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11820 Federal Register / Vol. 73, No.

44 / Wednesday, March 5, 2008 / Rules and Regulations

(MRLs) for cloquintocet-mexyl on wheat the requirements of the Regulatory Dated: February 20, 2008.
and barley at 0.1 ppm. Flexibility Act (RFA) (5 U.S.C. 601 et Lois Rossi,
seq.) do not apply. Director, Registration Division, Office of
F. Determination of Safety and
This final rule directly regulates Pesticide Programs.
Conclusions
growers, food processors, food handlers, ■Therefore, 40 CFR chapter I is
The Agency is granting the requested
and food retailers, not States or tribes, amended as follows:
increase in tolerances for cloquintocet-
mexyl and its metabolite on wheat, nor does this action alter the
relationships or distribution of power PART 180—[AMENDED]
forage at 0.20 ppm and wheat, hay at
0.50 ppm. The Agency is also granting and responsibilities established by ■ 1. The authority citation for part 180
the requested addition of reference to Congress in the preemption provisions continues to read as follows:
the active ingredient pyroxsulam for use of section 408(n)(4) of FFDCA. As such,
Authority: 21 U.S.C. 321(q), 346a and 371.
with the inert ingredient safener the Agency has determined that this
action will not have a substantial direct ■ 2. Section 180.560 is amended by
cloquintocet-mexyl on wheat. In revising paragraph (a) to read as follows:
addition, the Agency is removing the effect on States or tribal governments,
specification of a 1:4 ratio of on the relationship between the national § 180.560 Cloquintocet-mexyl (acetic acid
cloquintocet-mexyl to active ingredient government and the States or tribal [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl
from the existing tolerance expression of governments, or on the distribution of ester; CAS Reg. No. 99607–70–2);
40 CFR 180.560. The specification is not power and responsibilities among the tolerances for residues.
necessary when numerical tolerances various levels of government or between (a) General. Tolerances are
are already established. the Federal Government and Indian established for the combined residues of
Based on the information in this tribes. Thus, the Agency has determined cloquintocet-mexyl (acetic acid [(5-
preamble, EPA concludes that there is a that Executive Order 13132, entitled chloro-8-quinolinyl) oxy]-, 1-
reasonable certainty of no harm to the Federalism (64 FR 43255, August 10, methylhexyl ester; CAS Reg. No. 99607–
general population, including infants 1999) and Executive Order 13175, 70–2) and its acid metabolite (5-chloro-
and children, from aggregate exposure entitled Consultation and Coordination 8-quinlinoxyacetic acid) when used as
to residues of cloquintocet-mexyl and with Indian Tribal Governments (65 FR an inert ingredient (safener) in pesticide
its metabolite. Accordingly, EPA finds 67249, November 6, 2000) do not apply formulations containing the active
that the tolerances described above for to this rule. In addition, this rule does ingredients pinoxaden (wheat or barley),
residues of cloquintocet-mexyl and its not impose any enforceable duty or clodinafop-propargyl (wheat only), or
metabolite will be safe. contain any unfunded mandate as pyroxsulum (wheat only) in or on the
described under Title II of the Unfunded following food commodities:
IV. Statutory and Executive Order
Reviews Mandates Reform Act of 1995 (UMRA)
(Public Law 104–4). Commodity Parts per million
This final rule establishes a tolerance
under section 408(d) of FFDCA in This action does not involve any Barley, grain ............ 0.1
response to petitions submitted to the technical standards that would require Barley, hay .............. 0.1
Agency. The Office of Management and Agency consideration of voluntary Barley, straw ........... 0.1
consensus standards pursuant to section Wheat, forage .......... 0.2
Budget (OMB) has exempted these types Wheat, grain ............ 0.1
of actions from review under Executive 12(d) of the National Technology
Wheat, hay .............. 0.5
Order 12866, entitled Regulatory Transfer and Advancement Act of 1995
Wheat, straw ........... 0.1
Planning and Review (58 FR 51735, (NTTAA), Public Law 104–113, section
October 4, 1993). Because this rule has 12(d) (15 U.S.C. 272 note).
* * * * *
been exempted from review under V. Congressional Review Act [FR Doc. E8–4023 Filed 3–4–08; 8:45 am]
Executive Order 12866, this rule is not
BILLING CODE 6560–50–S
subject to Executive Order 13211, The Congressional Review Act, 5
Actions Concerning Regulations That U.S.C. 801 et seq., generally provides
Significantly Affect Energy Supply, that before a rule may take effect, the ENVIRONMENTAL PROTECTION
Distribution, or Use (66 FR 28355, May agency promulgating the rule must AGENCY
22, 2001) or Executive Order 13045, submit a rule report to each House of
entitled Protection of Children from the Congress and to the Comptroller 40 CFR Part 180
Environmental Health Risks and Safety General of the United States. EPA will
Risks (62 FR 19885, April 23, 1997). submit a report containing this rule and [EPA–HQ–OPP–2007–0495; FRL–8352–2]
This final rule does not contain any other required information to the U.S. Methoxyfenozide; Pesticide Tolerances
information collections subject to OMB Senate, the U.S. House of and Time-Limited Pesticide Tolerances
approval under the Paperwork Representatives, and the Comptroller
Reduction Act (PRA), 44 U.S.C. 3501 et General of the United States prior to AGENCY: Environmental Protection
seq., nor does it require any special publication of this final rule in the Agency (EPA).
considerations under Executive Order Federal Register. This final rule is not ACTION: Final rule.
12898, entitled Federal Actions to a ‘‘major rule’’ as defined by 5 U.S.C.
Address Environmental Justice in 804(2). SUMMARY: This regulation establishes
Minority Populations and Low-Income tolerances for residues of
Populations (59 FR 7629, February 16, List of Subjects in 40 CFR Part 180 methoxyfenozide per se; benzoic acid,
1994). 3-methoxy-2-methyl-2-(3,5-
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Since tolerances and exemptions that Environmental protection, dimethylbenzoyl)-2-(1,1-


are established on the basis of a petition Administrative practice and procedure, dimethylethyl)hydrazide in or on the
under section 408(d) of FFDCA, such as Agricultural commodities, Pesticides food commodities acerola; animal feed,
the tolerance in this final rule, do not and pests, Reporting and recordkeeping nongrass, group 18, forage; animal feed,
require the issuance of a proposed rule, requirements. nongrass, group 18, hay; avocado; bean,

