2024-14399. International Standard-Setting Activities  

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    AGENCY:

    Trade and Foreign Agricultural Affairs (TFAA), USDA.

    ACTION:

    Notice.

    SUMMARY:

    This notice informs the public of the sanitary and phytosanitary (SPS) standard-setting activities of the Codex Alimentarius (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 of June 1, 2023, to May 31, 2024, and June 1, 2024, to May 31, 2025, seeks comments on standards under consideration and recommendations for new standards.

    ADDRESSES:

    The U.S. Codex Office (USCO) 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: Send to Docket Clerk, U.S. Department of Agriculture, Trade and Foreign Agricultural Affairs, U.S. Codex Office, 1400 Independence Avenue SW, Mailstop S4861, Washington, DC 20250-3700.
    • Hand- or Courier-Delivered Submittals: Deliver to 1400 Independence Avenue SW, Room 4861, Washington, DC 20250-3700.

    Instructions: All items submitted by mail or email are to include the Agency name ( i.e., USCO) and docket number USDA-2024-0004. 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. 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 U.S. delegate to the committee.

    Docket: For access to background documents or comments received, email uscodex@usda.gov to schedule an appointment.

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    FOR FURTHER INFORMATION CONTACT:

    Ms. Mary Frances Lowe, United States Manager for Codex Alimentarius, U.S. Department of Agriculture, Office of the Under Secretary for Trade and Foreign Agricultural Affairs, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, Washington, DC 20250-3700, Email: uscodex@usda.gov.

    For information pertaining to committees, contact the U.S. delegate for that committee. A complete list of delegates and alternate delegates is accessible via the internet at: https://www.usda.gov/​sites/​default/​files/​documents/​us-codex-program-officials.pdf. Documents pertaining to Codex and specific committee agendas are accessible via the internet at http://www.fao.org/​fao-who-codexalimentarius/​meetings/​en/​. The U.S. Codex Office also maintains a website at http://www.usda.gov/​codex, a link that also offers an email subscription service providing access to information related to Codex. Customers can add or delete their subscription themselves and have the option to password protect their accounts.

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    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 the Codex Alimentarius (Codex), the World Organisation for Animal Health (WOAH, founded as OIE), and the International Plant Protection Convention (IPPC). 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 Trade and Foreign Agricultural Affairs Mission Area the responsibility to inform the public of the SPS standard-setting activities of Codex. The Trade and Foreign Agricultural Affairs Mission Area 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 Start Printed Page 54405 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 USCO 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: Sanitary and Phytosanitary Activities of Codex, please contact the U.S. 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 U.S. 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 each agenda item; and the time and place of planning meetings and debriefing meetings following the Codex committee sessions. In addition, the USCO makes much of the same information available through its web page at http://www.usda.gov/​codex. 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, 1400 Independence Avenue SW, Washington, DC 20250-3700, Email: uscodex@usda.gov.

    The information provided in Attachment 1: Sanitary and Phytosanitary Activities of Codex describes the status of Codex standard-setting activities by the Codex committees for the time periods from June 1, 2023, to May 31, 2024, and June 1, 2024, to May 31, 2025. A list of forthcoming Codex sessions may be found at: https://www.fao.org/​fao-who-codexalimentarius/​meetings/​en/​.

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, the USCO will announce this Federal Register publication on-line through the U.S. Codex web page located at https://www.usda.gov/​codex.

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    Done at Washington, DC.

    Mary Frances Lowe,

    U.S. Manager for Codex Alimentarius.

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    Attachment 1: Sanitary and Phytosanitary Activities of Codex

    Codex Alimentarius Commission and Executive Committee

    The Codex Alimentarius Commission (Commission or CAC) convened its 46th Session (CAC46) from November 27 to December 2, 2023, in Rome, Italy, with report adoption taking place on December 2, 2023. The relevant document is REP23/CAC. The actions taken by the Commission at CAC46 ( e.g., adoption, revocation, approval of new work, discontinuation of work, amendments, etc.) are described below under the respective Codex Committees.

    The Commission is scheduled to convene its 47th Session (CAC47) from November 25-30, 2024, in Geneva, Switzerland. At its 47th Session, the Commission will consider adopting standards recommended by committees at Step 8 or 5/8 (final adoption) and advance the work of committees by adopting draft standards at Step 5 (for further comment and consideration by the relevant committee). The Commission will also consider revocation of Codex texts; proposals for new work; discontinuation of work; amendments to Codex standards and related texts; and matters arising from the Reports of the Commission, the Executive Committee, and subsidiary bodies. Although the agenda for the 47th Session is not yet available, it is expected that the Commission will also consider Codex budgetary and financial matters; FAO/WHO scientific support to Codex (activities, budgetary and financial matters); matters arising from FAO/WHO; reports of side events; any other business; and adoption of the report.

