96-2750. Nominating Pesticides and Pesticide Treated Food Commodities as Candidates for Codex Alimentarius Maximum Residue Limits  

  • [Federal Register Volume 61, Number 28 (Friday, February 9, 1996)]
    [Notices]
    [Pages 4954-4956]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-2750]
    
    
    
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    DEPARTMENT OF AGRICULTURE
    Food Safety and Inspection Service
    [Docket No. 95-050N]
    
    
    Nominating Pesticides and Pesticide Treated Food Commodities as 
    Candidates for Codex Alimentarius Maximum Residue Limits
    
    AGENCY: Food Safety and Inspection Service, USDA.
    
    ACTION: Notice.
    
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    SUMMARY: The Food Safety and Inspection Service is setting forth in 
    this notice the procedure to be followed by an interested person who 
    may wish to request the United States government to propose pesticides 
    and their treated food commodities as candidates for Codex maximum 
    residue limits (MRLs) for pesticides in food. Obtaining such 
    international pesticide tolerances can be beneficial to U.S. food 
    exporters because a number of countries that do not recognize U.S. 
    pesticide tolerances may accept the use of Codex pesticide MRLs for 
    their food imports. Thus, having Codex MRLs for pesticides resulting 
    from agricultural uses of pesticides approved in the United States can 
    facilitate trade with these foreign countries.
    
    FOR FURTHER INFORMATION CONTACT: U.S. Delegate to the Codex Committee 
    on Pesticide Residues, Dr. Richard Schmitt, Deputy Director, Special 
    Review and Reregistration Division, Office of Pesticide Programs, U.S. 
    Environmental Protection Agency, 401 M Street, SW., (7508W), 
    Washington, DC 20460; (703) 308-8000.
    
    SUPPLEMENTARY INFORMATION: The Codex Alimentarius Commission (the 
    Commission) is an intergovernmental body comprised of the national 
    governments of over 150 countries. It operates under the auspices of 
    the Food and Agriculture Organization (FAO) of the United Nations and 
    the World Health Organization (WHO) to implement the Joint FAO/WHO Food 
    Standards Programme. The purpose of this program is to protect consumer 
    health and ensure fair practices in international food trade through 
    the use of Codex recommended food standards and codes of practice. The 
    Commission's basic work is conducted by various committees, one of 
    which is the Codex Committee on Pesticide Residues (CCPR), which has 
    the responsibility for the elaboration of all food standards pertaining 
    to pesticide residues in food. Such food standards are specifically 
    referred to as Codex MRLs (i.e., maximum residue limits for pesticides 
    in foods).
        The development of Codex MRLs for pesticides follows a detailed, 
    eight step 
    
