[Federal Register Volume 72, Number 219 (Wednesday, November 14, 2007)]
[Rules and Regulations]
[Pages 63994-63997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22223]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0305; FRL-8156-6]


Isoxadifen-ethyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate; CAS 
Reg. No. 163520-33-0) and its metabolite 4,5-dihydro-5,5,diphenyl-3-
isoxazolecarboxylic acid when used as an inert ingredient (safener) in 
or on corn, sweet, kernel plus cob with husks removed; corn, sweet, 
forage; corn, sweet, stover; corn, pop, grain; corn, pop, stover; and 
corn, oil. EPA is also revising existing tolerances for residues of 
isoxadifen-ethyl in or on corn, field, forage and corn, field, hay, and 
removing the seasonal application rate specification from existing 
tolerances. Interregional Research Project Number 4 (IR-4) and Bayer 
CropScience requested certain tolerance amendments for the inert 
ingredient safener isoxadifen-ethyl under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2007. Objections and 
requests for hearings must be received on or before January 14, 2008, 
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-2005-0305. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. 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: 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: [email protected].

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

[[Page 63995]]

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. 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-2005-0305 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 January 14, 2008.
    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-2005-0305, 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 Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA received several petitions requesting new tolerances and 
amendments to existing tolerances for the inert ingredient (safener) 
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate; CAS 
Reg. No. 163520-33-0). The most recent final rule that established 
tolerances for this safener was published in the Federal Register (69 
FR 29882) on May 26, 2004 (http://www.epa.gov/fedrgstr/EPA-PEST/2004/May/Day-26/p11561.htm). That final rule provides a description of the 
toxicity data and risk assessments for isoxadifen-ethyl, and the reader 
is referred to it for additional information. The new petitions 
received by the Agency are summarized below.
    In the Federal Register of January 18, 2006 (81 FR 2926) (FRL-7750-
1), the Agency issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a announcing the filing of pesticide petition (PP 5E6962) by 
Bayer CropScience, 2 Alexander Drive, Research Triangle Park, NC 27709. 
The petition requested an increase in the tolerances under 40 CFR 
180.570 for residues of isoxadifen-ethyl and its metabolite 4,5-
dihydro-5,5, diphenyl-3-isoxazolecarboxylic acid when used as an inert 
ingredient (safener) in or on the food commodities corn, field, forage 
at 0.20 parts per million (ppm) (increased from existing tolerance of 
0.10 ppm) and corn, field, stover at 0.40 ppm (increased from existing 
tolerance of 0.20 ppm). No substantive comments were received for this 
Notice.
    The Agency also issued a notice in the April 4, 2007 Federal 
Register (72 FR 163552) announcing the filing of pesticide petition (PP 
5E7007) by IR-4, 681 U.S. Highway 1 South, North Brunswick, NJ 
08902-3390. The petition requested the establishment of tolerances for 
residues of isoxadifen-ethyl and its metabolite in or on corn, sweet, 
kernel plus cob with husks removed (K+CWHR) at 0.05 ppm; corn, sweet, 
forage at 0.40 ppm; corn, sweet, stover at 0.40 ppm; corn, pop, grain 
at 0.02 ppm; and corn, pop, stover at 0.40 ppm. No comments were 
received for this Notice.
    In the same Federal Register of April 4, 2007, it was also noted 
that the seasonal application rates could be removed from the existing 
tolerances under 40 CFR 180.570. Seasonal application rates are not 
necessary when numerical tolerances are already established. No 
comments were received for this Notice.
    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(c)(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 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....'' These provisions were added to the FFDCA by the 
Food Quality Protection Act (FQPA) of 1996.

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

[[Page 63996]]

identifiable subgroups of consumers, including infants and children. 
The nature of the toxic effects caused by isoxadifen-ethyl are 
discussed in this unit. EPA has sufficient data to assess the hazards 
of and make a determination on aggregate exposure for the chemical.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of isoxadifen-ethyl. The Agency's 
full decision document and risk assessments for this action are 
available on EPA's Electronic Docket at http://www.regulations.gov/ 
under docket number EPA-HQ-OPP-2005-0305. For the full toxicity data 
and information on which this risk assessment is based, the reader is 
referred to a Final Rule establishing tolerances for isoxadifen-ethyl 
that published in the May 26, 2004 Federal Register (69 FR 29882).

A. Human Health

    The Agency reviewed the available information on isoxadifen-ethyl 
submitted by the petitioners as well as additional information 
available to EPA. The toxicity database is sufficient for isoxadifen-
ethyl. Isoxadifen-ethyl has low acute oral, dermal and inhalational 
toxicity to rats. It is non-irritating to rabbit skin, moderately 
irritating to the eye, and is a skin sensitizer in guinea pigs. The 
chemical did not produce systemic toxicity in a subchronic dermal 
toxicity study up to the limit dose. Isoxadifen-ethyl tested negative 
overall for mutagenicity, and it was classified as ``not likely to be a 
human carcinogen.'' In subchronic and chronic oral toxicity studies, 
kidney and liver effects and decreased body weight and weight gain were 
observed. Concerning developmental toxicity, the Agency concluded that 
there is no concern for increased susceptibility in offspring. For 
additional information on the human health toxicity data for 
isoxadifen-ethyl, see the docket and the Federal Register of May 26, 
2004 (69 FR 29882).

