cyfluthrin (Baythroid) Time-Limited Tolerance 3/96
[Federal Register: March 15, 1996 (Volume 61, Number 52)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180
[PP 4F4309/R2216; FRL-5354-9]
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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:
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
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:
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,
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
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
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-
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
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:
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
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
Dated: March 6, 1996.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:
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) * * *
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.