cyfluthrin (Baythroid) Time-Limited Tolerances 6/95
[Federal Register: June 28, 1995 (Volume 60, Number 124)]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 3F4204 and FAP 3H5670/R2145; FRL-4960-8]
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 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
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: email@example.com. 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:
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,
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
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
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)-
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
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
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:
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 Parts 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 9, 1995.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:
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
Sec. 180.436 Cyfluthrin; tolerances for residues.
* * * * *
Parts per Expiration
Commodity million date
* * * * *
Sugarcane..................................... 0.05 Do.
* * * * *
2. In part 186:
a. The authority citation for part 186 continues to read as
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.
* * * * *
* * * * *