97-11314. Codex Strategic Planning Meeting  

  • [Federal Register Volume 62, Number 84 (Thursday, May 1, 1997)]
    [Notices]
    [Pages 23745-23753]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-11314]
    
    
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    DEPARTMENT OF AGRICULTURE
    
    Food Safety and Inspection Service
    [Docket No. 97-027N]
    
    
    Codex Strategic Planning Meeting
    
    AGENCY: Food Safety and Inspection Service, USDA.
    
    ACTION: Notice; public hearing and request for comments.
    
    -----------------------------------------------------------------------
    
    SUMMARY: This notice informs the public of a strategic planning 
    activity relating to the U.S. Government's representation on the Codex 
    Alimentarius Commission, an international food standard-setting 
    program. The notice includes a description of Codex activities; 
    identifies five issues to be addressed; identifies specific objectives, 
    methods, timeframes, and persons or agencies responsible for addressing 
    them. A public hearing will be held in Washington, DC on May 8, 1997, 
    to allow a dialogue on the identified issues. U.S. Government agencies 
    plan to use the record of that hearing and of comments received in 
    finalizing their planned approaches to achieving U.S. goals for Codex 
    standard-setting activities.
    
    DATES: The public meeting will be held on May 8, 1997, from 9:30 a.m. 
    until 12:30 p.m.
    
    ADDRESSES: The conference will be held at the Holiday Inn Rosslyn-
    Westpark, 1900 N. Fort Myer Drive, Arlington, VA 22207. Send an 
    original and two copies of written comments to: FSIS Docket Clerk, 
    DOCKET NO. 97-027N, Room 102, Cotton Annex, 300 12th Street SW, 
    Washington, DC, 20250-3700. All comments submitted and a transcript of 
    the hearing will be available for public inspection in the Docket 
    Clerk's Office between 8:30 a.m. and 1:00 p.m., and
    
    [[Page 23746]]
    
    2:00 p.m. and 4:30 p.m., Monday through Friday.
    
    FOR FURTHER INFORMATION CONTACT: Patrick J. Clerkin, Director, U.S. 
    Codex Office, United States Department of Agriculture, Food Safety and 
    Inspection Service, West End Court, Room 311, Washington, DC 20250; 
    (202) 418-8852.
    
    SUPPLEMENTARY INFORMATION: The Codex Alimentarius Commission (Codex) is 
    an international governmental organization with current membership from 
    the national governments of 156 countries, including the United States. 
    It was formed in 1962 to facilitate world trade in foods and to promote 
    consumer protection.
        Codex is a subsidiary of two United Nations groups, the Food and 
    Agriculture Organization (FAO) and the World Health Organization (WHO). 
    It has worked to develop international food standards that protect 
    consumers' health as well as promote fair trade. Food production 
    practices all over the world have been upgraded as a result.
        The United States participates in Codex Alimentarius activities 
    through U.S. Codex, which consists of federal government officials 
    assisted by representatives of non-government interests.
    
    How Codex Currently Operates
    
        Codex provides a forum in which member countries and international 
    organizations can cooperate to achieve the dual goals of consumer 
    protection and fair food trade practices. The Commission meets every 
    other year; its Executive Committee meets between sessions.
    
    Codex Committees
    
        Codex has established several types of committees. The ones that 
    draft standards and codes of practice and guidelines are commodity 
    committees and general-subject committees.
        Fifteen commodity committees have operated from time to time. Those 
    currently active are Fats and Oils, Fish and Fishery Products, 
    Nutrition and Foods for Special Dietary Uses, Milk and Milk Products, 
    Fresh Fruits and Vegetables, Cereals, Pulses and Legumes, Natural 
    Mineral Waters, Cocoa and Chocolate Products, Sugars, and Processed 
    Fruits and Vegetables. Meat Hygiene, which had been inactive, was 
    reconvened in 1991 to update the codes of practice under its 
    jurisdiction. It adjourned in 1993 after completing this task.
        There are eight committees which deal with general subjects rather 
    than with particular commodities. They are: Food Labeling; Food 
    Additives and Contaminants; Food Hygiene; Pesticide Residues; Residues 
    of Veterinary Drugs in Foods; Methods of Analysis and Sampling; Food 
    Import and Export Inspection and Certification Systems; and General 
    Principles, which sets rules and procedures for Codex.
        There are also five regional coordinating committees representing 
    Africa, Asia, Europe, Latin America and the Caribbean, and North 
    America and the South-West Pacific. They define the regions' problems 
    and needs concerning food standards and food control.
        The United States serves on all the commodity and general subject 
    committees that are currently active, and on the regional committee 
    that includes North America.
        Two independent committees of experts work closely with Codex: the 
    Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Joint 
    FAO/WHO Meeting on Pesticide Residues (JMPR). These expert committees 
    perform the scientific evaluations which support Codex standards, 
    guidelines, Maximum Residue Levels (MRLs), and codes of practice.
        A comprehensive notice, detailing the sanitary and phytosanitary 
    standard-setting activity of Codex, is published annually in the 
    Federal Register (FR) (see June 4, 1996 (61 FR 28132)). It also details 
    other standard-setting activities of Codex, including commodity 
    standards, guidelines, codes of practice, and revised texts. Included 
    as an Appendix to that notice is a description of the system for 
    elaborating standards within the Codex Commission and its Committees. A 
    reading of that notice will enhance an understanding of the issues 
    identified in this strategic planning document.
        In 1994, the United States signed and ratified the Uruguay Round 
    Agreements Act, and thereby became a signatory member of the World 
    Trade Organization (WTO). The agreement on the Application of Sanitary 
    and Phytosanitary Measures (SPS Agreement) requires members to use 
    international standards as the basis for sanitary and phytosanitary 
    measures when such international standards meet the member's 
    appropriate level of protection. The SPS Agreement explicitly 
    recognizes Codex as an organization that develops such standards. In 
    this context, Codex standards will play a significant role with regard 
    to food safety and agricultural trade.
        In anticipation of the emerging importance of Codex standards, 
    Codex inaugurated a review of the policies, processes, and procedures 
    established over the course of its more than 30-year-history. This 
    examination grew out of an international conference held in Rome in 
    1991 to address three major areas of concern: (1) The heightened status 
    and responsibility that would be given to Codex standards under what 
    was then a draft proposal of the General Agreement on Tariffs and Trade 
    (GATT);
        (2) advances in food production technologies; and (3) changing 
    consumer expectations about food safety and composition. U.S. Codex 
    also engaged in a process of self-examination as a prelude to change.
        In February 1995, U.S. Codex issued a draft report setting forth 
    the results of work initiated in October 1992, by a Strategic Planning 
    Group to recommend a new course for United States participation in 
    Codex Alimentarius. The group was asked to consider how U.S. Codex can 
    become more effective in:
    
