97-13410. International Standard-Setting Activities

[Federal Register Volume 62, Number 100 (Friday, May 23, 1997)]
[Notices]
[Pages 28416-28441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13410]

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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,
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statements of organization and functions are examples of documents
appearing in this section.

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Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 /
Notices

[[Page 28416]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service
[Docket No. 97-026N]

International Standard-Setting Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: This notice informs the public of the sanitary and
phytosanitary standard-setting activities of the Codex Alimentarius
Commission (Codex), in accordance with section 491 of the Trade
Agreements Act of 1979, as amended by the Uruguay Round Agreements Act,
Pub. L. 103-465, 108 Stat. 4809 (1994), and seeks comments on standards
currently under consideration and recommendations for new standards. It
also lists other standard-setting activities of Codex, including
commodity standards, guidelines, codes of practice, and revised texts.
This notice covers the time periods from June 1, 1996, to May 31, 1997,
and May 31, 1997, to June 1, 1998.

ADDRESSES: Submit written comments to: FSIS Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Room
102, Cotton Annex, Washington, DC 20250-3700. Please state that your
comments refer to Codex and, if your comments relate to specific Codex
committees, please identify those committees in your comments and
submit a copy of your comments to the delegate from that particular
committee. All comments submitted will be available for public
inspection in the Docket Clerk's Office between 8:30 a.m. and 4:30
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Patrick J. Clerkin, Director, U.S.
Codex Office, U.S. Department of Agriculture, Food Safety and
Inspection Service, 1255 22nd Street, NW, Room 311, West End Court
Building, Washington, DC 20250-3700; (202) 418-8852. 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 Appendix 1 to this notice.)

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 Agreements. The WTO is the successor organization to the
General Agreements on Tariffs and Trade (GATT). U.S. membership in the
WTO was approved by Congress when it enacted the Uruguay Round
Agreements Act, which was signed into law by the President on December
8, 1994. 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 to the Office of U.S. Codex Alimentarius, located in 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 major 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 will
publish this notice in the Federal Register annually, setting 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;
The agenda for United States participation, if any; and
d. The agency responsible for representing the United States with
respect to the standard.

To obtain copies of those standards listed in this notice that are
under consideration by Codex, please contact the Codex delegate or the
office of U.S. Codex Alimentarius. This notice also solicits public
comment on those standards that are under consideration and on
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 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

[[Page 28417]]

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. Please notify the appropriate U.S.
delegate or the Office of U.S. Codex Alimentarius, West End Court
Building, Room 311, Washington, DC 20250-3700, if you would like to
receive information about specific committees.
The information provided below describes the status of Codex
standard-setting activities by the Codex Committees for the two year
period from June 1, 1996 to June 1, 1998. In addition, the following
information is included with this Federal Register notice:

Appendix 1. List of U.S. Codex Officials (includes U.S. delegates and
alternate delegates).
Appendix 2. Timetable of Codex Sessions (June 1996 through June 1998)
Appendix 3. Definitions for the Purpose of Codex Alimentarius
Appendix 4.
(A) Uniform Procedure for the Elaboration of Codex Standards and
Related Texts
(B) Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts
Appendix 5. Nature of Codex Standards

Done at Washington, DC on: May 15, 1997.
Thomas J. Billy,
Administrator.

Codex Alimentarius Commission and Executive Committee

The Codex Alimentarius Commission will hold its Twenty-second
Session on June 23-28, 1997 in Geneva, Switzerland. At that time it
will consider the standards, codes of practice, and related matters
brought to its attention by the general subject committees,
commodity committees, and member delegations.
Prior to the Commission meeting, the Executive Committee will
meet on June 19-20 in Geneva. It is composed of the chairperson,
vice-chairperson and six further members elected from the
Commission, one from each of the following geographic regions:
Africa, Asia, Europe, Latin America and the Caribbean, North
America, and South-West Pacific. The committee may make proposals to
the Commission regarding the general orientation and program work of
the Commission, study special problems and help implement the
program as approved by the Commission.

Codex Committee on Residues of Veterinary Drugs in Foods

The Codex Committee on Residues of Veterinary Drugs determines
priorities for the consideration of residues of veterinary drugs in
foods and recommends Maximum Residue Limits (MRLs) for veterinary
drugs. A 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 ug/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 a food.
An MRLVD is based on the type and amount of residue considered
to be without any toxicological 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 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).
Information about committee actions can be found in ALINORMS 97/
31 and 97/31A. Residues of Veterinary Drugs in Foods to be
considered at the Twenty-Second Session of the Codex Alimentarius
Commission include the following:

[[Page 28418]]

Dexamethasone.... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Diclazuril....... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Dihydrostreptomyc MRLs Under Yes................... HHS/FDA
in and Consideration at
streptomycin. Step 5.
Febantal/ MRLs Under Yes................... HHS/FDA
Fenbendazole/ Consideration at
Oxfendazole. Step 5.
Gentamicin....... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Neomycin......... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Spectinomycin.... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Thiamphenicol.... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
Tilmicosin....... MRLs Under Yes................... HHS/FDA
Consideration at
Step 5.
----------------------------------------------------------------------------------------------------------------

In addition, the following matter will be brought to the
attention of the 22nd Session of the Codex Alimentarius Commission
in June 1997 for adoption:
Amendments to Methods of Analysis for Previously
Adopted Maximum Residue Limits for Veterinary Drugs
Priority List of Veterinary Drugs Requiring Evaluation
or Reevaluation.

Responsible Agency:
HHS/FDA
USDA/FSIS
US Participation: Yes

Food Additives and Contaminants

The Codex Committee on Food Additives and Contaminants (CCFAC)
establishes or endorses permitted maximum or guideline levels for
individual food additives, contaminants, and naturally occurring
toxicants in food and animal feed. The 29th Session of the CCFAC met
March 17-21, 1997, in the Hague, The Netherlands. The 30th Session
of the CCFAC is tentatively scheduled for March 9-13, 1998, in the
Hague, The Netherlands. The following matters contained in ALINORMS
12 and 12A are under consideration by the CCFAC:

Food Additives

Proposed Draft General Standard for Food Additives:
Preamble (forward to Commission at Step 8); Annex A (Guidelines for
the Estimation of Appropriate Levels of Use of Food Additives) to be
revised for consideration at Step 5; additives with nonnumerical
JECFA ADIs (forward to Commission at Step 5 with recommendation to
adopt Step 8); antioxidants, preservatives, stabilizers, thickeners,
sweeteners with numerical JECFA ADIs (forward to Commission at Step
5); colours, colour retention agents, bulking agents, and
emulsifiers (Step 3) (see Table 1, below); and
Specifications for the following food additives are
recommended by the CCFAC for adoption by the Twenty-second Session
of the Codex Commission; acesulfame K, alitame, ammonia solution,
benzoic acid, benzyl alcohol, calcium benzoate, calcium cyclamate,
calcium dihydrogen phosphate, calcium stearoyl-2-lactylate,
carmines, curcumin, cyclohexysulfamic acid, dodecyl gallate, ethyl
acetate, ethyl alcohol, glycerol ester of wood rosin, hydrochloride
acid, isomalt, konjac flour, lactic acid, nitrogen, octyl gallate,
phosphoric acid, polydextrose, potassium benzoate, potassium
bromate, potassium nitrate, propyl gallate, sodium benzoate, sodium
cyclamate, sodium metaphosphate (insoluable), sodium nitrate, sodium
nitrite, sodium polyphosphates (glassy), sodium stearoyl-2-
lactylate, sorbitol syrup, stearyl tartrate, sucrose acetate
isobutyrate, triacetin, and xylitol. Specifications for the
following flavouring agents are recommended by the CCFAC for
adoption by the Twenty-second Session of the Codex Commission: allyl
butyrate, allyl 2-ethylbutyrate, allyl hexanoate, allyl isovalerate,
allyl nonanoate, allyl octanoate, benzaldehyde, benzyl acetate,
benzyl alcohol, benzyl benzoate, ethyl alcohol, ethyl butyrate,
ethyl decanoate, ethyl dodecanoate, ethyl formate, ethyl heptanoate,
ethyl hexadecanoate, ethyl hexanoate, ethyl octadecanoate, ethyl
pentanoate, ethyl propionate, ethyl tetradecanoate, isoamyl alcohol,
isoamyl formate, isoamyl hexanoate, and isoamyl propionate.
Specifications for the following food additives are recommended by
the CCFAC for adoption after changes considered editorial have been
made by the Twenty-second Session of the Codex Commission:
``-cyclodextrin, lactitol, maltitol, mannitol, mineral oil
(high viscosity), sodium thiocyanate, and sorbitol.
Specifications for the following flavouring agents are
recommended by the CCFAC for adoption after changes considered
editorial have been made by the Twenty-second Session of the Codex
Commission: allyl heptanoate, allyl phenoxyacetate, allyl 10-
undecanoate, and ethyl acetate.

Contaminants

Proposed Draft General Standard for Contaminants and
Toxicants in Food Annexes I (Criteria for the Establishment of
Maximum Levels in Foods), II (Procedure for Risk Management
Decisions), and III (Format of the Standard) to be forwarded to the
Twenty-second Session of the Commission at Step 8;
Proposed Draft General Standard for Contaminants and
Toxicants in Food: Introduction section of Annex IV (see attached
list) and the whole of Annex V (Food Categorisation System to be
used in the GSC) to be forwarded to the Twenty-second Session of the
Codex Committee for adoption at Step 8;
Position paper on zearalenone to be prepared for the
30th CCFAC;
Proposed Draft Code of Practice for the Reduction of
Aflatoxins in Raw Materials and Supplementary Feeding stuffs for
Milk-Producing Animals at Step 8;
Position paper on Ochratoxin A to be revised and to
include proposed maximum levels;
The CCFAC decided to discontinue consideration of the
guideline level of 0.5 mg/kg lead in the Draft Guideline Levels for
Cadmium and Lead in Cereals, Pulses and Legumes at Step 7 in view of
its decision to include a level of 0.2 mg/kg in the General Standard
for Contaminants and Toxins. The CCFAC decided to maintain the
guideline level of 0.1 mg/kg cadmium at Step 7;

Responsible Agency: HHS/FDA
U.S. Participation: Yes

Food Additives

For the purposes of Codex, a food additive means any substance
not normally consumed as a food by itself and not normally used as a
typical ingredient in 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.
The General Standard for Food Additives (GSFA) will set forth
maximum levels of use of food additives in various foods and food
categories. The maximum levels will be based on the food additive
provisions of previously established Codex commodity

[[Page 28419]]

standards, as well as on the use of the additives in non-
standardized foods.
Only those food additives for which an acceptable daily intake
(ADI) has been established by the Joint FAO/WHO Expert Committee on
Food Additives (JECFA) will be included in the general Standard for
Food Additives (GSFA). The draft GSFA, which is being developed in
stages, currently covers only those JECFA-reviewed food additives
that have non-numerical JECFA ADIs and additives with numerical
JECFA ADIs that are used as antioxidants, preservatives,
stabilizers, thickeners, and sweeteners. All of the additives that
are currently under consideration for inclusion in the draft GFSA
are listed below.

