98-19652. Capsaicin; Exemption from the Requirement of a Tolerance

[Federal Register Volume 63, Number 141 (Thursday, July 23, 1998)]
[Rules and Regulations]
[Pages 39519-39521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19652]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300422A; FRL-5799-7]
RIN 2070-AB78


Capsaicin; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of Capsaicin in or on all food commodities, 
when applied in accordance with approved product labeling and good 
agricultural practice. This exemption from requirement of a tolerance 
is being established by the Agency on its own initiative, under the 
Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food 
Quality Protection Act (FQPA) of 1996.
DATES: This regulation becomes effective July 23, 1998. Written 
objections and requests for hearings must be received by September 21, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300422A], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300422A], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [e-mail]. Copies of electronic objections 
and hearing requests must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
electronic objections and hearing requests must be identified by the 
docket number [OPP-300422A]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Copies of electronic objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Richard W. King, 
Biopesticides and Pollution Prevention Division (7511W), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St. SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 9th Floor (902W38), CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA; [phone], e-mail: [e-mail].
SUPPLEMENTARY INFORMATION: In the Federal Register of May 1, 1996 (61 
FR 19233) [OPP-300422; FRL-5362-9], EPA proposed, pursuant to section 
408(e) of the FFDCA, 21 U.S.C. 346a(d) to amend 40 CFR part 180 by 
establishing an exemption from the requirement of a tolerance for 
Capsaicin in or on all food commodities, when applied in accordance 
with approved product labeling and with good agricultural practice. 
There were no comments received in response to the proposed rule. Since 
the date of this proposal, FFDCA section 408 has been significantly 
amended by the Food Quality Protection Act of 1996 (FQPA). The FQPA 
amended the safety standard that applies to both tolerances and 
exemptions from the requirement for tolerance. Nonetheless, the 
legislative history indicates that the same rigorous safety standard 
EPA had always imposed as to tolerance exemptions should be the 
Agency's guide in implementing the new provision. On this specific 
point, the House Commerce Committee Report states:
    The Committee understands that EPA currently issues exemptions 
only for the pesticide chemical residues that do not pose a dietary 
risk under reasonably foreseeable circumstances. The Committee 
intends that EPA retain its current practice. H.Rep. 104-669 part 2, 
104th Cong., 2d Sess. 45 (1996).

Capsaicin clearly meets this standard. Capsaicin and related 
capsaicinoids are the ingredients that produce the ``hotness'' in 
certain species of peppers in the Genus Capsicum. As noted in the 
proposal, there are no known toxicological concerns from the ingestion 
of capsaicin and related capsaicinoids. Residues of capsaicin on food 
will not pose a dietary risk. Thus, EPA concludes that, consistent with 
the amended section 408, exempting

[[Page 39520]]

capsaicin from the requirement is safe in that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
capsaicin. This finding applies not only to the general population but 
also to infants and children as well. Further, EPA has determined that 
a safety factor analysis is not needed in making its conclusion 
regarding the safety of capsaicin due to the lack of toxicity of 
capsaicin. For this reason, EPA concludes that this exemption is safe 
for infants and children without use of the additional safety factor 
described in section 408(b)(2)(C). Accordingly, EPA establishes an 
exemption from tolerance for capsaicin as provided below.

I. Objections and Hearing Requests

     The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by September 21, 1998, file written objections to 
any aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information 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.

II. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300422A] (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 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [e-mail].

    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.

III. Regulatory Assessment Requirements

    This action finalizes an exemption from the tolerance requirement 
under FFDCA section 408(e). The Office of Management and Budget (OMB) 
has exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). In addition, this final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require special OMB 
review in accordance with Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997).
    In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), the Agency previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides

[[Page 39521]]

and pests, Reporting and recordkeeping requirements.

    Dated: July 10, 1998.

Anne E. Lindsay,

Acting Director, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371

    2. Section 180.1165 is added to read as follows:


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

    Capsaicin is exempt from the requirement of a tolerance in or on 
all food commodities when used in accordance with approved label rates 
and good agricultural practice.

[FR Doc. 98-19652 Filed 7-22-98; 8:45 am]
BILLING CODE 6560-50-F