next session on February 21-25, 2005, in
London, England.
The Committee continues work on:
Draft Standard for Fat Spreads and Blended Spreads.
Proposed Draft Amendments to the Standard for Named
Vegetable Oils:
Amendment to Sesame Seed Oil.
Rice Bran Oil.
Draft List of Acceptable Previous Cargoes.
Proposed Draft List of Acceptable Previous Cargoes.
Proposed Draft Amendment to the Standard for Olive Oil:
Linolenic Acid content.
Proposed Draft Amendments to the Recommended International
Code of Practice for the Storage and Transport of Edible Fats and Oils
in Bulk:
Amendments to Table 1.
Responsible Agency: HHS/FDA; USDA/ARS.
U.S. Participation: Yes.
Codex Committee on Processed Fruits and Vegetables
The Codex Committee on Processed Fruits and Vegetables is
responsible for elaborating standards for Processed Fruits and
Vegetables. After having been adjourned sine die, the Committee
reconvened in Washington, DC, in March 1998 to begin work revising the
standards. The Committee will hold its next session on September 27-
October 1, 2004.
The committee is continuing work on:
Draft Codex Standard for Pickled Products.
Proposed Draft Revised Standards for:
Processed Tomato Concentrates.
Canned Tomatoes.
Canned Vegetables including Guidelines for Packing Media
for Canned Vegetables.
Jams, Jellies and Marmalades.
Soy Sauce.
Canned Citrus Fruits.
Other work:
Methods of Analysis for Processed Fruits and Vegetables.
Priority List for the Standardization of Processed Fruits
and Vegetables.
Responsible Agency: USDA/AMS; HHS/FDA.
U.S. Participation: Yes.
Codex Committee on Meat Hygiene
The 24th Session of the Commission decided to reactivate the Codex
Committee on Meat Hygiene with New Zealand as Host Government. The
Terms of Reference were amended to reflect the inclusion of poultry in
its mandate. The relevant document is ALINORM 04/27/16.
The Committee continues to work on:
Proposed Draft Code of Hygienic Practice for Meat at Step
5.
Incorporating the Hygiene Provisions for Processed Meat in
the Draft Code of Hygienic Practice for Meat for discussion.
Attaching the Proposed Draft Annex on Risk-Based Post-
Mortem Examination Procedures for Meat and the Proposed Draft Annex on
Microbiological Verification of Process Control of Meat Hygiene as
Annex I and II, respectively.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Codex Committee on Cereals, Pulses, and Legumes
The 26th Session of the Codex Alimentarius Commission adopted the
Proposed Draft Standard for Instant Noodles at Step 5, on the
recommendation of the Coordinating Committee for Asia, and advanced it
to Step 6 for consideration by the Committee on Cereals, Pulses and
Legumes by correspondence. The United States, as host government, has
circulated the Draft Standard for comments and will circulate the
revised version for another round of comments following discussion in
CCFAC regarding additives and peroxide values.
Responsible Agency: HHS/FDA; USDA/GIPSA.
U.S. Participation: Yes.
Certain Codex Commodity Committees \1\
Several Codex Alimentarius Commodity Committees have adjourned sine
die. The following Committees fall into this category:
Cocoa Products and Chocolate.
Responsible Agency: HHS/FDA.
U.S. Participation: Yes.
Natural Mineral Water.
Responsible Agency: HHS/FDA.
U.S. Participation: Yes.
Sugars.
Responsible Agency: USDA/ARS; HHS/FDA.
U.S. Participation: Yes.
Vegetable Proteins.
Responsible Agency: USDA/ARS; HHS/FDA.
U.S. Participation: Yes.
Ad Hoc Intergovernmental Task Force on Animal Feeding
The Commission at its 23rd Session established the Ad Hoc
Intergovernmental Task Force on Animal Feeding to develop guidelines or
standards as appropriate on good animal feeding practices. The Revised
Draft Code of Practice for Good Animal Feeding was held at Step 8 by
the Commission at its 26th Session in June 2003, with the exception
that the definition of ``feed additive'' and paragraphs 11, 12, and 13
were advanced to step 6. The Task Force held its 5th Session on May 17-
19, 2004 and discussed:
Revised Draft Code of Practice for Good Animal Feeding
(definition of ``feed additive'' and paragraphs 11, 12, and 13)
Responsible Agency: HHS/FDA; USDA/APHIS.
U.S. Participation: Yes.
Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices
The Commission at its 23rd Session established this Task Force to
revise and consolidate the existing Codex standards and guidelines for
fruit and vegetable juices and related products, giving preference to
general standards. These standards were originally developed by the
Joint UNECE/Codex Group of Experts on the Standardization of Fruit
Juices which had been abolished by its parent organizations. The Task
Force will hold its fourth session in Brazil, on October 11-15, 2004.
The committee is discussing:
Proposed Draft Minimum Brix Level for Reconstituted Juice
and Reconstituted Puree and Minimum Juice
[[Page 31949]]
and/or Puree Content for Fruit Nectars (%v/v).
Grape, Guava, Mandarin/Tangerine, Mango, Passion Fruit and
Tamarind (Indian date) juice at step 7.
Orange, Lemon, Lime and Pineapple Juice at step 4.
Responsible Agency: HHS/FDA; USDA/AMS.
U.S. Participation: Yes.
