Document ID: EPA-HQ-OPP-2006-0970-0001
Agency: epa
Document Type: Rule
Title: Tris (2-ethylhexyl) Phosphate; Exemption from the Requirement of a Tolerance
Posted Date: 2007-02-07T05:00Z

[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]

BILLING CODE 6560-50-S