[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Rules and Regulations]
[Pages 42453-42455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19796]
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40 CFR Parts 180 and 185
[PP 2F4055 and FAP 5H5719/R2151; FRL-4966-3]
RIN 2070-AB78
Deltamethrin; Pesticide Tolerance and Food Additive Regulation
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances for residues
of the pyrethroid deltamethrin in or on the raw agricultural commodity
(RAC) cottonseed at 0.04 part per million (ppm) and the processed food
cottonseed oil at 0.2 ppm. The Hoechst-Roussel Agri-Vet Co. requested
this tolerance and food additive regulation in petitions submitted
pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA).
EFFECTIVE DATE: This regulation becomes effective August 16, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 2F4055 and FAP 5H5719/R2151], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency,
Rm. M3708, 401 M St., SW., Washington, DC 20460. 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 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. 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
2F4055 and FAP 5H5719/R2151]. 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: Rm. 204, CM #2, 1921
Jefferson Davis Hwy., 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 March 11, 1992 (57 FR 8659), which announced that
Hoechst-Roussel Agri-Vet Co. (HRAVC) had submitted pesticide petition
(PP) 2F4055 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), amend 40 CFR part 180 by establishing a regulation to
permit residues of the insecticide deltamethrin (S)-alpha-cyano-3-
phenoxybenzyl-(1R,3R)-3-(2-2-dibromovinyl)-2,2-dimethyl-
cyclopropanecarboxylate and its major metabolites, trans-deltamethrin
[(S)-alpha-cyano-m-phenoxybenzyl-(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropane-carboxylate] and alpha-R-deltamethrin [(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on cottonseed at 0.02 ppm. After
evaluation of metabolism, residue, and cottonseed processing data, EPA
concluded that the tolerance proposed for cottonseed should be
increased to 0.04 ppm and that a food additive regulation permitting
residues of 0.20 ppm in cottonseed oil was necessary. HRAVC submitted a
food additive petition to EPA requesting that the Administrator,
pursuant to section 409(b) of FFDCA establish a regulation permitting
residues of deltamethrin on the food commodity cottonseed oil at 0.2
ppm and amended the initial notice of filing to reflect an increase in
tolerance for cottonseed to 0.04 ppm. Notice of these changes was
published in the Federal Register of March 15, 1995 (60 FR 13979).
No comments were received in response to the notices of filing.
Tolerances of 0.2 ppm and 1.0 ppm had been previously established
for the combined residues of deltamethrin and its major metabolite
trans-deltamethrin on tomatoes imported from Mexico under 40 CFR
180.435 and tomato products (concentrated) under 40 CFR 185.1580,
respectively. Based upon the review of plant metabolism data, EPA has
determined that the residue to be regulated is deltamethrin and its
metabolites trans-deltamethrin and alpha-R-deltamethrin. Regulation of
this additional metabolite will be reflected in the tolerance
expression.
Because pyrethroids are toxic to fish and other aquatic organisms,
the Agency is concerned about adverse impacts on aquatic ecosystems
related to this use of the pyrethroids. In November 1990, the Agency
and five registrants of pyrethroid cotton insecticides (collectively,
the Pyrethroid Working Group (PWG)) in collaboration with the National
Cotton Council agreed to interim risk-reduction measures designed to
reduce the potential for exposure of aquatic habitats of concern to
pyrethroids applied to cotton. The interim risk reduction measures
included user surveys to assess current pyrethroid use practices on
cotton, label changes aimed at reducing the aquatic environmental
exposure to pyrethroids, and a program of data generation to estimate
the effectiveness of the steps taken. As part of this interim risk-
[[Page 42454]]
reduction program, the Agency agreed to extend the registration and
tolerances of these cotton pyrethroids to November 15, 1993, and
November 15, 1994, respectively. The registrations and time-limited
tolerances on cottonseed were extended once again to November 15, 1996,
and November 15, 1997, respectively (see the Federal Register of
February 22, 1995 (60 FR 9784)). These extensions were granted to allow
time for submission and evaluation of additional environmental effects
data. In order to evaluate effects of pyrethroid 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.
To be consistent with the conditional registration and extension of
pyrethroids on cottonseed, the Agency is issuing a conditional
registration for deltamethrin on cotton with an expiration date of
November 15, 1996, and establish a time-limited tolerance on cottonseed
and cottonseed oil 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 use of deltamethrin on cotton, the Agency
concluded that use of deltamethrin 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 short period of time the registration would be in effect
before the Agency completes its final regulatory and risk reviews of
cotton use of the pyrethroids.
2. HRAVC's commitment to agree to the terms and conditions
stipulated by the Agency for continued registration of current cotton
pyrethroid products. These conditions include aquatic risk mitigation
language for the cotton use labeling and conditional registration
subject to an Agency determination of aquatic risk.
