[Federal Register Volume 60, Number 148 (Wednesday, August 2, 1995)]
[Proposed Rules]
[Pages 39302-39304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18874]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300393; FRL-4967-1]
RIN 2070-AC18
Mevinphos; Proposed Amendment and Revocation of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes the revocation of all tolerances listed
at 40 CFR 180.157 and 185.4200 for residues of the insecticide
mevinphos (Phosdrin) in or on all raw agricultural
commodities and processed foods. EPA is initiating this action because
all U.S. mevinphos registrations were canceled on July 1, 1994. Because
existing stocks of mevinphos may be used through November 30, 1995, the
proposed revocations will become effective May 31, 1996, in order to
ensure that no mevinphos residue will occur on legally treated crops,
whether they are raw agricultural commodities or processed foods.
DATES: Written comments, identified by the docket control number OPP-
300393, must be received on or before October 2, 1995.
ADDRESSES: By mail, submit comments to: Public Response Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St. SW.,
Washington, DC 20460. In person, deliver comments to: Rm. 1132, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number ``OPP-300393.'' No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
document may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found in Unit
V. of this preamble.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
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. to 4:30 p.m., Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Richard Dumas, Special Review
and Reregistration Division (7508W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460.
In person: Special Review Branch, Third floor, Crystal Station 1, 2800
Crystal Drive, Arlington, VA 22202, Telephone number: (703) 308-8015,
e-mail: dumas.richard@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Introduction
Mevinphos (Phosdrin) is a broad-spectrum organophosphate
insecticide primarily used on specialty/minor use crops. It is used
chiefly as an acaricide and was registered for use on 25 crops
(principally leafy greens and cole crops) before cancellation. It has
been produced in the U.S. by the sole technical registrant, Amvac
Corporation of Los Angeles, California. Prior to its cancellation,
approximately 200,000 to 500,000 pounds of active ingredient were used
annually in the U.S.
II. Legal Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the
establishment by regulation of maximum permissible levels of pesticides
in or on foods. Such regulations are commonly referred to as
``tolerances.'' Without such tolerances or exemptions from tolerances,
a food containing pesticide residues is considered to be
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce (21 U.S.C. 342). Commodities
subject to this proposal must no longer contain mevinphos residues
following the revocation of the tolerances. To establish a tolerance
for pesticide residues in or on raw agricultural commodities under
section 408 of FFDCA, EPA must find that the promulgation of the rule
would ``protect the public health'' (21 U.S.C. 346a(b)). To establish
food additive regulations (FARs) to cover pesticide residues in
processed foods under section 409 of FFDCA, EPA must determine that the
proposed use of the food additive will be safe (21 U.S.C. 348). For a
pesticide to be sold and used in the production of a food crop or food
animal, the pesticide must not only have appropriate tolerances or FARs
under FFDCA, but must be registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.). FIFRA
requires the registration of pesticides that are sold and distributed
in the U.S.
This document proposes the revocation of all tolerances and FARs
(hereafter tolerances will refer to both tolerances and FARs)
established under sections 408 and 409 of the FFDCA, 21 U.S.C. 301 et
seq., for residues of the pesticide mevinphos in or on all previously
registered crops, as listed in 40 CFR 180.157 and 185.4200. In the
absence of the appropriate clearances under FFDCA for residues of a
pesticide on food or feed, any agricultural commodity or processed food
domestically produced and/or imported into the United States found to
contain mevinphos residues is adulterated under section 402 of FFDCA.
III. Regulatory Background
On June 30, 1994, when EPA was prepared to issue a Notice of Intent
to Suspend all mevinphos registrations because of acute poisoning
incidents involving agricultural workers, Amvac submitted a request for
voluntary cancellation. EPA accepted this request and on July 1, 1994,
issued a
[[Page 39303]]
Cancellation Order for all mevinphos registrations, effective
immediately. The Agency subsequently published a Notice of Receipt of
Request for Cancellation, Announcement of Cancellation Order, and FIFRA
section 6(g) Notification for Mevinphos in the Federal Register of
August 1, 1994 (59 FR 38973). The Cancellation Order was subsequently
modified on January 13, 1995, to extend the distribution, sale, and use
to November 30, 1995, from December 30, 1994, for sale and distribution
and February 28, 1995, for use. Notice of this amendment was published
on April 5, 1995 (60 FR 17357).
IV. Current Proposal
EPA is proposing to revoke all mevinphos tolerances. The proposed
date of revocation is May 31, 1996. EPA believes that there is little
likelihood, if any, that residues of mevinphos would be observed in
legally treated commodities after May 31, 1996. Also, mevinphos is not
persistent and the Agency does not believe that mevinphos residues will
be found in processed foods. Therefore, setting action levels is not
necessary.
