28416

Notices Federal Register Vol. 62, No. 100

Friday, May 23, 1997

This section of the FEDERAL REGISTER 1255 22nd Street, NW, Room 311, West interests of consumers. Through contains documents other than rules or End Court Building, Washington, DC adoption of food standards, codes of proposed rules that are applicable to the 20250–3700; (202) 418–8852. For practice, and other guidelines public. Notices of hearings and investigations, information pertaining to particular developed by its committees and by committee meetings, agency decisions and committees, the delegate of that promoting their adoption and rulings, delegations of authority, filing of petitions and applications and agency committee may be contacted. (A implementation by governments, Codex statements of organization and functions are complete list of U.S. delegates and seeks to ensure that the world’s food examples of documents appearing in this alternate delegates can be found in supply is sound, wholesome, free from section. Appendix 1 to this notice.) adulteration, and correctly labeled. In SUPPLEMENTARY INFORMATION: the United States, the United States Department of Agriculture (USDA); the DEPARTMENT OF AGRICULTURE Background Food and Drug Administration (FDA), The World Trade Organization (WTO) Department of Health and Human Food Safety and Inspection Service was established on January 1, 1995, as Services (HHS), and the Environmental [Docket No. 97±026N] the common international institutional Protection Agency (EPA) manage and framework for the conduct of trade carry out U.S. Codex activities. International Standard-Setting relations among its members in matters As the agency responsible for Activities related to the Uruguay Round informing the public of the sanitary and Agreements. The WTO is the successor phytosanitary standard-setting activities AGENCY: Food Safety and Inspection organization to the General Agreements of Codex, FSIS will publish this notice Service, USDA. on Tariffs and Trade (GATT). U.S. in the Federal Register annually, setting ACTION: Notice. membership in the WTO was approved forth the following information: by Congress when it enacted the 1. The sanitary or phytosanitary SUMMARY: This notice informs the public Uruguay Round Agreements Act, which standards under consideration or of the sanitary and phytosanitary was signed into law by the President on planned for consideration; and standard-setting activities of the Codex December 8, 1994. Pursuant to section 2. For each sanitary or phytosanitary Alimentarius Commission (Codex), in 491 of the Trade Agreements Act of standard specified: accordance with section 491 of the 1979, as amended, the President is a. A description of the consideration Trade Agreements Act of 1979, as required to designate an agency to be or planned consideration of the amended by the Uruguay Round responsible for informing the public of standard; Agreements Act, Pub. L. 103–465, 108 the sanitary and phytosanitary (SPS) b. Whether the United States is Stat. 4809 (1994), and seeks comments standard-setting activities of each participating or plans to participate in on standards currently under international standard-setting the consideration of the standard; consideration and recommendations for organization, Codex, International The agenda for United States new standards. It also lists other Office of Epizootics, and the participation, if any; and standard-setting activities of Codex, International Plant Protection d. The agency responsible for including commodity standards, Convention. The President, pursuant to representing the United States with guidelines, codes of practice, and Proclamation No. 6780 of March 23, respect to the standard. revised texts. This notice covers the 1995 (60 FR 15845), designated the U.S. To obtain copies of those standards time periods from June 1, 1996, to May Department of Agriculture as the agency listed in this notice that are under 31, 1997, and May 31, 1997, to June 1, responsible for informing the public of consideration by Codex, please contact 1998. sanitary and phytosanitary standard- the Codex delegate or the office of U.S. ADDRESSES: Submit written comments setting activities of each international Codex Alimentarius. This notice also to: FSIS Docket Clerk, U.S. Department standard-setting organization. The solicits public comment on those of Agriculture, Food Safety and Secretary of Agriculture has delegated to standards that are under consideration Inspection Service, Room 102, Cotton the Administrator, Food Safety and and on recommendations for new Annex, Washington, DC 20250–3700. Inspection Service (FSIS), the standards. The delegate, in conjunction Please state that your comments refer to responsibility to inform the public of with the responsible agency, will take Codex and, if your comments relate to the SPS standard-setting activities of the comments received into account in specific Codex committees, please Codex. The FSIS Administrator has, in participating in the consideration of the identify those committees in your turn, assigned the responsibility for standards and in proposing matters to comments and submit a copy of your informing the public to the Office of be considered by Codex. comments to the delegate from that U.S. Codex Alimentarius, located in The United States delegate will particular committee. All comments FSIS. facilitate public participation in the submitted will be available for public Codex was created in 1962 by two United States Government activities inspection in the Docket Clerk’s Office U.N. organizations, the Food and relating to Codex Alimentarius. The between 8:30 a.m. and 4:30 p.m., Agriculture Organization (FAO) and the United States delegate will maintain a Monday through Friday. World Health Organization (WHO). list of individuals, groups, and FOR FURTHER INFORMATION CONTACT: Codex is the major international organizations that have expressed an Patrick J. Clerkin, Director, U.S. Codex organization for encouraging fair interest in the activities of the Codex Office, U.S. Department of Agriculture, international trade in food and committees and will disseminate Food Safety and Inspection Service, protecting the health and economic information regarding United States Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28417 delegation activities to interested for the Elaboration of Codex Limits (MRLs) for veterinary drugs. A Codex parties. This information will include Standards and Related Texts Maximum Limit for Residues of Veterinary the current status of each agenda item, Appendix 5. Nature of Codex Standards Drugs (MRLVD) is the maximum concentration of residue resulting from the the United States Government’s position Done at Washington, DC on: May 15, 1997. or preliminary position on the agenda use of a veterinary drug (expressed in mg/kg Thomas J. Billy, or ug/kg on a fresh weight basis) that is items, and the time and place of Administrator. recommended by the Codex Alimentarius planning meetings and debriefing Commission to be legally permitted or meetings following Codex committee Codex Alimentarius Commission and recognized as acceptable in or on a food. sessions. Please notify the appropriate Executive Committee An MRLVD is based on the type and U.S. delegate or the Office of U.S. Codex The Codex Alimentarius Commission will amount of residue considered to be without Alimentarius, West End Court Building, hold its Twenty-second Session on June 23– any toxicological hazard for human health as Room 311, Washington, DC 20250– 28, 1997 in Geneva, Switzerland. At that time expressed by the Acceptable Daily Intake 3700, if you would like to receive it will consider the standards, codes of (ADI)*, or on the basis of a temporary ADI information about specific committees. practice, and related matters brought to its that utilizes an additional safety factor. An MRLVD also takes into account other The information provided below attention by the general subject committees, commodity committees, and member relevant public health risks as well as food describes the status of Codex standard- delegations. technological aspects. setting activities by the Codex Prior to the Commission meeting, the When establishing an MRLVD, Committees for the two year period from Executive Committee will meet on June 19– consideration is also given to residues that June 1, 1996 to June 1, 1998. In 20 in Geneva. It is composed of the occur in food of plant origin and/or the addition, the following information is chairperson, vice-chairperson and six further environment. Furthermore, the MRLVD may included with this Federal Register members elected from the Commission, one be reduced to be consistent with good notice: from each of the following geographic practices in the use of veterinary drugs and regions: Africa, Asia, Europe, Latin America to the extent that practical analytical Appendix 1. List of U.S. Codex Officials and the Caribbean, North America, and methods are available. (includes U.S. delegates and South-West Pacific. The committee may *Acceptable Daily Intake (ADI): An alternate delegates). make proposals to the Commission regarding estimate by the Joint FAO/WHO Expert Appendix 2. Timetable of Codex the general orientation and program work of Committee on Food Additives (JECFA) of the Sessions (June 1996 through June the Commission, study special problems and amount of a veterinary drug, expressed on a 1998) help implement the program as approved by body weight basis, that can be ingested daily Appendix 3. Definitions for the Purpose the Commission. over a lifetime without appreciable health of Codex Alimentarius risk (standard man = 60 kg). Codex Committee on Residues of Veterinary Information about committee actions can Appendix 4. Drugs in Foods be found in ALINORMS 97/31 and 97/31A. (A) Uniform Procedure for the The Codex Committee on Residues of Residues of Veterinary Drugs in Foods to be Elaboration of Codex Standards and Veterinary Drugs determines priorities for the considered at the Twenty-Second Session of Related Texts consideration of residues of veterinary drugs the Codex Alimentarius Commission include (B) Uniform Accelerated Procedure in foods and recommends Maximum Residue the following:

US participation/ Responsible Codex committee Standard Status of consideration agenda agency

Residues of Veterinary Drugs in Foods (to be con- Moxidectin ...... MRLs Under Consider- Yes ...... HHS/FDA sidered at Twenty-second Session of the Codex ation at Step 8 cattle Alimentarius Commission) (CAC) Ref. and sheep. ALINORM 97/31 and 97/31A. Levamisole ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Triclabendazole ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Carazolol ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Bovine Somatotropin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Doramectin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Spiramycin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 8. Moxidectin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5/8 deer. Oxtetracycline ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5/8. Abamectin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Azaperone ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Chlortetracycline, oxytetra- MRLs Under Consider- Yes ...... HHS/FDA cycline and tetracycline. ation at Step 5. Cypermethrin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Residues of Veterinary Drugs in Foods (to be con- ∞Cypermethrin ...... MRLs Under Consider- Yes ...... HHS/FDA sidered at Twenty-second Session of the Codex ation at Step 5. Alimentarius Commission) (CAC) Ref. ALINORM 97/31 and 97/31A. 28418 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

US participation/ Responsible Codex committee Standard Status of consideration agenda agency

Dexamethasone ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Diclazuril ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Dihydrostreptomycin and MRLs Under Consider- Yes ...... HHS/FDA streptomycin. ation at Step 5. Febantal/Fenbendazole/ MRLs Under Consider- Yes ...... HHS/FDA Oxfendazole. ation at Step 5. Gentamicin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Neomycin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Spectinomycin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Thiamphenicol ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5. Tilmicosin ...... MRLs Under Consider- Yes ...... HHS/FDA ation at Step 5.

In addition, the following matter will be gallate, ethyl acetate, ethyl alcohol, glycerol Introduction section of Annex IV (see brought to the attention of the 22nd Session ester of wood rosin, hydrochloride acid, attached list) and the whole of Annex V of the Codex Alimentarius Commission in isomalt, konjac flour, lactic acid, nitrogen, (Food Categorisation System to be used in the June 1997 for adoption: octyl gallate, phosphoric acid, polydextrose, GSC) to be forwarded to the Twenty-second ∫ Amendments to Methods of Analysis for potassium benzoate, potassium bromate, Session of the Codex Committee for adoption Previously Adopted Maximum Residue potassium nitrate, propyl gallate, sodium at Step 8; Limits for Veterinary Drugs benzoate, sodium cyclamate, sodium ∫ Position paper on zearalenone to be ∫ Priority List of Veterinary Drugs metaphosphate (insoluable), sodium nitrate, prepared for the 30th CCFAC; Requiring Evaluation or Reevaluation. sodium nitrite, sodium polyphosphates ∫ Proposed Draft Code of Practice for the Responsible Agency: (glassy), sodium stearoyl-2-lactylate, sorbitol Reduction of Aflatoxins in Raw Materials and HHS/FDA syrup, stearyl tartrate, sucrose acetate Supplementary Feeding stuffs for Milk- USDA/FSIS isobutyrate, triacetin, and xylitol. Producing Animals at Step 8; US Participation: Yes Specifications for the following flavouring ∫ Position paper on Ochratoxin A to be agents are recommended by the CCFAC for revised and to include proposed maximum Food Additives and Contaminants adoption by the Twenty-second Session of levels; The Codex Committee on Food Additives the Codex Commission: allyl butyrate, allyl ∫ The CCFAC decided to discontinue and Contaminants (CCFAC) establishes or 2-ethylbutyrate, allyl hexanoate, allyl consideration of the guideline level of 0.5 endorses permitted maximum or guideline isovalerate, allyl nonanoate, allyl octanoate, mg/kg lead in the Draft Guideline Levels for levels for individual food additives, benzaldehyde, benzyl acetate, benzyl alcohol, Cadmium and Lead in Cereals, Pulses and contaminants, and naturally occurring benzyl benzoate, ethyl alcohol, ethyl Legumes at Step 7 in view of its decision to toxicants in food and animal feed. The 29th butyrate, ethyl decanoate, ethyl dodecanoate, include a level of 0.2 mg/kg in the General ethyl formate, ethyl heptanoate, ethyl Session of the CCFAC met March 17–21, Standard for Contaminants and Toxins. The hexadecanoate, ethyl hexanoate, ethyl 1997, in the Hague, The Netherlands. The CCFAC decided to maintain the guideline octadecanoate, ethyl pentanoate, ethyl 30th Session of the CCFAC is tentatively level of 0.1 mg/kg cadmium at Step 7; scheduled for March 9–13, 1998, in the propionate, ethyl tetradecanoate, isoamyl Hague, The Netherlands. The following alcohol, isoamyl formate, isoamyl hexanoate, Responsible Agency: HHS/FDA matters contained in ALINORMS 12 and 12A and isoamyl propionate. Specifications for U.S. Participation: Yes are under consideration by the CCFAC: the following food additives are Food Additives recommended by the CCFAC for adoption Food Additives after changes considered editorial have been For the purposes of Codex, a food additive ∫ Proposed Draft General Standard for made by the Twenty-second Session of the means any substance not normally consumed Food Additives: Preamble (forward to Codex Commission: ‘‘β-cyclodextrin, lactitol, as a food by itself and not normally used as Commission at Step 8); Annex A (Guidelines maltitol, mannitol, mineral oil (high a typical ingredient in the food, whether or for the Estimation of Appropriate Levels of viscosity), sodium thiocyanate, and sorbitol. not it has nutritive value, the intentional Use of Food Additives) to be revised for Specifications for the following flavouring addition of which to food for a technological consideration at Step 5; additives with agents are recommended by the CCFAC for (including organoleptic) purpose in the nonnumerical JECFA ADIs (forward to adoption after changes considered editorial manufacture, processing, preparation, Commission at Step 5 with recommendation have been made by the Twenty-second treatment, packing, packaging, transport, or to adopt Step 8); antioxidants, preservatives, Session of the Codex Commission: allyl holding of such food results, or may be stabilizers, thickeners, sweeteners with heptanoate, allyl phenoxyacetate, allyl 10- reasonably expected to result (directly or numerical JECFA ADIs (forward to undecanoate, and ethyl acetate. indirectly), in it or its by-products becoming Commission at Step 5); colours, colour a component of or otherwise affecting the retention agents, bulking agents, and Contaminants characteristics of such foods. The food emulsifiers (Step 3) (see Table 1, below); and ∫ Proposed Draft General Standard for additive term does not include ∫ Specifications for the following food Contaminants and Toxicants in Food ‘‘contaminants’’ or substances added to food additives are recommended by the CCFAC Annexes I (Criteria for the Establishment of for maintaining or improving nutritional for adoption by the Twenty-second Session Maximum Levels in Foods), II (Procedure for qualities. of the Codex Commission; acesulfame K, Risk Management Decisions), and III (Format The General Standard for Food Additives alitame, ammonia solution, benzoic acid, of the Standard) to be forwarded to the (GSFA) will set forth maximum levels of use benzyl alcohol, calcium benzoate, calcium Twenty-second Session of the Commission at of food additives in various foods and food cyclamate, calcium dihydrogen phosphate, Step 8; categories. The maximum levels will be calcium stearoyl-2-lactylate, carmines, ∫ Proposed Draft General Standard for based on the food additive provisions of curcumin, cyclohexysulfamic acid, dodecyl Contaminants and Toxicants in Food: previously established Codex commodity Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28419 standards, as well as on the use of the be included in the general Standard for Food are used as antioxidants, preservatives, additives in non-standardized foods. Additives (GSFA). The draft GSFA, which is stabilizers, thickeners, and sweeteners. All of Only those food additives for which an being developed in stages, currently covers the additives that are currently under acceptable daily intake (ADI) has been only those JECFA-reviewed food additives consideration for inclusion in the draft GFSA established by the Joint FAO/WHO Expert that have non-numerical JECFA ADIs and are listed below. Committee on Food Additives (JECFA) will additives with numerical JECFA ADIs that

