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cyfluthrin (Baythroid) Cyfluthrin; Proposed Pesticide Tolerance 6/96



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185, and 186

[PP 4F4313 and FAP 4H5687/P670, FRL-5374-1]
RIN 2070-AC18

 
Cyfluthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish permanent tolerances for residues of 
the pyrethroid cyfluthrin in or on the raw agricultural commodities 
(RACs) group citrus, fruits; to withdraw the proposed food/feed 
additive petition for citrus oil, dried pulp, and molasses and to 
establish a maximum residue limit for cyfluthrin on citrus oil and 
dried pulp. Bayer Corporation (formerly Miles, Inc.) submitted 
petitions pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA) 
requesting these regulations to establish certain maximum permissible 
levels for residues of the insecticide.

DATES: Comments, identified by the docket control number [PP 4F4313 and 
FAP 4H5687/P670], must be received on or before August 16, 1996.

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 Highway, 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 4:30 p.m., Monday through 
Friday, excluding legal holidays.
    Comments and data may also be submitted to OPP by sending 
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PP 4F4313 and FAP 4H5687/P670]. Electronic comments on 
this proposed 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, telephone number, and e-mail address: Rm. 
200, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. (703) 
305-6100.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of July 13, 1994 (59 FR 35717), which announced that 
Miles Corp. had submitted pesticide petition PP 4F4313 and food/feed 
additive petition (FAP) 4H5687 to EPA. Pesticide petition 4F4313 
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 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 group citrus, fruits at 0.2 parts per millions 
(PPM).
    Food/feed additive petition 4H5687 requests that the Administrator, 
pursuant to section 409(b) of the FFDCA (21 U.S.C. 348), amend 40 CFR 
parts 185 and 186 by establishing food/feed additive regulations for 
cyfluthrin in or on the processed food commodity citrus oil at 1.0 ppm, 
and the feed commodities citrus dried pulp at 1.0 ppm and citrus 
molasses at 0.5 ppm.
    There were no comments or requests for referral to an advisory 
committee received in response to the notice of filing.
    On May 2, 1996, Miles Corp. requested that the proposed food/feed 
additive regulation (4H5687) for citrus oil, citrus dried pulp, and 
citrus molasses under section 409 of FFDCA be withdrawn and proposed 
establishment of a maximum residue level (MRL) for citrus oil and 
citrus dried pulp at 0.3 ppm under section 701 of FFDCA. The request to 
withdraw the feed additive petition for citrus molasses was submitted 
in response to EPA's determination that citrus molasses is no longer 
considered a significant feed item. See EPA's final 860 Series Residue 
Chemistry Guidelines (860.1000) published as public drafts on August 
25, 1995 (60 FR 44343) (formerly Table II of Subdivision O, Residue 
Chemistry, of the Pesticide Assessment Guidelines).
    The request to withdraw the food/feed additive petition under 
section 409 for citrus oil and citrus dried pulp and instead propose to 
establish a MRL for citrus oil and citrus dried pulp under section 701 
was submitted in response to EPA's policy changes regarding when 
pesticide residues concentrate in processed food and whether a 
particular processed food is considered ''ready to eat.'' In June 1995 
(60 FR 31300, June 14, 1995), EPA issued a revised policy concerning 
when section 409 food and feed additive tolerances were needed to
prevent the adulteration of foods and animal feeds. Under EPA's revised 
policy, a section 409 tolerance is necessary for pesticide residues in 
processed food when it is likely that the level of some residues of the 
pesticide will exceed the section 408 tolerance level in ''ready to 
eat'' processed food/feed. Of particular relevance to the proposed 
food/feed additive regulation for citrus oil and dried pulp is EPA's 
decision to interpret the term ''ready to eat'' processed food/feed as 
food ready for consumption ''as is'' without further preparation. For 
foods/feeds that are found to be not ''ready to eat,'' EPA takes into 
account the dilution of residues that occurs in preparing a ''ready to 
eat'' food/feed.
    Under the revised policy, EPA has determined that citrus fruit oil 
and dried citrus pulp are not ''ready to eat'' food or animal feed 
commodities. Citrus oil is not consumed ''as is'' but used as a 
flavoring in other foods. Likewise EPA has found no evidence that dried 
citrus pulp is fed to livestock as a stand-along feed stock. Rather 
dried citrus pulp is used as an ingredient in animal feeds. As such, 
dried citrus pulp can constitute up to 25% of animal feed.
    The proposed section 408 tolerance for cyfluthrin on citrus is 0.2 
ppm. The highest average residue found in crop field trials for 
cyfluthrin on citrus fruits was 0.06 ppm. A processing study showed 
that in producing citrus oil and dried pulp residues concentrated 530% 
(a concentration factor of 5.3x). Thus with this information it is 
likely that cyfluthrin residues of 0.32 ppm (0.06 x 5.3) could occur in 
citrus oil and dried pulp. However to project what residues are likely 
in ''ready to eat'' food or animal feed containing citrus oil and dried 
citrus pulp the 0.32 ppm must be divided by 238 for citrus oil and 3 
for dried citrus pulp to allow for dilution occurring when citrus oil 
and dried citrus pulp is added to other ingredients in the preparation 
of food and animal feed respectively. Once these dilutions are taken 
into account (0.32 divided by 238) and (0.32 divided by 3) the likely 
residues of cyfluthrin in food and animal feed would not be expected to 
exceed 0.001 ppm for citrus oil (or < 0.01 ppm which is the limit of 
