FLUORIDE ACTION NETWORK PESTICIDE PROJECT
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Norflurazon. September 26, 1996. Withdrawal of Proposed Revocations of Pesticide Tolerances. Federal Register.
Note from FAN:
Three fluorinated pesticides are included in this Notice:
Diflubenzuron, Norflurazon, Oxyfluorfen
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/September/Day-26/pr-873DIR/pr-873.txt.htm
[Federal Register: September 26, 1996 (Volume 61, Number 188)] [Proposed Rules]
[Page 50686-50688]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[[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.
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; email: 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:
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
cattle, and horses
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
rice hullsDiflubenzuron...................... Soybean hulls 186.2000 Imazalil........................... Dried citrus pulp 186.3650 Iprodione.......................... Rice bran, rice hulls 186.3750 Mancozeb........................... Milled wheat fractions 186.6300
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
Pesticide Commodity 40 CFR Citation Proposed Action
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
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:
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