[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39883-39887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19085]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 2F4137/R2259; FRL-5387-2]
RIN 2070-AB78
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 insecticide
cyfluthrin, a synthetic pyrethroid, in or on the raw agricultural
commodities (RAC's) sorghum, fodder, forage and grain; aspirated grain
fractions; the fat of cattle, goats, horses, hogs, and sheep; and
milkfat. The regulation to establish a maximum permissible level for
residues of the insecticide cyfluthrin was requested in a petition
submitted by Bayer Corporation.
EFFECTIVE DATE: This regulation becomes effective July 31, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 2F4137/R2259], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. A copy of any
[[Page 39884]]
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 2F4137/R2259] . 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.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR Part 2. A copy of the comment that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice. All
written comments will be available for public inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
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. 204, CM #2, 1921
Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6100.
SUPPLEMENTARY INFORMATION: EPA issued a public notice, published in the
Federal Register of December 30, 1992 (57 FR 62334), which announced
that Bayer Corp. (formerly Miles, Inc.) had submitted pesticide
petition (PP) 2F4137 to EPA. Pesticide petition (PP) 2F4137 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) sorghum, forage at 2.0 parts per
million (ppm); sorghum, grain at 4.00 ppm; sorghum, fodder, silage and
hay at 5.00 ppm.
In a letter dated October 16, 1995, Bayer Corp. (61 FR 26904, May
29, 1996) requested that the pesticide petition (2F4137) be amended by
increasing the existing tolerances in or on the fat of cattle, goats,
hogs, horses and sheep to 5.00 ppm; milkfat to 15.00 ppm (reflecting
0.50 ppm in whole milk) and establishing a tolerance for aspriated
grain fraction at 300 ppm. This amendment also addressed EPA's
preference for the sorghum, fodder, silage and hay tolerances to be
expressed in terms of sorghum, fodder. 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, 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
November 2, 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. On July 11, 1996, Bayer Corporation
submitted a 21-day subchronic dermal study on Baythroid 2 to the
Agency.
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 resorptions 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 a 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/
[[Page 39885]]
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 6.2 mg/kg/day. For
purposes of this dietary exposure/risk assessment tolerance level
residues were used and percent crop treated assumption made for some of
the commodities. The current estimated dietary exposure for the overall
U.S. population resulting from established tolerances is 0.001221 mg/
kg/bwt day, which represents 4.8 percent of the RfD. The current action
will increase exposure to 0.009420 mg/kg/bwt/day or 37.6 percent 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 0.002081 mg/kg bwt/day, which represents 8.3 percent of the RfD. The
current action will increase exposure to 0.025266 mg/kg bwt/day or 101
percent of the RfD. Although the estimate of dietary exposure for the
subgroup, non-nursing infants less than 1 year old, is slightly higher
than the Agency's level of concern, i.e., greater than 100 percent of
the RfD, the Agency believes that actual exposure and risk would be
lower. The basis for this is that the risk reflects a higher than
actual dietary exposure because it assumes that 100 percent of the U.S.
sorghum crop is treated with cyfluthrin and that all quantities of the
feed consumed will bear residue levels as high as the proposed
tolerance. In reality, the Agency knows that all sorghum will not be
treated with this pesticide and that actual levels on meat and milk
will be lower than tolerance levels. In addition the food commodity
that contributes the most to this slight risk exceedence is milk at
88.2 percent of the RfD; 71.2 percent from milk fat and 17 percent from
whole milk and milk sugars. Metabolism data indicates that most of the
cyfluthrin will concentrate in milk fat and very little in the other
components, whole milk and milk sugar. Thus the 17 percent contribution
is an overestimate of actual exposure. Thus, 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 2,500. 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 residues of concern is cyfluthrin per se.
Current established tolerances for cyfluthrin in poultry meat, fat and
meat-by-products are adequate. 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., SW., 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 Federal
Registers 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 issuing a
conditional registration with an expiration date of November 15, 1996
and establishing a time-limited tolerance on sorghum (fodder, forage
and grain), aspirated grain fractions 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.
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 and in accordance with provisions of
the conditional registration.
There are presently no actions pending against the continued
registration of this chemical.
The pesticide is considered useful for the purposes for which it is
sought. Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR 180.436
would protect the public health. 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
[[Page 39886]]
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 2F4137/R2259] (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 22202.
A copy of electronic objections and hearing request 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 of this rulemaking, as well as the public
eversion, 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.
This action does not impose any enforceable duty, or contain any
unfunded mandates as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this
determination was published in the Federal Register of May 4, 1981 (46
FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental Protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
Dated: July 19, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, chapter I of title 40 Code of Federal Regulations is
amended as follows:
PART 180--[AMENDED]
1. The Authority citation of part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.436, the table in paragraph (a) is amended by adding
alphabetically entries for the commodities ``aspriated grain
fractions'' and ``sorghum fodder,'' ``sorghum forage'' and ``sorghum
grain;'' and by revising the entries for cattle, fat; goats, fat; hogs,
fat; horses, fat; milkfat; and sheep, fat; to read as follows:
Sec. 180.436 Cyfluthrin: tolerances for residues.
(a) * * *
----------------------------------------------------------------------------------------------------------------
Parts per
Commodity million Expiration date
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Aspirated Grain Fractions................................. 300.00 Nov. 15, 1997.
Cattle, fat............................................... 5.00 Do.
* * * * * * *
Goats, fat................................................ 5.00 Do.
* * * * * * *
Hogs, fat................................................. 5.00 Do.
[[Page 39887]]
* * * * * * *
Horses, fat............................................... 5.00 Do.
Milkfat (reflecting 0.5 ppm in whole milk)................ 15.00 Do.
* * * * * * *
Sheep, fat................................................ 5.00 Do.
* * * * * * *
Sorghum, fodder........................................... 5.00 Do.
Sorghum, forage........................................... 2.00 Do.
Sorghum, grain............................................ 4.00 Do.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. 96-19085 Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F
