allyl isothiocyanate Exemption from Tolerance 5/96
[Federal Register: May 20, 1996 (Volume 61, Number 98)]
[Rules and Regulations]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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-
email@example.com. 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.