fenpropathrin (Danitol) Pesticide Tolerance 7/96
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180
[PP 4F4327/R2253; FRL-5385-1]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This rule establishes tolerances for residues of the
insecticide/miticide fenpropathrin, a synthetic pyrethroid, in or on
the raw agricultural commodities (RACs) peanuts and peanut hay, and
increases tolerances in meat, meat byproduct and fat of cattle, goats,
hogs, horses and sheep and poultry; eggs; and milkfat. 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 July 31, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number [PP 4F4327/R2253], 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 docket 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. Comments and
data may also be submitted to OPP 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 [PP 4F4327/R2253]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in the ``SUPPLEMENTARY INFORMATION'' section of this document.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (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 address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
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: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal
Register of July 13, 1994 (59 FR 35719), which announced that Valent
U.S.A. Corporation, 1333 N. California Blvd., Suite 600, Walnut Creek,
CA 94596 had submitted pesticide petition (PP) 4F4327 and food/feed
additive petition (FAP) 4H5690 to EPA. Pesticide petition 4F4327
requested that the Administrator, pursuant to section 408(d)of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend
40 CFR 180.466 by establishing tolerances for residues of the
insecticide fenpropathrin (alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate) in or on the raw agricultural
commodities (RACs) peanuts, vines and peanuts, hay (dried) at 20 parts
per million (ppm); milkfat at 2.0 ppm (reflecting 0.08 ppm in whole
milk); fat (cattle, goats, hogs, horses, and sheep) at 1.0 ppm; peanut
hulls at 0.3 ppm; meat and meat byproducts (cattle, goats, horses, and
sheep) at 0.1 ppm; poultry meat, fat, meat byproducts and eggs at 0.05
ppm; and peanut nut meat at 0.01 ppm. Food/feed additive petition (FAP)
4H5690 requested that the Administrator pursuant to section 409(b) of
the FFDCA (21 U.S.C. 348(b)) amend 40 CFR 185.3325 and 186.3225 by
establishing a food/feed additive regulation for fenpropathrin in and
on peanut oil at 0.05 ppm and peanut soapstock at 0.02 ppm.
In a letter dated January 5, 1996, Valent U.S.A. requested
withdrawal of the food/feed additive petition (FAP 4H5690) in or on
peanut oil and peanut soapstock and amended PP 4F4327 by deletion of
the proposed tolerances in/on peanut hulls and peanut vines. The notice
withdrawing FAP 4H5690 was published in the Federal Register July 24,
1996 (61 FR 38447). Valent U.S.A.'s withdrawal of the food/feed
additive petition was in response to EPA's determination that residues
of fenpropathrin in processed commodities will not exceed the
tolerances in the RAC. Although a processing study showed some
concentration in peanut meal and refined oil, EPA has determined that a
section 409 tolerance is unnecessary because it is unlikely
that the fenpropathrin residues in peanut meal and refined oil will
exceed the limit of quantification (LOQ) tolerance that is being
established on peanut nut meat. Valent's deletions of the proposed
tolerances in/on peanut hulls and peanut vines were submitted in
response to EPA's September 1995 revision to Table II of the Pesticide
Assessment Guidelines, Subdivision O (Residue Chemistry) Raw
Agricultural and Processed Commodities and Livestock Feeds Derived from
Field Crops. This document states that peanut soapstock and peanut
hulls are no longer considered significant livestock feed items, thus
tolerances are not required. This amendment also addressed EPA's
preference for peanut, dried hay to be expressed in term of peanuts,
hay.
The scientific data submitted in this petition 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 an 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 non-nursing infants (less than 1 year), the subgroup population
exposed to the highest risk, is 0.365% and 0.475% of the RfD,
respectively. The current action will increase exposure to 0.437% and
0.704% respectively. Generally speaking, the Agency has no cause for
concern if total residue contribution for published and proposed
tolerances is less than 100 percent of 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; milkfat and eggs will be covered by the tolerances outlined
above.
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 published in the Pesticide Analytical Manual Vol. I
(PAM I).
There are presently no actions pending against the continued
registration of this chemical. The pesticide is considered useful for
the purposes which it is sought. 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 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 docket
number [PP 4F4327/R2253](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 22202.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk can be sent directly to OPP at:
opp-Docket@epamail.epa.gov
An electronic copy of 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 Virginia 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.
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 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629, February
16, 1994).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
Pursuant to the requirements of the Regulatory Flexibility Act
(U.S.C. 601-612), the Administrator has determined that regulation
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 explaining the factual basis for this
determinations 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 and pests, Reporting and
recordkeeping requirements.
Dated: July 23, 1996.
Daniel M. Barolo,
Director, 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. In Sec. 180.466 the table is amended by adding alphabetically an
entry for the commodities peanut, nutmeat; peanut, hay, and poultry,
meat; and by revising the tolerances in meat, meat byproduct and fat of
cattle, goats, hogs, horses and sheep; milkfat; poultry fat and meat
byproduct; and eggs to read as follows:
Sec. 180.466 Fenpropathrin, tolerances for residues,
* * * * *
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Commodity Parts per
million Expiration date
----------------------------------------------------------------------------------------------------------------
* * * * *
* *
Cattle, fat........................................ 1.0
None
Cattle, mbyp....................................... 0.1
Do.
Cattle, meat....................................... 0.1
Do.
Eggs............................................... 0.05
Do.
Goats, fat......................................... 1.0
Do.
Goats, mbyp........................................ 0.1
Do.
Goats, meat........................................ 0.1
Do.
Hogs, fat.......................................... 1.0
Do.
Hogs, mbyp......................................... 0.1
Do.
Hogs, meat......................................... 0.1
Do.
Horses, fat....................................... 1.0
Do.
Horses, mbyp....................................... 0.1
Do.
Horses, meat....................................... 0.1
Do.
Milkfat (reflecting 0.08 in whole milk)............ 2.0
Do.
Peanut, hay........................................ 20.0
Do.
Peanut, nutmeat.................................... 0.01
Do.
Poultry, fat....................................... 0.05
Do.
Poultry, meat...................................... 0.05
Do.
Poultry, mbyp...................................... 0.05
Do.
* * * * *
* *
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[FR Doc. 96-19330 Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F
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