----------------------------------------------------------------------------------------------------------------
Status of US participation/
Codex committee Substance consideration agenda Responsible agency
----------------------------------------------------------------------------------------------------------------
(Food Additives and Acesulfame Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Potassium. Under
12 and 97/12A. Consideration at
Step 5.
Acetic Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Acetic and Fatty Maximum Levels Yes................ HHS/FDA
Acid Esters of Under
Glycerol. Consideration at
Step 5/8.
Acetylated Maximum Levels Yes................ HHS/FDA
Distarch Adipate. Under
Consideration at
Step 5/8.
Acetylated Maximum Levels Yes................ HHS/FDA
Distarch Under
Phosphate. Consideration at
Step 5/8.
Acid Treated Maximum Levels Yes................ HHS/FDA
Starch. Under
Consideration at
Step 5/8.
(Food Additives and Agar.............. Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
Alginic Acid...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Alitame........... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Alkaline Treated Maximum Levels Yes................ HHS/FDA
Starch. Under
Consideration at
Step 5/8.
Allura Red AC..... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Alpha-Amylase Maximum Levels Yes................ HHS/FDA
(Aspergillus Under
oryzae, var.). Consideration at
Step 3.
Alpha-amylase Maximum Levels Yes................ HHS/FDA
(Bacillus Under
megaterium Consideration at
expressed in Step 5/8.
Bacillus
subtilis).
Alpha-amylase Maximum Levels Yes................ HHS/FDA
(Bacillus Under
stearothermophilu Consideration at
s expressed in Step 5/8.
Bacillus
subtilis).
Alpha-amylase Maximum Levels Yes................ HHS/FDA
(Bacillus Under
stearothermophilu Consideration at
s). Step 5/8.
Alpha-amylase ( Maximum Levels Yes................ HHS/FDA
Bacillus Under
subtilis). Consideration at
Step 5/8.
Alpha-amylase Maximum Levels Yes................ HHS/FDA
(Carbohydrase) Under
(Bacillus Consideration at
lichenforms). Step 5/8.
Aluminum Ammonium Maximum Levels Yes................ HHS/FDA
Sulphate. Under
Consideration at
Step 5.
Aluminum Silicate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Amaranth.......... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 3.
Ammonium Acetate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Alginate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Carbonate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Chloride. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Citrate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Fumarate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Hydrogen Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
Ammonium Hydroxide Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Lactate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ammonium Malate, Maximum Levels Yes................ HHS/FDA
D,L-. Under
Consideration at
Step 5/8.
Ammonium Polyphos- Maximum Levels Yes................ HHS/FDA
phate. Under
Consideration at
Step 3.

[[Page 28420]]

Ammonium Sulphate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Annato Extracts Maximum Levels Yes................ HHS/FDA
(Includes Bixin Under
and Norbixin). Consideration at
Step 3.
Anoxomer.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
(Food Additives and Ascorbic Acid..... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
Ascorbyl Palmitate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Ascorbyl Stearate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Aspartame......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Azorubin.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Beeswax, White and Maximum Levels Yes................ HHS/FDA
Yellow. Under
Consideration at
Step 3.
Beet Red.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Benzoic Acid...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
BHA............... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
BHT............... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Bleached Starch... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Bone Phosphate Maximum Levels Yes................ HHS/FDA
(Essentially Under
Calcium Phosphate Consideration at
Tribasic). Step 3.
Brilliant Black PN Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Brilliant Blue FCF Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Bromelain......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Brown HT.......... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 3.
Calcium Acetate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Alginate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Aluminum Maximum Levels Yes................ HHS/FDA
Silicate. Under
Consideration at
Step 5/8.
Calcium Ascorbate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Benzoate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Calcium Carbonate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Chloride.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Citrate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Dihydrogen Maximum Levels Yes................ HHS/FDA
Diphosphate. Under
Consideration at
Step 3.
Calcium Disodium Maximum Levels Yes................ HHS/FDA
Ethylenediaminete Under
tra-acetate. Consideration at
Step 5.
Calcium Formate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Calcium Gluconate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Calcium Glutamate, Maximum Levels Yes................ HHS/FDA
DL, L-. Under
Consideration at
Step 5/8.
Calcium Guanylate, Maximum Levels Yes................ HHS/FDA
5'. Under
Consideration at
Step 5/8.
(Food Additives and Calcium Hydrogen Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Sulphite. Under
12 and 97/12A. Consideration at
Step 5/8.
Calcium Hydroxide. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Inosinate, Maximum Levels Yes................ HHS/FDA
5'. Under
Consideration at
Step 5/8.

[[Page 28421]]

Calcium Lactate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Malate, D, Maximum Levels Yes................ HHS/FDA
L-. Under
Consideration at
Step 5/8.
Calcium Oleyl Maximum Levels Yes................ HHS/FDA
Lactylate. Under
Consideration at
Step 3.
Calcium Oxide..... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Maximum Levels Yes................ HHS/FDA
Polyphosphate. Under
Consideration at
Step 5.
Calcium Propionate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Maximum Levels Yes................ HHS/FDA
Ribonucleotides, Under
5'-. Consideration at
Step 5/8.
Calcium Silicate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Sorbate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Calcium Stearoyl Maximum Levels Yes................ HHS/FDA
Lactylate. Under
Consideration at
Step 5.
Calcium Sulphate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Calcium Sulphite.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
(Food Additives and Candelilla Wax.... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 3.
Canthaxanthin..... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Caramel Colour, Maximum Levels Yes................ HHS/FDA
Class I. Under
Consideration at
Step 5/8.
Caramel Colour, Maximum Levels Yes................ HHS/FDA
Class III. Under
Consideration at
Step 3.
Caramel Colour, Maximum Levels Yes................ HHS/FDA
Class IV. Under
Consideration at
Step 3.
Carbon Dioxide.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Carmines (Includes Maximum Levels Yes................ HHS/FDA
Aluminum and Under
Calcium Lakes of Consideration at
Carminic Acid). Step 3.
Carnuba Wax....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Carob Bean Gum.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Carotenes, Maximum Levels Yes................ HHS/FDA
Vegetable. Under
Consideration at
Step 3.
Carotene, -(synthetic). Under
Consideration at
Step 3.
Carotene, -apo-8'-. Under
Consideration at
Step 3.
Carotenic Acid, Maximum Levels Yes................ HHS/FDA
-apo-8', Under
methyl or ethyl Consideration at
ester. Step 3.
Carrageenan....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Chlorophyll s..... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Chlorophylls, Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Copper Complex. Under
12 and 97/12A. Consideration at
Step 3.
Chlorophyllin Maximum Levels Yes................ HHS/FDA
Copper Complex, Under
Sodium and Consideration at
Potassium salts. Step 3.
Cholic Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Citric Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Citric and Fatty Maximum Levels Yes................ HHS/FDA
Acid Esters of Under
Glycerol. Consideration at
Step 5/8.
Curcumin.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Cyclamates (acid Maximum Levels Yes................ HHS/FDA
and Na, K, Ca Under
salts). Consideration at
Step 5.
Dextrins, White Maximum Levels Yes................ HHS/FDA
and Yellow, Under
Roasted Starch. Consideration at
Step 5/8.

[[Page 28422]]

Diacetyltartaric Maximum Levels Yes................ HHS/FDA
Acid and Fatty Under
Acid Esters of Consideration at
Glycerol. Step 5.
Dicalcium Maximum Levels Yes................ HHS/FDA
Diphosphate. Under
Consideration at
Step 3.
Dicalcium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Dilauryl Maximum Levels Yes................ HHS/FDA
Thiodipropionate. Under
Consideration at
Step 5.
Dimagnesium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 3.
Dimethyl Maximum Levels Yes................ HHS/FDA
Dicarbonate. Under
Consideration at
Step 3.
(Food Additives and Dioctyl Sodium Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Sulfosuccinate. Under
12 and 97/12A. Consideration at
Step 5.
Diphenyl.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Dipotassium Maximum Levels Yes................ HHS/FDA
Diphosphate. Under
Consideration at
Step 5.
Dipotassium Maximum Levels Yes................ HHS/FDA
Guanylate, 5'. Under
Consideration at
Step 5/8.
Dipotassium Maximum Levels Yes................ HHS/FDA
Inosinate, 5'. Under
Consideration at
Step 5/8.
Dipotassium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Dipotassium Maximum Levels Yes................ HHS/FDA
Tartrate. Under
Consideration at
Step 5.
Disodium Maximum Levels Yes................ HHS/FDA
Diphosphate. Under
Consideration at
Step 5.
Disodium Maximum Levels Yes................ HHS/FDA
Ethylenediaminete Under
tra-acetate. Consideration at
Step 5.
Disodium Maximum Levels Yes................ HHS/FDA
Guanylate, 5'. Under
Consideration at
Step 5/8.
Disodium Maximum Levels Yes................ HHS/FDA
Inosinate, 5'. Under
Consideration at
Step 5/8.
Disodium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Disodium Maximum Levels Yes................ HHS/FDA
Ribonucleotides, Under
5'. Consideration at
Step 5/8.
Disodium Tartrate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Disodium Phosphate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Enzyme Treated Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Starch. Under
12 and 97/12A. Consideration at
Step 5/8.
Erythorbic Acid... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Erythrosine....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Ethyl Cellulose... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Ethyl Hydroxyethyl Maximum Levels Yes................ HHS/FDA
Cellulose. Under
Consideration at
Step 5/8.
Ethyl p- Maximum Levels Yes................ HHS/FDA
Hydroxybenzoate. Under
Consideration at
Step 5.
Ethyl Maltol...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Fast Green FCF.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Ferrous Gluconate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Ferrous Lactate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Formic Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Fumaric Acid...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Gellan Gum........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Glucono delta- Maximum Levels Yes................ HHS/FDA
lactone. Under
Consideration at
Step 5/8.
Glucose Oxidase Maximum Levels Yes................ HHS/FDA
(Aspergillus Under
niger, var.). Consideration at
Step 5/8.

[[Page 28423]]

(Food Additives and Glutamic Acid, L-. Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
Glycerol.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Glycerol Ester of Maximum Levels Yes................ HHS/FDA
Wood Rosin. Under
Consideration at
Step 5.
Grape Skin Extract Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Guaiac Resin...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Guanylic Acid, 5'. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Guar Gum.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Gum Arabic........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Hexamethylene Maximum Levels Yes................ HHS/FDA
Tetramine. Under
Consideration at
Step 5.
Hydrochloric Acid. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Hydroxypropyl Maximum Levels Yes................ HHS/FDA
Cellulose. Under
Consideration at
Step 5/8.
Hydroxypropyl Maximum Levels Yes................ HHS/FDA
Distarch Under
Phosphate. Consideration at
Step 5/8.
Hydroxypropyl Maximum Levels Yes................ HHS/FDA
Methyl Cellulose. Under
Consideration at
Step 5/8.
Hydroxypropyl Maximum Levels Yes................ HHS/FDA
Starch. Under
Consideration at
Step 5/8.
Indigotine........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
(Food Additives and Inosinic Acid, 5'. Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
Insoluable Maximum Levels Yes................ HHS/FDA
Polyvinylpyrrolid Under
one. Consideration at
Step 5/8.
Iron Carbonate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Iron Oxides Maximum Levels Yes................ HHS/FDA
(Black, Red, & Under
Yellow). Consideration at
Step 3.
Isomalt........... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Isopropyl Citrates Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Karaya Gum........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Konjac Flour...... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Lactic Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Lactic and Fatty Maximum Levels Yes................ HHS/FDA
Acid Esters of Under
Glycerol. Consideration at
Step 5/8.
Lactitol.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Lethicin.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Lipase (Animal Maximum Levels Yes................ HHS/FDA
Sources). Under
Consideration at
Step 5/8.
Lipase Maximum Levels Yes................ HHS/FDA
(Aspergillus Under
oryzae, var.). Consideration at
Step 5/8.
(Food Additives and Lysozyme, Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Hydrochloride. Under
12 and 97/12A. Consideration at
Step 3.
Magnesium Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
Magnesium Chloride Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Magnesium Maximum Levels Yes................ HHS/FDA
Glutamate, DL, L-. Under
Consideration at
Step 5/8.
Magnesium Hydrogen Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
Magnesium Maximum Levels Yes................ HHS/FDA
Hydroxide. Under
Consideration at
Step 5/8.
Magnesium Lactate, Maximum Levels Yes................ HHS/FDA
DL, L-. Under
Consideration at
Step 5/8.

