[Federal Register Volume 61, Number 97 (Friday, May 17, 1996)]
[Rules and Regulations]
[Pages 24893-24894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12351]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5F4445/R2235; FRL-5366-4]
Allyl Isothiocyanate as a Component of Food Grade Oil of Mustard;
Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement for a
tolerance for residues of the insecticide and repellent, Allyl
isothiocyanate (as a component of food grade Oil of Mustard), in or on
all raw agricultural commodities, when applied according to approved
labeling. Champon 100% Natural Products, Inc. of Boca Raton, Florida,
requested this exemption.
EFFECTIVE DATE: This regulation becomes effective May 17, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [[PP 5F4445/R2235], may 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 should be
identified by the document control number and submitted 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 copy of
objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
5F4445/R2235]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this 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: Robert Forrest, Product
Manager (PM) 14, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 219, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA 22202. (703) [305-6600].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 25, 1995,
(60 FR 54689), EPA issued a notice that Champon 100% Natural Products,
Inc., had submitted pesticide petition (PP) 5F4445 to EPA proposing to
amend 40 CFR part 180 by establishing a regulation pursuant to section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), ``... to establish an exemption from the requirement of a
tolerance for allyl isothiocyanate (a component of oil of mustard) in
or on all fruits and vegetables, nuts, berries, and grains.'' There
were no public comments received as a result of the publication of the
notice of filing.
Allyl isothiocyanate, the subject of this exemption request, is a
component of Oil of Mustard. The Agency has registered this active
ingredient as a dog or cat repellent since 1962. Then, in 1991, the
Agency registered three products as an insecticide and repellent to
Champon 100% Natural Products for non-food/non-feed uses. This
exemption request expands the use of this active ingredient for food/
feed uses.
The Agency has evaluated the data and other relevant material
submitted with the petition or obtained from other sources. These data
and material show that:
1. Allyl isothiocyanate, as a component of oil of mustard, is on
the Food and Drug Administration (FDA) Generally Recognized as Safe
(GRAS) list (21 CFR 182.10, 182.20, 582.10 and 582.20).
[[Page 24894]]
2. Oil of Mustard, as a component of household Yellow Mustard and
Brown Mustard, has been used in a variety of food products [baked
goods, oils, meats, processed vegetables, snack foods, soups, nut
products, and gravies at concentrations up to 18,344 parts per million
(ppm)], for a long time, without any known deleterious health effects.
3. The Acute Oral LD50 for Allyl isothiocyanate, in rats, is
339 mg/kg body weight (Toxicity Category II). An end-use formulation,
as applied, contains only 0.2% Allyl isothiocyanate, which represents a
500-fold dilution of active ingredient.
4. The Acute Oral LD50 for Oil of Mustard, in rats, is 14.8 g/
kg body weight (Toxicity Category IV).
The toxicology data and other information provided are sufficient
to demonstrate that there are no foreseeable human health hazards
likely to arise from the use of the insecticide, Allyl isothiocyanate
(as a component of food grade Oil of Mustard), in or all raw
agricultural commodities.
This pesticide/repellent is considered useful for the purpose for
which the exemption from tolerance is sought and capable of achieving
its physical or technical effect.
Based on the information considered, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health. Therefore, the exemption from tolerance is established as set
forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections to the 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 issue(s) on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the objector (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 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 issue(s) in the manner sought by the requestor would be
adequate to justify the action requested (40 CFR 178.32).
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 ``significant'' and is therefore not subject to
OMB review. In addition, this action does not impose any enforceable
duty, or contain any ``unfunded mandates'' as described in Title II of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require
prior consultation as specified by Executive Order 12875 (58 FR 58093,
October 28, 1993), entitled Enhancing the Intergovernmental
Partnership, or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
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
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 8, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
PART 180--[AMENDED]
Therefore, 40 CFR Part 180 is amended as follows:
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346A and 371.
2. By adding Sec. 180.1167 to subpart D to read as follows:
Sec. 180.1167 Allyl isothiocyanate as a component of food grade oil
of mustard; exemption from the requirement of a tolerance.
The insecticide and repellent Allyl isothiocyanate is exempt from
the requirement of a tolerance for residues when used as a component of
food grade oil of mustard, in or on all raw agricultural commodities,
when applied according to approved labeling.
[FR Doc. 96-12351 Filed 5-16-96; 8:45 am]
BILLING CODE 6560-50-F
