[Federal Register Volume 61, Number 85 (Wednesday, May 1, 1996)]
[Proposed Rules]
[Pages 19233-19236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10804]



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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: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption.

[[Page 19234]]

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: 
[email protected].

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.

B. Ammonium Salts of Fatty Acids: Exemptions from the Requirement of a 
Tolerance

    1. Regulatory history. Pesticidal products containing mineral salts 
of fatty acids were first registered in 1947 (Reregistration 
Eligibility Document for Soap Salts, Case 4083, U.S. Environmental 
Protection Agency, September 1992). Currently, the two active 
ingredients are potassium salts of fatty acids, which are registered as 
insecticides, acaricides, herbicides, and algaecides, and ammonium 
salts of fatty acids which are registered for use as rabbit and deer 
repellent on forage and grain crops, vegetables, and field crops. 
Similar to potassium salts of fatty acids, structurally, ammonium salts 
are linked with naturally occurring fatty acids comprising of C8-
C18 saturated and C18 unsaturated chain lengths. Naturally 
occurring fatty acids constitute a significant part of the normal daily 
diet, are of low toxicity when taken orally, and pose no known health 
risks. The residues of these salts of fatty acids from pesticide use 
are not likely to exceed levels of naturally occurring fatty acids in 
commonly eaten foods. Both potassium and ammonium salts of fatty acids 
are generally recognized as safe by the Food and Drug Administration of 
the Department of Health and Human Services. An exemption from the 
requirement of a tolerance for all food uses already exists for 
potassium salts of fatty acids (40 CFR 180.1068).
     2.  Current proposal. On September 10, 1980, the Thompson-Hayward 
Co.

[[Page 19235]]

made a formal request to the EPA for an exemption from the requirement 
of a tolerance for ammonium salts of fatty acids. The request was 
reviewed by the Agency, which had no objections to the addition of food 
uses. The addition of food uses was accepted in 1982. However, a formal 
notice of the proposed exemption was not published in the Federal 
Register. The Agency is now proposing to establish an exemption from 
the requirement of a tolerance for all food uses under FFDCA section 
408 for ammonium salts of fatty acids, because a tolerance is not 
needed to protect the public health.

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:
    [email protected]
    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:


Sec. 180.1166  Ammonium salts of fatty acids; exemption from the 
requrement of a tolerance.

    Ammonium oleate and related C8-C18 fatty acids ammonium 
salts, are exempted from the requirement of a tolerance for residues in 
or on all raw agricultural commodities when used in

[[Page 19236]]

accordance with good agricultural practice.

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