US Codex committee Substance Status of consideration participation/ Responsible agenda agency

(Food Additives and Contaminants) Ref. Acesulfame Potassium ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Acetic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Acetic and Fatty Acid Esters of Maximum Levels Under Con- Yes ...... HHS/FDA Glycerol. sideration at Step 5/8. Acetylated Distarch Adipate .... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Acetylated Distarch Phosphate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Acid Treated Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Agar ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Alginic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Alitame ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Alkaline Treated Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Allura Red AC ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Alpha-Amylase (Aspergillus Maximum Levels Under Con- Yes ...... HHS/FDA oryzae, var.). sideration at Step 3. Alpha-amylase (Bacillus Maximum Levels Under Con- Yes ...... HHS/FDA megaterium expressed in sideration at Step 5/8. Bacillus subtilis). Alpha-amylase (Bacillus Maximum Levels Under Con- Yes ...... HHS/FDA stearothermophilus ex- sideration at Step 5/8. pressed in Bacillus subtilis). Alpha-amylase (Bacillus Maximum Levels Under Con- Yes ...... HHS/FDA stearothermophilus). sideration at Step 5/8. Alpha-amylase ( Bacillus Maximum Levels Under Con- Yes ...... HHS/FDA subtilis). sideration at Step 5/8. Alpha-amylase (Carbohydrase) Maximum Levels Under Con- Yes ...... HHS/FDA (Bacillus lichenforms). sideration at Step 5/8. Aluminum Ammonium Maximum Levels Under Con- Yes ...... HHS/FDA Sulphate. sideration at Step 5. Aluminum Silicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Amaranth ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 3. Ammonium Acetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Alginate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Chloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Citrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Fumarate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Hydrogen Carbon- Maximum Levels Under Con- Yes ...... HHS/FDA ate. sideration at Step 5/8. Ammonium Hydroxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Lactate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Malate, D,L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ammonium Polyphos- phate ... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. 28420 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

US Codex committee Substance Status of consideration participation/ Responsible agenda agency

Ammonium Sulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Annato Extracts (Includes Bixin Maximum Levels Under Con- Yes ...... HHS/FDA and Norbixin). sideration at Step 3. Anoxomer ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. (Food Additives and Contaminants) Ref. Ascorbic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Ascorbyl Palmitate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Ascorbyl Stearate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Aspartame ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Azorubin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Beeswax, White and Yellow .... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Beet Red ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Benzoic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. BHA ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. BHT ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Bleached Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Bone Phosphate (Essentially Maximum Levels Under Con- Yes ...... HHS/FDA Calcium Phosphate Tribasic). sideration at Step 3. Brilliant Black PN ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Brilliant Blue FCF ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Bromelain ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Brown HT ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 3. Calcium Acetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Alginate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Aluminum Silicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Ascorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Benzoate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Chloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Citrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Dihydrogen Maximum Levels Under Con- Yes ...... HHS/FDA Diphosphate. sideration at Step 3. Calcium Disodium Maximum Levels Under Con- Yes ...... HHS/FDA Ethylenediaminetetra-acetate. sideration at Step 5. Calcium Formate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Gluconate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Glutamate, DL, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Guanylate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Calcium Hydrogen Sulphite ..... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Calcium Hydroxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Inosinate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28421

US Codex committee Substance Status of consideration participation/ Responsible agenda agency

Calcium Lactate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Malate, D, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Oleyl Lactylate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Calcium Oxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Polyphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Propionate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Ribonucleotides, 5′- ... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Silicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Sorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Stearoyl Lactylate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Calcium Sulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Calcium Sulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. (Food Additives and Contaminants) Ref. Candelilla Wax ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 3. Canthaxanthin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Caramel Colour, Class I ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Caramel Colour, Class III ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Caramel Colour, Class IV ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Carbon Dioxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Carmines (Includes Aluminum Maximum Levels Under Con- Yes ...... HHS/FDA and Calcium Lakes of Car- sideration at Step 3. minic Acid). Carnuba Wax ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Carob Bean Gum ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Carotenes, Vegetable ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Carotene, β-(synthetic) ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Carotene, β-apo-8′- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Carotenic Acid, β-apo-8′, Maximum Levels Under Con- Yes ...... HHS/FDA methyl or ethyl ester. sideration at Step 3. Carrageenan ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Chlorophyll s ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Chlorophylls, Copper Complex Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 3. Chlorophyllin Copper Complex, Maximum Levels Under Con- Yes ...... HHS/FDA Sodium and Potassium salts. sideration at Step 3. Cholic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Citric Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Citric and Fatty Acid Esters of Maximum Levels Under Con- Yes ...... HHS/FDA Glycerol. sideration at Step 5/8. Curcumin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Cyclamates (acid and Na, K, Maximum Levels Under Con- Yes ...... HHS/FDA Ca salts). sideration at Step 5. Dextrins, White and Yellow, Maximum Levels Under Con- Yes ...... HHS/FDA Roasted Starch. sideration at Step 5/8. 28422 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

US Codex committee Substance Status of consideration participation/ Responsible agenda agency

Diacetyltartaric Acid and Fatty Maximum Levels Under Con- Yes ...... HHS/FDA Acid Esters of Glycerol. sideration at Step 5. Dicalcium Diphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Dicalcium Orthophosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Dilauryl Thiodipropionate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Dimagnesium Orthophosphate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Dimethyl Dicarbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. (Food Additives and Contaminants) Ref. Dioctyl Sodium Sulfosuccinate Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Diphenyl ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Dipotassium Diphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Dipotassium Guanylate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Dipotassium Inosinate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Dipotassium Orthophosphate .. Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Dipotassium Tartrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Disodium Diphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Disodium Maximum Levels Under Con- Yes ...... HHS/FDA Ethylenediaminetetra-acetate. sideration at Step 5. Disodium Guanylate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Disodium Inosinate, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Disodium Orthophosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Disodium Ribonucleotides, 5′ .. Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Disodium Tartrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Disodium Phosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Enzyme Treated Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Erythorbic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Erythrosine ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Ethyl Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ethyl Hydroxyethyl Cellulose ... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Ethyl p-Hydroxybenzoate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Ethyl Maltol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Fast Green FCF ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Ferrous Gluconate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Ferrous Lactate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Formic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Fumaric Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Gellan Gum ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Glucono delta-lactone ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Glucose Oxidase (Aspergillus Maximum Levels Under Con- Yes ...... HHS/FDA niger, var.). sideration at Step 5/8. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28423

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(Food Additives and Contaminants) Ref. Glutamic Acid, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Glycerol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Glycerol Ester of Wood Rosin Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Grape Skin Extract ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Guaiac Resin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Guanylic Acid, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Guar Gum ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Gum Arabic ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Hexamethylene Tetramine ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Hydrochloric Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Hydroxypropyl Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Hydroxypropyl Distarch Phos- Maximum Levels Under Con- Yes ...... HHS/FDA phate. sideration at Step 5/8. Hydroxypropyl Methyl Cel- Maximum Levels Under Con- Yes ...... HHS/FDA lulose. sideration at Step 5/8. Hydroxypropyl Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Indigotine ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. (Food Additives and Contaminants) Ref. Inosinic Acid, 5′ ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Insoluable Polyvinylpyrrolidone Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Iron Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Iron Oxides (Black, Red, & Maximum Levels Under Con- Yes ...... HHS/FDA Yellow). sideration at Step 3. Isomalt ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Isopropyl Citrates ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Karaya Gum ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Konjac Flour ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Lactic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Lactic and Fatty Acid Esters of Maximum Levels Under Con- Yes ...... HHS/FDA Glycerol. sideration at Step 5/8. Lactitol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Lethicin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Lipase (Animal Sources) ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Lipase (Aspergillus oryzae, Maximum Levels Under Con- Yes ...... HHS/FDA var.). sideration at Step 5/8. (Food Additives and Contaminants) Ref. Lysozyme, Hydrochloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 3. Magnesium Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Chloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Glutamate, DL, L- Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Hydrogen Carbon- Maximum Levels Under Con- Yes ...... HHS/FDA ate. sideration at Step 5/8. Magnesium Hydroxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Lactate, DL, L- ..... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. 28424 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

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Magnesium Oxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Silicate (Synthetic) Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Magnesium Sulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Malic Acid, D, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Malitol (Including Malitol Maximum Levels Under Con- Yes ...... HHS/FDA Syrup). sideration at Step 5/8. Maltol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Mannitol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Methyl Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Methyl Ethyl Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Methyl p-Hydroxybenzoate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Microcrystalline Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Microcrystalline Wax, Synthetic Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Mineral Oil ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Mono-and Diglycerides ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Monoammonium Glutamate, L- Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Monocalcium Orthophosphate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Monopotassium Glutamate, L- Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Monopotassium Maximum Levels Under Con- Yes ...... HHS/FDA Orthophosphate. sideration at Step 5. Monopotassium Tartrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Monosodium Glutamate, L- ..... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Monosodium Orthophosphate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Monosodium Tartrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Monosodium Phosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Nisin ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Nitrogen ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Orthophenylphenol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Orthophosphoric Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Oxidized Starch ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Papain ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Pectins (Amidated and non- Maximum Levels Under Con- Yes ...... HHS/FDA Amidated). sideration at Step 5/8. Pentapotassium Triphosphate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Pentasodium Triphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Phosphated Distarch Phos- Maximum Levels Under Con- Yes ...... HHS/FDA phate. sideration at Step 5/8. Pimaricin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Polydextroses ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Polyethylene Glycol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28425

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Polyglycerol Esters of Fatty Maximum Levels Under Con- Yes ...... HHS/FDA Acids. sideration at Step 5. (Food Additives and Contaminants) Ref. Polyglycerol Esters of Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. Interesterified Ricinoleic Acid. sideration at Step 5. Polyoxyethylene (8) Stearate .. Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Polysorbates 20, 40, 60, 65, Maximum Levels Under Con- Yes ...... HHS/FDA and 80. sideration at Step 5. Polyvinylpyrrolidone ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Ponceau 4R ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Potassium Acetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Benzoate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Alginate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Ascorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Bisulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Chloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Dihydrogen Citrate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Hydrogen Carbon- Maximum Levels Under Con- Yes ...... HHS/FDA ate. sideration at Step 5/8. (Food Additives and Contaminants) Ref. Potassium Hydrogen Malate, Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. D, L-. sideration at Step 5/8. Potassium Hydroxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Lactate (Solution) .. Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Malate, D, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Metabisul- phate .... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Nitrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Polyphos- phate ..... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Propiniate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Silicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Sodium Tartrate ..... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Sorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Potassium Sulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Potassium Sulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Powdered Cellulose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. (Food Additives and Contaminants) Ref. Processed Eucheuma Sea- Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. weed. sideration at Step 5. Propane ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Propionic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Propyl Gallate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Propyl p-Hydroxy- benzoate .... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Propylene Glycol ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Propylene Glycol Alginate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. 28426 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

