Document ID: EPA-HQ-OPP-2007-0495-0008
Agency: epa
Document Type: Rule
Title: Methoxyfenozide; Pesticide Tolerances and Time-Limited Pesticide Tolerances
Posted Date: 2008-03-05T05:00Z

[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Rules and Regulations]               
[Page 11820-11826]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-5]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0495; FRL-8352-2]

 
Methoxyfenozide; Pesticide Tolerances and Time-Limited Pesticide 
Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
methoxyfenozide per se; benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide in or on the food 
commodities acerola; animal feed, nongrass, group 18, forage; animal 
feed, nongrass, group 18, hay; avocado; bean,

[[Page 11821]]

dry, seed; bushberry subgroup 13-07B; canistel; feijoa; grass, forage, 
fodder and hay, group 17, forage; grass, forage, fodder and hay, group 
17, hay; guava; jaboticaba; kurrat; mango; onion, green, subgroup 3-
07B; papaya; passionfruit; peanut; peanut, hay; peanut oil; sapodilla; 
sapote, black; sapote, mamey; star apple; starfruit; vegetable, 
tuberous and corm, except potato, sub group 1D; and wax jambu. This 
regulation also establishes time-limited tolerances for indirect or 
inadvertent residues of methoxyfenozide; benzoic acid, 3-methoxy-2-
methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and 
indirect or inadvertent combined residues of methoxyfenozide and its 
metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-
dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl) 
hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethyl 
benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate 
of RH 117,236 in or on the food commodities animal feed, nongrass, 
group 18; grain, cereal, forage, fodder and straw, group 16; grass 
forage, fodder, and hay, group 17; herb and spice, group 19; vegetable, 
bulb, group 3-07; vegetable, foliage of legume, group 7; vegetable, 
leaves of root and tuber, group 2; vegetable, legume, group 6; and 
vegetable, root and tuber, group 1. Dow AgroSciences LLC and 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The 
time-limited tolerances will expire on September 30, 2010.

DATES: This regulation is effective March 5, 2008. Objections and 
requests for hearings must be received on or before May 5, 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-2007-0495. 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 website 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 
Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. 
Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Suarez, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-0120; e-mail address: suarez.mark@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 those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311) , e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    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 FFDCA, as amended by 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-2007-0495 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 May 5, 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-2007-0495, 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 
Bldg., 2777 S. Crystal Dr., 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

[[Page 11822]]

deliveries of boxed information. The Docket Facility telephone number 
is (703) 305-5805.