FAO/WHO Regional Coordinating Committees
The Codex Alimentarius Commission is made up of an Executive
Committee, as well as approximately 30 subsidiary bodies. Included in
these subsidiary bodies are coordinating committees for groups of
countries located in proximity to each other who share common concerns.
There are currently six Regional Coordinating Committees:
Coordinating Committee for Africa.
Coordinating Committee for Asia.
Coordinating Committee for Europe.
Coordinating Committee for Latin America and the
Caribbean.
Coordinating Committee for the Near East.
Coordinating Committee for North America and the South-
West Pacific.
The United States participates as an active member of the
Coordinating Committee for North America and the South-West Pacific,
and is informed of the other coordinating committees through meeting
documents, final reports, and representation at meetings. Each regional
committee:
Defines the problems and needs of the region concerning
food standards and food control;
Promotes within the committee contacts for the mutual
exchange of information on proposed regulatory initiatives and problems
arising from food control and stimulates the strengthening of food
control infrastructures;
Recommends to the Commission the development of world-wide
standards for products of interest to the region, including products
considered by the committee to have an international market potential
in the future; and
Serves a general coordinating role for the region and
performs such other functions as may be entrusted to it by the
Commission.
Codex Coordinating Committee for North America and the South-West
Pacific
The Coordinating Committee is responsible for defining problems and
needs concerning food standards and food control of all Codex member
countries of the region. The Eighth Session of the Committee will take
place in Apia, Samoa on October 19-22, 2004. Items on the agenda may
include:
Trust Fund for the Participation of Developing Countries
in Codex Standard Setting Procedures.
Joint FAO/WHO Evaluation of the Codex Alimentarius and
other FAO and WHO Work on Food Standards.
Consideration of Traceability/Product Tracing.
Strategic Plan for the Coordinating Committee for North
America and the Southwest Pacific.
Cooperation between Codex and the International Office of
Epizootics.
Responsible Agency: USDA/FSIS.
U.S. Participation: Yes.
Attachment 2: U.S. Codex Alimentarius Officials
Codex Committee Chairpersons
Codex Committee on Food Hygiene
Dr. Karen Hulebak, Assistant Administrator, Office of Public Health
Science, Food Safety and Inspection Service, U.S. Department of
Agriculture, 1400 Independence Avenue, SW., Room 3130, South Building,
Washington, DC 20250-3700, Phone: (202) 720-8609, Fax: (202) 720-9893,
E-mail: karen.hulebak@fsis.usda.gov.
Codex Committee on Processed Fruits and Vegetables
Mr. David L. Priester, International Standards Coordinator, Fruit &
Vegetable Division, Agricultural Marketing Service, U.S. Department of
Agriculture, Room 2049, South Building, Stop 0140, 1400 Independence
Avenue, SW., Washington, DC 20250-0240, Phone: (202) 720-2185, Fax:
(202) 720-8871, E-mail: 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) 827-4401, 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.
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, U.S. Department of
Agriculture, 1400 Independence Ave., 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-255), Food and Drug
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch
Parkway, College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202)
418-3131, E-mail: dennis.keefe@cfsan.fda.gov.
Codex Committee on Pesticide Residues (Host Government--The
Netherlands)
U.S. Delegate
Ms. Lois Rossi, Director of Registration Division, Office of
Pesticide Programs, U.S. Environmental Protection Agency, Ariel Rios
Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Phone:
(703) 305-5035, Fax: (703) 305-5147, E-mail:
Rossi.Lois@epamail.epa.gov.
Alternate Delegate
Dr. Robert Epstein, Associate Deputy Administrator, Science and
Technology, Agricultural Marketing Service, U.S.
[[Page 31950]]
Department of Agriculture, P.O. Box 96456, Room 3522S, Mail Stop 0222,
1400 Independence Ave., SW., Washington, DC 20090, Phone: (202) 720-
2158, Fax: (202) 720-1484, E-mail: 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-
2634, 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:
Donnald.C.Kendall@usda.gov.
Codex Committee on Food Import and Export Certification and Inspection
Systems (Host Government--Australia)
U.S. Delegate
Dr. Catherine Carnevale, Director, Office of Constituent
Operations, Center for Food Safety and Applied Nutrition, Food and Drug
Administration (HFS-550), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-2380,
Fax: (301) 436-2618, E-mail: Catherine.Carnevale@cfsan.fda.gov.
Alternate Delegate
Ms. Karen Stuck, Assistant Administrator, Office of International
Policy, Food Safety and Inspection Service, U.S. Department of
Agriculture, Room 2137, South Building, 1400 Independence Ave., SW.,
Washington, DC 20250-3700, Phone: (202) 720-3470, Fax: (202) 720-7990,
E-mail: 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)
Interim U.S. Delegate
Mr. L. Robert Lake, Director, Office of Regulations and Policy,
Center for Food Safety and Applied Nutrition (HFS-4), Food and Drug
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch
Parkway, College Park, MD 20740-3835, Phone: (301) 436-2379, Fax: (301)
436-2637, E-mail: RLake@cfsan.fda.gov.
Alternate Delegate
Mary K. Cutshall, Acting Director, Strategic Initiatives,
Partnerships and Outreach Staff, Food Safety and Inspection Service,
U.S. Department of Agriculture, 405 Aerospace Building, Washington, DC
20250-3700, Phone: (202) 690-6520, Fax: (202) 690-6519, E-mail:
Mary.Cutshall@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 (HFS-006), Food and Drug
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch
Parkway, College Park, MD 20740-3835, Phone: (301) 436-2369, Fax: (301)
436-2642, E-mail: Robert.Buchanan@cfsan.fda.gov.