[[Page 28424]]

Magnesium Oxide... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Magnesium Silicate Maximum Levels Yes................ HHS/FDA
(Synthetic). Under
Consideration at
Step 5/8.
Magnesium Sulphate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Malic Acid, D, L-. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Malitol (Including Maximum Levels Yes................ HHS/FDA
Malitol Syrup). Under
Consideration at
Step 5/8.
Maltol............ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Mannitol.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Methyl Cellulose.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Methyl Ethyl Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Cellulose. Under
12 and 97/12A. Consideration at
Step 5/8.
Methyl p- Maximum Levels Yes................ HHS/FDA
Hydroxybenzoate. Under
Consideration at
Step 5.
Microcrystalline Maximum Levels Yes................ HHS/FDA
Cellulose. Under
Consideration at
Step 5/8.
Microcrystalline Maximum Levels Yes................ HHS/FDA
Wax, Synthetic. Under
Consideration at
Step 3.
Mineral Oil....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Mono-and Maximum Levels Yes................ HHS/FDA
Diglycerides. Under
Consideration at
Step 5/8.
Monoammonium Maximum Levels Yes................ HHS/FDA
Glutamate, L-. Under
Consideration at
Step 5/8.
Monocalcium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Monopotassium Maximum Levels Yes................ HHS/FDA
Glutamate, L-. Under
Consideration at
Step 5/8.
Monopotassium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Monopotassium Maximum Levels Yes................ HHS/FDA
Tartrate. Under
Consideration at
Step 5.
Monosodium Maximum Levels Yes................ HHS/FDA
Glutamate, L-. Under
Consideration at
Step 5/8.
Monosodium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Monosodium Maximum Levels Yes................ HHS/FDA
Tartrate. Under
Consideration at
Step 5.
Monosodium Maximum Levels Yes................ HHS/FDA
Phosphate. Under
Consideration at
Step 5/8.
(Food Additives and Nisin............. Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5.
Nitrogen.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Orthophenylphenol. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Orthophosphoric Maximum Levels Yes................ HHS/FDA
Acid. Under
Consideration at
Step 5.
Oxidized Starch... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Papain............ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Pectins (Amidated Maximum Levels Yes................ HHS/FDA
and non-Amidated). Under
Consideration at
Step 5/8.
Pentapotassium Maximum Levels Yes................ HHS/FDA
Triphosphate. Under
Consideration at
Step 5.
Pentasodium Maximum Levels Yes................ HHS/FDA
Triphosphate. Under
Consideration at
Step 5.
Phosphated Maximum Levels Yes................ HHS/FDA
Distarch Under
Phosphate. Consideration at
Step 5/8.
Pimaricin......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Polydextroses..... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Polyethylene Maximum Levels Yes................ HHS/FDA
Glycol. Under
Consideration at
Step 5.

[[Page 28425]]

Polyglycerol Maximum Levels Yes................ HHS/FDA
Esters of Fatty Under
Acids. Consideration at
Step 5.
(Food Additives and Polyglycerol Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Esters of Under
12 and 97/12A. Interesterified Consideration at
Ricinoleic Acid. Step 5.
Polyoxyethylene Maximum Levels Yes................ HHS/FDA
(8) Stearate. Under
Consideration at
Step 5.
Polysorbates 20, Maximum Levels Yes................ HHS/FDA
40, 60, 65, and Under
80. Consideration at
Step 5.
Polyvinylpyrrolido Maximum Levels Yes................ HHS/FDA
ne. Under
Consideration at
Step 5.
Ponceau 4R........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Potassium Acetate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Potassium Benzoate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Potassium Alginate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Potassium Maximum Levels Yes................ HHS/FDA
Ascorbate. Under
Consideration at
Step 5/8.
Potassium Maximum Levels Yes................ HHS/FDA
Bisulphate. Under
Consideration at
Step 5.
Potassium Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
Potassium Chloride Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Potassium Maximum Levels Yes................ HHS/FDA
Dihydrogen Under
Citrate. Consideration at
Step 5/8.
Potassium Hydrogen Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
(Food Additives and Potassium Hydrogen Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Malate, D, L-. Under
12 and 97/12A. Consideration at
Step 5/8.
Potassium Maximum Levels Yes................ HHS/FDA
Hydroxide. Under
Consideration at
Step 5/8.
Potassium Lactate Maximum Levels Yes................ HHS/FDA
(Solution). Under
Consideration at
Step 5/8.
Potassium Malate, Maximum Levels Yes................ HHS/FDA
D, L-. Under
Consideration at
Step 5/8.
Potassium Maximum Levels Yes................ HHS/FDA
Metabisul- phate. Under
Consideration at
Step 5.
Potassium Nitrate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Potassium Polyphos- Maximum Levels Yes................ HHS/FDA
phate. Under
Consideration at
Step 5.
Potassium Maximum Levels Yes................ HHS/FDA
Propiniate. Under
Consideration at
Step 5/8.
Potassium Silicate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Potassium Sodium Maximum Levels Yes................ HHS/FDA
Tartrate. Under
Consideration at
Step 5.
Potassium Sorbate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Potassium Sulphate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Potassium Sulphite Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Powdered Cellulose Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Processed Eucheuma Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Seaweed. Under
12 and 97/12A. Consideration at
Step 5.
Propane........... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Propionic Acid.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Propyl Gallate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Propyl p-Hydroxy- Maximum Levels Yes................ HHS/FDA
benzoate. Under
Consideration at
Step 5.
Propylene Glycol.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Propylene Glycol Maximum Levels Yes................ HHS/FDA
Alginate. Under
Consideration at
Step 5.

[[Page 28426]]

Propylene Glycol Maximum Levels Yes................ HHS/FDA
Esters of Fatty Under
Acids. Consideration at
Step 5.
Quinoline Yellow.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Red 2G............ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Riboflavin........ Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Riboflavin 5'- Maximum Levels Yes................ HHS/FDA
Phosphate, Sodium. Under
Consideration at
Step 3.
Saccharin (and Na, Maximum Levels Yes................ HHS/FDA
K, Ca, salts). Under
Consideration at
Step 5.
Salts of Fatty Maximum Levels Yes................ HHS/FDA
Acids (Ammonium, Under
Calcium, Consideration at
Potassium, Step 5/8.
Sodium).
(Food Additives and Silicon Dioxide Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ (Amorphous). Under
12 and 97/12A. Consideration at
Step 5/8.
Sodium Acetate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Alginate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Maximum Levels Yes................ HHS/FDA
Aluminosilicate. Under
Consideration at
Step 5/8.
Sodium Aluminum Maximum Levels Yes................ HHS/FDA
Phosphate-Acidic. Under
Consideration at
Step 3.
Sodium Aluminum Maximum Levels Yes................ HHS/FDA
Phosphate-Basic. Under
Consideration at
Step 3.
Sodium Ascorbate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Benzoate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Calcium Maximum Levels Yes................ HHS/FDA
Polyphosphate. Under
Consideration at
Step 3.
Sodium Carbonate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Maximum Levels Yes................ HHS/FDA
Carboxymethyl Under
Cellulose. Consideration at
Step 5/8.
Sodium Diacetate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Dihydrogen Maximum Levels Yes................ HHS/FDA
Citrate. Under
Consideration at
Step 5/8.
Sodium Ethyl p- Maximum Levels Yes................ HHS/FDA
Hydroxybenzoate. Under
Consideration at
Step 5.
(Food Additives and Sodium Erythorbate Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
Sodium Formate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Fumarate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Hydrogen Maximum Levels Yes................ HHS/FDA
Carbonate. Under
Consideration at
Step 5/8.
Sodium Hydrogen Maximum Levels Yes................ HHS/FDA
Malate, D, L-. Under
Consideration at
Step 5/8.
Sodium Hydrogen Maximum Levels Yes................ HHS/FDA
Sulphite. Under
Consideration at
Step 5.
Sodium Hydroxide.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Lactate Maximum Levels Yes................ HHS/FDA
(Solution). Under
Consideration at
Step 5/8.
Sodium Malate, D, Maximum Levels Yes................ HHS/FDA
L-. Under
Consideration at
Step 5/8.
Sodium Maximum Levels Yes................ HHS/FDA
Metabisulphite. Under
Consideration at
Step 5.
Sodium Methyl p- Maximum Levels Yes................ HHS/FDA
Hydroxybenzoate. Under
Consideration at
Step 5.
Sodium Nitrate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Nitrite.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Oleyl Maximum Levels Yes................ HHS/FDA
Lactylate. Under
Consideration at
Step 5.

[[Page 28427]]

(Food Additives and Sodium o- Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Phenylphenol. Under
12 and 97/12A. Consideration at
Step 5.
Sodium Maximum Levels Yes................ HHS/FDA
Polyphosphate. Under
Consideration at
Step 5.
Sodium Propionate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Propyl p- Maximum Levels Yes................ HHS/FDA
Hydroxybenzoate. Under
Consideration at
Step 5.
Sodium Maximum Levels Yes................ HHS/FDA
Sesquicarbonate. Under
Consideration at
Step 5/8.
Sodium Silicate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Sorbate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Sulphite... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sodium Stearoyl Maximum Levels Yes................ HHS/FDA
Lactylate. Under
Consideration at
Step 5.
Sodium Sulphate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Sodium Sulphite... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sorbic Acid....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sorbitan Maximum Levels Yes................ HHS/FDA
Monolaurate. Under
Consideration at
Step 5.
Sorbitan Maximum Levels Yes................ HHS/FDA
Monooleate. Under
Consideration at
Step 5.
(Food Additives and Sorbitan Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Monpalmitate. Under
12 and 97/12A. Consideration at
Step 5.
Sorbitan Maximum Levels Yes................ HHS/FDA
Monostearate. Under
Consideration at
Step 5.
Sorbitan Trioleate Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sorbitan Maximum Levels Yes................ HHS/FDA
Triesterate. Under
Consideration at
Step 5.
Sorbitol Maximum Levels Yes................ HHS/FDA
(Including Under
Sorbitol Syrup). Consideration at
Step 5/8.
Stannous Chloride. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Starch Acetate.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Starch Sodium Maximum Levels Yes................ HHS/FDA
Octenylsuccinate. Under
Consideration at
Step 5/8.
Stearyl Citrate... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Stearyl Tartrate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Sucralose......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sucroglycerides... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Sucrose Acetate Maximum Levels Yes................ HHS/FDA
Isobutyrate. Under
Consideration at
Step 5.
Sucrose Fatty Acid Maximum Levels Yes................ HHS/FDA
Esters. Under
Consideration at
Step 5.
(Food Additives and Sulphur Dioxide... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5.
Sunset Yellow FCF. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 3.
Talc.............. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Tara Gum.......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Tartaric, Acetic Maximum Levels Yes................ HHS/FDA
and Fatty Acid Under
Esters of Consideration at
Glycerol (Mixed). Step 5/8.
Tartaric Acid Maximum Levels Yes................ HHS/FDA
(L(+)-). Under
Consideration at
Step 5.
tert- Maximum Levels Yes................ HHS/FDA
Butylhydroquinone Under
(TBHQ). Consideration at
Step 5.
Tetrapotassium Maximum Levels Yes................ HHS/FDA
Diphos- phate. Under
Consideration at
Step 5.

[[Page 28428]]

Tetrasodium Diphos- Maximum Levels Yes................ HHS/FDA
phate. Under
Consideration at
Step 5.
Thaumatin......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Thiodipropi- onic Maximum Levels Yes................ HHS/FDA
Acid. Under
Consideration at
Step 5/8.
Titanium Oxide.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Tocopherols Maximum Levels Yes................ HHS/FDA
(Mixed, Under
Concentrate). Consideration at
Step 5.
(Food Additives and Tocopheral, alpha- Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5.
Tocopherals, Delta- Maximum Levels Yes................ HHS/FDA
, Synthetic. Under
Consideration at
Step 5.
Tocopherals, Gamma- Maximum Levels Yes................ HHS/FDA
, Synthetic. Under
Consideration at
Step 5.
Tragacanth Gum.... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Triacetin......... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Triammonium Maximum Levels Yes................ HHS/FDA
Citrate. Under
Consideration at
Step 5/8.
Tricalcium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Triethyl Citrate.. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5.
Tripotassium Maximum Levels Yes................ HHS/FDA
Citrate. Under
Consideration at
Step 5/8.
Tripotassium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Trisodium Citrate. Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
Trisodium Diphos- Maximum Levels Yes................ HHS/FDA
phate. Under
Consideration at
Step 3.
Trisodium Maximum Levels Yes................ HHS/FDA
Orthophosphate. Under
Consideration at
Step 5.
Xanthan Gum....... Maximum Levels Yes................ HHS/FDA
Under
Consideration at
Step 5/8.
(Food Additives and Xylitol........... Maximum Levels Yes................ HHS/FDA
Contaminants) Ref. ALINORM 97/ Under
12 and 97/12A. Consideration at
Step 5/8.
----------------------------------------------------------------------------------------------------------------

Contaminants

A 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
contaminant does not include insect fragments, rodent hairs, and
other extraneous matter.
The Codex maximum level (ML) for a contaminant or naturally
occurring toxicant in a food or feed commodity is the maximum
concentration of that substance recommended by the Codex
Alimentarius Commission to be legally permitted in that commodity.
The ML is intended to ensure free movement of food in international
trade while protecting the health of the consumer.
The General Standard for Contaminants and Toxins in Foods will
establish maximum levels for contaminants in foods based on the
following considerations: toxicological data, human exposure
estimates, availability of analytical procedures, fair trade and
technological implications, regional variations, risk assessment,
and risk management.
The criteria for inclusion of a maximum level for a contaminant
in a food are: (a) consumption of the contaminated food presents a
significant risk to consumers; and (b) the existence of actual
problems in trade of food. The contaminants currently being examined
to determine whether they meet these criteria for inclusion in the
Codex General Standard for Contaminants and Toxins are listed below.

