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cyfluthrin (Baythroid) Time-Limited Tolerances 7/96

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.

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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
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/ 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
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<gr-thn-eq>); (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.                                  
                                     
     *                *                *                *                *
               *                *    
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.                                  
     *                *                *                *                *
               *                *    
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[FR Doc. 96-19085 Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F