    --maintaining and improving public health protection;
    --encouraging changes in Codex to enhance its public health mission;
    --broadening the involvement of public, consumer, and environmental 
    organizations as well as the chemical and food industries in developing 
    international food safety standards;
    --prioritizing its activities and using its resources more efficiently; 
    and
    --facilitating trade.
    
        The Strategic Planning Group identified five critical issues to be 
    addressed. The first two issues deal with changes in Codex itself; the 
    other three issues deal with internal U.S. changes. The Group 
    subsequently identified specific actions or approaches that the U.S. 
    Codex might take to address these issues. (The Group did not address 
    those parts of Codex standards that are not related to food safety; 
    e.g., food composition/identity standards which are subject to the WTO 
    Agreement on Technical Barriers to Trade. It might be useful for 
    another group to consider systematically the strategic issues 
    concerning these standards.) A brief description of each issue and 
    related actions is presented below.
    
    Issue 1: U.S. Support for Strengthening the Scientific Basis for Codex 
    Decisions
    
        Codex health and safety standards have been and must continue to be 
    based on scientific analysis and evidence. The procedures by which 
    those standards are elaborated should be transparent and consistently 
    applied. In many cases scientific work in support of Codex's 
    elaboration of standards is performed by Expert Committees that
    
    [[Page 23747]]
    
    are independent of Codex. In other cases, work is performed internally 
    by Codex Committees. In the latter case, those committees are termed, 
    ``process committees.'' In all cases, criteria for making decisions on 
    standards should be clear and science-based. The United States should 
    support the efforts of Codex and other international organizations to 
    improve the scientific basis for Codex standards to meet these goals.
    
    Expert Committees
    
        With regard to the elaboration of standards, primary responsibility 
    for performing the scientific evaluations that underlie most Codex 
    health and safety standards rests with FAO, and with WHO through the 
    International Programme for Chemical Safety (IPCS). This work is done 
    through two expert committees, The Joint FAO/WHO Meeting on Pesticide 
    Residues (JMPR) and the Joint FAO/WHO Expert Committee on Food 
    Additives (JECFA). In addition, FAO and WHO sponsor ad hoc expert 
    consultations on specific topics related to food safety.
        Governments and non-governmental organizations have no routine, 
    direct working relationship with JMPR and JECFA, although both EPA and 
    FDA have provided funds and support in kind to FAO and WHO/IPCS. While 
    the work of JECFA and JMPR has been of high quality, the procedures 
    under which they operate should be enhanced to assure that decisions 
    are firmly based in science, and that their operations are transparent 
    to all interested parties. The same would hold true for other expert 
    consultations.
        FAO and WHO/IPCS have begun to make changes in the way they conduct 
    scientific evaluations of chemicals. However, with demands and 
    expectations for change coming from many sources, a broader and more 
    systematic look is needed at the scientific framework, and the 
    processes of international chemical safety evaluation.
        The expert committees need effective processes that would allow 
    broader consideration of the views of countries, consumer and public 
    interest groups, the chemical industry, food producers, international 
    organizations involved in chemical safety, and any other interested 
    party.
        Codex and member countries should encourage the FAO/WHO to initiate 
    necessary changes internally or support development of and adoption of 
    such relevant and suitable procedures, as may be internationally agreed 
    on by other international organizations which will improve the quality, 
    consistency, integrity, and transparency of expert committee 
    evaluations.
        Issues that might be considered include:
    
    --establishment of minimum data sets for evaluation,
    --establishment of guidelines for data development,
    --establishment of standard data evaluation and reporting procedures,
    --development and application of good laboratory practice standards,
    --development and application of data quality standards (factors which 
    might render a study acceptable or unacceptable for review),
    --establishment of harmonized and articulated approaches to risk 
    assessment,
    --use of national evaluations which meet international standards 
    instead of creating new international evaluations,
    --tailoring evaluations to meet the practical needs of countries and 
    other international organizations,
    --establishment of processes and time frames for updating previous 
    evaluations as new scientific information emerges,
    --maintenance of administrative records,
    --establishment of roles and responsibilities of member countries and 
    non-governmental organizations,
    --development of guidelines how to establish priorities for chemical 
    evaluation work,
    --improved mechanisms to ensure FAO/WHO awareness of all relevant data, 
    including adverse effects data, are provided,
    --establishment of selection criteria for JMPR/JECFA experts, and
    --improvement in communicating of the results of all work that supports 
    the elaboration of Codex standards.
    