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Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations 11821

dry, seed; bushberry subgroup 13-07B; available, e.g., Confidential Business B. How Can I Access Electronic Copies
canistel; feijoa; grass, forage, fodder and Information (CBI) or other information of this Document?
hay, group 17, forage; grass, forage, whose disclosure is restricted by statute. In addition to accessing an electronic
fodder and hay, group 17, hay; guava; Certain other material, such as copy of this Federal Register document
jaboticaba; kurrat; mango; onion, green, copyrighted material, is not placed on through the electronic docket at http://
subgroup 3-07B; papaya; passionfruit; the Internet and will be publicly www.regulations.gov, you may access
peanut; peanut, hay; peanut oil; available only in hard copy form. this Federal Register document
sapodilla; sapote, black; sapote, mamey; Publicly available docket materials are
electronically through the EPA Internet
star apple; starfruit; vegetable, tuberous available either in the electronic docket
under the ‘‘Federal Register’’ listings at
and corm, except potato, sub group 1D; at http://www.regulations.gov, or, if only
http://www.epa.gov/fedrgstr. You may
and wax jambu. This regulation also available in hard copy, at the OPP
also access a frequently updated
establishes time-limited tolerances for Public Docket, in Rm. S–4400, One
electronic version of 40 CFR part 180
indirect or inadvertent residues of Potomac Yard (South Bldg.), 2777 S.
through the Government Printing
methoxyfenozide; benzoic acid, 3- Crystal Dr., Arlington, VA. The Docket
Office’s pilot e-CFR site at http://
methoxy-2-methyl-, 2-(3,5- Facility is open from 8:30 a.m. to 4 p.m.,
www.gpoaccess.gov/ecfr.
dimethylbenzoyl)-2-(1,1-dimethylethyl) Monday through Friday, excluding legal
hydrazide and indirect or inadvertent holidays. The Docket Facility telephone C. Can I File an Objection or Hearing
combined residues of methoxyfenozide number is (703) 305–5805. Request?
and its metabolites RH-117,236 free FOR FURTHER INFORMATION CONTACT: Under section 408(g) of FFDCA, as
phenol of methoxyfenozide; 3,5- Mark Suarez, Registration Division amended by FQPA, any person may file
dimethylbenzoic acid N-tert-butyl-N’-(3- (7505P), Office of Pesticide Programs, an objection to any aspect of this
hydroxy-2-methylbenzoyl) hydrazide, Environmental Protection Agency, 1200 regulation and may also request a
RH-151,055 glucose conjugate of RH- Pennsylvania Ave., NW., Washington, hearing on those objections. The EPA
117,236; 3,5-dimethyl benzoic acid N- DC 20460–0001; telephone number: procedural regulations which govern the
tert-butyl-N-[3 ([beta]-D- (703) 305–0120; e-mail address: submission of objections and requests
glucopyranosyloxy)-2-methylbenzoyl]- suarez.mark@epa.gov. for hearings appear in 40 CFR part 178.
hydrazide and RH-152,072 the
SUPPLEMENTARY INFORMATION: You must file your objection or request
malonylglycosyl conjugate of RH
a hearing on this regulation in
117,236 in or on the food commodities I. General Information
accordance with the instructions
animal feed, nongrass, group 18; grain,
A. Does this Action Apply to Me? provided in 40 CFR part 178. To ensure
cereal, forage, fodder and straw, group
You may be potentially affected by proper receipt by EPA, you must
16; grass forage, fodder, and hay, group
this action if you are an agricultural identify docket ID number EPA–HQ–
17; herb and spice, group 19; vegetable,
producer, food manufacturer, or OPP–2007–0495 in the subject line on
bulb, group 3-07; vegetable, foliage of
pesticide manufacturer. Potentially the first page of your submission. All
legume, group 7; vegetable, leaves of
affected entities may include, but are requests must be in writing, and must be
root and tuber, group 2; vegetable,
not limited to those engaged in the mailed or delivered to the Hearing Clerk
legume, group 6; and vegetable, root and
following activities: on or before May 5, 2008.
tuber, group 1. Dow AgroSciences LLC
• Crop production (NAICS code 111), In addition to filing an objection or
and Interregional Research Project
e.g., agricultural workers; greenhouse, hearing request with the Hearing Clerk
Number 4 (IR-4) requested these
nursery, and floriculture workers; as described in 40 CFR part 178, please
tolerances under the Federal Food,
farmers. submit a copy of the filing that does not
Drug, and Cosmetic Act (FFDCA). The
• Animal production (NAICS code contain any CBI for inclusion in the
time-limited tolerances will expire on
112), e.g., cattle ranchers and farmers, public docket that is described in
September 30, 2010.
dairy cattle farmers, livestock farmers. ADDRESSES. Information not marked
DATES: This regulation is effective
• Food manufacturing (NAICS code confidential pursuant to 40 CFR part 2
March 5, 2008. Objections and requests may be disclosed publicly by EPA
311) , e.g., agricultural workers; farmers;
for hearings must be received on or without prior notice. Submit your
greenhouse, nursery, and floriculture
before May 5, 2008, and must be filed copies, identified by docket ID number
workers; ranchers; pesticide applicators.
in accordance with the instructions • Pesticide manufacturing (NAICS EPA–HQ–OPP–2007–0495, by one of
provided in 40 CFR part 178 (see also code 32532), e.g., agricultural workers; the following methods:
Unit I.C. of the SUPPLEMENTARY commercial applicators; farmers; • Federal eRulemaking Portal: http://
INFORMATION). www.regulations.gov. Follow the on-line
greenhouse, nursery, and floriculture
ADDRESSES: EPA has established a workers; residential users. instructions for submitting comments.
docket for this action under docket This listing is not intended to be • Mail: Office of Pesticide Programs
identification (ID) number EPA–HQ– exhaustive, but rather provides a guide (OPP) Regulatory Public Docket (7502P),
OPP–2007–0495. To access the for readers regarding entities likely to be Environmental Protection Agency, 1200
electronic docket, go to http:// affected by this action. Other types of Pennsylvania Ave., NW., Washington,
www.regulations.gov, select ‘‘Advanced entities not listed in this unit could also DC 20460–0001.
Search,’’ then ‘‘Docket Search.’’ Insert be affected. The North American • Delivery: OPP Regulatory Public
the docket ID number where indicated Industrial Classification System Docket (7502P), Environmental
and select the ‘‘Submit’’ button. Follow (NAICS) codes have been provided to Protection Agency, Rm. S–4400, One
the instructions on the regulations.gov assist you and others in determining Potomac Yard (South Bldg., 2777 S.
website to view the docket index or whether this action might apply to Crystal Dr., Arlington, VA. Deliveries
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access available documents. All certain entities. If you have any are only accepted during the Docket’s
documents in the docket are listed in questions regarding the applicability of normal hours of operation (8:30 a.m. to
the docket index available in this action to a particular entity, consult 4 p.m., Monday through Friday,
regulations.gov. Although listed in the the person listed under FOR FURTHER excluding legal holidays). Special
index, some information is not publicly INFORMATION CONTACT. arrangements should be made for

