Trade and Foreign Agriculture Affairs; Codex Alimentarius Commission: International Standard-Setting Activities

Federal RegisterAug 8, 2018

83 Fed. Reg. 39041 (Aug. 8, 2018)

AGENCY:

Office of Trade and Foreign Agriculture Affairs (TFAA), USDA.

ACTION:

Notice.

SUMMARY:

This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts. This notice, which covers Codex activities during the time periods from June 1, 2016, to May 31, 2017, and June 1, 2017, to July 20, 2018, seeks comments on standards under consideration and recommendations for new standards.

ADDRESSES:

The U.S. Codex Office invites interested persons to submit their comments on this notice. Comments may be submitted by one of the following methods:

Federal e-Rulemaking Portal: This website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at the website for submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to 1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

Instructions: All items submitted by mail or email are to include the Agency name and docket number FSIS-2018-0013. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information to http://www.regulations.gov.

Please state that your comments refer to Codex and, if your comments relate to specific Codex committees, please identify the committee(s) in your comments and submit a copy of your comments to the delegate from that particular committee.

Docket: For access to background documents or comments received, call (202) 720-5627 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT:

Mary Frances Lowe, United States Manager for Codex Alimentarius, U.S. Department of Agriculture, Office of Food Safety, South Agriculture Building, 1400 Independence Avenue SW, Room 4861, Washington, DC 20250-3700; Telephone: (202) 205-7760; Fax: (202) 720-3157; Email: USCodex@fsis.usda.gov.

For information pertaining to particular committees, contact the delegate of that committee. A complete list of U.S. delegates and alternate delegates can be found in Attachment 2 of this notice. Documents pertaining to Codex and specific committee agendas are accessible via the internet at http://www.codexalimentarius.org/meetings-reports/en/. The U.S. Codex Office also maintains a website at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius.

SUPPLEMENTARY INFORMATION:

Background

The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). United States membership in the WTO was approved and the Uruguay Round Agreements Act (Uruguay Round Agreements) was signed into law by the President on December 8, 1994, Public Law 103-465, 108 Stat. 4809. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. The Uruguay Round Agreements amended the Trade Agreements Act of 1979. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be “responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization” (19 U.S.C. 2578). The main international standard-setting organizations are Codex, the World Organisation for Animal Health, and the International Plant Protection Convention. The President, pursuant to Proclamation No. 6780 of March 23, 1995, (60 FR 15845), designated the U.S. Department of Agriculture as the agency responsible for informing the public of the SPS standard-setting activities of each international standard-setting organization. The Secretary of Agriculture has delegated to the Office of Trade and Foreign Agricultural Affairs the responsibility to inform the public of the SPS standard-setting activities of Codex. The Office of Trade and Foreign Agricultural Affairs has, in turn, assigned the responsibility for informing the public of the SPS standard-setting activities of Codex to the U.S. Codex Office (USCO).

Codex was created in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for establishing standards for food. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of food standards work undertaken by international governmental and nongovernmental organizations. In the United States, U.S. Codex activities are managed and carried out by the United States Department of Agriculture (USDA); the Food and Drug Administration (FDA), Department of Health and Human Services (HHS); the National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC); and the Environmental Protection Agency (EPA).

As the agency responsible for informing the public of the SPS standard-setting activities of Codex, the U.S. Codex Office publishes this notice in the Federal Register annually. Attachment 1 (Sanitary and Phytosanitary Activities of Codex) sets forth the following information:

1. The SPS standards under consideration or planned for consideration; and

2. For each SPS standard specified:

a. A description of the consideration or planned consideration of the standard;

b. Whether the United States is participating or plans to participate in the consideration of the standard;

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

d. The agency responsible for representing the United States with respect to the standard.

TO OBTAIN COPIES OF THE STANDARDS LISTED IN ATTACHMENT 1, PLEASE CONTACT THE CODEX DELEGATE OR THE U.S. CODEX OFFICE.

This notice also solicits public comment on standards that are currently under consideration or planned for consideration and recommendations for new standards. The delegate, in conjunction with the responsible agency, will take the comments received into account in participating in the consideration of the standards and in proposing matters to be considered by Codex.

The U.S. delegate will facilitate public participation in the United States Government's activities relating to Codex. The U.S. delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex Committees and will disseminate information regarding U.S. delegation activities to interested parties. This information will include the status of each agenda item; the U.S. Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following the Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its web page at http://www.fsis.usda.gov/wps/portal/fsis/topics/international-affairs/us-codex-alimentarius. If you would like to access or receive information about specific committees, please visit the web page or notify the appropriate U.S. delegate or the U.S. Codex Office, Room 4861, South Agriculture Building, 1400 Independence Avenue SW, Washington, DC 20250-3700 (uscodex@fsis.usda.gov).

The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2016, to May 31, 2017, and June 1, 2017, to July 20, 2018. Attachment 2 provides a list of U.S. Codex Officials (including U.S. delegates and alternate delegates). A list of forthcoming Codex sessions may be found at: http://www.fao.org/fao-who-codexalimentarius/meetings/en/.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: http://www.fsis.usda.gov/federal-register.

Done at Washington, DC.

Mary Frances Lowe,

U.S. Manager for Codex Alimentarius.