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Propylene Glycol Esters of Maximum Levels Under Con- Yes ...... HHS/FDA Fatty Acids. sideration at Step 5. Quinoline Yellow ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Red 2G ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Riboflavin ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Riboflavin 5′-Phosphate, So- Maximum Levels Under Con- Yes ...... HHS/FDA dium. sideration at Step 3. Saccharin (and Na, K, Ca, Maximum Levels Under Con- Yes ...... HHS/FDA salts). sideration at Step 5. Salts of Fatty Acids (Ammo- Maximum Levels Under Con- Yes ...... HHS/FDA nium, Calcium, Potassium, sideration at Step 5/8. Sodium). (Food Additives and Contaminants) Ref. Silicon Dioxide (Amorphous) ... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Sodium Acetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Alginate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Aluminosilicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Aluminum Phosphate- Maximum Levels Under Con- Yes ...... HHS/FDA Acidic. sideration at Step 3. Sodium Aluminum Phosphate- Maximum Levels Under Con- Yes ...... HHS/FDA Basic. sideration at Step 3. Sodium Ascorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Benzoate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Calcium Maximum Levels Under Con- Yes ...... HHS/FDA Polyphosphate. sideration at Step 3. Sodium Carbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Carboxymethyl Cel- Maximum Levels Under Con- Yes ...... HHS/FDA lulose. sideration at Step 5/8. Sodium Diacetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Dihydrogen Citrate ..... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Ethyl p- Maximum Levels Under Con- Yes ...... HHS/FDA Hydroxybenzoate. sideration at Step 5. (Food Additives and Contaminants) Ref. Sodium Erythorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5/8. Sodium Formate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Fumarate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Hydrogen Carbonate .. Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Hydrogen Malate, D, Maximum Levels Under Con- Yes ...... HHS/FDA L-. sideration at Step 5/8. Sodium Hydrogen Sulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Hydroxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Lactate (Solution) ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Malate, D, L- ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Metabisulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Methyl p- Maximum Levels Under Con- Yes ...... HHS/FDA Hydroxybenzoate. sideration at Step 5. Sodium Nitrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Nitrite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Oleyl Lactylate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28427

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(Food Additives and Contaminants) Ref. Sodium o-Phenylphenol ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Sodium Polyphosphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Propionate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Propyl p- Maximum Levels Under Con- Yes ...... HHS/FDA Hydroxybenzoate. sideration at Step 5. Sodium Sesquicarbonate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Silicate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Sorbate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Sulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Stearoyl Lactylate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sodium Sulphate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Sodium Sulphite ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbic Acid ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbitan Monolaurate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbitan Monooleate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. (Food Additives and Contaminants) Ref. Sorbitan Monpalmitate ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Sorbitan Monostearate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbitan Trioleate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbitan Triesterate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sorbitol (Including Sorbitol Maximum Levels Under Con- Yes ...... HHS/FDA Syrup). sideration at Step 5/8. Stannous Chloride ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Starch Acetate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Starch Sodium Maximum Levels Under Con- Yes ...... HHS/FDA Octenylsuccinate. sideration at Step 5/8. Stearyl Citrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Stearyl Tartrate ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Sucralose ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sucroglycerides ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sucrose Acetate Isobutyrate ... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Sucrose Fatty Acid Esters ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. (Food Additives and Contaminants) Ref. Sulphur Dioxide ...... Maximum Levels Under Con- Yes ...... HHS/FDA ALINORM 97/12 and 97/12A. sideration at Step 5. Sunset Yellow FCF ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 3. Talc ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Tara Gum ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5/8. Tartaric, Acetic and Fatty Acid Maximum Levels Under Con- Yes ...... HHS/FDA Esters of Glycerol (Mixed). sideration at Step 5/8. Tartaric Acid (L(+)¥) ...... Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. tert-Butylhydroquinone (TBHQ) Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. Tetrapotassium Diphos- phate Maximum Levels Under Con- Yes ...... HHS/FDA sideration at Step 5. 28428 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

US Codex committee Substance Status of consideration participation/ Responsible agenda agency

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

Contaminants A contaminant means any substance not intentionally added to food, which is present in such food as a result of the production (including operations carried out in crop husbandry, animal husbandry and veterinary medicine), manufacture, processing, preparation, treatment, packing, packaging, transport, or holding of such food or as a result of environmental contamination. The term contaminant does not include insect fragments, rodent hairs, and other extraneous matter. The Codex maximum level (ML) for a contaminant or naturally occurring toxicant in a food or feed commodity is the maximum concentration of that substance recommended by the Codex Alimentarius Commission to be legally permitted in that commodity. The ML is intended to ensure free movement of food in international trade while protecting the health of the consumer. The General Standard for Contaminants and Toxins in Foods will establish maximum levels for contaminants in foods based on the following considerations: toxicological data, human exposure estimates, availability of analytical procedures, fair trade and technological implications, regional variations, risk assessment, and risk management. The criteria for inclusion of a maximum level for a contaminant in a food are: (a) consumption of the contaminated food presents a significant risk to consumers; and (b) the existence of actual problems in trade of food. The contaminants currently being examined to determine whether they meet these criteria for inclusion in the Codex General Standard for Contaminants and Toxins are listed below.

U.S. participa- Responsible Codex committee Standard Status of consideration tion/agenda agency

(CCFAC) Ref. ALINORM 97/12 ...... Arsenic ...... Position Paper to be re- Yes ...... HHS/FDA vised for discussion during the 1998 CCFAC. Cadmium ...... Position Paper to be re- Yes ...... HHS/FDA vised for discussion during the 1998 CCFAC. (CCFAC) Ref. ALINORM 97/12 ...... Lead ...... Forwarded draft maximum Yes ...... HHS/FDA levels to the Commis- sion at Step 5 with rec- ommendation for adop- tion. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28429

U.S. participa- Responsible Codex committee Standard Status of consideration tion/agenda agency

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

Codex Committee on Pesticide Residues The Codex Committee on Pesticide Residues recommends to the Codex Alimentarius Commission establishment of maximum limits for pesticide residues for specific food items or in groups of food. A Codex Maximum Limit for Pesticide Residues (MRLP) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. Foods derived from commodities that comply with the respective MRLPs are intended to be toxicologically acceptable, that is, consideration of the various dietary residue intake estimates and determina- tions both at the national and international level in comparison with the ADI*, should indicate that foods complying with Codex MRLPs are safe for human consumption. Codex MRLPs are primarily intended to apply in international trade and are derived from reviews conducted by the Joint Meeting on Pesticide Residues (JMPR) following: (a) Review of residue data from supervised trials and supervised uses including those reflecting national good agricultural practices (GAP). Data from supervised trials conducted at the highest nationally recommended, authorized, or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLPs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices, and (b) Toxicological assessment of the pesticide and its residue. MRLs recommended for advancement to steps 5 or 8 by the 28th and 29th CCPRs will be considered by the 22nd Session of the Codex Alimentarius Commission in June 1997. *Acceptable Daily Intake (ADI) of a chemical is the daily intake which, during an entire lifetime, appears to be without appreciable risk to the health of the consumer on the basis of all the known facts at the time of the evaluation of the chemical by the Joint FAO/WHO Meeting on Pesticide Residues. It is expressed in milligrams of the chemical per kilogram of body weight.

US Participation/ Responsible Codex committee Standard Status of consideration agenda agency

Pesticide Residues (considered at the 28th and 29th Aldicarb ...... MRLs under consideration Yes ...... EPA CCPRs (Annex II to ALINORMS 97/42 and 97/ at Steps 5 and 5/8 and 42A). CXL deletions. Aldrin/dieldrin ...... EMRLs at Step 8 ...... Yes ...... EPA Azinphos-methyl ...... MRLs under consideration Yes ...... EPA at Steps 5/8 and 8 and CXL deletions. Pesticide Residues (considered at the 28th and 29th Bentazone ...... MRLs under consideration Yes ...... EPA Session of the Codex Committee on Pesticide at Step 8. Residues (Annex II to ALINORMS 97/24 and 97/ 24A). Bifenthrin ...... MRLs under consideration Yes ...... EPA at Step 8. Bromide Ion ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Bromopropylate ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Buprofezin ...... MRLs under consideration Yes ...... EPA at Step 8. Captan ...... Temporary CXLs deleted Yes ...... EPA Cartap ...... CXL deletions (all) ...... Yes ...... EPA Chlormequat ...... CXL deletions ...... Yes ...... EPA Chlorothalonil ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Chlorpyrifosmethyl ...... MRLs under consideration Yes ...... EPA at Step 5. 28430 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

US Participation/ Responsible Codex committee Standard Status of consideration agenda agency

Clethodim ...... MRLs under consideration Yes ...... EPA at Step 5. Cycloxydim ...... MRLs under consideration Yes ...... EPA at Step 8. DDT ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letion. Pesticide Residues (considered at the 28th and 29th Diazinon ...... MRLs under consideration Yes ...... EPA Session of the Codex Committee on Pesticide at Steps 5/8 and 8 and Residues (Annex II to ALINORMS 97/24 and 97/ CXL deletions. 24A). Dichlorvos ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Dicloran ...... CXL deletions ...... Yes ...... EPA Dicofol ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Dimethoate ...... MRLs under consideration Yes ...... EPA at Step 8. Diquat ...... MRLs under consideration Yes ...... EPA at Step 5 and CXL de- letions. Dithianon ...... MRLs under consideration Yes ...... EPA at Step 8. Dithiocarbamates ...... MRLs under consideration Yes ...... EPA at Step 5 and CXL de- letions. Endrin ...... EMRLs under consider- Yes ...... EPA ation at Step 8 and CXL deletions. Ethephon ...... MRLs under consideration Yes ...... EPA at Steps 5, 5/8 and 8. Ethion ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Pesticide Residues (considered at the 28th and 29th Ethofenprox ...... MRLs under consideration Yes ...... PA Sesssion of the Codex Committee on Pesticide at Step 8. Residues (Annex II to ALINORMS 97/24 and 97/ 24A). Ethoxyquin ...... CXL deletion ...... Yes ...... EPA Etrimfos ...... CXL deletions (all) ...... Yes ...... EPA Fenarimol ...... MRLs under consideration Yes ...... EPA at Step 5 and 5/8. Fenbutatin Oxide ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letions. Fenpropathrin ...... MRLs under consideration Yes ...... EPA at Step 8. Fenpropimorph ...... MRLs under consideration Yes ...... EPA at Step 5. Fenthion ...... MRLs under consideration Yes ...... EPA at Steps 5 and 5/8 and CXL deletions. Fentin ...... CXL deletion ...... Yes ...... EPA Flucythrinate ...... CXL deletion ...... Yes ...... EPA Flusilazole ...... MRLs under consideration Yes ...... EPA at Step 8. Folpet ...... MRLs under consideration Yes ...... EPA at Step 8 and CXL de- letion. Glufosinate-ammonium .... MRLs under consideration Yes ...... EPA at Steps 5/8 and 8. Pesticide Residues (considered at the 28th and 29th Glyphosate ...... MRLs under consideration Yes ...... EPA Session of the Codex Committee on Pesticide at Step 5/8 and CXL Residues (Annex II to ALINORMS 97/24 and 97/ deletions. 24A). Hexythiazox ...... MRLs under consideration Yes ...... EPA at Step 8. Imazalil ...... MRL under consideration Yes ...... EPA at Step 5/8. Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28431

US Participation/ Responsible Codex committee Standard Status of consideration agenda agency

