International Standard-Setting Activities

Federal RegisterJun 4, 1996

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 96-018N]

International Standard-Setting Activities

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: This notice informs the public of the sanitary and

phytosanitary standard-setting activities of the Codex Alimentarius

Commission (Codex), in accordance with section 491 of the Trade

Agreements Act of 1979, as amended 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, 1995, to May 31, 1996,

and May 31, 1996, to June 1, 1997.

ADDRESSES: Submit written comments to: FSIS Docket Clerk, U.S.

Department of Agriculture, Food Safety and Inspection Service, Room

4352, South Agriculture Building, 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 in response to the

standard-setting activities of Codex will be available for public

inspection in the Docket Clerk's Office between 8:30 a.m. and 1 p.m.,

and 2 p.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Joan Mondschein, Confidential

Assistant to the Administrator, U.S. Department of Agriculture, Food

Safety and Inspection Service, Room 1763, South Agriculture Building,

14th & Independence Avenue, SW., Washington, DC 20250-3700; (202) 720-

7323. 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

[[Page 28133]]

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 is delegating to the Under Secretary for Food Safety the

responsibility to inform the public of the SPS standard-setting

activities of Codex. The Acting Under Secretary for Food Safety has, in

turn, assigned the responsibility for informing the public to the

Office of U.S. Codex Alimentarius in the Food Safety and Inspection

Service (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 be

publishing a 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;

c. The agenda for United States participation, if any; and

d. The agency responsible for representing the United States with

respect to the standard.

TO OBTAIN COPIES OF THOSE STANDARDS LISTED IN 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 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, 1995 to June 1, 1997. 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 1995 through June 1997)

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

Appendix 6. Provisional Agenda of the Joint FAO/WHO Food Standards

Program, Executive Committee of Codex Alimentarius Commission, 43rd

Session. Geneva, Switzerland--June, 1996

Appendix 7. List of Standards and Related Texts Adopted by the 21st

Session of the Codex Alimentarius Commission, July, 1995

Done at Washington, DC.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

Codex Committee on Residues of Veterinary Drugs in Foods

The Codex Committee on Residues of Veterinary Drugs in Foods was

established in 1986. The Committee 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 and analytical

methods are available.

[[Page 28134]]

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Status of US participation/

Codex committee Standard consideration agenda Responsible agency

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

Residues of Veterinary Drugs in Levamisole........ MRL under Yes................ HHS/FDA

Foods (to be considered at consideration at

twenty-second Session of the step 8.

Codex Alimentarius Commission)

(CAC) Ref. Alinorm 97/31.

Triclabendazole... MRLs under Yes................ HHS/FDA

consideration at

step 8.

Carazolol......... MRLs under Yes................ HHS/FDA

consideration at

step 5.

Ceftiofur sodium.. MRLs under Yes................ HHS/FDA

consideration at

step 5.

Bovine MRL under Yes................ HHS/FDA

Somatotropin. consideration at

step 8.

Doramectin........ MRLs under Yes................ HHS/FDA

consideration at

step 5.

Moxidectin........ MRLs under Yes................ HHS/FDA

consideration at

step 5.

Residues of Veterinary Drugs in Spiramycin........ MRLs under Yes................ HHS/FDA

Foods (to be considered at consideration at

twenty-second Session of the step 5.

Codex Alimentarius Commission)

(CAC) Ref. Alinorm 97/31.

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* 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).

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 is

tentatively scheduled for March 17-21, 1997, in the Hague, The

Netherlands.

The following matters are contained in Alinorm 97/12 and are under

consideration by the CCFAC:

Proposed Draft General Standard for Food Additives, Annex

A (Guidelines for the Estimation of Appropriate Levels of Use of Food

Additives) for adoption at Step 5;

Note: The draft standard is being developed in stages according

to food additive functional classes, beginning with antioxidants and

preservatives, and stabilizers, thickeners, and sweeteners; see

attached list.

Specifications \1\ for carmines, curcumin, nitrogen,

phosphoric acid, polydextrose, potassium bromate, potassium nitrate,

potassium nitrite, sodium nitrate, and sodium nitrite will be

recommended by CCFAC to the Twenty-second Session of the Codex

Commission for adoption;

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\1\ Not in Step Procedure.

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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 22nd Session of the

Commission at Step 8;

Proposed Draft General Standard for Contaminants and

Toxicants in Food, Annexes IV (see attached list) and V (Food

Categorisation System to be used in the GSC) to be forwarded to the

43rd Session of the Executive Committee for adoption at Step 5;

Position paper on aflatoxins at Step 1;

Draft Maximum Level for Aflatoxin M1 in Milk at Step 7;

Draft Codex Guideline Levels and Sampling Plans for Total

Aflatoxins in Peanuts at Step 6;

Proposed Draft Code of Practice for the Reduction of

Aflatoxins in Raw Materials and Supplementary Feeding stuffs for Milk-

Producing Animals at Step 5;

Position Paper on Ochratoxins at Step 3;

Proposed Draft Standard for Lead at Step 3; and

Draft Guideline Levels for Cadmium and Lead in Cereals,

Pulses and Legumes at Step 6.

Agency Responsible: HHS/FDA.

U.S. Participation: Yes.

Food Additives and Contaminants

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 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. The draft GSFA, which is being developed in stages,

currently covers only those JECFA-reviewed food additives that are used

as antioxidants, preservatives, stabilizers, thickeners, and

sweeteners. These JECFA-reviewed food additives are listed in the table

below.

[[Page 28135]]

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Status of U.S. participation/ Responsible

Codex committee Substance consideration agenda agency

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

(Food Additives and Acetic Acid...... Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A. 4.

Anoxomer......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Ascorbic Acid.... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Ascorbyl Maximum Levels Under Yes............... HHS/FDA

Palmitate. Consideration at Step

4.

Ascorbyl Stearate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Benzoic Acid..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Benzoyl Peroxide. Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A. 4.

Acetylated Maximum Levels Under Yes............... HHS/FDA

Distarch Consideration at Step

Phosphate. 4.

Acetylated Starch Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Acid Treated Maximum Levels Under Yes............... HHS/FDA

Starch. Consideration at Step

4.

Agar............. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Alitame.......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Alkaline Treated Maximum Levels Under Yes............... HHS/FDA

Starch. Consideration at Step

4.

Aluminum Ammonium Maximum Levels Under Yes............... HHS/FDA

Sulphate. Consideration at Step

4.

Ammonium Alginate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Amylose and Maximum Levels Under Yes............... HHS/FDA

Amylopectin. Consideration at Step

4.

Arabinogalactan.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Aspartame........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Baker's Yeast Maximum Levels Under Yes............... HHS/FDA

Glycan. Consideration at Step

4.

Bentonite........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Bleached Starch.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Brominated Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Vegetable Oil. Consideration at Step

12A. 4.

Calcium Acetate.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Butylated Maximum Levels Under Yes............... HHS/FDA

Hydroxyanisole. Consideration at Step

4.

Butylated Maximum Levels Under Yes............... HHS/FDA

Hydroxytoluene. Consideration at Step

4.

Calcium Ascorbate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Benzoate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Disodium Maximum Levels Under Yes............... HHS/FDA

Ethylenediaminet Consideration at Step

etr acetate. 4.

Calcium Hydrogen Maximum Levels Under Yes............... HHS/FDA

Sulphite. Consideration at Step

4.

Calcium Maximum Levels Under Yes............... HHS/FDA

Propionate. Consideration at Step

4.

Calcium Alginate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Chloride. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Disodium Maximum Levels Under Yes............... HHS/FDA

EDTA. Consideration at Step

4.

