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Tefluthrin; Renewal of Time-limited Tolerances
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 3, 1996 (Volume 61, Number 87)]
[Rules and Regulations]
[Page 19852-19854]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my96-23]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4406/R2222; FRL-5358-5]
RIN 2070-AB78
Tefluthrin; Renewal of Time-limited Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for the combined residues of
the pyrethroid tefluthrin and its metabolites in or on the raw
agricultural commodity (RAC) corn, fresh (including sweet K + CWHR) at
0.06 parts per million (ppm), and corn, forage and fodder, sweet at
0.06 ppm and renews time-limited tolerances for tefluthrin on the RAC's
corn, grain, field, and pop; corn forage and fodder, field and pop.
These regulations to establish maximum permissible levels for residues
of the chemical and renew tolerances were requested in a petition
submitted by Zeneca Ag Products.
EFFECTIVE DATE: This regulation becomes effective May 3, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4406/R2222], may be submitted to:
Hearing Clerk (A-1900), Environmental Protection Agency, Rm. M3708, 401
M St., SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted 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 copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submitted to OPP by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov.
Copies of electronic objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 5.1 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket number [PP 4F4406/R2222] . No
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic objections and hearing requests on this 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: By mail: George T. LaRocca, Product
Manager (PM) 13, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 200, CM#2, 1921
Jefferson Davis Highway, Arlington, VA 22202 (703) 305-6100; e-mail:
larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice published in the Federal
Register of February 8, 1995 (60 FR 7540)(FRL-4926-4), which announced
that Zeneca Ag Products had submitted pesticide petition (PP) 4F4406 to
EPA requesting that the Administrator, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d ),
establish a tolerance for the combined residues of the insecticide
tefluthrin (2,3,5,6-tetrafluro-4-methylphenyl)methyl-(1 alpha, 3
alpha)-(Z)-( ±)-3(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate) and its metabolite (Z)-3-(2-chloro-
3,3,3-trifluroro-1-propenyl)-2,2-dimethylcyclopropanecarboxylic acid,
in or on the raw agricultural commodity corn, fresh (including sweet K
+ CWHR) at 0.06 ppm, and corn, forage and fodder, sweet at 0.06 parts
per million (ppm).
No comments were received in response to the notice of filing.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological and metabolism data
considered in support of the tolerance are discussed in detail in
related documents published in the Federal Register of February 1, 1989
(54 FR 5080).
A dietary exposure/risk assessment was performed for teflutrhin on
sweet corn using a Reference Dose (RfD) of 0.005 mg/kg/day, based on a
no-observed-effect-level (NOEL) of 0.5 mg/kg bwt/day from a 1- year dog
feeding study with an uncertainty factor of 100. The endpoint of
concern was increased incidence of ataxia. The Theoretical Maximum
Residue Contribution (TMRC) from established tolerances utilizes 0.41%
of the RfD for the U. S. population or 0.69% of the RfD if the new
tolerance is granted. Established tolerances utilize 1.06% of the RfD
for nonnursing infants less than 1 year old, the subgroup with the
highest estimated exposure to tefluthrin residues or 1.71% of the RfD
if the new tolerance is granted.
Generally speaking, EPA has no cause for concern if total residue
contribution for published and final tolerances is less than the RfD.
The nature of tefluthrin residue in plants and animals for this
corn use is adequately understood. The residues of concern is
tefluthrin and its metabolite. There is no reasonable expectation of
secondary residues in animal tissues and milk from the use as
delineated in 40 CFR 180.6(a)(3). An adequate analytical method, gas
liquid chromatography with an electron capture detector, is available
for enforcement purposes. The enforcement methodology has been
submitted to the Food and Drug Administration, and is published in the
Pesticide Analytical Manual Vol. II (PAM II).
In the Federal Register of September 30, 1994 (59 FR 49824) EPA
amended 40 CFR 180.440 by extending to November 15, 1995 tolerances of
0.06 ppm for residues of tefluthrin in or on field and pop, corn grain
including, forage and fodder. The tolerances were extedned to coincide
with the extension of the conditional registration of this pesticide to
allow time for EPA to review data and complete an aquatic risk
assessment for use on field and pop corn. The basis for the extension
is discussed in detail in the above Federal Register notice. On
November 14, 1995 EPA again amended the conditional
[[Page 19853]]
registration of this pesticide on field and pop corn by extending the
expiration date to November 15, 1996. The registration was amended and
extended for an additional year to allow time for submission and
evaluation of additional data/information on aquatic risk mitigation,
specifically, surface-water runoff data. Zeneca Ag Products submitted
this information on December 1, 1995.
To be consistent with the extension issued for the conditional
registration the Agency is renewing the tolerances on field and pop
corn grains, including their forage and fodder, with an expiration date
of November 15, 1997 to cover residues expected to result from use
during the period of conditional registration.
With respect to the additional use of tefluthrin on sweet corn, the
Agency concluded that this additional use would not cause a significant
increase in the risk of adverse effects to the environment. This
conclusion was premised mainly on the following:
1. The directions for use and precautions for use of tefluthrin on
sweet corn are identical to the current directions for use for
tefluthrin on field and pop corn.
2. Current, interim aquatic risk mitigation measures approved for
use on field and pop corn will also be used for application on sweet corn.
To be consistent with the conditional registration and renewal on
field and pop corn the Agency is issuing a conditional registration
with an expiration date of November 15, 1996 and establishing a time-
limited tolerance on sweet corn and its forage and fodder with an
expiration date of November 15, 1997 to cover residues expected to
result from use during the period of conditioanl registration.
Upon evaluation of the additional data/information required as a
condition of the registration for this insecticide on corn the Agency
will reassess the tolerances and the registration, and if appropriate,
will issue permanent tolerances and an unconditional registration for
the insecticide on corn.
Residues remaining in or on the above commodities after expiration
of these tolerances will not be considered actionable if the pesticide
is legally applied during the term of and in accordance with the
provisions of the conditional registration.
There are presently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
will protect the public health. Therefore, the tolerance is established
as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the regulation and may also request a hearing on
those objections. Objections and hearing requests must be filed with
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy
of the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
A record has been established for this rulemaking under the docket
number [PP 4F4406/R2222] (including any comments and data submitted
electronically). 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 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.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rule-making 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.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to 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 governments or communities (also known 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 entitlement,
grants, user fees, or loan programs; 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 ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 9-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has
determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
In addition, this action does not impose any enforceable duty, or
contain any ``unfunded mandates'' as described in Title II of the
Unfunded Mandates Reform Act of 1995 (P.L. 104-4), or require prior
consultation as specified by Executive Order 12875 (58 FR 58093,
October 28, 1993), entitled Enhancing the Intergovenmental Partnership,
or special considerations as required by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
[[Page 19854]]
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 4, 1996.
Susan Lewis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. By revising 180.440, and the table therein to read as follows:
Sec. 180.440 Tefluthrin; tolerances for residues.
Tolerances, to expire on November 15, 1997, are established for the
combined residues of the insecticide tefluthrin (2,3,5,6-tetrafluro-4-
methylphenyl)methyl-(1-alpha, 3-alpha)-(Z)-()-3(2-chloro-
3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate) and
its metabolite (Z)3-3-(2-chloro-3,3,3-trifluro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylic acid raw agricultural commodities:
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Parts per
Commodity million
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Corn, grain, field and pop................................. 0.06
Corn, forage and fodder, field, pop and sweet.............. 0.06
Corn, fresh (including sweet K and CWHR)................... 0.06
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[FR Doc. 96-10917 Filed 5-2-96; 8:45 am]
BILLING CODE 6560-50-F