Alternate Delegate
Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of
Policy, Program and Employee Development, Food Safety and Inspection
Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th
St., SW. Washington, DC 20250, Phone: (202) 205-0699, Fax: (202) 401-
1760, E-mail: Perfecto.Santiago@fsis.usda.gov.
Codex Committee on Nutrition and Food for Special Dietary Uses (Host
Government--Germany)
U.S. Delegate
Vacant.
Alternate Delegate
Vacant.
Worldwide Commodity Codex Committees
Codex Committee on Fresh Fruits and Vegetables (Host Government--
Mexico)
U.S. Delegate
Mr. Dorian LaFond, International Standards Coordinator, Fruit and
Vegetables Program, Agricultural Marketing Service, U.S. Department of
Agriculture, Room 2086, South Building, 1400 Independence Ave., SW.,
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-4722, E-
mail: 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 (HFS-400),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, Harvey W. Wiley Federal Building, 5100 Paint Branch
Parkway, College Park, MD 20740-3835, Phone: (301) 436-2300, Fax: (301)
436-2599, E-mail: Philip.Spiller@cfsan.fda.gov.
Alternate Delegate
Richard V. Cano, Acting Director, National Seafood Inspection
Program, NOAA, U.S. Department of Commerce, 1315 East-West Highway,
Silver Spring, MD 20910, Phone: (301) 713-2355, Fax: (301) 713-1081,
Email: richard.cano@noaa.gov.
Codex Committee on Cereals, Pulses and Legumes (Host Government--United
States)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Policy and Industry
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail 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
Ave., 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, Chief, Dairy Standardization Branch, Agricultural
Marketing Service, U.S. Department of Agriculture, Room 2750, South
Building, 1400 Independence Ave., SW., Washington, DC 20250, Phone:
(202)
[[Page 31951]]
720-9382, Fax: (202) 720-2643, E-mail: duane.spomer@usda.gov.
Alternate Delegate
John F. Sheehan, Director, Division of Dairy and Egg Safety, Office
of Plant and Dairy Foods and Beverages, Center for Food Safety and
Applied Nutrition (HFS-365), Food and Drug Administration, Harvey W.
Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD
20740, Phone: (301) 436-1488, Fax: (301) 436-2632, E-mail:
john.sheehan@cfsan.fda.gov.
Codex Committee on Fats and Oils (Host Government--United Kingdom)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Policy and Industry
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: Charles.Cooper@cfsan.fda.gov.
Alternate Delegate
Ms. Kathleen Warner (Acting), U.S. Department of Agriculture, 1815
N. University Street, Peoria, IL 61604, Phone (309) 681-6584, Fax:
(309) 681-6668, E-mail: warnerk@ncaur.usda.gov.
Codex Committee on Cocoa Products and Chocolate (Host Government--
Switzerland)
U.S. Delegate
Mr. Charles W. Cooper, Director, International Policy and Industry
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: 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, U.S. Department of Agriculture, 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-
255), Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway,
College Park, MD 20740-3835, Phone: (202) 418-3113, Fax: (202) 418-
3131, E-mail: dennis.keefe@cfsan.fda.gov.
Codex Committee on Processed Fruits and Vegetables (Host Government--
United States)
U.S. Delegate
Mr. Dorian Lafond, International Standards Coordinator, Fruit and
Vegetable Division, Agricultural Marketing Service, U.S. Department of
Agriculture, Room 2086, South Building, 1400 Independence Ave., SW.,
Washington, DC 20250, Phone: (202) 690-4944, Fax: (202) 720-0016, E-
mail: Dorian.Lafond@usda.gov.
Alternate Delegate
Mr. Charles W. Cooper, Director, International Policy and Industry
Outreach Branch, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-585), Harvey W. Wiley Federal Building, 5100
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1714, Fax: (301) 436-2618, E-mail: 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, U.S. Department of Agriculture, 600 E.
Mermaid Lane, Wyndmoor, PA 19038, Phone: (215) 233-6593, Fax: (215)
233-6719, E-mail: wmartinez@ars.usda.gov.
Alternate Delegate
Dr. Jeanne Rader, Director, Division of Research and Applied
Technology, Office of Nutritional Products, Labeling and Dietary
Supplements, Center for Food Safety and Applied Nutrition, Food and
Drug Administration (HFS-840), Harvey W. Wiley Federal Building, 5100
Paint Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-
1786, Fax: (301) 436-2640, E-mail: Jeanne.Rader@cfsan.fda.gov.
Codex Committee on Meat Hygiene (Host Government--New Zealand)
U.S. Delegate
Dr. Perfecto Santiago, Assistant Deputy Administrator, Office of
Policy, Program and Employee Development, Food Safety and Inspection
Service, U.S. Department of Agriculture, 402 Cotton Annex, 300 12th
Street, SW., Washington, DC 20250, Phone: (202) 205-0699, Fax: (202)
401-1760, E-mail: Perfecto.Santiago@fsis.usda.gov.
