[Federal Register Volume 60, Number 230 (Thursday, November 30, 1995)]
[Proposed Rules]
[Pages 61504-61506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29251]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 185 and 186

[FAP 4H5710/P636; FRL-4983-5]
RIN 2070-AC18


Deltamethrin; Food and Feed Additive Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish food and feed additive regulations 
for residues of the pyrethroid deltamethrin in or on food and feed 
items as a result of use in food- and feed-handling establishments. 
Roussel Uclaf Corp. requested these regulations pursuant to Federal 
Food, Drug and Cosmetic Act (FFDCA) that would establish the maximum 
permissible levels for residues of the pesticide in or on certain food 
and feed items.

DATES: Comments, identified by the document control number [PP4H5710/
P636], must be received on or before January 2, 1996.

ADDRESSES: Submit written comments by mail 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 document may be claimed confidential by 
marking any parts or all of that information as ``Confidential Business 
Information (CBI). Information so marked will not be disclosed except 
in accordance with procedures as set forth in 40 CFR part 2. A copy of 
the comment that does not contain CBI must be submitted for inclusion 
in the record. Information not marked confidential will be included in 
the public docket by EPA without prior notice. The public docket is 
available for public inspection in Rm. 1132 at the above address, from 
8 a.m. through 4:30 p.m., Monday through Friday, excluding legal 
holidays. Comments and data may also be submitted by sending electronic 
mail (e-mail) to:
    [email protected]
    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 4H5710/P636]. No Confidential 
Business Information (CBI) should be submitted through e-mail. 
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 and telephone number: Rm. 202, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6100; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of February 8, 1995 (60 FR 7541), which announced 
that, Roussel Uclaf Corp., 95 Chestnut Ridge Rd., P.O. Box 30, 
Montvale, NJ 07645, had submitted pursuant to section 409 of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 348, a food 
additive petition, FAP 4H5710, that proposed amending 40 CFR part 185 
by establishing a food additive regulation to permit residues of the 
insecticide deltamethrin [(1R,3R)-3-(2,2-dibromovinyl)-2,2-
dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl 
ester] in or on food as a result of use in food-handling establishments 
at 0.02 part per million (ppm). On March 20, 1995, Roussel Uclaf Corp. 
submitted a request to amend 40 CFR part 186 by proposing a feed 
additive regulation to permit residues of the insecticide deltamethrin 
in or on feed items as a result of use in feed-handling establishment 
at 0.02 ppm.
    The scientific data submitted in the petitions and other relevant 
material have been evaluated. The toxicological and metabolism data and 
analytical methods for enforcement purposes considered in support of 
these tolerances include the following:
    1. Chronic 2-year feeding in dogs with a systemic NOEL greater than 
40 ppm (highest doses treated (HDT)).
    2. A 24-month chronic feeding/carcinogenicity study in rats with a 
systemic NOEL of 20 ppm (1 mg/kg/day) and LEL of 50 ppm (2.5 mg/kg/day 
based on decreased body weight. No carcinogenic effects were observed 
in this study.
    3. Mutagenicity tests include an Ames assay, a structural 
chromosomal aberration assay in Chinese hamster ovary (CHO) cells, and 
an unscheduled DNA synthesis assay in rat hepatocyte. All tests were 
negative for genotoxicity.
    4. A metabolism study in rats demonstrates that deltamethrin is 
relatively well absorbed. Urine and fecal excretions were almost 
complete at 48 hours post dose.
    5. An oral development toxicity study in rats with a developmental 
NOEL of 11 mg/kg/day (highest dose tested). The maternal NOEL was 3.3 
mg/kg/day with the LEL of 7 mg/kg/day based on one death and excessive 
salivation. An oral developmental toxicity study in rabbits with a 
maternal NOEL of 10 mg/kg/day and a maternal LEL of 25 mg/kg/day based 
on decreased defecation. The developmental NOEL was 25 mg/kg/day with a 
developmental LEL of 100 mg/kg/day based on statistically significant 
trend for an increase in fetal incidence of unossification of pubic and 
tail bones.
    6. A three-generation reproduction study in rats noted no parental 
effects. NOEL greater than 50 ppm.
    A chronic dietary exposure/risk assessment was performed for 
deltamethrin using a reference dose (RfD) of 0.01 mg/kg bwt/day based 
on a NOEL 1.00 mg/kg bwt/day from the 2-year rat feeding study with an 
uncertainty factor of 100. The end-point effect of concern was 
decreased body weight. The Theoretical Maximum Residue Contribution 
(TMRC) from established tolerances utilizes 3.7% of the RfD for the 
U.S. population and 2.3% of the RfD for the subpopulation 