3. The total number of treated acres of cotton is essentially the
same and the registration of new pyrethroid on cotton, such as
deltamethrin, would result in no significant increase in the number of
acres treated. Instead, it would result in only changes in market
share, i.e., the percentage of acres that are treated with any
particular cotton pyrethroid.
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 conditional registration.
The scientific data submitted in support of these petitions and
other relevant material have been evaluated. The toxicology data
considered in support of these tolerances include:
1. Chronic 2-year feeding in dogs with a systemic NOEL greater than
40 ppm (highest does treated (HDT)).
2. A 24-month chronic feeding/carcinogenicity study in rats with a
systemic NOEL of 20 ppm (1 mg/kg/day) and LEL of 50 mg/kg/day based on
decreased body weight. No carcinogenic effects were observed in the
study.
3. A carcinogenicity study in mice in which no evidence of
carcinogenicity was noted up to and including 100 ppm (HDT).
4. An oral development toxicity study in rats with a developmental
NOEL of 11 mg/kg/day (highest dose tested). The maternal NOEL was 3.3
mg/kg/day with the LEL of 7 mg/kg/day based on one death and excessive
salivation. An oral developmental toxicity study in rabbits with a
maternal NOEL of 10 mg/kg/day and a maternal LEL of 25 mg/kg/day based
on decreased defecation. The developmental NOEL was 25 mg/kg/day with a
developmental LEL of 100 mg/kg/day based on statistically significant
increase in fetal incidence of unossification of pubic bone and tail
bone. These skeletal variations were not considered to be statistically
significant.
5. A three-generation reproduction study in rats noted no parental
or fetal effects up to and including 50 ppm (HDT).
6. A metabolism study in rats demonstrates that deltamethrin is
relatively well absorbed and excreted. Urine and fecal excretions were
almost complete at 48 hours post dose.
7. Mutagenicity tests included a reverse mutation Ames assay, a
structural chromosomal aberration assay in Chinese hamster ovary (CHO)
cells, and an unscheduled DNA synthesis assay in rat hepatocytes. All
tests were negative for genotoxicity.
A chronic dietary exposure/risk assessment was performed for
deltamethrin using a reference dose (RfD) of 0.01 mg/kg bwt/day based
on a NOEL of 1.00 mg/kg bwt/day from a 2-year rat feeding study with an
uncertainty factor of 100. The end-point effect of concern was
decreased body weight. The Theoretical Maximum Residue Contribution
from established tolerances utilizes 3.7% of the RfD for the U.S.
population and 7.3% in children ages 1 to 6 years old, the subgroup
with the highest estimated exposure to deltamethrin residues. The use
on cotton does not contribute any more to the dietary exposure for the
general population of children ages 1 to 6 years. Generally speaking,
EPA has no cause for concern if total residue contribution for
published tolerances is less than the RfD. EPA concludes that the
chronic dietary risk of deltamethrin, as estimated by the dietary risk
assessment, does not appear to be of concern.
The nature of the deltamethrin residue in plants and animals for
this use is adequately understood. The residues of concern are combined
residues of deltamethrin and its metabolites trans-deltamethrin and
alpha-R-deltamethrin. There is no reasonable expectation of secondary
residues in eggs, meat, milk, or poultry from the proposed use as
delineated in 40 CFR 180.6(a)(3).
An adequate analytical method involving gas-liquid chromatography
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).
There are currently no actions pending against the continued
registration of this chemical.
The pesticide is considered useful for the purposes for which it is
sought and capable of achieving its 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
would protect the public health and that use of the pesticide in
accordance with the tolerance established by amending 40 CFR part 185
would be safe. Therefore, the tolerances and food additive regulations
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
[[Page 42455]]
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 2F4055 and FAP 5H5719/R2151] (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 2F4055 and FAP 5H5719/R2151], 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-Docket@epamail.epa.gov
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, or establishing or raising food additive regulations 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 Parts 180 and 185
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: July 27, 1995.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. By revising Sec. 180.435, to read as follows:
Sec. 180.435 Deltamethrin; tolerances for residues.
A tolerance is established for residues of the insecticide
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] and its major
metabolites, trans-deltamethrin [(S)-alpha-cyano-m-
phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] and alpha-R-deltamethrin [(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Cottonseed.................................... 0.04 Nov. 15,
1997
Tomatoes...................................... 0.2 None
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PART 185--[AMENDED]
2. In part 185:
a. The authority citation for part 185 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. By revising Sec. 185.1580, to read as follows:
Sec. 185.1580 Deltamethrin.
Tolerances are established for residues of the insecticide
deltamethrin [(S)-alpha-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate] and its major
metabolites, trans-deltamethrin [(S)-alpha-cyano-m-
phenoxybenzyl(1R,3S)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] and alpha-R-deltamethrin [(R)-alpha-
cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylate] in or on the following food
commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
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Cottonseed oil................................ 0.2 Nov. 15,
1997
Tomato (products) concentrated................ 1.0 None
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[FR Doc. 95-19796 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F