Alternate Delegate
Dr. William James, Deputy Assistant Administrator, Office of
International Affairs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Room 3143, South Building, 1400 Independence
Ave., SW., Washington, DC 20250, Phone: (202) 720-8601, Fax: (202) 690-
3856, E-mail: 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 and Applied Nutrition, Food and Drug
Administration (HFS-300), Harvey W. Wiley Federal Building, 5100 Paint
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1700,
Fax: (301) 436-2632, E-mail: terry.troxell@cfsan.fda.gov.
Alternate Delegate
Ms. Shellee Anderson, Food Technologist, Office of Nutritional
Products, Labeling and Dietary Supplements, Center for Food Safety and
Applied Nutrition, Food and Drug Administration (HFS-800), Harvey W.
Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD
20740-3835, Phone: (301) 436-1491, Fax: (301) 436-2636, E-mail:
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, Consumer Safety Officer, Office of Plant and
Dairy Foods and Beverages, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-306), Harvey W. Wiley
Federal Building, 5100 Paint
[[Page 31952]]
Branch Parkway, College Park, MD 20740-3835, Phone: (301) 436-1642,
Fax: (301) 436-2651, E-mail: Martin.Stutsman@cfsan.fda.gov.
Alternate Delegate
Vacant.
Ad Hoc Intergovernmental Task Group on Animal Feeding (Host
Government--Denmark)
U.S. Delegate
Dr. Stephen F. Sundlof, Director, Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Place (HFV-1), Metro Park
N. 4, Rockville, MD 20855, Phone: (301) 827-2950, Fax: (301) 827-4401,
E-mail: ssundlof@cvm.fda.gov.
Alternate Delegate
Dr. Lawrence E. Miller, Program Manager, Veterinary Regulatory
Support, Plant Protection and Quarantine, Animal and Plant Health
Inspection Service, Unit 129, Room 4D79, 4700 River Road, Riverdale, MD
20737, Phone: (301) 734-7633, Fax: (301) 734-8538, E-mail:
Lawrence.E.Miller@usda.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 American and the South-West
Pacific.
Contact
Paulo Almeida, Office Manager, U.S. Codex Office, Food Safety and
Inspection Service, Room 4861, South Building, 1400 Independence Ave.,
SW., Washington, DC 20250-3700, Phone: (202) 205-7760, Fax: (202) 720-
3157, E-mail: Paulo.Almeida@fsis.usda.gov.
Attachment 3: Timetable of Codex Sessions
[June 2003 through June 2005]
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
2003:
CX 702-52..................... Executive Committee 26-27 June............................ Rome.
(52nd Session).
CX 701-26..................... Codex Alimentarius 30 June-5 July........................ Rome.
Commission (26th
Session).
CX 731-11..................... Codex Committee on 8-12 September........................ Mexico City.
Fresh Fruits and
Vegetables (11th
Session).
CX 722-26..................... Codex Committee on 13-17 October......................... Aalesund (Norway).
Fish and Fishery
Products (26th
Session).
CX 720-25..................... Codex Committee on 3-7 November.......................... Berlin.
Nutrition and Foods
for Special Dietary
Uses (25th Session).
CX 716-19..................... Codex Committee on 17-21 November........................ Paris.
General Principles
(19th Session).
CX-733-12..................... Codex Committee on 1-5 December.......................... Brisbane.
Food Import and
Export Inspection and
Certification (12th
Session).
2004:
CX 702-53..................... Executive Committee 4-6 February.......................... Geneva.
(53rd Session).
CX 723-10..................... Codex Committee on 16-20 February........................ Auckland.
Meat and Poultry
Hygiene (10th
Session).
CX 715-25..................... Codex Committee on 8-12 March............................ Budapest.
Methods of Analysis
and Sampling (25th
Session).
CX 711-36..................... Codex Committee on 22-26 March........................... Rotterdam.
Food Additives and
Contaminants (36th
Session).
CX 712-36..................... Codex Committee on 29 March-3 April...................... Washington, DC.
Food Hygiene (36th
Session).
CX 718-36..................... Codex Committee on 19-24 April........................... New Delhi.
Pesticide Residues
(36th Session).
CX-703-06..................... Codex Committee on 26-30 April........................... Auckland.
Milk and Milk
Products (6th
Session).
CX 716-19..................... Codex Committee on 3-7 May............................... Paris.
General Principles
(19th Session).
CX 714-32..................... Codex Committee on 10-14 May............................. Montreal.
Food Labelling (32nd
Session).
CX 803-05..................... Ad Hoc 17-19 May............................. Copenhagen.
Intergovernmental
Task Force on Animal
Feeding (5th Session).
CX 702-54..................... Executive Committee 24-26 June............................ Geneva.
(54th Session).
CX 701-27..................... Codex Alimentarius 28 June-3 July........................ Geneva.
Commission (27th
Session).
CX 727-14..................... Regional Coordinating 7-10 September........................ JeJu (City) Republic of Korea.
Committee for Asia
(14th Session).
CX 706-24..................... Regional Coordinating 20-23 September....................... Bratislava (Slovak Republic).
Committee for Europe
(24th Session).
CX 713-22..................... Codex Committee on 27 September-1 October................ Alexandria, VA.
Processed Fruits and
Vegetables (22nd
Session).
CX 801-03..................... Ad Hoc 11-15 October......................... TBA (Brazil).
Intergovernmental
Task Force on Fruit
and Vegetable Juices
(3rd Session).
