[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Rules and Regulations]
[Pages 49793-49795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24004]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4186/R2174; FRL-4979-1]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes time-limited tolerances with an
expiration date of November 15, 1997, for residues of the pyrethroid
fenpropathrin in or on the raw agricultural commodities (RACs)
strawberries and tomatoes. Valent U.S.A. submitted petitions under the
Federal Food, Drug and Cosmetic Act (FFDCA) that requested a regulation
to establish these maximum permissible levels for residues of the
insecticide.
EFFECTIVE DATE: This regulation becomes effective September 27, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number [PP 3F4186/R2174], may be submitted to: Hearing
Clerk (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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
3F4186/R2174]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Second Floor, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
6100; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal
Register of October 21, 1993 (58 FR 54354), which announced that Valent
U.S.A. Corp., 1333 N. California Blvd., Suite 600, Walnut Creek, CA
94596, had submitted pesticide petition (PP) 3F4186 and food/feed
additive petition (FAP) 3H5661 to EPA requesting that the
Administrator, pursuant to sections 408(d) and 409(b) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348(b),
establish tolerances for residues of the insecticide fenpropathrin
(alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate) in or on the raw agricultural
commodities (RACs) strawberries at 2 parts per million (PPM); tomatoes
(fresh market, Florida only) at 0.5 ppm; and tomato cannery waste at 5
ppm. EPA issued a revised notice, published in the Federal Register of
November 2, 1994 (59 FR 54911), in which Valent U.S.A. proposed to
amend PP 3F4186 by increasing the tolerances for fenpropathrin in or on
the RAC tomatoes from 0.5 to 0.6 ppm and removing the fresh marketing
regional restrictions for tomatoes; establish tolerances for
fenpropathrin in or on strawberries (caps removed) at 2.0 ppm; meat and
meat byproducts of cattle, goats, hogs, horses, and sheep at 0.1 ppm;
fat of cattle, goats, hogs, horses, and sheep at 1.0 ppm; milk fat
(reflecting 0.11 ppm in whole milk) at 2.75 ppm; poultry meat, fat, and
meat byproducts and eggs at 0.02 ppm; and amending the FAP 3H5661 by
replacing the proposed tomato cannery waste tolerance with proposals
for tolerances in or on tomato pomaces (wet) at 6.00 ppm and tomato
pomaces (dry) at 3.00 ppm.
In a letter dated August 30, 1995, Valent U.S.A. requested
withdrawal of the feed additive petition (3H5661) in or on tomato
pomaces and deletion of the proposed tolerances in meat, milk, poultry,
and eggs. Valent U.S.A.'s withdrawal and deletion of certain tolerances
were submitted in response to EPA's latest revision (unpublished) to
Table II of the Pesticide Assessment Guidelines, Subdivision O (Residue
Chemistry) Raw Agricultural and Processed Commodities and Livestock
Feeds Derived from Field Crops. With respect to tomatoes, EPA concluded
that tomato pomaces (wet and dry) are no longer considered significant
animal feedstuffs. Although the latest revisions to the Livestock Feed
Table for Subdivision O of the Pesticide Assessment Guidelines have not
yet been published, pending petitions will continue to be processed
based upon previous regulations, except they will be given the benefit
of any appropriate revised or reduced residue data requirements if
needed.
No comments were received in response to the notices of filing.
The scientific data submitted in the petitions and other relevant
material have been evaluated. The toxicological and metabolism data and
analytical methods for enforcement purposes considered in support of
these tolerances are discussed in detail in related documents published
in the Federal Register of April 14, 1993 (58 FR 19357).
A dietary exposure/risk assessment was performed for fenpropathrin
using a Reference Dose (RfD) of 0.025 mg/kg/day. The RfD is based on a
no-observable- effect level (NOEL) of 2.5 mg/kg/body weight/day (100
ppm) and a uncertainty factor of 100 from a 1-year dog-feeding study
that demonstrated tremors in test animals at the lowest effect level.
The current estimated dietary exposure for the overall U.S. population
and nonnursing infants (less than 1 year old), the subgroup population
exposed to the highest risk, is 0.4% and 0.5% of the RfD, respectively.
The current action will increase exposure to 4.1% and 3%, respectively.
Generally speaking, the Agency has no cause for concern if total
residue contribution for published and proposed tolerances is less than
the RfD.
The metabolism of the chemical in plants and livestock is
adequately understood for this use. Any secondary residues occurring in
meat, fat, meat by products of cattle, goats, hogs, horses, poultry,
sheep and eggs will be covered by the existing tolerances. An adequate
[[Page 49794]]
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
published in the Pesticide Analytical Manual Vol. II (PAM II).
The Agency issued a conditional registration for fenpropathrin for
use on cotton with an expiration date of November 15, 1993 (see the
Federal Register of April 14, 1993 (58 FR 19357)). The conditional
registration was subsequently amended and extended to November 15, 1996
(see the Federal Register dated February 22, 1995 (60 FR 9783)). The
registrations were amended and extended to allow time for submission
and evaluation of additional environmental effects data. In order to
evaluate the effects of the pyrethroids on fish and aquatic organisms
and its fate in the environment, additional data were required to be
collected and submitted during the period of conditional registration.
Such requirements included a sediment bioavailability and toxicity
study and a small-plot runoff study that must be submitted to the
Agency by July 1, 1996. Due to the conditional status of the
registration, tolerances have been established for fenpropathrin on a
temporary basis, (until November 15, 1997) on cottonseed, meat, fat and
meat-byproducts of hogs, horses, cattle, goats, sheep, poultry, eggs,
and milk to cover residues expected to be present from use during the
period of conditional registration. To be consistent with the
conditional registration status of fenpropathrin on cotton the Agency
is establishing these tolerances with an expiration date of November
15, 1997.
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 provisions
of the conditional registration.
There are currently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purposes which it is sought and capable of achieving the intended
physical or technical effect. Based on the information and data
considered, the Agency has determined that the tolerances established
by amending 40 CFR part 180 will protect the public health. Therefore,
the tolerances are 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 docket
number [PP 3F4186/R2174] (including objections and hearing requests
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 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.
Written objections and hearing requests, identified by the document
control number [PP 3F4186/R2174], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-D[email protected]
A copy of electronic objections and hearing requests filed with the
Hearing Clerk must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption.
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 objections and hearing requests 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 objections and hearing requests 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. 96-354, 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).
List of Subjects in 40 CFR Part 180
Environmental Protection, Administrative practice and procedure,
Agricultural commodities, Pesticides
[[Page 49795]]
and pests, Reporting and recordkeeping requirements.
Dated: September 15, 1995.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
PART 180--[AMENDED]
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By amending Sec. 180.466 in the table therein by adding and
alphabetically inserting entries for the commodities tomatoes and
strawberries, to read as follows:
Sec. 180.466 Fenpropathrin; tolerances for residues.
* * * * *
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Parts per Expiration
Commodity million date
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* * * * *
Strawberries.................................. 2.0 Do.
Tomatoes...................................... 0.6 Do.
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[FR Doc. 95-24004 Filed 9-26-95; 8:45 am]
BILLING CODE 6560-50-F