[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Rules and Regulations]
[Page 5621-5624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe07-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0970; FRL-8112-2]
Tris (2-ethylhexyl) Phosphate; 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 tris (2-ethylhexyl) phosphate (TEHP, CAS
Reg. No. 78-42-2) when used as an inert ingredient in pesticide
formulations with the active ingredients pinoxaden, clodinafop-
propargyl, and tralkoxydium, with no more than two applications per
season when applied to wheat and barley up to the pre-boot
[[Page 5622]]
stage (prior to formation of edible grain). Syngenta Crop Protection,
LLC submitted a petition to EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of
1996 (FQPA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of TEHP.
DATES: This regulation is effective February 7, 2007. Objections and
requests for hearings must be received on or before April 9, 2007, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0970. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The 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.
FOR FURTHER INFORMATION CONTACT: R. Tracy Ward, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9361; e-mail address: ward.tracyh@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 entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 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 unit 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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in [insert appropriate
cite to either another unit in the preamble or a section in a rule]. 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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0970 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before April 9, 2007.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0970, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of August 9, 2006 (71 FR 45559) (FRL-8082-
9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Public Law 104-170), announcing the
filing of a pesticide petition (PP 6E7078) by Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27410. The petition requested that
40 CFR 180.910 be amended by establishing an exemption from the
requirement of a tolerance for residues of tris (2-ethylhexyl)
phosphate (TEHP, CAS Reg. No. 78-42-2). That notice referenced a
summary of the petition prepared by the petitioner. Syngenta Crop
Protection, LLC requested the use of TEHP as an adjuvant in pesticide
formulations with the active ingredients pinoxaden, clodinafop-
propargyl, and tralkoxydium applied to the growing crops wheat and
barley. There were no substantive comments received in response to the
notice of filing.
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 tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the FFDCA
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 information.'' This includes
exposure through drinking water and in residential settings, but does
not include
[[Page 5623]]
occupational exposure. Section 408(b)(2)(C) of the FFDCA 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. . . .''
III. Risk Characterization and Conclusion
Consistent with section 408(b)(2)(D) of the 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 TEHP are discussed in this unit. The following provides a brief
summary of the risk assessment and conclusions for the Agency's review
of TEHP. The full decision document for this action is available on
EPA's Electronic Docket at http://www.regulations.gov under docket
number EPA-HQ-OPP-2006-0970.
A. Human Health
The Agency reviewed the available information submitted by the
petitioner as well as additional information available to the Agency
and has determined that TEHP is of low acute and subchronic oral and
inhalation toxicity, but is a moderate skin irritant. TEHP is not a
cancer concern, is not mutagenic and is not a neurotoxin. Although no
developmental toxicity study is available on TEHP, the Agency has
determined that tributyl phosphate is an acceptable analog and can be
used to characterize the developmental toxicity of TEHP. Based on
developmental and reproductive toxicity studies on the analog tributyl
phosphate, TEHP is expected to produce developmental toxicity only at
maternally toxic doses. One developmental study conducted on tributyl
phosphate showed one incident of a rare fetal malformation. The
observed effect is not likely to have resulted from exposure to
tributyl phosphate. The petitioner has agreed to conduct an acceptable
rat developmental study on TEHP and submit it to EPA within 18 months
in order to confirm that this malformation is not an effect of TEHP.
The Agency concludes that dietary and drinking water exposures of
concern are not anticipated from the inert ingredient use of TEHP
considering its physical and chemical properties, including low
volatility and rapid biodegradation, and the limitations imposed by its
proposed use as an adjuvant in pesticide formulations only with the
active ingredients pinoxaden, clodinafop-propargyl, and tralkoxydium,
limited to no more than two applications per season on two crops, wheat
and barley, up to the pre-boot stage (prior to formation of edible
grain).
Residential exposures (inhalation and dermal) to TEHP are not
expected due to its low volatility, limited use pattern in agricultural
pesticides, and rapid biodegradation in the environment.
Taking into consideration all available information on TEHP, it has
been determined that there is a reasonable certainty that no harm to
any population subgroup will result from aggregate exposure to TEHP
when used as an inert ingredient in pesticide formulations when
considering dietary exposure and all other non-occupational sources of
pesticide exposure for which there is reliable information. Therefore,
the exemption from the requirement of a tolerance requested by the
petitioner, Syngenta Crop Protection, LLC, for residues of TEHP, can be
considered assessed as safe under section 408(q) of the FFDCA.
B. Analytical Methods
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 limitations.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
tris (2-ethylhexyl) phosphate nor have any CODEX Maximum Residue Levels
(MRLs) been established for any food crops at this time.
IV. Conclusions
Based on the information in this preamble and in the decision
document, EPA concludes that there is a reasonable certainty of no harm
to the general population, including infants and children, from
aggregate exposure to residues of tris (2-ethylhexyl) phosphate (TEHP).
Accordingly, EPA finds that exempting TEHP from the requirement of a
tolerance will be safe. EPA is establishing a tolerance exemption for
TEHP on wheat and barley when it is used as an inert ingredient in
pesticide formulations with the active ingredients pinoxaden,
clodinafop-propargyl, and tralkoxydium. TEHP is limited to no more than
two applications per season and these applications must occur no later
than the pre-boot stage (prior to formation of edible grain).
V. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA 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 due to its lack of significance, 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 section 408(d) of the FFDCA, such as the 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
[[Page 5624]]
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 alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of the FFDCA. 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.
VI. Congressional Review Act
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: January 25, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--AMENDED
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1274 is added to subpart D to read as follows:
Sec. 180.1274 Tris (2-ethylhexyl) phosphate; exemption from the
requirement of a tolerance.
Tris (2-ethylhexyl) phosphate (TEHP, CAS Reg. No. 78-42-2) is
exempt from the requirement of a tolerance for residues in wheat and
barley when used under the following conditions:
(a) The use is in accordance with good agricultural practices;
(b) Tris (2-ethylhexyl) phosphate is used as an inert ingredient in
pesticide formulations with the active ingredients pinoxaden,
clodinafop-propargyl, and tralkoxydium;
(c) Tris (2-ethylhexyl) phosphate is applied no more than twice per
season; and
(d) The applications occur no later than the pre-boot stage (prior
to formation of edible grain).
[FR Doc. 07-460 Filed 1-30-07; 12:41 pm]
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