95-20888. Urea; Exemption From the Requirement of a Tolerance

[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: [e-mail]. 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: [e-mail].

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:
    [e-mail]


    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]

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