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11822 Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations

deliveries of boxed information. The 6E7086); peanut oil at 0.09 ppm (PP changes is explained in Unit IV.D. EPA
Docket Facility telephone number is 6E7086); salal at 3.0 ppm (PP 6E7086); is also deleting all the tolerances in
(703) 305–5805. sapodilla at 0.6 ppm (PP 7E7218); § 180.544(b) for sorghum and soybean
sapote, black at 0.6 ppm (PP 7E7218); commodities that are no longer needed
II. Petition for Tolerances
sapote, mamey at 0.6 ppm (PP 7E7218); since they have expired. The deletions
In the Federal Register of October 20, sea buckthorn at 3.0 ppm (PP 6E7086); under § 180.544(b) are time-limited
2006 (71 FR 61971) (FRL–8098–6), shallot, fresh leaves at 5.0 ppm (PP tolerances that were established under
August 1, 2007 (72 FR 42072) (FRL– 7E7218); star apple at 0.6 ppm (PP section 18 emergency exemptions that
8138–1), and October 24, 2007 (72 FR 7E7218); starfruit at 0.4 ppm (PP have since expired.
60367) (FRL–8154–1), EPA issued 7E7218); vegetable, tuberous and corm,
notices pursuant to section 408(d)(3) of III. Aggregate Risk Assessment and
except potato, sub group 1D at 0.02 ppm Determination of Safety
FFDCA, 21 U.S.C. 346a(d)(3), (PP 6E7086); wax jambu at 0.4 ppm (PP
announcing the filing of pesticide 7E7218). In the petition 0F6201, Dow Section 408(b)(2)(A)(i) of FFDCA
petitions (PPs 6E7086, 7E7218, 6F7135, requested that tolerances that expired allows EPA to establish a tolerance (the
and 0F6201) by, Dow AgroSciences on September 30, 2007 be re-established legal limit for a pesticide chemical
LLC, Zionsville Road -Indianapolis, IN for indirect or inadvertent residues of residue in or on a food) only if EPA
46268 (PPs 6F7135 and 0F6201) and IR- methoxyfenozide; benzoic acid, 3- determines that the tolerance is ‘‘safe.’’
4, 500 College Road East, Suite 201 W., methoxy-2-methyl-, 2-(3,5- Section 408(b)(2)(A)(ii) of FFDCA
Princeton, NJ 08540 (PPs 7E7218 and dimethylbenzoyl)-2-(1,1-dimethylethyl) defines ‘‘safe’’ to mean that ‘‘there is a
6E7086). The petitions requested that 40 hydrazide and indirect or inadvertent reasonable certainty that no harm will
CFR 180.544 be amended by combined residues of methoxyfenozide; result from aggregate exposure to the
establishing tolerances for residues of benzoic acid, 3-methoxy-2-methyl-, 2- pesticide chemical residue, including
the insecticide, methoxyfenozide, in or (3,5-dimethylbenzoyl)-2-(1,1- all anticipated dietary exposures and all
on the food commodities acerola at 0.4 dimethylethyl) hydrazide and its other exposures for which there is
parts per million (ppm) (PP 7E7218); metabolites RH-117,236 free phenol of reliable information.’’ This includes
arionia berry at 3.0 ppm (PP 6E7086); methoxyfenozide; 3,5-dimethylbenzoic exposure through drinking water and in
avocado at 0.6 ppm (PP 7E7218); bean, acid N-tert-butyl-N’-(3-hydroxy-2- residential settings, but does not include
dry, seed at 0.15 ppm (PP 6E7086); methylbenzoyl) hydrazide, RH-151,055 occupational exposure. Section
blueberry, lowbush at 3.0 ppm (PP glucose conjugate of RH-117,236; 3,5- 408(b)(2)(C) of FFDCA requires EPA to
6E7086); buffalo currant at 3.0 ppm (PP give special consideration to exposure
dimethyl benzoic acid N-tert-butyl-N-[3
6E7086); bushberry subgroup 13B at 3.0 of infants and children to the pesticide
([beta]-D-glucopyranosyloxy)-2-
ppm (PP 6E7086); canistel at 0.6 ppm chemical residue in establishing a
methylbenzoyl]-hydrazide and RH-
(PP 7E7218); Chilean guava at 3.0 ppm tolerance and to ‘‘ensure that there is a
152,072 the malonylglycosyl conjugate
(PP 6E7086); chive, Chinese, fresh reasonable certainty that no harm will
of RH 117,236 in or on the food
