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allyl isothiocyanate Exemption from Tolerance 5/96

[Federal Register: May 20, 1996 (Volume 61, Number 98)]
[Rules and Regulations]               
[Page 25152-25153]
>From the Federal Register Online via GPO Access []
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.

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- 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 
    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).
    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 LD<INF>50 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 

    Dated: May 8, 1996.

Daniel M. Barolo, Director, Office of Pesticide Programs.


    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.