[Federal Register Volume 60, Number 163 (Wednesday, August 23, 1995)]
[Rules and Regulations]
[Pages 43718-43719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20888]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP-8F3662/R1176; FRL-4178-2]
RIN 2070-AB78
Urea; Exemption From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a permanent exemption from the
requirement of a tolerance for residues of the frost protectant urea in
or on various agricultural commodities. Unocal Corp. requested this
regulation pursuant to the Federal Food, Drug and Cosmetic Act.
EFFECTIVE DATE: This regulation becomes effective August 23, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 8F3662/R1176], 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
8F3662/R1176]. 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: Cynthia Giles-Parker, Product
Manager (PM) 22, Registration Division, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm. 229, CM #2, 1921 Jefferson Davis Hwy., Arlington,
VA 22202, (703)-308-8323; e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 12, 1988 (53 FR 39784), which announced
that the Unocal Corp., 3960 Industrial Blvd., Suite 600-B, West
Sacramento, CA 95691, had submitted pesticide petition (PP) 8F3662 to
EPA requesting that the Administrator, pursuant to section 408(d) of
the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
establish an exemption from the requirement of a tolerance for the
frost protectant urea in or on all raw agricultural products. The
proposed exemption was subsequently editorially amended to specify the
following crops on the label of the product proposed for registration
under the Federal Insecticide, Fungicide, and Rodenticide Act, as
amended: alfalfa, almonds, apples, apricots, artichokes, asparagus,
avocados, beans, bell peppers, blackberries, blueberries, broccoli,
brussles sprouts, boysenberries, caneberries, canola, cantaloupe,
carrots, cauliflower, casaba, celery, cherries, chili peppers, chinese
cabbage (bok choy, napa), cooking peppers, corn, cotton, crenshaw,
cucumbers, figs, grapefruit, grapes, honeydew melon, hops, kiwifruit,
kohlrabi, lemons, lentils, lettuce, limes, macadamia nuts, musk melon,
nectarines, olives, onions, oranges, peaches, pears, peanuts, peas,
persian melon, pistachios, plums, potatoes, pumpkin, prunes, radish,
raspberries, rice, safflower, sorghum, spinach, spinach (New Zealand),
squash (winter and summer), strawberries, sugar beets, sunflower, sweet
pepper, table beets, tangerines, tomatoes, walnuts, watermelon, and
zucchini.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The toxicological data considered in support of the exemption from
the requirement of a tolerance include an acute oral toxicity study in
the rat, an acute dermal toxicity study in the rabbit, an acute
inhalation toxicity study in the rat, a primary eye irritation study in
the rabbit, a primary dermal irritation study in rabbits, and a dermal
sensitization study in the guinea pig. These studies were performed on
the end-use product, ``Enfrost,'' with 42.9-percent urea. A review of
these studies indicates that the frost protectant has a low toxicity to
animals when administered via the oral, dermal, or inhalation routes of
exposure (Toxicity Categories III and IV). The active ingredient, urea,
has GRAS (Generally Recognized as Safe) status as a direct food
additive under title 21 of the Code of Federal Regulations (CFR) under
40 CFR 184.1923. Urea is exempt from the requirement of a tolerance
under 40 CFR 180.1001(c) as an inert ingredient in formulations applied
to growing crops or crops after harvest. The amount to be used is
similar to that permitted for the inert ingredient use. Urea is a
normal constituent of animal tissues and body fluid. Humans excrete
about 25 grams per day in the urine. Urea is a naturally occurring
crop/plant constituent.
Acceptable daily intake (ADI) and maximum permissible intake (MPI)
considerations are not relevant to this petition. No enforcement
actions are expected. Therefore, the requirement for an analytical
method for enforcement purposes is not applicable to this exemption
request.
Urea is considered useful for the purpose for which the exemption
from the requirement of a tolerance is sought. There are no regulatory
actions pending against the registration of urea. Based on the
information considered, the Agency concludes that establishment of a
tolerance is not necessary to protect the public health, and therefore,
the exemption from the requirement of a tolerance is established as set
forth below.
The data submitted with the proposal and other relevant material
have been evaluated and discussed in the proposed rule. Based on the
data and information considered, the Agency concludes that the
tolerance exemption will protect the public health. Therefore, the
tolerance exemption is established as set forth below.
[[Page 43719]]
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing 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 a 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 issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
A record has been established for this rulemaking under docket
number [PP 8F3662/R1176] (including any objections and hearing requests
submitted electronically as described below). 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 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Written objections and hearing requests, identified by the document
control number [PP 8F3662/R1176], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-D[email protected]
A copy of electronic objections and hearing requests filed with the
Hearing Clerk 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 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 objections and hearing requests submitted directly in
writing. The official rulemaking record is the paper record maintained
at the address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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 the Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
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: August 4, 1995.
Allen Jennings,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 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. In subpart D, adding new Sec. 180.1117, to read as follows:
Sec. 180.1117 Urea; exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the frost protectant urea in or on the following raw
agricultural commodities when used before harvest in the production of:
alfalfa, almonds, apples, apricots, artichokes, asparagus, avocados,
beans, bell peppers, blackberries, blueberries, broccoli, brussels
sprouts, boysenberries, caneberries, canola, cantaloupes, carrots,
cauliflower, casaba, celery, cherries, chili peppers, chinese cabbage
(bok choy, napa), cooking peppers, corn, cotton, crenshaw, cucumbers,
figs, grapefruit, grapes, honeydew melon, hops, kiwifruit, kohlrabi,
lemons, lentils, lettuce, limes, macadamia nuts, musk melon,
nectarines, olives, onions, oranges, peaches, pears, peanuts, peas,
persian melon, pistachios, plums, potatoes, pumpkin, prunes, radish,
raspberries, rice, safflower, sorghum, spinach, spinach (New Zealand),
squash (winter and summer), strawberries, sugar beets, sunflower, sweet
pepper, table beets, tangerines, tomatoes, walnuts, watermelon, and
zucchini.
[FR Doc. 95-20888 Filed 8-22-95; 8:45 am]
BILLING CODE 6560-50-F