[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