Calcium Gluconate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Hydroxide Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

[[Page 28136]]

Calcium Lactate.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Calcium Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Polyphosphate. Consideration at Step

12A. 4.

Calcium Stearate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Sulphate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Dioxide.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Carbonates....... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Carob Bean Gum... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Carrageenan and Maximum Levels Under Yes............... HHS/FDA

Salts of Consideration at Step

Carrageenan. 4.

Carrageenan and Maximum Levels Under Yes............... HHS/FDA

its Salts with Consideration at Step

Polysorbate 80. 4.

Carrageenan Maximum Levels Under Yes............... HHS/FDA

(Including Consideration at Step

Furcelleran). 4.

Catalase, Maximum Levels Under Yes............... HHS/FDA

Aspergillus Consideration at Step

niger. 4.

Calcium Sorbate.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Calcium Sulphite. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Citric Acid...... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Dilauryl Maximum Levels Under Yes............... HHS/FDA

Thiodipropionate. Consideration at Step

4.

(Food Additives and Dimethyl Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Dicarbonate. Consideration at Step

12A. 4.

Diphenyl......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Disodium Maximum Levels Under Yes............... HHS/FDA

Ethylenediaminet Consideration at Step

etr acetate. 4.

Catalase, Bovine Maximum Levels Under Yes............... HHS/FDA

Liver. Consideration at Step

4.

Cellulase, Maximum Levels Under Yes............... HHS/FDA

Aspergillus Consideration at Step

niger. 4.

Celluloses, Maximum Levels Under Yes............... HHS/FDA

Modified. Consideration at Step

4.

Chymosin, Maximum Levels Under Yes............... HHS/FDA

Aspergillus Consideration at Step

awamori. 4.

Chymosin, Maximum Levels Under Yes............... HHS/FDA

Escherichia coli Consideration at Step

K-12. 4.

Chymosin, Maximum Levels Under Yes............... HHS/FDA

Kluveromyces Consideration at Step

marxianus v. 4.

Lactis.

Citrates......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Citric and Fatty Maximum Levels Under Yes............... HHS/FDA

Acids Esters of Consideration at Step

Glycerol. 4.

Cyclamates....... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Dextrins, White Maximum Levels Under Yes............... HHS/FDA

and Yellow, Consideration at Step

Roasted Starch. 4.

Dicalcium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Dioctyl Sodium Maximum Levels Under Yes............... HHS/FDA

Sulfosuccinate. Consideration at Step

4.

(Food Additives and Disptassium Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Diphoshate. Consideration at Step

12A. 4.

Dipotassium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Dipotassium Maximum Levels Under Yes............... HHS/FDA

Tartrate. Consideration at Step

4.

[[Page 28137]]

Disodium Maximum Levels Under Yes............... HHS/FDA

Diphosphate. Consideration at Step

4.

Disodium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Disodium Tartrate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Distarch Glycerol Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Distarch Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Edible Gelatin... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Enzyme Treated Maximum Levels Under Yes............... HHS/FDA

Starches. Consideration at Step

4.

Ethyl Maltol..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Ethylene Oxide Maximum Levels Under Yes............... HHS/FDA

Polymer. Consideration at Step

4.

Dodecyl Gallate.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Erthorbic Acid... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

p-Hydroxybenzoate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Formic Acid...... Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A. 4.

Glucose Oxidase Maximum Levels Under Yes............... HHS/FDA

from Aspergillus Consideration at Step

niger. 4.

Guaiac Resin..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Hexamethylene Maximum Levels Under Yes............... HHS/FDA

Tetramine. Consideration at Step

4.

Isopropyl Maximum Levels Under Yes............... HHS/FDA

Citrates. Consideration at Step

4.

Ethylene Oxide- Maximum Levels Under Yes............... HHS/FDA

Propylene Oxide Consideration at Step

Copolymer. 4.

Ferrous Sulphate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Fumaric Acid..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Furcelleran and Maximum Levels Under Yes............... HHS/FDA

Salts of Consideration at Step

Furcelleran. 4.

Gellan Gum....... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Glucose Oxidase, Maximum Levels Under Yes............... HHS/FDA

Aspergillus Consideration at Step

niger. 4.

Glycerol......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Glycerol Esters Maximum Levels Under Yes............... HHS/FDA

of Wood Rosin. Consideration at Step

4.

Glycine.......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Guar Gum......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Gum Arabic....... Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A. 4.

Gum Ghatti....... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Hydroxypropyl Maximum Levels Under Yes............... HHS/FDA

Distarch Adipate. Consideration at Step

4.

Hydroxypropyl Maximum Levels Under Yes............... HHS/FDA

Distarch Consideration at Step

Glycerol. 4.

Hydroxyproyl Maximum Levels Under Yes............... HHS/FDA

Distarch Consideration at Step

Phosphate. 4.

Hyroxypropyl Maximum Levels Under Yes............... HHS/FDA

Starch. Consideration at Step

4.

Insoluble Maximum Levels Under Yes............... HHS/FDA

Polyvinylpyrroli Consideration at Step

done. 4.

[[Page 28138]]

Invertase........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Isomalt.......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Karaya Gum....... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Konjac Flour..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Lactic Acid...... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Lactic and Fatty Maximum Levels Under Yes............... HHS/FDA

Acid Esters of Consideration at Step

Glycerol. 4.

Lactitol......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Lecithin......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

(Food Additives and Lysozyme......... Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A. 4.

Magnesium Maximum Levels Under Yes............... HHS/FDA

Hydroxide. Consideration at Step

4.

Maltitol......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Maltol........... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Malto-Lacto Maximum Levels Under Yes............... HHS/FDA

Bacteria, Consideration at Step

Leuconostoc 4.

oenos.

Mannitol......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Metatartaric Acid Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Microcystalline Maximum Levels Under Yes............... HHS/FDA

Cellulose. Consideration at Step

4.

Microparticulated Maximum Levels Under Yes............... HHS/FDA

Protein Produce. Consideration at Step

4.

Monocalcium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Lysozyme......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

methyl p- Maximum Levels Under Yes............... HHS/FDA

Hydroxybenzoate. Consideration at Step

4.

Nisin............ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Octyl Gallate.... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Ortho- Maximum Levels Under Yes............... HHS/FDA

Phenylphenol. Consideration at Step

4.

(Food Additives and Pectins (Amidated Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ and non- Consideration at Step

12A. Amidated). 4.

Peptone.......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Phosphated Maximum Levels Under Yes............... HHS/FDA

Distarch Consideration at Step

Phosphate. 4.

Phosphatidic Maximum Levels Under Yes............... HHS/FDA

Acid, Ammonium Consideration at Step

Salt. 4.

Polydextrose..... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Polyethuylene Maximum Levels Under Yes............... HHS/FDA

Glycol. Consideration at Step

4.

Polyglycerol Maximum Levels Under Yes............... HHS/FDA

Esters of Fatty Consideration at Step

Acids. 4.

Polyglycerol Maximum Levels Under Yes............... HHS/FDA

Esters of Consideration at Step

Interesterified 4.

Ricinoleic Acid.

Polyoxyethylene Maximum Levels Under Yes............... HHS/FDA

(8) Stearate. Consideration at Step

4.

Polysorbates 20, Maximum Levels Under Yes............... HHS/FDA

40, 60, 65, and Consideration at Step

80. 4.

Polyvinylpyrrolid Maximum Levels Under Yes............... HHS/FDA

one. Consideration at Step

4.

