[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: [email protected]. 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: [email protected].

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-D[email protected]

    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]
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