Attachment 1

Sanitary and Phytosanitary Activities of Codex

Codex Alimentarius Commission and Executive Committee

The Codex Alimentarius Commission convened for its 41st Session July 2-6, 2018, in Rome, Italy. At that time, the Commission adopted standards recommended by Committees at Step at 8 or Step 5/8 (final adoption), and it advanced the work of Committees by adopting draft standards at Step 5 (for further comment and consideration by the relevant committee). The Commission also considered proposals for new work; discontinuation of work; amendments to Codex standards and related texts; matters arising from the reports of the Commission, the Executive Committee and subsidiary bodies; committees working by correspondence and a possible pilot for a committee on standards advancement; regular review of Codex work management; Codex budgetary and financial matters for 2020-2021; FAO/WHO Scientific Support for Codex activities; matters arising from FAO and WHO; reports on side events on FAO and WHO capacity development activities, the Codex Trust Fund, and discussion panels with International Government Organizations and Non-Governmental Organizations; election of the chairperson and vice-chairpersons of Codex; and other business.

Before the Commission meeting, the Executive Committee met for its 75th Session from June 26 to 29, 2018. It is composed of the chairperson and vice-chairpersons of the CAC; seven members elected by the Commission from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific; and regional coordinators from the six regional committees. The United States participated as the member elected on a geographic basis for North America. The Executive Committee conducted a critical review of the elaboration of Codex standards; reviewed the implementation status of the 2014-2019 Strategic Plan and preparation of the 2020-2025 Strategic Plan; and considered the work of committees working by correspondence and the possibility of a pilot for a committee on standards advancement, FAO/WHO Scientific Support for Codex work, other matters arising from FAO and WHO, and financial and budgetary issues.

Responsible Agency: USDA/TFAA/USCO.

U.S. Participation: Yes.

Codex Committee on Residues of Veterinary Drugs in Foods

The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. The Committee also develops codes of practice, as may be required, and considers methods of sampling and analysis for the determination of veterinary drug residues in food. A veterinary drug is defined as any substance applied or administered to any food producing animal such as meat or milk producing animals, poultry, fish, or bees, whether used for therapeutic, prophylactic or diagnostic purposes, or for modification of physiological functions or behavior.

A Codex MRL for residues of veterinary drugs is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. Residues of a veterinary drug include the parent compounds or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. An MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI) or on the basis of a temporary ADI that utilizes an additional safety factor. When establishing an MRL, consideration is also given to residues that occur in food of plant origin or the environment. Furthermore, the MRL may be reduced to be consistent with official recommended or authorized usage, approved by national authorities, of the veterinary drugs under practical conditions.

An ADI is an estimate made by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, which can be ingested daily in food over a lifetime without appreciable health risk.

The Committee convened for its 24th Session (CCRVDF24) in Chicago, Illinois, April 23-27, 2018. The relevant document is REP18/RVDF. The following items were adopted by the 41st Session of the Commission in July 2018:

Adopted at Step 5/8:

Proposed draft MRLs for amoxicillin (finfish fillet, muscle); ampicillin (finfish fillet, muscle; lufenuron (salmon and trout fillet); monepantel (cattle fat, kidney, liver, muscle).

Adopted at Step 8:

Draft Risk Management Recommendation for gentian violet.

Adopted at Step 5:

Proposed draft MRL for flumethrin (honey).

The Commission also adopted the proposed amendment to the Risk Analysis Principles Applied by CCRVDF in the Codex Procedural Manual, and approved new work on the priority list of veterinary drugs for evaluation by the Joint Expert Committee on Food Additives, as recommended by CCRVDF24.

The Committee will continue working on the following items:

Proposed draft MRLs for zilpaterol hydrochloride (cattle fat, kidney, liver, muscle);
Draft Priority List of veterinary drugs requiring approval by CAC;
Discussion paper on extrapolation of MRLs to one or more species (including a pilot on extrapolation of MRLs identified in Part D of the Priority List);
Coordination with the Codex Committee on Pesticide Residues/Electronic Working Group on the revision of the Classification of Food and Feed for the development of a harmonized definition for edible offal/animal tissues for the establishment of MRLs;
Database on countries needs for MRLs; and
Discussion paper on advantages and disadvantages of a parallel approach to compound evaluation.

The following items were discontinued:

Discussion paper on the revision of the criteria for the use of multi-residue analytical methods for the determination and identification of veterinary drugs in foods in the Guidelines for the design and implementation of national regulatory food safety assurance programs associated with the use of veterinary drugs in food producing animals; and
Discussion paper on MRLs for groups of fish species.

Responsible Agencies: HHS/FDA/Center for Veterinary Medicine; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Contaminants in Foods

The Codex Committee on Contaminants in Foods (CCCF) establishes or endorses permitted maximum levels (MLs), as necessary, revises existing guideline levels (GLs) for contaminants and naturally occurring toxicants in food and feed; prepares priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); considers and elaborates methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed; considers and elaborates on standards or codes of practice (COPs) for related subjects; and considers other matters assigned to it by the Commission in relation to contaminants and naturally occurring toxicants in food and feed.

The Committee convened for its 12th Session (CCCF12) in Utrecht, the Netherlands, March 12-16, 2018. The relevant document is REP18/CF. The following standards were forwarded to the CAC for consideration and adopted by the 41st Session of the Commission in July 2018:

Adopted at Step 5/8:

MLs for lead in selected commodities (revision of MLs and consequential revocation of corresponding MLs/amendments to MLs in the General Standard for Contaminants and Toxins in Food and Feed (GSCTFF) (CXS 193-1995));
MLs for cadmium in chocolate containing or declaring ≥50% to <70% total cocoa solids on a dry matter basis; and chocolate containing or declaring ≥70% total cocoa solids on a dry matter basis;
MLs for methylmercury in tuna, alfonsino, marlin and shark, and revocation of the GLs for methylmercury in predatory and non-predatory fish;
Amendment to the note for the ML on inorganic arsenic in rice (consequential amendment); and
COP for the prevention and reduction of dioxins, dioxin-like PCBs and non-dioxin-like polychlorinated biphenyls (PCB) contamination in food and feed.