----------------------------------------------------------------------------------------------------------------
Status of U.S. participation/
Codex committee Standard consideration agenda Responsible agency
----------------------------------------------------------------------------------------------------------------
(CCFAC) Ref. ALINORM 97/12.... Arsenic.......... Position Paper to Yes................... HHS/FDA
be revised for
discussion
during the 1998
CCFAC.
Cadmium.......... Position Paper to Yes................... HHS/FDA
be revised for
discussion
during the 1998
CCFAC.
(CCFAC) Ref. ALINORM 97/12.... Lead............. Forwarded draft Yes................... HHS/FDA
maximum levels
to the
Commission at
Step 5 with
recommendation
for adoption.

[[Page 28429]]

Patulin.......... 29th CCFAC Yes................... HHS/FDA
requested
additional
information.
Position Paper
will be revised
for discussion
during 1998 CFAC.
Tin.............. 29th CCFAC Yes................... HHS/FDA
requested
additional
information.
Position Paper
will be revised
for discussion
during 1998
CCCAC.
Aflatoxin M1..... 29th CCFAC Yes................... HHS/FDA
maintained draft
maximum levels
in milk at Step
7.
Aflatoxins in Raw Draft Codex Yes................... HHS/FDA
Peanuts. Guideline Levels
and Sampling
Plans for Total
Aflatoxins in
raw shelled
peanuts at Step
7.
----------------------------------------------------------------------------------------------------------------

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 Limit for Pesticide Residues (MRLP) is the maximum
concentration of a pesticide residue (expressed as mg/kg),
recommended by the Codex Alimentarius Commission to be legally
permitted in or on food commodities and animal feeds. Foods derived
from commodities that comply with the respective MRLPs are intended
to be toxicologically acceptable, that is, consideration of the
various dietary residue intake estimates and determinations both at
the national and international level in comparison with the ADI*,
should indicate that foods complying with Codex MRLPs are safe for
human consumption.
Codex MRLPs are primarily intended to apply in international
trade and are derived from reviews conducted by the Joint Meeting on
Pesticide Residues (JMPR) following:
(a) Review of residue data from supervised trials and supervised
uses including those reflecting national good agricultural practices
(GAP). Data from supervised trials conducted at the highest
nationally recommended, authorized, or registered uses are included
in the review. In order to accommodate variations in national pest
control requirements, Codex MRLPs take into account the higher
levels shown to arise in such supervised trials, which are
considered to represent effective pest control practices, and
(b) Toxicological assessment of the pesticide and its residue.
MRLs recommended for advancement to steps 5 or 8 by the 28th and
29th CCPRs will be considered by the 22nd Session of the Codex
Alimentarius Commission in June 1997.

*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.

----------------------------------------------------------------------------------------------------------------
Status of US Participation/
Codex committee Standard consideration agenda Responsible agency
----------------------------------------------------------------------------------------------------------------
Pesticide Residues (considered Aldicarb......... MRLs under Yes................... EPA
at the 28th and 29th CCPRs consideration at
(Annex II to ALINORMS 97/42 Steps 5 and 5/8
and 97/42A). and CXL
deletions.
Aldrin/dieldrin.. EMRLs at Step 8.. Yes................... EPA
Azinphos-methyl.. MRLs under Yes................... EPA
consideration at
Steps 5/8 and 8
and CXL
deletions.
Pesticide Residues (considered Bentazone........ MRLs under Yes................... EPA
at the 28th and 29th Session consideration at
of the Codex Committee on Step 8.
Pesticide Residues (Annex II
to ALINORMS 97/24 and 97/24A).
Bifenthrin....... MRLs under Yes................... EPA
consideration at
Step 8.
Bromide Ion...... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Bromopropylate... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Buprofezin....... MRLs under Yes................... EPA
consideration at
Step 8.
Captan........... Temporary CXLs Yes................... EPA
deleted.
Cartap........... CXL deletions Yes................... EPA
(all).
Chlormequat...... CXL deletions.... Yes................... EPA
Chlorothalonil... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Chlorpyrifosmethy MRLs under Yes................... EPA
l. consideration at
Step 5.

[[Page 28430]]

Clethodim........ MRLs under Yes................... EPA
consideration at
Step 5.
Cycloxydim....... MRLs under Yes................... EPA
consideration at
Step 8.
DDT.............. MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletion.
Pesticide Residues (considered Diazinon......... MRLs under Yes................... EPA
at the 28th and 29th Session consideration at
of the Codex Committee on Steps 5/8 and 8
Pesticide Residues (Annex II and CXL
to ALINORMS 97/24 and 97/24A). deletions.
Dichlorvos....... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Dicloran......... CXL deletions.... Yes................... EPA
Dicofol.......... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Dimethoate....... MRLs under Yes................... EPA
consideration at
Step 8.
Diquat........... MRLs under Yes................... EPA
consideration at
Step 5 and CXL
deletions.
Dithianon........ MRLs under Yes................... EPA
consideration at
Step 8.
Dithiocarbamates. MRLs under Yes................... EPA
consideration at
Step 5 and CXL
deletions.
Endrin........... EMRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Ethephon......... MRLs under Yes................... EPA
consideration at
Steps 5, 5/8 and
8.
Ethion........... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Pesticide Residues (considered Ethofenprox...... MRLs under Yes................... PA
at the 28th and 29th Sesssion consideration at
of the Codex Committee on Step 8.
Pesticide Residues (Annex II
to ALINORMS 97/24 and 97/24A).
Ethoxyquin....... CXL deletion..... Yes................... EPA
Etrimfos......... CXL deletions Yes................... EPA
(all).
Fenarimol........ MRLs under Yes................... EPA
consideration at
Step 5 and 5/8.
Fenbutatin Oxide. MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Fenpropathrin.... MRLs under Yes................... EPA
consideration at
Step 8.
Fenpropimorph.... MRLs under Yes................... EPA
consideration at
Step 5.
Fenthion......... MRLs under Yes................... EPA
consideration at
Steps 5 and 5/8
and CXL
deletions.
Fentin........... CXL deletion..... Yes................... EPA
Flucythrinate.... CXL deletion..... Yes................... EPA
Flusilazole...... MRLs under Yes................... EPA
consideration at
Step 8.
Folpet........... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletion.
Glufosinate- MRLs under Yes................... EPA
ammonium. consideration at
Steps 5/8 and 8.
Pesticide Residues (considered Glyphosate....... MRLs under Yes................... EPA
at the 28th and 29th Session consideration at
of the Codex Committee on Step 5/8 and CXL
Pesticide Residues (Annex II deletions.
to ALINORMS 97/24 and 97/24A).
Hexythiazox...... MRLs under Yes................... EPA
consideration at
Step 8.
Imazalil......... MRL under Yes................... EPA
consideration at
Step 5/8.

[[Page 28431]]

Iprodione........ MRLs under Yes................... EPA
consideration at
Step 5, 5/8 and
8 and CXL
deletions.
Isofenphos....... CXL deletions Yes................... EPA
(all).
Methacrifos...... CXL deletions Yes................... EPA
(all).
Methamidophos.... MRLs under Yes................... EPA
consideration at
Steps 5 and 8
and CXL deletion.
Methidathion..... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletion.
Monocrotophos.... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Myclobutanil..... MRL under Yes................... EPA
consideration at
Step 8.
Parathion........ MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletion.
Parathion-methyl. MRLs under Yes................... EPA
consideration at
Steps 5/8 and
CXL deletion.
Pesticide Residues Penconazole...... MRLs under Yes................... EPA
(considered at the 28th and consideration at
29th Session of the Codex Step 5/8 and 8.
Committee on Pesticide
Residues (Annex II to
ALINORMS 97/24 and 97/24A)
Phosalone........ CXL deletions.... Yes................... EPA
Pirimiphosmethyl. MRLs under Yes................... EPA
consideration at
Step 8.
Profenofos....... MRLs under Yes................... EPA
consideration at
Steps 5/8 and 8.
Propiconazole.... MRLs under Yes................... EPA
consideration at
Steps 5/8 and 8
and CXL deletion.
Pyrazophos....... MRLs under Yes................... EPA
consideration at
step 8.
Quintozene....... CXL deletion..... Yes................... EPA
Tebuconazole..... MRLs under Yes................... EPA
consideration at
Step 5/8.
Tolclofos-methyl. MRLs under Yes................... EPA
consideration at
Step 5/8.
Tecnazene........ MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Triadimefon...... MRLs under Yes................... EPA
consideration at
Step 8 and CXL
deletions.
Triadimenol...... MRLs under Yes................... EPA
consideration at
Step 8.
Triazophos....... MRL under Yes................... EPA
consideration at
Step 8.
Trichlorfon...... CXL deletions Yes................... EPA
(all).
----------------------------------------------------------------------------------------------------------------

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 micro-biological 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 following matters will be brought to the attention of the
22nd Session of the Codex Alimentarius Commission in June 1997, for
adoption:
Analytical Terminology for Codex Use;
Guidelines for the Assessment of the Competence of
Testing Laboratories Involved in the Import and Export Control of
Food; and
Revised Terms of Reference for the
Committee.^*
---------------------------------------------------------------------------

\*\ Not in Step procedure.
---------------------------------------------------------------------------

The Committee is continuing work on:
Proposed Draft Codex General Guidelines on Sampling;
Criteria for evaluating acceptable methods of
analysis for Codex purposes;

[[Page 28432]]

Harmonization of test results corrected for recovery
factors;
Harmonization of analytical terminology in
accordance with international standards;--Report of Inter-Agency
Meeting on ``limits;''
Measurement uncertainty; and
Report of the Inter-Agency Meeting; and
Endorsement of methods of analysis for Codex
purposes.
The Committee agreed to propose the following new work:
In-house method validation.
The reference documents are ALINORM 97/23 and 97/23a.

RESPONSIBLE AGENCY: HHS/FDA USDA/AMS
U.S. PARTICIPATION: Yes

Codex Committee on Food Import and Export Inspection and
Certification Systems

The Codex Committee on Food Import and Export Certification and
Inspection Systems is charged with developing principles and
guidelines for food import and export inspection and certification
systems. Included in the charge are application of measures by
competent authorities to provide assurance that foods comply with
essential food safety and quality requirements. Recognition of
quality assurance systems through the development of guidelines will
help ensure that foods conform to the essential requirements. Draft
guidelines to be considered by the Codex Alimentarius Commission at
its Twenty-second session in June can be found in ALINORMS 97.30 and
30A.
To be considered at Step 8:
Guidelines for the Exchange of Information Between
Countries on Rejections of Imported Food
Draft Guidelines for the Design, Operation,
Assessment and Accreditation of Food Import and Export Inspection
and Certification Systems
In addition, the Committee agreed:
to append the Criteria for a Generic Certificate for
the Export of Food and Food Products and the Model Certificate to
its report in order to facilitate Commission discussions as to the
need for further consideration by CCFICS of this matter from the
different perspectives of Codex commodity committees.
that a discussion paper on issues relating to the
process of judgment of equivalence be prepared for circulation and
comment prior to its next session.
with regard to elaboration of guidelines on Food
Import Control Systems that the delegations of Mexico and the United
States should further develop a discussion paper for review at the
Committee's next session.
that the United States should revise the proposed
Draft Guidelines for the Development of Agreements Regarding Food
Import and Export Inspection and Certification Systems for
circulation and comment at Step 3 prior to the Committee's Sixth
Session based on discussion and comments received.