    The Executive Committee (CCEXEC) is composed of the Commission chairperson; vice-chairpersons; 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 coordinating committees. The United States currently participates as an advisor to Canada, the member elected on a geographical basis for North America.

    CCEXEC convened its 84th Session (CCEXEC84) from July 10-14, 2023, in Geneva, Switzerland. The relevant document is REP23/EXEC1. In addition to critical review of standards development ( i.e., discussion of recommendations to CAC46 on the work of Codex Committees), CCEXEC84 discussed the Blueprint on the Future of Codex; a revised monitoring framework for the Codex Strategic Plan 2020-2025; timetable and process for development of the Codex Strategic Plan 2026-2031; review of international non-governmental organizations with observer status in Codex; application of the criteria for regional Codex standards; plans outlined by the CAC chair and vice-chairs for additional consultations related to the consideration of maximum residue limits for the veterinary drug zilpaterol hydrochloride (adopted at Step 5, interim adoption, by CAC45 in 2022); and other business, including a brief exchange of views regarding the importance of the joint WHO/FAO scientific advice program and independent expert risk assessments in supporting Codex standards and the need to avoid potential duplication and inconsistent communications due to the undertaking of hazard identification reviews by another WHO-affiliated body.

    CCEXEC convened its 85th Session (CCEXEC85) from November 20-24, 2023, in Rome, Italy. The relevant document is REP23/EXEC2. In addition to critical review ( i.e., discussion of recommendations to CAC46 on the work of additional Codex Committees that had met since CCEXEC84), CCEXEC85 discussed the Blueprint on the Future of Codex; intersessional work on the draft of initial sections of the Codex Strategic Plan 2026-2031; Codex budgetary and financial matters; matters arising from FAO and WHO; review of international non-governmental organizations with observer status in Codex; application of the criteria for regional Codex standards; and other business including a report from the CAC chair and vice-chairs on consultations related to the consideration of maximum residue limits for zilpaterol hydrochloride, and a proposal from the United States to consider the development of Codex guidance on food safety considerations related to the use of recycled material in food packaging. CCEXEC85 also had further discussion on the need to avoid duplication of scientific reviews by WHO-affiliated bodies and noted the commitment of WHO to address the matter and enhance coordination in the future.

    CCEXEC will convene its 86th Session (CCEXEC86) from July 1-5, 2024, in Rome, Italy. CCEXEC86 is expected to discuss critical review ( i.e., recommendations to Start Printed Page 54406 CAC47 on the work of Codex Committees); key elements of the Model for Future Codex Work; the Codex Strategic Plan for 2026-2031; Codex budgetary and financial matters; applications from international non-governmental organizations for observer status in Codex; and other business.

    Responsible Agency: USDA/TFAA/USCO.

    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) or 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 standards or codes of practice 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 had the following items which were considered by the 46th Session of the Codex Alimentarius Commission (CAC46) in November 2023:

    Final adoption at Step 8 or Step 5/8:

    • Code of Practice for Prevention and Reduction of Mycotoxin Contamination in Cassava and cassava-based products
    • ML for lead in ready-to eat meals for infants and young children
    • ML for lead in soft brown, raw and non-centrifugal sugars
    • ML for total aflatoxins in dried chilli and nutmeg, and ML for ochratoxin A in dried chilli, paprika, and nutmeg

    Approval as new work:

    • Code of Practice/Guidelines for the prevention or reduction of ciguatera poisoning

    CCCF convened its 17th Session (CCCF17) from April 15-19, 2024, in Panama City, Panama, with report adoption taking place on April 19, 2024. The relevant document is REP24/CF17. CCCF17 advanced the following items for consideration by the 47th Session of the Codex Alimentarius Commission (CAC47) in November 2024:

    For final adoption at Step 8 and Step 5/8:

    • MLs for lead in spices, dried aril; dried seeds (including a separate ML for celery seeds); dried rhizomes and roots, dried floral parts; and spices, dried fruit, and berries (including separate MLs for Sichuan pepper, star anise, paprika, and sumac)
    • Sampling plans for methylmercury in fish
    • Code of Practice for the Prevention and Reduction of Ciguatera Poisoning
    • MLs for cadmium and lead in quinoa

    For approval as new work:

    A revision of theCode of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts (CXC 55-2004)

  • A code of practice for the prevention and reduction of cadmium contamination in foods
  • The 18th Session of CCCF (CCCF18) is scheduled to convene again from June 23-27, 2025. The Committee is expected to continue working on:

    • ML for total aflatoxins in ready to-eat peanuts and associated sampling plan
    • MLs for lead in dried bark and dried culinary herbs
    • Sampling plans for total aflatoxins and ochratoxin A in certain spices
    • New work on the revision of theCode of Practice for the Prevention and Reduction of Aflatoxin Contamination in Peanuts (CXC 55-2004)