II. Petition for Tolerances

    In the Federal Register of October 20, 2006 (71 FR 61971) (FRL-
8098-6), August 1, 2007 (72 FR 42072) (FRL-8138-1), and October 24, 
2007 (72 FR 60367) (FRL-8154-1), EPA issued notices pursuant to section 
408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of 
pesticide petitions (PPs 6E7086, 7E7218, 6F7135, and 0F6201) by, Dow 
AgroSciences LLC, Zionsville Road -Indianapolis, IN 46268 (PPs 6F7135 
and 0F6201) and IR-4, 500 College Road East, Suite 201 W., Princeton, 
NJ 08540 (PPs 7E7218 and 6E7086). The petitions requested that 40 CFR 
180.544 be amended by establishing tolerances for residues of the 
insecticide, methoxyfenozide, in or on the food commodities acerola at 
0.4 parts per million (ppm) (PP 7E7218); arionia berry at 3.0 ppm (PP 
6E7086); avocado at 0.6 ppm (PP 7E7218); bean, dry, seed at 0.15 ppm 
(PP 6E7086); blueberry, lowbush at 3.0 ppm (PP 6E7086); buffalo currant 
at 3.0 ppm (PP 6E7086); bushberry subgroup 13B at 3.0 ppm (PP 6E7086); 
canistel at 0.6 ppm (PP 7E7218); Chilean guava at 3.0 ppm (PP 6E7086); 
chive, Chinese, fresh leaves at 5.0 ppm (PP 7E7218); chive, fresh 
leaves at 5.0 ppm (PP 7E7218); elegans hosta at 5.0 ppm (PP 7E7218); 
European barberry at 3.0 ppm (PP 6E7086); feijoa at 0.4 ppm (PP 
7E7218); fritillaria leaves at 5.0 ppm (PP 7E7218); grass forage, 
fodder, and hay group 17, forage at 18.0 ppm (PP 6E7086); grass forage, 
fodder, and hay, group 17, hay at 30.0 ppm (PP 6E7086); guava at 0.4 
ppm (PP 7E7218); highbush cranberry at 3.0 ppm (PP 6E7086); honeysuckle 
at 3.0 ppm (PP 6E7086); jaboticaba at 0.4 ppm (PP 7E7218); jostaberry 
at 3.0 ppm (PP 6E7086); juneberry at 3.0 ppm (PP 6E7086); kurrat at 5.0 
ppm (PP 7E7218); Lady's leek at 5.0 ppm (PP 7E7218); leek at 5.0 ppm 
(PP 7E7218); leek, wild at 5.0 ppm (PP 7E7218); lingonberry at 3.0 ppm 
(PP 6E7086); mango at 0.6 ppm (PP 7E7218); native currant at 3.0 ppm 
(PP 6E7086); nongrass animal feeds, group 18, forage at 35.0 ppm (PP 
6F7135); nongrass animal feeds, group 18, hay at 85.0 ppm (PP 6F7135); 
onion, Beltsville bunching at 5.0 ppm (PP 7E7218); onion, fresh at 5.0 
ppm (PP 7E7218); onion, green at 5.0 ppm (PP 7E7218); onion, macrostem 
at 5.0 ppm (PP 7E7218); onion, tree, tops at 5.0 ppm (PP 7E7218); 
onion, Welsh, tops at 5.0 ppm (PP 7E7218); papaya at 0.6 ppm (PP 
7E7218); passionfruit at 0.4 ppm (PP 7E7218); peanut at 0.02 ppm (PP 
6E7086); peanut, hay at 60 ppm (PP 6E7086); peanut oil at 0.09 ppm (PP 
6E7086); salal at 3.0 ppm (PP 6E7086); sapodilla at 0.6 ppm (PP 
7E7218); sapote, black at 0.6 ppm (PP 7E7218); sapote, mamey at 0.6 ppm 
(PP 7E7218); sea buckthorn at 3.0 ppm (PP 6E7086); shallot, fresh 
leaves at 5.0 ppm (PP 7E7218); star apple at 0.6 ppm (PP 7E7218); 
starfruit at 0.4 ppm (PP 7E7218); vegetable, tuberous and corm, except 
potato, sub group 1D at 0.02 ppm (PP 6E7086); wax jambu at 0.4 ppm (PP 
7E7218). In the petition 0F6201, Dow requested that tolerances that 
expired on September 30, 2007 be re-established for indirect or 
inadvertent residues of methoxyfenozide; benzoic acid, 3-methoxy-2-
methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and 
indirect or inadvertent combined residues of methoxyfenozide; benzoic 
acid, 3-methoxy-2-methyl-, 2-(3,5-dimethylbenzoyl)-2-(1,1-
dimethylethyl) hydrazide and its metabolites RH-117,236 free phenol of 
methoxyfenozide; 3,5-dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-
methylbenzoyl) hydrazide, RH-151,055 glucose conjugate of RH-117,236; 
3,5-dimethyl benzoic acid N-tert-butyl-N-[3 ([beta]-D-
glucopyranosyloxy)-2-methylbenzoyl]-hydrazide and RH-152,072 the 
malonylglycosyl conjugate of RH 117,236 in or on the food commodities 
grain, cereal, forage, fodder, and straw, group 16 at 10.0 ppm; grass 
forage, fodder, and hay, group 17 at 10.0 ppm; herb and spice, group 19 
at 10.0 ppm; nongrass animal feeds crop group 18 at 10.0 ppm; 
vegetable, bulb, group 3 at 0.2 ppm; vegetable, foliage of legume, 
group 7 at 10.0 ppm; vegetable, leaves of root and tuber, group 2 at 
0.2 ppm; vegetable, legume, group 6 at 0.1 ppm; and vegetable, root and 
tuber, group 1 at 0.1 ppm. Those notices referenced summaries of the 
petitions prepared by Dow AgroSciences LLC and IR-4, the registrants, 
which are available to the public in the docket,  http://
www.regulations.gov. Comments were received on the notices of filing. 
EPA's response to these comments is discussed in Unit IV.C. The time-
limited tolerances will expire on September 30, 2010.
    Based upon review of the data supporting the petition, EPA has 
modified the tolerance expression for the food commodities bean, dry, 
seed to 0.24 ppm (PP 6E7086); animal feeds, nongrass, group 18, forage 
to 50.0 ppm (PP 6F7135); animal feeds, nongrass, group 18, hay to 150.0 
ppm (PP 6F7135); onions, green, subgroup 3-07B at 5.0 ppm (PP 7E7218); 
peanut, hay to 55 ppm (PP 6E7086); peanut oil to 0.04 ppm (PP 6E7086). 
The reason for these changes is explained in Unit IV.D. EPA is also 
deleting all the tolerances in Sec.  180.544(b) for sorghum and soybean 
commodities that are no longer needed since they have expired. The 
deletions under Sec.  180.544(b) are time-limited tolerances that were 
established under section 18 emergency exemptions that have since 
expired.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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 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 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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for tolerances for the petitioned-for tolerances 
for residues of methoxyfenozide on the food commodities named above. 
EPA's assessment of exposures and risks associated with establishing 
the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information

