[Federal Register Volume 61, Number 188 (Thursday, September 26, 1996)]
[Proposed Rules]
[Pages 50686-50688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24603]
Federal Register / Vol. 61, No. 188 / Thursday, September 26, 1996 /
Proposed Rules
[[Page 50686]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[OPP-300439; FRL-5397-5]
RIN 2070-AC55
Withdrawal of Proposed Revocations of Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Withdrawal of proposed revocations.
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SUMMARY: EPA is withdrawing the proposed revocations of a number of
pesticide tolerances established under the Federal Food, Drug and
Cosmetic Act (FFDCA). The enactment of the Food Quality Protection Act
removed the legal basis for these revocations. Accordingly, EPA is
withdrawing these proposed rules. EPA is also withdrawing the various
proposed decisions to retain certain tolerances because the obligation
to make decisions on these tolerances has been removed.
FOR FURTHER INFORMATION CONTACT: By mail: Niloufar Nazmi-Glosson,
Special Review Branch, (7508W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460; telephone number: (703) 308-8028; e-
mail: nazmi-glosson.niloufar@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Statutory Background
The Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301 et
seq.) authorizes the establishment of maximum permissible levels of
pesticides in foods, which are referred to as ``tolerances'' (21 U.S.C.
346a). Without such a tolerance or an exemption from a tolerance, a
food containing a pesticide residue is ``adulterated'' under section
402 of the FFDCA and may not be legally moved in interstate commerce
(21 U.S.C. 342). Monitoring and enforcement of pesticide residues are
carried out by the U.S. Food and Drug Administration and the U.S.
Department of Agriculture.
The FFDCA's provisions governing pesticides were significantly
amended on August 3, 1996 by the enactment of the Food Quality
Protection Act of 1996 (FQPA) (Pub. L. 104-170). The FQPA amendments
were effective immediately.
Among other things, the FQPA amends the FFDCA to bring all EPA
pesticide tolerance-setting activities under a single section of the
statute -- section 408 -- and added a new safety standard and new
procedures in that section. Previously, regulatory authority over
pesticides in the FFDCA had been divided between sections 408 and 409.
The division of pesticides between sections 408 and 409 had been the
subject of some controversy because of the differing safety standards
in the two sections. Of particular significance was the inclusion in
section 409, but not section 408, of the Delaney anti-cancer clause.
The FQPA converted all existing section 409 tolerances for pesticide
residues in processed food into section 408 tolerances. 21 U.S.C.
346a(j).
The FQPA also amended the so-called ``flow-through'' provision in
section 402(a)(2) that governed whether tolerances for pesticide
residues in raw agricultural commodities apply to pesticide residues in
processed foods. Before being amended, the FFDCA had specified that a
pesticide residue in a processed food would not render that food
adulterated if, among other things, the level of the residue in the
processed food ``when ready to eat'' is below the tolerance level for
the pesticide in the precursor raw agricultural commodity. The FQPA
maintained this flow-through concept that raw agricultural commodity
tolerances would apply to pesticides in processed food but modified
existing law by dropping the requirement that the level of residue in
the processed food be evaluated at the ready-to-eat stage. 21 U.S.C.
346a(a)(2)(C).
II. Regulatory Background
In response to the decision in Les v. Reilly, 968 F.2d 985 (9th
Cir.), cert. denied, 113 S.Ct. 1361 (1993), in which the U.S. Court of
Appeals, Ninth Circuit held there was no de minimis exception to the
Delaney clause, EPA began to initiate revocation actions against those
existing section 409 tolerances which were inconsistent with the
Delaney clause. EPA also began identifying those section 408 tolerances
which would have to be revoked under EPA's coordination policy. Under
the coordination policy, EPA will not permit use of a pesticide on a
raw agricultural commodity if tolerances needed to prevent the
adulteration of processed food can not be approved. Application of this
policy was triggered by the revocation of various section 409
tolerances on Delaney clause grounds.