    • New work on a code of practice for the prevention and reduction of cadmium contamination in foods
    • Discussion paper on the revision of theCode of Practice to Prevent and Reduce Pyrrolizidine Alkaloid Contamination in Food and Feed

    • Discussion paper on tropane alkaloids
    • Discussion paper on the revision of theCode of Practice for the Reduction of Acrylamide in Foods

      Discussion paper on the revision of theCode of Practice for the Reduction of Aflatoxin B1 in Raw Materials and Supplemental Feedingstuffs for Milk-Producing Animals

    • Numeric Performance Criteria for methods for Total Aflatoxins utilizing the sum of components concept (in relevant sampling plans)
    • Guidance on data analysis for ML development and improved data collection
    • Review of Codex standards for contaminants
    • Priority list of contaminants for evaluation by JECFA and follow-up work to the outcomes of JECFA evaluations and FAO/WHO expert consultations
    • Comments in response to a Circular Letter requesting information on the application of MLs to multi-ingredient products, new risk management measures for the reduction of acrylamide in food, and emerging issues relevant to CCCF

    Responsible Agencies: HHS/FDA/Center for Food Safety and Applied Nutrition (CFSAN); USDA/Food Safety and Inspection Service (FSIS).

    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.

    CCFO convened its 28th Session (CCFO28) from February 19-23, 2024, in Kuala Lumpur, Malaysia, with report adoption taking place on February 23, 2024. The relevant document is REP24/FO. CCFO28 advanced the following items for consideration by CAC47 in November 2024:

    For final adoption at Step 8 and Step 5/8:

    Amendment/Revision of theStandard for Named Vegetable Oils (CXS 210-1999): inclusion of avocado oil, camellia seed oil, sacha inchi oil, and high oleic acid soya bean oil

    Revision of theStandard for Olive Oils and Pomace Olive Oils (CXS 33-1981)

    Amendment/Revision of theStandard for Fish Oils (CXS 329-2017): inclusion of Calanus oil

    For approval as new work:

    • A standard for microbial omega-3 oils
    • Proposed revisions to the Codex standards on fats and oils to reduce Trans-Fatty Acid intake

    CCFO is tentatively scheduled to convene its 29th Session (CCFO24) from February 9-13, 2026. The Committee is expected to continue work on:

    • Collection and assessment for suitability of global scientific data and information on individual samples of olive oil, in order to make recommendations on the need and process for further analysis of the data and establishment of methods of analysis and sampling
    • Consideration of proposals on new substances to be added to the List of Acceptable Previous Cargoes

    Responsible Agencies: HHS/FDA/Center for Food Safety and Applied Nutrition (CFSAN); USDA/Agricultural Research Service (ARS).

    U.S. Participation: Yes.

    Codex Committee on Fish and Fishery Products

    The Committee on Fish and Fishery Products (CCFFP) is responsible for elaborating standards for fresh, frozen, and otherwise processed fish, crustaceans, and mollusks.

    CCFFP is working by correspondence and will meet virtually from October 7-17, 2024 on the Electronic Working Group (EWG) platform to complete its current work. The Committee is working on:

    TheStandard for Canned Sardines and Sardine-Type Products (CXS 94-1981), inclusion of the fish species S. lemuru (Bali Sardinella) in the list of Sardinella species under section 2.1.

    Responsible Agencies: HHS/FDA/CFSAN; DOC/NOAA/National Marine Fisheries Service (NMFS).

    U.S. Participation: Yes.

    Codex Committee on Food Additives

    The Codex Committee on Food Additives (CCFA) establishes or endorses acceptable MLs for individual food additives; prepares a priority list of food additives for risk assessment by the 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 Committee had the following items which were considered by CAC46 in November 2023:

    Final adoption at Step 8 and Step 5/8:

    Draft and proposed draft food additive provisions of the General Standard for Start Printed Page 54407 Food Additives (GSFA, CXS 192-1995) and revisions to adopted provisions

    Proposed draft revision of theClass Names and the International Numbering System for Food Additives (CXG 36-1989)

    Proposed draftSpecifications for the Identity and Purity of Food Additives (CXA 6-2021)

    Approval as new work:

    • Proposals for new food additive provisions of the GSFA
    • Priority List of substances proposed for evaluation by JECFA

    The 54th Session of CCFA (CCFA54) convened from April 22-26, 2024 in Chengdu, Sichuan Province, China. The relevant document is REP24/FA. CCFA54 advanced the following items for consideration by CAC47 in November 2024:

    For final adoption at Step 8 and Step 5/8:

    • Draft and proposed draft food additive provisions of the GSFA (CXS 192-1995) and revisions to adopted provisions
    • Proposed draft revision of theClass Names and the International Numbering System for Food Additives (CXG 36-1989)

      Proposed draftSpecifications for the Identity and Purity of Food Additives (CXM 6-2021)