RESPONSIBLE AGENCY: HHS/FDA, USDA/FSIS
U.S. PARTICIPATION: Yes

Codex Committee on General Principles

The Codex Committee on General Principles deals with rules and
procedures referred to it by the Codex Alimentarius Commission. None
of the following recommendations for changing the rules of procedure
for Codex are in the Step Procedure. The reference document is
ALINORM 97/33.
The Committee recommended the following matters for adoption by
the 22nd Session of the Codex Alimentarius Commission:
Amendment to the Rules of Procedure (Rules II and IX
to provide for the appointment of Members of the Commission as
Coordinators and to confirm their attendance as observers at
sessions of the Executive Committee.)
Addition of an Appendix to the Procedural Manual
entitled ``General Decisions of the Commission.'' The proposed
Appendix to the Procedural Manual to include: Four Statements of
Principle on the Role of Science in the Codex Decision-Making
Process and the extent to which other factors are taken into account
and Four Statements of Principle relating to the Role of Food Safety
Risk Assessment
Revision of the following sections of the Procedural
Manual:

Definitions
Guidelines for Codex Committees
Guidelines for the Inclusion of Specific Provisions in Codex
Standards
Criteria for the Establishment of Work Priorities
Relations between Commodity Committees and General Subject
Committees--Section K

Proposed specific recommendations in order to
clarify the status of ``advisory'' codes, Guidelines and related
texts
The committee also recommended that the Code of Principles
concerning Milk and Milk Products be redrafted as a standard and
recommended that the Draft Guidelines for Codex Contact Points and
National Codex Committees prepared by CCASIA be circulated to other
Regional Coordinating Committees.

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 applicable to all foods and to
address issues assigned by the Codex Alimentarius Commission. The
following draft guidelines are being considered by the Codex
Alimentarius Commission at their June 1997 meeting. The guidelines
and other documents listed below are located in ALINORMS 97/22 and
92/22A.
To be considered at Step 8:
Draft Guidelines for Use of Nutrition Claims
Draft General Guidelines for Use of the term
``Halal'' (foods permitted under Islamic Law).
To be considered at Step 5 of the Accelerated Procedure:
Proposed Draft Amendment to the Labelling Section of
the Standard for Quick Frozen Fish Sticks, Fish Portions and Fish
Fillets--Breaded or in Batter
To be considered at Step 5:
Draft Guidelines for Labelling Foods that can cause
Hypersensitivity (Proposed Draft Amendment to the General Standard
for the Labelling of Prepackaged Foods)
The committee is continuing to work on:
Draft Guidelines for the Production, Processing,
Labelling and Marketing of Organically Produced Foods at Step 6
Draft Recommendations for the Labelling of Foods
Obtained through Biotechnology at Step 3
Review of General Guidelines for Nutrition Labelling
including consideration of expanding the list of nutrients required
to be declared to include saturated fat, sodium, sugars, and fiber
whenever nutrition labelling is used.
Review of Guidelines for Use of Health Claims
including circulating for government comment the sections on health
claims previously removed form the guidelines.

RESPONSIBLE AGENCY: HHS/FDA, USDA/FSIS
U.S. PARTICIPATION: Yes

Codex Committee on Food Hygiene

The Food Hygiene Committee drafts basic provisions on food
hygiene for all foods. The term ``hygiene'' also includes, where
applicable, microbiological specifications for food and associated
methodology.
The following matters will be considered by the Codex
Alimentarius Commission at its Twenty-second session in June 1997.
Information about the Codes and Guidelines can be found in ALINORMS
97/13 and 13A.
To be considered at Step 8:
Draft Revised International Code of Practice--
General Principles of Food Hygiene
Draft Revised Guidelines for the Application of the
Hazard Analysis Critical Control Point (HACCP) System
Draft Revised Principles for the Establishment and
Application of Microbiological Criteria for Foods
In addition, the committee requested approval to initiate
development of the following when necessary:
Code of Hygienic Practice for Milk and Milk Products
Guidance on the hygienic recycling of processing
water in food processing plants
Guidance on the application of microbiological risk
evaluation to international trade
Revision of the standard wording for Food Hygiene
Provisions (Procedural Manual)
Risk-based guidance for the use of HACCP-like
systems in small business, with special reference to developing
countries
Recommendations for the management of
microbiological hazards for foods in international trade
The Commission is invited to advise FAO and WHO to consider the
establishment of an international advisory body addressing the
microbiological aspects of food safety and provide scientific advice
in the form of formal microbiological risk assessments.
Other matters to be discussed at the 30th Committee Session in
October 1997 include:

[[Page 28433]]

Proposed Draft Code of Practice for Refrigerated
Packaged Foods with Extended Shelf-Life
Principles and Guidelines for the Conduct of
Microbiological Risk Assessment
Recommendations for the Control of Listeria
monocytogenes in Foods
Code of Hygienic Practice for Uncured/Unripened
Cheese and Ripened Soft Cheese
Code of Hygienic Practice for the Transport of Foods
in Bulk
Code of Hygienic Practice for Bottled Waters (other
than Mineral Water)
Consideration of a technical paper (to be prepared
by CCFFP) on residual chlorine in frozen shrimp and prawns
RESPONSIBLE AGENCY: USDA/FSIS, USDC/NOAA, HHS/FDA
U.S. PARTICIPATION: Yes

Codex Committee on Fresh Fruits and Vegetables

The Codex Committee on Fresh Fruits and Vegetables was
established in June 1988. The Committee is responsible for
elaborating world-wide standards and codes of practice for fresh
fruits and vegetables. Several of the standards listed below are
contained in ALINORM 97/35.
The sixth session of the Committee recommended that the
following standards and codes of practice be considered for adoption
by the Twenty-second Session of the Codex Alimentarius Commission in
June, 1997, at Step 8:
Draft Standard for Banana; and
Draft Standard for Mangosteen
The Committee also recommended initiation or continuation of
work in the following areas:
Draft Standard for Limes (at Step 5);
Draft Standard for Pummelo (at Step 5);
Draft Standard for Guava (at Step 5);
Draft Standard for Chayote (at Step 5);
Code of Practice for the Quality Inspection and
Certification of Fresh Fruits and Vegetables (at Step 5);
Draft Standard for Oranges (at Step 3);
Draft Standard for Asparagus (at Step 3);
Draft Revised Standard for Pineapple (at Step 3);
Draft Standard for Mexican Limes (at Step 1);
Draft Standard for Grapefruit (at Step 1);
Draft Standard for Longan (at Step 1);
Draft Standard for Ginger (at Step 1);
Preparation of a paper on the Objective Indices of
Maturity in Commercial Transactions of Fruits and Vegetables (at
Step 1); and,
Document concerning the Application of Quality
Tolerances at Import (at Step 1)

RESPONSIBLE AGENCY: USDA/AMS
U.S. PARTICIPATION: Yes

Codex Committee on Nutrition and Foods for Special Dietary Uses

The 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 provisions on
nutritional aspects for all foods and develops guidelines, general
principles, and standards for foods for special dietary uses.
The reference document for the following matters is ALINORM 97/
26. The Twentieth Session of the Committee recommended that the
following documents be considered by the Twenty-Second Session of
the Codex Alimentarius Commission in June 1997:
Draft guidelines on the procedure for the Table of
Conditions for Claims and Nutrient Contents, to be included in the
Draft Guidelines for Use of Health and Nutrition Claims at Step 8;
Proposed Draft Standard for Food Grade Sale at Steps
5 and 8;
Proposed Draft Amendment to the Standard for Infant
Formula; Vitamin B12, at Step 5 of the accelerated procedure;
Proposal to amend the Terms of Reference of the
Committee;
Proposed Draft Revised Standard for Gluten-Free
Foods at Step 5;
Proposed Draft Guidelines for Vitamin and Mineral
Supplements at Step 5; and
Proposal to discontinue work on Proposed Draft
Guidelines on the Inclusion of Nutrition Provisions on Nutritional
Quality in Food Standards.
In addition to the above documents being circulated for comment
prior to their consideration by the Commission, the following
documents are open for comment for consideration at the next
Committee meeting in March, 1998:
Part B of the Table of Conditions for Claims for
nutrient contents, to be included in the Draft Guidelines for Use of
Health and Nutrition Claims, at Step 6;
Proposed Draft Revised Standard for Cereal-Based
Foods for Infants and Young Children at Step 3.

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 and frozen fish, crustaceans, and
mollusks.
The following draft guideline will be considered for adoption by
the Codex Alimentarius Committee at its meeting in June. The
guideline is contained in ALINORM 97/18.
To be considered at Step 5:
Proposed Draft Guidelines for the Sensory Evaluation
of Fish and Shellfish
The committee is continuing work on draft revised codes of
practice for Frozen Fish, Minced Fish, Fresh Fish, Frozen Shrimps
and Prawns, Molluscan Shellfish, Salted Fish, and Smoked Fish at
Step 3.
In addition, it is working on a Proposed Draft Code of Practice
for the Products of Aquaculture at Step 3 and a draft section on
training for the Proposed Guidelines for the Sensory Evaluation of
Fish and Shellfish at Step 3.

RESPONSIBLE AGENCY: HHS/FDA, USDC/NOAA/NMFS
U.S. PARTICIPATION: Yes

Codex Committee on Milk and Milk Products

The Codex Committee on Milk and Milk Products is responsible for
establishing international codes and standards for milk and milk
products. The following revised standards and draft revised codes of
principles will be considered for adoption of the Codex Alimentarius
Commission in June 1997. The standards listed below are contained in
ALINORM 97/11.
To be considered at Step 8:
Draft Revised Standard for Butter
Draft Revised Standard for Milkfat Products
Draft Revised Standard for Evaporated Milks
Draft Revised Standard for Sweetened Condensed Milk
Draft Revised Standard for Milk and Cream Powders
Draft Revised Standard for Cheese
Draft Revised Standard for Whey Cheese
Draft Revised Standard for Cheeses in Brine
To be considered at Step 5:
Draft Revised Code of Principles Concerning Milk and
Milk Products
In addition, the committee requested approval to initiate
elaboration of standards for Dairy Spreads and Mozzarella Cheese and
a Model Export Certificate for Milk Products.
It also recommended the withdrawal of Cheese Standards for
Danablu, Gruyere, Gudbrandsdalsost, Norvegia, Esrom, certain Blue
Veined Cheeses and Cream Cheese (pending the inclusion in the
Standard for Unripened Cheese Including Fresh 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 reference document is ALINORM 97/17. The Fifteenth Session
of the Committee recommended the following be adopted by the
Commission in June 1997:
Draft Standard for Named Animal Fats at Step 8;
Draft Standard for Edible Fats and Oils Not Covered
by Individual Standards at Step 8;
Draft Revised Code of Practice for the Storage and
Transport of Fats and Oils in Bulk at Step 8;
In addition, the Commission is invited to consider the decision
of the Committee to discontinue work on the revision and revoke the
current Standard for Specified Vegetable Fat products and Specified
Animal and Vegetable Fat products. The Commission is also invited to
consider whether work should proceed in converting the European
Regional Standard for mayonnaise into a world-wide standard.

RESPONSIBLE AGENCY: HHS/FDA
U.S. PARTICIPATION: Yes

Codex Committee on Cocoa Products and Chocolate

The Codex Committee on Cocoa Products and Chocolate held 15
sessions. The last meeting, at which the original program of work
was completed, was held in 1982. The Committee elaborated world-wide
standards for cocoa products and chocolate.

[[Page 28434]]

The Commission in 1991 decided to embark on a program of work to
update and revise all of the standards.
The revisions were to include updating of the sections on food
hygiene and food labeling and removal from the standards of all non-
essential details. The standards, when updated and revised, should
contain only those provisions that are necessary to protect consumer
health and prevent fraud.
Provisions of an advisory nature reflecting quality factors and
criteria typically used in trade to define or describe the quality
of the product are to be removed from the standard. These guidance
provisions are intended to assist users of the Codex standard when
making international purchases and are, therefore, not subject to
formal acceptance by users of the standard.
The Twenty-first Session of the Commission endorsed the
recommendation of the forty-second session of the Executive
Committee to initiate the revision of the Cocoa Products and
Chocolate Standards.
The Swiss Secretariat prepared updated versions of the Standards
and requested government comments in CL 1995/28 CPC. The technical
contents of the standards were not amended and comments were
requested from governments on amendments.
The amended standards for chocolate and chocolate products were
considered at Step 4 by the Sixteenth Session of the Committee,
October 1996. The Committee returned the Proposed Draft Revised
Standard for Chocolate and Chocolate Products to Step 3 for further
consideration.
Proposed Draft Revised Standards for Cocoa Butter, Cocoa (Cacao)
Nib, Cocoa (Cacao) Mass, Cocoa Press Cake and Cocoa Dust (Cocoa
Fines) for use in the manufacture of Cocoa and Chocolate products,
and for Cocoa Powders (Cacaos) and Dry Cocoa-Sugar Mixture will be
considered at the Seventeenth Session of the Committee tentatively
scheduled for the Fall of 1998.

