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cyfluthrin (Baythroid) Time-Limited Tolerances 6/95

[Federal Register: June 28, 1995 (Volume 60, Number 124)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 3F4204 and FAP 3H5670/R2145; FRL-4960-8]
RIN 2070-AB78
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances with an 
expiration date of November 15, 1997, for residues of the synthetic 
pyrethroid cyfluthrin in or on the raw agricultural commodity (RAC) 
sugarcane at 0.05 ppm and in or on the processed feed sugarcane 
molasses at 0.2 ppm. Bayer Corp., Animal Products (formerly Miles 
Corp.), requested the regulations to establish maximum permissible 
levels for residues of the insecticide.

EFFECTIVE DATE: This regulation becomes effective June 28, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 3F4204 and FAP 3H5670/R2145], 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 3F4024 and FAP 3H5670/R2145]. 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. 200, 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 October 21, 1993 (58 FR 54353), which announced 
that the Bayer Corp. had submitted pesticide petition (PP) 3F4204 and 
feed additive petition (FAP) 3H5670 to EPA requesting that the 
Administrator, pursuant to sections 408(d) and 409(b) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348(b), 
establish tolerances for residues of the insecticide cyfluthrin, 
cyano(4-fluoro-3-phenoxyphenyl)-methyl-3-(2,2-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the raw agricultural 
commodities sugarcane at 0.05 ppm and the feed commodities sugarcane 
bagasse (0.2 ppm) and sugarcane molasses (0.2 ppm). The proposed 
tolerance for sugarcane bagasse was subsequently withdrawn since 
bagasse in not considered a feed item.
    No comments were received in response to the notice of filing.
    The data base for cyfluthrin is essentially complete. Data lacking 
but desirable are a new 21-day subchronic dermal study, an acute 
neurotoxicity study in rats, and a 90-day neurotoxicity study in rats. 
Although these data are lacking, the Agency believes it has sufficient 
toxicity data to support the proposed tolerance, and these missing data 
will not significantly change its risk assessment. In a letter dated 
April 20, 1995, Bayer Corp. has committed to submit the 21-day 
subchronic dermal study by June 1996, the acute neurotoxicity study by 
December 1996, and the 90-day neurotoxicity study by May 1997.
    In addition, the Agency is requiring submission of a processing 
study for blackstrap molasses. The submitted sugarcane processing 
studies show that only molasses was produced. No residue data were 
submitted for blackstrap molasses. In commercial processing, as 
molasses is further concentrated to recover more sugar, blackstrap is 
produced. Although blackstrap is an animal feed commodity (about 10% of 
diet), minor amounts can enter the human diet. In a letter dated 
January 25, 1995, Bayer Corp. submitted additional information 
confirming that residues of cyfluthrin do not concentrate in molasses. 
Thus it is unlikely residues will be concentrated in blackstrap. 
However, Bayer Corp has initiated an additional sugarcane processing 
study to obtain residue data for blackstrap which will be submitted by 
December 31, 1996. In the interim, Bayer Corp. proposes that the 0.2 
ppm tolerance in molasses should cover any potential for the 
concentration of residues in blackstrap.
    Based upon the submitted data in molasses, the Agency does not 
believe that residues will concentrate in blackstrap; however, since 
there is a potential for concentration, the Agency will establish a 
time-limited tolerance in molasses. After submission and evaluation of 
the blackstrap processing study, the Agency will determine the need for 
a permanent feed additive tolerance.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicology data submitted in support 
of the tolerance include:
    1. A 12-month chronic feeding study in dogs with a no-observed-
effect level (NOEL) of 4 mg/kg/day. The lowest-effect level (LEL) for 
this study is established at 16 mg/kg/day, based on slight ataxia, 
increased vomiting, diarrhea, and decreased body weight.
    2. A 24-month chronic feeding/carcinogenicity study in rats with a 
NOEL of 2.5 mg/kg/day and LEL of 6.2 mg/kg/day, based on decreased body 
weights in males and females, decreased food consumption in males, and 
inflammatory foci in the kidneys in females. There were no carcinogenic 
effects observed under the conditions of the study.
    3. A 24-month carcinogenicity study in mice. There were no 
carcinogenic effects observed under the conditions of the study.
    4. An oral developmental toxicity study in rats with a maternal and 
fetal NOEL of 10 mg/kg/day (highest dose tested). An oral developmental 
toxicity study in rabbits with a maternal NOEL of 20 mg/kg/day and a 
maternal LEL of 60 mg/kg/day, based on decreased body weight gain and 
decreased food consumption during the dosing period. A fetal NOEL of 20 
mg/kg/day and a fetal LEL of 60 mg/kg/day were also observed in this 
study. The LEL was based on increased resorption and 
increased postimplantation loss.
    5. A developmental toxicity study in rats by the inhalation route 
of administration with a maternal NOEL of 0.0011 mg/L and an LEL of 
0.0047 mg/L, based on reduced mobility, dyspnea, piloerection, 
ungroomed coats, and eye irritation. The fetal NOEL is 0.00059 mg/L, 
and the fetal LEL is 0.0011 mg/L, based on sternal anomalies and 
increased incidence of runts. A second developmental toxicity study in 
rats by the inhalation route of administration is currently under 
review. The issue of whether cyfluthrin directly induces fetotoxicity 
under these conditions is unresolved at this time.
    6. A three-generation reproduction study in rats with a systemic 
NOEL of 2.5 mg/kg/day and a systemic LEL of 7.5 mg/kg/day due to 
decreased parent and pup body weights. The reproductive NOEL and LEL 