leaves at 5.0 ppm (PP 7E7218); chive, result to infants and children from
commodities grain, cereal, forage,
fresh leaves at 5.0 ppm (PP 7E7218); aggregate exposure to the pesticide
fodder, and straw, group 16 at 10.0 ppm;
elegans hosta at 5.0 ppm (PP 7E7218); chemical residue. . . .’’
grass forage, fodder, and hay, group 17
European barberry at 3.0 ppm (PP EPA performs a number of analyses to
at 10.0 ppm; herb and spice, group 19
6E7086); feijoa at 0.4 ppm (PP 7E7218); determine the risks from aggregate
fritillaria leaves at 5.0 ppm (PP 7E7218); at 10.0 ppm; nongrass animal feeds crop
exposure to pesticide residues. For
grass forage, fodder, and hay group 17, group 18 at 10.0 ppm; vegetable, bulb,
further discussion of the regulatory
forage at 18.0 ppm (PP 6E7086); grass group 3 at 0.2 ppm; vegetable, foliage of
requirements of section 408 of FFDCA
forage, fodder, and hay, group 17, hay legume, group 7 at 10.0 ppm; vegetable,
and a complete description of the risk
at 30.0 ppm (PP 6E7086); guava at 0.4 leaves of root and tuber, group 2 at 0.2
assessment process, see http://
ppm (PP 7E7218); highbush cranberry at ppm; vegetable, legume, group 6 at 0.1
www.epa.gov/fedrgstr/EPA-PEST/1997/
3.0 ppm (PP 6E7086); honeysuckle at ppm; and vegetable, root and tuber,
November/Day-26/p30948.htm.
3.0 ppm (PP 6E7086); jaboticaba at 0.4 group 1 at 0.1 ppm. Those notices Consistent with section 408(b)(2)(D)
ppm (PP 7E7218); jostaberry at 3.0 ppm referenced summaries of the petitions of FFDCA, EPA has reviewed the
(PP 6E7086); juneberry at 3.0 ppm (PP prepared by Dow AgroSciences LLC and available scientific data and other
6E7086); kurrat at 5.0 ppm (PP 7E7218); IR-4, the registrants, which are available relevant information in support of this
Lady’s leek at 5.0 ppm (PP 7E7218); leek to the public in the docket, http:// action. EPA has sufficient data to assess
at 5.0 ppm (PP 7E7218); leek, wild at 5.0 www.regulations.gov. Comments were the hazards of and to make a
ppm (PP 7E7218); lingonberry at 3.0 received on the notices of filing. EPA’s determination on aggregate exposure,
ppm (PP 6E7086); mango at 0.6 ppm (PP response to these comments is consistent with section 408(b)(2) of
7E7218); native currant at 3.0 ppm (PP discussed in Unit IV.C. The time-limited FFDCA, for tolerances for the
6E7086); nongrass animal feeds, group tolerances will expire on September 30, petitioned-for tolerances for residues of
18, forage at 35.0 ppm (PP 6F7135); 2010. methoxyfenozide on the food
nongrass animal feeds, group 18, hay at Based upon review of the data commodities named above. EPA’s
85.0 ppm (PP 6F7135); onion, Beltsville supporting the petition, EPA has assessment of exposures and risks
bunching at 5.0 ppm (PP 7E7218); modified the tolerance expression for associated with establishing the
onion, fresh at 5.0 ppm (PP 7E7218); the food commodities bean, dry, seed to tolerance follows.
onion, green at 5.0 ppm (PP 7E7218); 0.24 ppm (PP 6E7086); animal feeds,
onion, macrostem at 5.0 ppm (PP nongrass, group 18, forage to 50.0 ppm A. Toxicological Profile
7E7218); onion, tree, tops at 5.0 ppm (PP 6F7135); animal feeds, nongrass, EPA has evaluated the available
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(PP 7E7218); onion, Welsh, tops at 5.0 group 18, hay to 150.0 ppm (PP toxicity data and considered its validity,
ppm (PP 7E7218); papaya at 0.6 ppm 6F7135); onions, green, subgroup 3-07B completeness, and reliability as well as
(PP 7E7218); passionfruit at 0.4 ppm (PP at 5.0 ppm (PP 7E7218); peanut, hay to the relationship of the results of the
7E7218); peanut at 0.02 ppm (PP 55 ppm (PP 6E7086); peanut oil to 0.04 studies to human risk. EPA has also
6E7086); peanut, hay at 60 ppm (PP ppm (PP 6E7086). The reason for these considered available information