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

Codex Committee on Methods of Analysis and sampling proposed by Codex The following matters will be brought to and Sampling (Commodity) Committees, except that the attention of the 22nd Session of the The Codex Committee on Methods of methods of analysis and sampling for Codex Alimentarius Commission in June Analysis and Sampling: residues of pesticides or veterinary drugs in 1997, for adoption: (a) Defines the criteria appropriate to food, the assessment of micro-biological fl Analytical Terminology for Codex Use; Codex Methods of Analysis and Sampling; quality and safety in food, and the fl Guidelines for the Assessment of the (b) Serves as a coordinating body for Codex assessment of specifications for food Competence of Testing Laboratories Involved with other international groups working in additives do not fall within the terms of in the Import and Export Control of Food; methods of analysis and sampling and reference of this Committee; and quality assurance systems for laboratories; (e) Elaborates sampling plans and fl Revised Terms of Reference for the (c) Specifies, on the basis of final procedures, as may be required; Committee.* recommendations submitted to it by the other (f) Considers specific sampling and The Committee is continuing work on: bodies referred to in (b) above, Reference analysis problems submitted to it by the fl Proposed Draft Codex General Methods of Analysis and Sampling Commission or any of its Committees; and Guidelines on Sampling; appropriate to Codex Standards which are (g) Defines procedures, protocols, fl Criteria for evaluating acceptable generally applicable to a number of foods; guidelines or related texts for the assessment methods of analysis for Codex purposes; (d) Considers, amends, if necessary, and of food laboratory proficiency, as well as endorses, as appropriate, methods of analysis quality assurance systems for laboratories. * Not in Step procedure. 28432 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

fl Harmonization of test results corrected Codex Committee on General Principles Frozen Fish Sticks, Fish Portions and Fish for recovery factors; The Codex Committee on General Fillets—Breaded or in Batter fl Harmonization of analytical Principles deals with rules and procedures To be considered at Step 5: terminology in accordance with international referred to it by the Codex Alimentarius fl Draft Guidelines for Labelling Foods standards;—Report of Inter-Agency Meeting Commission. None of the following that can cause Hypersensitivity (Proposed on ‘‘limits;’’ recommendations for changing the rules of Draft Amendment to the General Standard for fl Measurement uncertainty; and procedure for Codex are in the Step the Labelling of Prepackaged Foods) fl Report of the Inter-Agency Meeting; Procedure. The reference document is The committee is continuing to work on: and ALINORM 97/33. fl Draft Guidelines for the Production, fl Endorsement of methods of analysis for The Committee recommended the Processing, Labelling and Marketing of Codex purposes. following matters for adoption by the 22nd Organically Produced Foods at Step 6 The Committee agreed to propose the Session of the Codex Alimentarius fl Draft Recommendations for the following new work: Commission: Labelling of Foods Obtained through fl In-house method validation. fl Amendment to the Rules of Procedure Biotechnology at Step 3 The reference documents are ALINORM (Rules II and IX to provide for the fl Review of General Guidelines for 97/23 and 97/23a. appointment of Members of the Commission Nutrition Labelling including consideration RESPONSIBLE AGENCY: HHS/FDA USDA/ as Coordinators and to confirm their of expanding the list of nutrients required to AMS attendance as observers at sessions of the be declared to include saturated fat, sodium, U.S. PARTICIPATION: Yes Executive Committee.) sugars, and fiber whenever nutrition labelling fl Addition of an Appendix to the is used. Codex Committee on Food Import and Export Procedural Manual entitled ‘‘General Inspection and Certification Systems fl Review of Guidelines for Use of Health Decisions of the Commission.’’ The proposed Claims including circulating for government The Codex Committee on Food Import and Appendix to the Procedural Manual to comment the sections on health claims Export Certification and Inspection Systems include: Four Statements of Principle on the previously removed form the guidelines. is charged with developing principles and Role of Science in the Codex Decision- guidelines for food import and export Making Process and the extent to which other RESPONSIBLE AGENCY: HHS/FDA, USDA/ inspection and certification systems. factors are taken into account and Four FSIS Included in the charge are application of Statements of Principle relating to the Role U.S. PARTICIPATION: Yes measures by competent authorities to provide of Food Safety Risk Assessment Codex Committee on Food Hygiene assurance that foods comply with essential fl Revision of the following sections of food safety and quality requirements. the Procedural Manual: The Food Hygiene Committee drafts basic Recognition of quality assurance systems Definitions provisions on food hygiene for all foods. The through the development of guidelines will Guidelines for Codex Committees term ‘‘hygiene’’ also includes, where help ensure that foods conform to the Guidelines for the Inclusion of Specific applicable, microbiological specifications for essential requirements. Draft guidelines to be Provisions in Codex Standards food and associated methodology. considered by the Codex Alimentarius Criteria for the Establishment of Work The following matters will be considered Commission at its Twenty-second session in Priorities by the Codex Alimentarius Commission at its June can be found in ALINORMS 97.30 and Relations between Commodity Committees Twenty-second session in June 1997. 30A. and General Subject Committees— Information about the Codes and Guidelines To be considered at Step 8: Section K can be found in ALINORMS 97/13 and 13A. To be considered at Step 8: fl Guidelines for the Exchange of fl Proposed specific recommendations in fl Draft Revised International Code of Information Between Countries on Rejections order to clarify the status of ‘‘advisory’’ Practice—General Principles of Food Hygiene of Imported Food codes, Guidelines and related texts fl fl Draft Guidelines for the Design, The committee also recommended that the Draft Revised Guidelines for the Operation, Assessment and Accreditation of Code of Principles concerning Milk and Milk Application of the Hazard Analysis Critical Food Import and Export Inspection and Products be redrafted as a standard and Control Point (HACCP) System Certification Systems recommended that the Draft Guidelines for fl Draft Revised Principles for the In addition, the Committee agreed: Codex Contact Points and National Codex Establishment and Application of fl to append the Criteria for a Generic Committees prepared by CCASIA be Microbiological Criteria for Foods Certificate for the Export of Food and Food circulated to other Regional Coordinating In addition, the committee requested Products and the Model Certificate to its Committees. approval to initiate development of the report in order to facilitate Commission following when necessary: RESPONSIBLE AGENCY: USDA/FSIS, HHS/ discussions as to the need for further fl Code of Hygienic Practice for Milk and FDA consideration by CCFICS of this matter from Milk Products U.S. PARTICIPATION: Yes the different perspectives of Codex fl Guidance on the hygienic recycling of commodity committees. Codex Committee on Food Labelling processing water in food processing plants fl that a discussion paper on issues The Codex Committee on Food Labelling is fl Guidance on the application of relating to the process of judgment of responsible for drafting provisions on microbiological risk evaluation to equivalence be prepared for circulation and labelling applicable to all foods and to international trade comment prior to its next session. address issues assigned by the Codex fl Revision of the standard wording for fl with regard to elaboration of guidelines Alimentarius Commission. The following Food Hygiene Provisions (Procedural on Food Import Control Systems that the draft guidelines are being considered by the Manual) delegations of Mexico and the United States Codex Alimentarius Commission at their fl Risk-based guidance for the use of should further develop a discussion paper for June 1997 meeting. The guidelines and other HACCP-like systems in small business, with review at the Committee’s next session. documents listed below are located in special reference to developing countries fl that the United States should revise the ALINORMS 97/22 and 92/22A. fl Recommendations for the management proposed Draft Guidelines for the To be considered at Step 8: of microbiological hazards for foods in Development of Agreements Regarding Food fl Draft Guidelines for Use of Nutrition international trade Import and Export Inspection and Claims The Commission is invited to advise FAO Certification Systems for circulation and fl Draft General Guidelines for Use of the and WHO to consider the establishment of an comment at Step 3 prior to the Committee’s term ‘‘Halal’’ (foods permitted under Islamic international advisory body addressing the Sixth Session based on discussion and Law). microbiological aspects of food safety and comments received. To be considered at Step 5 of the provide scientific advice in the form of RESPONSIBLE AGENCY: HHS/FDA, USDA/ Accelerated Procedure: formal microbiological risk assessments. FSIS fl Proposed Draft Amendment to the Other matters to be discussed at the 30th U.S. PARTICIPATION: Yes Labelling Section of the Standard for Quick Committee Session in October 1997 include: Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28433

fl Proposed Draft Code of Practice for The reference document for the following standards and draft revised codes of Refrigerated Packaged Foods with Extended matters is ALINORM 97/26. The Twentieth principles will be considered for adoption of Shelf-Life Session of the Committee recommended that the Codex Alimentarius Commission in June fl Principles and Guidelines for the the following documents be considered by 1997. The standards listed below are Conduct of Microbiological Risk Assessment the Twenty-Second Session of the Codex contained in ALINORM 97/11. fl Recommendations for the Control of Alimentarius Commission in June 1997: To be considered at Step 8: Listeria monocytogenes in Foods fl Draft guidelines on the procedure for fl Draft Revised Standard for Butter fl Code of Hygienic Practice for Uncured/ the Table of Conditions for Claims and fl Draft Revised Standard for Milkfat Unripened Cheese and Ripened Soft Cheese Nutrient Contents, to be included in the Draft Products fl Code of Hygienic Practice for the Guidelines for Use of Health and Nutrition fl Draft Revised Standard for Evaporated Transport of Foods in Bulk Claims at Step 8; Milks fl Code of Hygienic Practice for Bottled fl Proposed Draft Standard for Food fl Draft Revised Standard for Sweetened Waters (other than Mineral Water) Grade Sale at Steps 5 and 8; Condensed Milk fl Consideration of a technical paper (to fl Proposed Draft Amendment to the fl Draft Revised Standard for Milk and be prepared by CCFFP) on residual chlorine Standard for Infant Formula; Vitamin B12, at Cream Powders in frozen shrimp and prawns Step 5 of the accelerated procedure; fl Draft Revised Standard for Cheese RESPONSIBLE AGENCY: USDA/FSIS, fl Proposal to amend the Terms of fl Draft Revised Standard for Whey USDC/NOAA, HHS/FDA Reference of the Committee; Cheese U.S. PARTICIPATION: Yes fl Proposed Draft Revised Standard for fl Draft Revised Standard for Cheeses in Codex Committee on Fresh Fruits and Gluten-Free Foods at Step 5; Brine Vegetables fl Proposed Draft Guidelines for Vitamin To be considered at Step 5: and Mineral Supplements at Step 5; and fl Draft Revised Code of Principles The Codex Committee on Fresh Fruits and fl Proposal to discontinue work on Vegetables was established in June 1988. The Concerning Milk and Milk Products Proposed Draft Guidelines on the Inclusion In addition, the committee requested Committee is responsible for elaborating of Nutrition Provisions on Nutritional world-wide standards and codes of practice approval to initiate elaboration of standards Quality in Food Standards. for Dairy Spreads and Mozzarella Cheese and for fresh fruits and vegetables. Several of the In addition to the above documents being standards listed below are contained in a Model Export Certificate for Milk Products. circulated for comment prior to their It also recommended the withdrawal of ALINORM 97/35. consideration by the Commission, the The sixth session of the Committee Cheese Standards for Danablu, Gruyere, following documents are open for comment Gudbrandsdalsost, Norvegia, Esrom, certain recommended that the following standards for consideration at the next Committee and codes of practice be considered for Blue Veined Cheeses and Cream Cheese meeting in March, 1998: (pending the inclusion in the Standard for adoption by the Twenty-second Session of fl Part B of the Table of Conditions for Unripened Cheese Including Fresh Cheese). the Codex Alimentarius Commission in June, Claims for nutrient contents, to be included 1997, at Step 8: in the Draft Guidelines for Use of Health and RESPONSIBLE AGENCY: USDA/AMS, HHS/ fl Draft Standard for Banana; and Nutrition Claims, at Step 6; FDA fl Draft Standard for Mangosteen fl Proposed Draft Revised Standard for The Committee also recommended U.S. PARTICIPATION: Yes Cereal-Based Foods for Infants and Young initiation or continuation of work in the Children at Step 3. Codex Committee on Fats and Oils following areas: fl Draft Standard for Limes (at Step 5); RESPONSIBLE AGENCY: HHS/FDA The Codex Committee on Fats and Oils is fl Draft Standard for Pummelo (at Step 5); U.S. PARTICIPATION: Yes responsible for elaborating standards for fats fl Draft Standard for Guava (at Step 5); and oils of animal, vegetable, and marine Codex Committee on Fish and Fishery origin. fl Draft Standard for Chayote (at Step 5); Products fl Code of Practice for the Quality The reference document is ALINORM 97/ Inspection and Certification of Fresh Fruits The Fish and Fishery Products Committee 17. The Fifteenth Session of the Committee and Vegetables (at Step 5); is responsible for elaborating standards for recommended the following be adopted by fl Draft Standard for Oranges (at Step 3); fresh and frozen fish, crustaceans, and the Commission in June 1997: fl Draft Standard for Asparagus (at Step mollusks. fl Draft Standard for Named Animal Fats 3); The following draft guideline will be at Step 8; fl Draft Revised Standard for Pineapple considered for adoption by the Codex fl Draft Standard for Edible Fats and Oils (at Step 3); Alimentarius Committee at its meeting in Not Covered by Individual Standards at Step fl Draft Standard for Mexican Limes (at June. The guideline is contained in 8; Step 1); ALINORM 97/18. fl Draft Revised Code of Practice for the fl Draft Standard for Grapefruit (at Step To be considered at Step 5: Storage and Transport of Fats and Oils in 1); fl Proposed Draft Guidelines for the Bulk at Step 8; fl Draft Standard for Longan (at Step 1); Sensory Evaluation of Fish and Shellfish In addition, the Commission is invited to fl Draft Standard for Ginger (at Step 1); The committee is continuing work on draft consider the decision of the Committee to fl Preparation of a paper on the Objective revised codes of practice for Frozen Fish, discontinue work on the revision and revoke Indices of Maturity in Commercial Minced Fish, Fresh Fish, Frozen Shrimps the current Standard for Specified Vegetable Transactions of Fruits and Vegetables (at Step and Prawns, Molluscan Shellfish, Salted Fat products and Specified Animal and 1); and, Fish, and Smoked Fish at Step 3. Vegetable Fat products. The Commission is fl Document concerning the Application In addition, it is working on a Proposed also invited to consider whether work should of Quality Tolerances at Import (at Step 1) Draft Code of Practice for the Products of proceed in converting the European Regional RESPONSIBLE AGENCY: USDA/AMS Aquaculture at Step 3 and a draft section on Standard for mayonnaise into a world-wide U.S. PARTICIPATION: Yes training for the Proposed Guidelines for the standard. Sensory Evaluation of Fish and Shellfish at RESPONSIBLE AGENCY: HHS/FDA Codex Committee on Nutrition and Foods for Step 3. U.S. PARTICIPATION: Yes Special Dietary Uses RESPONSIBLE AGENCY: HHS/FDA, USDC/ The Committee on Nutrition and Foods for NOAA/NMFS Codex Committee on Cocoa Products and Special Dietary Uses is responsible for U.S. PARTICIPATION: Yes Chocolate studying nutritional problems referred by the The Codex Committee on Cocoa Products Codex Alimentarius Commission. The Codex Committee on Milk and Milk Products and Chocolate held 15 sessions. The last Committee also drafts provisions on The Codex Committee on Milk and Milk meeting, at which the original program of nutritional aspects for all foods and develops Products is responsible for establishing work was completed, was held in 1982. The guidelines, general principles, and standards international codes and standards for milk Committee elaborated world-wide standards for foods for special dietary uses. and milk products. The following revised for cocoa products and chocolate. 28434 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

