[Federal Register Volume 60, Number 128 (Wednesday, July 5, 1995)]
[Rules and Regulations]
[Pages 34874-34876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16426]
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40 CFR Part 180
[PP 1F4026/R2147; FRL-4963-2]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a time-limited tolerance for residues of
the insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl 3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate) in or on the
raw agricultural commodities corn, sweet (K+CWHR); corn, grain, field
and pop; and corn, forage and fodder, field, pop, and sweet at 0.01
part per million (ppm). The Agricultural Division of Miles, Inc.,
submitted a petition under the Federal Food, Drug and Cosmetic Act
(FFDCA) to EPA for a regulation to establish a maximum permissible
level for residues of the insecticide.
EFFECTIVE DATE: This regulation becomes effective July 5, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1F4026/R2147], 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
1F4026/R2147]. 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: Robert A. Forrest, Product
Manager (PM) 14, Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 219, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6600; e-mail:
forrest.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of April 5, 1995 (60 FR 17356), which announced that
Miles, Inc., P.O. Box 4913, Kansas City, MO 64120, had submitted a
pesticide petition, PP 1F4026, 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), establish a tolerance for
residues of the insecticide cyfluthrin, cyano (4-fluoro-2-
phenoxyphenyl)methyl-3-(2,2-dichloroethyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the raw agricultural
commodities corn, fresh; corn, grain, field and pop; and corn, forage
and fodder, field, pop, and sweet at 0.01 part per million (ppm). For
consistency, the raw agricultural commodity corn, fresh is expressed as
corn, sweet (K+CWHR).
There were no comments received in response to the notice of
filing. The scientific data submitted in the petition and other
relevant material have been evaluated. The toxicological data
considered in support of the tolerance include:
1. Several acute toxicological studies placing the technical grade
of the insecticide in toxicity category 1 (acute oral); 3 (acute dermal
and primary eye irritation); 2 (acute inhalation) and 4 (primary dermal
irritation). It is not a dermal sensitizer.
2. A 21-day rabbit dermal study with a no-observed-effect level
(NOEL) greater than 250 mg/kg/day (highest dose tested).
3. A 21-day rat inhalation study with a NOEL of 0.0014 mg/L in
which a decrease in body weight gain was observed.
4. A 90-day rat inhalation study with a NOEL of 0.00009 mg/L/day.
Systemic effects observed included unthriftiness, unkept fur, lethargy,
and increased urinary protein.
5. A chronic dog-feeding study with a NOEL of 4.0 mg/kg/day.
Systemic effects of slight ataxia, increased vomiting, diarrhea, and
decreased male body weights were observed at the lowest-effect level
(LEL).
6. A two-year rat feeding/carcinogenicity study with a systemic
NOEL of 2.5 mg/kg/day. Decreased body weights in males and inflammatory
foci in kidneys of females were observed at the lowest-observed-effect
level (LOEL) of 7.5 mg/kg/day. There was no evidence of carcinogenicity
under conditions of the study. Levels tested were 50, 150, and 450 ppm.
[[Page 34875]]
7. A chronic mouse feeding/carcinogenicity study with a systemic
NOEL of less than 7.5 mg/kg/day (lowest dose tested) in which increased
alkaline phosphatase activity in males was observed. There was no
evidence of carcinogenicity under conditions of the study. Levels
tested were 50, 200, and 800 ppm.
8. A three-generation rat reproduction study with a NOEL of 7.5 mg/
kg/day for reproductive effects and a systemic NOEL of 2.5 mg/kg/day.
Decreased viability and decreased pup body weights were observed.
Levels tested were 50, 150, and 450 ppm.
9. A rat oral developmental study with no clinical signs resulting
from the test article. Levels tested were 1, 3, and 10 mg/kg/day.
A second rat oral developmental study with a maternal NOEL of 3 mg/
kg/day and a LOEL of 10 mg/kg/day (high-stepping gait, occasional
ataxia, and reduced motility). There were no developmental effects.
Levels tested were 3, 10, and 30 mg/kg/day.
10. A rabbit oral developmental study with a developmental NOEL and
LOEL of 20 mg/kg/day and 60 mg/kg/day, respectively, in which increased
numbers of resorptions and percent incidence of postimplantation loss
were observed at the LOEL. The maternal NOEL and LOEL were 20 mg/kg/day
and 60 mg/kg/day, respectively, with decreased body weight gain and
food consumption observed at the LOEL. Levels tested were 20, 60, and
180 mg/kg/day administered by gavage on gestational days 6 to 18,
inclusively.
11. A rat inhalation developmental study with a developmental NOEL
and LOEL of 0.00059 mg/L and 0.0011 mg/L, respectively, with
unspecified sternal anomalies and increased runt incidence observed at
the LOEL. The maternal NOEL and LOEL were 0.0011 mg/L and 0.0047 mg/L,
respectively, with reduced motility, dyspnea, piloerection, ungroomed
coats, and eye irritation observed at the LOEL.