Adopted at Step 5:

COP for the reduction of 3-MCPDE and GE in refined oils and products made with refined oils; and
Guidelines for risk analysis of instances of contaminants in food where there is no regulatory level or risk management framework established.

The Commission also approved discontinuation of work on the following items, as recommended by CCCF12:

Establishment of MLs for cadmium in dry mixtures of cocoa and sugars sold for final consumption; and

Establishment of MLs for methylmercury in amberjack and swordfish.

The Committee suspended working on the following items:

Establishment of MLs for total aflatoxins in ready-to-eat peanuts; and
Establishment of MLs for total aflatoxins and ochratoxin A in nutmeg, chili and paprika, ginger, pepper and turmeric.

The Committee will continue working on the following items:

MLs for lead in wine and edible offals;
MLs for cadmium in chocolate and cocoa-derived products (category of chocolate and chocolate products containing or declaring (1) <30% and (2) ≥30% to <50% total cocoa solids on a dry matter basis;
Discussion paper on establishment of MLs for hydrocyanic acid (HCN) in cassava and cassava-based products and occurrence of mycotoxins in these products;
Discussion paper on structured approach to prioritize commodities for which new MLs for lead could be established for inclusion in the General Standard for Contaminants and Toxins in Food and Feed;
Discussion paper on aflatoxins in cereals (establishment of MLs for total aflatoxins in wheat, maize, sorghum and rice (specifying the categories));
Discussion paper on development of a COP for the prevention and reduction of cadmium contamination in cocoa;
Discussion paper on forward workplan for CCCF; and
Priority list of contaminants and naturally occurring toxicants for evaluation by JECFA.

The Committee also agreed to start discussion on the following items:

Discussion paper on lead and cadmium in quinoa;
Discussion paper on general guidance on data analysis for ML development; and
Discussion paper, including a project document, for a proposal for new work on the revision of the COP for prevention and reduction of lead contamination in foods (CXC 56-2004).

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Additives

The Codex Committee on Food Additives (CCFA) establishes or endorses acceptable maximum levels (MLs) for individual food additives; prepares a priority list of food additives for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); assigns functional classes to individual food additives; recommends specifications of identity and purity for food additives for adoption by the Codex Alimentarius Commission; considers methods of analysis for the determination of additives in food; and considers and elaborates standards or codes of practice for related subjects such as the labeling of food additives when sold as such. The 50th Session of the Committee (CCFA50) convened in Xiamen, China, March 26-30, 2018. The relevant document is REP18/FA. Immediately prior to the Plenary Session, there was a two-day physical Working Group (PWG) on the General Standard for Food Additives (GSFA) chaired by the United States.

The following items were recommended by CCFA50 and considered by the 41st Session of the Commission in July 2018:

Adopted at Step 5/8:

Proposed draft specifications for the identity and purity of food additives; and
Proposed draft amendments to the Class Names and International Numbering System (INS) for Food Additives (CAC/GL 36-1989).

Adopted at Step 8 and 5/8:

Draft and proposed draft food additive provisions of the GSFA.

Adopted:

Replacement of the name “sodium aluminosilicate” with “sodium aluminum silicate” in the GSFA (CXS 192-1995); Class Names and the INS for Food Additives (CXG 36-1989); Standard for Milk Powders and Cream Powder (CXS 207-1999); Standard for a Blend of Skimmed Milk and Vegetable Fat in Powdered Form (CXS 251-2006); and Standard for Edible Casein Products (CXS 290-1995);
Revised food additive provisions of the GSFA related to the alignment of the annexes of the Standard for Certain Canned Fruits (CXS 319-2015) and to the alignment of 14 standards for fish and fish products; and
Revised food additive sections of 14 standards for fish and fish products and the Standard for Certain Canned Fruits (CXS 319-2015).

Revoked:

Food additive provisions of the GSFA;
Food-additive provisions for specific malates and/or tartrates from the Standards for Mozzarella (CXS 262-2006), Cottage Cheese (CXS 273-1968), Cream Cheese (CXS 275-1973), Fermented Milks (CXS 243-2003), and Dairy Fat Spreads (CXS 253-2006) due to a lack of JECFA specifications for these additives; and
Food-additive provisions for sodium sorbate (INS 201) from the Standards for Instant Noodles (CXS 249-2006), Fermented Milks (CXS 243-2003), Dairy Fat Spreads (CXS 253-2006), Cottage Cheese (CXS 273-1968), Cream Cheese (CXS 275-1973), the General Standard for Cheese (CXS 283-197), and 11 standards for named cheeses due to a lack of JECFA specifications for the additive.