    Process Committees
    
        Codex committees performing work primarily related to food 
    production and inspection activities, notably the Meat Hygiene and Food 
    Hygiene committees and the Committee on Food Import and Export 
    Inspection and Certification Systems, are sometimes known as 
    ``process'' committees. They do not use JECFA or JMPR evaluations as 
    part of their deliberation. They develop Codes of Practice through 
    discussion and assignment of working groups. Codes of Practice are not 
    considered official standards by Codex in that countries are not 
    requested to provide a formal acknowledgment of acceptance or 
    rejection. However, they are established through the Codex step process 
    and will probably be considered as standards under WTO, NAFTA and 
    future trade agreements.
        Criteria for decision-making relating to such standards within 
    Codex should be clearly articulated to allow consideration of only 
    those factors relevant to the health protection of consumers and to the 
    promotion of fair practices in trade. Such criteria for decision making 
    should be used in all Codex committees and in the Commission itself. 
    The decisions should be arrived at through an open process, with a 
    clearly defined rationale. Previous decisions should be revisited if 
    new scientific information becomes available.
        Availability of information on Codex activities and on work 
    performed in support of Codex activities, in the form of working 
    documents and standards, is critical to achieving the transparency 
    necessary to assure the public's confidence in Codex. Mechanisms to 
    improve communications must be sought by Codex and all member states.
    
             Actopm Plan--Issue #1: U.S. Support for Strengthening the Scientific Basis for Codex Decisions         
    ----------------------------------------------------------------------------------------------------------------
                                                      Responsibility                       Initiation     Completion
              Objective                 Method         (person/area)       Resources          date           date   
    ----------------------------------------------------------------------------------------------------------------
    A. Develop and promote                                                                                          
     criteria to be used by WHO/                                                                                    
     FAO in selecting experts to                                                                                    
     serve on the JMPR/JECFA                                                                                        
     which will be based on the                                                                                     
     following:                                                                                                     
        (1) Open process for the   (1) U.S. will     U.S. Codex        ................  2/1/97........        (\1\)
         submission of              develop paper.    Office to                                                     
         nominations/acceptance                       establish an                                                  
         and tenure;.                                 inter-agency                                                  
                                                      group.                                                        
    
    [[Page 23748]]
    
                                                                                                                    
        (2) Conflict of interest   (2) Paper will                                                                   
         disclosure; and;.          be circulated                                                                   
                                    to U.S.                                                                         
                                    Government/                                                                     
                                    NGO's as well                                                                   
                                    as other                                                                        
                                    countries for                                                                   
                                    input.                                                                          
        (3) Technical              (3) Document                                                                     
         Qualifications.            will be                                                                         
                                    introduced in                                                                   
                                    appropriate                                                                     
                                    Codex forum and                                                                 
                                    will form basis                                                                 
                                    for U.S.                                                                        
                                    Position in any                                                                 
                                    related                                                                         
                                    deliberations                                                                   
                                    of any Codex                                                                    
                                    Committee.                                                                      
    B. Establish better            (1) U.S. Codex    U.S. Codex        ................  11/01/96......       7/1/96
     communication mechanisms to    establish Codex   Office.                                                       
     ensure that information on     Home Page.                                                                      
     Codex activities is readily   (2) Encourage                                                                    
     and easily available.          Codex to expand                                                                 
                                    use of the                                                                      
                                    Internet (See                                                                   
                                    item 2(A)).                                                                     
    C. Develop and promote the     (1) U.S. Develop  U.S. Codex        ................  2/1/97........    10/15/97 
     establishment of minimum/      paper.            Office to                                                     
     adequate data sets for        ( 2) Circulate     establish an                                                  
     expert bodies (JECFA/JMPR).    document to       inter-agency                                                  
                                    Government        technical                                                     
                                    officials as      working group.                                                
                                    well as other                                                                   
                                    countries for                                                                   
                                    input.                                                                          
                                   (3) Document                                                                     
                                    will be                                                                         
                                    introduced in                                                                   
                                    appropriate                                                                     
                                    Codex forum and                                                                 
                                    will form basis                                                                 
                                    for U.S.                                                                        
                                    Position in any                                                                 
                                    related                                                                         
                                    deliberations                                                                   
                                    of any Codex                                                                    
                                    Committee.                                                                      
    ----------------------------------------------------------------------------------------------------------------
    \1\ Ongoing.                                                                                                    
    