Potassium Acetate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

[[Page 28139]]

Potassium Maximum Levels Under Yes............... HHS/FDA

Alginate. Consideration at Step

4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Caseinate. Consideration at Step

4.

(Food Additives and Potassium Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Chloride. Consideration at Step

12A. 4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Hydroxide. Consideration at Step

4.

Potassium Lactate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Polyphosphate. Consideration at Step

4.

Potassium Sorbate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Powdered Maximum Levels Under Yes............... HHS/FDA

Cellulose. Consideration at Step

4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Ascorbate. Consideration at Step

4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Benzoate. Consideration at Step

4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Hydrogen Consideration at Step

Sulphite. 4.

Potassium Maximum Levels Under Yes............... HHS/FDA

Metabisulphite. Consideration at Step

4.

Sodium Nitrite... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium o- Maximum Levels Under Yes............... HHS/FDA

Phenylphenol. Consideration at Step

4.

Processed Maximum Levels Under Yes............... HHS/FDA

Eucheuma Seaweed. Consideration at Step

4.

Propylene Glycol Maximum Levels Under Yes............... HHS/FDA

Alginate. Consideration at Step

4.

(Food Additives and Propylene Glycol Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Esters of Fatty Consideration at Step

12A. Acids. 4.

Propylene Glycol. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Rapeseed Oil, Maximum Levels Under Yes............... HHS/FDA

Hydrogenated. Consideration at Step

4.

Rennet........... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Saccharin........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Silicates........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Alginate.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Aluminum Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Sodium Caseinate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Maximum Levels Under Yes............... HHS/FDA

Hypophosphite. Consideration at Step

4.

Sodium Lactate... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Maximum Levels Under Yes............... HHS/FDA

Polyphosphate. Consideration at Step

4.

Sodium Potassium Maximum Levels Under Yes............... HHS/FDA

Tartrate. Consideration at Step

4.

Sodium Stearyl Maximum Levels Under Yes............... HHS/FDA

Fumarate. Consideration at Step

4.

Sorbitan Esters Maximum Levels Under Yes............... HHS/FDA

of Fatty Acids. Consideration at Step

4.

(Food Additives and Sorbitol......... Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Consideration at Step

12A 4.

Sorbitol Syrup... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Starch Acetate... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Starch Aluminum Maximum Levels Under Yes............... HHS/FDA

Octenyl Consideration at Step

Succinate. 4.

[[Page 28140]]

Starch Sodium Maximum Levels Under Yes............... HHS/FDA

Octenylacetate. Consideration at Step

4.

Sodium Propionate Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Sorbate... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Sulphite.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sodium Maximum Levels Under Yes............... HHS/FDA

Thiosulphate. Consideration at Step

4.

Sorbic Acid...... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Stannous Chloride Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sulphur dioxide.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

tert- Maximum Levels Under Yes............... HHS/FDA

Butylhydroquin Consideration at Step

one. 4.

Starch Sodium Maximum Levels Under Yes............... HHS/FDA

Octenylsuccinate. Consideration at Step

4.

Starch Sodium Maximum Levels Under Yes............... HHS/FDA

Succinate. Consideration at Step

4.

(Food Additives and Stearoyl-2- Maximum Levels Under Yes............... HHS/FDA

Contaminants) Ref. Alinorm 95/ Lactylates. Consideration at Step

12A. 4.

Succinyl Distarch Maximum Levels Under Yes............... HHS/FDA

Glycerol. Consideration at Step

4.

Sucrolose........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sucroglycerides.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Sucrose Acetate Maximum Levels Under Yes............... HHS/FDA

Isobutyrate. Consideration at Step

4.

Sucrose Fatty Maximum Levels Under Yes............... HHS/FDA

Acid Esters. Consideration at Step

4.

Tara Gum......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tartaric, Acetic Maximum Levels Under Yes............... HHS/FDA

and Fatty Acid Consideration at Step

Esters of 4.

Glycerol.

Tetrapotassium Maximum Levels Under Yes............... HHS/FDA

Diphosphate. Consideration at Step

4.

Thiodipropionic.. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tocopherols...... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tocopherols, d- Maximum Levels Under Yes............... HHS/FDA

alpha. Consideration at Step

4.

Tocopherols, d- Maximum Levels Under Yes............... HHS/FDA

Alpha, Consideration at Step

Concentrate. 4.

(CCFAC) Ref. CX/FAC 96/8...... Acelsulfame Maximum Levels Under Yes............... HHS/FDA

Potassium. Consideration at Step

4.

Acetic and Fatty Maximum Levels Under Yes............... HHS/FDA

Acid Esters of Consideration at Step

Glycerol. 4.

Acetylated Maximum Levels Under Yes............... HHS/FDA

Distarch Adipate. Consideration at Step

4.

Acetylated Maximum Levels Under Yes............... HHS/FDA

Distarch Consideration at Step

glycerol. 4.

Tetrasodium Maximum Levels Under Yes............... HHS/FDA

Diphosphate. Consideration at Step

4.

Thaumatin........ Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tragacanth Gum... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tricalcium Maximum Levels Under Yes............... HHS/FDA

Phsophate. Consideration at Step

4.

Triethyl Citrate. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Tripotassium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

Trisodium Maximum Levels Under Yes............... HHS/FDA

Phosphate. Consideration at Step

4.

[[Page 28141]]

Urea............. Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Xanthan Gum...... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

Xylitol.......... Maximum Levels Under Yes............... HHS/FDA

Consideration at Step

4.

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

Food Additives and 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 that: (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/ Responsible

Codex committee Standard consideration agenda agency

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

(CCFAC) Ref. ALINORM 97/12.... Arsenic.......... Position Paper to be Yes............... HHS/FDA

revised for

discussion during the

1997 CCFAC.

Cadmium.......... Additional information Yes............... HHS/FDA

requested during 1996

CCFAC.

Lead............. Additional information Yes............... HHS/FDA

requested during 1996

CCFAC.

Tin.............. Position Paper to be Yes............... HHS/FDA

drafted for 1997

CCFAC.

Patulin.......... CCFAC Evaluation will Yes............... HHS/FDA

be developed for the

1997 CCFAC.

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

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.

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

* Acceptable Daily Intake (ADI) of a chemical is the daily

intake which, during an entire lifetime, appears to be without

appreciable risk to the health of the consumer on the basis of all

the known facts at the time of the evaluation of the chemical by the

Joint FAO/WHO Meeting on Pesticide Residues. It is expressed in

milligrams of the chemical per kilogram of body weight.

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

Codex MRLPs are primarily intended to apply in international trade

and are derived from reviews conducted by the Joint Meeting on

Pesticide Residues (JMPR) following:

(a) Review of residue date 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 CCPR

will be considered by the 22nd Session of the Codex Alimentarius

Commission in 1997.

[[Page 28142]]

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

Status of U.S. participation/ Responsible

Codex committee Standard consideration agenda agency

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

Pesticide Residues (considered abamectin........ MRL under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 5 & MRLs under

Residues Ref. CL 1995/44-PR; consideration at step

Annex II, Report 28th 6 & 7.

Session).

acephate......... Withdrawals........... Yes............... EPA

aldicarb......... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

Pesticide Residues (considered aldrin/dieldrin.. MRLs under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 8.

