[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]


=======================================================================
-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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