FLUORIDE ACTION NETWORK PESTICIDE PROJECT

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Sulfuryl fluoride. February 9, 1996. General discussion of pesticide treated food commodities as candidates for Codex Maximum Residue Limits. Federal Register.


Note from EC:

This Notice does not cite any specific pesticide. I include it due to the impending discussion of replacing the fumigant methyl bromide with Sulfuryl fluoride.

http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/February/Day-09/pr-537.html

[Federal Register: February 9, 1996 (Volume 61, Number 28)] [Notices]
[Page 4954-4956]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]


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.


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

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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 timeframes as specified below.

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    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 <SUP>1 of Data (Toxicology, Metabolism, Residue) Available: \1\ Bibliographical list to include title, author, date, report number or reference, data developer/owner, etc.

      13. Date Data Could be Submitted by (Country): [FR Doc. 96-2750 Filed 2-8-96; 8:45 am] BILLING CODE 3410-DM-P