    [[Page 4955]]
    procedure. The first step involves the selection of pesticides for 
    placement on the CCPR's priority list. The criteria for inclusion of a 
    pesticide on the priority list are: (1) The pesticide must be 
    registered for use in at least one country; (2) the pesticide must not 
    have been already accepted for CCPR consideration; (3) the pesticide 
    must give rise to residues in or on a food commodity (including animal 
    feed) moving in international trade; and (4) the presence of residues 
    of the pesticide in a food commodity is or may become a matter of 
    public health concern and thus create, or have the potential to create, 
    problems in international trade. An ad hoc Working Group on Priorities 
    is formed by the CCPR each year to provide the initial screening of all 
    pesticides proposed for inclusion on the priority list. The Working 
    Group on Priorities considers the proposals that were submitted and 
    prepares recommendations to the CCPR at its annual sessions. The 
    priority list of new pesticides adopted by the CCPR is then referred to 
    the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) for evaluation.
        The JMPR, which is comprised of scientific experts from governments 
    and academia appointed by FAO and WHO, is convened annually for the 
    purpose of evaluating, among other things, the pesticides on the CCPR's 
    priority list. In conducting these evaluations, the JMPR reviews all 
    available toxicological data to estimate the acceptable daily intake 
    (ADI) for the pesticide and all available residue, metabolism, and 
    processing data to propose MRLs for residues on food commodities from 
    the use of the pesticide in accordance with nationally approved uses, 
    referred to as good agricultural practice (GAP). The remaining steps of 
    the process allow national governments several opportunities to review 
    and comment on proposed MRLs prior to final acceptance by the 
    Commission.
        Codex MRLs for additional food commodities can be sought even after 
    Codex MRLs for a pesticide have completed the eight step process. In 
    such cases, it is not necessary to renominate the chemical to the ad 
    hoc Working Group on Priorities, but rather it is only necessary to 
    request the FAO Joint Secretariat of the JMPR to place the pesticide--
    food commodity combination on the agenda for evaluation by an upcoming 
    JMPR. Expanding MRLs for a pesticide to additional food commodities, 
    does not require reevaluation of the pesticide's toxicological 
    properties.
        A key element in having a pesticide placed on the CCPR's priority 
    list is the availability of a complete data package that contains data 
    on the pesticide from all relevant acute and chronic toxicity studies, 
    the chemistry of the pesticide, residue information (including detailed 
    data from supervised field trials), information concerning metabolism 
    of the pesticide, and processing data and information on national GAP 
    in the use of the pesticide.
        Only national governments may nominate a pesticide chemical as a 
    candidate for the CCPR's priority list. Because manufacturers of 
    pesticides usually conduct or sponsor studies to generate the toxicity 
    and residue data for their pesticides, and in fact, actually own these 
    data, nominations submitted by governments often are initiated by 
    pesticide manufacturers. There are, however, no restrictions that 
    prevent food or feed producers and processors, or their trade 
    associations, or any other interested person from requesting their 
    respective national governments to seek Codex MRLs for pesticides used 
    on commodities that may be shipped in international trade. In such 
    cases, the commitment of pesticide manufacturers to submit supporting 
    data must be obtained before nomination for an MRL is made. The 
    advantage of having Codex MRLs for food commodities that may be 
    marketed in international trade is the possible removal of non-tariff 
    trade barriers in importing countries that utilize Codex MRLs rather 
    than tolerances of the exporting country for determining compliance 
    with their national residue requirements.
        The United States is vitally interested in assuring access to world 
    markets for U.S. produced food commodities, and in particular, not 
    being denied entry to these markets because of the presence of 
    pesticide residues that are legal and safe by U.S. standards, but not 
    by the standards of importing countries. While having Codex MRLs 
    established for U.S. pesticide uses for food production does not 
    guarantee access to markets of other countries, a number of countries 
    apply Codex MRLs to imported foods in situations where they have not 
    established national tolerances for a particular pesticide residue/food 
    combination. The U.S. government considers it important that interested 
    persons be aware of the opportunity to obtain Codex MRLs for existing 
    pesticide uses in the United States on foods that may be sold to 
    foreign countries. The opportunity for nominating to the CCPR 
    pesticides registered for food uses in the United States generally is 
    known to pesticide manufacturers, but may be largely unknown to other 
    segments of the private sector or to the general public. Accordingly, 
    it is the intent of this notice to inform all interested persons of the 
    opportunity for nominating pesticides/food commodities for Codex MRL 
    development.
        U.S. government agencies directly involved in the work of the CCPR 
    are the U.S. Environmental Protection Agency, Food and Drug 
    Administration, and U.S. Department of Agriculture. Official 
    representatives from these agencies comprise the U.S. Delegation to the 
    CCPR. The function of the delegation is to develop U.S. positions on 
    Codex MRLs and related matters and to represent the U.S. at the CCPR's 
    annual sessions. Among other things, this function includes submitting 
    on behalf of the U.S. proposed pesticide nominations for the CCPR 
    priority list which have been requested by interested persons.
        The procedure for interested persons seeking such nominations by 
    the U.S.-CCPR Delegation is based on the one formulated by the CCPR's 
    ad hoc Working Group on Priorities. The format and commitment to be 
    made are as follows:
    
    U.S. Procedure for Proposing Pesticides for the Codex Priority List and 
    Extension of Codex MRLs to Additional Food Commodities
    
    1. Criteria for Nominating a Pesticide and Its Treated Food Commodities 
    for Codex MRL Development
    
        Before a pesticide and food commodities that contain residues of 
    the pesticide may be considered by the U.S.-CCPR Delegation for 
    nomination for Codex MRL development:
        a. The pesticide must be registered for agricultural use in the 
    United States and have registrations and tolerances for its residues 
    for the specific food commodities for which Codex MRLs are being 
    sought.
        b. The food commodities that may contain residues of the pesticide 
    in question must represent a component of U.S. export trade or have the 
    potential of representing a component of U.S. export trade.
        c. The expected residues of the pesticide in the food commodities 
    in question must be or have the potential to become a matter of public 
    health concern and either create or have the potential to create 
    problems in international trade.
        d. There must be a confirmed commitment for submission of complete 
    and current data for review by the JMPR within the FAO and WHO time-
    frames as specified below. 
    
