[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