12. A rat inhalation developmental study with a NOEL and LOEL of
0.46 and 2.55 mg/m3, respectively, with reduced fetal and
placental weight, reduced ossification in the phalanx, metacarpals and
vertebrae observed at the LOEL. The maternal LOEL was less than 0.46
mg/m3 with decreased body weight gain and reduced relative food
efficiency observed at this dose level.
13. Mutagenicity studies including a CHO/HGPRT gene mutation test,
a structural chromosome aberration: sister chromatid exchange, and an
unscheduled DNA synthesis, which were all negative for mutagenic
effects.
14. Two metabolism studies in rats showing that the test material
was rapidly and nearly completely absorbed and that the radioactivity
was rapidly and nearly completely excreted in the urine and feces by 48
hours. The studies showed that the parent is cleaved at the ester bond
and then oxidized to yield 3-phenoxy-4-fluorobenzoic acid. This
intermediate is then either hydroxylated and subsequently conjugated
and excreted, or first bound to glycine and then hydroxylated,
conjugated, and excreted.
The Reference Dose (RfD) is established at 0.025 mg/kg day, based
on an NOEL of 2.5 mg/kg/day from the 2-year rat feeding study and an
uncertainty factor of 100. The Theoretical Maximum Residue Contribution
(TMRC) from established tolerances and the current action is estimated
at 0.002730 mg/kg bwt/day and utilizes 11.0 percent of the RfD for the
U.S. population. The TMRC for the subgroup most highly exposed,
nonnursing infants less than 1-year old, utilizes 32.0 percent of the
RfD.
Because there was a sign of developmental effects seen in animal
studies, the Agency used the rabbit developmental toxicity study with a
maternal NOEL of 20 mg/kg/day to assess acute dietary exposure and
determine a margin of exposure (MOE) for the overall U.S. population
and certain subgroups. Since the toxicological end-point pertains to
developmental toxicity, the population group of concern for this
analysis is women aged 13 and above, the subgroup which most closely
approximates women of child-bearing age. The MOE is calculated as the
ratio of the NOEL to the exposure. For this analysis the Agency
calculated the MOE for women aged 13 and above to be 1,250. Generally
speaking, MOE's greater than 100 for data derived from animal studies
are acceptable to the Agency.
The nature of the residues in plants is adequately understood. The
nature of residue in animals is adequately understood for the purpose
of the requested tolerances. An adequate analytical method, gas
chromatography, is available for enforcement purposes.
The enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual,
Volume II (PAM). Because of the long lead time for publication of the
method in PAM II, the analytical methodology is being made available in
the interim to anyone interested in pesticide enforcement when
requested from: Calvin Furlow, Public Response and Program Resources
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202, (703)-305-5232.
Any secondary residues occurring in milk and the meat, fat, and
meat by-products (mbyp) of cattle, goats, hogs, horses, and sheep will
fall within existing tolerances for these commodities. There is no
reasonable expectation that secondary residues will occur in eggs, and
the meat, fat, and mbyp of poultry as a result of this action. The
pesticide is considered useful for the purpose for which the tolerance
is sought.
To be consistent with the conditional registration and the
regulation for establishing a time-limited tolerance for residues of
another insecticide, O-[2-(1,1-dimethlyethyl)-5-pyrimidinyl] O-ethyl-O-
(1-methylethyl) phosphorothioate, which are being issued both in
conjunction with, and concurrently with, this regulation, the Agency is
limiting the period of time that the regulation is to be in effect. The
conditional registration is for a product consisting of cyfluthrin in
combination with the other insecticide as the two active ingredients.
Upon receipt and evaluation of the additional data/information required
as a condition of the time-limited tolerance for the other insecticide
and of the conditional registration for the use of these two
insecticides on corn, the Agency will reassess the tolerances and the
registration and, if appropriate, will issue permanent tolerances and
an unconditional registration for the insecticides on corn.
There are currently no actions pending against the continued
registration of this chemical.
Elsewhere in this issue of the Federal Register, the Agency is
concurrently issuing a notice of conditional registration for the use
of the combination product on corn and for a time-limited tolerance for
residues of the other insecticide referenced above in/on corn
commodities.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR 180.436
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.
[[Page 34876]]
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 1F4026/R2147] (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 1F4026/R2147], 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
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 and pests, Reporting and
recordkeeping requirements.
Dated: June 23, 1995.
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. 180.436, by designating the existing text as paragraph
(a) and adding new paragraph (b), to read as follows:
Sec. 180.436 Cyfluthrin; tolerances for residues.
(a) * * *
(b) Time-limited tolerances are established for residues of the
insecticide cyfluthrin (cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate; CAS Reg. No
68359-37-5) in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
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Corn, forage and fodder, field, pop, and sweet 0.01 July 5,
1999
Corn, grain, field and pop.................... 0.01 Do.
Corn, sweet (K+CWHR).......................... 0.01 Do.
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[FR Doc. 95-16426 Filed 7-3-95; 8:45 am]
BILLING CODE 6560-50-F
