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cyfluthrin (Baythroid) Time-Limited Tolerance 3/96

[Federal Register: March 15, 1996 (Volume 61, Number 52)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180
[PP 4F4309/R2216; FRL-5354-9]
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 commodities (RAC's) 
alfalfa, sunflowers, and fat of cattle, goats, horses, hogs, and sheep; 
and an expiration date of July 5, 1999 for residues of cyfluthrin in or 
on sweet corn. The proposed tolerances and regulations to establish a 
maximum permissible level for residues of the pesticide was requested 
in a petition submitted by Bayer Corp. (formerly Miles Corp.).

EFFECTIVE DATE: This regulation becomes effective March 15, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4F4309/R2216], may be submitted to: 
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M 
St., SW., Washington, DC 20460. 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. Fees 
accompanying objections shall be labeled "Tolerance Petition Fees" and 
forwarded: EPA Headquarters Accounting Operations Branch, OPP (Tolerance 
Fees), P.O. Box 360277M, Pittsburgh, PA 15251. An electronic copy of 
objections and hearing requests filed with the Hearing Clerk may be 
submitted to OPP by sending electronic mail (e-mail) to: 
            opp-docket@epamail.epa.gov.
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 4F4309/R2216]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic 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 public notice, published in the 
Federal Register of July 13, 1994 (59 FR 35719), which announced that 
Bayer Corp. had submitted pesticide petition (PP) 4F4309 and feed 
additive petition (FAP) 4H5686 to EPA.
    Pesticide petition (PP) 4F4309 requests that the Administrator, 
pursuant to sections 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d) and 348(b), amend 40 CFR 180.436 by 
establishing 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 (RACs) sweet corn, forage at 54.0 ppm; alfalfa, hay at 10.0 
ppm; soybean, forage at 10.0 ppm; alfalfa, forage at 5.0 ppm; soybean, 
hay at 1.5 ppm; sunflower, forage at 1.0 ppm; sweet corn at 0.05 ppm; 
soybeans at 0.03 ppm and sunflower, seed at 0.02 ppm.
    Food/feed additive petition (FAP) 4H5686 requests that the 
Administrator pursuant to section 409(e) of the FFDCA (21 U.S.C. 
348(e)) amend 40 CFR 186.1250 by establishing a food/feed additive 
regulation for cyfluthrin in or on sunflower hulls at 2.5 ppm and 
soybean hulls at 0.1 ppm.
    On September 18, 1995, Bayer Corp. requested (60 FR 64059, December 
13, 1995) that the pesticide petition (4F4309) be amended by decreasing 
the proposed tolerances on sweet corn forage from 54.0 ppm to 30.0 ppm; 
increasing tolerances for fat of cattle, goats, hogs, horses and sheep 
from 0.05 ppm to 5.0 ppm; establishing a tolerance of 15.0 ppm for 
milkfat (representing 0.5 ppm in whole milk); and withdrawing proposed 
tolerances for soybean forage, soybean hay, and soybeans; and the food/
feed additive regulation petition (3H5686) for sunflower hulls at 2.5 
ppm and soybeans hulls at 0.1 ppm without prejudice to future filing. 
On November 3, 1995, Bayer Corp. requested that the pesticide petition 
(4F4309) be further amended by reducing the tolerances for fat of 
cattle, goats, hogs, horses and sheep from 5.0 ppm to 1.0 ppm; and 
withdrawing the tolerance for milkfat. An increased milkfat tolerance 
was established in (59 FR 53130, May 31, 1995) at 2.5 ppm (reflecting 
0.08 ppm in whole milk) which adequately addresses secondary tolerances 
for this proposed action. This amendment also addressed EPA's 
preference for the sweet corn tolerance to be expressed in terms of 
kernel plus cob with husk removed (K+CWHR).
    There were no comments or requests to the advisory committee 
received in response to the initial and amended notices 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 
and a dermal sensitization study on the end use product Baythroid 2. 
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. On 
October 12, 1995, Bayer Corp submitted to the Agency a dermal 
sensitization study on Baythroid 2.
    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, 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 3-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 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 0.003403 mg/kg bwt/
day, which represents 13.6% of the RfD. The current action will 
increase exposure to 0.003766 mg/kg/bwt/day of 15% of the RfD. The 
current estimated dietary exposure for the subgroup population exposed 
to the highest risk, non-nursing infants less than 1 year old, is 
0.010622 mg/kg bwt/day, which represents 42.5% of the RfD. The current 
action will increase exposure to 0.010850 mg/kg bwt/day or 43.4% of the 
RfD. 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 666. Generally 
speaking, MOE's greater than 100 for data derived from animal studies 
are regarded as showing no appreciable risk.
    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 time-limited 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 alfalfa (forage and 
hay), sunflowers (forage and hay) and livestock animal commodities with 
an expiration date of November 15, 1997, to cover residues expected to 
result from use during the period of conditional registration.
    On July 5, 1995 EPA issued a conditional registration and time-
limited tolerance for cyfluthrin use in or on corn (field, pop and 
sweet) in combination with another insecticide O-[2-(1-dimethylethyl)-
5-pyrimidinyl]O-ethyl-O-(1-methylethyl)phosphorothioate with an 
expiration date of July 5, 1999. See the Federal Register of Wednesday, 
July 5, 1995 (60 FR 34874). Because of the lack of mammalian 
neurotoxicity studies for the other insecticide, the Agency limited the 
period of time that the regulation is to be in effect to allow time for 
submission and evaluation of the data. To be consistent with the 
conditional registration and the regulation for establishing a time-
limited tolerance for the other insecticide, the Agency is issuing a 
time-limited tolerance with an expiration date of July 5, 1999 for 
residues of cyfluthrin in or on sweet corn, forage and fodder.
    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 4F4309/R2216] (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 4F4309/R2216], 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 Part 180

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

    Dated: March 6, 1996.

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]

    a. The authority citation of part 180 continues to read as follows:

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


    b. In Sec. 180.436, the table to paragraph (a) by adding alphabetically 
entries for "alfalfa, forage", "alfalfa, hay", "sunflower, forage", and 
"sunflower, seed", and by revising the entries "cattle, fat", "goats, fat", 
"hogs, fat", "horses, fat", and "sheep, fat", and in paragraph (b) by revising 
the table, to read as follows:


Sec. 180.436   Cyfluthrin, tolerances for residues.

    (a) *        *        *

------------------------------------------------------------------------
                                           Parts per                    
                Commodity                   million     Expiration date 
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Alfalfa, forage.........................         5.00      Nov. 15, 1997
alfalfa, hay............................        10.00                Do.
Cattle, fat.............................         1.00                Do.
Goats, fat..............................         1.00                Do.
Hogs, fat...............................         1.00                Do.
Horses, fat.............................         1.00                Do.
Sheep, fat..............................         1.00                Do.
Sunflower, forage.......................         1.00                Do.
Sunflower, seed.........................         0.02                Do.
                                                                        
                  *        *        *        *        *                 
------------------------------------------------------------------------

    (b) *        *        *

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date   
------------------------------------------------------------------------
Corn, forage and fodder, field and pop........     0.01     July 5, 1999
Corn, grain, field and pop....................     0.01          Do.
Corn, sweet, (K+CWHR).........................     0.05          Do
Corn, sweet, fodder...........................    15.00          Do.
Corn, sweet, forage...........................    30.00          Do.
------------------------------------------------------------------------