[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Proposed Rules]
[Pages 18562-18565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9149]



-----------------------------------------------------------------------



ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186

[PP 9F3731 and FAP 9H5574/P612; FRL-4948-4]
RIN 2070-AC18


Cyfluthrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA proposes to establish 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) 
tomatoes; carrots; peppers; radishes; meat, fat, and meat byproducts of 
cattle, goats, horses, hogs, poultry, and sheep; milkfat; and eggs and 
in food/feed additive commodities tomato, pomace (dry and wet) and 
tomato concentrated products. Miles Corp., Animal Products (formerly 
Mobay Corp.), requested the proposed tolerances and regulations to 
establish maximum permissible levels for residues of the pesticide.
DATES: Comments, identified by the document control number, [PP 9F3731 
and FAP 9H5574/P612], must be received on or before May 12, 1995.
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. In person, bring comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202.
    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. 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 March 23, 1989 (54 FR 35434), which announced that 
Miles Corp. had submitted pesticide petition (PP) 9F3731 and food/feed 
additive petition (FAP) 9H5574 to EPA.
    Pesticide petition (PP) 9F3731 requests 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-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the raw agricultural 
commodities alfalfa forage at 5.0 ppm; alfalfa hay at 10.0 ppm; 
broccoli at 2.0 ppm; brussels sprouts at 0.5 ppm; cabbage at 1.0 ppm; 
cauliflower at 0.5 ppm; carrots at 0.1 ppm; celery at 1.5 ppm; lettuce 
at 2.5 ppm; peppers at 0.2 ppm; radishes at 0.5 ppm; spinach at 1.0 
ppm; sweet corn at 0.05 ppm; sweet corn forage at 1.0 ppm; sunflower 
seed at 0.02 ppm; sunflower forage at 1.0 ppm; soybeans at 0.03 ppm; 
soybean forage at 10.0 ppm; soybean hay at 1.5 ppm; soybean straw at 
1.0 ppm; tomato at 0.2 ppm; milk at 0.1 ppm; eggs at 0.01 ppm; meat, 
fat and meat byproduct of cattle, goats, hogs, horses, and sheep at 1.5 
ppm; and meat, fat, and meat byproducts of poultry at 0.01 ppm.
    Food/feed additive petition (FAP) 9H5574 requests that the 
Administrator, pursuant to section 409(e) of the FFDCA (21 U.S.C. 
348(e)) amend 40 CFR parts 185 and 186 by establishing a food/feed 
additive regulation for cyfluthrin in or on processed food commodities 
tomato concentrated products at 0.5 ppm and feed commodities sweet corn 
(cannery wastes) at 1.5 ppm; tomato, pomace (wet) at 1.5 ppm; tomato, 
pomace dry at 5.0 ppm.; soybean hulls at 0.1 ppm; and sunflower hulls 
at 2.5 ppm.
    On July 20, 1993, Miles Corp. requested that the pesticide petition 
and food/feed additive petition be amended by withdrawing the proposed 
tolerance [[Page 18563]] for broccoli, brussels sprouts, cabbage, 
cauliflower, celery, lettuce, soybeans (straw), spinach and the feed 
additive regulation for sweet corn (cannery wastes) without prejudice 
to future filing and by raising the tolerances for carrots, peppers, 
and radishes to 0.2, 0.5 and 1.5 ppm, respectively. In a letter dated 
November 18, 1993, Miles amended the petition by withdrawing the crops 
alfalfa, soybeans, sweet corn, and sunflowers from the subject 
petitions and proposing them under a separate petition. On June 10, 
1994, Miles requested that the pesticide petition be further amended by 
reducing the tolerance for radishes to 1.0 ppm; proposing one tolerance 
for wet and dry tomato pomace; reducing the animal commodities to 0.4 
ppm; and revising the milk tolerances to be expressed as 2.5 ppm milk 
fat (reflecting 0.08 ppm in whole milk). This amendment was submitted 
in response to EPA's preference that an integer tolerance (i.e, one 
significant figure) rather than a fraction be proposed for radishes; 
EPA's current practice to set one tolerance on tomato pomace, wet and 
dry, rather than individual tolerances on the two pomaces; and to make 
the above tolerances for animal commodities consistent with the feed 
items in this petition.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. All toxicology data necessary to support 
these tolerances have been previously submitted, reviewed, and 
accepted. The toxicology data considered in support of the proposed 
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 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 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 
incidents in 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 a gene mutation assay (reverse 
mutation and recombination assays in bacteria and a Chinese hamster 
ovary (CHO)/(HGPRT)); a structural chromosome aberration assay (CHO/
sister chromatid exchange assay); and an unscheduled DNA synthesis 
assay in rat hepatocytes. All test 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 end-
point 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 0.001378 mg/kg/bwt 
day, which represents 5.5 % of the RfD. The current action will 
increase exposure to 0.002730 mg/kg/ bwt/day or 11% of the RfD. In the 
subgroup population exposed to the highest risk, nonnursing infants 
less than 1 year old, the current action will increase exposure to 
0.008044 mg/kg bwt/day or 32% 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 concern.
    Because there was a sign of developmental effects seen in animal 
studies, the Agency used the rat developmental toxicity study (with a 
NOEL of 0.00059 mg/L by the inhalation route of exposure) 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 metabolism of the chemical in animals for this use is 
adequately understood. 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)-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 the 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 [[Page 18564]] 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 establishing a time-limited tolerance on 
tomatoes, carrots, peppers, radishes, meat, milk, and egg tolerances 
with an expiration date of November 15, 1997, to cover residues 
expected to result from use during the period of 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 parts 
180, 185, and 186 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 regulation. Comments must bear a notation indicating the 
document control number, [PP 9F3731 and FAP 9H5574/P612]. All written 
comments filed in response to this petition 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 
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, 185, and 186