      Other:

      • Revised food additive provisions of the GSFA in relation to the alignment of standards from the Codex Committee on Milk and Milk Products (CCMMP); the Codex Committee on Processed Fruits and Vegetables (CCPFV); the Coordinating Committee for the Near East (CCNE); the Coordinating Committee for Asia (CCASIA); and the Coordinating Committee for Latin America and the Caribbean (CCLAC)
      • Discontinuation of draft and proposed food additive provisions and revocation of existing food additive provisions as recommended by CCFA54

      For approval as new work:

      • Proposed new work on the development of a standard for baker's yeast

      CCFA is scheduled to convene its 55th Session (CCFA55) from March 24-28, 2025. The Committee is expected to continue work on:

      • New or revised provisions of the GSFA
      • The alignment and the endorsement of food-additive provisions referred by Commodity Committees
      • Revision of theClass Names and the International Numbering System for Food Additives (CXG 36-1989)

      • Proposal for additions and changes to the Priority List of Substances proposed for evaluation by JECFA

      Responsible Agency: HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Codex Committee on Food Hygiene

      The Codex Committee on Food Hygiene (CCFH) is responsible for developing basic provisions on food hygiene, applicable to all food; considering and amending or endorsing provisions on food hygiene contained in Codex commodity standards and Codex codes of practice developed by other committees; considering specific food hygiene problems assigned to it by the Commission; suggesting and prioritizing areas where there is a need for microbiological risk assessment at the international level and developing questions to be addressed by the risk assessors; and considering microbiological risk management matters in relation to food hygiene and in relation to the FAO/WHO risk assessments.

      The Committee had the following items which were considered by CAC46 in November 2023:

      Final adoption at Step 8:

      • Guidelines for the Control of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef, Fresh Leafy Vegetables, Raw Milk and Raw Milk Cheeses, and Sprouts (General Section, Annex I on raw beef, and Annex III on raw milk and raw milk cheeses)
      • Guidelines for the Safe Use and Reuse of Water in Food Production and Processing (General Section and Annex I on Fresh Produce)

      Approval as new work:

      • Guidelines for food hygiene control measures in traditional markets for food
      • Revision of theGuidelines on the Application of the General Principles of Food Hygiene to the Control of Pathogenic Vibrio Species in Seafood (CXG 73-2010)

        The 54th Session of CCFH (CCFH54) convened from March 11-15, 2024, in Nairobi, Kenya. The relevant document is REP 24/FH. CCFH54 advanced the following items for consideration by CAC47 in November 2024:

        For final adoption at Step 5/8:

        Guidelines for the Control of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef, Fresh Leafy Vegetables, Raw Milk and Raw Milk Cheeses, and Sprouts (CXG 99-2023) (Annexes on Fresh Leafy Vegetables and Sprouts)

        Guidelines for the Safe Use and Reuse of Water in Food Production and Processing (CXG 100-2023) (Annex on Milk and Milk Products)

        Guidelines for Food Hygiene Control Measures in Traditional Markets for Food

        For approval as new work:

        Revision of theGuidelines on the Application of General Principles of Food Hygiene to the Control of Viruses in Food (CXG 79-2012)

        Revision of theGuidelines for the Control of Campylobacter and Salmonella in Chicken Meat (CXG 78-2011)

        Revision of theGuidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Foods (CXG 61-2007)

        CCFH is scheduled to convene its 55th Session (CCFH55) from December 8-11, 2025, in the United States. The Committee is expected to continue work on:

        Guidelines for the Safe Use and Re-Use of Water in Food Production (CXG 100-2023) (Revision on Annex on Fish and Fishery Products and Drafting of Annex related to water-fit-for-purpose assessment, safety management, and technologies for recovery and treatment of water for reuse)

        Alignment of CCFH documents with the revisedGeneral Principles of Food Hygiene (CXC 1-1969)

      • New work proposals/forward workplan

      Responsible Agencies: HHS/FDA/CFSAN; 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 Committee had the following items which were considered by CAC46 in November 2023:

      Final adoption at Step 5/8:

      • Guidelines on recognition and maintenance of equivalence of national food control systems (NFCS)
      • Principles and guidelines on the use of remote audit and inspection in regulatory frameworks

      Approval as new work:

      Reviewing and updating thePrinciples for Traceability/Product Tracing as a Tool within a Food Inspection and Certification System (CXG 60-2006)

      The 27th Session of CCFICS (CCFICS27) is scheduled to convene from September 16-20, 2024, in Cairns, Australia. We are unable to determine if CCFICS27 will recommend adoptions or approvals at CAC47.

