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Cyfluthrin (Miles). July 5, 1995. Pesticide Tolerance. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1995/July/Day-05/pr-324.html
[Federal Register: July 5, 1995 (Volume 60, Number 128)] [Rules and Regulations]40 CFR Part 180
[PP 1F4026/R2147; FRL-4963-2]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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:
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/m<SUP>3, 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/m<SUP>3
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]
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
1999
Corn, grain, field and pop.................... 0.01 Do.
[FR Doc. 95-16426 Filed 7-3-95; 8:45 am] BILLING CODE 6560-50-F