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triphenyltin hydroxide (TPTH) Proposed Tolerance Revocation 2/96

[Federal Register: March 6, 1996 (Volume 61, Number 45)]
40 CFR Part 180
[OPP-300414; FRL-5347-7]
RIN 2070-AB18
Triphenyltin Hydroxide; Proposed Tolerance
AGENCY:  Environmental Protection Agency (EPA).
ACTION:  Proposed rule.

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 
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 
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: 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 

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:


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 
    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 
    Any person who has registered or submitted an application for 
registration of a pesticide, under FIFRA, as 
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:

    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:


    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 

    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.