[[Page 11823]]

concerning the variability of the sensitivities of major identifiable 
subgroups of consumers, including infants and children.
    The toxicology studies conducted with methoxyfenozide demonstrate 
that it has few or no biologically significant toxic effects at 
relatively low-dose levels and only mild or no toxic effects at 
relatively high-dose levels. In subchronic and chronic oral studies in 
rats, the most toxicologically significant effects were mild anemia and 
mild effects on the liver, thyroid gland, and adrenal gland. In 
subchronic and chronic oral studies in dogs, the predominant toxic 
effect was anemia, which was often accompanied by signs of a 
compensatory response. Methoxyfenozide is not acutely toxic, not a 
dermal sensitizer, not neurotoxic, carcinogenic or mutagenic and is not 
a developmental or reproductive toxicant. There was no evidence for 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
or rat pups to post-natal exposure to methoxyfenozide. Minimal or no 
toxic effects were observed in studies in which methoxyfenozide was 
administered by the dermal or inhalation routes of exposure. 
Methoxyfenozide is classified as a ``not likely'' human carcinogen.
    Specific information on the studies received and the nature of the 
adverse effects caused by methoxyfenozide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov. The referenced document is available in the docket 
established by this action, which is described under ADDRESSES, and is 
identified as EPA-HQ-OPP-2007-0495 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for methoxyfenozide used 
for human risk assessment can be found at http://www.regulations.gov in 
document ``Methoxyfenozide. Human Health Risk Assessment for Proposed 
Use on Sweet Potato, Blueberry, Dry Bean, Grass, Peanut, Green Onion, 
Avocado, Guava, Alfalfa and Clover. PC Code:121027, Petition No: 
6E7086, 7E7218, and 6F7135. DP Num: 331948, 340540, and 371933'' at 
page 30 in docket ID number EPA-HQ-OPP-2007-0495.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to methoxyfenozide, EPA considered exposure under the 
petitioned-for tolerances as well as all existing methoxyfenozide 
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from 
methoxyfenozide in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
methoxyfenozide; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA assumed all foods for 
which there are tolerances were treated and contain tolerance-level 
residues.
    iii. Cancer. Methoxyfenozide is not likely to be carcinogenic to 
humans; therefore, a cancer exposure assessment was not conducted.
    iv. Anticipated residue and percent crop treated. Anticipated 
residues/PCT data were not needed to refine the risk assessment so they 
were not used.
    2. Dietary exposure from drinking water. Methoxyfenozide is 
expected to be a ground water and surface water contaminant primarily 
due to its persistence in the environment.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of 
methoxyfenozide for acute exposures are estimated to be 43 parts per 
billion (ppb) for surface water and 7.43 ppb for ground water. The EECs 
for chronic exposures are estimated to be 33.1 ppb for surface water 
and <7.43 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 43 ppb was used to access 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 33.1 ppb was used to 
access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Methoxyfenozide is not registered for use on any sites that would 
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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 methoxyfenozide and any 
other substances and methoxyfenozide 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 methoxyfenozide 
has a common

[[Page 11824]]