Residues Ref. CL 1995/44-PR;

Annex II, Report 28th

Session).

azinphos-methyl.. MRLs under Yes............... EPA

consideration at step

6.

bentazone........ MRLs under Yes............... EPA

consideration at step

8.

bifenthrin....... MRLs under Yes............... EPA

consideration at step

7.

bromide ion...... MRLs under Yes............... EPA

consideration at step

8.

bromopropylate... MRLs under Yes............... EPA

consideration at step

7 & 8 & withdrawals.

buprofezin....... MRLs under Yes............... EPA

consideration at step

6.

captan........... MRLs under Yes............... EPA

consideration at step

3 & withdrawals &

amendments.

carbendazim...... MRLs under Yes............... EPA

consideration at step

3 & MRLs under

consideration at step

6 & withdrawals.

chlormequat...... withdrawals........... Yes............... EPA

chlorpyrifos- MRLs under Yes............... EPA

methyl. consideration at step

5 & MRLs under

consideration at step

7.

chlorothalonil... MRLs under Yes............... EPA

consideration at step

7 & 8 & withdrawals.

clethodim........ MRLs under Yes............... EPA

consideration at step

5.

Pesticide Residues (considered cycloxydim....... MRLs under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 8.

Residues Ref. CL 1995/44-PR;

Annex II, Report 28th

Session).

DDT.............. MRL under Yes............... EPA

consideration at step

3 & MRLs under

consideration at step

8 & amendment &

withdrawals.

diazinon......... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

dicofol.......... MRLs under Yes............... EPA

consideration at step

7 & 8 & withdrawals.

dichlorvos....... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

dimethoate....... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

diquat........... MRLs under Yes............... EPA

consideration at step

5 & withdrawals.

disulfoton....... MRLs under Yes............... EPA

consideration at step

7 & withdrawals.

dithianon........ MRLs under Yes............... EPA

consideration at step

8.

dithiocarbamates. MRLs under Yes............... EPA

consideration at step

6.

endosulfan....... MRLs under Yes............... EPA

consideration at step

3 & MRLs under

consideration at step

6.

Pesticide Residues (considered endrin........... MRLs under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 8 & withdrawals.

Residues Ref. CL 1995/44-PR;

Annex II, Report 28th

Session).

ethephon......... MRLs under Yes............... EPA

consideration at step

5 & 8 & withdrawals.

ethion........... MRLs under Yes............... EPA

consideration at step

5 & withdrawals.

ethofenprox...... MRLs under Yes............... EPA

consideration at step

8.

fenbutatin oxide. MRLs under Yes............... EPA

consideration at step

7 & 8 & withdrawals.

fenpropathrin.... MRLs under Yes............... EPA

consideration at step

8.

fentin........... withdrawal............ Yes............... EPA

flusilazole...... MRL under Yes............... EPA

consideration at step

8.

folpet........... MRLs under Yes............... EPA

consideration at step

3 & MRLs under

consideration at step

7 & 8 & withdrawals.

glufosinate- MRLs under Yes............... EPA

ammonium. consideration at step

8.

[[Page 28143]]

glyphosate....... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

hexythiazox...... MRLs under Yes............... EPA

consideration at step

8.

imazalil......... MRL under Yes............... EPA

consideration at step

8.

Pesticide Residues (considered iprodione........ MRLs under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 5 & 8 & withdrawals.

Residues Ref. CL 1995/44-PR;

Annex II, Report 28th

Session).

metalazyl........ MRL under Yes............... EPA

consideration at step

6.

methamidophos.... MRL under Yes............... EPA

consideration at step

5 & MRLs under

consideration at step

8 & withdrawals.

methidathion..... MRLs under Yes............... EPA

consideration at step

7 & 8 & withdrawals.

monocrotophos.... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

myclobutanil..... MRLs under Yes............... EPA

consideration at step

8.

oxydemeton-methyl MRLs under Yes............... EPA

consideration at step

3 & MRLs under

consideration at step

6.

parathion-methyl. MRLs under Yes............... EPA

consideration at step

3 & withdrawals.

penconazole...... MRLs under Yes............... EPA

consideration at step

8.

pirimiphos-methyl MRL under Yes............... EPA

consideration at step

8.

procymidone...... Withdrawals........... Yes............... EPA

profenofos....... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

Pesticide Residues (considered propiconazole.... MRL under Yes............... EPA

at the 28th Session of the consideration at step

Codex Committee on Pesticide 8 & withdrawal.

Residues Ref. CL 1995/44-PR;

Annex II, Report 28th

Session).

propylenethiourea withdrawals........... Yes............... EPA

pyrazophos....... MRLs under Yes............... EPA

consideration at step

8.

tebuconazole..... MRLs under Yes............... EPA

consideration at step

5 & 8.

tecnazene........ MRL under Yes............... EPA

consideration at step

8 & withdrawal.

tolclofos methyl. MRLs under Yes............... EPA

consideration at step

8.

triadimefon...... MRLs under Yes............... EPA

consideration at step

8 & withdrawals.

triadimenol...... MRLs under Yes............... EPA

consideration at step

8.

etrimfos......... Withdrawals........... Yes............... EPA

flucythrinate.... Withdrawal............ Yes............... EPA

phosalone........ Withdrawals........... Yes............... EPA

trichlorfon...... Withdrawals........... Yes............... EPA

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

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, the assessment of specifications

for food additives, and those methods elaborated by the Codex Committee

on Milk and Milk Products, 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:

Harmonized Guidelines for Internal Control in

Analytical Chemistry Laboratories;*

Revised Terms of Reference for the Committee.*

The Committee is continuing work on:

Proposed Draft Codex General Guidelines on Sampling;

Criteria for evaluating acceptable methods of analysis

for Codex purposes;

Development of objective criteria for assessing the

competence of testing laboratories involved in the official import and

export control of food;

Harmonization of test results corrected for recovery

factors;

Harmonization of analytical terminology in accordance

with international standards; and

Endorsement of methods of analysis for Codex purposes.

The Committee agreed to propose the following new work:

[[Page 28144]]

Review of methods of analysis using ozone-depleting

substances; and

Measurement uncertainty.

The reference document is Alinorm 97/23.

*Not in Step procedure.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Food Import and Export Certification and Inspection

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 certification systems. Included in the

charge are application of measures by competent authorities to provide

assurance that foods comply with essential requirements. Recognition of

quality assurance systems through the development of guidelines will

help ensure that foods conform to the essential requirements.

The Fourth Session of the Committee (Alinorm 97/30) recommended

that Draft Guidelines for the Exchange of Information Between Countries

on Rejections be adopted at Step 8 by the Twenty-second session of the

Codex Alimentarius Commission in June, 1997.

The Proposed Draft Guidelines for the Design, Operation, Assessment

and Accreditation of Food Import and Export Inspection and

Certification Systems will be considered at Step 5 by the forty-third

session of the Executive Committee.

Several documents are being prepared for future discussion by the

Committee:

Proposed Revised Draft Guidelines on the Principle

Elements in an Electronic Documentation System at Step 3;

Proposed Draft Guidelines for Taking into Account of

ISO Standards of the 9000 Series by Official Systems for Food Export

and Import Inspection and Certification at Step 3;

Proposed Draft Guidelines for the Development of

Agreements Regarding Food Import and Export Inspection and

Certification Systems at Step 3; and

Guidelines on Food Import Control Systems at Step 1.

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 Twelfth Session will consider changes to the Rules of Procedure

of Codex Alimentarius to integrate the role of science in Codex

decision-making. The Committee will also consider the following matters

at its next session:

Strategic planning;

Relationship with Non-Governmental Organizations;

Establishment of a General Policy for Food Safety; and

Streamlining Codex elaboration/adoption procedures.

Responsible Agency: USDA/FSIS.

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 study specific

labelling problems assigned by the Codex Alimentarius Commission. All

of the guidelines and recommendations documents listed below are in

Alinorm 97/22.