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Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations 11823

concerning the variability of the aggregate exposure to the pesticide to iii. Cancer. Methoxyfenozide is not
sensitivities of major identifiable the acute population adjusted dose likely to be carcinogenic to humans;
subgroups of consumers, including (aPAD) and chronic population adjusted therefore, a cancer exposure assessment
infants and children. dose (cPAD). The aPAD and cPAD are was not conducted.
The toxicology studies conducted calculated by dividing the LOC by all iv. Anticipated residue and percent
with methoxyfenozide demonstrate that applicable UFs. Short-, intermediate-, crop treated. Anticipated residues/PCT
it has few or no biologically significant and long-term risks are evaluated by data were not needed to refine the risk
toxic effects at relatively low-dose levels comparing aggregate exposure to the assessment so they were not used.
and only mild or no toxic effects at LOC to ensure that the margin of 2. Dietary exposure from drinking
relatively high-dose levels. In exposure (MOE) called for by the water. Methoxyfenozide is expected to
subchronic and chronic oral studies in product of all applicable UFs is not be a ground water and surface water
rats, the most toxicologically significant exceeded. contaminant primarily due to its
effects were mild anemia and mild For non-threshold risks, the Agency persistence in the environment.
effects on the liver, thyroid gland, and assumes that any amount of exposure Based on the Pesticide Root Zone
adrenal gland. In subchronic and will lead to some degree of risk and Model/Exposure Analysis Modeling
chronic oral studies in dogs, the estimates risk in terms of the probability System (PRZM/EXAMS) and Screening
predominant toxic effect was anemia, of occurrence of additional adverse Concentration in Ground Water (SCI-
which was often accompanied by signs cases. Generally, cancer risks are GROW) models, the estimated
of a compensatory response. considered non-threshold. For more environmental concentrations (EECs) of
Methoxyfenozide is not acutely toxic, information on the general principles methoxyfenozide for acute exposures
not a dermal sensitizer, not neurotoxic, EPA uses in risk characterization and a are estimated to be 43 parts per billion
carcinogenic or mutagenic and is not a complete description of the risk (ppb) for surface water and 7.43 ppb for
developmental or reproductive toxicant. assessment process, see http:// ground water. The EECs for chronic
There was no evidence for increased www.epa.gov/fedrgstr/EPA-PEST/1997/ exposures are estimated to be 33.1 ppb
susceptibility of rat or rabbit fetuses to November/Day-26/p30948.htm. for surface water and <7.43 ppb for
in utero exposure or rat pups to post- A summary of the toxicological ground water.
natal exposure to methoxyfenozide. endpoints for methoxyfenozide used for Modeled estimates of drinking water
Minimal or no toxic effects were human risk assessment can be found at concentrations were directly entered
observed in studies in which http://www.regulations.gov in document into the dietary exposure model. For
methoxyfenozide was administered by ‘‘Methoxyfenozide. Human Health Risk acute dietary risk assessment, the water
the dermal or inhalation routes of Assessment for Proposed Use on Sweet concentration value of 43 ppb was used
exposure. Methoxyfenozide is classified Potato, Blueberry, Dry Bean, Grass, to access the contribution to drinking
as a ‘‘not likely’’ human carcinogen. Peanut, Green Onion, Avocado, Guava, water. For chronic dietary risk
Specific information on the studies Alfalfa and Clover. PC Code:121027, assessment, the water concentration of
received and the nature of the adverse Petition No: 6E7086, 7E7218, and value 33.1 ppb was used to access the
effects caused by methoxyfenozide as 6F7135. DP Num: 331948, 340540, and contribution to drinking water.
well as the no-observed-adverse-effect- 371933’’ at page 30 in docket ID number 3. From non-dietary exposure. The
level (NOAEL) and the lowest-observed- EPA–HQ–OPP–2007–0495. term ‘‘residential exposure’’ is used in
adverse-effect-level (LOAEL) from the this document to refer to non-
toxicity studies can be found at http:// C. Exposure Assessment occupational, non-dietary exposure
www.regulations.gov. The referenced 1. Dietary exposure from food and (e.g., for lawn and garden pest control,
document is available in the docket feed uses. In evaluating dietary indoor pest control, termiticides, and
established by this action, which is exposure to methoxyfenozide, EPA flea and tick control on pets).
described under ADDRESSES, and is considered exposure under the Methoxyfenozide is not registered for
identified as EPA–HQ–OPP–2007–0495 petitioned-for tolerances as well as all use on any sites that would result in
in that docket. existing methoxyfenozide tolerances in residential exposure.
40 CFR 180.544. EPA assessed dietary 4. Cumulative effects from substances
B. Toxicological Endpoints with a common mechanism of toxicity.
exposures from methoxyfenozide in
For hazards that have a threshold food as follows: Section 408(b)(2)(D)(v) of FFDCA
below which there is no appreciable i. Acute exposure. Quantitative acute requires that, when considering whether
risk, the toxicological level of concern dietary exposure and risk assessments to establish, modify, or revoke a
(LOC) is derived from the highest dose are performed for a food-use pesticide, tolerance, the Agency consider
at which no adverse effects are observed if a toxicological study has indicated the ‘‘available information’’ concerning the
(the NOAEL) in the toxicology study possibility of an effect of concern cumulative effects of a particular
identified as appropriate for use in risk occurring as a result of a 1–day or single pesticide’s residues and ‘‘other
assessment. However, if a NOAEL exposure. substances that have a common
cannot be determined, the lowest dose No such effects were identified in the mechanism of toxicity.’’
at which adverse effects of concern are toxicological studies for Unlike other pesticides for which EPA
identified (the LOAEL) is sometimes methoxyfenozide; therefore, a has followed a cumulative risk approach
used for risk assessment. Uncertainty/ quantitative acute dietary exposure based on a common mechanism of
safety factors (UFs) are used in assessment is unnecessary. toxicity, EPA has not made a common
conjunction with the LOC to take into ii. Chronic exposure. In conducting mechanism of toxicity finding as to
account uncertainties inherent in the the chronic dietary exposure assessment methoxyfenozide and any other
extrapolation from laboratory animal EPA used the food consumption data substances and methoxyfenozide does
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data to humans and in the variations in from the USDA 1994–1996 and 1998 not appear to produce a toxic metabolite
sensitivity among members of the CSFII. As to residue levels in food, EPA produced by other substances. For the
human population as well as other assumed all foods for which there are purposes of this tolerance action,
unknowns. Safety is assessed for acute tolerances were treated and contain therefore, EPA has not assumed that
and chronic risks by comparing tolerance-level residues. methoxyfenozide has a common

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11824 Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations

mechanism of toxicity with other iii. In developmental toxicity studies (considered to be a background
substances. For information regarding in rats and rabbits, no increased exposure level).
EPA’s efforts to determine which susceptibility in fetuses as compared to Methoxyfenozide is not registered for
chemicals have a common mechanism maternal animals was observed use on any sites that would result in
of toxicity and to evaluate the following in utero exposures. residential exposure. Therefore, the
cumulative effects of such chemicals, iv. In a 2–generation reproduction aggregate risk is the sum of the risk from
see the policy statements released by study in rats, no increased susceptibility food and water, which do not exceed
EPA’s Office of Pesticide Programs in pups as compared to adults was the Agency’s level of concern.
concerning common mechanism observed following in utero and 5. Aggregate cancer risk for U.S.
determinations and procedures for postnatal exposures. population. Methoxyfenozide is
cumulating effects from substances v. The exposure assessments will not classified as a ‘‘not likely’’ human
found to have a common mechanism on underestimate the potential dietary carcinogen and thus is not expected to
EPA’s website at http://www.epa.gov/ (food and drinking water) or nondietary pose a cancer risk to humans.
pesticides/cumulative. exposures for infants and children from 6. Determination of safety. Based on
the use of methoxyfenozide. The these risk assessments, EPA concludes
D. Safety Factor for Infants and chronic dietary food exposure that there is a reasonable certainty that
Children no harm will result to the general
assessment utilizes tolerance level
1. In general. Section 408 of FFDCA residues and assumes 100 PCT. population or to infants and children
provides that EPA shall apply an Conservative ground water and surface from aggregate exposure to
additional tenfold margin of safety for water modeling estimates were used. methoxyfenozide residues.
infants and children in the case of These assessments will not IV. Other Considerations
threshold effects to account for prenatal underestimate the exposure and risks
and postnatal toxicity and the posed by methoxyfenozide. A. Analytical Enforcement Methodology
completeness of the database on toxicity Adequate enforcement methodology
and exposure unless EPA determines E. Aggregate Risks and Determination of
Safety (high pressure liquid chromatography
based on reliable data that a different with mass spectrometry (HPLC/MS)) is
margin of safety will be safe for infants Safety is assessed for acute and available to enforce the tolerance
and children. This additional margin of chronic risks by comparing aggregate expression. The method may be
safety is commonly refered to as the exposure to the pesticide to the aPAD requested from: Chief, Analytical
FQPA safety factor. In applying this and cPAD. The aPAD and cPAD are Chemistry Branch, Environmental
provision, EPA either retains the default calculated by dividing the LOC by all Science Center, 701 Mapes Rd., Ft.
value of 10X when reliable data do not applicable UFs. For linear cancer risks, Meade, MD 20755–5350; telephone
support the choice of a different factor, EPA calculates the probability of number: (410) 305–2905; e-mail address:
or, if reliable data are available, EPA additional cancer cases given aggregate residuemethods@epa.gov.
uses a different additional FQPA safety exposure. Short-, intermediate- and log-
factor value based on the use of term risks are evaluated by comparing B. International Residue Limits
traditional UFs and/or special FQPA aggregate exposure to the LOC to ensure There are currently no Codex,
safety factors, as appropriate. that the MOE called for by the product Canadian or Mexican MRLs for
2. Prenatal and postnatal sensitivity. of all applicable UTs is not exceeded. methoxyfenozide, so there are no
There is not a concern for prenatal and/ 1. Acute risk. No acute risk is international harmonization issues
or postnatal toxicity resulting from expected from exposure to associated with this action.
exposure to methoxyfenozide. The methoxyfenozide since no acute
prenatal and postnatal toxicology endpoints were identified for the C. Response to Comments
database for methoxyfenozide includes general U.S. population (including Public comments were received from
rat and rabbit developmental toxicity infants and children) or the females 13- a citizen who objected to the proposed
studies and a 2–generation reproduction 50 years old population subgroup. tolerances because ‘‘methoxyfenozide
toxicity study in rats. There was no 2. Chronic risk. Using the exposure harms fish and birds so that they die’’
quantitative or qualitative evidence of assumptions described in this unit for and also opposes ‘‘any exemption or
increased susceptibility of rats or rabbit chronic exposure, EPA has concluded residue left on plants after use from this
fetuses to in utero exposure in the that exposure to methoxyfenozide from product.’’ The comments contained no
developmental studies; similarly, there food and water will utilize 56% of the scientific data or evidence to rebut the
was no evidence of increased cPAD for the most highly exposed Agency’s conclusion that there is a
susceptibility of rat pups following population group, children 1-2 years reasonable certainty that no harm will
prenatal/postnatal exposure in the 2– old. There are no residential uses for result from human or environmental
generation reproduction study. methoxyfenozide. exposure to methoxyfenozide. EPA has
3. Conclusion. The FQPA SF for the 3. Short-term risk. Short-term responded to similar comments on
protection of infants and children be aggregate exposure takes into account numerous previous occasions. (January
removed (i.e. reduced to 1x) for residential exposure plus chronic 7, 2005, 70 FR 1349) (October 29, 2004,
methoxyfenozide for the following exposure to food and water (considered 69 FR 63083).
reasons: to be a background exposure level).
i. The toxicology database for Methoxyfenozide is not registered for D. Explanation of Tolerance Revisions
methoxyfenozide is complete for use on any sites that would result in The tolerances established here have
assessment of potential hazard to infants residential exposure. Therefore, the been modified in some instances from
and children. aggregate risk is the sum of the risk from the tolerances originally proposed in the
yshivers on PROD1PC62 with RULES

ii. Based on weight-of-the-evidence food and water. notices of filing. These modifications
considerations, EPA determined that a 4. Intermediate-term risk. have been based upon specific data, as
developmental neurotoxicity study in Intermediate-term aggregate exposure described in unit IV.D. The data
rats is not required to support the takes into account residential exposure indicate that the requested tolerance on
registration of methoxyfenozide. plus chronic exposure to food and water dry beans at 0.15 ppm is not appropriate

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Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations 11825