RESPONSIBLE AGENCY: HHS/FDA
U.S. PARTICIPATION: Yes

Codex Committee on Processed Fruits and Vegetables

During its eighteen sessions, the United States-hosted Codex
Committee on Processed Fruits and Vegetables (CCPFV) elaborated 37
standards for various types of processed fruits and vegetables,
including dried products (prunes), canned products (except juices),
and jams and jellies. The most recent session of the CCPFV was held
in 1986, after which the CCPFV adjourned sine die.
In keeping with the Commission's charge to update and revise
Codex standards, the United States Secretariat, with assistance from
the Codex Secretariat in Rome, has prepared proposed draft revised
standards for the 37 standards covered by the CCPFV. These proposed
drafts are for circulation for government comment and consideration
at the nineteenth session on the CCPFV. This next session is
tentatively scheduled for March 1998.
The following Proposed Draft Revised Standards are expected to
be considered at the 19th Session of the Committee at Step 3 of the
Codex process:
Proposed Draft Revised Standard for Canned Tomatoes
Proposed Draft Revised Standard for Canned Peaches
Proposed Draft Revised Standard for Canned
Grapefruit
Proposed Draft Revised Standard for Canned Green
Beans and Wax Beans
Proposed Draft Revised Standard for Canned
Applesauce
Proposed Draft Revised Standard for Canned Sweet
Corn
Proposed Draft Revised Standard for Edible Fungi and
Fungus Products
Proposed Draft Revised Standard for Edible Dried
Fungi
Proposed Draft Revised Standard for Fresh Fungus
``Chanterelle''
Proposed Draft Revised Standard for Canned Pineapple
Proposed Draft Revised Standard for Canned Asparagus
Proposed Draft Revised Standard for Processed Tomato
Concentrates
Proposed Draft Revised Standard for Canned Green
Peas
Proposed Draft Revised Standard for Canned Plums
Proposed Draft Revised Standard for Canned
Raspberries
Proposed Draft Revised Standard for Canned Pears
Proposed Draft Revised Standard for Canned
Strawberries
Proposed Draft Revised Standard for Table Olives
Proposed Draft Revised Standard for Raisins
Proposed Draft Revised Standard for Canned Mandarin
Oranges
Proposed Draft Revised Standard for Canned Fruit
Cocktail
Proposed Draft Revised Standard for Jams (Fruit
Preserves) and Jellies
Proposed Draft Revised Standard for Citrus Marmalade
Proposed Draft Revised Standard for Canned Mature
Processed Peas
Proposed Draft Revised Standard for Canned Tropical
Fruit Salad
Proposed Draft Revised Standard for Pickled
Cucumbers
Proposed Draft Revised Standard for Canned Carrots
Proposed Draft Revised Standard for Canned Apricots
Proposed Draft Revised Standard for Dried Apricots
Proposed Draft Revised Standard for Unshelled
Pistachio Nuts
Proposed Draft Revised Standard for Dates
Proposed Draft Revised Standard for Canned Palmito
Proposed Draft Revised Standard for Canned Chestnuts
and Chestnut Puree
Proposed Draft Revised Standard for Canned Mangoes
Proposed Draft Revised Standard for Mango Chutney
Proposed Draft Revised Standard for Grated
Desiccated Coconut
RESPONSIBLE AGENCY: HHS/FDA, USDA/AMS
U.S. PARTICIPATION: Yes

Certain Codex Commodity Committees

Several Codex Alimentarius Commodity Committees have adjourned
sine die. The following Committees fall into this category:
Cereals, Pulses and Legumes*
Responsible Agency: HHS/FDA, USDA/GIPSA
U.S. Participation: Yes
Edible Ices
Responsible Agency: HHS/FDA
U.S. Participation: Yes
Meat Hygiene*
Responsible Agency: USDA/FSIS
U.S. Participation: Yes
Processed Meat and Poultry Products*
Responsible Agency: USDA/FSIS
U.S. Participation: Yes
Sugars
Responsible Agency: HHS/FDA
U.S. Participation: Yes
Soups and Broths*
Responsible Agency: USDA/FSIS
U.S. Participation: Yes
Vegetable Proteins*
Responsible Agency: HHS/FDA, USDA/ARS
U.S. Participation: Yes
*There is no planned activity for these Committees in the next
year.
A brief report on activities of the Codex Committee on Edible
Ices and the Codex Committee on Sugars follows:

Edible Ices

The Committee on Edible Ices is responsible for elaborating
standards for all types of edible ices, including mixes and powders
used for their manufacture. The Forty-third Session of the Executive
Committee in June 1996 recommended that the Codex Standard for
Edible Ices and Mixed Ices be revoked. It was reported that there
was no need for a standard as there was not a significant
international trade. The Executive Committee further recommended
that the Codex Committee on Edible Ices be abolished. The Twenty-
second Session of the Codex Alimentarius Commission will decide the
issues in June 1997.

RESPONSIBLE Agency: HHS/FDA
U.S. PARTICIPATION: Yes

Sugars

The Codex Committee on Sugars is responsible for elaborating
world-wide standards for all types of sugars and sugar products. The
Committee has been adjourned since 1974. At the direction of the
Codex Alimentarius Commission, the Secretariat of the Host
Government (the United Kingdom) was asked to examine the existing
Codex Standards relating to Sugars and the Codex Standard for Honey.
During the Nineteenth session of the Codex Alimentarius Commission,
the Commission agreed that existing Codex Standards should be
reviewed in order to simplify them. Those documents were revised and
circulated to member governments (see CL 1995/5-S) for comments. The
objective of the revision is to focus the standards only on public
health, food safety, and consumer protection. The Twenty-first
session of the Commission noted that substantial late comments were
received and agreed that further revision of the Draft Standards
should be carried out by

[[Page 28435]]

correspondence. The Secretariat has prepared revised Draft Standards
and circulated them for government comments at Step 6 in document CL
1996/1-S.
To be considered at Step 8:
Draft Revised Standard for Sugar
Draft Revised Standard for Honey

RESPONSIBLE Agency: HHS/FDA
U.S. PARTICIPATION: Yes

Joint U.N.E.C.E. Codex Alimentarius Groups of Experts

Two groups of experts dealt with specific commodities much as
the Codex Commodity Committees do. The Joint Groups of Experts have
completed their main tasks and have adjourned. They could be called
to meet again if the Codex Alimentarius Commission so decides. These
Groups are:
Standardization of Quick Frozen Foods; and
Standardization of Fruit Juices.
There are no standards from either group being considered by the
Twenty-second session of the Commission in June, 1997.

RESPONSIBLE Agency: HHS/FDA
U.S. PARTICIPATION: Yes

Codex Committee for Natural Mineral Waters

The Codex Committee for Natural Mineral Waters (CCNMW) is
responsible for elaborating standards for natural mineral water
products. The following draft standard will be considered by the
Codex Alimentarius Commission at its June meeting. Information about
the standard and new committee work can be found in ALINORM 97/20.
To be considered at Step 8:
Draft Revised Standard for Natural Mineral Waters
In addition, the committee requested approval to initiate
development of a general standard applicable to bottled/packaged
waters other than natural mineral waters.

RESPONSIBLE Agency: HHS/FDA
U.S. PARTICIPATION: Yes

FAO/WHO Regional Coordinating Committees

The Codex Alimentarius Commission is made up of an Executive
Committee, as well as approximately 25 subsidiary bodies. Included
in these subsidiary bodies are several coordinating committees.
There are currently five 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 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
--exercises a general coordinating role for the region and such
other functions as may be entrusted to it by the Commission.

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

The Coordinating Committee is responsible for defining problems
and needs concerning food standards and food control of all Codex
member countries of the regions.
The Fourth Session of the Committee addressed the following
matters of interest to the Commission. Information about their
deliberations can be found in ALINORM 97/32.
Suggested that consideration be given to a further
consultation on risk communication mechanisms and methodologies;
Supported the current alignment of Codex membership
of the region and more active collaboration between Codex and APEC;
and
Agreed to bring concerns regarding the length and
procedures of the Codex Alimentarius Commission and the timely
distribution of Codex documents to the attention of the Executive
Committee.
In addition, the Committee identified main objectives and
priorities related to the identification of Codex Standards and
related texts which have a major impact in the Region and discussed
papers on Dietary Modeling and Guidelines for the Development of
Agreements Regarding Food Import and Export Inspection and
Certification Systems.

AGENCY RESPONSIBLE: USDA/FSIS
U.S. PARTICIPATION: Yes

Appendix 1--US. Codex Alimentarius Officials Steering Committee Members

Mr. Thomas J. Billy, Administrator, Food Safety and Inspection
Service, U.S. Department of Agriculture, Room 331-E, Jamie L.
Whitten Federal Bldg., 1400 Independence Avenue, SW, Washington, DC
20250-3700, Phone: (202) 720-7025, Fax: (202) 205-0158
Mr. Michael V. Dunn, Assistant Secretary, Marketing and Regulatory
Programs, U.S. Department of Agriculture, Room 228-W, Jamie L.
Whitten Federal Bldg., 1400 Independence Avenue, SW, Washington, DC
20250, Phone #: (202) 720-4256, Fax #: (202) 720-5775
Dr. Lynn R. Goldman, Assistant Administrator, Office of Prevention,
Pesticides and Toxic Substances, U.S. Environmental Protection
Agency, 401 M Street, SW (7101), 637 East Tower, Washington, DC
20460, Phone #: (202) 260-2902, Fax #: (202) 260-1847
Ms. Penny Fenner-Crisp, Deputy Director, Office of Pesticide
Programs, U.S. Environmental Protection Agency, 401 M Street, SW,
Washington, DC 20460, Phone #: (202) 260-0947, Fax #: (202) 260-1847
Mr. William Schultz, Deputy Commissioner for Policy, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, Phone #:
(301) 827-3360, Fax #: (301) 594-6777
Dr. Fred R. Shank, Director, Center for Food Safety and Applied
Nutrition (HFS-1), Food and Drug Administration, Room 6815, 200 C
Street, SW, Washington, DC 20204, Phone #: (202) 205-4850, Fax #:
(202) 205-5025
Ms. Linda R. Horton, Director, International Policy, Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, Phone #: (301) 827-3344, Fax #: (301) 443-6906
Mr. August Schumacher, Jr., Administrator, Foreign Agricultural
Service, U.S. Department of Agriculture, Room 5071, South
Agriculture Building, 1400 Independence Avenue, SW, Washington, DC
20250-3700, Phone #: (202) 720-3935, Fax #: (202) 690-2159

Codex Committee Chairpersons

Mr. Steven N. Tanner, Director, Technical Services Division, Grain
Inspection, Packers & Stockyards Administration, U.S. Department of
Agriculture, 10383 N. Executive Hills Blvd., Kansas City, MO 64153-
1394, Phone #: (816) 891-0401, Fax #: (816) 891-0478--Cereals,
Pulses and Legumes (adjourned Sine Die)
Dr. I. Kaye Wachsmuth, Acting Deputy Administrator, Office of Public
Health and Science, Food Safety and Inspection Service, U.S.
Department of Agriculture, Room 341-E, Jamie L. Whitten Federal
Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700,
Phone #: (202) 720-2644, Fax #: (202) 690-2980--Food Hygiene
Mr. James Rodeheaver, Chief, Processed Product Branch, Fruit and
Vegetable Division, Agricultural Marketing Service, U.S. Department
of Agriculture, Room 0709, South Agriculture Building, 1400
Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202)
720-4693, Fax #: (202) 690-1527--Processed Fruits and Vegetables
Dr. Stephen F. Sundlof, Director, Center for Veterinary Drugs in
Foods Medicine, Food and Drug Administration, 7500 Standish Place
(HFV-1), Rockville, MD 20855, Phone #: (301) 594-1740, Fax #: (301)
594-1830--Residues of Veterinary Drugs in Food

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

Codex Committee on Residues of Veterinary Drugs in Foods

(Host Government--United States)