The following Draft Guidelines will be considered at Step 6 by the

Twenty-fourth Session of the Committee, May, 1996, Ottawa, Canada:

Draft Guidelines for the Labelling, Production,

Processing, and Marketing of Organically Produced Foods;

Draft Guidelines for Use of Health and Nutrition

Claims; and

Draft Guidelines for Use of the term ``Halal.''

Proposed Draft Recommendations for the Labelling of Foods that can

cause Hypersensitivity will be considered at Step 3 and General

Guidelines for Nutrition Labelling will be reviewed in light of new

developments at the Twenty-fourth Session of the Committee.

In addition, the document on the Implications of Biotechnology

prepared by the United States for the Twenty-third Session of the

Committee was circulated for additional comment and recommendations on

how the Committee should proceed. The document is on the Agenda for

further discussion at the Twenty-fourth Session.

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 Proposed Revised Draft Code of Practice on the General

Principles of Food Hygiene, will be considered at Step 8 by the Codex

Alimentarius Commission at its Twenty-second session in June, 1997. In

addition, the next Executive Committee Meeting will consider adoption

of the following texts, each of which then may be considered at Step 8

during the 1997 Commission Meeting:

Draft Revised Recommended International Code of

Practice--General Principles of Food Hygiene at Step 8;

The Committee agreed to recommend to the Commodity

Committees to consider utilizing Method A in the elaboration/revision

of their Product Codes;

Revised Guidelines for the Application of the Hazard

Analysis Critical Control Point System at Step 5; and

Revised Principles for the Establishment and

Application of Microbiological Criteria for Foods at Step 5;

Proposed Draft Code of Practice for Refrigerated Foods

with Extended Shelf-Life at Step 5.

The following matters will be discussed at the twenty-ninth

committee session, October, 1996:

*Application of the Hazard Analysis and Critical

Control Point (HACCP) Approach for the Specific Production of Normandy

Camembert Cheese;

*A redrafted recommendation for the control of Listeria

monocytogenes, background documents on the revised text will include

criteria for Listeria monocytogenes, Salmonella, with special reference

to S. Enteritidis, Campylobacter and entero haemorrhagic Escherichia

coli;

*A discussion paper on ``Guidelines on the application

of the principles of risk assessment and risk management to food

hygiene including strategies for their application'';

*Implications for the Broader Application of the HACCP

system;

*A first draft Code of Practice for all Foodstuffs

Transported in Bulk; and

*A first draft Code of Hygienic Practice for Bottled

Water (other than natural mineral water).

*Not in Step Procedure.

All documents listed above are contained in Alinorm 97/13.

Responsible Agency: HHS/FDA USDA/FSIS.

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

[[Page 28145]]

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 95/26.

The following documents were adopted by the Twenty-first session of the

Codex Alimentarius Commission in July 1995:

Draft Standard for Formula Foods for Use in Very Low

Energy Diets for Weight Reduction at Step 8; and

Proposed Draft Table of Conditions for Claims for

Nutrient Contents at Step 5.

Seven documents were circulated for comment prior to consideration

at the next Committee meeting in October 1996:

Revision of Codex Standard for Processed Cereal-Based

Foods for Infants and Children at Step 3;

Proposed Draft Revised Standard for Food Grade Salt at

Step 3 of the procedure;

Proposed Draft Guidelines for Dietary Supplements

(Vitamins and Minerals) at Step 3;

Proposed Draft Revised Standard for Gluten-Free Foods

at Step 3;

Proposed Draft Amendment to the Standard for Infant

Formula: Amount of Vitamin B12 at Step 3 of accelerated procedure;

Proposed Draft Revised Guidelines for the Use of Codex

Committees on the Inclusion of Provisions on Nutritional Quality in

Food Standards and Other Codex Texts at Step 3; and

Revision to the Codex Standard for Infant Formula at

Step 3.

The Committee is initiating work in the following areas:

Proposed Definitions for Vitamins and Minerals as

Nutrient Reference Values for Labelling at Step 1; and

Proposed Levels of Vitamins and Minerals in Foods for

Special Medical Purposes at Step 1.

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 revised codes, incorporating the HACCP approach, will

be considered at the Twenty-second session of the Committee at Step 3:

Proposed Draft Revised Code of Practice for Frozen

Fish;

Proposed Draft Revised Code of Practice for Canned

Fish;

Proposed Draft Revised Code of Practice for Frozen

Shrimps and Prawns;

Proposed Draft Revised Code of Practice for Molluscan

Shellfish;

Proposed Draft Revised Code of Practice for Smoked

Fish; and

Proposed Draft Revised Code of Practice for Salted

Fish.

The Committee will also consider the following documents at Step 3:

Proposed Draft Code of Hygienic Practice for the

Products of Aquaculture;

Proposed Draft Code of Hygienic Practice for Frozen

Surimi; and

Proposed Draft Code of Practice for the Sensory

Evaluation of Fish and Shellfish.

In addition, the Committee will consider a List of Predatory

Species to which the Higher Level of Methylmercury Applies.

The reference document containing the above information is Alinorm

97/18.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Milk and Milk Products

The Codex Committee on Milk and Milk Products was established by

the Codex Alimentarius at its Twentieth session. The Committee was

originally established by the Food and Agriculture Organization (FAO)

and the World Health Organization (WHO) in 1958. The Committee was

integrated into the Joint FAO/WHO Foods Standards Programme in 1962.

Until 1993, the Committee was named the Joint FAO/WHO Committee of

Government Experts on the Code of Principles Concerning Milk and Milk

Products. The Committee is responsible for establishing international

codes and standards for milk and milk products. All of the standards

listed below are contained in CX/MMP 96/1.

The following Proposed Draft and Proposed Draft Revised Standards

will be considered at the Second session of the Codex Committee on Milk

and Milk Products in May 1996 at Step 3:

Proposed Draft Standard for Process(ed) Cheese and

Process(ed) Cheese Preparation;

Proposed Draft Revised Standard for Creams;

Proposed Draft Standards for Fermented Milks and for

Milk Products Obtained from Fermented Milk Heat-Treated After

Fermentation;

Proposed Draft Revised Standard for Cheddar Cheese;

Proposed Draft Revised Standard for Danablu Cheese;

Proposed Draft Revised Standard for Danbo Cheese;

Proposed Draft Revised Standard for Harvarti Cheese;

Proposed Draft Revised Standard for Samso Cheese;

Proposed Draft Revised Standard for Chesire Cheese;

Proposed Draft Revised Standard for Limburger Cheese;

Proposed Draft Revised Standard for Saint-Paulin

Cheese;

[[Page 28146]]

Proposed Draft Revised Standard for Svecia Cheese;

Proposed Draft Revised Standard for Harzer Kase Cheese;

Proposed Draft Revised Standard for Hushallsost Cheese;

Proposed Draft Revised Standard for Marbio Cheese;

Proposed Draft Revised Standard for Fynbo Cheese;

Proposed Draft Revised Standard for Esrom Cheese;

Proposed Draft Revised Standard for Romadur Cheese;

Proposed Draft Revised Standard for Amsterdam Cheese;

Proposed Draft Revised Standard for Leidse Cheese;

Proposed Draft Revised Standard for Freise Cheese;

Proposed Draft Revised Standard for Edelpilzkase

Cheese;

Proposed Draft Revised Standard for Extra Hard Grating

Cheese;

Proposed Draft Revised Standard for Tilsiter Cheese;

Proposed Draft Revised Standard for Provolone Cheese;

Proposed Draft Revised Standard for Cottage Cheese;

Proposed Draft Revised Standard for Butterkase Cheese;

Proposed Draft Revised Standard for Coulommiers Cheese;

Proposed Draft Revised Standard for Herrgardsost

Cheese.

