[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: [email protected]. 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