      The Committee is expected to continue work on:

      • Draft Consolidated Codex Guidelines related to Equivalence;
      • Draft Guidelines on the Prevention and Control of Food Fraud;
      • Draft revision and updating of thePrinciples for Traceability/Product Tracing as a Tool Within a Food Inspection and Certification System (CXG 60-2006); Start Printed Page 54408

      • Discussion paper on guidance on appeals mechanism in the context of rejection of imported food; and
      • Review and update of Appendix A—the list of emerging global issues.

      Responsible Agencies: USDA/FSIS; HHS/FDA/CFSAN.

      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, and guidelines; and studies specific labeling problems assigned to it 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 advanced the following items for consideration by CAC46 in November 2023:

      Interim adoption at Step 5:

      Revision to theGeneral Standard for the Labelling of Pre-packaged Foods (CXS 1-1985): provisions relevant to allergen labelling

    • Guidelines on the Provision of Food Information for Pre-packaged Foods to be Offered Via E-Commerce
    • Guidelines on the Use of Technology to Provide Food Information

    Approval as new work:

    Amendment to theGeneral Standard for the Labelling of Pre-packaged Foods (CXS 1-1985): Labelling of pre-packaged foods in joint presentation and multipack formats

    The 48th Session of CCFL (CCFL48) will convene from October 27-November 1, 2024, in Quebec City, Canada. We are unable to determine if CCFL48 will recommend adoptions or approvals at CAC47.

    The Committee is expected to continue work on:

    • Proposed draft guidelines on the provision of food information for pre-packaged foods to be offered via e-commerce
    • Proposed draft revision to theGeneral Standard for the Labelling of Prepackaged Foods (CXS 1-1985): provisions relevant to allergen labeling and guidelines on precautionary allergen labeling

    • Proposed draft guidelines on the use of technology to provide food information
    • Discussion paper on the labelling of alcoholic beverages
    • Discussion paper on the application of food labelling provisions in emergencies
    • Discussion paper on trans fatty acids (TFA)
    • Discussion paper on sustainability-related labelling: revision to theGeneral Guidelines on Claims (CXG 1-1979)

    • Discussion paper on future work and direction of CCFL: criteria for the evaluation and prioritization of work of CCFL

    Responsible Agencies: HHS/FDA/CFSAN; USDA/FSIS.

    U.S. Participation: Yes.

    Codex Committee on General Principles

    The Codex Committee on General Principles (CCGP) is responsible for procedural and general matters referred to it by the Codex Alimentarius Commission, including: (a) The review or endorsement of procedural provisions/texts forwarded by other subsidiary bodies for inclusion in the Procedural Manual of the Codex Alimentarius Commission; and (b) The consideration and recommendation of other amendments to the Procedural Manual.

    The 33rd Session of CCGP (CCGP33) met in October 2-6, 2023, in Bordeaux, France. The relevant document is REP 24/GP. CCGP33 recommended minor updating and editorial amendments to the Procedural Manual, which were adopted by CAC46. The Committee is expected to continue discussions on:

    • Revisions/amendments to Codex texts
    • Format and structure of the CodexProcedural Manual (PM)

      ○ Proposed changes to Section 2 of the PM, Elaboration of Codex standards and related texts, Procedures for the elaboration of Codex standards and related texts, Part 7 Guide to the procedure for the amendment and revision of Codex standards and related texts, and related paragraphs

      ○ Procedures in section 3 of the PM, Guidelines for subsidiary bodies, to identify text to be updated, in line with current practices; and

      ○ Inconsistencies in language and superseded content of the PM, apart from section 3.

      The 34th Session of CCGP (CCGP34) is expected to convene sometime in the spring of 2025 in France.

      Responsible Agencies: USDA/TFAA/USCO.

      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 those 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.

      CCMAS convened its 42nd Session (CCMAS42) from June 12-16, 2023, in Budapest, Hungary, with virtual report adoption on June 20, 2023. The relevant document is REP23/MAS. The Committee advanced the following items for consideration at CAC46 in November 2023:

      Final adoption at Step 8 and 5/8:

      RevisedGeneral Guidelines on Sampling (CXG 50-2004)

    • Methods of analysis/performance criteria for provisions in Codex commodity standards for fats and oils; cereals, pulses and legumes; and processed fruits and vegetables for inclusion in CXS 234-1999, and the sampling plans for total aflatoxins in certain cereals and cereal-based products including foods for infants and young children for inclusion in CXS 193-1995 (CXS 234-1999, CXS 193-1995)

    CCMAS convened its 43rd Session (CCMAS43) from May 13-18, 2024, in Budapest, Hungary, with report adoption taking place on May 18, 2024. The relevant document is Draft REP24/MAS. CCMAS43 advanced the following items for consideration by CAC47 in November 2024:

    • Methods of analysis and numeric performance criteria for sorbates, benzoic acid, and calcium for selected processed fruits and vegetables for adoption/revocation
    • Sampling plan for methylmercury in fish for inclusion in theGeneral Standard for Contaminants and Toxins in Food and Feed (CXS 193-1995)