Proposed Draft Revised Standard for Edam Cheese;

Proposed Draft Revised Standard for Gouda Cheese;

Proposed Draft Revised Standard for Camembert Cheese;

Proposed Draft Revised Standard for Brie Cheese;

Proposed Draft Revised Standard for Emmentaler Cheese;

Proposed Draft Revised Standard for Gruyere Cheese; and

Code of Principles Concerning Milk and Milk Products.

The following Proposed Draft and Proposed Draft Revised Standards

will be considered at the Second session of the Codex Committee on Milk

and Milk Products in May 1996 at Step 7:

Draft Revised Standard for Butter;

Draft Revised Standard for Milkfat Products;

Draft Revised Standard for Evaporated Milk;

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 Cheese in Brine; and

Draft Revised Standard for Unripened Cheese.

Agency Responsible: 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 following Draft Code and Standards will be considered at the

Fifteenth Session of the Committee, November, 1996, at Step 6:

Draft Code of Practice for the Storage and Transport of

Fats and Oils in Bulk;

Draft Standard for Fats and Oils not Covered by

Individual Standards;

Draft Standard for Named Animal Fats;

Draft Standard for Named Vegetable Oils;

Draft Standard for Olive Oils and Olive-Pomace Oils;

and

Draft Standard for Mayonnaise.

The following Proposed Draft Standards will be considered at Step

4:

Proposed Draft Standard for Fat Spreads; and

Proposed Draft Standard for Products Sold as an

Alternative to Ghee.

All of the above documents are contained in Alinorm 97/17.

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.

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 has 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 are:

Chocolate;

Cocoa Butters;

Cocoa Butters Confectionery;

Cocoa (Cacao) Nib, Cocoa (Cacao) Mass, Cocoa Press Cake

and Cocoa Dust (Cocoa Fines), For Use in the Manufacture of Cocoa and

Chocolate Products;

Cocoa Powders (Cacaos) and Dry Cocoa-Sugar Mixtures;

and

Composite and Filled Chocolate.

The amended standards will be considered at Step 3 by the Sixteenth

Session of the Committee, October, 1996.

Responsible Agency: HHS/FDA.

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 Fruits and Vegetables

Responsible Agency: HHS/FDA

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

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,

the Codex Committee on Sugars, the Codex

[[Page 28147]]

Committee Processed Fruits and Vegetables and the Codex Committee on

Soups and Broths 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 Committee has been adjourned since

1978. However, as directed by the Codex Alimentarius Commission, the

Secretariat of the Host Country (Sweden) has prepared a Revised Codex

Standard for Edible Ices and Ices Mixes (see CL 1995/7-EI). This

Revised Standard was circulated to member governments for comments by

May 15, 1995. The objective of the revision was to focus the standard

only on public health, food safety, and consumer protection. Provisions

in the existing standard that deal with quality factors and criteria

typically used in commerce to define or describe the product are of an

advisory nature and have been removed in the Revised Standard. The

Twenty-first session of the Commission decided to suspend further work

on the Revised Standard pending a study to be submitted to the Forty-

third Session of the Executive Committee in June 1996.

Agency Responsible: 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

correspondence. The Secretariat has prepared revised Draft Standards

and circulated them for government comments at Step 6 in document CL

1996/1-S.

Agency Responsible: HHS/FDA.

U.S. Participation: Yes.

Soups and Broths

The Codex Committee on Soups and Broths is responsible for

elaborating world-wide standards for soups, broths, bouillons, and

consommes. The committee adjourned sine die in 1977.

In light of the decision made by the 19th Session of the Commission

to simplify and revise Codex standards, a revised version of the

standard for Bouillon and Consommes was presented to the Twenty-first

Session of the Commission in July, 1995, for adoption. The Commission

adopted the Standard at Step 8 and noted that a revision of the

Standard in light of late substantive comments would be initiated

immediately. The Revised Standard for Bouillons and Consommes can be

found in Alinorm 95/20, Appendix I.

Agency Responsible: USDA/FSIS.

U.S. Participation: Yes.

Processed Fruits and Vegetables

The Codex Committee on Processed Fruits and Vegetables elaborated

world-wide standards for all types of processed fruits and vegetables

including dried products (except prunes), canned products (except

juices), and jams and jellies. The Committee held eighteen sessions,

the last in 1986.

In keeping with the Commission's charge to update and revise

standards, the United States Secretariat is preparing the revisions.

They will then be circulated for government comment and considered at

the Nineteenth Session of the Committee, February, 1997.

Agency Responsible: 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.

Agency Responsible: 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 all types of mineral water

products. At the recommendation of the Nineteenth Session of the Codex

Alimentarius Commission concerning the conversion of Regional Standards

into World-Wide Standards, the Codex European Regional Standard for

Natural Mineral Waters was circulated to member governments for

comments at Step 3 in 1993 (CL 1993/4-NMW). Although, based on the

comments received, the Commission adopted a number of proposed

amendments for incorporation in the Draft Standard, no further action

was taken at the time for the finalization of the standard because the

CCNMW was in adjournment. However, after consultation between the Host

Government (Switzerland) and the Codex Secretariat, it was agreed that

the CCNMW should meet again to finalize the Standard for Natural

Mineral Waters. Therefore, a Draft Standard for Natural Mineral Waters

(CL 1996/3-NMW) at Step 6 was circulated to member governments for

comment by June 15, 1996 and a Session by the CCNMW was tentatively

scheduled to be held in the first week of October 1996 in Switzerland

to consider the Draft Standard at Step 7.

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;

[[Page 28148]]

--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 Committee, at its Third Session, recommended that the Executive

Committee consider proposals concerning the broader application of the

HACCP system and that the proposals also be considered by the Twenty-

first Session of the Codex Alimentarius Commission. The Committee also

requested that a comprehensive plan for risk assessment methodology and

decision making criteria be developed by the Commission, and that risk

analysis be considered as part of the Codex Strategic Plan.

The Committee expressed the view that the Commission should be the

focus of international harmonization initiatives with respect to

genetically engineered foods. In addition, the Committee recommended

that further work should be carried out on the sale of potentially

harmful herbs and botanicals as food. Finally, the Committee

recommended that the work of the Commission should be expedited.

The Fourth Session of the Committee, May, 1996, will continue

deliberations on the implications of the Agreement on Sanitary and

Phytosanitary Measures and Technical Barriers to trade to countries in

the Regions and on the application of risk analysis in the countries of

the Regions.

Agency Responsible: USDA/FSIS.

U.S. Participation: Yes.

Appendix 1--U.S. Codex Alimentarius Officials

Steering Committee Members

Mr. Thomas J. Billy, Associate Administrator, Food Safety and

Inspection Service, U.S. Department of Agriculture, Room 331-E, Jamie

L. Whitten Federal Bldg., 14th and Independence Avenue, SW.,

Washington, DC 20250-3700, Phone: (202) 720-8217, Fax: (202) 690-4437

Mr. Michael R. Taylor, Acting Under Secretary for Food Safety, U.S.