CX 732-08..................... Regional Coordinating 19-22 October......................... Apia (Samoa).
Committee for North
America and South
West Pacific (8th
Session).
[[Page 31953]]
CX 730-15..................... Codex Committee on 25-28 October......................... TBA, USA.
Residue of Veterinary
Drugs in Foods (15th
Session).
CX 720-26..................... Codex Committee on 1-5 November.......................... Bonn (Germany).
Nutrition and Foods
for Special Dietary
Uses (26th Session).
CX 716-21..................... Codex Committee on 15-19 November........................ Paris.
General Principles
(21st Session).
CX 701-55..................... Executive Committee 22-24 November........................ Rome.
(55th Session).
CX 725-14..................... Regional Coordinating 29 November-3 December................ Buenos Aires.
Committee for Latin
America and the
Caribbean (14th
Session).
CX 733-13..................... Codex Committee on 6-10 December......................... TBA, (Australia).
Food Import and
Export Inspection and
Certification Systems
(13th Session).
2005:
CX 707-16..................... Regional Coordinating 14-17 December........................ Rabat (Morocco).
Committee for Africa
(16th Session).
CX 723-11..................... Codex Committee on 14-18 February........................ TBA, (New Zealand).
Meat and Poultry
Hygiene (11th
Session).
CX 709-19..................... Codex Committee on 21-25 February........................ London.
Fats and Oils (19th
Session).
CX 722-27..................... Codex Committee on 28 February-4 March................... TBA (South Africa).
Fish and Fishery
Products (27th
Session).
CX 734-03..................... Regional Coordinating 7-10 March............................ Amman (Jordan).
Committee for Near
East (3rd Session).
CX 712-37..................... Codex Committee on 14-19 March........................... TBA, USA.
Food Hygiene (37th
Session).
CX 711-37..................... Codex Committee on 21-25 March........................... Rotterdam.
Food Additives and
Contaminants (37th
Session).
CX 715-26..................... Codex Committee on 4-8 April............................. Budapest.
Methods of Analysis
and Sampling (26th
Session).
CX 716-22..................... Codex Committee on 11-15 April........................... Paris.
General Principles
(22nd Session).
CX 718-37..................... Codex Committee on 18-23 April........................... The Hague.
Pesticide Residues
(37th Session).
CX 714-33..................... Codex Committee on 9-13 May.............................. TBA.
Food Labelling (33rd
Session).
CX 731-12..................... Codex Committee on 16-20 May............................. Mexico City.
Fresh Fruits and
Vegetables (12th
Session).
CX 702-56..................... Executive Committee 23-24 June............................ Rome.
(56th Session).
CX 701-28..................... Codex Alimentarius 27 June-1 July........................ Rome.
Commission (28th
Session).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 4: Definitions for the Purpose of Codex Alimentarius
Words and phrases have specific meanings when used by the Codex
Alimentarius. For the purposes of Codex, the following definitions
apply:
1. Food means any substance, whether processed, semi-processed or
raw, which is intended for human consumption, and includes drink,
chewing gum, and any substance which has been used in the manufacture,
preparation or treatment of ``food'' but does not include cosmetics or
tobacco or substances used only as drugs.
2. Food hygiene comprises conditions and measures necessary for the
production, processing, storage and distribution of food designed to
ensure a safe, sound, wholesome product fit for human consumption.
3. Food additive means any substance not normally consumed as a
food by itself and not normally used as a typical ingredient of the
food, whether or not it has nutritive value, the intentional addition
of which to food for a technological (including organoleptic) purpose
in the manufacture, processing, preparation, treatment, packing,
packaging, transport, or holding of such food results, or may be
reasonably expected to result (directly or indirectly), in it or its
by-products becoming a component of or otherwise affecting the
characteristics of such foods. The food additive term does not include
``contaminants'' or substances added to food for maintaining or
improving nutritional qualities.
4. Contaminant means any substance not intentionally added to food,
which is present in such food as a result of the production (including
operations carried out in crop husbandry, animal husbandry, and
veterinary medicine), manufacture, processing, preparation, treatment,
packing, packaging, transport or holding of such food or as a result of
environmental contamination. The term does not include insect
fragments, rodent hairs and other extraneous matters.
5. Pesticide means any substance intended for preventing,
destroying, attracting, repelling, or controlling any pest including
unwanted species of plants or animals during the production, storage,
transport, distribution and processing of food, agricultural
commodities, or animal feeds or which may be administered to animals
for the control of ectoparasites. The term includes substances intended
for use as a plant-growth regulator, defoliant, desiccant, fruit
thinning agent, or sprouting inhibitor and substances applied to crops
either before of after harvest to protect the commodity from
[[Page 31954]]
deterioration during storage and transport. The term pesticides
excludes fertilizers, plant and animal nutrients, food additives, and
animal drugs.
6. Pesticide residue means any specified substance in food,
agricultural commodities, or animal feed resulting from the use of a
pesticide. The term includes any derivatives of a pesticide, such as
conversion products, metabolites, reaction products, and impurities
considered to be of toxological significance.
7. Good Agricultural Practice in the Use of Pesticides (GAP)
includes the nationally authorized safe uses of pesticides under actual
conditions necessary for effective and reliable pest control. It
encompasses a range of levels of pesticide applications up to the
highest authorized use, applied in a manner that leaves a residue,
which is the smallest amount practicable.