The Committee will continue working on:

Draft and proposed draft food additive provisions of the GSFA, and technological justification for the use of preservatives and anticaking agents for surface treatment of mozzarella with high moisture content covered by Standard for Mozzarella (CXS 262-2006) (EWG led by the United States);
Proposals for additions and changes to the Priority List of Substances Proposed for Evaluation by JECFA (PWG led by Canada);
Alignment of the food additive provisions of commodity standards and relevant provisions of the GSFA; consider revisions to the “References to Commodity Standard for GSFA Table 3 Additives” section of Table 3; proposed revisions to food-additive provisions in Food Categories 13.1.1, 13.1.2, and 13.1.3 for ascorbyl palmitate (INS 304) and ascorbyl stearate (INS 305) (EWG led by Australia, Japan and the United States);
Revision of the Class Names and the INS for Food additives (EWG led by Iran and Belgium);
New or revised provisions of the GSFA (PWG led by the United States);
Clarification of the appropriate descriptors for Food Categories 14.1.4.2 and 14.1.5 for ready-to-drink coffee and tea beverages (Codex Secretariat);
Review of all group food additives in the GSFA to determine if all food-additives in the group share a Group Acceptable Daily Intake (Codex Secretariat in consultation with JECFA Secretariat);
Development of an inventory of data available on the use of nitrates (INS 251, 252) and nitrites (INS 249, 250) with a view to consulting with JECFA and CCFA regarding next steps (eWG led by the European Union and the Netherlands);
Development of an alternative to Note 161 relating to the use of sweeteners and, subject to agreement on the wording of an alternative, review of recommendations in CX FA 14/47/13 in the context of pending and adopted provisions (EWG led by United States and the European Union); and
Preparation of a discussion paper on the use of the terms “fresh”, “plain”, “unprocessed” and “untreated” in existing Codex texts (Russian Federation).

The Committee also agreed to hold a one and one-half day PWG on the GSFA immediately preceding the 51st Session of the CCFA, to be chaired by the United States. That group will discuss the recommendations of the EWG on the GSFA, new proposals and proposed revisions of food additive provisions in the GSFA.

The Committee also agreed to hold a half day PWG on the GSFA immediately preceding the 51st Session of the CCFA to be chaired by Australia. That group will discuss the recommendations of the PWG on alignment.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Pesticide Residues

The Codex Committee on Pesticide Residues (CCPR) is responsible for establishing MRLs for pesticide residues in specific food items or in groups of food; establishing MRLs for pesticide residues in certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health; preparing priority lists of pesticides for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); considering methods of sampling and analysis for the determination of pesticide residues in food and feed; considering other matters in relation to the safety of food and feed containing pesticide residues; and establishing maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides in specific food items or groups of food.

The 50th Session of the Committee (CCPR50) met in Haikou, China, April 9-14, 2018. The relevant document is REP18/PR. The following items were considered at the 41st Session of the Codex Alimentarius Commission in July 2018:

Adopted at Step 8 and 5/8:

Three hundred eighty-six (386) MRLs for different pesticide residues.
Revisions of the Classification: Class A—Primary Commodities of Plant Origin—Type 04 Nuts, Seeds, and SAPs (Step 8 and 5/8);
Revision of the Classification: Class A-Primary Commodities of Plant Origin—Type 05 Herbs and Spices (Step 8).

Adopted at Step 5/8:

Tables with Examples of Representative Commodities for Commodity Groups in Type 04 and Type 05 (For inclusion in the Principles and Guidance for the Selection of Representative Commodities for the Extrapolation of Maximum Residue Limits for Pesticides for Commodity Groups).

The Commission also discontinued work, approved new work, and revoked existing MRLs as recommended by CCPR50.

The Committee will continue working on the following items:

Revision of the Classification: Impact of the Revised Commodity Groups and Subgroups in Type 03, Type 04 and Type 05 on the CXLs adopted by the Codex Alimentarius Commission;
Draft and proposed draft Revision of the Classification of Food and Feed;
Development of a system within the classification of food and feed to provide codes for commodities not meeting the criteria for crop grouping;
Discussion Paper on the review of the International Estimated Short-term Intake Equations (IESTI);
Discussion paper on management of unsupported compounds;
Discussion paper on biopesticides;
Discussion paper on the revision of the guidelines on the use of mass spectrometry for the identification, confirmation and quantitative determination of residues;
Discussion paper on the opportunities and challenges related to the participation of JMPR in an international joint review of a new compounds;
National Registration Database of Pesticides; and
Establishment of Codex Schedules and Priority Lists of Pesticides.

Responsible Agencies: EPA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Import and Export Inspection and Certification Systems

The Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) is responsible for developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs; developing principles and guidelines for the application of measures by the competent authorities of exporting and importing countries to provide assurance, where necessary, that foodstuffs comply with requirements, especially statutory health requirements; developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries; developing guidelines and criteria with respect to format, declarations, and language of such official certificates as countries may require with a view towards international harmonization; making recommendations for information exchange in relation to food import/export control; consulting as necessary with other international groups working on matters related to food inspection and certification systems; and considering other matters assigned to it by the Commission in relation to food inspection and certification systems. The 24th Session of the Committee will convene in Brisbane, Australia, October 22-26, 2018.

The Committee will continue working on the following items:

Project document for new work on guidance on paperless use of electronic certificates (Revision of Guidelines for Design, Production, Issuance and Use of Generic Official Certificates);
Project document for new work on guidance on regulatory approaches to third party assurance schemes in food safety and fair practices in the food trade;
Discussion paper on food integrity and food authenticity;
Discussion paper on consideration of emerging issues and future directions for the work of the Codex Committee on Food Import and Export Inspection and Certification Systems;
Framework for the preliminary assessment and identification of priority areas for CCFICs; and
Inter-sessional physical working groups: trial.