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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of 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 based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly refered to as the FQPA safety factor. In applying 
this provision, EPA either retains the default value of 10X when 
reliable data do not support the choice of a different factor, or, if 
reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is not a concern for 
prenatal and/or postnatal toxicity resulting from exposure to 
methoxyfenozide. The prenatal and postnatal toxicology database for 
methoxyfenozide includes rat and rabbit developmental toxicity studies 
and a 2-generation reproduction toxicity study in rats. There was no 
quantitative or qualitative evidence of increased susceptibility of 
rats or rabbit fetuses to in utero exposure in the developmental 
studies; similarly, there was no evidence of increased susceptibility 
of rat pups following prenatal/postnatal exposure in the 2-generation 
reproduction study.
    3. Conclusion. The FQPA SF for the protection of infants and 
children be removed (i.e. reduced to 1x) for methoxyfenozide for the 
following reasons:
    i. The toxicology database for methoxyfenozide is complete for 
assessment of potential hazard to infants and children.
    ii. Based on weight-of-the-evidence considerations, EPA determined 
that a developmental neurotoxicity study in rats is not required to 
support the registration of methoxyfenozide.
    iii. In developmental toxicity studies in rats and rabbits, no 
increased susceptibility in fetuses as compared to maternal animals was 
observed following in utero exposures.
    iv. In a 2-generation reproduction study in rats, no increased 
susceptibility in pups as compared to adults was observed following in 
utero and postnatal exposures.
    v. The exposure assessments will not underestimate the potential 
dietary (food and drinking water) or nondietary exposures for infants 
and children from the use of methoxyfenozide. The chronic dietary food 
exposure assessment utilizes tolerance level residues and assumes 100 
PCT. Conservative ground water and surface water modeling estimates 
were used. These assessments will not underestimate the exposure and 
risks posed by methoxyfenozide.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate- and log-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UTs is 
not exceeded.
    1. Acute risk. No acute risk is expected from exposure to 
methoxyfenozide since no acute endpoints were identified for the 
general U.S. population (including infants and children) or the females 
13-50 years old population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
methoxyfenozide from food and water will utilize 56% of the cPAD for 
the most highly exposed population group, children 1-2 years old. There 
are no residential uses for methoxyfenozide.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Methoxyfenozide is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Methoxyfenozide is not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    5. Aggregate cancer risk for U.S. population. Methoxyfenozide is 
classified as a ``not likely'' human carcinogen and thus is not 
expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high pressure liquid 
chromatography with mass spectrometry (HPLC/MS)) 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: residuemethods@epa.gov.

B. International Residue Limits

    There are currently no Codex, Canadian or Mexican MRLs for 
methoxyfenozide, so there are no international harmonization issues 
associated with this action.

C. Response to Comments

    Public comments were received from a citizen who objected to the 
proposed tolerances because ``methoxyfenozide harms fish and birds so 
that they die'' and also opposes ``any exemption or residue left on 
plants after use from this product.'' The comments contained no 
scientific data or evidence to rebut the Agency's conclusion that there 
is a reasonable certainty that no harm will result from human or 
environmental exposure to methoxyfenozide. EPA has responded to similar 
comments on numerous previous occasions. (January 7, 2005, 70 FR 1349) 
(October 29, 2004, 69 FR 63083).

D. Explanation of Tolerance Revisions

    The tolerances established here have been modified in some 
instances from the tolerances originally proposed in the notices of 
filing. These modifications have been based upon specific data, as 
described in unit IV.D. The data indicate that the requested tolerance 
on dry beans at 0.15 ppm is not appropriate

[[Page 11825]]