      Revocation of theGeneral Methods for the Detection of Irradiated Foods (CXS 231-2001)

      Methods of analysis for cereals, pulses, and legumes for adoption/revocation as part of the update toRecommended Methods of Analysis and Sampling (CXS 234-1999)

    • Methods of analysis for fish and fishery products and new or amended performance criteria for adoption/revocation as part of the update to CXS 234-1999
    • Methods of analysis for spices and culinary herbs for adoption
    • Methods of analysis for olive and olive pomace oils and fish oil for adoption/revocation
    • Document titled “Nitrogen to protein conversion factors” for adoption and inclusion as an Appendix to the CXS 234-1999

    The 44th Session of CCMAS (CCMAS44) will convene from May 5-9, 2025 in Budapest, Hungary. The Committee is expected to continue work on:

    • Amendments to certain provisions in CXS 234-1999
    • Review the methods for fruit juices and cocoa products and chocolate
    • Methods of analysis for precautionary allergen labeling
    • Information document for theGeneral Guidelines on Sampling (CXG 50-2004) e-book with sampling plans applications

    • Numeric performance criteria for the determination of nitrate and nitrite ions in certain food matrices
    • Harmonization of names and format for principles identified in CXS 234-1999
    Start Printed Page 54409

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

    U.S. Participation: Yes.

    Codex Committee on Nutrition and Foods for Special Dietary Uses

    The Codex Committee on Nutrition and Foods for Special Dietary Uses (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, or 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 had the following items which were considered by CAC46 in November 2023:

    Final adoption at Step 8 and 5/8:

    RevisedStandard for Follow-up Formula (CXS 156-1987), renamed as the Standard for Follow-up Formula for Older Infants and Product for Young Children

    Interim adoption at Step 5:

    General Principles for establishing Nutrient Reference Values (NRVs-R) for persons aged 6 to 36 months

    CCNFSDU will convene its 44th Session (CCNFSDU44) from October 2-6, 2024 in Dresden, Germany. We are unable to determine if CCNFSDU44 will recommend adoptions or approvals at CAC47.

    The Committee is expected to continue work on:

    • General Principles for the Establishment of Nutrient Reference Values—Requirements (NRVs-R) for persons aged 6-36 months
    • Collection and review of information on the use, and use levels for five identified additives and their technological justification
    • Methods of analysis for optional ingredients in theStandard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72-1981)

    • Redrafting of the prioritization mechanism/emerging issues for new work proposals
    • Redrafting of the discussion paper for harmonized probiotic guidelines
    • Redrafting the discussion paper on guidelines for the nutritional composition of foods and beverages made from non-animal and insect protein sources

    Responsible Agencies: HHS/FDA/CFSAN; USDA/ARS.

    U.S. Participation: Yes.

    Codex Committee on Pesticide Residues

    The Codex Committee on Pesticide Residues (CCPR) is responsible for establishing maximum residue limits (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 54th Session of CCPR (CCPR54) convened in Beijing, China from June 26-July 1, 2023. The relevant document is REP23/PR. CCPR54 advanced the following items for consideration by CAC46 in November 2023:

    Final adoption at Step 8 and 5/8:

    • Over 400 Maximum Residue Limits (MRLs) for different combinations of pesticides/commodities
    • Revision of the CodexClassification of Foods and Animal Feeds (CXA 4-1989):

      ○ the revised Class B- Primary food commodities of animal origin and Class E -Processed Foods of Animal Origin (All Types) and their respective table of representative commodities;

      ○ the consequential amendment to Table 2, Subgroup 12C Eggplant and eggplant-like commodities to the Principles and Guidance on the Selection of Representative Commodities for the Extrapolation of MRLs for Pesticides to Commodity Groups (CXG 84-2012);

      ○ the consequential amendment to the revised definition for the portion of the commodity to which MRLs apply and which is analyzed for Group 006—Tropical Fruits of Inedible Peel and 023—Oil fruits; and

      ○ the consequential amendments to the inclusion of new commodities/commodity codes in Class A—Primary food commodities of plant origin and Class D—Processed commodities of plant origin

      CAC46 also discontinued work, approved new work, and revoked existing MRLs as recommended by CCPR54.

