[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Proposed Rules]
[Pages 8901-8903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5242]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300414; FRL-5347-7]
RIN 2070-AB18
Triphenyltin Hydroxide; Proposed Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This notice proposes to revoke tolerances for residues of
Triphenyltin Hydroxide in or on carrots, peanuts and peanut hulls. All
domestic registrations for use on these crops have been cancelled,
therefore there is no longer a need to maintain these tolerances.
DATES: Written comments should be submitted to EPA by May 6, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental
[[Page 8902]]
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring comments to: Rm. 1132, CM #2, 1921 Jefferson Davis Highway,
Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information.'' CBI should not be submitted
through e-mail. Information marked as CBI 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 address given above,
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
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 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [OPP-300414]. Electronic comments on this proposed rule
may be filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found below in this
document.
FOR FURTHER INFORMATION CONTACT: Jude Andreasen, Special Review and
Reregistration Division (7508W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Telephone: (703) 308-8016; e-
mail:andreasen.jude-epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et
seq.) authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered
``adulterated'' under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would ``protect the public
health'' [21 U.S.C. 346a(b)]. For a pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.).
In 1988, Congress amended the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and required EPA to
review and reassess the potential hazards arising from currently
registered uses of pesticides registered prior to November 1, 1984. As
part of this process, the Agency must determine whether a pesticide is
eligible for reregistration or whether any subsequent actions are
required to fully attain reregistration status. EPA has chosen to
include in the reregistration process a reassessment of existing
tolerances or exemptions from the need for a tolerance. Through this
reassessment process, based on more recent data, EPA can determine
whether a tolerance must be amended, revoked, or established, or
whether an exemption from the requirement of one or more tolerances
must be amended or is necessary.The procedure for establishing,
amending, or revoking tolerances or exemptions from the requirement of
tolerances is set forth in 40 CFR parts 177 through 180. The
Administrator or EPA, or any person by petition, may initiate an action
proposing to establish, amend, revoke, or exempt a tolerance for a
pesticide registered for food uses. Each petition or request for a new
tolerance, an amendment to an existing tolerance, or a new exemption
from the requirement of a tolerance must be accompanied by a fee.
Current Agency policy on tolerance actions identified during the
reregistration process is to waive the payment of fees if the tolerance
action concerns revision or revocation of an established tolerance, or
if the proposed exemption from the requirement of a tolerance requires
the concurrent revocation of an approved tolerance. Comments submitted
in response to the Agency's published proposals are reviewed; the
Agency then publishes its final determination regarding the specific
tolerance actions.
II. Chemical--Specific Information and Proposed Actions On
Triphenyltin hydroxide: Revocation of Tolerances
1. Regulatory background. Triphenyltin hydroxide (TPTH) was first
registered under FIFRA in 1971; a Registration Standard was issued in
September, 1984. The Standard established the restricted use
classification, announced EPA's intent to initiate a Special Review
based on developmental toxicity, imposed label warnings, established a
24-hour reentry period, and required data to fill gaps in product
chemistry, residue chemistry, environmental fate, ecological effects
and toxicology.
Data Call-In Notices were issued in 1986, 1988, 1990 and 1993.
Worker exposure studies and reentry studies for pecan harvesters were
submitted in early 1995 and are under review. The registrants (Griffin
Corporation, Elf Atochem and Hoechst, now Agrevo) formed a Task Force
and agreed that carrots and peanuts would not be supported uses, but
that data for use on sugar beets, potatoes and pecans would be
generated jointly by the Task Force.
A notice announcing receipt of a request for a voluntary
cancellation of the use of TPTH on carrots was published in the Federal
Register on March 6, 1991 (56 FR 9358). No comments were received in
connection with this notice and the registration was subsequently
canceled 60 days later. Earlier, the technical registrant, Griffin
Corporation, submitted an application and proposed label amendments
which deleted the use of TPTH on peanuts. The Agency approved this
action on June 13, 1988.
2. Current proposal. Revocation of tolerances under 40 CFR 180.236
are proposed. Registrants are not supporting the use of TPTH on peanuts
or carrots. Therefore, the Agency is proposing to revoke the tolerances
for peanuts, peanut hulls and carrots.
III. Public Comment Procedures
EPA invites interested parties to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by May 6, 1996. Comments must bear a notation indicating
the docket number. Three copies of the comments should be submitted to
either location listed under the ``ADDRESSES'' section above.
Information submitted as a comment concerning this document may be
claimed confidential by marking any or all of that information as
``Confidential Business Information'' (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
must also be submitted for inclusion in the public record. EPA may
publicly disclose without prior notice information not marked
confidential.
Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA, as
[[Page 8903]]
amended, that contains any of the ingredients listed herein, may
request within 30 days after publication of this notice in the Federal
Register that this rulemaking proposal be referred to an Advisory
Committee in accordance with section 408(e) of the FFDCA.
EPA has established a record for this proposed rule under docket
number [OPP-300414] (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 4:00 p.m., Monday through Friday, except legal holidays.
The public record is located in Room 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
The official record for this proposed rule, 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 proposed rule record which will also include all comments
submitted directly in writing. The official proposed rule record is the
paper record maintained at the ``ADDRESSES'' listed at the beginning of
this document.
IV. References
1. U.S. Environmental Protection Agency. 56 FR 9358, TPTH: Deletion
of Uses and Directions for Use on Carrots, March 6, 1991.
2. Application and revised label from Griffin Corporation to EPA,
October 16, 1987, deleting the use on peanuts for EPA registration
number 1812-244. Accepted application, June 13, 1988.
V. Regulatory Assessment Requirements
To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and
the Unfunded Mandates Reform Act, EPA has considered the impacts of
this proposal.
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 tribal
governments or communities (also referred to 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 entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not a ``significant regulatory action,'' because it
does not meet any of the regulatory-significance criteria listed above.
The use sites for which tolerance revocation is proposed have been
cancelled for some time. Revoking the tolerances is not expected to
have any significant impact.
B. Regulatory Flexibility Act
EPA has reviewed this proposed rule under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601et
seq.], and has determined that it will not have a significant economic
impact on any small businesses, governments, or organizations. The
proposed rule is not expected to have any significant impact on
entities of any size. Accordingly, I certify that this proposed rule
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 OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
D. Unfunded Mandates
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector, because it would
not impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 22, 1996.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 would continue to read as
follows:
Authority: 15 U.S.C. 346a and 371.
2. Section 180.236 is revised to read as follows:
Sec. 180.236 Triphenyltin hydroxide; tolerances for residues.
Tolerances are established for residues of the fungicide
triphenyltin hydroxide in or on raw agricultural commodities as
follows:
0.1 part per million in or on sugar beet roots.
0.05 part per million in or on pecans and potatoes.
0.05 part per million in the kidney and liver of cattle, goats,
hogs, horses and sheep.
[FR Doc. 96-5242 Filed 3-5-96; 8:45 am]
BILLING CODE 6560-50-F