B. Exposure Assessment

    The Agency conducted a dietary exposure assessment using the 
Dietary Exposure Evaluation Model-Food Consumption Intake Database 
(DEEM-FCIDTM) for all uses requested by the petitioners. 
Dietary food and drinking water exposures from the inert ingredient 
safener use of isoxadifen-ethyl are low for all population subgroups, 
and therefore, not of concern. The highest dietary exposure value 
estimated was 2.3% of the chronic population adjusted dose (PAD) for 
infants (< 1 year old).
    The Agency conducted a residential exposure assessment. Residential 
dermal and inhalation exposures for the general population (including 
toddlers) are also not of concern given that the estimated margins of 
exposure (MOEs) range from 790 to 1,500. Isoxadifen-ethyl is currently 
in pesticide formulations applied by professional pesticide applicators 
to commercial and residential lawns, recreational facilities, etc. 
There are no non-pesticidal uses of this chemical. Therefore, no 
further aggregate assessment is necessary. For additional information 
on the exposure assessment for isoxadifen-ethyl, see the docket and the 
Federal Register of May 26, 2004 (69 FR 29882).

C. Safety Factor for Infants and Children

    Section 408 of the FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. The toxicity database is 
sufficient for isoxadifen-ethyl and potential exposure is adequately 
characterized based on modeling. In terms of hazard, there are low 
concerns and no residual uncertainties regarding prenatal and/or 
postnatal toxicity. Accordingly, EPA concludes that the additional 
tenfold safety factor for the protection of infants and children is 
unnecessary. For additional information on the Safety Factor 
determination for infants and children for isoxadifen-ethyl, see the 
docket and the Federal Register of May 26, 2004 (69 FR 29882).

D. Cumulative Exposure

    Section 408(b)(2)(D)(v) of the FFDCA 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.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to isoxadifen-ethyl and any other substances, and the 
chemical does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that isoxadifen-ethyl has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see EPA's website at 
http://www.epa.gov/pesticides/cumulative.

E. Other Considerations

    1. Analytical methods. Adequate enforcement methodology is 
available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; e-mail address: [email protected]. For the 
complete description of Analytical Methods for isoxadifen-ethyl, see 
the docket and the Federal Register of May 26, 2004 (69 FR 29882).
    2. International tolerances. There are no Codex tolerances 
established for isoxadifen-ethyl. Canada has established a Maximum 
Residue Limits for isoxadifen-ethyl on corn, field, grain at 0.08 ppm.

F. Determination of Safety and Conclusions

    The Agency is granting the requested tolerances for isoxadifen-
ethyl and its metabolite on corn, field, forage at 0.20 ppm and corn, 
field, stover at 0.40 ppm. Although the petitioner requested tolerances 
in or on corn, sweet, kernal plus cob with husk removed at 0.05 ppm; 
corn, sweet, forage at 0.40 ppm; corn, sweet, stover at 0.40 ppm; corn, 
pop, grain at 0.02 ppm; and corn, pop, stover at 0.40 ppm, based on the 
Agency's review of the data and information available for isoxadifen-
ethyl, including toxicity endpoints and previously submitted field 
trial data, the Agency is granting tolerances for these uses under 40 
CFR 180.570 as follows: corn, sweet, kernal plus cob with husk removed 
at 0.04 ppm; corn, sweet, forage at 0.30 ppm; corn, sweet, stover at 
0.45 ppm; corn, pop, grain at 0.04 ppm; and corn, pop, stover at 0.25 
ppm. In addition, based on the results of the risk assessment, the 
Agency is lowering the current tolerance on corn, field, grain to 0.08 
ppm (from the established 0.10 ppm) and establishing an exemption for 
corn, oil at 0.50 ppm. A new field corn processing study is needed if 
the petitioner wishes to remove the corn, oil tolerance.
    Finally, the Agency is removing the seasonal application rates from 
the existing tolerance expression of 40 CFR

[[Page 63997]]

180.570. Seasonal application rates are not necessary when numerical 
tolerances are already established.
    Based on the information in this preamble, 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 
isoxadifen-ethyl and its metabolite. Accordingly, EPA finds that the 
tolerances described above for residues of isoxadifen-ethyl and its 
metabolite will be safe. EPA is establishing tolerances for residues of 
isoxadifen-ethyl and its metabolite when it is used as an inert 
ingredient safener in pesticide formulations.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section 
408(d) of 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, 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) or Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 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.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not 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).
    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).

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: November 5, 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 180.570 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.570  Isoxadifen-ethyl; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
isoxadifen-ethyl (ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate, (CAS 
No. 163520-33-0), and its metabolite: 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid, when used as an inert ingredient (safener) in 
or on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, grain.........................................         0.08
Corn, field, forage........................................         0.20
Corn, field, stover........................................         0.40
Corn, oil..................................................         0.50
Corn, pop, grain...........................................         0.04
Corn, pop, stover..........................................         0.25
Corn, sweet, forage........................................         0.30
Corn, sweet, kernel plus cob with husk removed.............         0.04
Corn, sweet, stover........................................         0.45
------------------------------------------------------------------------

    (2) Tolerances are established for the residues of isoxadifen-ethyl 
(3-isoxazolecarboxylic acid, 4,5-dihydro-5,5-diphenyl-, ethyl ester 
(CAS No. 164520-33-0)), and its metabolites 4,5-dihydro-5,5-diphenyl-3-
isoxazolecarboxylic acid and [beta]-hydroxy-[beta]-
benzenepropanenitrile when used as an inert ingredient (safener) in or 
on the following raw agricultural commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Rice, grain................................................         0.10
Rice, hulls................................................         0.50
Rice, straw................................................         0.25
------------------------------------------------------------------------

[FR Doc. E7-22223 Filed 11-13-07; 8:45 am]
BILLING CODE 6560-50-S