    Issue 2: U.S. Support for Codex Efforts to Improve its Management 
    Processes
    
        U.S. Codex should support the revitalization of Codex. 
    Revitalization of Codex should include conducting a systematic review 
    of priorities, streamlining the decision-making processes, increasing 
    transparency, and improving communication. These steps will enhance the 
    credibility of Codex with national regulatory authorities and 
    consumers.
        FAO/WHO began a formal reevaluation of Codex procedures and guiding 
    principles in March 1991 at the Conference on Food Standards, Chemicals 
    in Foods and Food Trade. Codex is now streamlining its standards to 
    concentrate on essential health-related aspects. This represents a 
    shift in emphasis. Now that over l00 countries have become members of 
    the WTO, it is important that Codex again re-examine its operation with 
    particular attention to the following areas:
        1. Codex should conduct a formal strategic planning exercise, 
    including a systematic review of Codex priorities. This would provide a 
    framework for major policy decisions and serve as a basis for 
    refocusing priorities. Codex needs to strengthen its links with other 
    international food safety organizations and ensure that its activities 
    are integrated with and do not duplicate the activities of others in 
    the broad area of chemical safety.
        2. Codex decision-making procedures should be clearly defined and 
    transparent so that interested parties can more fully understand, 
    evaluate, and participate in the process.
        3. Codex needs to streamline its processes so that standards can be 
    developed and adopted more rapidly. In addition, it needs a process, 
    including an emergency procedure, to reevaluate and update its 
    standards as new scientific information emerges.
        4. The public needs to understand how Codex operates in order to 
    work within the system and use it effectively. Codex should more 
    frequently and more broadly communicate information on its activities 
    and on how to obtain standards, meeting reports and other documents.
        5. Codex should review the terms of reference of the Executive 
    Committee to expand its area of responsibility to include strategic 
    planning and better ensuring that priority areas of work are on target 
    in terms of time and other considerations. The Executive Committee must 
    refocus itself to become the ``Board of Directors'' of the 
    organization, responsible for making decisions on significant issues 
    occurring between Commission meetings such as establishing work 
    priorities and directing issues to the appropriate committees for 
    action.
        6. Codex should examine its use of resources to determine whether 
    increased efficiency is possible. If appropriate, additional resources 
    should be identified.
    
    [[Page 23749]]
    
    
    
                Action Plan--Issue #2: U.S. Support for Codex Efforts to Improve Its Management Processes           
    ----------------------------------------------------------------------------------------------------------------
                                                      Responsibility                       Initiation     Completion
              Objective                 Method         (person/area)       Resources          date           date   
    ----------------------------------------------------------------------------------------------------------------
    A. Encourage Codex to          U.S. submit a     U.S. Codex        ................  2/1/97........      5/15/97
     establish standard             proposal to the   Office.                                                       
     procedures for handling        Executive                                                                       
     Codex documents to ensure      Committee for                                                                   
     timeliness and opportunity     discussion.                                                                     
     for adequate review by                                                                                         
     member countries.                                                                                              
                                   One               ................  ................  ..............        (\1\)
                                    recommendation                                                                  
                                    is that Codex                                                                   
                                    move                                                                            
                                    expeditiously                                                                   
                                    to put                                                                          
                                    Committee                                                                       
                                    documents on                                                                    
                                    the World Wide                                                                  
                                    Web so that                                                                     
                                    countries could                                                                 
                                    have immediate                                                                  
                                    access to the                                                                   
                                    working                                                                         
                                    documents.                                                                      
    B. Codex review its policies   U.S. submit a     U.S. Codex        ................  2/1/97........         5/97
     for drafting the Committee     proposal to the   Office.                                                       
     reports to assure adequate     Executive                                                                       
     information is provided on     Committee for                                                                   
     assignments and history of     discussion.                                                                     
     evolving standards.                                                                                            
    C. Commission meeting          U.S. submit a     U.S. Codex        ................  2/1/97........      5/15/97
     operating practices be         proposal to the   Office.                                                       
     reviewed to assure the most    Executive                                                                       
     efficient/effective use of     Committee for                                                                   
     members time.                  discussion.                                                                     
    D. Encourage Codex review of   Develop           U.S. Codex        ................  3/1/97........         5/97
     operating practices to         appropriate       Office.                                                       
     utilize strategic thinking     follow-up to                                                                    
     in developing the work plan    1995 Executive                                                                  
     and to determine if            Committee                                                                       
     additional efficiencies can    discussion of                                                                   
     be realized. This could        this issue.                                                                     
     include related changes to                                                                                     
     the Executive Committee's                                                                                      
     terms of reference.                                                                                            
    E. In the appropriate Codex    1. U.S. develop   U.S. Codex        ................  2/97..........        11/97
     Committee promote the          paper.            Office.                                                       
     development of a process for  2. Circulate                                                                     
     establishing emergency         document to                                                                     
     procedures (developing,        government                                                                      
     revising or elaborating        officials as                                                                    
     Codex standards where          well as other                                                                   
     warranted to protect public    countries for                                                                   
     health by newly developed      input.                                                                          
     food safety scientific        3. Present paper                                                                 
     information which              in appropriate                                                                  
     invalidates the existing       Codex Committee.                                                                
     standard).                                                                                                     
    ----------------------------------------------------------------------------------------------------------------
    \1\ Ongoing.                                                                                                    
    
    Issue 3: U.S. Acceptance of Codex Standards
    
        To facilitate U.S. decisions on increased acceptance of Codex 
    standards related to food safety, U.S. Codex should develop processes 
    for systematically evaluating such existing Codex standards and 
    proposed new Codex standards using established U.S. approaches to risk 
    assessment.
        Historically, two factors have worked against U.S. Acceptance of 
    Codex Standards. These are:
    
    --current U.S. workloads, which force the regulatory agencies to place 
    a low priority on reaching decisions on whether they can accept 
    proposed Codex standards, and;
    --differences between the Codex standards and U.S. regulations.
    