The Commission in 1991 decided to fl Proposed Draft Revised Standard for Certain Codex Commodity Committees embark on a program of work to update and Canned Peaches Several Codex Alimentarius Commodity revise all of the standards. fl Proposed Draft Revised Standard for Committees have adjourned sine die. The The revisions were to include updating of Canned Grapefruit following Committees fall into this category: the sections on food hygiene and food fl Proposed Draft Revised Standard for fl Cereals, Pulses and Legumes* labeling and removal from the standards of Canned Green Beans and Wax Beans Responsible Agency: HHS/FDA, USDA/ all non-essential details. The standards, fl Proposed Draft Revised Standard for GIPSA when updated and revised, should contain Canned Applesauce U.S. Participation: Yes only those provisions that are necessary to fl Proposed Draft Revised Standard for fl Edible Ices protect consumer health and prevent fraud. Responsible Agency: HHS/FDA Provisions of an advisory nature reflecting Canned Sweet Corn U.S. Participation: Yes quality factors and criteria typically used in fl Proposed Draft Revised Standard for fl Meat Hygiene* trade to define or describe the quality of the Edible Fungi and Fungus Products Responsible Agency: USDA/FSIS product are to be removed from the standard. fl Proposed Draft Revised Standard for U.S. Participation: Yes These guidance provisions are intended to Edible Dried Fungi fl Processed Meat and Poultry Products* assist users of the Codex standard when fl Proposed Draft Revised Standard for Responsible Agency: USDA/FSIS making international purchases and are, Fresh Fungus ‘‘Chanterelle’’ U.S. Participation: Yes therefore, not subject to formal acceptance by fl Proposed Draft Revised Standard for fl Sugars users of the standard. Canned Pineapple Responsible Agency: HHS/FDA The Twenty-first Session of the fl Proposed Draft Revised Standard for Commission endorsed the recommendation U.S. Participation: Yes Canned Asparagus fl of the forty-second session of the Executive Soups and Broths* fl Proposed Draft Revised Standard for Responsible Agency: USDA/FSIS Committee to initiate the revision of the Processed Tomato Concentrates Cocoa Products and Chocolate Standards. U.S. Participation: Yes fl Proposed Draft Revised Standard for The Swiss Secretariat prepared updated fl Vegetable Proteins* versions of the Standards and requested Canned Green Peas Responsible Agency: HHS/FDA, USDA/ government comments in CL 1995/28 CPC. fl Proposed Draft Revised Standard for ARS The technical contents of the standards were Canned Plums U.S. Participation: Yes not amended and comments were requested fl Proposed Draft Revised Standard for *There is no planned activity for these from governments on amendments. Canned Raspberries Committees in the next year. The amended standards for chocolate and fl Proposed Draft Revised Standard for A brief report on activities of the Codex chocolate products were considered at Step Canned Pears Committee on Edible Ices and the Codex 4 by the Sixteenth Session of the Committee, fl Proposed Draft Revised Standard for Committee on Sugars follows: October 1996. The Committee returned the Canned Strawberries Edible Ices Proposed Draft Revised Standard for fl Proposed Draft Revised Standard for The Committee on Edible Ices is Chocolate and Chocolate Products to Step 3 Table Olives for further consideration. responsible for elaborating standards for all fl Proposed Draft Revised Standard for types of edible ices, including mixes and Proposed Draft Revised Standards for Raisins Cocoa Butter, Cocoa (Cacao) Nib, Cocoa powders used for their manufacture. The fl Proposed Draft Revised Standard for (Cacao) Mass, Cocoa Press Cake and Cocoa Forty-third Session of the Executive Canned Mandarin Oranges Dust (Cocoa Fines) for use in the manufacture Committee in June 1996 recommended that fl of Cocoa and Chocolate products, and for Proposed Draft Revised Standard for the Codex Standard for Edible Ices and Cocoa Powders (Cacaos) and Dry Cocoa- Canned Fruit Cocktail Mixed Ices be revoked. It was reported that Sugar Mixture will be considered at the fl Proposed Draft Revised Standard for there was no need for a standard as there was Seventeenth Session of the Committee Jams (Fruit Preserves) and Jellies not a significant international trade. The tentatively scheduled for the Fall of 1998. fl Proposed Draft Revised Standard for Executive Committee further recommended that the Codex Committee on Edible Ices be RESPONSIBLE AGENCY: HHS/FDA Citrus Marmalade abolished. The Twenty-second Session of the U.S. PARTICIPATION: Yes fl Proposed Draft Revised Standard for Canned Mature Processed Peas Codex Alimentarius Commission will decide Codex Committee on Processed Fruits and fl Proposed Draft Revised Standard for the issues in June 1997. Vegetables Canned Tropical Fruit Salad RESPONSIBLE Agency: HHS/FDA During its eighteen sessions, the United fl Proposed Draft Revised Standard for U.S. PARTICIPATION: Yes States-hosted Codex Committee on Processed Pickled Cucumbers Sugars Fruits and Vegetables (CCPFV) elaborated 37 fl Proposed Draft Revised Standard for standards for various types of processed Canned Carrots The Codex Committee on Sugars is fruits and vegetables, including dried fl Proposed Draft Revised Standard for responsible for elaborating world-wide products (prunes), canned products (except Canned Apricots standards for all types of sugars and sugar juices), and jams and jellies. The most recent fl Proposed Draft Revised Standard for products. The Committee has been adjourned since 1974. At the direction of the Codex session of the CCPFV was held in 1986, after Dried Apricots Alimentarius Commission, the Secretariat of which the CCPFV adjourned sine die. fl Proposed Draft Revised Standard for the Host Government (the United Kingdom) In keeping with the Commission’s charge Unshelled Pistachio Nuts was asked to examine the existing Codex to update and revise Codex standards, the fl Proposed Draft Revised Standard for United States Secretariat, with assistance Standards relating to Sugars and the Codex Dates from the Codex Secretariat in Rome, has Standard for Honey. During the Nineteenth fl Proposed Draft Revised Standard for prepared proposed draft revised standards for session of the Codex Alimentarius Canned Palmito the 37 standards covered by the CCPFV. Commission, the Commission agreed that fl These proposed drafts are for circulation for Proposed Draft Revised Standard for existing Codex Standards should be reviewed government comment and consideration at Canned Chestnuts and Chestnut Puree in order to simplify them. Those documents the nineteenth session on the CCPFV. This fl Proposed Draft Revised Standard for were revised and circulated to member next session is tentatively scheduled for Canned Mangoes governments (see CL 1995/5–S) for March 1998. fl Proposed Draft Revised Standard for comments. The objective of the revision is to The following Proposed Draft Revised Mango Chutney focus the standards only on public health, Standards are expected to be considered at fl Proposed Draft Revised Standard for food safety, and consumer protection. The the 19th Session of the Committee at Step 3 Grated Desiccated Coconut Twenty-first session of the Commission of the Codex process: RESPONSIBLE AGENCY: HHS/FDA, USDA/ noted that substantial late comments were fl Proposed Draft Revised Standard for AMS received and agreed that further revision of Canned Tomatoes U.S. PARTICIPATION: Yes the Draft Standards should be carried out by Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28435 correspondence. The Secretariat has prepared proposed regulatory initiatives and Street, SW, Washington, DC 20460, Phone revised Draft Standards and circulated them problems arising from food control and #: (202) 260–0947, Fax #: (202) 260–1847 for government comments at Step 6 in stimulates the strengthening of food Mr. William Schultz, Deputy Commissioner document CL 1996/1–S. control infrastructures; for Policy, Food and Drug Administration, To be considered at Step 8: —recommends to the Commission the 5600 Fishers Lane, Rockville, MD 20857, fl Draft Revised Standard for Sugar development of world-wide standards for Phone #: (301) 827–3360, Fax #: (301) 594– fl Draft Revised Standard for Honey products of interest to the region, including 6777 RESPONSIBLE Agency: HHS/FDA products considered by the committee to Dr. Fred R. Shank, Director, Center for Food U.S. PARTICIPATION: Yes have an international market potential in Safety and Applied Nutrition (HFS–1), the future; and Food and Drug Administration, Room Joint U.N.E.C.E. Codex Alimentarius Groups —exercises a general coordinating role for the 6815, 200 C Street, SW, Washington, DC of Experts region and such other functions as may be 20204, Phone #: (202) 205–4850, Fax #: Two groups of experts dealt with specific entrusted to it by the Commission. (202) 205–5025 commodities much as the Codex Commodity Ms. Linda R. Horton, Director, International Committees do. The Joint Groups of Experts Codex Coordinating Committee for North Policy, Office of the Commissioner, Food have completed their main tasks and have America and the South—West Pacific and Drug Administration, 5600 Fishers adjourned. They could be called to meet The Coordinating Committee is responsible Lane, Rockville, MD 20857, Phone #: (301) again if the Codex Alimentarius Commission for defining problems and needs concerning 827–3344, Fax #: (301) 443–6906 so decides. These Groups are: food standards and food control of all Codex Mr. August Schumacher, Jr., Administrator, fl Standardization of Quick Frozen member countries of the regions. Foreign Agricultural Service, U.S. Foods; and The Fourth Session of the Committee Department of Agriculture, Room 5071, fl Standardization of Fruit Juices. addressed the following matters of interest to South Agriculture Building, 1400 There are no standards from either group the Commission. Information about their Independence Avenue, SW, Washington, being considered by the Twenty-second deliberations can be found in ALINORM 97/ DC 20250–3700, Phone #: (202) 720–3935, session of the Commission in June, 1997. 32. Fax #: (202) 690–2159 fl Suggested that consideration be given RESPONSIBLE Agency: HHS/FDA Codex Committee Chairpersons U.S. PARTICIPATION: Yes to a further consultation on risk communication mechanisms and Mr. Steven N. Tanner, Director, Technical Codex Committee for Natural Mineral Waters methodologies; Services Division, Grain Inspection, The Codex Committee for Natural Mineral fl Supported the current alignment of Packers & Stockyards Administration, U.S. Waters (CCNMW) is responsible for Codex membership of the region and more Department of Agriculture, 10383 N. elaborating standards for natural mineral active collaboration between Codex and Executive Hills Blvd., Kansas City, MO # water products. The following draft standard APEC; and 64153–1394, Phone : (816) 891–0401, Fax # will be considered by the Codex fl Agreed to bring concerns regarding the : (816) 891–0478—Cereals, Pulses and Alimentarius Commission at its June length and procedures of the Codex Legumes (adjourned Sine Die) meeting. Information about the standard and Alimentarius Commission and the timely Dr. I. Kaye Wachsmuth, Acting Deputy new committee work can be found in distribution of Codex documents to the Administrator, Office of Public Health and ALINORM 97/20. attention of the Executive Committee. Science, Food Safety and Inspection To be considered at Step 8: In addition, the Committee identified main Service, U.S. Department of Agriculture, fl Draft Revised Standard for Natural objectives and priorities related to the Room 341–E, Jamie L. Whitten Federal Mineral Waters identification of Codex Standards and related Building, 1400 Independence Avenue, SW, In addition, the committee requested Washington, DC 20250–3700, Phone #: texts which have a major impact in the # approval to initiate development of a general Region and discussed papers on Dietary (202) 720–2644, Fax : (202) 690–2980— standard applicable to bottled/packaged Modeling and Guidelines for the Food Hygiene waters other than natural mineral waters. Development of Agreements Regarding Food Mr. James Rodeheaver, Chief, Processed RESPONSIBLE Agency: HHS/FDA Import and Export Inspection and Product Branch, Fruit and Vegetable U.S. PARTICIPATION: Yes Certification Systems. Division, Agricultural Marketing Service, U.S. Department of Agriculture, Room FAO/WHO Regional Coordinating AGENCY RESPONSIBLE: USDA/FSIS 0709, South Agriculture Building, 1400 Committees U.S. PARTICIPATION: Yes Independence Avenue, SW, Washington, The Codex Alimentarius Commission is Appendix 1—US. Codex Alimentarius DC 20250–3700, Phone #: (202) 720–4693, # made up of an Executive Committee, as well Officials Steering Committee Members Fax : (202) 690–1527—Processed Fruits and Vegetables as approximately 25 subsidiary bodies. Mr. Thomas J. Billy, Administrator, Food Included in these subsidiary bodies are Dr. Stephen F. Sundlof, Director, Center for Safety and Inspection Service, U.S. Veterinary Drugs in Foods Medicine, Food several coordinating committees. Department of Agriculture, Room 331–E, There are currently five Regional and Drug Administration, 7500 Standish Jamie L. Whitten Federal Bldg., 1400 Coordinating Committees: Place (HFV–1), Rockville, MD 20855, Independence Avenue, SW, Washington, Phone #: (301) 594–1740, Fax #: (301) 594– —Coordinating Committee for Africa DC 20250–3700, Phone: (202) 720–7025, —Coordinating Committee for Asia 1830—Residues of Veterinary Drugs in Fax: (202) 205–0158 Food —Coordinating Committee for Europe Mr. Michael V. Dunn, Assistant Secretary, —Coordinating Committee for Latin America Marketing and Regulatory Programs, U.S. Listing of U.S. Delegates and Alternate and the Caribbean Department of Agriculture, Room 228–W, Delegates, Worldwide General Subject Codex —Coordinating Committee for North America Jamie L. Whitten Federal Bldg., 1400 Committees and the South-West Pacific Independence Avenue, SW, Washington, Codex Committee on Residues of Veterinary The United States participates as an active DC 20250, Phone #: (202) 720–4256, Fax #: Drugs in Foods member of the Coordinating Committee for (202) 720–5775 North America and the South-West Pacific, Dr. Lynn R. Goldman, Assistant (Host Government—United States) and is informed of the other coordinating Administrator, Office of Prevention, U.S. Delegate—Dr. Robert C. Livingston, committees through meeting documents, Pesticides and Toxic Substances, U.S. Director, Office of New Animal Drug final reports, and representation at meetings. Environmental Protection Agency, 401 M Evaluation, Center for Veterinary Medicine Each regional committee: Street, SW (7101), 637 East Tower, (HFV–100), Food and Drug Administration, —defines the problems and needs of the Washington, DC 20460, Phone #: (202) 7500 Standish Place, Rockville, MD 20855, region concerning food standards and food 260–2902, Fax #: (202) 260–1847 Phone #: (301) 594–1620, Fax #: (301) 594– control; Ms. Penny Fenner-Crisp, Deputy Director, 2297 —promotes within the committee contacts Office of Pesticide Programs, U.S. Alternate Delegate—Dr. Pat Basu, Director, for the mutual exchange of information on Environmental Protection Agency, 401 M Chemistry and Toxicology Division, Office 28436 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