Responsible Agencies: USDA/FSIS; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Methods of Analysis and Sampling

The Codex Committee on Methods of Analysis and Sampling (CCMAS) defines the criteria appropriate to Codex Methods of Analysis and Sampling; serves as a coordinating body for Codex with other international groups working on methods of analysis and sampling and quality assurance systems for laboratories; specifies, on the basis of final recommendations submitted to it by the bodies referred to above, reference methods of analysis and sampling appropriate to Codex standards which are generally applicable to a number of foods; considers, amends if necessary, and endorses as appropriate, methods of analysis and sampling proposed by Codex commodity committees, except for methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives; elaborates sampling plans and procedures, as may be required; considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.

The 39th Session of the Committee (CCMAS39) met in Budapest, Hungary, May 7-11, 2018. The relevant document is REP18/MAS.

At its 41st Session in July 2018, the Commission adopted, amended and revoked methods of analysis and sampling as recommended by CCMAS39. The Commission also approved new work as proposed by CCMAS:

Revision of the Guidelines on Measurement Uncertainty (CXG 54-2004); and
Project plan and amendment of the General Guidelines on Sampling (CXG 50-2004).

The Committee will continue working on the following item:

Review/Revision of the General Standard for Methods of Analysis and Sampling (CSX 234.

At CCMAS 39, the Committee agreed to discontinue work on criteria for endorsement of biological methods to detect chemicals of concern.

Responsible Agencies: HHS/FDA; USDA/AMS.

U.S. Participation: Yes.

Codex Committee on Food Labelling

The Codex Committee on Food Labelling (CCFL) drafts provisions on labeling applicable to all foods; considers, amends, and endorses draft specific provisions on labeling prepared by the Codex Committees drafting standards, codes of practice, guidelines; and studies specific labeling problems assigned by the Codex Alimentarius Commission. The Committee also studies problems associated with the advertisement of food with particular reference to claims and misleading descriptions.

The Committee convened its 44th Session (CCFL44) in Asuncion, Paraguay, October 16-20, 2017. The relevant document is REP18/FL. The following item was adopted by the Commission at its 41st Session in July 2018, as recommended by CCFL44:

Adopted at Step 8:

Draft Revision of the General Standard for the Labelling of Prepackaged Foods: Date marking.

The Committee will continue working on the following items:

Proposed draft Guidance for the Labelling of Non-Retail Containers;
Proposed draft Guidelines on Front of Pack Nutrition Labelling;
Discussion paper on internet sales/e-commerce;
Discussion paper on allergen labelling;
Discussion paper on innovation—use of technology in food labelling;
Discussion paper on labelling of alcoholic beverages;
Discussion paper on criteria for the definition of “high in” nutritional descriptors for fats, sugars and sodium;
Discussion paper on labelling of foods in joint presentation and multipack formats; and
Discussion paper on future work and direction of CCFL (update).

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Food Hygiene

The Codex Committee on Food Hygiene (CCFH):

Develops basic provisions on food hygiene, applicable to all food or to specific food types;
Considers and amends or endorses provisions on food hygiene contained in Codex commodity standards and codes of practice developed by Codex commodity committees;
Considers specific food hygiene problems assigned to it by the Commission;
Suggests and prioritizes areas where there is a need for microbiological risk assessment at the international level and develops questions to be addressed by the risk assessors; and
Considers microbiological risk management matters in relation to food hygiene and in relation to the FAO/WHO risk assessments.

The Committee convened for its 49th Session (CCFH49) in Chicago, Illinois, November 13-17, 2017. The relevant document is REP 18/FH. The following item was adopted by the 41st Session of the Commission in July 2018, as recommended by CCFH49:

Adopted at Step 5/8:

Proposed draft Revision of the Code of Practice (COP) for Fish and Fishery Products (Guidance for histamine control), with minor amendment accepted to section 13.1.2.

The Commission also approved new work as recommended by CCFH49:

Code of Practice on food allergen management for food business operators; and

Guidance for the management of (micro)biological foodborne crises/outbreaks.

The Committee will continue working on the following items:

Proposed draft Revision of the General Principles of Food Hygiene and its HACCP Annex;
The placement for the guidance on histamine control in CXC 52-2003, the amendments of other sections of CXC 52-3002, and the revision of the section on sampling, examination and analyses in standards for fish and fishery products related to histamine food safety;
Discussion paper on future work on Shiga toxin-producing Escherichia coli (STEC); and
New work proposals/Forward Workplan.

Responsible Agencies: HHS/FDA; USDA/FSIS.

U.S. Participation: Yes.

Codex Committee on Fresh Fruits and Vegetables

The Codex Committee on Fresh Fruits and Vegetables (CCFFV) is responsible for elaborating worldwide standards and codes of practice, as may be appropriate, for fresh fruits and vegetables, consulting as necessary, with other international organizations in the standards development process to avoid duplication.

The 20th Session of the Committee (CCFFV20) met in Kampala, Uganda, October 2-6, 2017. The relevant document is REP 18/FFV.

The following items were considered by the Commission at its 40th Session in July 2018, and the Commission took action as recommended by CCFFV20:

Adopted at Step 8:

Draft Standard for Aubergines.

Adopted at Step 5:

Draft Standard for Ware Potatoes.

Approved new work:

Standards for yam, onions and shallots, and berry fruits.

