PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> Insecticides, D to E --> Deltamethrin --> Deltamethrin - Proposed Food and Feed Additive Regulations 11/95

Deltamethrin - Proposed Food and Feed Additive Regulations 11/95

[Federal Register: November 30, 1995 (Volume 60, Number 230)]
[Notices]
[Page 61552]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
-----------------------------------------------------------------------

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.
-----------------------------------------------------------------------

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: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 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:
larocca.george@epamail.epa.gov.

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 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-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 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:

    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]