since the field trial data indicate that subgroups for bulb and green onions, Time-limited tolerances are
residues could be higher than the and changing the name of one of the established for the indirect or
tolerance request. Therefore, a more representative commodities from inadvertent residues for
appropriate tolerance is being ‘‘onion, dry bulb’’ to ‘‘onion, bulb.’’ EPA methoxyfenozide in or on vegetable,
established for the residues of also expanded and revised berries group bulb, group 3 at 0.2 ppm; vegetable,
methoxyfenozide on bean, dry at 0.24 13. Changes to crop group 13 (berries) leaves of root and tuber, group 2 at 0.2
ppm. The data for peanut hay are included adding new commodities, ppm; and vegetable, root and tuber,
adequate. EPA’s Review indicates that revising existing subgroups and creating group 1 at 0.1 ppm; and the combined
the requested tolerance of 60 ppm is not new subgroups (including a bushberry residues of methoxyfenozide; benzoic
appropriate. Therefore, a more subgroup 13-07B consisting of the acid, 3-methoxy-2-methyl-, 2-(3,5-
appropriate tolerance is being commodities requested in PP 6E7086 dimethylbenzoyl)-2-(1,1-dimethylethyl)
established for the residues of and cultivars, varieties, and/or hybrids hydrazide and its metabolites RH-
methoxyfenozide on peanut, hay at 55.0 of these). 117,236 free phenol of
ppm. The data for animal feed, EPA indicated in the December 7, methoxyfenozide; 3,5-dimethylbenzoic
nongrass, group 18, forage and hay are 2007 final rule as well as the earlier May acid N-tert-butyl-N’-(3-hydroxy-2-
adequate. EPA’s Review indicates that 23, 2007 proposed rule (72 FR 28920) methylbenzoyl) hydrazide, RH-151,055
the requested tolerances are not (FRL–8126–1) that, for existing petitions glucose conjugate of RH-117,236; 3,5-
appropriate. Residue field trial data for which a Notice of Filing had been dimethyl benzoic acid N-tert-butyl-N-[3
from representative crops should be published, the Agency would attempt to ([beta]-D-glucopyranosyloxy)-2-
analyzed separately and the highest conform these petitions to the rule. methylbenzoyl]-hydrazide and RH-
result used for tolerance setting Therefore, consistent with this rule, 152,072 the malonylglycosyl conjugate
purposes. This was not done. A more EPA is establishing tolerances on onion, of RH 117,236 in or on the food
appropriate tolerance is being green, subgroup 3-07B and bushberry commodities animal feed, nongrass,
established for the residues of subgroup 13-07B. group 18 at 10.0 ppm; grain, cereal,
methoxyfenozide on animal feed, EPA concludes it is reasonable to forage, fodder and straw, group 16 at
nongrass, group 18, forage at 50 ppm, revise the petitioned-for tolerances so 10.0 ppm; grass forage, fodder and hay,
and hay at 150 ppm. The only processed that they agree with the recent crop group 17 at 10.0 ppm; herb and spice,
commodities of regulatory concern for grouping revisions because: group 19 at 10.0 ppm; vegetable, foliage
this petition are peanut meal and oil. A 1. Although the subgroups are new of legume, group 7 at 10.0 ppm; and
study was conducted using a 3x the commodities in the new group were vegetable, legume, group 6 at 0.10 ppm.
exaggerated application rate to the proposed as individual tolerances and
the added commodities are closely VI. Statutory and Executive Order
peanut raw agricultural commodity and
related minor crops which contribute Reviews
simulated commercial processing to
produce the peanut processed little to overall dietary or aggregate This final rule establishes a tolerance
commodities. Results of the study exposure and risk; and under section 408(d) of FFDCA in
indicate that residues of 2. Methoxyfenozide exposure from response to a petition submitted to the
methoxyfenozide are not expected to these added commodities was Agency. The Office of Management and
concentrate in peanut meal but do considered when EPA conducted the Budget (OMB) has exempted these types
concentrate 3x in oil. The requested dietary and aggregate risk assessments of actions from review under Executive
tolerance level for peanut oil is supporting this action. Order 12866, entitled Regulatory
inadequate. Using the highest average Planning and Review (58 FR 51735,
V. Conclusion
field trial values from the submitted October 4, 1993). Because this rule has
field trial data and the concentration Therefore, tolerances are established been exempted from review under
factor for peanut oil, the tolerance level for residues of methoxyfenozide; Executive Order 12866, this rule is not
should be 0.04 ppm. benzoic acid, 3-methoxy-2-methyl-2- subject to Executive Order 13211,
IR-4 petitioned for individual (3,5-dimethylbenzoyl)-2-(1,1- Actions Concerning Regulations That
tolerances on green onion, fresh chive dimethylethyl)hydrazide, in or on the Significantly Affect Energy Supply,
leaves, fresh Chinese chive leaves, food commodities acerola at 0.4 ppm; Distribution, or Use (66 FR 28355, May
elegans hosta, fritillaria leaves, kurrat, animal feeds, nongrass, group 18, forage 22, 2001) or Executive Order 13045,
Lady’s leek, leek, wild leek, Beltsville at 50.0 ppm; animal feeds, nongrass, entitled Protection of Children from
bunching onion, fresh onion, macrostem group 18, hay at 150.0 ppm; avocado at Environmental Health Risks and Safety
onion, tree onion tops, Welsh onion 0.6 ppm; bean, dry, seed at 0.24 ppm; Risks (62 FR 19885, April 23, 1997).
tops, and fresh shallot leaves at 5.0 ppm bushberry subgroup 13-07B at 3.0 ppm; This final rule does not contain any
(PP 7E7128) as well as for a tolerance for canistel at 0.6 ppm; feijoa at 0.4 ppm; information collections subject to OMB
bushberry subgroup 13B and individual grass, forage, fodder, and hay group 17, approval under the Paperwork
tolerances on aronia berry, buffalo forage at 18.0 ppm; grass, forage, fodder, Reduction Act (PRA), 44 U.S.C. 3501 et
currant, Chilean guava, European and hay, group 17, hay at 30.0 ppm; seq., nor does it require any special
barberry, highbush cranberry, guava at 0.4 ppm; jaboticaba at 0.4 ppm; considerations under Executive Order
honeysuckle, jostaberry, juneberry, mango at 0.6 ppm; onions, green, 12898, entitled Federal Actions to
lingonberry, native currant, salal, and subgroup 3-07B at 5.0 ppm; papaya at Address Environmental Justice in
sea buckthorn (PP 6E7086). 0.6 ppm; passionfruit at 0.4 ppm; Minority Populations and Low-Income
In the Federal Register of December 7, peanut at 0.02 ppm; peanut, hay at 55 Populations (59 FR 7629, February 16,
2007 (72 FR 69150) (FRL–8340–6), EPA ppm; peanut oil at 0.04 ppm; sapodilla 1994).
issued a final rule that revised the crop at 0.6 ppm; sapote, black at 0.6 ppm; Since tolerances and exemptions that
yshivers on PROD1PC62 with RULES

grouping regulations. As part of this sapote, mamey at 0.6 ppm; star apple at are established on the basis of a petition
action, EPA expanded and revised bulb 0.6 ppm; starfruit at 0.4 ppm; vegetable, under section 408(d) of FFDCA, such as
vegetables group 3. Changes to crop tuberous and corm, except potato, sub the tolerance in this final rule, do not
group 3 (bulb vegetables) included group 1D at 0.02 ppm; wax jambu at 0.4 require the issuance of a proposed rule,
adding new commodities, creating ppm. the requirements of the Regulatory

