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Deltamethrin - Time-Limited Tolerance 8/95

[Federal Register: August 16, 1995 (Volume 60, Number 158)] [Rules and Regulations]
[Page 42453-42455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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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