since the field trial data indicate that residues could be higher than 
the tolerance request. Therefore, a more appropriate tolerance is being 
established for the residues of methoxyfenozide on bean, dry at 0.24 
ppm. The data for peanut hay are adequate. EPA's Review indicates that 
the requested tolerance of 60 ppm is not appropriate. Therefore, a more 
appropriate tolerance is being established for the residues of 
methoxyfenozide on peanut, hay at 55.0 ppm. The data for animal feed, 
nongrass, group 18, forage and hay are adequate. EPA's Review indicates 
that the requested tolerances are not appropriate. Residue field trial 
data from representative crops should be analyzed separately and the 
highest result used for tolerance setting purposes. This was not done. 
A more appropriate tolerance is being established for the residues of 
methoxyfenozide on animal feed, nongrass, group 18, forage at 50 ppm, 
and hay at 150 ppm. The only processed commodities of regulatory 
concern for this petition are peanut meal and oil. A study was 
conducted using a 3x exaggerated application rate to the peanut raw 
agricultural commodity and simulated commercial processing to produce 
the peanut processed commodities. Results of the study indicate that 
residues of methoxyfenozide are not expected to concentrate in peanut 
meal but do concentrate 3x in oil. The requested tolerance level for 
peanut oil is inadequate. Using the highest average field trial values 
from the submitted field trial data and the concentration factor for 
peanut oil, the tolerance level should be 0.04 ppm.
    IR-4 petitioned for individual tolerances on green onion, fresh 
chive leaves, fresh Chinese chive leaves, elegans hosta, fritillaria 
leaves, kurrat, Lady's leek, leek, wild leek, Beltsville bunching 
onion, fresh onion, macrostem onion, tree onion tops, Welsh onion tops, 
and fresh shallot leaves at 5.0 ppm (PP 7E7128) as well as for a 
tolerance for bushberry subgroup 13B and individual tolerances on 
aronia berry, buffalo currant, Chilean guava, European barberry, 
highbush cranberry, honeysuckle, jostaberry, juneberry, lingonberry, 
native currant, salal, and sea buckthorn (PP 6E7086).
    In the Federal Register of December 7, 2007 (72 FR 69150) (FRL-
8340-6), EPA issued a final rule that revised the crop grouping 
regulations. As part of this action, EPA expanded and revised bulb 
vegetables group 3. Changes to crop group 3 (bulb vegetables) included 
adding new commodities, creating subgroups for bulb and green onions, 
and changing the name of one of the representative commodities from 
``onion, dry bulb'' to ``onion, bulb.'' EPA also expanded and revised 
berries group 13. Changes to crop group 13 (berries) included adding 
new commodities, revising existing subgroups and creating new subgroups 
(including a bushberry subgroup 13-07B consisting of the commodities 
requested in PP 6E7086 and cultivars, varieties, and/or hybrids of 
these).
    EPA indicated in the December 7, 2007 final rule as well as the 
earlier May 23, 2007 proposed rule (72 FR 28920) (FRL-8126-1) that, for 
existing petitions for which a Notice of Filing had been published, the 
Agency would attempt to conform these petitions to the rule. Therefore, 
consistent with this rule, EPA is establishing tolerances on onion, 
green, subgroup 3-07B and bushberry subgroup 13-07B.
    EPA concludes it is reasonable to revise the petitioned-for 
tolerances so that they agree with the recent crop grouping revisions 
because:
    1. Although the subgroups are new the commodities in the new group 
were proposed as individual tolerances and the added commodities are 
closely related minor crops which contribute little to overall dietary 
or aggregate exposure and risk; and
    2. Methoxyfenozide exposure from these added commodities was 
considered when EPA conducted the dietary and aggregate risk 
assessments supporting this action.