Department of Agriculture, Room 331-E, Jamie L. Whitten Federal Bldg.,

14th and Independence Avenue, SW., Washington, DC 20250-3700, Phone #:

(202) 720-7025, Fax #: (202) 690-4437

Mr. Michael V. Dunn, Assistant Secretary, Marketing and Regulatory

Programs, U.S. Department of Agriculture, Room 228-W, Jamie L. Whitten

Federal Bldg., 14th & Independence Avenue, SW., Washington, DC 20250,

Phone #: (202) 720-4256, Fax #: (202) 720-5775

Dr. Alex Thiermann, Deputy Administrator, International Services,

Animal and Plant Health Inspection Service, U.S. Department of

Agriculture, Room 324-E, Jamie L. Whitten Federal Bldg., 14th &

Independence Avenue, SW., Washington, DC 20250, Phone #: (202) 720-

7593, Fax #: (202) 690-1484

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., Rm. 1119G,

Waterside Mall, Washington, DC 20460, Phone #: (703) 305-7092, Fax #:

(703) 308-4776

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

Codex Committee Chairpersons

Mr. Steven N. Tanner, Deputy Director, Quality Assurance, Grain

Inspection, Packers & Stockyards Administration, U.S. Department of

Agriculture, 10383 N. Executive Hills Blvd., Kansas City, MO 64153-

1394, Phone #: (816) 891-0404, Fax #: (816) 891-8070

Cereals, Pulses and Legumes and Research Division (adjourned Sine

Die)

Dr. I. Kaye Wachsmuth, Assistant Deputy Administrator, Science and

Technology, U.S. Department of Agriculture, Room 405-Cotton Annex

Bldg., 12th & C Street, SW., Washington, DC 20250, Phone #: (202) 205-

0675, Fax # (202) 205-0080

Food Hygiene

Mr. James Rodeheaver, Chief, Fruit and Vegetable Division, Processed

Product Branch, Agricultural Marketing Service, U.S. Department of

Agriculture, Room 0709, South Agriculture Building, Washington, DC

20250, Phone #: (202) 720-4693, Fax #: (202) 690-1527

Processed Fruits and Vegetables (adjourned Sine Dine)

Dr. Stephen F. Sundlof, Director, Center for Veterinary 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 Foods

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. Marvin A. Norcross, 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) 254-2517,

Fax #: (202) 254-2530

Alternate 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

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

[[Page 28149]]

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, Acting Deputy Director, Program

Management and Support Division, Office of Pesticide Programs, U.S.

Environmental Protection Agency, 401 M Street, SW., (7502C), Crystal

Station, 3rd Floor, Washington, DC 20460, 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, 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--Dr. William Franks, Director, Science Division,

Agricultural Marketing Service, U.S. Department of Agriculture, Room

3507, South Agriculture Building, 14th & Independence Avenue, SW.,

Washington, DC 20250, 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, Asst. to Deputy Administrator,

International Programs, Food Safety and Inspection Service, U.S.

Department of Agriculture, Room 341-E, Jamie L. Whitten Federal Bldg.,

Washington, DC 20250-3700, Phone #: (202) 720-4566, Fax #: (202) 690-

3856

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 Labeling

(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--Ms. Cheryl Wade, Director, Food Labeling Division,

Food Safety and Inspection Service, U.S. Department of Agriculture,

Room 201, West End Court, Washington, DC 20250-3700, Phone #: (202)

254-2590, Fax #: (202) 254-2482

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, 14th

and Independence Ave., SW., Washington, DC 20250, Phone #: (202) 720-

2184, Fax #: (202) 720-0016

Alternate Delegate--Ms. Sharon E. Bomer-Lauritsen, Deputy Director,

Fruit and Vegetable Div., Agricultural Marketing Service, U.S.

Department of Agriculture, Room 2077, South Agriculture Building, 14th

& Independence Avenue, SW., Washington, DC 20250, Phone #: (202) 720-

6393, Fax #: (202) 720-0016

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) 401-6144

Alternate Delegate--Mr. David Shipman, Deputy Administrator, GIPSA,

U.S. Department of Agriculture, Room 1092, South Agriculture Building,

Washington, DC 20250, Phone #: (202) 720-9170, Fax #: (202) 205-9237

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, 14th and Independence Ave., SW.,

Washington, DC 20250, Phone #: (202) 720-9382, Fax #: (202) 720-2643

[[Page 28150]]

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-206), Washington, DC

20204, Phone #: (202) 418-3113, Fax #: (202) 418-3131

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) 401-6144

Alternate Delegate--Mr. Timothy L. Mounts, Research Leader, Food

Quality and Safety Research Unit, National Center for Agricultural

Utilization Research, Agricultural Research Service, USDA, 1815 North

University Street, Peoria, IL 61604, Phone #: (309) 681-6555, Fax #:

(309) 681-6679

Worldwide Commodity Codex Committees (Adjourned Sine Die)

Codex Committee on Cocoa Products and Chocolate\1\

(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) 401-6144

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 \1\

(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 Processed Fruits and Vegetables \1\

(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, 14th &

Independence Avenue, SW., Washington, DC 20250, 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) 401-6144

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) 401-6144

Alternate Delegate--VACANT

Codex Committee on Soups and Broths \1\

(Host Government--Switzerland)

Delegate--Mr. Charles Edwards, Director, Product Assessment Division,

Regulatory Programs, Food Safety and Inspection Service, U.S.

Department of Agriculture, West End Court Building, Room 329,

Washington, DC 20250-3700, Phone #: (202) 254-2565, Fax #: (202) 254-

2499

Alternate Delegate--Mr. Robert Post, Branch Chief, Food Standards and

Ingredients Branch, Product Assessment Division, Regulatory Programs,

Food Safety & Inspection Service, U.S. Department of Agriculture, West

End Court Building, Room 327, Washington, DC 20250-3700, Phone #: (202)

254-2588, Fax #: (202) 254-2499

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, Deputy Administrator, International

Programs, Food Safety and Inspection Service, U.S. Department of

Agriculture, Room 341-E, Jamie L. Whitten Federal Bldg., Washington, DC

20250-3700, Phone #: (202) 720-3473, Fax #: (202) 690-3856

Alternate Delegate--Dr. Richard Mikita, Export Advisor, International

Programs, Food Safety and Inspection Service, U.S. Department of

Agriculture, Room 341-E, Jamie L. Whitten Federal Bldg., 14th &

Independence Ave., SW., Washington, DC 20250-3700, Phone #: (202) 720-

0290, Fax #: (202) 690-3856

Codex Committee on Processed Meat and Poultry Products \1\

(Host Government--Denmark)

U.S. Delegate--Mr. Daniel Engeljohn, Branch Chief, Quality Control,

Food Safety and Inspection Service, U.S. Department of Agriculture,

Franklin Court Building, Room 6912, Washington, DC 20250-3700, Phone #:

(202) 501-7319, Fax #: (202) 501-7639

Alternate Delegate--Mr. Charles Edwards, Director, Product Assessment

Division, Regulatory Programs, Food Safety and Inspection Service, U.S.

Department of Agriculture, West End Court Building, Room 329,

Washington, DC 20250-3700, Phone #: (202) 254-2565, Fax #: (202) 254-

2499

Codex Committee on Natural Mineral Waters \1\

(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,

[[Page 28151]]

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, 14th &

Independence Avenue, SW., Washington, DC 20250, 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) 401-6144

Joint ECE/Codex Alimentarius Group of Experts on Standardization of

Fruit Juices \1\

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

\1\ Adjourned sine die. The main tasks of these Committees are

completed. However, the committees may be called to meet again if

required.

