[Federal Register Volume 59, Number 66 (Wednesday, April 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7701]
[[Page Unknown]]
[Federal Register: April 6, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-300333; FRL-4767-7]
Pesticides; Prioritization of Actions Subject to the Delaney
Clause; Policy Notice
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing that it will temporarily cease review and
processing of tolerance petitions received under the Federal Food, Drug
and Cosmetic Act (FFDCA) and the associated registration applications
received under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) if any of the pesticide uses that are subject of the
applications and petitions appear to result in a residue that needs a
food additive regulation under section 409 of the FFDCA and such a
regulation would be barred by the Delaney Clause. EPA is adopting this
policy to concentrate on food additive regulations currently in force
which are inconsistent with the Delaney Clause and to avoid expending
EPA resources on action which may be revised once various policy issues
are resolved.
EFFECTIVE DATE: April 6, 1994.
FOR FURTHER INFORMATION CONTACT: Tina E. Levine, Registration Support
Branch, Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington DC 20460,
(703)- 308-8393.
SUPPLEMENTARY INFORMATION:
I. Background
EPA's regulations regarding FIFRA registration in 40 CFR 152.112(g)
require that all needed tolerances for pesticide residues in food be in
place prior to the approval of a FIFRA registration for the use of a
pesticide which will result in such residues. Raw food tolerances for
pesticides are established under section 408 of FFDCA, 21 U.S.C. 346a,
and tolerances for certain processed foods and for feed additives
(``food additive regulations'') for pesticides are established under
FFDCA section 409, 21 U.S.C. 348.
EPA's current policy is that a food additive regulation is needed
when there is a possibility that the processing of a raw food
containing pesticide residues would result in residues in the processed
food or in animal feed at a level greater than the raw food tolerance.
EPA determines whether there is such a possibility based on the review
of processing data supplied by the applicant for registration purposes
or the petitioner for a tolerance.
Under section 409, a food additive regulation for a pesticide
residue may not be promulgated if EPA concludes that the pesticide
``induces cancer'' in man or animal as specified in the Delaney Clause.
21 U.S.C. 348(c)(3). In Les v. Reilly, the United States Court of
Appeals for the Ninth Circuit held that the Delaney Clause barred the
establishment of a food additive regulation for any pesticide that
meets the induce-cancer standard no matter how infinitesimal the risk,
968 F.2d 985 (9th Cir. 1992), cert. denied, 113 S. Ct. 1361 (1993). The
court overturned EPA's interpretation of the Delaney Clause as subject
to an exception for pesticide residues which pose a de minimis risk.
FIFRA and section 408 of the FFDCA contain no Delaney Clause and
instead require consideration of both risks and benefits in making
regulatory decisions. Thus, pesticide uses which might qualify under
the standards for registration and a section 408 tolerance could still
fail to meet the standard for a food additive regulation under section
409. Where that is the case, and a section 409 food additive regulation
is needed, EPA regulations state that a FIFRA registration may not be
granted, and it is EPA policy not to approve a section 408 tolerance
for such a use either.
In the wake of Les v. Reilly, the National Food Processors
Association (NFPA) and other food processing and production groups have
petitioned EPA to change its policy linking actions under section 408
(raw food) and section 409 (processed food). Such a change in policy
would require EPA to amend its regulations concerning the registration
requirement that all needed section 409 food additive regulations be in
place. Additionally, the NFPA petition challenges the factual basis for
EPA's conclusion that processing studies are an accurate measure of
whether processed foods will contain pesticide residues greater than
the section 408 tolerance and thus need a section 409 tolerance.
In response to the NFPA petition, EPA has published for public
comment a notice (``NFPA petition notice'') summarizing the petition
and current EPA policies and procedures that are potentially affected
by issues raised in the NFPA petition, including EPA's procedures for
determining when a 409 food additive regulation is needed and EPA's
policy of coordinating the decision on the 408 tolerance and
registration with the 409 food additive regulation (58 FR 7473, Feb. 5,
1993). Further, EPA also has released, on Febrary 2, 1993, a list of 32
pesticides that either have or need section 409 food additive
regulations under EPA's policy and that also appear to induce cancer
within the meaning of the Delaney Clause. EPA intends to update this
list periodically. Although EPA has not made a formal ``induces
cancer'' finding for many of these pesticides, EPA currently believes
that most, if not all, of the pesticides classified in Group A, B, or C
according to EPA's Cancer Assessment Guidelines will come within the
Delaney Clause standard. EPA places a high priority on responding to
the legal, policy, science, and factual issues raised by the NFPA
petition and the Les v. Reilly decision. However, these issues are both
complex and interrelated and cannot be addressed quickly.
II. Reasons for Policy on Tolerance Petitions and Registration
Actions Affected by Delaney Clause
EPA is adopting this policy at the present time as part of the
priorities it has established following the decision in Les v. Reilly.
The Les v. Reilly decision clearly established that the Delaney Clause
bars the existence of a food additive regulation for any pesticide that
induces cancer in man or animal. EPA has determined that there
presently exist as many as 50 food additive regulations for pesticides
that may meet the induce-cancer standard. EPA's first priority, thus,
following the Les v. Reilly decision is to determine which of these
regulations must be revoked and to do so promptly. Because food
additive regulations are only established in situations where EPA
believes they are needed to prevent the adulteration of food, EPA's
second priority will be to determine what action should be taken, if
any, against the FIFRA registrations and section 408 tolerances which
are associated with the food additive regulations to be revoked. This
issue has been made more complex, as explained above, by the NFPA
petition which challenges EPA's existing policies on this matter.
Finally, EPA's third priority is to address the many petitions for
establishing food additive regulations which raise Delaney Clause
problems.