Authorized safe uses are determined at the national level and
include nationally registered or recommended uses, which take into
account public and occupational health and environmental safety
considerations.
Actual conditions include any stage in the production, storage,
transport, distribution and processing of food commodities and animal
feed.
8. Codex Maximum Limit for Pesticide Residues (MRLP) is the maximum
concentration of a pesticide residue (expressed as mg/kg), recommended
by the Codex Alimentarius Commission to be legally permitted in or on
food commodities and animal feeds. MRLPs are based on their toxological
affects and on GAP data and foods derived from commodities that comply
with the respective MRLPs are intended to be toxologically acceptable.
Codex MRLPs, which are primarily intended to apply in international
trade, are derived from reviews conducted by the JMPR following:
(a) toxological assessment of the pesticide and its residue, and
(b) review of residue data from supervised trials and supervised
uses including those reflecting national good agricultural practices.
Data from supervised trials conducted at the highest nationally
recommended, authorized, or registered uses are included in the review.
In order to accommodate variations in national pest control
requirements, Codex MRLPs take into account the higher levels shown to
arise in such supervised trials, which are considered to represent
effective pest control practices.
Consideration of the various dietary residue intake estimates and
determinations both at the national and international level in
comparison with the ADI, should indicate that foods complying with
Codex MRLPs are safe for human consumption.
9. Veterinary Drug means any substance applied or administered to
any food-producing animal, such as meat or milk-producing animals,
poultry, fish or bees, whether used for therapeutic, prophylactic or
diagnostic purposes or for modification of physiological functions or
behavior.
10. Residues of Veterinary Drugs include the parent compounds and/
or their metabolites in any edible portion of the animal product, and
include residues of associated impurities of the veterinary drug
concerned.
11. Codex Maximum Limit for Residues of Veterinary Drugs (MRLVD) is
the maximum concentration of residue resulting from the use of a
veterinary drug (expressed in mg/kg or [mu]g/kg on a fresh weight
basis) that is recommended by the Codex Alimentarius Commission to be
legally permitted or recognized as acceptable in or on food.
An MRLVD is based on the type and amount of residue considered to
be without any toxological hazard for human health as expressed by the
Acceptable Daily Intake (ADI), or on the basis of a temporary ADI that
utilizes an additional safety factor. An MRLVD also takes into account
other relevant public health risks as well as food technological
aspects.
When establishing an MRLVD, consideration is also given to residues
that occur in food of plant origin and/or the environment. Furthermore,
the MRLVD may be reduced to be consistent with good practices in the
use of veterinary drugs and to the extent that practical and analytical
methods are available.
12. Good Practice in the Use of Veterinary Drugs (GPVD) is the
official recommended or authorized usage including withdrawal periods
approved by national authorities, of veterinary drugs under practicable
conditions.
13. Processing Aid means any substance or material, not including
apparatus or utensils, not consumed as a food ingredient by itself,
intentionally used in the processing of raw materials, foods or its
ingredients, to fulfill a certain technological purpose during
treatment or processing and which may result in the non-intentional but
unavoidable presence of residues or derivatives in the final product.
Definitions of Risk Analysis Terms Related to Food Safety
Hazard: A biological, chemical or physical agent in, or condition
of, food with the potential to cause an adverse health effect.
Hazard Identification: The identification of biological, chemical,
and physical agents capable of causing adverse health effects and which
may be present in a particular food or group of foods.
Hazard Characterization: The qualitative and/or quantitative
evaluation of the nature of the adverse health effects associated with
biological, chemical and physical agents that may be present in food.
For chemical agents, a dose-response assessment should be performed.
For biological or physical agents, a dose-response assessment should be
performed if the data are obtainable.
Dose-Response Assessment: The determination of the relationship
between the magnitude of exposure (dose) to a chemical, biological or
physical agent and the severity and/or frequency of associated adverse
health effects (response).
Exposure Assessment: The qualitative and/or quantitative evaluation
of the likely intake of biological, chemical, and physical agents via
food as well as exposures from other sources if relevant.
Risk: A function of the probability of an adverse health effect and
the severity of that effect, consequential to a hazard(s) in food.
Risk Analysis: A process consisting of three components: risk
assessment, risk management and risk communication.
Risk Assessment: A scientifically based process consisting of the
following steps: (i) hazard identification, (ii) hazard
characterization, (iii) exposure assessment, and (iv) risk
characterization.
Risk Assessment Policy: Documented guidelines on the choice of
options and associated judgments for their application at appropriate
decision points in the risk assessment such that the scientific
integrity of the process is maintained.
Risk Characterization: The qualitative and/or quantitative
estimation, including attendant uncertainties, of the probability of
occurrence and severity of known or potential adverse health effects in
a given population based on hazard identification, hazard
characterization and exposure assessment.
Risk Communication: The interactive exchange of information and
opinions throughout the risk analysis process concerning risk, related
risk factors and risk perceptions, among risk assessors, risk managers,
consumers, industry, the academic community and other interested
parties, including the
[[Page 31955]]
explanation of risk assessment findings and the basis of risk
management decisions.
Risk Estimate: The quantitative estimation of risk resulting from
risk characterization.
Risk Management: The process, distinct from risk assessment, of
weighing policy alternatives, in consultation with all interested
parties, considering risk assessment and other factors relevant for the
health protection of consumers and for the promotion of fair trade
practices, and, if needed, selecting appropriate prevention and control
options.