[[Page 61505]]
most highly exposed, nonnursing infants (less than 1-year old). 
Establishing the new tolerances would utilize 5.1% of the RfD for the 
U.S. population and 20.7% for nonnursing infants (less than 1-year 
old). If the new tolerances are approved, the total percentages of the 
RfD utilized for the U.S. population and nonnursing infants (less than 
1-year old) are 8.8% and 23.0%, respectively. Generally speaking, EPA 
has no cause for concern if total residue contribution for published 
tolerances is less than the RfD. EPA concludes that the chronic dietary 
risk of deltamethrin, as estimated by the dietary risk assessment, does 
not appear to be of concern.
    The nature of the deltamethrin residue in plants and animals for 
this use is adequately understood. The residues of concern is 
deltamethrin. There is no reasonable expectation of secondary residues 
in eggs, meat, milk, or poultry from the proposed use as delineated in 
40 CFR 180.6(a)(3).
    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.
    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 
concludes that the proposed tolerances will 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, [FAP 4H5710/P636]. 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 
4:30 p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [FAP 4H5710/P636] (including comments and data 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.
    Electronic comments can be sent directly to EPA at:
    opp-D[email protected]


    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 all comments 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.
    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 a ``significant regulatory action'' because it 
does not meet any of the regulatory signficance crieteria listed above.
    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).
    This proposed regulatory action does not contain any information 
collection requirements subject to review by OMB under the Paper 
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
    This proposed rule contains no Federal mandates under Title II of 
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State, 
local, or tribal governments or the private sector because it would not 
impose enforceable duties on them.

List of Subjects in 40 CFR Parts 185 and 186

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

    Dated: November 7, 1995.

Susan Lewis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR parts 185 and 186 be amended 
as follows:

PART 185--[AMENDED]

    1. In part 185:

[[Page 61506]]

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

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

    b. In Sec. 185.1580, by designating the existing text as paragraph 
(a) and by adding new paragraph (b), to read as follows:


Sec. 185.1580   Deltamethrin.

* * * * *
    (b) A food additive tolerance of 0.02 part per million is 
established for residues of the insecticide deltamethrin [(1R,3R)-
3(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-
cyano-3-phenoxybenzyl ester] as follows:
    (1) In or on all food items (other than those covered by a higher 
tolerance as a result of use on growing crops) resulting from use in 
food- handling establishments.
    (2) The insecticide may be present as a residue from application of 
deltamethrin in food-handling establishments, including food service, 
manufacturing and processing establishments, such as restaurants, 
cafeterias, supermarkets, bakeries, breweries, dairies, meat 
slaughtering and packing plants, and canneries in accordance with the 
following prescribed conditions:
    (i) Application shall be limited to a general surface and spot and/
or crack and crevice treatment in food-handling establishments where 
food and food products are held, processed, prepared, and served. 
General surface application may be used only when facility is not in 
operation provided exposed food is covered or removed from area being 
treated. Spot and/or crack and crevice application may be used while 
the facility is in operation provided exposed food is covered or 
removed from area being treated prior to application. Spray 
concentration shall be limited to a maximum of 0.06 percent active 
ingredient. Contamination of food-contact surfaces shall be avoided.
    (ii) To assure safe use of the pesticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.

PART 186--[AMENDED]

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

    Authority: 21 U.S.C. 348.

    b. By adding new Sec. 186.1580, to read as follows:


Sec. 186.1580   Deltamethrin.

    (a) A feed additive tolerance of 0.02 part per million is 
established for residues of the insecticide deltamethrin [(1R,3R)-3-
(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-
cyano-3-phenoxybenzyl ester] as follows:
    (1) In or on all feed items (other than those covered by a higher 
tolerance as a result of use on growing crops) resulting from use in 
feed- handling establishments.
    (2) The insecticide may be present as a residue from application of 
deltamethrin in feed-handling establishments, including feed 
manufacturing and processing establishments in accordance with the 
following prescribed conditions:
    (i) Application shall be limited to a general surface and spot and/
or crack and crevice treatment in feed-handling establishments where 
feed and feed products are held, processed, prepared, and served. 
General surface application may be used only when facility is not in 
operation provided exposed food is covered or removed from area being 
treated. Spot and/or crack and crevice application may be used while 
the facility is in operation provided exposed feed is covered or 
removed from area being treated prior to application. Spray 
concentration shall be limited to a maximum of 0.06 percent active 
ingredient. Contamination of feed-contact surfaces shall be avoided.
    (ii) To assure safe use of the pesticide, its label and labeling 
shall conform to that registered with the U.S. Environmental Protection 
Agency and shall be used in accordance with such label and labeling.
    (b) [Reserved]

[FR Doc. 95-29251 Filed 11-29-95; 8:45 am]
BILLING CODE 6560-50-F