detection of the analytical method) and 0.11 for dried citrus pulp. 
Since these levels are below the 408 tolerance level (0.2 ppm) food and 
animal feed would not be adulterated and no section 409 tolerances are 
needed. However since residues could be present in the not ''ready to 
eat'' commodities at levels (0.32 ppm) appreciably higher than the 0.2 
ppm RAC tolerance, section 701 MRL's are being proposed. A section 701 
MRL represents the highest level of pesticide residue in a not ''ready 
to eat'' processed commodity that is consistent with the requirements 
in 21 U.S.C. 342(a)(2)(C) that the pesticide be applied in accordance 
with the section 408 tolerance and that good manufacturing processes be 
used.
    EPA will compute the MRL by multiplying the highest average residue 
found in the raw commodity in field trials by the concentration factor 
determined in processing studies using good manufacturing practices. As 
noted above, the highest average residue from the cyfluthrin fields 
trials is 0.06 ppm and the concentration factor for processing is 5.3x. 
Multiplying 0.06 by 5.3 yields a product of 0.318 ppm. EPA believes it 
is appropriate to round 0.318 ppm and proposes 0.3 ppm as MRL for 
cyfluthrin residues in citrus oil and dried citrus pulp. For purposes 
of enforcement of the MRL, the same analytical method used for 
enforcement of the section 408 tolerances should be used.
    EPA is proposing to place this MRL in existing parts 185 and 186 of 
title 40 of the Code of Federal Regulations (CFR) rather than creating 
a new part of title 40. Currently, 40 CFR parts 185 and 186 contain 
section 409 food and feed additive tolerances organized by pesticide. 
EPA believes it will be clearer to the regulated community and to 
enforcement personnel if all regulations pertaining to residue levels 
of a pesticide in food and animal feeds are located in the same part of 
the CFR. Because EPA is respectively proposing to expand the type of 
regulation that would be included in part 185 and 186, EPA proposes 
modifying the titles of parts 185 and 186 to ''Pesticides in Food and 
Pesticides in Animal Feeds'' to reflect these changes.
    The science data submitted in support of the petitions and other 
relevant material have been reviewed. The toxicological and metabolism 
data considered in support of this tolerance are discussed in detail in 
a related document published in the Federal Register of March 15, 1996 
(61 FR 10678).
    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 U.S. population resulting from established tolerances is 0.002907 
mg/kg/bwt day, which represents 11.6% of the RfD and 0.00662 mg/kg/day, 
which represents 26.4% of the RfD for children (1-6 years old), the 
subgroup population exposed to the highest risk. The current action 
will increase exposure to 0.003268 mg/kg/day or 13% of the RfD and 
0.007605 mg/kg/day or 30.4% of the RfD respectively. 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 rabbit developmental toxicity study (with 
a 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 666. Generally speaking, MOE's greater 
than 100 for data derived from animal studies are generally not of 
concern.
    The metabolism of cyfluthrin in plants and livestocks for this use 
is adequately understood. The residues of concern is cyfluthrin. 
Adequate analytical methodology (Gas liquid chromatography with an 
electron capture detector) 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 Resource 
Branch, Field Operations Division (7506C), Office of Pesticide 
Programs, U.S. 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.
    The established tolerances for residues of cyfluthrin in/on eggs, 
milk, fat, meat and meat by-products of cattle,
goats, hogs, horses, sheep and poultry are adequate to cover secondary 
residues resulting from the proposed use as delinated in 40 CFR 
180.6(a)(2).
    There are presently no actions pending against the continued 
registration of this chemical.
    The pesticide is considered useful for the purpose for which the 
tolerances are sought. Based on the information and data considered, 
the Agency concludes that the establishment of the proposed tolerances 
will protect the public health and proposed MRLs are consistent with 21 
U.S.C. 342 (a)(c). 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 notice 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 4F4313/FAP 4H5687/P670]. All written 
comments filed in response to this petition will be available in the 
Public Responses and Program Resources Branch, at the address given 
above from 8 a.m. to 4:30 p.m., Monday through Friday, except legal 
holidays.
    A record has been established for this rulemaking under the docket 
number [PP 4F4313/FAP 4H5687/P670] (including any comments and data 
submitted electronically). 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 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 1B2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    opp-docket epamail.epa.gov.
    Electronic comments 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 copies of 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 comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ''ADDRESSES'' at the beginning of this document.
    The Office of Management and Budget has exempted this document from 
the requirement of review pursuant to Executive Order 12866.
    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. In addition, 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 1993), entitled ''Enhancing the Intergovernmental 
Partnership,'' or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    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). EPA has treated 
regulations similar to the establishment of tolerances as also not 
having a significant economic impact on substantial number of small 
entities. Therefore, the proposed MRL is not expected to have such 
impact.