Risk Profile: The description of the food safety problem and its
context.
Attachment 5
Part 1--Uniform Procedure for the Elaboration of Codex Standards and
Related Texts
Steps 1, 2 and 3
(1) The Commission decides, taking into account the ``Criteria for
the Establishment of Work Priorities and for the Establishment of
Subsidiary Bodies,'' to elaborate a Worldwide Codex Standard and also
decides which subsidiary body or other body should undertake the work.
A decision to elaborate a Worldwide Codex Standard may also be taken by
subsidiary bodies of the Commission in accordance with the above-
mentioned criteria, subject to subsequent approval by the Commission or
its Executive Committee at the earliest possible opportunity. In the
case of Codex Regional Standards, the Commission shall base its
decision on the proposal of the majority of members belonging to a
given region or group of countries submitted at a session of the Codex
Alimentarius Commission.
(2) The Secretariat arranges for the preparation of a proposed
draft standard. In the case of Maximum Limits for Residues of
Pesticides or Veterinary Drugs, the Secretariat distributes the
recommendations for maximum limits, when available from the Joint
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Panel of Experts on Pesticide Residues
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives
(JECFA). In the cases of milk and milk products or individual standards
for cheeses, the Secretariat distributes the recommendations of the
International Dairy Federation (IDF).
(3) The proposed draft standard is sent to members of the
Commission and interested international organizations for comment on
all aspects including possible implications of the proposed draft
standard for their economic interests.
Step 4
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned which has the power to consider such
comments and to amend the proposed draft standard.
Step 5
The proposed draft standard is submitted through the Secretariat to
the Commission or to the Executive Committee with a view to its
adoption as a draft standard. When making any decision at this step,
the Commission or the Executive Committee will give due consideration
to any comments that may be submitted by any of its members regarding
the implications which the proposed draft standard or any provisions of
the standard may have for their economic interests. In the case of
Regional Standards, all members of the Commission may present their
comments, take part in the debate and propose amendments, but only the
majority of the Members of the region or group of countries concerned
attending the session can decide to amend or adopt the draft. When
making any decisions at this step, the members of the region or group
of countries concerned will give due consideration to any comments that
may be submitted by any of the members of the Commission regarding the
implications which the proposed draft standard or any provisions of the
proposed draft standard may have for their economic interests.
Step 6
The draft standard is sent by the Secretariat to all members and
interested international organizations for comment on all aspects,
including possible implications of the draft standard for their
economic interests.
Step 7
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned, which has the power to consider such
comments and amend the draft standard.
Step 8
The draft standard is submitted through the Secretariat to the
Commission together with any written proposals received from members
and interested international organizations for amendments at Step 8
with a view to its adoption as a Codex Standard. In the case of
Regional standards, all members and interested international
organizations may present their comments, take part in the debate and
propose amendments but only the majority of members of the region or
group of countries concerned attending the session can decide to amend
and adopt the draft.
Part 2--Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts
Steps 1, 2 and 3
(1) The Commission or the Executive Committee between Commission
sessions, on the basis of a two-thirds majority of votes cast, taking
into account the ``Criteria for the Establishment of Work Priorities
and for the Establishment of Subsidiary Bodies'', shall identify those
standards which shall be the subject of an accelerated elaboration
process. The identification of such standards may also be made by
subsidiary bodies of the Commission, on the basis of a two-thirds
majority of votes cast, subject to confirmation at the earliest
opportunity by the Commission or its Executive Committee by a two-
thirds majority of votes cast.
(2) The Secretariat arranges for the preparation of a proposed
draft standard. In the case of Maximum Limits for Residues of
Pesticides or Veterinary Drugs, the Secretariat distributes the
recommendations for maximum limits, when available from the Joint
Meetings of the FAO Panel of Experts on Pesticide Residues in Food and
the Environment and the WHO Panel of Experts on Pesticide Residues
(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives
(JECFA). In the cases of milk and milk products or individual standards
for cheeses, the Secretariat distributes the recommendations of the
International Dairy Federation (IDF).
(3) The proposed draft standard is sent to Members of the
Commission and interested international organizations for comment on
all aspects including possible implications of the proposed draft
standard for their economic interests. When standards are subject to an
accelerated procedure, this fact shall be notified to the Members of
the Commission and the interested international organizations.
Step 4
The comments received are sent by the Secretariat to the subsidiary
body or other body concerned which has the power to consider such
comments and to amend the proposed draft standard.
Step 5
In the case of standards identified as being subject to an
accelerated
[[Page 31956]]
elaboration procedure, the draft standard is submitted through the
Secretariat to the Commission together with any written proposals
received from Members and interested international organizations for
amendments with a view to its adoption as a Codex standard. In taking
any decision at this step, the Commission will give due consideration
to any comments that may be submitted by any of its Members regarding
the implications which the proposed draft standard or any provisions
thereof may have for their economic interests.
Attachment 6: Nature of Codex Standards
Codex standards contain requirements for food aimed at ensuring for
the consumer a sound, wholesome food product free from adulteration,
and correctly labelled. A Codex standard for any food or foods should
be drawn up in accordance with the Format for Codex Commodity Standards
and contain, as appropriate, the criteria listed therein.
