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Capsaicin - Proposed Tolerance 4/96

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300422; FRL-5362-9]
RIN 2070-AB18

Capsaicin, and Ammonium Salts of Fatty Acids; Proposed Tolerance
Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: For the pesticides subject to the actions listed in this
proposed rule, EPA has completed the reregistration process and issued
a Reregistration Eligibility Decision (RED). In the reregistration
process, all information to support a pesticide's continued
registration is reviewed for adequacy and, when needed, supplemented
with new scientific studies. Based on the RED tolerance assessments for
the pesticide chemicals subject to this proposed rule, EPA is proposing
to exempt from the requirement of a tolerance, all registered food uses
for the pesticides, capsaicin and ammonium salts of fatty acids.

DATES: Written comments, identified with the docket number [OPP-300422]
should be submitted to EPA by July 1, 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 Hwy., Arlington, VA. 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(s) 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 to the submitter. Any written
comments will be available for public inspection in Rm. 1132 at the
Virginia 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 electronically 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 in 5.1
file format or ASCII file format. All comments and data in electronic
form must be identified by the docket number [OPP-300422]. 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: David H. Chen, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location: Special Review
Branch, Crystal Station #1, 3rd floor, 2800 Crystal Drive, Arlington,
VA 22202. Telephone: (703)-308-8017, e-mail:
chen.david@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Legal Authorization

    The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et
seq.) authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the requirement of a tolerance for residues
of pesticide chemicals in or on raw agricultural commodities pursuant
to section 408 [21 U.S.C. 346(a)]. Without such tolerances or
exemptions, a food containing pesticide residues is considered
"adulterated" under section 402 of the FFDCA, and hence may not
legally be moved in interstate commerce [21 U.S.C. 342]. To establish a
tolerance or an exemption under section 408 of the FFDCA, EPA must make
a finding that the promulgation of the rule would "protect the public
health" [21 U.S.C. 346a(b)]. For a pesticide to be sold and
distributed, the pesticide must not only have appropriate tolerances
under the FFDCA, but also must be registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 136 et
seq.).
    In 1988, Congress amended the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and required EPA to
review and reassess the potential hazards arising from currently
registered uses of pesticides registered prior to November 1, 1984. As
part of this process, the Agency must determine whether a pesticide is
eligible for reregistration or whether any subsequent actions are
required to fully attain reregistration status. EPA has chosen to
include in the reregistration process a reassessment of existing
tolerances or exemptions from the need for a tolerance. Through this
reassessment process, based on more recent data, EPA can determine
whether a tolerance must be amended, revoked, or established, or
whether an exemption from the requirement of one or more tolerances
must be amended or is necessary.
    The procedure for establishing, amending, or revoking tolerances or
exemptions from the requirement of tolerances is set forth in 40 CFR
parts 177 through 180. The Administrator of EPA, or any person by
petition, may initiate an action proposing to establish, amend, revoke,
or exempt a tolerance for a pesticide registered for food uses. Each
petition or request for a new tolerance, an amendment to an existing
tolerance, or a new exemption from the requirement of a tolerance must
be accompanied by a fee. Current Agency policy on tolerance actions
arising from the reregistration process is to administratively process
some actions without requiring payment of a fee; this waiver of fees
applies to revisions or revocations of established tolerances, and to
proposed exemptions from the requirement of a tolerance if the proposed
exemption requires the concurrent revocation of an established
tolerance. Comments submitted in response to the Agency's published
proposals are reviewed; the Agency then publishes its final
determination regarding the specific tolerance actions.

II. Chemical-Specific Information and Proposed Actions

A. Capsaicin: Exemption from the Requirement of a Tolerance

    1. Regulatory history. Capsaicin (8-methyl-n-vanillyl-6-non) and
related capsaicinoids are the ingredients that produce the
"hotness"in certain species of peppers in the Genus Capsicum. When
used as a toxicant or repellent, products may consist simply of ground
hot peppers or as an oleoresin extracted from the ground hot peppers.
In either case, the amount of the actives must be verified by High
Performance Liquid Chromatography. Products containing capsaicin and
related capsaicinoids typically are formulated alone or in combinations
with other active ingredients, such as garlic, allyl isothiocyanate
(the active ingredient in oil of mustard), and egg solids. Formulations
include dusts, granulars, gels, aerosols, and liquids. The U.S.
Department of Agriculture first registered a product containing these
actives in 1962, as a dog-attack repellent (Reregistration Eligibility
Document for Capsaicin, Case 4018, U.S. Environmental Protection
Agency, June 1992, Page 3).
    Currently, capsaicin is registered for use as an animal repellent
against attacking dogs, birds, voles, deer, rabbits, and tree
squirrels, and for use as an insect toxicant and repellent. Capsaicin
products are used indoors in crack and crevice, on carpets and
upholstered furniture, and outdoors on fruit and vegetable crops,
grains, ornamental plants and shrubs, flowers, lawns, gardens and
garbage bags. Because capsaicin is a naturally-occurring substance
which exhibits a non-toxic mode of action in humans, in 1991, EPA
reclassified capsaicin as a biochemical pesticide.
    2. Current proposal. Red peppers have long been used as a food
without any known adverse health effects to man. In the absence of
known toxicological concerns from the ingestion of capsaicin and
related capsaicinoids, the Agency does not believe a tolerance for
capsaicin is needed to protect the public health. Therefore, EPA
proposes to exempt capsaicin from the requirement of a tolerance for
residues in or on fruits, vegetables, and grains.

III. Public Comment Procedures

    EPA invites interested parties to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by July 1, 1996. Comments must bear a notation indicating
the docket number. Three copies of the comments should be submitted to
either location listed under ADDRESSES.
    Information submitted as a comment concerning this document may be
claimed confidential by marking any or all of that information as
"Confidential Business Information" (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
must also be submitted for inclusion in the public record. EPA may
publically disclose without prior notice information not marked
confidential.
    Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA, as amended, that 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.
    EPA has established a record for this proposed rule under docket
number [OPP-300422], (including comments 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, except 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
    The official record for this proposed rule, 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 proposed rule record which will also include all comments
submitted directly in writing. The official proposed rule record is the
paper record maintained at the "ADDRESSES" at the beginning of this
document.

IV. Regulatory Assessment Requirements

    To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and
the Unfunded Mandates Reform Act, EPA has considered the impacts of
this proposal.

A. 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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a "significant regulatory action" as an action that
is likely to result in 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 tribal
governments or communities (also referred to 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 entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; 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-significance criteria listed above.

B. Regulatory Flexibility Act

    EPA has reviewed this proposed rule under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.], and has determined that it will not have a significant economic
impact on any small businesses, governments, or organizations. The
proposed actions are not expected to significantly impact entities of
any size.
    Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
Flexibility Act.

C. Paperwork Reduction Act

    This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.

D. Unfunded Mandates

    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 Part 180

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

    Dated: April 12, 1996.

Lois Rossi,

Director, Special Review and Reregistration 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 would continue to read as
follows:

    Authority: 15 U.S.C. 346a and 371.

    2. Section 180.1165 is added to subpart D to read as follows:

Sec. 180.1165  Capsaicin; exemption from the requirement of a
tolerance.

    Capsaicin is exempted from the requirement of a tolerance for
residues in or on fruits, vegetables, and grains, when used in
accordance with labelled rates and with good agricultural practice.
    3. Section 180.1166 is added to subpart D to read as follows:

[FR Doc. 96-10804 Filed 4-30-96; 8:45 am]
BILLING CODE 6560-50-F