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cyfluthrin (Baythroid) Proposed Pesticide Tolerances 10/94

40 CFR Part 180


[PP 1F3923/P593; FRL-4916-1]


RIN 2070-AC18


Pesticide Tolerances for Cyfluthrin


AGENCY: Environmental Protection Agency (EPA). 


ACTION: Proposed rule. 

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SUMMARY: EPA proposes to amend tolerances for residues of the 

synthetic pyrethroid cyfluthrin in or on the raw agricultural 

commodities (RAC's) milk, meat, fat, and meat byproducts of 

cattle and establish a tolerance for milkfat. The proposed regulation 

to amend the tolerances and establish a maximum permissible 

level for residues of the pesticide in milkfat was requested 

in a petition submitted by Miles Corp., Animal Products (formerly 

Mobay Corp.).



DATES: Comments, identified by the document control number, 

[PP 1F3923/P593], must be received on or before November 21, 

1994.



ADDRESSES: By mail, submit written comments 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. Office location and telephone 

number: In person, bring comments to: Rm. 1132, CM #2, 1921 

Jefferson Davis Hwy., Arlington, VA 22202. 



   Information submitted as a comment concerning this document 

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), 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.



SUPPLEMENTARY INFORMATION: EPA issued a notice, published in 

the Federal Register of April 3, 1991 (56 FR 13642), which announced 

that Miles Corp. had submitted pesticide petition (PP) 1F3923 

to EPA requesting that the Administrator, pursuant to section 

408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a(d), amend 40 CFR 180.436 by increasing tolerances 

for residues of the insecticide cyfluthrin, [cyano[4-fluoro-

3-phenoxyphenyl]-methyl-3-[2,2-dichloroethenyl]-2,2-
dimethylcyclopropanecarboxylate], 

in or on the raw agricultural commodities milk to 0.08 part 

per million (ppm) (from 0.01 ppm) and meat, fat, and meat byproducts 

of cattle to 0.40 ppm (from 0.05 ppm). The proposal to increase 

tolerances was submitted in support of direct application (pour-

on) of the pesticide Bayocide Pour On Insecticide containing 

cyfluthrin to lactating dairy and beef cattle.



   A review of the data indicated that cyfluthrin residues concentrate 

in fat; therefore, Miles Corp. was asked to amend the petition 

by requesting an appropriate milkfat tolerance. On February 

14, 1994, Miles Corp. submitted an amended pesticide petition 

proposing that tolerances be established for milkfat at 2.5 

ppm (reflecting 0.08 ppm in whole milk).

   The data submitted in support of these tolerances and other 

relevant material have been evaluated. The toxicological and 

metabolism data and analytical methods for enforcement purposes 

considered in support of these tolerances are discussed in detail 

in related documents published in the Federal Register of August 

16, 1989 (54 FR 33718).

   A 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 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 and inflammation of the kidneys. The 

Theoretical Maximum Residue Contribution (TMRC) from established 

tolerances utilizes 5.5% of the RfD for the U.S. population 

or 11% of the RfD if the new tolerances are granted. Established 

tolerances utilize 20% of the RfD for nonnursing infants less 

than 1 year old, the subgroup with the highest estimated exposure 

to cyfluthrin residues or 30% of the RfD if the new tolerances 

are granted. Generally speaking, EPA has no cause for concern 

if total residue contribution for published and proposed tolerances 

is less than the RfD. 

   The metabolism of the chemical in animals for these uses 

is adequately understood. An adequate analtyical 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 Opearations 

Division (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. 

   There are currently no actions pending against the continued 

registration of this chemical.

   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. Therefore, it 

is proposed that the tolerances be established as set forth 

below.

   Any person who has registered or submitted an application 

for registration of a pesticide under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) as amended which contains 

any of the ingredients listed herein may request within 30 days 

after publication of this document in the Federal Register that 

this rulemaking proposal be referred to an Advisory Committee 

in accordance with section 408(e) of the FFDCA. 

   Interested persons are invited to submit written comments 

on the proposed regulations. Comments must bear a notation indicating 

the document control number, [PP 1F3923/P593]. All written comments 

filed in response to these petitions will be available in the 

Public Response and Program Resources Branch, at the address 

given above from 8 a.m. to 4 p.m., Monday through Friday, except 

legal holidays.

   Under Executive Order 12866 (58 FR 51735, Oct. 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: October 11, 1994.


Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs. 

   Therefore, it is proposed that 40 CFR part 180 be amended 

as follows: 


PART 180-[AMENDED]


   1. The authority citation for part 180 continues to read 

as follows: 


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



   2. By amending sec 180.436 in the table therein by revising 

the entries for the fat, meat, and meat byproducts (mbyp) of 

cattle and revising the entry for milk, to read as follows:



sec 180.436   Cyfluthrin; tolerances for residues.

*     *     *     *     *     

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                           Commodity                       Parts per   
                                                            million    
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Cattle, fat....................................................0.40  

Cattle, meat...................................................0.40  

Cattle, mbyp...................................................0.40  


      *              *              *              *              *  

Milkfat (reflecting 0.08 ppm in whole milk)....................2.50  

      *              *              *              *               

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[FR Doc. 94-26195 Filed 10-20-94; 8:45 am]