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cyfluthrin (Baythroid) Time-Limited Tolerance 6/95

[Federal Register: July 5, 1995 (Volume 60, Number 128)]
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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.
    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. 
    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.
------------------------------------------------------------------------