The Committee will continue working on the following items:

Proposed Layout for Standards for Fresh Fruits and Vegetables;
Draft Standard for Garlic;
Draft Standard for Kiwifruit;
Draft Standard for Ware Potatoes;
Proposed Draft Standard for Fresh Dates;
Discussion paper on glossary of terms used in the layout for Codex standards for fresh fruits and vegetables; and
Recommendation on the inclusion of mono and di-glycerides of fatty acids and salts of myristic, palmitic and stearic acids with ammonia, calcium, potassium and sodium in the GSFA under the food categories “surface-treated fresh fruits” and “surface treated fresh vegetables.”

Responsible Agencies: USDA/Agricultural Marketing Service (AMS); HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Nutrition and Foods for Special Dietary Uses

The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is responsible for studying nutrition issues referred to it by the Codex Alimentarius Commission. The Committee also drafts general provisions, as appropriate, on nutritional aspects of all foods and develops standards, guidelines, and related texts for foods for special dietary uses, in cooperation with other committees where necessary; considers, amends if necessary, and endorses provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts.

The Committee convened for its 39th Session (CCNFSDU) in Berlin, Germany, December 4-8, 2017. The reference document is REP 18/NFSDU. The following item was adopted by the Commission at its 41st Session in July 2-6, 2018, as recommended by CCNFSDU39.

Adopted at Step 5:

Review of the Standard for Follow-up Formula: Proposed “Essential composition requirements for older infants and young children.”

The Committee will continue working on the following items:

Proposed draft Claim for “free of” trans fatty acids;
Discussion of biological methods used to detect chemicals of concern;
Review of the Standard for Follow-up Formula: Scope, product definition, labelling;
Proposed draft definition for biofortification;
Proposed draft Nutrient Reference Values—Noncommunicable Disease (NRV-NCD) for EPA and DHA;
Proposed draft guideline for ready to use therapeutic foods;
Nutrient Reference Values—Requirements (NRV-R) for older infants and young children;
Mechanism/framework for considering the technological justification of food additives;
Discussion paper on harmonized probiotic guidelines for use in foods and dietary supplements; and
General guidelines to establish nutritional profiles.

Responsible Agencies: HHS/FDA; USDA/Agricultural Research Service (ARS).

U.S. Participation: Yes.

Ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (re-activated in 2016).

The Ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) is responsible for (1) reviewing and revising, as appropriate, the Code of Practice to Minimize and Contain Antimicrobial Resistance (CAC/RCP 61-2005) to address the entire food chain, in line with the mandate of Codex; and (2) considering the development of Guidance on Integrated Surveillance of Antimicrobial Resistance, taking into account the guidance developed by the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and relevant World Organisation for Animal Health (OIE) documents. The objective of the Task Force is to develop science-based guidance on the management of foodborne antimicrobial resistance, taking full account of the WHO Global Action Plan on Antimicrobial Resistance, in particular objectives 3 and 4, the work and standards of relevant international organizations, such as FAO, WHO, and OIE, and the One-Health approach, to ensure members have the necessary guidance to enable coherent management of antimicrobial resistance along the food chain. The Task Force is expected to complete its work within three (or a maximum of four) sessions.

The Task Force will convene for its 6th Session (the 2nd Session since reactivation in 2016) in the Republic of Korea, December 10-14, 2018.

The Committee will continue to discuss:

The Proposed draft Revision of the Code of Practice to Minimize and Contain Antimicrobial Resistance;
Proposed draft Guidelines on Integrated surveillance of Antimicrobial Resistance; and
Request for Scientific Advice from Food and Agriculture Organization (FAO) and World Health Organization (WHO) in collaboration with OIE.

Responsible Agencies: FDA/USDA.

U.S. Participation: Yes.

Codex Committee on Fats and Oils

The Codex Committee on Fats and Oils (CCFO) is responsible for elaborating worldwide standards for fats and oils of animal, vegetable, and marine origin, including margarine and olive oil.

The Committee will convene in 2019 for its 26th Session.

The Committee will continue working on the following items:

Revision of the Standard for Named Vegetable Oils: Essential composition of sunflower seed oils;
Revision of the Standard for Named Vegetable Oils: Inclusion of walnut oil, almond oil, hazelnut oil, pistachio oil, flaxseed oil, and avocado oil;
Revision of the Standard for Named Vegetable Oils: Replacement of acid value with free fatty acids for virgin palm oil and inclusion of free fatty acids for crude palm kernel oil; and
Revision of the Standard for Olive Oils and Pomace Olive Oils (Codex Stan 33-1981).
Gathering information on technical difficulties in the implementation of the fish oil standard, specifically on monitoring its application with respect to the conformity of named fish oils with the requirements (especially the fatty acid profile), and its effect on trade;
Alignment of food additives provisions in standards for fats and oils (except fish oils) and technological justification for use of emulsifiers;
Proposals for new substances to be added to the list of acceptable previous cargoes;
Provision of relevant information (if available from Member countries) to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) on the 23 substances on the list of acceptable previous cargoes currently on the list; and
Discussion paper on the applicability of the fatty acid composition of all oils listed in Table 1 in relation to the fatty acid composition of corresponding crude (unrefined) forms in the Standard for Named Vegetable Oils.

Responsible Agencies: HHS/FDA; USDA/Agricultural Research Service (ARS).

U.S. Participation: Yes.