Ideally, EPA would prefer to address simultaneously all pending
petitions to establish food additive regulations and all existing food
additive regulations which are inconsistent with the Delaney Clause.
EPA, however, has limited resources. EPA estimates that in the next
several months it will initiate revocation actions against over 25 food
additive regulations based on the Delaney Clause. EPA will also have to
resolve what policy to follow on the associated section 408 tolerances
and registrations and implement those actions as well. This could
result in EPA action against 80 or more pesticide uses. Aggressively
moving to deny pending applications which raise Delaney Clause problems
could exhaust EPA's limited resources on pesticide uses not on the
market while tolerances inconsistent with the statute remain in place.
Finally, EPA also must take into account that it receives thousands of
registration and tolerance actions each year. Devoting substantial
resources to petitions raising Delaney Clause issues will delay action
on the more routine actions. This is especially the case where EPA has
not yet resolved the important policy issues relating to the
interrelationship of section 409 food additive regulations and section
408 tolerances and FIFRA registrations because actions taken today
might have to be revised if EPA policies are altered. EPA will
reexamine this policy once it has resolved the policy issues raised by
the NFPA petition.
III. Policy
EPA will temporarily stop all review and processing work related to
establishing a registration and/or tolerance(s) for any chemical/crop
combination in which: (1) either the chemical has been found to induce
cancer in man or animal or the chemical has shown evidence of
carcinogenicity in animals or humans; and (2) the pesticide residue in
or on a raw agricultural commodity concentrates when that commodity is
processed or EPA otherwise determines that a food additive regulation
is needed for the use. This will include any work on registrations
under FIFRA section 3, experimental use permits under FIFRA section 5,
associated tolerances under section 408 of the FFDCA, as well as food
additive regulations under section 409 of the FFDCA.
Work on tolerances and registrations for other uses of the
chemical, where a food additive regulation is not needed, may continue.
However, EPA approves or denies tolerance petitions in toto. Therefore,
if a petition seeks a tolerance for any residue that appears subject to
the Delaney Clause, that petition cannot be approved and work on all
tolerances in that petition will temporarily stop. The Agency advises
any person who has submitted a pending tolerance petition containing a
tolerance that appears to be subject to the Delaney Clause to amend the
petition to separate the tolerances not affected by the Delaney Clause
so that work on these tolerances may resume.
EPA will also disapprove any State registrations approved under
section 24 of FIFRA if the registration depends on the existence of a
food additive regulation that is subject to revocation under the
Delaney Clause. The basis of such disapproval would be that the
registration is ``inconsistent with the Federal Food, Drug, and
Cosmetic Act,'' FIFRA sec. 24(c)(3). States are urged not to approve
such section 24(c) registrations, since State approval followed within
90 days by EPA disapproval will be disruptive and cause unncessary
economic burdens.
IV. Implementation
Once the determination has been made that a pesticide use may
result in a residue that appears to be subject to the Delaney Clause,
the PM will notify the applicant or petitioner in writing of the status
of the tolerance petition and associated application(s), i.e., that all
review and processing work has been stopped and the reason for this
action. These registrations and petitions will continue to be
considered pending; EPA is not denying these registrations and
petitions. If a registrant wishes to amend the tolerance petition after
such notification to allow work to continue on uses not affected by the
Delaney Clause, such an amendment may be submitted to the PM by the
usual procedure. The tolerance petitions or registration applications
will not be returned to the registrant or subject to any ``abandoned
petition'' policy unless EPA, in the future, prescribes some further
action that registrants must respond to affirmatively within a set time
period. EPA will notify applicants and petitioners if and when the the
Agency resumes review and processing of a petition and associated
registration applications on which review was stopped under this
policy. Such notice may be by letter, or by issuance of a policy notice
or rule in which implementation is addressed.
EPA believes its limited resources are best directed at first
removing regulations inconsistent with the statute and EPA policies and
then making final determinations on petitions which, because they meet
the above criteria, are likely to be denied. To the extent, however,
that a petitioner believes that EPA has wrongly characterized its
petition as meeting the criteria or that there exists some other basis
for granting the petition, EPA will, on a case-by-case basis,
consistent with its obligation to protect the public health, adjust its
priorities so that a formal action can be taken on the petition. In
addition, EPA will give any petitioner a denial, if that is requested.
There are approximately 60 actions currently in review that EPA
believes are subject to this policy. EPA will begin sending individual
notices to registrants and petitioners within 30 days of this notice
and expects to complete notification within 90 days. A registrant who
receives no notification may assume that petitions and application
actions continue in active review.
This policy does not affect the registration of new products or new
uses which have an associated 409 tolerance that has already been
established even if, under the Delaney Clause, that tolerance would not
now be granted. However, EPA intends to revoke such tolerances in the
future, and will, after revocation, immediately stop review and
processing of additional pending actions dependent on the tolerance at
that time. Registrants who intend to submit new registration
applications under these circumstances may wish to await further Agency
action before submitting applications that may be affected by such
revocations.
A final decision on whether to approve or deny the tolerance
petitions and associated FIFRA applications that appear to be subject
to the Delaney Clause must await resolution of the complex,
interrelated issues raised in the NFPA petition and summarized above
and will be staggered in such a manner so as to conserve resources for
addressing currently approved food additive regulations, tolerances,
and registrations. Some of these issues may be addressed by pending
legislation. In the absence of such legislative changes, EPA does not
believe that most of the issues will be addressed until later this
year.
List of Subjects
Environmental protection, Agricultural commodities, Food and feed
additives, Pesticides and pests.
Dated: March 21, 1994.
Susan H. Wayland,
Acting Director, Office of Pesticide Programs.
[FR Doc. 94-7701 Filed 4-5-94; 8:45 am]
BILLING CODE 6560-50-F