The Agency believes that it is appropriate to initiate revocation
of tolerances at this time because mevinphos is no longer registered in
the U.S. In accordance with the voluntary cancellation requested by
Amvac, the sole technical registrant for mevinphos, all use of
mevinphos is scheduled to cease after November 30, 1995. EPA believes
that it is appropriate to revoke tolerances covering residues of a
pesticide for which there is no legal domestic use unless it can be
shown by interested parties that there is a need for the tolerances,
and that the tolerances are protective of the public health. Such
tolerances may be needed, for example, if interested parties can show
that the pesticide is used in foreign countries on crops that may be
destined for the U.S.
It should be noted that in order for any tolerances to be retained,
EPA must determine, under sections 408 and 409 of FFDCA, that the
particular tolerance is protective of public health. For EPA to make
this public safety finding, it must have adequate data to assess the
risks that may result from exposure to mevinphos residues in or on
food. EPA generally requires submission of such information (such as
residue data) to support pesticide registrations under FIFRA and to
maintain tolerances under FFDCA. With all domestic use of mevinphos
ending November 30, 1995, EPA must have adequate data to demonstrate
that imported foods treated with mevinphos are safe. Such data are not
available at this time and EPA does not anticipate the receipt of such
data because the sole technical registrant for mevinphos has
voluntarily canceled all of its U.S. mevinphos registrations.
Based upon available data, the Agency has completed a preliminary
acute dietary risk assessment from exposure to mevinphos. The
assessment indicates a concern, particularly for infants and children.
EPA recognizes that the dietary risk concern may be diminished if
interested parties submit adequate exposure and/or toxicity data that
show that the preliminary assessment is not accurate. However, the data
base currently available to EPA is inadequate and does not appear to
provide a basis to conclude that the preliminary assessment is
inaccurate.
This proposal serves as a notice to all parties interested in the
disposition of mevinphos tolerances. If EPA does not receive comment by
October 2, 1995, EPA will issue a final order revoking all mevinphos
tolerances. Because EPA believes it is appropriate to preclude review
of objections raising issues not provided in comments submitted in
response to the proposal, EPA encourages all parties interested in the
status of mevinphos tolerances to submit comments.
V. Public Docket
A record has been established for this rulemaking under docket
number ``OPP-300393'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Rm. 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for the rulemaking as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ADDRESSES at the beginning of
this document.
VI. Other Regulatory Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1994), the
Agency must determine whether the regulatory action is ``significant,''
and therefore, subject to all the requirements of the Order, such as
Regulatory Impact Assessments and review by the Office of Management
and Budget (OMB). In section 3(f), the Order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the national economy of $100 million or more, or adversely and
materially affecting a sector of the national economy, such as
productivity, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) creating serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlements, grants, user fees, or loan programs; or (4) raising novel
legal or policy issues out of legal mandates, the President's
priorities, or the principles set forth in the Order.
Pursuant to the terms of this Order, EPA has determined that this
proposed rule is not ``significant'' and, therefore, is not subject to
the requirements of the Order, such as OMB review or other actions. EPA
does not expect any significant economic impacts to result from the
revocation of mevinphos tolerances, because all U.S. mevinphos
registrations have been canceled and no further use of mevinphos will
be permitted after November 30, 1995.
B. Regulatory Flexibility Act
This proposed rule has been reviewed under the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.), and it has been determined that it will not have any impact on
small businesses, small governments, or small organizations.
This proposed rule is intended to prevent the sale of food
commodities containing pesticide residues where the subject pesticide
has been used in an unregistered or illegal manner, as well as to
prevent food commodities containing any mevinphos residues from
entering the U.S.
As stated above, because mevinphos is not registered in the U.S.
and will not be used in the U.S. after November 30,
[[Page 39304]]
1995, EPA does not expect significant any economic impact at any level
of business enterprise if mevinphos tolerances are revoked on May 31,
1996; especially since all use of mevinphos will have ended 6 months
before this date. Accordingly, I certify that this regulatory action
does not require a separate regulatory flexibility analysis under the
Regulatory Flexibility Act.
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. (Sec. 408(m) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 346 a(m))).
List of Subjects in Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: July 25, 1995.
Losi Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR parts 180 and 185 be amended
to read as follows:
1. In Part 180:
PART 180--AMENDED
a. The authority citation for part 180 would continue to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 180.157 [Removed]
b. Section 180.157 is removed.
2. In Part 185:
a. The authority citation for part 185 would continue to read as
follows:
Authority: 21 U.S.C. 346a and 348.
Sec. 185.4200 [Removed]
b. Section 185.4200 is removed.
[FR Doc. 95-18874 Filed 8-1-95; 8:45 am]
BILLING CODE 6560-50-F