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11826 Federal Register / Vol. 73, No. 44 / Wednesday, March 5, 2008 / Rules and Regulations

Flexibility Act (RFA) (5 U.S.C. 601 et Dated: February 14, 2008. Commodity Parts per million
seq.) do not apply. Donald R. Stubbs,
Acting Director, Registration Division, Office * * * * *
This final rule directly regulates Vegetable, tuberous and
of Pesticide Programs.
growers, food processors, food handlers, corm, except potato,
and food retailers, not States or tribes, ■Therefore, 40 CFR chapter I is subgroup 1D ............... 0.02
nor does this action alter the amended as follows: Wax jambu ...................... 0.4
relationships or distribution of power
and responsibilities established by PART 180—AMENDED (b) Section 18 emergency exemptions.
Congress in the preemption provisions ■ 1. The authority citation for part 180 [Reserved]
of section 408(n)(4) of FFDCA. As such, continues to read as follows: (c) Tolerances with regional
the Agency has determined that this registrations. [Reserved]
Authority: 21 U.S.C. 321(q), 346a and 371. (d) * * *
action will not have a substantial direct (1) * * *
effect on States or tribal governments, ■ 2. Section 180.544 is amended by:
on the relationship between the national ■ i. Revising the entries ‘‘canistel’’; Expiration/
Parts per
government and the States or tribal ‘‘mango’’; ‘‘papaya’’; ‘‘sapodilla’’; Commodity million revocation
governments, or on the distribution of ‘‘sapote, black’’; ‘‘sapote, mamey’’; and date
power and responsibilities among the ‘‘star apple’’ in paragraph (a)(1).
Vegetable, bulb,
various levels of government or between ■ ii. Alphabetically adding commodities group 3-07 ..... 0.20 9/30/10
the Federal Government and Indian to the table in paragraph (a)(1). Vegetable,
tribes. Thus, the Agency has determined ■ iii. Removing the text from paragraph leaves of root
that Executive Order 13132, entitled (b) and reserving the heading. and tuber,
Federalism (64 FR 43255, August 10, ■ iv. Revising the tables in paragraphs group 2 .......... 0.20 9/30/10
(d)(1) and (d)(2) to read as follows: Vegetable, root
1999) and Executive Order 13175,
and tuber,
entitled Consultation and Coordination § 180.544 Methoxyfenozide; tolerances for group 1 .......... 0.10 9/30/10
with Indian Tribal Governments (65 FR residues.
67249, November 6, 2000) do not apply (a) General. (1) * * * (2) * * *
to this rule. In addition, This rule does
not impose any enforceable duty or Commodity Parts per million Parts per Expiration/
contain any unfunded mandate as Commodity revocation
million
Acerola ............................ 0.4 date
described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA) * * * * *
Animal feed,
Animal feed, nongrass,
(Public Law 104–4). non-grass,
group 18, forage ......... 50.0
group 18 ........ 10.0 9/30/10
This action does not involve any Animal feed, nongrass,
Grain, cereal,
technical standards that would require group 18, hay .............. 150.0
forage, fodder
Agency consideration of voluntary * * * * *
and straw,
consensus standards pursuant to section Avocado .......................... 0.6
group 16 ........ 10.0 9/30/10
Bean, dry, seed .............. 0.24
12(d) of the National Technology * * * * *
Grass, forage,
Transfer and Advancement Act of 1995 fodder and
Bushberry subgroup 13-
(NTTAA), Public Law 104–113, section hay, group 17 10.0 9/30/10
07B .............................. 3.0
Herb and spice,
12(d) (15 U.S.C. 272 note). Canistel ........................... 0.6
group 19 ........ 10.0 9/30/10
* * * * *
VII. Congressional Review Act Vegetable, foli-
Feijoa .............................. 0.4 age of leg-
* * * * *
The Congressional Review Act, 5 ume, group 7 10.0 9/30/10
Grass, forage, fodder
U.S.C. 801 et seq., generally provides Vegetable, leg-
and hay, group 17, for- ume, group 6 0.10 9/30/10
that before a rule may take effect, the age .............................. 18.0
agency promulgating the rule must Grass, forage, fodder
[FR Doc. E8–4027 Filed 3–4–08; 8:45 am]
submit a rule report to each House of and hay, group 17, hay 30.0
Guava ............................. 0.4 BILLING CODE 6560–50–S
the Congress and to the Comptroller
* * * * *
General of the United States. EPA will
Jaboticaba ...................... 0.4
submit a report containing this rule and * * * * * ENVIRONMENTAL PROTECTION
other required information to the U.S. Mango ............................. 0.6 AGENCY
Senate, the U.S. House of * * * * *
Representatives, and the Comptroller Onion, green, subgroup 40 CFR Part 180
General of the United States prior to 3-07B ........................... 5.0
Papaya ............................ 0.6 [EPA–HQ–OPP–2007–0308; FRL–8352–5]
publication of this final rule in the
Passionfruit ..................... 0.4
Federal Register. This final rule is not * * * * * Flumioxazin; Pesticide Tolerance
a ‘‘major rule’’ as defined by 5 U.S.C. Peanut ............................ 0.02 AGENCY: Environmental Protection
804(2). Peanut, hay .................... 55.0 Agency (EPA).
Peanut, oil ....................... 0.04
List of Subjects in 40 CFR Part 180 * * * * * ACTION: Final rule.
Sapodilla ......................... 0.6
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Environmental protection, SUMMARY: This regulation establishes a


Sapote, black .................. 0.6
Administrative practice and procedure, Sapote, mamey .............. 0.6 tolerance for residues of flumioxazin in
Agricultural commodities, Pesticides * * * * * or on alfalfa, forage; alfalfa, hay;
and pests, Reporting and recordkeeping Star apple ....................... 0.6 asparagus; bean, dry seed; bushberry
requirements. Starfruit ........................... 0.4 subgroup 13-07B; melon, subgroup 9A;

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