      Revocation:

      TheGuidelines on Portion of Commodities to which MRLs Apply and which is Analyzed (CXG 41-1993); this document was replaced by the revised Classification of Foods and Animal Feeds (CXA 4-1989) as the single, authoritative reference for the establishment of MRLs for pesticides

      Approval as new work:

      • Guidance for monitoring the purity and stability of reference materials of multi-class pesticides during prolonged storage

      The 55th Session of CCPR (CCPR55) convened in Chengdu, China from June 3-8, 2024, in Chengdu, China. The relevant document is Draft REP24/PR. CCPR55 advanced the following items for consideration by CAC47 in November 2024:

      For final adoption at Step 8 and 5/8:

      • Over 275 Maximum Residue Limits (MRLs) for different combinations of pesticides/commodities

      For interim adoption at Step 5:

      • Guidelines for Monitoring the Stability and Purity of Reference Materials and Related Stock Solutions of Pesticides during Prolonged Storage

      Other:

      • Consequential amendments to CXLs for peppers groups and subgroups to implement the decision taken by CCPR on MRLs for okra
      • Discontinuation/withdrawal of work and revocation of existing MRLs as recommended by CCPR55

      The 56th Session of CCPR (CCPR56) will convene from May 19-24, 2025 in China. The Committee is expected to continue work on:

      • Coordination of work between CCPR and the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF): Joint CCPR/CCRVDF Working Group on Compounds for Dual Use as both pesticides and veterinary drugs
      • Management of unsupported compounds without public health concern scheduled for periodic review
      • Establishment of Codex schedules and priority lists of pesticides for evaluation/re-evaluation by JMPR
      • Enhancement of the operational procedures of CCPR and JMPR

      Responsible Agencies: EPA/Office of Chemical Safety and Pollution Prevention (OCSPP)/Office of Pesticide Programs (OPP); USDA/FSIS.

      U.S. Participation: Yes.

      Codex Committee on Residues of Veterinary Drugs in Foods

      The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends 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.

      The Committee had the following items which were considered by CAC46 in November 2023:

      Final adoption at Step 8 and Step 5/8:

      • MRLs for ivermectin (sheep, pigs, and goats—fat, kidney, liver, and muscle)
      • MRLs for nicarbazin (chicken)
      • MRLs extrapolated to ruminants and finfish
      • MRLs for zilpaterol hydrochloride (cattle kidney, liver, muscle)

      The 27th Session of CCRVDF (CCRVDF27) is scheduled to convene from October 21-25, 2024. The CCRVDF27 location and agenda are currently unavailable, and we are unable to determine if CCRVDF27 will recommend adoptions or approvals at CAC47. The Committee is expected to continue work on:

      • Extrapolation of MRLs between species and to edible offal tissues
      • Establishment of action levels for residues of veterinary drugs in edible tissues caused by unavoidable and unintended carryover of veterinary drug residues in animal feed
      • Coordination between CCRVDF and CCPR on issues affecting both committees (e.g., harmonization of MRLs for similar edible commodities of animal origin; harmonization of risk assessment methodologies; data-sharing for dual-use compounds)

      • Priority List of veterinary drugs requiring evaluation or re-evaluation by JECFA
      Start Printed Page 54410

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

      U.S. Participation: Yes.

      Codex Committee on Spices and Culinary Herbs

      The Codex Committee on Spices and Culinary Herbs (CCSCH) is responsible for elaborating worldwide standards for spices and culinary herbs in their dried and dehydrated state in whole, ground, and cracked or crushed form. CCSCH also consults, as necessary, with other international organizations in the standards development process to avoid duplication.

      The 7th Session of CCSCH (CCSCH7) convened from January 29 to February 2, 2024, in Kochi, Kerala, India. The relevant document is REP24/SCH. CCSCH7 advanced the following items for consideration by CAC47 in November 2024:

      For adoption at Step 8 and/or Step 5/8:

      • draft standard for dried or dehydrated small cardamom
      • draft standard for spices derived from dried or dehydrated fruits and berries—allspice, juniper berry and star anise
      • draft standard for dried or dehydrated roots, rhizomes and bulbs—turmeric

      For interim adoption at Step 5:

      • draft standard for spices derived from dried or dehydrated fruits and berries—vanilla

      For approval as new work:

      • development of a standard for sweet marjoram
      • development of a standard for dried seeds—coriander
      • development of a standard for large cardamom
      • development of a standard for cinnamon

      The 8th Session of the CCSCH (CCSCH8) is expected to convene approximately 18 months following CCSCH7. The Committee is expected to continue work on:

      • a standard for spices derived from dried or dehydrated fruits and berries—vanilla
      • a standard for sweet marjoram
      • a standard for dried seeds—coriander
      • a standard for large cardamon
      • a standard for cinnamon
      • a potential update to the template for spices and culinary herbs standards

      Responsible Agencies: USDA/AMS; HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Adjourned Codex Commodity Committees

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

      Cereals, Pulses and Legumes—Adjourned sine die 2020

      Responsible Agency: HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Cocoa Products and Chocolate—Adjourned sine die 2001

      Responsible Agency: HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Meat Hygiene—Adjourned sine die 2003

      Responsible Agency: USDA/FSIS.

      U.S. Participation: Yes.

