[Federal Register Volume 59, Number 104 (Wednesday, June 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13192]
[[Page Unknown]]
[Federal Register: June 1, 1994]
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DEPARTMENT OF TRANSPORTATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300341; FRL-4864-1]
RIN No. 2070-AC18
1,1-Dichloro-2,2-Bis(p-Ethylphenyl) Ethane; Proposed Revocation of
Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke the tolerances listed at 40 CFR
180.139 for residues of the pesticide 1,1-Dichloro-2,2-bis(p-
ethylphenyl) ethane (also known as Perthane, Ethylan, or diethyl
diphenyl dichloroethane, and hereafter referred to as Perthane) in or
on raw agricultural commodities. This revocation is proposed because
all registrations of Perthane have been canceled. The revocation would
take effect 30 days after the date of publication of the final rule in
the Federal Register.
DATES: Written comments, identified by the OPP document control number
[OPP-300341], must be received on or before July 1, 1994.
ADDRESSES: By mail, submit comments to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., Washington, DC 20460. In person, deliver
comments to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed as confidential by marking any or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the Virginia address given above, from 8 a.m. until 4:30 p.m., Monday
through Friday, except legal holidays.
FOR FURTHER INFORMATION CONTACT: Ann Sibold, Special Review and
Reregistration Division (7508W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Special Review Branch, Crystal
Station #1, 3rd Floor, 2800 Crystal Drive, Arlington, VA 22202,
Telephone: (703)-308-8033.
SUPPLEMENTARY INFORMATION:
I. Introduction
Currently, a tolerance of 15 ppm exists at 40 CFR 180.139 for
residues of Perthane in or on the raw agricultural commodities apples,
broccoli, brussels sprouts, cabbage, cauliflower, cherries, kohlrabi,
lettuce, pears, and spinach; and a tolerance of 0 ppm for residues in
milk and meat.
II. Background
Perthane is a chlorinated hydrocarbon insecticide chemically
related to DDT. It was used for insect control on agricultural crops,
on agricultural premises such as barns and corrals, in pet areas for
tick control, in homes for mosquito and fly control, and in fabric for
moth control. Rohm and Haas was the sole producer of technical
Perthane, although many companies formulated end-use products.
On May 11, 1978, Rohm and Haas informed EPA that it was
discontinuing production and sale of their Perthane insecticide because
of its inability to produce the product at a reasonable cost and its
loss of market share. Rohm and Haas also stated that it had already
discontinued production of its last remaining Perthane product, which
was technical Perthane. Rohm and Haas further stated that the expected
sale of the remaining inventory was to be completed in the fourth
quarter of 1978. The company also submitted a copy of a letter it was
sending to its Perthane customers telling them of its business decision
to stop producing this product and further stating that it would
allocate existing stocks against open orders received by May 31, 1978.
On March 28, 1980, EPA issued a Data Call-In (DCI) for toxicology
data to all technical and end-use registrants of Perthane. EPA had
determined that it lacked adequate data to determine whether pesticide
products containing Perthane cause unreasonable adverse effects on
humans and the environment. Further, after reviewing all of the
available acute, subchronic, and chronic toxicity studies supporting
the registration of Perthane, the Agency determined that the available
data were not sufficient to support the continued registration of these
products.
On May 14, 1980, Rohm and Haas notified EPA by letter that it was
choosing to voluntarily withdraw all the registrations it held for
Perthane (Perthane 75% Solution -- Registration 707-60, Perthane EC --
Registration 707-65, and Perthane Technical -Registration 707-96).
Subsequently, on June 20, 1980 (45 FR 41694), EPA announced that Rohm
and Haas Co. had requested voluntary cancellation of the registrations
of its three Perthane products. The effective date of the cancellation
was July 21, 1980. Rohm and Haas was permitted to sell existing stocks
of Perthane for 1 year.
