[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: [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 
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: 
[email protected].

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-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, 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
------------------------------------------------------------------------

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   
------------------------------------------------------------------------
                                                                        
Cottonseed oil................................          0.2     Nov. 15,
                                                                    1997
Tomato (products) concentrated................          1.0         None
------------------------------------------------------------------------


[FR Doc. 95-19796 Filed 8-15-95; 8:45 am]
BILLING CODE 6560-50-F