      Milk and Milk Products—Aadjourned sine die 2017

      Responsible Agency: USDA/AMS; HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Natural Mineral Waters—Adjourned sine die 2008

      Responsible Agency: HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Processed Fruits and Vegetables—Adjourned sine die 2020

      Responsible Agency: USDA/AMS; HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Sugars—Adjourned sine die 2019

      Responsible Agency: HHS/FDA/CFSAN.

      U.S. Participation: Yes.

      Vegetable Proteins—Adjourned sine die 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 Coordinating Committee for Africa (CCAFRICA) convened its 24th Session (CCAFRICA24) virtually from September 5-9, 2022, and expected to convene its 25th Session (CCAFRICA25) in approximately two years' time following CCAFRICA24. The CCAFRICA25 date, location, and agenda are currently unavailable. CAC47 is not expected to consider any agenda items from CCAFRICA.

      Responsible Party: USDA/TFAA/USCO.

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

      Coordinating Committee for Asia

      The Coordinating Committee for Asia (CCASIA) convened its 22nd Session (CCASIA22) virtually from October 12-18, 2022, with report adoption taking place on October 21, 2022. The relevant document is REP23/ASIA. CCASIA22 agreed to advance the following items for consideration at CAC46 in November 2023:

      For final adoption at Step 8 or Step 5/8:

      Proposed draft regional standard for soybean products fermented withBacillus species;

    • Proposed draft regional standard for cooked rice wrapped in plant leaves;
    • Amendment to the labelling provisions for non-retail containers in relevant CCASIA regional standards.

    For interim adoption at Step 5:

    • Proposed draft regional standard for quick frozen dumpling.

    CCASIA planned to convene its 23rd Session (CCASIA23) in approximately two years' time following CCASIA22. The date, location, and agenda for CCASIA23 are currently unavailable. CAC47 is not expected to consider any agenda items from CCASIA.

    Responsible Party: USDA/TFAA/USCO.

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

    Coordinating Committee for Europe

    The Coordinating Committee for Europe (CCEURO) convened its 33rd Session (CCEURO33) from May 27-31, 2024, in Berlin, Germany. The relevant document is REP24/EURO. CCEURO33 agreed to advance the following items for consideration at CAC46 in November 2023:

    • Reappointment of Germany as the Coordinator for Europe for a second term
    • To request that the CAC address inclusion of the One Health approach, digitalization and loss of biodiversity, and collaboration with other international organizations in the Codex Strategic Plan 2026-2031

    CCEURO plans to convene its 34th Session (CCEURO34) in approximately two and half years' time following CCEURO33.

    Responsible Party: USDA/TFAA/USCO.

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

    Coordinating Committee for Latin America and the Caribbean

    The Coordinating Committee for Latin America and the Caribbean (CCLAC) will convene its 23rd Session (CCLAC23) virtually from July 22-26, 2024. CCLAC23 is expected to consider work relevant to the region; current and emerging food safety and quality in the region; a draft regional standard for Castilla lulo; implementation of the Codex Strategic Plan in the LAC region; use and impact of Codex standards in the region; nomination of the Coordinator for LAC; and other business. We are unable to determine if CCLAC23 will recommend adoptions or approvals at CAC47.

    Responsible Party: USDA/TFAA/USCO.

    U.S. Participation: Yes (as an observer). Start Printed Page 54411

    Coordinating Committee for North America and the South West Pacific

    The Coordinating Committee for North America and the South West Pacific (CCNASWP) convened its 16th Session (CCNASWP16) in Nadi, Fiji, from January 30 to February 3, 2023. CCNASWP16 advanced the following item for consideration by CAC46 in November 2023:

    For final adoption at Step 8:

    • Draft regional standard for fermented noni fruit juice

    CCNASWP is expected to convene its 17th Session (CCNASWP17) sometime in early 2025 in Fiji. The CCNASWP17 date, location, and agenda are currently unavailable.

    Responsible Party: USDA/TFAA/USCO.

    U.S. Participation: Yes.

    Coordinating Committee for the Near East

    The Coordinating Committee for the Near East (CCNE) convened its 11th Session (CCNE11) in 2023 in Rome, Italy from September 18-22, 2023. CCNE advanced the following items for consideration by CAC46 in November 2023:

    For interim adoption at Step 5:

    • Regional Standard for Maamoul

    CCNE is expected to convene its 12th session (CCNE12) in approximately two years' time following CCNE11. The CCNE12 date, location, and agenda are currently unavailable. CAC47 is not expected to consider any agenda items from CCNE.

    Responsible Party: USDA/TFAA/USCO.

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

    End Supplemental Information

    [FR Doc. 2024-14399 Filed 6-28-24; 8:45 am]

    BILLING CODE 3420-3F-P

Document Information

Published:
07/01/2024
Department:
597
Entry Type:
Notice
Action:
Notice.
Document Number:
2024-14399
Pages:
54404-54411 (8 pages)
Docket Numbers:
Docket No. USDA-2024-0004
PDF File:
2024-14399.pdf