Codex Committee on Processed Fruits and Vegetables

The Codex Committee on Processed Fruits and Vegetables (CCPFV) is responsible for elaborating worldwide standards and related texts for all types of processed fruits and vegetables including, but not limited to canned, dried, and frozen products, as well as fruit and vegetable juices and nectars. Proposals for new work were received by Executive Committee of the Codex Alimentarius Commission (CCEXEC) and approved by CAC40 (July 17-22, 2017) for cashew kernels, chili sauce, mango chutney, dried sweet potato, gochujang, dried fruits, and canned mixed fruits.

The Commission authorized CCPFV to work by correspondence until CAC 41 (2018) to prioritize the proposals for new work, prepare a work plan, and prepare recommendations on the establishment of electronic working groups. The Commission at its 41st Session in July 2018 endorsed the CCPFV Chairperson's proposed work plan and recommendations (1) to establish 7 EWGS to prepare proposed drafts for comments and consideration by the CCPFV, and (2) to schedule a physical meeting of the Committee at an appropriate time.

Responsible Agencies: USDA/Agricultural Marketing Service; HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Sugars

The Codex Committee on Sugars (CCS) elaborates worldwide standards for all types of sugars and sugar products.

The Committee has been re-activated to work by correspondence on a draft Standard for Non-Centrifuged Dehydrated Sugar Cane Juice. The work is behind schedule. The Commission at its 41st Session in July 2018 agreed to extend the work by correspondence by one year, reporting back to the Commission at its 42nd session, and noted the possibility that a physical meeting could be convened.

Responsible Agencies: HHS/FDA.

U.S. Participation: Yes.

Codex Committee on Cereals, Pulses and Legumes

The Codex Committee on Cereals, Pulses and Legumes (CCCPL) elaborates worldwide standards and/or codes of practice, as appropriate, for cereals, pulses and legumes and their products.

The Committee has been reactivated to work by correspondence to draft an international Codex Standard for quinoa. The following item was considered by the Commission at its 41st Session in July 2018:

Standard for Quinoa

The Commission agreed to adopt, subject to the endorsement of the labelling provisions by CCFL45, the draft standard for quinoa at Step 8, except for the provisions for moisture content and grain size, which were returned to Step 6. The Commission also established an EWG, chaired by Costa Rica and co-chaired by Chile and the United States of America, to continue the work on the provisions for moisture content and grain size. The Commission further encouraged members to identify a validated method of analysis for saponins to allow for full implementation of the standard.

Responsible Agencies: HHS/FDA.

U.S. Participation: Yes.

Certain Codex Commodity Committees

Several Codex Alimentarius Commodity Committees have adjourned sine die. The following Committees fall into this category:

Cocoa Products and Chocolate—adjourned 2001.

Responsible Agency: HHS/FDA; DCO/NOAA.

U.S. Participation: Yes.

Fish and Fishery Products—adjourned 2016.

Responsible Agency: HHS/FDA/NOAA.

U.S. Participation: Yes.

Meat Hygiene—adjourned 2003.

Responsible Agency: USDA/FSIS.

U.S. Participation: Yes.

Milk and Milk Products—adjourned 2017.

Responsible Agency: USDA/AMS; HHS/FDA.

U.S. Participation: Yes.

Natural Mineral Waters—adjourned 2008.

Responsible Agency: HHS/FDA.

U.S. Participation: Yes.

Vegetable Proteins—adjourned 1989.

Responsible Agency: USDA/ARS.

U.S. Participation: Yes.

FAO/WHO Regional Coordinating Committees

The FAO/WHO Regional Coordinating Committees define the problems and needs of the regions concerning food standards and food control; promote within the Committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulate the strengthening of food control infrastructures; recommend to the Commission the development of worldwide standards for products of interest to the region, including products considered by the Committees to have an international market potential in the future; develop regional standards for food products moving exclusively or almost exclusively in intra-regional trade; draw the attention of the Commission to any aspects of the Commission's work of particular significance to the region; promote coordination of all regional food standards work undertaken by international governmental and non-governmental organizations within each region; exercise a general coordinating role for the region and such other functions as may be entrusted to them by the Commission; and promote the use of Codex standards and related texts by members.

There are six regional coordinating committees:

Coordinating Committee for Africa

Coordinating Committee for Asia

Coordinating Committee for Europe

Coordinating Committee for Latin America and the Caribbean

Coordinating Committee for the Near East

Coordinating Committee for North America and the South West Pacific

Coordinating Committee for Africa

The Committee (CCAFRICA) will convene its 23rd Session in 2019.

The Committee will continue to work on the following items:

Proposed draft Regional Standard for Unrefined Shea Butter;
Proposed draft Regional Standard for Fermented Cooked Cassava Based Products;
Proposed draft Regional Standard for Gnetum Spp leaves;
Priority Setting criteria for the establishment of work priorities as laid down in the Codex Procedural Manual;
Comments on the preparation of the new global Codex Strategic Plan;
Food quality and safety situation in countries of the Region (on-line platform, prioritization of needs in the region and comments for future consideration);
Use of Codex Standards in the Region;
Proposed draft Standard on Dried Meat;
Discussion paper and project document on a Harmonized Food Law; and
Discussion paper/project on a Regional Standard for a Fermented Non-Alcoholic Cereal Based Drink (Mahewu).

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: Yes (as observer).

Coordinating Committee for Asia

The Committee (CCASIA) will convene its 21st Session in 2019.