V. Conclusion

    Therefore, tolerances are established for residues of 
methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl)hydrazide, in or on the food 
commodities acerola at 0.4 ppm; animal feeds, nongrass, group 18, 
forage at 50.0 ppm; animal feeds, nongrass, group 18, hay at 150.0 ppm; 
avocado at 0.6 ppm; bean, dry, seed at 0.24 ppm; bushberry subgroup 13-
07B at 3.0 ppm; canistel at 0.6 ppm; feijoa at 0.4 ppm; grass, forage, 
fodder, and hay group 17, forage at 18.0 ppm; grass, forage, fodder, 
and hay, group 17, hay at 30.0 ppm; guava at 0.4 ppm; jaboticaba at 0.4 
ppm; mango at 0.6 ppm; onions, green, subgroup 3-07B at 5.0 ppm; papaya 
at 0.6 ppm; passionfruit at 0.4 ppm; peanut at 0.02 ppm; peanut, hay at 
55 ppm; peanut oil at 0.04 ppm; sapodilla at 0.6 ppm; sapote, black at 
0.6 ppm; sapote, mamey at 0.6 ppm; star apple at 0.6 ppm; starfruit at 
0.4 ppm; vegetable, tuberous and corm, except potato, sub group 1D at 
0.02 ppm; wax jambu at 0.4 ppm.
    Time-limited tolerances are established for the indirect or 
inadvertent residues for methoxyfenozide in or on vegetable, bulb, 
group 3 at 0.2 ppm; vegetable, leaves of root and tuber, group 2 at 0.2 
ppm; and vegetable, root and tuber, group 1 at 0.1 ppm; and the 
combined residues of methoxyfenozide; benzoic acid, 3-methoxy-2-methyl-
, 2-(3,5-dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide and its 
metabolites RH-117,236 free phenol of methoxyfenozide; 3,5-
dimethylbenzoic acid N-tert-butyl-N'-(3-hydroxy-2-methylbenzoyl) 
hydrazide, RH-151,055 glucose conjugate of RH-117,236; 3,5-dimethyl 
benzoic acid N-tert-butyl-N-[3 ([beta]-D-glucopyranosyloxy)-2-
methylbenzoyl]-hydrazide and RH-152,072 the malonylglycosyl conjugate 
of RH 117,236 in or on the food commodities animal feed, nongrass, 
group 18 at 10.0 ppm; grain, cereal, forage, fodder and straw, group 16 
at 10.0 ppm; grass forage, fodder and hay, group 17 at 10.0 ppm; herb 
and spice, group 19 at 10.0 ppm; vegetable, foliage of legume, group 7 
at 10.0 ppm; and vegetable, legume, group 6 at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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

[[Page 11826]]

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).

VII. 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: February 14, 2008.
 Donald R. Stubbs,
Acting 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 180.544 is amended by:
0
i. Revising the entries ``canistel''; ``mango''; ``papaya''; 
``sapodilla''; ``sapote, black''; ``sapote, mamey''; and ``star apple'' 
in paragraph (a)(1).
0
ii. Alphabetically adding commodities to the table in paragraph (a)(1).
0
iii. Removing the text from paragraph (b) and reserving the heading.
0
iv. Revising the tables in paragraphs (d)(1) and (d)(2) to read as 
follows:

Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Acerola..............................................                0.4
                                * * * * *
Animal feed, nongrass, group 18, forage..............               50.0
Animal feed, nongrass, group 18, hay.................              150.0
                                * * * * *
Avocado..............................................                0.6
Bean, dry, seed......................................               0.24
                                * * * * *
Bushberry subgroup 13-07B............................                3.0
Canistel.............................................                0.6
                                * * * * *
Feijoa...............................................                0.4
                                * * * * *
Grass, forage, fodder and hay, group 17, forage......               18.0
Grass, forage, fodder and hay, group 17, hay.........               30.0
Guava................................................                0.4
                                * * * * *
Jaboticaba...........................................                0.4
                                * * * * *
Mango................................................                0.6
                                * * * * *
Onion, green, subgroup 3-07B.........................                5.0
Papaya...............................................                0.6
Passionfruit.........................................                0.4
                                * * * * *
Peanut...............................................               0.02
Peanut, hay..........................................               55.0
Peanut, oil..........................................               0.04
                                * * * * *
Sapodilla............................................                0.6
Sapote, black........................................                0.6
Sapote, mamey........................................                0.6
                                * * * * *
Star apple...........................................                0.6
Starfruit............................................                0.4
                                * * * * *
Vegetable, tuberous and corm, except potato, subgroup               0.02
 1D..................................................
Wax jambu............................................                0.4
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) * * *
    (1) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Vegetable, bulb, group 3-07...................         0.20      9/30/10
Vegetable, leaves of root and tuber, group 2..         0.20      9/30/10
Vegetable, root and tuber, group 1............         0.10      9/30/10
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Animal feed, non-grass, group 18..............         10.0      9/30/10
Grain, cereal, forage, fodder and straw, group         10.0      9/30/10
 16...........................................
Grass, forage, fodder and hay, group 17.......         10.0      9/30/10
Herb and spice, group 19......................         10.0      9/30/10
Vegetable, foliage of legume, group 7.........         10.0      9/30/10
Vegetable, legume, group 6....................         0.10      9/30/10
------------------------------------------------------------------------

[FR Doc. E8-4027 Filed 3-4-08; 8:45 am]

BILLING CODE 6560-50-S