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

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, 14th

& Independence Avenue, SW., Washington, DC 20250, 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 S. Nally, Executive Officer for Codex,

Alimentarius, Food Safety & Inspection Service, U.S. Department of

Agriculture, West End Court, Room 311, 1255 22nd Street, NW.,

Washington, DC 20250-3700, Phone #: (202) 254-2517, Fax #: (202) 254-

2530

Appendix 2 Timetable of Codex Sessions

(June 1995 through June 1997)

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

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

1995

CX 702-42 Executive Committee of 28-30 June Rome.

the Codex Alimentarius

Commission (42nd

Session).

CX 701-21 CODEX ALIMENTARIUS 3-8 July Rome.

COMMISSION (21st

Session).

CX 715-20 Codex Committee on 2-6 October Budapest.

Methods of Analysis

and Sampling (20th

Session).

CX 712-28 Codex Committee on Food 28 November- Washington, DC.

Hygiene (28th Session). 1 December

CX 730-9 Codex Committee on 4-8 December Washington, DC.

Residues of Veterinary

Drugs in Foods (9th

Session).

1996

CX 731-6 Codex Committee on 29 January- Mexico City.

Fresh Fruits and 2 February

Vegetables (6th

Session).

CX 733-4 Codex Committee on Food 19-23 February Sydney.

Export and Import

Inspection and

Certification Systems

(4th Session).

CX 727-10 Codex Regional 5-8 March Tokyo.

Coordinating Committee

for Asia (10th

Session).

CX 711-28 Codex Committee on Food 18-22 March Manila.

Additives and

Contaminants (28th

Session).

CX 718-28 Codex Committee on 15-20 April The Hague.

Pesticide Residues

(28th Session).

CX 706-20 Codex Regional 23-26 April Uppsala.

Coordinating Committee

for Europe (20th

Session).

CX 732-4 Codex Coordinating 30 April-3 May Rotorua.

Committee for North

America and the

SouthWest Pacific (4th

Session).

CX 722-22 Codex Committee on Fish 6-10 May Bergen.

and Fishery Products

(22nd Session).

CX 714-24 Codex Committee on Food 14-17 May Ottawa.

Labeling (24th

Session).

CX 703-1 Codex Committee on Milk 27-31 May Rome.

and Milk Products (2nd

Session).

CX 702-43 Executive Committee of 4-7 June Geneva.

the Codex Alimentarius

Commission (43rd

Session).

CX 708-16 Codex Committee on 30 September-2 October TBA.

Cocoa Products and

Chocolate (16th

Session).

CX 719-5 Codex Committee on 3-5 October TBA.

Natural Mineral Waters

(5th Session).

CX 707-12 Codex Regional TBA Harare.

Coordinating Committee

for Africa (12th

Session).

CX 720-20 Codex Committee on 7-11 October Bonn Bad-Godesberg.

Nutrition and Food for

Special Dietary Uses

(20th Session).

[[Page 28152]]

CX 712-29 Codex Committee on Food 21-25 October Washington, DC.

Hygiene (29th Session).

CX 730-10 Codex Committee on 29 October- TBA.

Residues of Veterinary 1 November

Drugs in Foods(10th

Session).

CX 709-11 Codex Committee on Fats 4-8 November London.

and Oils (15th

Session).

CX 716-12 Codex Committee on 25-28 November Paris.

General Principles

(12th Session).

1997

CX 713-19 Codex Committee on 3-7 February Washington, DC.

Processed Fruits and

Vegetables (19th

Session).

CX 725-10 Codex Regional 25-28 February Montevideo

Coordinating Committee

for Latin America and

the Caribbean (10th

Session).

CX 711-29 Codex Committee on Food 17-21 March The Hague.

Additives and

Contaminants (29th

Session).

CX 715-21 Codex Committee on 24-28 March Budapest.

Methods of Analysis

and Sampling (21st

Session).

CX 718-29 Codex Committee on 7-12 April The Hague.

Pesticide Residues

(29th Session).

CX 714-25 Codex Committee on Food 15-18 April Ottawa.

Labeling (25th

Session).

CX 702-44 Executive Committee of 18-20 June Geneva.

the Codex Alimentarius

Commission (44th

Session).

CX 701-22 CODEX ALIMENTARIUS 23-28 June Geneva.

COMMISSION (22nd

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 or 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 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

[[Page 28153]]

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.

Apendix 4--Part 1, Uniform Procedure for the Elaboration of Codex

Standards and Related Texts

Steps 1, 2 and 3

(1) The Commission decides, taking into account the ``Criteria for

the Establishment of Work Priorities and for the Establishment of

Subsidiary Bodies,'' to elaborate a Worldwide Codex Standard and also

decides which subsidiary body or other body should undertake the work.

A decision to elaborate a Worldwide Codex Standard may also be taken by

subsidiary bodies of the Commission in accordance with the above-

mentioned criteria, subject to subsequent approval by the Commission or

its Executive Committee at the earliest possible opportunity. In the

case of Codex Regional Standards, the Commission shall base its

decision on the proposal of the majority of members belonging to a

given region or group of countries submitted at a session of the Codex

Alimentarius Commission.

(2) The Secretariat arranges for the preparation of a proposed

draft standard. In the case of Maximum Limits for Residues of

Pesticides or Veterinary Drugs, the Secretariat distributes the

recommendations for maximum limits, when available from the Joint

Meetings of the FAO Panel of Experts on Pesticide Residues in Food and

the Environment and the WHO Panel of Experts on Pesticide Residues

(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives

(JECFA). In the cases of milk and milk products or individual standards

for cheeses, the Secretariat distributes the recommendations of the

International Dairy Federation (IDF).

(3) The proposed draft standard is sent to members of the

Commission and interested international organizations for comment on

all aspects including possible implications of the proposed draft

standard for their economic interests.

Step 4

The comments received are sent by the Secretariat to the subsidiary

body or other body concerned which has the power to consider such

comments and to amend the proposed draft standard.

Step 5 2

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

\2\ 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 28154]]

Appendix 4--Part 2, Uniform Accelerated Procedure for the

Elaboration of Codex Standards and Related Texts

Steps 1, 2 and 3

(1) The Commission or the Executive Committee between Commission

sessions, on the basis of a two-thirds majority of votes cast, taking

into account the ``Criteria for the Establishment of Work Priorities

and for the Establishment of Subsidiary Bodies'', shall identify those

standards which shall be the subject of an accelerated elaboration

process.* The identification of such standards may also be made by

subsidiary bodies of the Commission, on the basis of a two-thirds

majority of votes cast, subject to confirmation at the earliest

opportunity by the Commission or its Executive Committee by a two-

thirds majority of votes cast.

(2) The Secretariat arranges for the preparation of a proposed

draft standard. In the case of Maximum Limits for Residues of

Pesticides or Veterinary Drugs, the Secretariat distributes the

recommendations for maximum limits, when available from the Joint

Meetings of the FAO Panel of Experts on Pesticide Residues in Food and

the Environment and the WHO Panel of Experts on Pesticide Residues

(JMPR), or the Joint FAO/WHO Expert Committee on Food Additives

(JECFA). In the cases of milk and milk products or individual standards

for cheeses, the Secretariat distributes the recommendations of the

International Dairy Federation (IDF).

(3) The proposed draft standard is sent to Members of the

Commission and interested international organizations for comment on

all aspects including possible implications of the proposed draft

standard for their economic interests. When standards are subject to an

accelerated procedure, this fact shall be notified to the Members of

the Commission and the interested international organizations.

Step 4

The comments received are sent by the Secretariat to the subsidiary

body or other body concerned which has the power to consider such

comments and to amend the proposed draft standard.

Step 5

In the case of standards identified as being subject to an

accelerated 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 definition

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

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