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Feed additives, Food additives, Pesticides 
and pests, Reporting and recordkeeping requirements.

Dated: April 5, 1995.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that chapter I of title 40 of the Code of 
Federal Regulations be amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

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

    b. By amending Sec. 180.436, by revising the table therein, to read 
as follows:


Sec. 180.436  Cyfluthrin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                                                 Parts per    Expiration
                  Commodities                     million        date   
------------------------------------------------------------------------
Carrots.......................................         0.20     Nov. 15,
                                                                    1997
Cattle, fat...................................         0.40          Do.
Cattle, meat..................................         0.40          Do.
Cattle, mbyp..................................         0.40          Do.
Cottonseed....................................          1.0          Do.
Eggs..........................................         0.01          Do.
Goats, fat....................................         0.40          Do.
Goats, meat...................................         0.40          Do.
Goats, mbyp...................................         0.40          Do.
Hogs, fat.....................................         0.40          Do.
Hogs, meat....................................         0.40          Do.
Hogs, mbyp....................................         0.40          Do.
Hops, fresh...................................          4.0         None
Horses, fat...................................         0.40     Nov. 15,
                                                                    1997
Horses, meat..................................         0.40          Do.
Horses, mbyp..................................         0.40          Do.
Milkfat (reflecting 0.08 ppm in whole milk)...         2.50          Do.
Peppers.......................................         0.50          Do.
Poultry, fat..................................         0.01          Do.
Poultry, meat.................................         0.01          Do.
Poultry, mbyp.................................         0.01          Do.
Radishes......................................         1.00          Do.
Sheep, fat....................................         0.40          Do.
Sheep, meat...................................         0.40          Do.
Sheep, mbyp...................................         0.40          Do.
Tomato........................................         0.20          Do.
------------------------------------------------------------------------

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

    b. In Sec. 185.1250, by revising paragraph (a) and removing 
paragraph (b) and designating it as reserved, as follows:


Sec. 185.1250   Cyfluthrin.

    (a) A tolerance, to expire on November 15, 1997 is established for 
residue of the insecticide cyfluthrin (cyano(4-fluoro-3-
phenoxyphenyl)methyl-3-(2,2-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the following food 
commodities:

                                                                        
[[Page 18565]]                                                          
------------------------------------------------------------------------
        Commodity           Parts per million       Expiration date     
------------------------------------------------------------------------
Cottonseed oil...........  2.0...............  Nov. 15, 1997            
Tomato, concentrated       0.5...............  Do.                      
 products.                                                              
------------------------------------------------------------------------

    (b) [Reserved]
* * * * *

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 348.

    b. In Sec. 186.1250, by revising paragraph (a) and removing 
paragraph (b) and designating it as reserved, as follows:


Sec. 186.1250   Cyfluthrin.

    (a) A tolerance, to expire on November 15, 1997, is established for 
residues of the insecticide cyfluthrin (cyano[4-fluoro-3-
phenoxyphenyl]methyl-3-(2,2-dicloroethenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on the following feed 
commodities:

------------------------------------------------------------------------
        Commodity           Parts per million       Expiration date     
------------------------------------------------------------------------
Cottonseed, hulls........  2.0...............  November 15, 1997        
Tomato, pomace (dry and    5.0...............  Do.                      
 wet).                                                                  
------------------------------------------------------------------------


    (b) [Reserved]
* * * * *

[FR Doc. 95-9149 Filed 4-10-95; 1:53 pm]
BILLING CODE 6560-50-F