Format for Codex Commodity Standards Including Standards Elaborated
Under the Code of Principles Concerning Milk and Milk Products
Introduction
The format is also intended for use as a guide by the subsidiary
bodies of the Codex Alimentarius Commission in presenting their
standards, with the object of achieving, as far as possible, a uniform
presentation of commodity standards. The format also indicates the
statements which should be included in standards as appropriate under
the relevant headings of the standard. The sections of the format
required to be completed for a standard are only those provisions that
are appropriate to an international standard for the food in question.
Name of the Standard
Scope
Description
Essential Composition and Quality Factors
Food Additives
Contaminants
Hygiene
Weights and Measures
Labelling
Methods of Analysis and Sampling
Format for Codex Standards
Name of the Standard
The name of the standard should be clear and as concise as
possible. It should usually be the common name by which the food
covered by the standard is known or, if more than one food is dealt
with in the standard, by a generic name covering them all. If a fully
informative title is inordinately long, a subtitle could be added.
Scope
This section should contain a clear, concise statement as to the
food or foods to which the standard is applicable unless the name of
the standard clearly and concisely identifies the food or foods. A
generic standard covering more than one specific product should clearly
identify the specific products to which the standard applies.
Description
This section should contain a definition of the product or products
with an indication, where appropriate, of the raw materials from which
the product or products are derived and any necessary references to
processes of manufacture. The description may also include references
to types and styles of product and to type of pack. The description may
also include additional definitions when these additional definitions
are required to clarify the meaning of the standard.
Essential Composition and Quality Factors
This section should contain all quantitative and other requirements
as to composition including, where necessary, identity characteristics,
provisions on packing media and requirements as to compulsory and
optional ingredients. It should also include quality factors that are
essential for the designation, definition, or composition of the
product concerned. Such factors could include the quality of the raw
material, with the object of protecting the health of the consumer,
provisions on taste, odor, color, and texture which may be apprehended
by the senses, and basic quality criteria for the finished products,
with the object of preventing fraud. This section may refer to
tolerances for defects, such as blemishes or imperfect material, but
this information should be contained in appendix to the standard or in
another advisory text.
Food Additives
This section should contain the names of the additives permitted
and, where appropriate, the maximum amount permitted in the food. It
should be prepared in accordance with guidance given on page 84 of the
Codex Procedural Manual and may take the following form:
``The following provisions in respect of food additives and
their specifications as contained in section * * * of the Codex
Alimentarius are subject to endorsement [have been endorsed] by the
Codex Committee on Food Additives and Contaminants.''
A tabulation should then follow, viz.:
``Name of additive, maximum level (in percentage or mg/kg).''
Contaminants
(a) Pesticide Residues: This section should include, by reference,
any levels for pesticide residues that have been established by the
Codex Committee on Pesticide Residues for the product concerned.
(b) Other Contaminants: In addition, this section should contain
the names of other contaminants and where appropriate the maximum level
permitted in the food, and the text to appear in the standard may take
the following form:
``The following provisions in respect of contaminants, other
than pesticide residues, are subject to endorsement [have been
endorsed] by the Codex Committee on Food Additives and
Contaminants.''
A tabulation should then follow, viz.:
``Name of contaminant, maximum level (in percentage or mg/kg).''
Hygiene
Any specific mandatory hygiene provisions considered necessary
should be included in this section. They should be prepared in
accordance with the guidance given in the Codex Procedural Manual.
Reference should also be made to applicable codes of hygienic practice.
Any parts of such codes, including in particular any end-product
specifications, should be set out in the standard, if it is considered
necessary that they should be made mandatory. The following statement
should also appear:
``The following provisions in respect of the food hygiene of the
product are subject to endorsement [have been endorsed] by the Codex
Committee on Food Hygiene.''
Weights and Measures
This section should include all provisions, other than labelling
provisions, relating to weights and measures, e.g., where appropriate,
fill of container, weight, measure or count of units determined by an
appropriate method of sampling and analysis. Weights and measures
should be expressed in S.I. units. In the case of standards which
include provisions for the sale of products in standardized amounts,
e.g. multiples of 100 grams, S.I. units should be used, but this would
not preclude additional statements in the standards of these
standardized amounts in approximately similar amounts in other systems
of weights and measures.
[[Page 31957]]
Labelling
This section should include all the labelling provisions contained
in the standard and should be prepared in accordance with the guidance
given in the Codex Procedural Manual. Provisions should be included by
reference to the General Standard for the Labelling of Prepackaged
Foods. The section may also contain provisions which are exemptions
from, additions to, or which are necessary for the interpretation of
the General Standard in respect of the product concerned provided that
these can be justified fully. The following statement should also
appear:
``The following provisions in respect of the labelling of this
product are subject to endorsement [have been endorsed] by the Codex
Committee on Food Labelling.''
Methods of Analysis and Sampling
This section should include, either specifically or by reference,
all methods of analysis and sampling considered necessary and should be
prepared in accordance with the guidance given in the Codex Procedural
Manual. If two or more methods have been proved to be equivalent by the
Codex Committee on Methods of Analysis and Sampling, these could be
regarded as alternatives and included in this section either
specifically or by reference. The following statement should also
appear:
``The methods of analysis and sampling described hereunder are
to be endorsed [have been endorsed] by the Codex Committee on
Methods of Analysis and Sampling.''
[FR Doc. 04-12736 Filed 6-7-04; 8:45 am]