    [[Page 4956]]
    
    
    2. Procedure To Be Followed for Pesticides for Which There Are 
    Currently No Proposed or Adopted Codex MRLs
    
        a. For pesticides and food commodities that fall into this category 
    and meet the criteria in part 1, it is necessary to complete the form 
    in the appendix to this notice. Persons that do not own the data for 
    the pesticide in question, must consult with the owner about the 
    existence of sufficient toxological and residue data; confirm the 
    owner's commitment to submit these data to the JMPR and in what year; 
    and seek assistance in completing the form.
        b. Either the owner of the data or other interested persons may 
    submit the completed form and confirmed commitment to submit necessary 
    data to the U.S.--CCPR Delegation for consideration as a candidate for 
    the CCPR's priority list. If the U.S. Delegation agrees, the form, 
    along with an official transmittal letter and data commitment (also in 
    writing), will be forwarded to the Working Group on Priorities.
        c. The completed nomination may be submitted to the U.S. Delegation 
    at any time; however, in order for the delegation to review the 
    submission and forward it to the Working Group on Priorities in time 
    for the upcoming session of the CCPR, the U.S. Delegate must receive 
    the completed form and data commitment by the end of a calendar year. 
    (The WHO component of the JMPR schedules new pesticides for toxological 
    evaluations two years in advance and the FAO component, one year in 
    advance.)
    
    3. Procedure To Be Followed for Pesticides for Which Codex MRLs Are 
    Proposed or Adopted
    
        a. The criteria listed in part 1 must be met for each food 
    commodity for which a Codex MRL is being sought.
        b. For an interested person who did not develop the required data 
    for the pesticide food commodity in question, it is necessary to 
    consult with the person who developed the required data to ascertain 
    the existence of sufficient residue data and obtain the commitment that 
    such data will be available for submission to JMPR at an appropriate 
    time.
        c. Either person identified in paragraph 3b may submit a written 
    proposal to the U.S.--CCPR Delegation requesting that a Codex MRL be 
    developed for each additional pesticide--food combination. The 
    delegation will consider each request, and if the criteria are met, 
    will submit it directly to the FAO Joint Secretary of the JMPR. The 
    timing of the submission of the data for evaluation will be determined 
    by the FAO Joint Secretary.
    
        Done at Washington, DC on: February 2, 1996.
    Michael R. Taylor,
    Administrator.
    
    Appendix
    
    Pesticide Information for CCPR Working Group on Priorities
    
    for evaluation __________
    for reevaluation __________
    
        1. Name:
        2. Structural Formula:
        3. Chemical Name:
        4. Names and Addresses of Basic Producers:
        5. Justification for Use:
        6. Uses: Major, Minor.
        7. Commodities Moving in International Trade and Expected Levels of 
    Residues:
        8. Countries Where Pesticide is Registered:
        9. National Maximum Residue Limits:
        10. Commodities for Which the Need for Establishing Codex MRL's is 
    Recognized:
        11. Major International Use Pattern:
        12. List 1 of Data (Toxicology, Metabolism, Residue) 
    Available:
    
        \1\ Bibliographical list to include title, author, date, report 
    number or reference, data developer/owner, etc.
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        13. Date Data Could be Submitted by (Country):
    [FR Doc. 96-2750 Filed 2-8-96; 8:45 am]
    BILLING CODE 3410-DM-P
    
    

Document Information

Published:
02/09/1996
Department:
Food Safety and Inspection Service
Entry Type:
Notice
Action:
Notice.
Document Number:
96-2750
Pages:
4954-4956 (3 pages)
Docket Numbers:
Docket No. 95-050N
PDF File:
96-2750.pdf