[Federal Register: December 26, 2002 (Volume 67, Number 248)]
[Rules and Regulations]
[Page 78715-78718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de02-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0277; FRL-7284-2]
Urea; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of urea when used in pesticide
formulations. Ecolab, Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996, requesting an exemption from the requirement of
a tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of urea. This final rule is being
published in today's Federal Register with a companion Direct Final
Rule entitled ``Urea: Revocation of Tolerance Exemptions''
DATES: This regulation is effective December 26, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0277,
must be received on or before February 24, 2003.
ADDRESSES: Written objections and hearing requests submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Treva C. Alston, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8373; e-mail address: alston.treva@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2002-0277. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html
, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of April 7, 2000 (65 FR 18324) (FRL-6499-
7), EPA issued a notice pursuant to section 408 of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act (FQPA) (Public Law 104-170), announcing the
filing of a pesticide tolerance petition (PP 9E6028) by Ecolab, Inc.,
370 N. Wabasha Street, St. Paul, MN 55102. This notice included a
summary of the petition prepared by the petitioner Ecolab. There were
no comments received in response to the notice of filing.
The petition requested that 40 CFR 180.1001 be amended by
establishing an exemption from the requirement of a tolerance for
residues of urea in or on raw agricultural commodities, in processed
commodities, and in or on meat and meat by products of cattle, sheep,
hogs, goats, horses, poultry, milk, dairy products, eggs, seafood and
shellfish, and fruits and vegetables when such residues result from the
use of urea as a component of a food contact surface sanitizing
solution for use in food handling establishments.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption from tolerance is ``safe.'' Section 408(b)(2)(A)(ii)
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable
[[Page 78716]]
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) requires EPA to give special consideration to
exposure of infants and children to the pesticide chemical residue in
establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. * * *''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by urea
are discussed in this unit.
In the Federal Register of April 15, 2002 (67 FR 18197) (FRL-6860-
6), the Agency published its report of the Tolerance Reassessment
Decision for urea. This Report contained the hazard characterization of
urea. For a complete description of the use summary, hazard
characterization, exposure assessment and risk assessment findings, see
the Notice of April 15, 2002. These data are considered by the Agency
to be sufficient to assess the potential hazard to humans, including
infants and children.
IV. Summary of Risk Assessment Findings
From the available animal studies and other data, EPA has concluded
that urea exhibits a low toxicity and exposures to urea used either as
an active or inert pesticide ingredient present a reasonable certainty
of no harm to human health.
V. Cumulative Effects
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify or revoke a tolerance, the Agency consider available
information concerning the cumulative effects of a particular
pesticide's residues and other substances that have a common mechanism
of toxicity. Urea is a low toxicity chemical. EPA does not have, at
this time, available data to determine whether urea has a common
mechanism of toxicity with other subtances or how to include these
pesticide chemicals in a cumulative risk assessment.
VI. Determination of Safety for U.S. Population, Infants and Children
Based on the available data, EPA concludes that urea does not pose
a dietary risk under reasonable foreseeable circumstances. Accordingly,
EPA finds that there is a reasonable certainty that no harm will result
to the general population, and to infants and chldren from aggregate
exposure to urea. Because of the low toxicity of urea, a safety factor
analysis has not been used to assess the risk. For the same reason, the
tenfold safety factor for the protection of infants and children is
unnecessary.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. EPA has been working with interested
stakeholeders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing urea may be
required.
B. Analytical Method(s)
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
C. Existing Tolerances
There are four existing tolerance exemptions for urea. They are as
follows: Sec. 180.1001(c), (d), and (e); and Sec. 180.1117. However,
in today's Federal Register, the Agency, acting on its on initiative,
published a direct final rule revoking these four tolerance exemptions
as they are no longer necessary. No uses are lost by revoking the above
four tolerance exemptions, as the tolerance exemption established in
this rule will cover these uses and the use requested by the
petitioner.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
urea nor have any CODEX Maximum Residue Levels been established for any
food crops at this time.
E. List 4A Classification
Based on its low toxicity, urea will be classified as a List 4A
inert ingredient. List 4A inert ingredients are minimal risk inert
ingredients. Minimal risk does not imply no risk under any
circumstances. Every substance can present some risk in certain
circumstances. Minimal risk is used to indicate a substance for which
there is no information to indicate that there is a basis for concern.
Thus, the tolerance exemption will be established in 40 CFR 180.950
which holds minimal risk chemicals instead of 40 CFR 180.1001 as
requested by the petitioner, Ecolab.
VIII. Conclusions
Based on the information in the record, EPA concludes that there is
a reasonable certainty of no harm from aggregate exposure to residues
of urea. Accordingly, EPA finds that exempting urea from the
requirement of a tolerance will be safe.
IX. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0277 in the subject line on the
first page of your submission. All
[[Page 78717]]
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before February 24, 2003.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2002-0277, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.1. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. Regulatory Assessment Requirements
This final rule establishes an exemption from the tolerance
requirement under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866, this rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerance exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not
[[Page 78718]]
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of FFDCA section
408(n)(4). For these same reasons, the Agency has determined that this
rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This rule will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
XI. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 12, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.950 is amended by adding alphabetically the
following ingredient to the table in paragraph (e) to read as follows.
Sec. 180.950 Tolerance exemptions for minimal risk active and inert
ingredients.
* * * * *
(e) * * *
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Chemical CAS No.
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Urea....................................................... 57-13-6
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[FR Doc. 02-32564 Filed 12-24-02; 8:45 am]
BILLING CODE 6560-50-S