Further, on February 9, 1995, EPA entered into a court-approved
consent decree in which EPA agreed to a timetable for deciding whether
to revoke an extensive list of section 408 and 409 tolerances. Under
the consent decree, EPA has taken a number of proposed and final
revocation actions.
III. Today's Action
EPA is today withdrawing certain proposed revocations included in
two separate proposals:
1. September 21, 1995 Proposed Revocations (60 FR 49141)(FRL-4977-
3). Proposed revocation of 36 section 409 tolerances (feed additives)
for 16 pesticides (Appendix I, Group C). EPA is withdrawing the
proposed revocations of 11 of these tolerances. EPA is not withdrawing
the remaining 25 proposed revocations in the September 21, 1995 notice
and, in the future, EPA will complete action on these proposals.
EPA is withdrawing 2 of the 11 proposed revocations because they
were based on the Delaney clause in section 409. Under the modified
FFDCA, pesticide residues are no longer governed by section 409 or its
Delaney clause and all of the section 409 tolerances which were still
in effect on August 3, 1996 were converted to section 408 tolerances. A
section 408 processed food tolerance cannot be revoked on the basis of
the Delaney clause in section 409 and thus all pending revocations
premised solely on the Delaney clause are being withdrawn as lacking
any legal basis.
EPA is withdrawing 9 proposed revocations because they were based
on EPA's conclusion that the tolerances in question are set on not
ready-to-eat foods. EPA had reasoned that once the dilution associated
with final processing of ready-to-eat foods is taken into account the
ready-to-eat food is unlikely to contain residues above the tolerance
for the precursor raw commodity and hence no section 409 tolerance is
necessary to prevent the processed food from being deemed adulterated.
Because the FQPA removed the ready-to-eat factor from the flow-through
provision governing the applicability of raw agricultural commodity
tolerances to processed foods, revocations relying on the dilution
which occurs in processing to a ready-to-eat food have no basis in law
and are therefore being withdrawn.
In the future, EPA will complete action on the remaining 25
proposed revocations, which were based on determinations that the
pesticide does not concentrate in the processed feed or that the
processed feed is no longer a significant animal feed for which a
tolerance is necessary. These determinations are not affected by the
enactment of the FQPA.
2. March 1, 1996 Proposed Revocations (61 FR 8173)(FRL-5351-6).
Proposed revocation of 9 section 408 tolerances under the coordination
[[Page 50687]]
policy, and the proposed decision to retain 32 section 408 tolerances.
EPA proposed to revoke 9 section 408 tolerances on the ground that
the associated pesticide use needed a section 409 tolerance as well as
a section 408 tolerance to prevent the adulteration of processed food
and such section 409 tolerance is barred by the Delaney clause. Because
the FQPA has moved authority for regulation of all pesticide residues
into section 408, the Delaney clause in section 409 no longer bars the
establishment of needed processed food tolerances. Thus there is no
longer any basis for EPA to apply its coordination policy to this
situation and the proposed revocations are withdrawn.
In the same notice, EPA proposed to retain 32 section 408
tolerances. EPA had issued a proposal to retain these tolerances
because the consent decree mentioned in Unit II of this document
required EPA to announce its decision regarding such tolerances and EPA
believed revocation was not warranted. As provided by its own terms,
the consent decree has now been superseded by the FQPA and EPA and all
parties to the litigation have filed a joint motion seeking dismissal
of the case and termination of the consent decree. Accordingly, EPA is
withdrawing its proposed decisions to retain section 408 tolerances
because there is no obligation on the Agency to make a decision
regarding those specific tolerances.
In withdrawing these proposed revocations, EPA would like to make
clear two points. First, because these revocations concerned legal
requirements no longer applying to pesticides, EPA will not assert a
preclusive effect as to any factual findings regarding such
requirements. Second, today's action should not be interpreted to mean
that EPA has made a ``safety finding'' as to the pesticide tolerances
in question under the FFDCA, as amended by the FQPA. EPA will
systematically review the safety of all the tolerances within the next
ten years, as required under the FQPA.
IV. Specific Proposals Being Withdrawn
The specific actions EPA is withdrawing are presented in three
tables.