are 7.5 mg/kg/day and 22.5 mg/kg/day, respectively.
    7. Mutagenicity tests, including several gene mutation assays 
(reverse mutation and recombination assays in bacteria and a Chinese 
hamster ovary(CHO)/HGPRT assay); a structural chromosome aberration 
assay (CHO/sister chromatid exchange assay); and an unscheduled DNA 
synthesis assay in rat hepatocytes. All tests were negative for 
genotoxicity.
    8. A metabolism study in rats showing that cyfluthrin is rapidly 
absorbed and excreted, mostly as conjugated metabolites in the urine, 
within 48 hours. An enterohepatic circulation was observed.
    A chronic dietary exposure/risk assessment was performed for 
cyfluthrin using a Reference Dose (RfD) of 0.025 mg/kg bwt/day, based 
on a no-observed- effect level (NOEL) of 50 ppm (2.5 mg/kg bwt/day) and 
an uncertainty factor of 100. The NOEL was determined in a 2-year rat 
feeding study. The endpoint effects of concern were decreased body 
weights in males and inflammation of the kidneys in females at the LEL 
of 150 ppm (6.2 mg/kg/day). The current estimated dietary exposure for 
the overall U.S. population resulting from established tolerances is 
0.002730 mg/kg/bwt day, which represents 11% of the RfD. Established 
tolerances utilize 32% of the RfD in the subgroup population with the 
highest exposure levels, nonnursing infants less than 1-year old. The 
proposed use on sugarcane would not significantly contribute to the 
dietary exposure of the overall U.S. population or nonnursing infants. 
Generally speaking, EPA has no cause for concern if total residue 
contribution for published and proposed tolerances is less than the 
RfD. EPA concludes that the chronic dietary risk of cyfluthrin, as 
estimated by the dietary risk assessment, does not appear to be of 
concern.
    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 ages 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 established tolerances of 0.40 ppm for residues of cyfluthrin 
in/on fat, meat, and meat byproducts of cattle, goats, hogs, horses, 
and sheep and 0.01 ppm in/on fat, meat, and meat byproducts of poultry 
and eggs are adequate to cover secondary residues resulting from the 
proposed use as delineated in 40 CFR 180.6(a)(2).
    The metabolism of cyfluthrin in plants and livestock for this use 
is adequately understood. The residue of concern is cyfluthrin per se. 
An adequate analytical method, gas-liquid 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, Vol. II (PAM II). 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 Divisions 
(7506C), Office of Pesticide Programs, Environmental Protection Agency 
401 M St., Washington, DC 20460. Office location and telephone number: 
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-
305-5232.
    On August 5, 1988, EPA issued a conditional registration and time-
limited tolerance for cyfluthrin for use on cottonseed with an 
expiration date of October 31, 1991 (see the Federal Register of August 
15, 1988 (53 FR 30676)). On November 12, 1992, the conditional 
registration was amended and extended to November 15, 1993, and the 
tolerance on cottonseed extended to November 15, 1994 (see the Federal 
Registers of October 20, 1993 (58 FR 54094) and February 22, 1994 (54 
FR 9411)). On November 15, 1993, EPA amended the conditional 
registration on cottonseed by extending the expiration date to November 
15, 1996, and extending the timelimited tolerance to November 15, 1997. 
The conditional registration was amended and extended to allow time for 
submission and evaluation of additional environmental effects data. In 
order to evaluate the effects of cyfluthrin 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 on cottonseed, the Agency is proposing to 
issue a conditional registration with an expiration date of November 
15, 1996, and establish a time-limited tolerance on sugarcane and 
sugarcane molasses with an expiration date of November 15, 1997, to 
cover residues expected to result from use during the period of 
conditional registration.
    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 the conditional registration.
    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 186 
would be safe. Therefore, the tolerances 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 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 3F4204 and FAP 3H5670/R2145] (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 3F4204 and FAP 3H5670/R2145], 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 186

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 9, 1995.

Peter Caulkins,
Acting Director, Registration Division, 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 of part 180 continues to read as follows:

    Authority: 21 U.S.C. 346a and 371.

    b. By amending Sec. 180.436 in the table therein, by adding and 
alphabetically inserting an entry for the commodity sugarcane, to read 
as follows:


Sec. 180.436   Cyfluthrin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date   
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Sugarcane.....................................         0.05          Do.
                                                                        
                  *        *        *        *        *                 
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PART 186--[AMENDED]

    2. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

    b. In Sec. 186.1250, by amending paragraph (a) in the table therein 
by adding and alphabetically inserting an entry for the commodity 
sugarcane molasses as follows:


Sec. 186.1250   Cyfluthrin.

    (a) *  *  *  

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date   
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Sugarcane, molasses...........................          0.2          Do.
                                                                        
                  *        *        *        *        *                 
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