        Under current Codex rules and procedures, Codex member countries 
    are obligated to consider for acceptance all pesticide and veterinary 
    drug MRLs as well as all food additive, commodity and general standards 
    adopted by Codex. Current U.S. acceptance procedures vary among 
    agencies having responsibilities for each of these categories of 
    standards. The agencies include EPA, FDA and USDA. These agencies need 
    to harmonize their processes for considering Codex Standards and for 
    developing U.S. standards with the Codex processes for data evaluation 
    and standard development. Where methods supporting the Codex processes 
    pose impediments to harmonization, the U.S. Codex needs to address 
    those processes in all appropriate forums. The Food Quality Protection 
    Act of 1996 provides for consideration by the U.S. Government of Codex 
    pesticide MRLs.
    
    [[Page 23750]]
    
    
    
                                Action Plan--Issue #3: U.S. Acceptance of Codex Standards                           
    ----------------------------------------------------------------------------------------------------------------
                                                      Responsibility                       Initiation     Completion
              Objective                 Method         (person/area)       Resources          date           date   
    ----------------------------------------------------------------------------------------------------------------
    A. Agencies shall consider     (1) Develop       U.S. Codex        Individual        2/1/97........        10/97
     Codex Standards in the         model SOP with    Office with       agency                                      
     development of U.S.            examples. (The    input from        resources (to                               
     Standards for food.            model should      agencies.         be determined).                             
                                    accommodate the                                                                 
                                    variable                                                                        
                                    complexity of                                                                   
                                    different type                                                                  
                                    standards.).                                                                    
                                   (2) Have model    U.S. Codex        ................  ..............  ...........
                                    Standard          Office Steering                                               
                                    Operating         Committee.                                                    
                                    Practice                                                                        
                                    endorsed by                                                                     
                                    Steering                                                                        
                                    Committee.                                                                      
                                   (3) Distribute    U.S. Codex        ................  ..............  ...........
                                    to relevant       Office.                                                       
                                    agencies for                                                                    
                                    implementation                                                                  
    B. Improve understanding and   --Establish and   U.S. Codex        ................  1/1/97........        06/97
     level of quality input into    implement an      Office.                                                       
     all phases of Codex            outreach                                                                        
     standards development by       program                                                                         
     stakeholders (government,      including                                                                       
     non-government                 elements such                                                                   
     organizations).                as:                                                                             
                                     --Home page                                                                    
                                     --Workshops                                                                    
                                     --Paper                                                                        
                                      distribution                                                                  
    C. Encourage U.S. industry to  Enhance dialog    U.S. Manager for  ................  1/1/97........        (\1\)
     submit data relevant to U.S.   with U.S.         Codex.                                                        
     consideration of acceptance    industry.                                                                       
     of Codex standards.                                                                                            
    D. Establish and codify        Agencies develop  Individual        Implementation    01/96.........       3/1/98
     process for routine review     their own model.  agencies.         of the                                      
     of Codex standards,                                                objective will                              
     guidelines, and                                                    require                                     
     recommendations for                                                substantial                                 
     consideration for acceptance.                                      resources by                                
                                                                        individual                                  
                                                                        agencies (to be                             
                                                                        determined).                                
    E. In recognition of the       Issue joint       Steering          ................  6/97..........        08/97
     obligations under Article 3    policy            Committee U.S.                                                
     of the SPS Agreement, issue    statement         Manager for                                                   
     policy statement regarding     across all        Codex.                                                        
     acceptance of Codex            agencies.                                                                       
     standards, guidelines and                                                                                      
     recommendations.                                                                                               
    F. Establish model format for                                                                                   
     U.S. positions on proposed                                                                                     
     Codex standards at Step 3 to                                                                                   
     specifically identify:                                                                                         
        (a) whether acceptance of  (1) Prepare       Steering          ................  2/11/97.......        03/97
         the Codex standard would   format for U.S.   Committee U.S.                                                
         affect U.S. consumer       positions to      Manager for                                                   
         health and safety.         address issues    Codex EPA,                                                    
                                    ``a''-``c'' to    USDA, FDA, DOC.                                               
                                    be applied by                                                                   
                                    committees.                                                                     
                                   --for any                                                                        
                                    document going                                                                  
                                    through step                                                                    
                                    procedures.                                                                     
        (b) whether acceptance of  (2) Train U.S.    U.S. Codex        ................  02/97.........  ...........
         the Codex standard would   delegates in      Office.                                                       
         require changes in U.S.    implementation                                                                  
         food production,           of format.                                                                      
         marketing and regulatory                                                                                   
         practices.                                                                                                 
        (c) steps which need to    (3) Implement     Individual        Substantial       06/97.........  ...........
         be initiated to            new format.       agencies.         resources (to                               
         harmonize the relevant                                         be determined.).                            
         U.S. standard and the                                                                                      
         proposed Codex standard.                                                                                   
    ----------------------------------------------------------------------------------------------------------------
    \1\ Ongoing.                                                                                                    
    
    Issue 4: Effective Participation of Non-Governmental Organizations in 
    U.S. Codex
    