Table 1 lists section 409 tolerances for which a proposed
revocation was issued on Delaney grounds.
Table 1.--Proposed Revocations That Were Based on Delaney Grounds
------------------------------------------------------------------------
40 CFR
Pesticide Commodity citation
------------------------------------------------------------------------
Simazine........................... Sugarcane molasses 186.5350
Tetrachlorvinphos.................. Feed of beef, dairy 186.950
cattle, and horses
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Table 2 lists section 409 tolerances for which a proposed
revocation was issued on not ready- to-eat grounds.
Table 2.--Proposed Revocations That Were Based on Not Ready-To-Eat
Grounds
------------------------------------------------------------------------
40 CFR
Pesticide Commodity citation
------------------------------------------------------------------------
Acephate........................... Cottonseed hulls 186.100
Benomyl............................ Dried citrus pulp, 186.350
rice hulls
Diflubenzuron...................... Soybean hulls 186.2000
Imazalil........................... Dried citrus pulp 186.3650
Iprodione.......................... Rice bran, rice hulls 186.3750
Mancozeb........................... Milled wheat fractions 186.6300
Thiodicarb......................... Soybean hulls 186.5650
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Table 3 lists section 408 tolerances for which EPA made a proposed
determination to either retain or revoke based upon its coordination
policy.
Table 3.--Proposed Revocations and Decisions on Section 408 Tolerances
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Pesticide Commodity 40 CFR Citation Proposed Action
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Acephate............................... Cottonseed 180.108 Retain
Alachlor............................... Sunflower seed 180.249 Retain
Benomyl................................ Citrus 180.294 Retain
Rice 180.294 Retain
Captan................................. Grapes,Tomatoes 180.103 Retain
Carbaryl............................... Pineapples 180.169 Retain
Dicofol................................ Apples 180.163 Revoke
Grapes 180.163 Revoke
Plums 180.163 Revoke
Tomatoes 180.163 Retain
Diflubenzuron.......................... Soybeans 180.377 Retain
Dimethipin............................. Cottonseed 180.406 Retain
Ethylene Oxide......................... Whole spices (direct 180.151 Retain
treatment)
Iprodione.............................. Peanuts 180.399 Retain
Rice 180.399 Retain
Lindane................................ Tomatoes 180.133 Retain
Mancozeb............................... Barley 180.176 Retain
Grapes 180.176 Retain
Oats 180.176 Revoke
Rye 180.176 Retain
Wheat 180.176 Revoke
Maneb.................................. Grapes 180.110 Retain
Methomyl............................... Wheat 180.253 Retain
Norflurazon............................ Grapes 180.356 Retain
Oxyfluorfen............................ Cottonseed 180.381 Retain
Peppermint 180.381 Retain
Spearmint 180.381 Retain
Soybeans 180.381 Retain
PCNB................................... Tomatoes 180.319 Retain
[[Page 50688]]
Permethrin............................. Tomatoes 180.378 Retain
Propargite............................. Apples 180.259 Revoke
Figs 180.259 Revoke
Grapes 180.259 Retain
Plums 180.259 Retain
Simazine............................... Sugarcane 180.213 Revoke
Thiodicarb............................. Cottonseed 180.407 Retain
Soybeans 180.307 Retain
Triadimefon............................ Grapes 180.410 Retain
Wheat 180.410 Revoke
Pineapple 180.410 Retain
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List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, reporting and
recordkeeping requirements.
40 CFR Part 186
Environmental protection, Animal feeds, Pesticide and pests.
Accordingly, for the reasons set out in the preamble above, EPA is
withdrawing the following:
1. The proposed rule published at 61 FR 8174, March 1, 1996
proposing changes to part 180 is withdrawn.
2. The amendments proposing to remove Secs. 186.100, 186.350,
186.950, 186.2000, 186.3650, 186.3750 and 186.5350, 186.5650, and
186.6300, published at 60 FR 49141, September 21, 1995 are withdrawn.
Dated: September 19, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 96-24603 Filed 9-25-96; 8:45 am]
BILLING CODE 6560-50-F