On December 31, 1984, EPA issued a Data Call-In to the remaining
registrants of Perthane to give them the opportunity to generate
chronic toxicology data to support registrations of Perthane for food
and certain non-food uses. In the ensuing years, registrations of end-
use products of Perthane were canceled as a result of regulatory action
and follow-up to the 1980 and 1984 DCIs. In 1990, the last Perthane
registration, for a non-food use, was found to be unsupported for Phase
II of reregistration and was subsequently canceled by Agency action (55
FR 31164).
III. Current Proposal
EPA is proposing to revoke all tolerances for Perthane under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 et seq. The Agency is taking this action because all
registrations for uses of Perthane have been canceled.
Once the tolerances for Perthane on these raw agricultural
commodities are revoked, it will be unlawful to import into the United
States any commodities or products containing any Perthane. EPA has no
evidence of recent foreign usage of Perthane on commodities which may
be imported into the United States.
EPA believes for the following reasons that it is unlikely that
residues of perthane will be found in food commodities for which
tolerances have been established. EPA has no evidence of domestic
distribution of Perthane since at least 1985. In addition, the
persistence of Perthane in crops (the half life) is about 30 to 40
days. Perthane may be moderately persistent in the environment.
However, EPA believes that since so much time has lapsed since Perthane
was produced and distributed for use, it is unlikely that Perthane will
be found in either the commodities for which there are tolerances or in
commodities for which there are not tolerances. For these reasons, EPA
does not recommend an action level.
IV. Public Comment Procedures
Any person who has registered or submitted an application for the
registration of a pesticide under FIFRA, as amended, which contains
Perthane, may request within 30 days after publication in the Federal
Register that this proposal to revoke the Perthane tolerance listed in
40 CFR 180.139 be referred to an advisory committee in accordance with
section 408(e) of FFDCA. Such requests should be addressed to the
contact person listed at the beginning of this proposal.
Interested persons are invited to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by July 1, 1994. Comments must bear a notation indicating
the document control number [OPP-300341]. Three copies of the comments
should be submitted to either location listed under ``ADDRESSES'' above
in this document. Documents considered and relied upon by EPA in
reaching its decision and all written comments filed pursuant to this
document will be available for public inspection at the Virginia
address listed at the beginning of this document.
V. Other Regulatory Requirements
To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, and the Paperwork Reduction Act,
EPA has analyzed the impacts of this proposal. The complete analysis,
summarized below, is available for public inspection at the address
listed at the beginning of this proposal.
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3 (f), the order defines ``significant''
as those actions likely to lead to a rule (1) having an annual effect
on the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities ( also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another Agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in the Executive Order.
The last registration of Perthane was canceled voluntarily in 1990
as part of reregistration. However, the registrant requested
cancellation of Perthane technical in 1980, and EPA understands that
production of technical Perthane ceased in 1978. EPA has no evidence of
recent domestic or foreign usage of Perthane. There has been no
domestic distribution of Perthane since at least 1985. For these
reasons, EPA believes that existing stocks of those products should
have been depleted and that sufficient time has elapsed for residues to
dissipate and for legally treated commodities to have gone through
channels of trade. Thus, revocation of Perthane tolerances is expected
to have no impact which meets the conditions set forth in E.O. 12866.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
B. Regulatory Flexibility Act
The proposed tolerance revocation has been reviewed under the
provisions of the Regulatory Flexibility Act and the Agency has
determined that it will have no economic impact on small businesses,
small governments, or small organizations. As indicated in Unit V.A.
above, the revocation of the tolerance for perthane is expected to have
no impact on any entity of any size, since there appears to have been
no distribution of the pesticide for several years. The proposed
regulatory action is intended to prevent the sale of food commodities
containing pesticide residues where the subject pesticide might be used
in an unregistered or illegal manner.
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the Administrator certifies that this rule will not have
a significant economic impact on a substantial number of small
entities.
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by the Office of Management
and Budget under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et
seq.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recorkeeping requirements.
Dated: May 17, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 180.139 [Removed]
2. By removing Sec. 180.139 1,1-Dichloro-2,2-bis(p-ethylphenyl)
ethane; tolerances for residues.
[FR Doc. 94-13192 Filed 5-31-94; 8:45 am]
BILLING CODE 6560-50-F