        Balanced non-governmental participation is needed and will help 
    ensure that the positions taken by U.S. Codex have broad support. In 
    line with this objective, the process of gathering information and 
    developing positions should be transparent--open to public scrutiny.
        Codex delegations are led by U.S. government officials, primarily 
    managers and scientists, who serve as the formal U.S. representatives 
    in Codex committee meetings. Nevertheless, in the development of U.S. 
    positions, parties outside the government have traditionally provided 
    technical information and support to such representatives, in some 
    cases serve as members of the delegation. These experts primarily from 
    the regulated industry, serve a useful purpose because of their 
    expertise in specific technical matters before the various Codex 
    committees. In addition to providing technical information, they convey 
    the views of their constituents to the
    
    [[Page 23751]]
    
    committees and relay information about U.S. Codex activities to those 
    constituents.
        U.S. Codex should involve a greater variety of groups in its 
    activities and, for all of its activities, should expand their criteria 
    for participation. In addition, U.S. Codex's entire process of 
    gathering information and developing positions must be transparent.
        U.S. Codex must develop and implement mechanisms to involve a far 
    broader range of interests in U.S. Codex activities. This expanded 
    participation can occur on many levels, ranging from simply receiving 
    written information on Codex activities to actively participating in 
    the development of U.S. positions. U.S. Codex should conduct an 
    extensive outreach effort to include national, regional, and local 
    organizations and individuals with a stake in the establishment of 
    international food standards. U.S. Codex should explore the possibility 
    of creating a network of scientists and food and nutrition 
    technologists interested in Codex issues.
        In order for the U.S. Government to formally accept standards 
    adopted by Codex, it is essential that such standards not only provide 
    adequate public health protection, but that non-governmental 
    organizations (public interest, industry, professional, etc.) have 
    confidence in the integrity of all aspects of the standard elaboration 
    process.
    
          Action Plan--Issue #4: Effective Participation of Non-Governmental Organizations (NGOs) in U.S. Codex     
    ----------------------------------------------------------------------------------------------------------------
                                                      Responsibility                       Initiation     Completion
              Objective                 Method         (person/area)       Resources          date           date   
    ----------------------------------------------------------------------------------------------------------------
    A. Establish guidelines and    Develop           U.S. Codex        ................  Started               (\1\)
     criteria for consistency in    guidelines and    Office and                         Operations....             
     the operations of U.S. Codex   provide           agency                                                        
     delegations including the      training for      representatives                                               
     selection process of NGOs on   all U.S.                                                                        
     delegations and                delegates to                                                                    
     participation of NGOs in       ensure                                                                          
     U.S. Codex.                    awareness of                                                                    
                                    operating                                                                       
                                    procedures for                                                                  
                                    delegations                                                                     
                                    (See Item 5                                                                     
                                    (E)).                                                                           
    B. Establish a system for      Papers should be  U.S. Codex        ................  4/5/96........        (\1\)
     timely distribution of         posted on         Office.                                                       
     papers to allow for routine    Internet and a                                                                  
     and early opportunity for      cut-off date                                                                    
     public comment on U.S.         should be                                                                       
     positions as well as papers    established for                                                                 
     from the Codex Secretariat.    submissions of                                                                  
                                    papers by all                                                                   
                                    Codex                                                                           
                                    Committees.                                                                     
                                    (Discussed in                                                                   
                                    Executive                                                                       
                                    Committee, June                                                                 
                                    1996).                                                                          
    C. Request the establishment   U.S. will         U.S. Codex        ................  6/96..........        (\1\)
     of a procedure for increased   request that      Office.                                                       
     participation of NGO's in      names be         Codex                                                          
     Expert Consultations.          submitted to      Secretariat.                                                  
     Specifically recommend that    the Codex                                                                       
     NGO's attend Expert            Office by                                                                       
     Consultations as               public interest                                                                 
     participants.                  groups to                                                                       
                                    facilitate                                                                      
                                    participation                                                                   
                                    in Expert                                                                       
                                    Consultations.                                                                  
                                   Bring to the                                                                     
                                    attention of                                                                    
                                    FAO/WHO the                                                                     
                                    need to notify                                                                  
                                    interested                                                                      
                                    officials when                                                                  
                                    such expert                                                                     
                                    consultations                                                                   
                                    are planned.                                                                    
    D. Continue to work with       The United        U.S. Codex        ................  ..............        (\1\)
     other Codex members to         States will       Office.                                                       
     promote effective NGO          continue to                                                                     
     participation.                 provide strong                                                                  
                                    support for NGO                                                                 
                                    participation                                                                   
                                    in appropriate                                                                  
                                    Codex forums.                                                                   
    E. Continue to provide         U.S. will         U.S. Codex        ................  ..............        (\1\)
     opportunities for NGOs to      develop regular   Office.                                                       
     increase awareness of the      briefings and                                                                   
     Codex Alimentarius Food        public meetings                                                                 
     Standards Programme.           and utilize                                                                     
                                    USDA's                                                                          
                                    Communications                                                                  
                                    Office and the                                                                  
                                    Office of                                                                       
                                    Intergovernment                                                                 
                                    al Relations,                                                                   
                                    as well as FR                                                                   
                                    notices                                                                         
                                    Internet,                                                                       
                                    consumer and                                                                    
                                    industry-                                                                       
                                    sponsored                                                                       
                                    forums and                                                                      
                                    interagency                                                                     
                                    communications                                                                  
                                    to promote                                                                      
                                    awareness.                                                                      
    ----------------------------------------------------------------------------------------------------------------
    \1\ Ongoing.                                                                                                    
    