U.S. Delegate--Dr. Robert C. Livingston, Director, Office of New
Animal Drug Evaluation, Center for Veterinary Medicine (HFV-100),
Food and Drug Administration, 7500 Standish Place, Rockville, MD
20855, Phone #: (301) 594-1620, Fax #: (301) 594-2297
Alternate Delegate--Dr. Pat Basu, Director, Chemistry and Toxicology
Division, Office

[[Page 28436]]

of Public Health and Science, Food Safety and Inspection Service,
U.S. Department of Agriculture, 6912 Franklin Court, 1099 14th
Street, NW, Washington, DC 20250-3700, Phone #: (202) 501-7319, Fax:
(202) 501-7639

Codex Committee on Food Additives and Contaminants

(Host Government--The Netherlands)

U.S. Delegate--Dr. Alan Rulis, Director, Office of Premarket
Approval, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 200 C Street, SW, (HFS-200), Washington, DC
20204, Phone #: (202) 418-3100, Fax #: (202) 418-3131
Alternate Delegate--Dr. Terry C. Troxell, Director, Division of
Programs and Enforcement Policy, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C Street, SW, (HFS-
456), Washington, DC 20204, Phone #: (202) 205-5321, Fax #: (202)
205-4422

Codex Committee on Pesticide Residues

(Host Government--The Netherlands)

U.S. Delegate--Dr. Richard Schmitt, Deputy Director, Special Review
and Registration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 1921 Jefferson Davis Highway, Mail
Code (7502C), Room 712, CM-2, Arlington, VA 22204, Phone #: (703)
305-6352, Fax #: (703) 305-5512
Alternate Delegate--Dr. Richard Parry, Jr., Assistant Administrator,
Cooperative Interactions, Agricultural Research Service, U.S.
Department of Agriculture, Room 358-A, Jamie L. Whitten Federal
Bldg., Washington, DC 20250-3700, Phone #: (202) 720-3973, Fax #:
(202) 720-5427

Codex Committee on Methods of Analysis and Sampling

(Host Government--Hungary)

U.S. Delegate--Dr. William Horwitz, Scientific Advisor, Center for
Food Safety and Applied, Nutrition (HFS-500), Food and Drug
Administration, Room 3832, 200 C Street, SW, Washington, DC 20204,
Phone #: (202) 205-4346, Fax #: (202) 401-7740
Alternate Delegate--Mr. William Franks, Director, Science and
Technology Division, Agricultural Marketing Service, U.S. Department
of Agriculture, Room 3507, South Agriculture Building 1400
Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202)
720-5231, Fax #: (202) 720-6496

Codex Committee on Food Import and Export Certification and
Inspection Systems

(Host Government--Australia)

Delegate--Dr. Fred R. Shank, Director, Center for Food Safety and
Applied Nutrition (HFS-1), Food and Drug Administration, Room 6815,
200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-4850,Fax
#: (202) 205-5025
Alternate Delegate--Mr. Mark Manis, Director, International Policy
Development Division, Office of Policy, Program Development, and
Evaluation, Food Safety and Inspection Service, U.S. Department of
Agriculture, Room 4434, South Agriculture Building, 1400
Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202)
720-6400, Fax #: (202) 720-7990

Codex Committee on General Principles

(Host Government--France)

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

Codex Committee on Food Labelling

(Host Government--Canada)

Delegate--Dr. F. Edward Scarbrough, Director, Office of Food
Labeling Center for Food Safety and Applied Nutrition (HFS-150),
Food and Drug Administration, 200 C Street, SW, Room 1832,
Washington, DC 20204, Phone #: (202) 205-4561, Fax #: (202) 205-4594
Alternate Delegate--Mr. Robert Post, Deputy Director, Facilities,
Equipment, Labeling & Compounds Review Division, Office of Policy,
Program Development, and Evaluation, Food Safety and Inspection
Service, U.S. Department of Agriculture, West End Court Building,
Room 327, Washington, DC 20250-3700, Phone #: (202) 418-8900, Fax #:
(202) 418-8834

Codex Committee on Food Hygiene

(Host Government--United States)

Acting Delegate--Mr. E. Spencer Garrett, Director, National Seafood
Inspection Laboratory, National Marine Fisheries, 705 Convent
Street, Pascagoulla, MS 39568-1207, Phone #: (601) 769-8964, Fax #:
(601) 762-7144
Alternate Delegate--VACANT

Worldwide Commodity Codex Committees

Codex Committee on Fresh Fruits and Vegetables

(Host Government--Mexico)

Delegate--Mr. David Priester, International Standards Coordinator,
FPB, Fruit & Vegetable Division, Agricultural Marketing Service,
U.S. Department of Agriculture, Room 2069, South Agriculture
Building, 1400 Independence Avenue, SW, Washington, DC 20250-3700,
Phone #: (202) 720-2184, Fax #: (202) 720-0016
Alternate Delegate--Mr. Larry B. Lace, Branch Chief, Fresh Products
Branch, Fruits and Vegetables Division, Agricultural Marketing
Service, U.S. Department of Agriculture, Room 2049, South
Agriculture Building, 1400 Independence Avenue, SW, Washington, DC
20250-3700, Phone #: (202) 720-5870, Fax #: (202) 720-0393

Codex Committee on Nutrition and Foods for Special Dietary Uses

(Host Government--Germany)

Delegate--Dr. Elizabeth Yetley, Acting Director, Office of Special
Nutritionals, Center for Food Safety and Applied Nutrition, FDA, 200
C Street, SW (HFS-450), Washington, DC 20204, Phone #: (202) 205-
4168, Fax #: (202) 205-5295
Alternate Delegate--Dr. Robert J. Moore, Senior Regulatory
Scientist, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 200 C Street, SW (HFS-456), Washington, DC
20204, Phone #: (202) 205-4605, Fax #: (202) 260-8957

Codex Committee on Fish and Fishery Products

(Host Government--Norway)

Delegate--Mr. Philip C. Spiller, Director, Office of Seafood (HFS-
400) VERB, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 200 C Street, SW, Washington, DC 20204, Phone
#: (202) 418-3133, Fax #: (202) 418-3198
Alternate Delegate--Mr. Samuel W. McKeen, Director, Office of Trade
and Industry Services, National Oceanic and Atmospheric
Administration, NMFS, 1335 East-West Highway, Room 6490, Silver
Spring, MD 20910, Phone #: (301) 713-2351, Fax #: (301) 713-1081

Codex Committee on Cereals, Pulses and Legumes

(Host Government--United States)

Delegate--Mr. Charles W. Cooper, Director, International Activities
Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-
585), Food and Drug Administration, 200 C Street, SW, Washington, DC
20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739
Alternate Delegate--Mr. David Shipman, Deputy Administrator, Grain
Inspection Packers and Stockyards Administration, U.S. Department of
Agriculture, Room 1092, South Agriculture Building, 1400
Independence Avenue, SW, Washington, DC 20250-3700, Phone #: (202)
720-9170, Fax #: (202) 720-1015

Codex Committee on Milk and Milk Products

(Host Government--New Zealand)

Delegate--Mr. Duane Spomer, Chief, Dairy Standardization Branch,
U.S. Department of Agriculture, Agricultural Marketing Service, Room
2750, South Agriculture Building, 1400 Independence Avenue, SW,
Washington, DC 20250-3700, Phone #: (202) 720-9382, Fax #: (202)
720-2643
Alternate Delegate--Dr. John C. Mowbray, Division of Programs and
Enforcement Policy, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C Street, SW, (HFS-306),
Washington, DC 20204, Phone #: (202) 205-1731, Fax #: (202) 205-4422

Codex Committee on Fats and Oils

(Host Government--United Kingdom)

Delegate--Mr. Charles W. Cooper, Director, International Activities,
Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-
585), Food and Drug Administration, 200 C Street, SW, Washington, DC
20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739
Alternate Delegate--Dr. Dwayne Buxton, National Program Leader for
Oilseeds and Bioscience, Agricultural Research Service, Room 212,
Bldg. 005, BARC West, Beltsville, MD 20705, Phone #: (301) 504-5321,
Fax #: (301) 504-5467

[[Page 28437]]

Codex Committee on Processed Fruits and Vegetables

(Host Government--United States)

U.S. Delegate--Mr. Richard B. Boyd, Senior Marketing Specialist,
Fruit and Vegetable Division, Agricultural Marketing Service, U.S.
Department of Agriculture, Room 0717, South Agriculture Building,
1400 Independence Avenue, SW, Washington, DC 20250-3700, Phone #:
(202) 720-5021, Fax #: (202) 690-1527
Alternate Delegate--Mr. Charles W. Cooper, Director, International
Activities Staff, Center for Food Safety and Applied Nutrition, Room
5823 (HFS-585), Food and Drug Administration, 200 C Street, SW,
Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739

Worldwide Commodity Codex Committees

Codex Committee on Cocoa Products and Chocolate

(Host Government--Switzerland)

Delegate--Mr. Charles W. Cooper, Director, International Activities
Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-
585), Food and Drug Administration, 200 C Street, SW, Washington, DC
20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739
Alternate Delegate--Dr. Michelle Smith, Food Technologist, Office of
Food Labeling, Center for Food Safety and Applied Nutrition (HFS-
158), 200 C Street, SW, Washington, DC 20204, Phone #: (202) 205-
5099, Fax #: (202) 205-4594

Codex Committee on Sugars

(Host Government--United Kingdom)

Delegate--Dr. Thomas J. Army, Area Director, Mid-South Area, USDA/
Agricultural Research Center, P.O. Box 225, Stoneville, MS 38776-
0225, Phone #: (601) 686-5265, Fax #: (601) 626-5259
Alternate Delegate--Dr. Dennis M. Keefe, Office of Premarket
Approval, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 200 C Street, SW (HFS-206), Washington, DC
20204, Phone #: (202) 418-3113, Fax #: (202) 418-3131

Codex Committee on Edible Ices \1\

(Host Government--Sweden)

Delegate--Mr. Charles W. Cooper, Director, International Activities
Staff, Center for Food Safety and Applied Nutrition, Room 5823 (HFS-
585), Food and Drug Administration 200 C Street, SW, Washington, DC
20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739
Alternate Delegate--VACANT

Codex Committee on Soups and Broths \1\

(Host Government--Switzerland)

Delegate--Mr. Charles Edwards, Director, Facilities, Equipment,
Labeling & Compounds Review Division, Office of Policy, Program
Development, and Evaluation, Food Safety and Inspection Service,
U.S. Department of Agriculture, West End Court Building, Room 329,
1255 22nd Street, NW, Washington, DC 20250-3700, Phone #: (202) 418-
8900, Fax #: (202) 418-8834
Alternate Delegate--Mr. Robert Post, Deputy Director, Facilities,
Equipment, Labeling & Compounds Review Division, Office of Policy,
Program Development, and Evaluation, Food Safety and Inspection
Service, U.S. Department of Agriculture, West End Court Building,
Room 327, Washington, DC 20250-3700, Phone #: (202) 418-8900, Fax #:
(202) 418-8834

Codex Committee on Vegetable Proteins \1\

(Host Government--Canada)

U.S. Delegate--Dr. Wilda H. Martinez, Associate Deputy
Administrator, Aqua Products and Human Nutrition Sciences, U.S.
Department of Agriculture, Agricultural Research Service, Room 107,
B-005, Beltsville, MD 20705, Phone #: (301) 504-6275, Fax #: (301)
504-6699
Alternate Delegate--Ms. Elizabeth J. Campbell, Director, Division of
Programs and Enforcement Policy, Center for Food Safety and Applied
Nutrition (HFS-155), Food and Drug Administration, 200 C Street, SW,
Washington, DC 20204, Phone #: (202) 205-5229, Fax #: (202) 205-4594

Codex Committee on Meat Hygiene \1\

(Host Government--New Zealand)

Delegate--Dr. John Prucha, Assistant Deputy Administrator,
International and Domestic Policy, Food Safety and Inspection
Service, U.S. Department of Agriculture, Room 350-E, Jamie L.
Whitten Federal Bldg., Washington, DC 20250-3700, Phone #: (202)
720-3473, Fax #: (202) 690-3856
Alternate Delegate--Dr. Richard Mikita, Special Assistant,
International Activities, Food Safety and Inspection Service, U.S.
Department of Agriculture, Room 344-E, Jamie L. Whitten Federal
Bldg., Washington, DC 20250-3700, Phone #: (202) 720-0290, Fax #:
(202) 690-0766