of Public Health and Science, Food Safety and Inspection Service, U.S. Department of Food Safety and Applied Nutrition, Food and Inspection Service, U.S. Department of Agriculture, Room 4434, South Agriculture and Drug Administration, 200 C Street, SW Agriculture, 6912 Franklin Court, 1099 Building, 1400 Independence Avenue, SW, (HFS–456), Washington, DC 20204, Phone 14th Street, NW, Washington, DC 20250– Washington, DC 20250–3700, Phone #: #: (202) 205–4605, Fax #: (202) 260–8957 3700, Phone #: (202) 501–7319, Fax: (202) (202) 720–6400, Fax #: (202) 720–7990 501–7639 Codex Committee on Fish and Fishery Codex Committee on General Principles Products Codex Committee on Food Additives and (Host Government—France) Contaminants (Host Government—Norway) Delegate—Note: A member of the Steering (Host Government—The Netherlands) Delegate—Mr. Philip C. Spiller, Director, Committee heads the delegation to Office of Seafood (HFS–400) VERB, Center meetings of the General Principles U.S. Delegate—Dr. Alan Rulis, Director, for Food Safety and Applied Nutrition, Committee. Office of Premarket Approval, Center for Food and Drug Administration, 200 C Food Safety and Applied Nutrition, Food Codex Committee on Food Labelling Street, SW, Washington, DC 20204, Phone and Drug Administration, 200 C Street, #: (202) 418–3133, Fax #: (202) 418–3198 SW, (HFS–200), Washington, DC 20204, (Host Government—Canada) Alternate Delegate—Mr. Samuel W. McKeen, Phone #: (202) 418–3100, Fax #: (202) 418– Delegate—Dr. F. Edward Scarbrough, Director, Office of Trade and Industry 3131 Director, Office of Food Labeling Center for Alternate Delegate—Dr. Terry C. Troxell, Food Safety and Applied Nutrition (HFS– Services, National Oceanic and Director, Division of Programs and 150), Food and Drug Administration, 200 Atmospheric Administration, NMFS, 1335 Enforcement Policy, Center for Food Safety C Street, SW, Room 1832, Washington, DC East-West Highway, Room 6490, Silver # and Applied Nutrition, Food and Drug 20204, Phone #: (202) 205–4561, Fax #: Spring, MD 20910, Phone : (301) 713– # Administration, 200 C Street, SW, (HFS– (202) 205–4594 2351, Fax : (301) 713–1081 # 456), Washington, DC 20204, Phone : Alternate Delegate—Mr. Robert Post, Deputy Codex Committee on Cereals, Pulses and # (202) 205–5321, Fax : (202) 205–4422 Director, Facilities, Equipment, Labeling & Legumes Compounds Review Division, Office of Codex Committee on Pesticide Residues Policy, Program Development, and (Host Government—United States) (Host Government—The Netherlands) Evaluation, Food Safety and Inspection Delegate—Mr. Charles W. Cooper, Director, U.S. Delegate—Dr. Richard Schmitt, Deputy Service, U.S. Department of Agriculture, International Activities Staff, Center for West End Court Building, Room 327, Food Safety and Applied Nutrition, Room Director, Special Review and Registration # Washington, DC 20250–3700, Phone : 5823 (HFS–585), Food and Drug Division, Office of Pesticide Programs, U.S. # Environmental Protection Agency, 1921 (202) 418–8900, Fax : (202) 418–8834 Administration, 200 C Street, SW, # Jefferson Davis Highway, Mail Code Codex Committee on Food Hygiene Washington, DC 20204, Phone : (202) (7502C), Room 712, CM–2, Arlington, VA 205–5042, Fax #: (202) 401–7739 (Host Government—United States) 22204, Phone #: (703) 305–6352, Fax #: Alternate Delegate—Mr. David Shipman, (703) 305–5512 Acting Delegate—Mr. E. Spencer Garrett, Deputy Administrator, Grain Inspection Alternate Delegate—Dr. Richard Parry, Jr., Director, National Seafood Inspection Packers and Stockyards Administration, Assistant Administrator, Cooperative Laboratory, National Marine Fisheries, 705 U.S. Department of Agriculture, Room Interactions, Agricultural Research Service, Convent Street, Pascagoulla, MS 39568– # # 1092, South Agriculture Building, 1400 U.S. Department of Agriculture, Room 1207, Phone : (601) 769–8964, Fax : (601) Independence Avenue, SW, Washington, 762–7144 358–A, Jamie L. Whitten Federal Bldg., DC 20250–3700, Phone #: (202) 720–9170, # Alternate Delegate—VACANT Washington, DC 20250–3700, Phone : Fax #: (202) 720–1015 # (202) 720–3973, Fax : (202) 720–5427 Worldwide Commodity Codex Committees Codex Committee on Milk and Milk Products Codex Committee on Methods of Analysis Codex Committee on Fresh Fruits and (Host Government—New Zealand) and Sampling Vegetables (Host Government—Hungary) Delegate—Mr. Duane Spomer, Chief, Dairy (Host Government—Mexico) Standardization Branch, U.S. Department U.S. Delegate—Dr. William Horwitz, Delegate—Mr. David Priester, International of Agriculture, Agricultural Marketing Scientific Advisor, Center for Food Safety Standards Coordinator, FPB, Fruit & Service, Room 2750, South Agriculture and Applied, Nutrition (HFS–500), Food Vegetable Division, Agricultural Marketing Building, 1400 Independence Avenue, SW, and Drug Administration, Room 3832, 200 Service, U.S. Department of Agriculture, Washington, DC 20250–3700, Phone #: C Street, SW, Washington, DC 20204, Room 2069, South Agriculture Building, (202) 720–9382, Fax #: (202) 720–2643 Phone #: (202) 205–4346, Fax #: (202) 401– 1400 Independence Avenue, SW, Alternate Delegate—Dr. John C. Mowbray, 7740 Washington, DC 20250–3700, Phone #: Alternate Delegate—Mr. William Franks, # Division of Programs and Enforcement (202) 720–2184, Fax : (202) 720–0016 Policy, Center for Food Safety and Applied Director, Science and Technology Division, Alternate Delegate—Mr. Larry B. Lace, Agricultural Marketing Service, U.S. Nutrition, Food and Drug Administration, Branch Chief, Fresh Products Branch, 200 C Street, SW, (HFS–306), Washington, Department of Agriculture, Room 3507, Fruits and Vegetables Division, DC 20204, Phone #: (202) 205–1731, Fax #: South Agriculture Building 1400 Agricultural Marketing Service, U.S. (202) 205–4422 Independence Avenue, SW, Washington, Department of Agriculture, Room 2049, # DC 20250–3700, Phone : (202) 720–5231, South Agriculture Building, 1400 Codex Committee on Fats and Oils Fax #: (202) 720–6496 Independence Avenue, SW, Washington, # (Host Government—United Kingdom) Codex Committee on Food Import and Export DC 20250–3700, Phone : (202) 720–5870, Fax #: (202) 720–0393 Delegate—Mr. Charles W. Cooper, Director, Certification and Inspection Systems International Activities, Staff, Center for (Host Government—Australia) Codex Committee on Nutrition and Foods for Food Safety and Applied Nutrition, Room Special Dietary Uses Delegate—Dr. Fred R. Shank, Director, Center 5823 (HFS–585), Food and Drug for Food Safety and Applied Nutrition (Host Government—Germany) Administration, 200 C Street, SW, # (HFS–1), Food and Drug Administration, Delegate—Dr. Elizabeth Yetley, Acting Washington, DC 20204, Phone : (202) Room 6815, 200 C Street, SW, Washington, Director, Office of Special Nutritionals, 205–5042, Fax #: (202) 401–7739 DC 20204, Phone #: (202) 205–4850,Fax #: Center for Food Safety and Applied Alternate Delegate—Dr. Dwayne Buxton, (202) 205–5025 Nutrition, FDA, 200 C Street, SW (HFS– National Program Leader for Oilseeds and Alternate Delegate—Mr. Mark Manis, 450), Washington, DC 20204, Phone #: Bioscience, Agricultural Research Service, Director, International Policy Development (202) 205–4168, Fax #: (202) 205–5295 Room 212, Bldg. 005, BARC West, Division, Office of Policy, Program Alternate Delegate—Dr. Robert J. Moore, Beltsville, MD 20705, Phone #: (301) 504– Development, and Evaluation, Food Safety Senior Regulatory Scientist, Center for 5321, Fax #: (301) 504–5467 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28437