    Issue 5: Management and Effectiveness of U.S. Codex
    
        To enhance its effectiveness in Codex, the U.S. government should 
    consider a larger role for U.S. Codex, including a senior executive 
    position for the U.S. Manager, staffing, and funding.
        The United States has actively participated in and been considered 
    a leader in Codex since the organization was established. Its 
    contributions have centered around science and technology. It is now 
    clear that to capitalize on its scientific and technical capabilities 
    and increase the effectiveness of its participation, the United States 
    must expand its focus and investment.
        The following points need to be addressed to enhance the 
    effectiveness of current U.S. participation:
        1. U.S. Codex needs to take into account the changing Codex 
    dynamics and develop increased social, political and economic 
    sensitivity and awareness
    
    [[Page 23752]]
    
    of the global implications of such change. U.S. representatives must be 
    fully informed about the needs of other countries as well as domestic 
    needs. The United States must function as a team player, sharing 
    information, seeking coalitions and engaging in partnerships to advance 
    and support proposals of mutual concern. It must be well-prepared to 
    step into a leadership role when the situation warrants, and be willing 
    to negotiate in support of the development of science-based standards 
    for all member countries.
        2. The U.S. government should provide adequate resources for 
    effective participation in Codex and consider a larger organizational 
    role for U.S. Codex, thus promoting increased efficiency, 
    effectiveness, and participation. Full support from all management 
    levels is needed to ensure that Codex activities receive high priority, 
    with full time staff, targeted funding, and a senior executive position 
    for the U.S. Manager.
        3. The federal managers and scientists in U.S. Codex need training 
    in international negotiations and intercultural relations. There should 
    be regular interaction among them to strengthen their sense of 
    identity, improve awareness of cross-cutting issues, and identify at an 
    early stage controversial issues that need attention by the coordinator 
    of U.S. Codex. Early identification of emerging issues will allow 
    effective coalition building with other countries' delegates to promote 
    mutual interests.
        4. U.S. Codex needs a mechanism to allow it to routinely evaluate 
    the results of its efforts.
        5. The makeup of U.S. Codex should reflect a balance between trade 
    and regulatory perspectives.
    
                                                Action Plan--Issue #5: Management and Effectiveness of U.S. Codex                                           
    --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Responsibility                                                                          
                 Objective                       Method             (person/area)            Resources            Initiation date         Completion date   
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    A. Establish and recruit/select a    --Included in FSIS     Under Secretary for    .....................  4/30/96...............  1/30/97.              
     U.S. Manager for Codex               reorganization         Food Safety.                                                                               
     Alimentarius in the Office of the    package.                                                                                                          
     Under Secretary for Food Safety in  --Announce position..                                                                                              
     order to better facilitate          --Designate a review                                                                                               
     interagency process.                 panel.                                                                                                            
    B. Provide adequate staffing for     --Appropriately        Administrator for      .....................  8/31/96...............  Ongoing.              
     the U.S. Codex Office.               classify and staff     FSIS.                                                                                      
                                          positions consistent                                                                                              
                                          with Strategic Plan                                                                                               
                                          and Action Plan                                                                                                   
                                          assumptions.                                                                                                      
    Further enhance technical and        --Detail staff from    U.S. Codex Office      No new resources--FTE  4/1/97................  Ongoing.              
     policy expertise in U.S. Codex       relevant U.S.          Steering Committee.    would be borne by                                                   
     Office.                              Government agencies.                          participating                                                       
                                                                                        agencies.                                                           
                                         --Internship Programs  U.S. Codex Office....  .....................  08/05/97..............  Ongoing.              
                                         --e.g. George                                                                                                      
                                          Washington                                                                                                        
                                          University Program/                                                                                               
                                          School for Advanced                                                                                               
                                          Studies at John                                                                                                   
                                          Hopkins/investigate                                                                                               
                                          other interagency                                                                                                 
                                          fellowship                                                                                                        
                                          possibilities.                                                                                                    
    C. Seek appropriations to establish  Prepare estimates of   Under Secretary for    .....................  1/1/97................  FY-1999.              
     specific funding for U.S. Codex      needed resources.      Food Safety,                                                                               
     Office and funding for U.S. hosted                          Steering Committee,                                                                        
     meetings.                                                   U.S. Manager for                                                                           
                                                                 Codex, U.S. Codex                                                                          
                                                                 Office.                                                                                    
                                         Develop appropriation  .....................  .....................  1/1/97................  ......................
                                          package to include                                                                                                
                                          in FY-99                                                                                                          
                                          appropriation                                                                                                     
                                          submission.                                                                                                       
    D. Seek Congressional funding for    Prepare estimate of    --Policy level         .....................  2/1/97................  12/97.                
     individual Federal Agency            resources needed.      Steering Committee.                                                                        
     activities in the development,                             --U.S. Manager for                                                                          
     review, and acceptance of Codex                             Codex.                                                                                     
     standards.                                                                                                                                             
    E. Provide training for all U.S.     Interagency working    U.S. Codex Office....  .....................  2/1/97................  Ongoing.              
     Codex officials to ensure            group to define                                                                                                   
     awareness of operating procedures    training                                                                                                          
     for delegations and to enhance       requirements and                                                                                                  
     knowledge and skills. (Include       plan. (FDA, EPA,                                                                                                  
     training modules which distinguish   USDA, USTR, DOC,                                                                                                  
     between food safety and quality      State).                                                                                                           
     requirements in Codex standards                                                                                                                        
     and the implications under WTO).                                                                                                                       
     See 4(A).                                                                                                                                              
    