Codex Committee on Processed Meat and Poultry Products \1\

(Host Government--Denmark)

U.S. Delegate--Mr. Daniel Engeljohn, Branch Chief, Standards
Development Branch, Inspection Methods Development Division, Office
of Policy, Program Development, and Evaluation, Food Safety and
Inspection Service, U.S. Department of Agriculture, Room 405, Cotton
Annex, 300 12th Street, SW., Washington, DC 20250-3700, Phone #:
(202) 205-0210, Fax #: (202) 205-0080
Alternate Delegate--Mr. Charles Edwards, Director, Facilities,
Equipment, Labeling & Compounds Review Division, Office of Policy,
Program Development, and Evaluation, Food Safety and Inspection
Service, U.S. Department of Agriculture, West End Court Building,
Room 329, 1255 22nd Street, NW., Washington, DC 20250-3700, Phone #:
(202) 418-8900, Fax #: (202) 418-8834

Codex Committee on Natural Mineral Waters

(Host Government--Switzerland)

U.S. Delegate--Dr. Terry C. Troxell, Director, Division of Programs
and Enforcement Policy, Center for Food Safety & Applied Nutrition
(HFS-305), Food and Drug Administration, 200 C Street, SW.,
Washington, DC 20204, Phone #: (202) 205-5321, Fax #: (202) 205-4422
Alternate Delegate--Ms. Shellee A. Davis, Division of Programs and
Enforcement Policy, Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 200 C Street, SW (HFS-306),
Washington, DC 20204, Phone #: (202) 205-4681, Fax #: (202) 205-4422

Joint U.N.E.C.E. Codex Alimentarius Groups of Experts

Joint ECE/Codex Alimentarius Group of Experts on Standardization of
Quick Frozen Foods \1\

U.S. Delegate--Mr. Richard B. Boyd, Senior Marketing Specialist,
Fruit and Vegetable Division, Agricultural Marketing Service, U.S.
Department of Agriculture, Room 0717, South Agriculture Building,
1400 Independence Avenue, SW., Washington, DC 20250-3700, Phone #:
(202) 720-5021, Fax #: (202) 690-1527
Alternate Delegate--Mr. Charles W. Cooper, Director, International
Activities Staff, Center for Food Safety and Applied Nutrition, Room
5823 (HFS-585), Food and Drug Administration, 200 C Street, SW.,
Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202) 401-7739

Joint ECE/Codex Alimentarius Group of Experts on Standardization of
Fruit Juices \1\

U.S. Delegate--Mr. Charles W. Cooper, Director, International
Activities, Staff, Center for Food Safety and Applied Nutrition,
Room 5823 (HFS-585), Food and Drug Administration, 200 C Street,
SW., Washington, DC 20204, Phone #: (202) 205-5042, Fax #: (202)
401-7739
Alternate Delegate--Mr. Richard B. Boyd, Senior Marketing
Specialist, Fruit and Vegetable Division, Agricultural Marketing
Service, U.S. Department of Agriculture, Room 0717, Agriculture
South Building, 1400 Independence Avenue, SW., Washington, DC 20250-
3700, Phone #: (202) 720-5021, Fax #: (202) 690-1527

Subsidiary Bodies of the Codex Alimentarius

There are five regional coordinating committees:

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

Contact--Ms. Rhonda Bond, Executive Officer for Codex Alimentarius,
Food Safety and Inspection Service, U.S. Department of Agriculture,
West End Court, Room 311, 1255 22nd Street, NW., Washington, DC
20250-3700, Phone #: (202) 418-8841, Fax #: (202) 418-8865.

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

[[Page 28438]]

Appendix 2.--Timetable of Codex Sessions
[June 1996 through June 1998]
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
1996:
CX 702-43 Executive Committee of 4-7 June............................... Geneva.
the Codex Alimentarius
Commission (43rd Session).
CX 708-16 Codex Committee on 30 Sept.-2 Oct......................... Thun, Switzerland.
Cocoa Products and Chocolate
(16th Session).
CX 719-5 Codex Committee on 3-5 October............................ Thun, Switzerland.
Natural Mineral Waters (5th
Session).
CX 707-12 Codex Regional TBA.................................... Harare.
Coordinating Committee for
Africa (12th Session).
CX 720-2 Codex Committee on 7-11 October........................... Bonn Bad-Godesberg.
Nutrition and Food for Special
Dietary Uses (20th Session).
CX-712-29 Codex Committee on 21-25 October.......................... Washington, DC.
Food Hygiene (29th Session).
CX-730-10 Codex Committee on 20 October-1 November.................. San Jose, Costa Rica.
Residues of Veterinary Drugs in
Foods (10th Session).
CX-709-11 Codex Committee on 4-8 November........................... London.
Fats and Oils (15th Session).
CX-716-12 Codex Committee on 25-28 November......................... Paris.
General Principles Principles
(12th Session).
1997:
CX 713-19 Codex Committee on 3-7 February........................... Washington, DC.
Processed Fruits and Vegetables
(19th Session).
CX 733-5 Codex Committee on Food 17-21 February......................... Sydney.
Import and Export Inspection and
Certification Systems (5th
Session).
CX 725-10 Codex Regional 25-28 February......................... Montevideo.
Coordinating Committee for Latin
America and the Caribbean (10th
Session).
CX 715-21 Codex Committee on 10-14 March............................ Budapest.
Methods of Analysis and Sampling
(21st Session).
CX 711-29 Codex Committee on 17-21 March............................ The Hague.
Food Additives and Contaminants
(29th Session).
CX 718-29 Codex Committee on 7-12 April............................. The Hague.
Pesticide Residues (29th
Session).
CX 714-25 Codex Committee on 15-18 April............................ Ottawa.
Food Labelling (25th Session).
CX 702-44 Executive Committee of 19-20 June............................. Geneva.
the Codex Alimentarius
Commission (44th Session).
CX 701-22 CODEX ALIMENTARIUS 23-28 June............................. Geneva.
COMMISSION (44th Session).
CX 731-7 Codex Committee on 8-12 September......................... Mexico City.
Fresh Fruits and Vegetables (7th
Session).
CX 712-30 Codex Committee on 20-24 October.......................... Washington, DC.
Food Hygiene (30th Session).
CX 727-11 Codex Regional 16-19 December......................... Chiang Rai.
Coordinating Committee for Asia
(11th Session).
1998:
CX 711-30 Codex Committee on 9-13 March............................. The Hague.
Food Additives and Contaminants
(30th Session).
CX 733-6 Codex Committee on Food 16-21 March............................ TBA.
Import and Export Certification
and Inspection (6th Session).
CX 713-20 Codex Committee on 16-20 March............................ Washington, DC.
Processed Fruits and Vegetables
(19th Session).
CX 722-23 Codex Committee on 30-3 April............................. Bergen.
Fish and Fishery Products (23rd
Session).
CX 718-30 Codex Committee on 20-25 April............................ The Hague.
Pesticide Residues (30th
Session).
CX-730-11 Codex Committee on 27 April-1 May......................... Washington, DC.
Residues of Veterinary Drugs in
Foods (11th Session).
CX 719-21 Codex Regional 5-8 May................................ TBA.
Coordinating Committee for
Europe (21st Session).
CX 714-26 Codex Committee on May-98-May-98.......................... Ottawa.
Food Labelling (26th Session).
CX 703-3 Codex Committee on Milk 25-29 May.............................. TBA.
and Milk Products (3rd Session).
CX 702-45 Executive Committee of 3-5 June............................... Rome.
the Codex Alimentarius
Commission (45th Session).
----------------------------------------------------------------------------------------------------------------

Appendix 3--Definitions for the Purpose of Codex Alimentarius

Words and phrases have specific meanings when used by the Codex
Alimentarius. For the purposes of Codex, the following definitions
apply:
1. Food means any substance, whether processed, semi-processed
or raw, which is intended for human consumption, and includes drink,
chewing gum, and any substance which has been used in the
manufacture, preparation or treatment of ``food'' but does not
include cosmetics or tobacco or substances used only as drugs.
2. Food hygiene comprises conditions and measures necessary for
the production, processing, storage and distribution of food
designed to ensure a safe, sound, wholesome product fit for human
consumption.
3. Food additive means any substance not normally consumed as a
food by itself and not normally used as a typical ingredient of the
food, whether or not it has nutritive value, the intentional
addition of which to food for a technological (including
organoleptic) purpose in the manufacture, processing, preparation,
treatment, packing, packaging, transport, or holding of such food
results, or may be reasonably expected to result, (directly or
indirectly) in it or its by-products becoming a component of or
otherwise affecting the characteristics of such foods. The food
additive term does not include ``contaminants'' or substances added
to food for maintaining or improving nutritional qualities.
4. Contaminant means any substance not intentionally added to
food, which is present in such food as a result of the production
(including operations carried out in crop husbandry, animal
husbandry, and veterinary medicine), manufacture, processing,
preparation, treatment, packing, packaging, transport or holding of
such food or as a result of environmental contamination. The term
does not include insect fragments, rodent hairs and other extraneous
matters.
5. Pesticide means any substance intended for preventing,
destroying, attracting, repelling, or controlling any pest including
unwanted species of plants or animals during the production,
storage, transport, distribution and processing of food,
agricultural commodities, or animal feeds or which may be
administered to animals for the control of ectoparasites. The term
includes substances intended for use as a plant-growth regulator,
defoliant, desiccant, fruit thinning agent, or sprouting inhibitor
and substances applied to crops either before of after harvest to
protect the commodity from deterioration during storage and
transport. The term pesticides excludes fertilizers, plant and
animal nutrients, food additives, and animal drugs.
6. Pesticide residue means any specified substance in food,
agricultural commodities, or animal feed resulting from the use of a
pesticide. The term includes any derivatives of a pesticide, such as
conversion products, metabolites, reaction products, and impurities
considered to be of toxological significance.
7. Good Agricultural Practice in the Use of Pesticides (GAP)
includes the nationally authorized safe uses of pesticides under
actual conditions necessary for effective and reliable pest control.
It encompasses a range of levels of pesticide applications up to the
highest authorized use, applied in a manner

[[Page 28439]]

which 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 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.

Appendix 4--Uniform Procedure for the Elaboration of Codex Standards
and Related Texts

Part 1

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 ¹
---------------------------------------------------------------------------

\1\ Without prejudice to any decision that may be taken by the
Commission at Step 5, the proposed draft standard may be sent by the
Secretariat for government comment prior to its consideration at
Step 5, when, in the opinion of the subsidiary body or other body
concerned, the time between the relevant session of the Commission
and the subsequent session of the subsidiary or other body concerned
requires such actions in order to advance the work.
---------------------------------------------------------------------------

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.

[[Page 28440]]

Appendix 4--Uniform Accelerated Procedure for the Elaboration of Codex
Standards and Related Texts

Part 2

Steps 1, 2 and 3

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

Step 4

The comments received are sent by the Secretariat to the
subsidiary body or other body concerned which has the power to
consider such comments and to amend the proposed draft standard.

Step 5

In the case of standards identified as being subject to an
accelerated elaboration procedure, the draft standard is submitted
through the Secretariat to the Commission together with any written
proposals received from Members and interested international
organizations for amendments with a view to its adoption as a Codex
standard. In taking any decision at this step, the Commission will
give due consideration to any comments that may be submitted by any
of its Members regarding the implications which the proposed draft
standard or any provisions thereof may have for their economic
interests.

Appendix 5--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 which 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 pages 93 to
96 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 on pages 96 to 98 of 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

[[Page 28441]]

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

Labelling

This section should include all the labelling provisions
contained in the standard and should be prepared in accordance with
the guidance given on pages 91 to 93 of 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 on
pages 99 to 102 of 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
alternative 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. 97-13410 Filed 5-22-97; 8:45 am]
BILLING CODE 3410-DM-P

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Document Information

Published:: 05/23/1997
Department:: Food Safety and Inspection Service
Entry Type:: Notice
Action:: Notice.
Document Number:: 97-13410
Pages:: 28416-28441 (26 pages)
Docket Numbers:: Docket No. 97-026N
PDF File:: 97-13410.pdf