Mevinphos - Proposed Amendment and Revocation of Tolerances 8/95
[Federal Register: August 2, 1995 (Volume 60, Number 148)] [Proposed Rules]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
Mevinphos; Proposed Amendment and Revocation of Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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,
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@example.com. 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,
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
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
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:
Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of
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,
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.
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:
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