    [[Page 23753]]
    
                                                                                                                                                            
    F. Reorganize current Codex          Discuss proposal w/    --Under Secretary for  .....................  2/96..................  5/1/97.               
     Steering Committee to better         current Steering       Food Safety.                                                                               
     manage and provide oversight in a    Committee.            --Existing Steering                                                                         
     timely manner to Codex issues,                              Committee.                                                                                 
     e.g. form separate policy and                              --U.S. Manager for                                                                          
     technical committees. (1 senior-                            Codex.                                                                                     
     level policy committee) (1 senior-                                                                                                                     
     level technical committee).                                                                                                                            
                                         Review Steering        --Under Secretary for  .....................  6/1/97................  8/1/97.               
                                          Committee comments     Food Safety.                                                                               
                                          and get Steering      --Steering Committee.                                                                       
                                          Committee             --U.S. Manager for                                                                          
                                          endorsement.           Codex.                                                                                     
                                         Prepare draft terms    --Under Secretary for  .....................  8/1/97................  10/1/97.              
                                          of reference for new   Food Safety.                                                                               
                                          committees and        --Steering Committee.                                                                       
                                          determine membership. --U.S. Manager for                                                                          
                                                                 Codex.                                                                                     
    G. Develop a process to define       Agencies document      --FDA, USDA, EPA,      To be determined.....  2/1/97................  Ongoing.              
     inter/intra agency communication     current procedures     DOC, USTR.                                                                                 
     problems and necessary steps to      of inter/intra        --Policy level                                                                              
     resolve them. Such steps should be   process to U.S.        Steering Committee.                                                                        
     oriented toward sharing              Codex office and      --U.S. Manager for                                                                          
     information with a view toward       identify steps taken   Codex.                                                                                     
     identifying significant cross-       to resolve problems.                                                                                              
     cutting or controversial issues to   Manager routinely                                                                                                 
     Codex Steering Committee.            participate as                                                                                                    
                                          member.                                                                                                           
    H Establish relationship with SPS    Share data on          --U.S. Manager for     To be determined.....  2/1/97................  10/1/97.              
     Committee.                           acceptance of          Codex.                                                                                     
                                          standards.            --U.S. Codex Office..                                                                       
    I. Establish Homepage on Internet    .....................  --FSIS Administrator.  .....................  2/1/97................  7/1/97.               
     in the U.S. Codex Office and                               --U.S. Codex Office..                                                                       
     utilize electronic transmission of                                                                                                                     
     documents:                                                                                                                                             
     transmitting U.S. response                                                                                                                     
     to request for country comments.                                                                                                                       
     receiving working Codex                                                                                                                        
     documents.                                                                                                                                             
    J. Ensure that Codex duties are      U.S. Codex office to   Individual Agencies..  .....................  2/1/97................  7/1/97.               
     reflected in Codex managers          introduce subject/                                                                                                
     (delegates/alternates) position      need to the Steering                                                                                              
     descriptions/performance plans.      Committee.                                                                                                        
    Develop generic performance          Codex office to        .....................  .....................  10/1/97...............  ......................
     standards.                           provide agencies                                                                                                  
                                          generic statement of                                                                                              
                                          duties of U.S.                                                                                                    
                                          Delegates.                                                                                                        
                                         Steering Committee to  .....................  .....................  ......................  10/1/97.              
                                          contact individual                                                                                                
                                          agencies to request                                                                                               
                                          initiation of this                                                                                                
                                          objective.                                                                                                        
    --------------------------------------------------------------------------------------------------------------------------------------------------------
    
    Public Hearing
    
        A public hearing is scheduled for May 8, 1997, from 9:30 AM to 
    12:30 PM, at the Holiday Inn Rosslyn-Westpark, 1900 N. Fort Myer Drive, 
    Arlington, VA 22207. Attendees will hear brief descriptions of the 
    issues and action plans, and will have the opportunity to pose 
    questions and offer comments. A transcript will be made of the 
    proceedings. The Agencies plan to use the record of this hearing and of 
    comments received in finalizing their planned approaches to achieving 
    U.S. goals for Codex standard-setting activities.
        Comments regarding the Codex standard-setting activities may be 
    sent to the FSIS Docket Room (see ADDRESSES). Please state that your 
    comments relate to Codex activities and specify which issues and 
    objectives your comments address.
    
        Done at Washington, DC on: April 25, 1997.
    Thomas J. Billy,
    Administrator, Food Safety and Inspection Service.
    [FR Doc. 97-11314 Filed 4-28-97; 1:43 pm]
    BILLING CODE 3410-DM-P
    
    
    

Document Information

Published:
05/01/1997
Department:
Food Safety and Inspection Service
Entry Type:
Notice
Action:
Notice; public hearing and request for comments.
Document Number:
97-11314
Dates:
The public meeting will be held on May 8, 1997, from 9:30 a.m. until 12:30 p.m.
Pages:
23745-23753 (9 pages)
Docket Numbers:
Docket No. 97-027N
PDF File:
97-11314.pdf