List of Subjects in 40 CFR Parts 180, 185, and 186

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

    Dated: June 19, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I 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. In Sec. 180.436(a), by adding and alphabetically inserting the 
following entry in the table therein to read as follows:


Sec. 180.436   Cyfluthrin; tolerances for residues.

    (a) *  *  *

                                                                        
------------------------------------------------------------------------
         Commodities              Parts per million      Expiration date
------------------------------------------------------------------------
                                                                        
     *        *        *        *        *        *        *            
Citrus, fruits...............                      0.2  None            
                                                                        
     *        *        *        *        *        *        *            
------------------------------------------------------------------------


    *    *    *    *    *    

PART 185--PESTICIDES IN FOOD

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

    Authority: 21 U.S.C. 342, 348, and 701.

    b. By revising the part heading for part 185 to read as set forth 
above.

    c. In Sec. 185.1250, by adding paragraph (b) to read as follows:


Sec. 185.1250   Cyfluthrin.

    *  *  *  *  *
    (b)(1) A maximum residue level regulation 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 food 
commodities:

                                                                        
------------------------------------------------------------------------
                  Commodities                       Parts per million   
------------------------------------------------------------------------
Citrus oil.....................................                      0.3
------------------------------------------------------------------------

    (2) This regulation reflects the maximum level of residues in 
citrus oil consistent with use of cyfluthrin on citrus, fruits in 
conformity with Sec.  180.436 of this chapter and with the use of good 
manufacturing practices.
    *  *  *  *  *

PART 186 -- [AMENDED]

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

Authority: 21 U.S.C. 342, 348, and 701.

    b. In Sec. 186.1250, by adding paragraph (b), to read as follows:


Sec. 186.1250   Cyfluthrin.

    *  *  *  *  *
    (b)(1) A maximum residue level regulation 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:

                                                                        
------------------------------------------------------------------------
                  Commodities                       Parts per million   
------------------------------------------------------------------------
Citrus, dried pulp.............................                      0.3
------------------------------------------------------------------------

    (2) This regulation reflects the maximum level of residues in 
citrus, dried pulp consistent with use of cyfluthrin on citrus, fruits 
in conformity with Sec. 180.436 of this chapter and with the use of 
good manufacturing practices.
      *  *  *  *  *

[FR Doc. 96-18183 Filed 7-15-96; 8:45 am]
BILLING CODE 6560-50-F