Codex Committee on Processed Fruits and Alternate Delegate—Mr. Robert Post, Deputy Washington, DC 20204, Phone #: (202) Vegetables Director, Facilities, Equipment, Labeling & 205–5321, Fax #: (202) 205–4422 (Host Government—United States) Compounds Review Division, Office of Alternate Delegate—Ms. Shellee A. Davis, Policy, Program Development, and U.S. Delegate—Mr. Richard B. Boyd, Senior Division of Programs and Enforcement Evaluation, Food Safety and Inspection Policy, Center for Food Safety and Applied Marketing Specialist, Fruit and Vegetable Service, U.S. Department of Agriculture, Nutrition, Food and Drug Administration, Division, Agricultural Marketing Service, West End Court Building, Room 327, U.S. Department of Agriculture, Room Washington, DC 20250–3700, Phone #: 200 C Street, SW (HFS–306), Washington, # # 0717, South Agriculture Building, 1400 (202) 418–8900, Fax #: (202) 418–8834 DC 20204, Phone : (202) 205–4681, Fax : Independence Avenue, SW, Washington, (202) 205–4422 DC 20250–3700, Phone #: (202) 720–5021, Codex Committee on Vegetable Proteins 1 Joint U.N.E.C.E. Codex Alimentarius Groups Fax #: (202) 690–1527 (Host Government—Canada) Alternate Delegate—Mr. Charles W. Cooper, of Experts U.S. Delegate—Dr. Wilda H. Martinez, Director, International Activities Staff, Joint ECE/Codex Alimentarius Group of Center for Food Safety and Applied Associate Deputy Administrator, Aqua Products and Human Nutrition Sciences, Experts on Standardization of Quick Frozen Nutrition, Room 5823 (HFS–585), Food Foods 1 and Drug Administration, 200 C Street, U.S. Department of Agriculture, SW, Washington, DC 20204, Phone #: (202) Agricultural Research Service, Room 107, U.S. Delegate—Mr. Richard B. Boyd, Senior # B–005, Beltsville, MD 20705, Phone #: 205–5042, Fax : (202) 401–7739 # Marketing Specialist, Fruit and Vegetable (301) 504–6275, Fax : (301) 504–6699 Division, Agricultural Marketing Service, Worldwide Commodity Codex Committees Alternate Delegate—Ms. Elizabeth J. U.S. Department of Agriculture, Room Campbell, Director, Division of Programs Codex Committee on Cocoa Products and and Enforcement Policy, Center for Food 0717, South Agriculture Building, 1400 Chocolate Safety and Applied Nutrition (HFS–155), Independence Avenue, SW., Washington, # (Host Government—Switzerland) Food and Drug Administration, 200 C DC 20250–3700, Phone : (202) 720–5021, # Delegate—Mr. Charles W. Cooper, Director, Street, SW, Washington, DC 20204, Phone Fax : (202) 690–1527 International Activities Staff, Center for #: (202) 205–5229, Fax #: (202) 205–4594 Alternate Delegate—Mr. Charles W. Cooper, Food Safety and Applied Nutrition, Room Director, International Activities Staff, Codex Committee on Meat Hygiene 1 5823 (HFS–585), Food and Drug Center for Food Safety and Applied Administration, 200 C Street, SW, (Host Government—New Zealand) Nutrition, Room 5823 (HFS–585), Food Washington, DC 20204, Phone #: (202) Delegate—Dr. John Prucha, Assistant Deputy and Drug Administration, 200 C Street, # 205–5042, Fax : (202) 401–7739 Administrator, International and Domestic SW., Washington, DC 20204, Phone #: Alternate Delegate—Dr. Michelle Smith, Policy, Food Safety and Inspection Service, (202) 205–5042, Fax #: (202) 401–7739 Food Technologist, Office of Food U.S. Department of Agriculture, Room Labeling, Center for Food Safety and 350–E, Jamie L. Whitten Federal Bldg., Joint ECE/Codex Alimentarius Group of Applied Nutrition (HFS–158), 200 C Street, Washington, DC 20250–3700, Phone #: Experts on Standardization of Fruit Juices 1 # SW, Washington, DC 20204, Phone : (202) (202) 720–3473, Fax #: (202) 690–3856 U.S. Delegate—Mr. Charles W. Cooper, 205–5099, Fax #: (202) 205–4594 Alternate Delegate—Dr. Richard Mikita, Director, International Activities, Staff, Codex Committee on Sugars Special Assistant, International Activities, Center for Food Safety and Applied Food Safety and Inspection Service, U.S. Nutrition, Room 5823 (HFS–585), Food (Host Government—United Kingdom) Department of Agriculture, Room 344–E, and Drug Administration, 200 C Street, Delegate—Dr. Thomas J. Army, Area Jamie L. Whitten Federal Bldg., # # SW., Washington, DC 20204, Phone : Director, Mid-South Area, USDA/ Washington, DC 20250–3700, Phone : # Agricultural Research Center, P.O. Box (202) 720–0290, Fax #: (202) 690–0766 (202) 205–5042, Fax : (202) 401–7739 225, Stoneville, MS 38776–0225, Phone #: Alternate Delegate—Mr. Richard B. Boyd, Codex Committee on Processed Meat and (601) 686–5265, Fax #: (601) 626–5259 Senior Marketing Specialist, Fruit and Poultry Products 1 Alternate Delegate—Dr. Dennis M. Keefe, Vegetable Division, Agricultural Marketing Office of Premarket Approval, Center for (Host Government—Denmark) Service, U.S. Department of Agriculture, Food Safety and Applied Nutrition, Food U.S. Delegate—Mr. Daniel Engeljohn, Branch Room 0717, Agriculture South Building, and Drug Administration, 200 C Street, SW Chief, Standards Development Branch, 1400 Independence Avenue, SW., (HFS–206), Washington, DC 20204, Phone Inspection Methods Development Division, Washington, DC 20250–3700, Phone #: # # : (202) 418–3113, Fax : (202) 418–3131 Office of Policy, Program Development, (202) 720–5021, Fax #: (202) 690–1527 Codex Committee on Edible Ices 1 and Evaluation, Food Safety and Inspection Service, U.S. Department of Subsidiary Bodies of the Codex Alimentarius (Host Government—Sweden) Agriculture, Room 405, Cotton Annex, 300 There are five regional coordinating Delegate—Mr. Charles W. Cooper, Director, 12th Street, SW., Washington, DC 20250– committees: International Activities Staff, Center for 3700, Phone #: (202) 205–0210, Fax #: (202) Coordinating Committee for Africa Food Safety and Applied Nutrition, Room 205–0080 Coordinating Committee for Asia 5823 (HFS–585), Food and Drug Alternate Delegate—Mr. Charles Edwards, Administration 200 C Street, SW, Director, Facilities, Equipment, Labeling & Coordinating Committee for Europe Washington, DC 20204, Phone #: (202) Compounds Review Division, Office of Coordinating Committee for Latin America 205–5042, Fax #: (202) 401–7739 Policy, Program Development, and and the Caribbean, and Alternate Delegate—VACANT Evaluation, Food Safety and Inspection Coordinating Committee for North America Service, U.S. Department of Agriculture, and the South-West Pacific Codex Committee on Soups and Broths 1 West End Court Building, Room 329, 1255 Contact—Ms. Rhonda Bond, Executive (Host Government—Switzerland) 22nd Street, NW., Washington, DC 20250– Officer for Codex Alimentarius, Food # # Delegate—Mr. Charles Edwards, Director, 3700, Phone : (202) 418–8900, Fax : (202) Safety and Inspection Service, U.S. 418–8834 Facilities, Equipment, Labeling & Department of Agriculture, West End Compounds Review Division, Office of Codex Committee on Natural Mineral Waters Court, Room 311, 1255 22nd Street, NW., Policy, Program Development, and Washington, DC 20250–3700, Phone #: Evaluation, Food Safety and Inspection (Host Government—Switzerland) (202) 418–8841, Fax #: (202) 418–8865. Service, U.S. Department of Agriculture, U.S. Delegate—Dr. Terry C. Troxell, Director, West End Court Building, Room 329, 1255 Division of Programs and Enforcement 1 Adjourned sine die. The main tasks of 22nd Street, NW, Washington, DC 20250– Policy, Center for Food Safety & Applied these Committees are completed. However, 3700, Phone #: (202) 418–8900, Fax #: (202) Nutrition (HFS–305), Food and Drug the committees may be called to meet again 418–8834 Administration, 200 C Street, SW., if required. 28438 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

APPENDIX 2.ÐTIMETABLE OF CODEX SESSIONS [June 1996 through June 1998]

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

Appendix 3—Definitions for the Purpose of processing, preparation, treatment, packing, agricultural commodities, or animal feeds or Codex Alimentarius packaging, transport, or holding of such food which may be administered to animals for Words and phrases have specific meanings results, or may be reasonably expected to the control of ectoparasites. The term when used by the Codex Alimentarius. For result, (directly or indirectly) in it or its by- includes substances intended for use as a products becoming a component of or plant-growth regulator, defoliant, desiccant, the purposes of Codex, the following otherwise affecting the characteristics of such fruit thinning agent, or sprouting inhibitor definitions apply: foods. The food additive term does not and substances applied to crops either before 1. Food means any substance, whether include ‘‘contaminants’’ or substances added of after harvest to protect the commodity processed, semi-processed or raw, which is to food for maintaining or improving from deterioration during storage and intended for human consumption, and nutritional qualities. transport. The term pesticides excludes includes drink, chewing gum, and any 4. Contaminant means any substance not fertilizers, plant and animal nutrients, food substance which has been used in the intentionally added to food, which is present additives, and animal drugs. manufacture, preparation or treatment of in such food as a result of the production 6. Pesticide residue means any specified ‘‘food’’ but does not include cosmetics or (including operations carried out in crop substance in food, agricultural commodities, tobacco or substances used only as drugs. husbandry, animal husbandry, and veterinary or animal feed resulting from the use of a 2. Food hygiene comprises conditions and medicine), manufacture, processing, pesticide. The term includes any derivatives measures necessary for the production, preparation, treatment, packing, packaging, of a pesticide, such as conversion products, processing, storage and distribution of food transport or holding of such food or as a metabolites, reaction products, and designed to ensure a safe, sound, wholesome result of environmental contamination. The impurities considered to be of toxological product fit for human consumption. term does not include insect fragments, significance. 3. Food additive means any substance not rodent hairs and other extraneous matters. 7. Good Agricultural Practice in the Use of normally consumed as a food by itself and 5. Pesticide means any substance intended Pesticides (GAP) includes the nationally not normally used as a typical ingredient of for preventing, destroying, attracting, authorized safe uses of pesticides under the food, whether or not it has nutritive repelling, or controlling any pest including actual conditions necessary for effective and value, the intentional addition of which to unwanted species of plants or animals during reliable pest control. It encompasses a range food for a technological (including the production, storage, transport, of levels of pesticide applications up to the organoleptic) purpose in the manufacture, distribution and processing of food, highest authorized use, applied in a manner Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28439 which leaves a residue which is the smallest When establishing an MRLVD, consider such comments and to amend the amount practicable. consideration is also given to residues that proposed draft standard. Authorized safe uses are determined at the occur in food of plant origin and/or the national level and include nationally environment. Furthermore, the MRLVD may Step 5 1 registered or recommended uses, which take be reduced to be consistent with good The proposed draft standard is submitted into account public and occupational health practices in the use of veterinary drugs and through the Secretariat to the Commission or to the extent that practical and analytical and environmental safety considerations. to the Executive Committee with a view to Actual conditions include any stage in the methods are available. its adoption as a draft standard. When production, storage, transport, distribution 12. Good Practice in the Use of Veterinary and processing of food commodities and Drugs (GPVD) is the official recommended or making any decision at this step, the animal feed. authorized usage including withdrawal Commission or the Executive Committee will 8. Codex Maximum Limit for Pesticide periods approved by national authorities, of give due consideration to any comments that Residues (MRLP) is the maximum veterinary drugs under practicable may be submitted by any of its members concentration of a pesticide residue conditions. regarding the implications which the (expressed as mg/kg), recommended by the 13. Processing Aid means any substance or proposed draft standard or any provisions of Codex Alimentarius Commission to be material, not including apparatus or utensils, the standard may have for their economic legally permitted in or on food commodities not consumed as a food ingredient by itself, interests. In the case of Regional Standards, intentionally used in the processing of raw and animal feeds. MRLPs are based on their all members of the Commission may present toxological affects and on GAP data and materials, foods or its ingredients, to fulfill a their comments, take part in the debate and foods derived from commodities that comply certain technological purpose during with the respective MRLPs are intended to be treatment or processing and which may propose amendments, but only the majority toxologically acceptable. result in the non-intentional but unavoidable of the Members of the region or group of Codex MRLPs, which are primarily presence of residues or derivatives in the countries concerned attending the session intended to apply in international trade, are final product. can decide to amend or adopt the draft. derived from reviews conducted by the JMPR Appendix 4—Uniform Procedure for the When making any decisions at this step, the following: Elaboration of Codex Standards and Related members of the region or group of countries (a) toxological assessment of the pesticide Texts concerned will give due consideration to any and its residue, and comments that may be submitted by any of Part 1 (b) review of residue data from supervised the members of the Commission regarding trials and supervised uses including those Steps 1, 2 and 3 the implications which the proposed draft reflecting national good agricultural standard or any provisions of the proposed practices. Data from supervised trials (1) The Commission decides, taking into conducted at the highest nationally account the ‘‘Criteria for the Establishment of draft standard may have for their economic recommended, authorized, or registered uses Work Priorities and for the Establishment of interests. Subsidiary Bodies,’’ to elaborate a Worldwide are included in the review. In order to Step 6 accommodate variations in national pest Codex Standard and also decides which subsidiary body or other body should control requirements, Codex MRLPs take into The draft standard is sent by the Secretariat undertake the work. A decision to elaborate account the higher levels shown to arise in to all members and interested international a Worldwide Codex Standard may also be such supervised trials, which are considered organizations for comment on all aspects, taken by subsidiary bodies of the to represent effective pest control practices. including possible implications of the draft Commission in accordance with the above- Consideration of the various dietary mentioned criteria, subject to subsequent standard for their economic interests. residue intake estimates and determinations approval by the Commission or its Executive both at the national and international level in Step 7 Committee at the earliest possible comparison with the ADI, should indicate opportunity. In the case of Codex Regional The comments received are sent by the that foods complying with Codex MRLPs are Standards, the Commission shall base its Secretariat to the subsidiary body or other safe for human consumption. decision on the proposal of the majority of body concerned, which has the power to 9. Veterinary Drug means any substance members belonging to a given region or group consider such comments and amend the draft applied or administered to any food- of countries submitted at a session of the standard. producing animal, such as meat or milk- Codex Alimentarius Commission. producing animals, poultry, fish or bees, (2) The Secretariat arranges for the Step 8 whether used for therapeutic, prophylactic or preparation of a proposed draft standard. In The draft standard is submitted through diagnostic purposes or for modification of the case of Maximum Limits for Residues of physiological functions or behavior. the Secretariat to the Commission together Pesticides or Veterinary Drugs, the with any written proposals received from 10. Residues of Veterinary Drugs include Secretariat distributes the recommendations members and interested international the parent compounds and/or their for maximum limits, when available from the metabolites in any edible portion of the Joint Meetings of the FAO Panel of Experts organizations for amendments at Step 8 with animal product, and include residues of on Pesticide Residues in Food and the a view to its adoption as a Codex Standard. associated impurities of the veterinary drug Environment and the WHO Panel of Experts In the case of Regional standards, all concerned. on Pesticide Residues (JMPR), or the Joint members and interested international 11. Codex Maximum Limit for Residues of FAO/WHO Expert Committee on Food organizations may present their comments, Veterinary Drugs (MRLVD) is the maximum Additives (JECFA). In the cases of milk and take part in the debate and propose concentration of residue resulting from the milk products or individual standards for amendments but only the majority of use of a veterinary drug (expressed in mg/kg cheeses, the Secretariat distributes the µ members of the region or group of countries or g/kg on a fresh weight basis) that is recommendations of the International Dairy recommended by the Codex Alimentarius concerned attending the session can decide Federation (IDF). to amend and adopt the draft. Commission to be legally permitted or (3) The proposed draft standard is sent to recognized as acceptable in or on food. members of the Commission and interested An MRLVD is based on the type and international organizations for comment on 1 Without prejudice to any decision that may be amount of residue considered to be without all aspects including possible implications of taken by the Commission at Step 5, the proposed any toxological hazard for human health as the proposed draft standard for their draft standard may be sent by the Secretariat for government comment prior to its consideration at expressed by the Acceptable Daily Intake economic interests. (ADI), or on the basis of a temporary ADI that Step 5, when, in the opinion of the subsidiary body Step 4 or other body concerned, the time between the utilizes an additional safety factor. An relevant session of the Commission and the MRLVD also takes into account other The comments received are sent by the subsequent session of the subsidiary or other body relevant public health risks as well as food Secretariat to the subsidiary body or other concerned requires such actions in order to advance technological aspects. body concerned which has the power to the work. 28440 Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices

Appendix 4—Uniform Accelerated adulteration, and correctly labelled. A Codex optional ingredients. It should also include Procedure for the Elaboration of Codex standard for any food or foods should be quality factors which are essential for the Standards and Related Texts drawn up in accordance with the Format for designation, definition, or composition of the Part 2 Codex Commodity Standards and contain, as product concerned. Such factors could appropriate, the criteria listed therein. include the quality of the raw material, with Steps 1, 2 and 3 the object of protecting the health of the Format For Codex Commodity Standards consumer, provisions on taste, odor, color, (1) The Commission or the Executive Including Standards Elaborated Under the Committee between Commission sessions, on and texture which may be apprehended by Code of Principles Concerning Milk and Milk the senses, and basic quality criteria for the the basis of a two-thirds majority of votes Products cast, taking into account the ‘‘Criteria for the finished products, with the object of Establishment of Work Priorities and for the Introduction preventing fraud. This section may refer to Establishment of Subsidiary Bodies’’, shall The format is also intended for use as a tolerances for defects, such as blemishes or identify those standards which shall be the guide by the subsidiary bodies of the Codex imperfect material, but this information subject of an accelerated elaboration process. Alimentarius Commission in presenting their should be contained in appendix to the The identification of such standards may also standards, with the object of achieving, as far standard or in another advisory text. be made by subsidiary bodies of the as possible, a uniform presentation of Food Additives Commission, on the basis of a two-thirds commodity standards. The format also majority of votes cast, subject to confirmation indicates the statements which should be This section should contain the names of at the earliest opportunity by the included in standards as appropriate under the additives permitted and, where Commission or its Executive Committee by a the relevant headings of the standard. The appropriate, the maximum amount permitted two-thirds majority of votes cast. sections of the format required to be in the food. It should be prepared in (2) The Secretariat arranges for the completed for a standard are only those accordance with guidance given on pages 93 to 96 of the Codex Procedural Manual and preparation of a proposed draft standard. In provisions that are appropriate to an may take the following form: the case of Maximum Limits for Residues of international standard for the food in ‘‘The following provisions in respect of Pesticides or Veterinary Drugs, the question. food additives and their specifications as Secretariat distributes the recommendations Name of the Standard contained in section llll of the Codex for maximum limits, when available from the Scope Alimentarius are subject to endorsement Joint Meetings of the FAO Panel of Experts Description [have been endorsed] by the Codex on Pesticide Residues in Food and the Essential Composition and Quality Factors Committee on Food Additives and Environment and the WHO Panel of Experts Food Additives Contaminants.’’ on Pesticide Residues (JMPR), or the Joint Contaminants A tabulation should then follow, viz.: FAO/WHO Expert Committee on Food Hygiene Weights and Measures ‘‘Name of additive, maximum level (in Additives (JECFA). In the cases of milk and percentage or mg/kg).’’ milk products or individual standards for Labelling cheeses, the Secretariat distributes the Methods of Analysis and Sampling Contaminants recommendations of the International Dairy Format for Codex Standards (a) Pesticide Residues: This section should Federation (IDF). include, by reference, any levels for pesticide (3) The proposed draft standard is sent to Name of the Standard residues that have been established by the Members of the Commission and interested The name of the standard should be clear Codex Committee on Pesticide Residues for international organizations for comment on and as concise as possible. It should usually the product concerned. all aspects including possible implications of be the common name by which the food (b) Other Contaminants: In addition, this the proposed draft standard for their covered by the standard is known or, if more section should contain the names of other economic interests. When standards are than one food is dealt with in the standard, contaminants and where appropriate the subject to an accelerated procedure, this fact by a generic name covering them all. If a fully maximum level permitted in the food, and shall be notified to the Members of the informative title is inordinately long, a the text to appear in the standard may take Commission and the interested international subtitle could be added. the following form: organizations. ‘‘The following provisions in respect of Scope Step 4 contaminants, other than pesticide residues, This section should contain a clear, are subject to endorsement [have been The comments received are sent by the concise statement as to the food or foods to endorsed] by the Codex Committee on Food Secretariat to the subsidiary body or other which the standard is applicable unless the Additives and Contaminants.’’ body concerned which has the power to name of the standard clearly and concisely A tabulation should then follow, viz.: consider such comments and to amend the identifies the food or foods. A generic ‘‘Name of contaminant, maximum level (in proposed draft standard. standard covering more than one specific percentage or mg/kg).’’ product should clearly identify the specific Step 5 products to which the standard applies. Hygiene In the case of standards identified as being Any specific mandatory hygiene provisions Description subject to an accelerated elaboration considered necessary should be included in procedure, the draft standard is submitted This section should contain a definition of this section. They should be prepared in through the Secretariat to the Commission the product or products with an indication, accordance with the guidance given on pages together with any written proposals received where appropriate, of the raw materials from 96 to 98 of the Codex Procedural Manual. from Members and interested international which the product or products are derived Reference should also be made to applicable organizations for amendments with a view to and any necessary references to processes of codes of hygienic practice. Any parts of such its adoption as a Codex standard. In taking manufacture. The description may also codes, including in particular any end- any decision at this step, the Commission include references to types and styles of product specifications, should be set out in will give due consideration to any comments product and to type of pack. The description the standard, if it is considered necessary that may be submitted by any of its Members may also include additional definitions when that they should be made mandatory. The regarding the implications which the these additional definitions are required to following statement should also appear: proposed draft standard or any provisions clarify the meaning of the standard. ‘‘The following provisions in respect of the thereof may have for their economic food hygiene of the product are subject to Essential Composition and Quality Factors interests. endorsement [have been endorsed] by the This section should contain all quantitative Codex Committee on Food Hygiene.’’ Appendix 5—Nature of Codex Standards and other requirements as to composition Codex standards contain requirements for including, where necessary, identity Weights and Measures food aimed at ensuring for the consumer a characteristics, provisions on packing media This section should include all provisions, sound, wholesome food product free from and requirements as to compulsory and other than labelling provisions, relating to Federal Register / Vol. 62, No. 100 / Friday, May 23, 1997 / Notices 28441 weights and measures, e.g. where ADDRESSES: Committee for Purchase in the prices charged the Government by appropriate, fill of container, weight, From People Who Are Blind or Severely the nonprofit agency. measure or count of units determined by an Disabled, Crystal Square 3, Suite 403, The Following Comments Pertain to appropriate method of sampling and 1735 Jefferson Davis Highway, analysis. Weights and measures should be Folder, Zebley Claim (7530–00–000– expressed in S.I. units. In the case of Arlington, Virginia 22202–3461. 0430/2) standards which include provisions for the FOR FURTHER INFORMATION CONTACT: sale of products in standardized amounts, Beverly Milkman (703) 603–7740. Comments were received from the e.g. multiples of 100 grams, S.I. units should current contractor in response to a SUPPLEMENTARY INFORMATION: On request for sales data. A Member of be used, but this would not preclude November 1, 22, December 20, 1996, additional statements in the standards of Congress also wrote to request a review these standardized amounts in approximately February 14, March 7, 28 and April 4, of the contractor’s contentions. The similar amounts in other systems of weights 1997, the Committee for Purchase From contractor claimed that the Committee’s and measures. People Who Are Blind or Severely Procurement List additions have Disabled published notices (61 FR Labelling disproportionately affected the 56511, 59401, 67306, 62 FR 6946, This section should include all the company, that the company has lost 10519, 14883 and 16135) of proposed millions of dollars in sales and many labelling provisions contained in the additions to the Procurement List. standard and should be prepared in jobs as a result of the additions, and that accordance with the guidance given on pages The Following Comments Pertain to the the company has not fully recovered 91 to 93 of the Codex Procedural Manual. Envelope, Translucent (7530–01–354– from the losses. Provisions should be included by reference 3983+2) The contract value for these zebley to the General Standard for the Labelling of claim folders represents less than one Prepackaged Foods. The section may also Comments were received from one of percent of the contractor’s 1996 annual contain provisions which are exemptions two current contractors for these sales. The Committee last added an item from, additions to, or which are necessary for envelopes. The contractor indicated that to the Procurement List where the the interpretation of the General Standard in it has been a longtime supplier of the respect of the product concerned provided contractor was the current contractor in envelopes, and that production of them January 1994. The contractor’s sales that these can be justified fully. The for the Government is the anchor following statement should also appear: have continued to grow significantly ‘‘The following provisions in respect of the business of one department of the plant since that time. The contractor did not labelling of this product are subject to where the contractor produces the provide any details on the jobs it claims endorsement [have been endorsed] by the envelopes. Without this anchor were lost because of Procurement List Codex Committee on Food Labelling.’’ business, the contractor speculated that additions. Consequently, the Committee the department would be closed and its Methods of Analysis and Sampling has concluded that the current addition employees discharged. The contractor This section should include, either will not have a severe adverse impact on also noted that it recently modified a the contractor or its work force. specifically or by reference, all methods of production machine to make the analysis and sampling considered necessary The Following Comments Pertain to and should be prepared in accordance with envelopes in a more efficient manner, and that these efficiencies and the Janitorial/Custodial, Mare Island Naval the guidance given on pages 99 to 102 of the Shipyard, Vallejo, CA Codex Procedural Manual. If two or more contractor’s investment would be lost if methods have been proved to be equivalent the envelopes are added to the Comments were received from the by the Codex Committee on Methods of Procurement List. previous contractor for the service when Analysis and Sampling, these could be The contractor is a very large it submitted its sales data to the regarded as alternative and included in this corporation, and the impact on its sales Committee. The contractor noted that it section either specifically or by reference. of losing this business is insignificant. has been greatly affected by base The following statement should also appear: The Committee is not adding the total ‘‘The methods of analysis and sampling closures, as indicated by its net income described hereunder are to be endorsed [have Government requirement for one of the figures for the past three years. Removal been endorsed] by the Codex Committee on three types of these envelopes to the of this service from competition, Methods of Analysis and Sampling.’’ Procurement List, so some of the according to the contractor, would business will remain available for hinder its ability to stay in business [FR Doc. 97–13410 Filed 5–22–97; 8:45 am] competitive procurement from this while making the transition from BILLING CODE 3410±DM±P contractor. For this reason, the dependence on Government work. likelihood of the contractor’s Despite the reduction in the department being closed is lessened. contractor’s business in recent years, COMMITTEE FOR PURCHASE FROM Given the size of the contractor’s this service represents only a small PEOPLE WHO ARE BLIND OR operations, the Committee considers it percentage of the contractor’s remaining SEVERELY DISABLED unlikely that any affected employees total sales. As a result, the Committee could not be employed elsewhere in the does not believe the adverse impact will Procurement List; Additions plant’s operation. The contractor will be be severe, even when the Committee’s AGENCY: Committee for Purchase From able to use its modified equipment to 1994 action in adding to the People Who Are Blind or Severely produce these envelopes for its Procurement List an even smaller Disabled. commercial business and the contract where the firm was the current ACTION: Additions to the procurement Government business left open to contractor is taken into account. While list. competition, so the Procurement List the contractor’s sales have declined addition will not cause the loss of this since 1994, the firm has not shown that SUMMARY: This action adds to the investment. Moreover, if the modified it will inevitably suffer grievous Procurement List commodities and equipment reduces production costs financial harm as a result of the services to be furnished by nonprofit and those savings are reflected in the Committee’s action, which will create agencies employing persons who are contractor’s prices to the Government, jobs for people with severe disabilities blind or have other severe disabilities. the Committee’s pricing system will who would likely otherwise be EFFECTIVE DATE: June 23, 1997. assure the similar savings are reflected unemployed, and will restore