The Committee will continue to work on the following items:

Report on the status of the Implementation of the Activities of the Strategic Plan Relevant to CCASIA;
Discussion paper and project document on the Development of a Regional Standard for Rice Based Low Alcohol Beverages (cloudy types);
Discussion paper and project document on the Development of a Regional Standard for Soybean Products Fermented with the Bacterium Bacillus Subtilis;
Discussion paper and project document on the Development of a Regional Standard for Quick Frozen Dumpling (Jiaozi);
Discussion paper and the project document on the Development of a Regional Standard/Code of Practice for Zongzi;
Emerging Issues as priorities for the CCASIA region; and
Information sharing on the Food Safety Control Systems.

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: Yes (as observer).

Coordinating Committee for Europe

The Committee (CCEUROPE) will convene its 31st Session in 2019.

The Committee will continue to work on the following items:

Survey of critical and emerging issues;
On-line Platform and information sharing on the Food Safety Control Systems;
Survey on the use of Codex Standards;
Relevant languages of the Codex Alimentarius Commission in the work of CCEUROPE; and
Funding translation and interpretation services into Russian for the effective operation of CCEUROPE.

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: Yes (as observer).

Coordinating Committee for Latin America and the Caribbean

The Coordinating Committee for Latin America and the Caribbean (CCLAC) will convene its 21st in 2019.

The Committee will continue to work on the following items:

Monitoring of the Strategic Plan for CCLAC;
Critical and Emerging Issues and prioritization of CCLAC issues within the framework of Codex;
Comments on the Food Safety Control Systems Platform;
Cross-cutting topics for the region, proposed draft standards and seeking regional support; and
Proposal for the Development of a Standard for Yams.

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: Yes (as observer).

Coordinating Committee for the Near East

The Coordinating Committee for the Near East (CCNEA) will convene its 10th Session in 2019.

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: No.

Coordinating Committee for North America and the South West Pacific (CCNASWP)

The Committee (CCNASWP) will convene its 15th Session in 2019.

The Committee will continue to work on the following items:

New work on the development of a Regional Standard for Kava as a beverage when mixed with cold water;
Recommendation that Vanuatu be re-appointed as Coordinator for North America and the South West Pacific;
Proposed draft Regional Standard for Fermented Noni-Juice; and
Development of on-line platform for information on sharing food quality and safety systems.

Responsible Agency: USDA/FSIS/USCO.

U.S. Participation: Yes.

Contact: U.S. Codex Office, United States Department of Agriculture, Room 4861, South Agriculture Building, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: (202) 205-7760, Fax: (202) 720-3157, Email: uscodex@fsis.usda.gov.

Attachment 2

U.S. Codex Alimentarius Officials

Codex Chairpersons From the United States

Codex Committee on Food Hygiene

Emilio Esteban, DVM, MBA, MPVM, Ph.D., Executive Associate for Laboratory Services, Office of Public Health Science, Food Safety and Inspection Service, U.S. Department of Agriculture, 950 College Station Road, Athens, GA 30605, Phone: (706) 546-3429, Fax: (706) 546-3428, Email: emilio.esteban@fsis.usda.gov.

Codex Committee on Processed Fruits and Vegetables

Richard Boyd, Chief, Contract Services Branch, Specialty Crops Inspection Division, Specialty Crops Program, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Avenue SW, Mail Stop 0247, Room 0726—South Building, Washington, DC 20250, Phone: (202) 690-1201, Fax: (202) 690-1527, Email: richard.boyd@ams.usda.gov.

Codex Committee on Residues of Veterinary Drugs in Foods

Kevin Greenlees, Ph.D., DABT, Senior Advisor for Science and Policy, Office of New Animal Drug Evaluation, HFV-100, Center for Veterinary Medicine, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, Phone: (240) 402-0638, Fax: (240) 276-9538, kevin.greenlees@fda.hhs.gov.

U.S. Delegates and Alternate Delegates

Worldwide General Codex Subject Committees

Contaminants in Foods

(Host Government—The Netherlands)

U.S. Delegate

Dr. Lauren Posnick Robin, Branch Chief, Plant Products Branch, Division of Plant Products and Beverages, Office of Food Safety (HFS-317), Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, Phone: +1 (240) 402-1639, Lauren.Robin@fda.hhs.gov.

Alternate Delegate

Dr. Terry Dutko, Ph.D., Laboratory Director, Food Safety and Inspection Service, Office of Public Health Science, U.S. Department of Agriculture, 4300 Goodfellow Building, 105D Federal, St. Louis, MO 63120-0005, Phone: +1 (314) 263-2680, Extension 344, Tery.Dutko@fsis.usda.gov.

(Host Government—Mexico)

U.S. Delegate

U.S. Delegate

Dr. Chia-Pei Charlotte Liang, Chemist, Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, Phone: +1 (240) 402-2785, Charlotte.Liang@fda.hhs.gov.

Worldwide Ad Hoc Codex Task Forces (Active)

Antimicrobial Resistance (Reactivated 2016)

(Host Government—Republic of Korea)

U.S. Delegate

Donald A. Prater, DVM, Assistant Commissioner for Food Safety Integration, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: +1-301-348-3007, Donald.Prater@fda.hhs.gov.

Alternate Delegate

Neena Anandaraman, DVM, MPH, Veterinary Science Policy Advisor, Office of Chief Scientist, U.S. Department of Agriculture, Jamie L. Whitten Building, Room 339A, 1200 Independence Avenue SW, Washington, DC 20024, Phone: +1 (202) 260-8789, Neena.Anandaraman@osec.usda.gov.

[FR Doc. 2018-16944 Filed 8-7-18; 8:45 am]

BILLING CODE 3410-DM-P