[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