Document ID: EPA-HQ-OPP-2008-0556-0012
Agency: epa
Document Type: Rule
Title: Fenpyroximate; Pesticide Tolerances
Posted Date: 2009-12-02T05:00Z

[Federal Register: December 2, 2009 (Volume 74, Number 230)]
[Rules and Regulations]               
[Page 63074-63079]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de09-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0556; FRL-8799-2]

 
Fenpyroximate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of fenpyroximate and its Z-isomer in or on berry, low growing, subgroup 
13-07G, at 1.0 part per million (ppm). Nichino America, Inc. requested 
this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 2, 2009. Objections and 
requests for hearings must be received on or before February 1, 2010, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

[[Page 63075]]

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0556. All documents in the 
docket are listed in the docket index available at http://
www.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 in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South 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:  Rosanna Louie, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0037; e-mail address: louie.rosanna@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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide 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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2008-0556 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 as required by 40 CFR part 178 
on or before February 1, 2010.
    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 this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0556, 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 Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9F7520) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, 
Wilmington, DE, 19808. The petition requested that 40 CFR 180.566 be 
amended by establishing tolerances for combined residues of the 
insecticide fenpyroximate, (E)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-
phenoxy-1H-pyrazol-4-yl)methylene]amino]oxy]methyl] benzoate, and its 
Z-isomer, (Z)-1,1-dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-
pyrazol-4-yl)methylene]amino]oxy]methyl] benzoate, in or on berry, low 
growing, subgroup 13-07G, at 1.0 part per million (ppm). That notice 
referenced a summary of the petition prepared by Nichino America, Inc., 
the registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.

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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerance for combined residues of fenpyroximate and its Z-isomer in or 
on berry, low growing, subgroup 13-07G, at 1.0 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity,

[[Page 63076]]

completeness, and reliability as well as the relationship of the 
results of the studies to human risk. EPA has also considered available 
information concerning the variability of the sensitivities of major 
identifiable subgroups of consumers, including infants and children.
    Fenpyroximate has moderate oral and inhalation toxicity. It has low 
dermal toxicity and is not an eye or skin irritant. Fenpyroximate is a 
slight to moderate skin sensitizer.
    Subchronic oral toxicity studies in the rat show the primary 
effects included decreased body weight and weight gain at the lowest 
observed adverse effect level (LOAEL) while there were hematological 
effects at higher doses. In the 21-day dermal toxicity study in rats, 
there were clinical signs in the females (including red nose/mouth/
nasal discharge); decreased body weights, body weight gains, and food 
consumption in males and females; and increased liver weights and 
hepatocellular necrosis in the females. In the subchronic oral dog 
study, there was bradycardia observed at the LOAEL. This effect was 
present at 6 weeks (first time point measured) and did not appear to 
increase in severity with time. Also observed at this dose level were 
diarrhea, decreased body weight, body weight gain, and food 
consumption. At higher doses, there was also emesis (vomiting). The 
highest dose resulted in first- and second-degree heart block, 
increased urea concentration, decreased glucose and altered plasma 
electrolyte levels among other signs of toxicity.
    In the chronic oral rat and mouse studies, signs of toxicity were 
similar to those in the oral subchronic rat study. The chronic dog 
study also revealed signs of toxicity including bradycardia, diarrhea, 
decreased body weight gain, and food consumption.
    The 2-generation reproductive toxicity study indicated that 
maternal (decreased body weight) and offspring toxicity (decreased 
lactational weight gain) occurred at the same dose, suggesting no 
evidence of sensitivity or susceptibility. Reproductive parameters were 
not affected in this 2-generation reproduction study. The rat and 
rabbit developmental toxicity studies were tested at doses that 
produced minimal or no maternal or offspring toxicity.
    There are no neurotoxicity studies other than a negative delayed 
acute neurotoxicity study in the hen. There was no indication of 
neurotoxicity present in any of the existing subchronic or chronic 
toxicity studies.
    There was no concern for mutagenic activity in several studies 
including: Salmonella, E. Coli, in vitro mammalian cell gene mutation 
assay at the Hypoxanthine guanine phophoribosyl transferase (HGPRT) 
locus, mammalian cell chromosome aberration assay, in vivo mouse bone 
marrow micronucleus assay, DNA repair disk diffusion assay, and an 
unscheduled DNA synthesis assay.
    There was no evidence of carcinogenic potential in either the rat 
or mouse study. Therefore, fenpyroximate is classified as ``not likely 
to be carcinogenic to humans'' by all relevant routes of exposure.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpyroximate as well as the no-observed-
adverse-effect-level (NOAEL) and LOAEL from the toxicity studies can be 
found at http://www.regulations.gov in document ``Fenpyroximate. Human-
Health Risk Assessment for Proposed Section 3 Uses on Berry, Low 
growing Subgroup 13-07G,'' pages 10-13, in docket ID number EPA-HQ-OPP-
2008-0556.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. 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/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenpyroximate used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Fenpyroximate. Human-Health Risk Assessment for Proposed 
Section 3 Uses on Berry, Low growing Subgroup 13-07G,'' page 5, in 
docket ID number EPA-HQ-OPP-2008-0556.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpyroximate, EPA considered exposure under the 
petitioned-for tolerance, as well as all existing fenpyroximate 
tolerances in (40 CFR 180.566). EPA assessed dietary exposures from 
fenpyroximate 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. An acute dietary exposure 
assessment was conducted for females 13-49 years old. Since an effect 
of concern attributable to a single dose in toxicity studies was not 
identified for the general U.S. population, an acute dietary exposure 
assessment was not performed for subgroups other than females 13-49 
years old.
    In estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA conducted acute dietary 
analysis for fenpyroximate assuming 100% crop treated (CT) and existing 
and proposed tolerance-level residues for all commodities. Dietary 
Exposure Evaluation Model (DEEM\(TM)\) (ver. 7.81) default processing 
factors were assumed for all commodities excluding apple, pear, and 
grape juice (0.11X); grape, raisin (2.7X); orange, grapefruit, 
tangerine, lemon and lime juice (0.06X); tomato paste and puree (1.0X); 
and peppermint and spearmint oil (0.08X). The petitioner submitted 
adequate tomato processing data indicating that residues of 
fenpyroximate per se did not concentrate in tomato paste or puree as

[[Page 63077]]

all processing factors were <1.0X. Residues of the Z-isomer did not 
concentrate in tomato puree; however, residues of Z-isomer concentrated 
slightly in tomato paste. When residues are combined, the average 
processing factors were <0.89X for tomato paste and <0.57X for tomato 
puree. Default processing factor of 1.0X was assumed for both tomato 
paste and tomato puree.
    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 100% CT and 
existing and proposed tolerance-level residues for all commodities. 
DEEM(\TM\) (ver.7.81) default processing factors were assumed with the 
exceptions listed in Unit III.C.1.
    iii. Cancer. Fenpyroximate is classified as ``not likely to be a 
human carcinogen.'' There was no evidence of carcinogenicity in mouse 
studies or in combined chronic/carcinogenicity studies in the rat. In 
addition, bacterial reverse mutation and in vitro mammalian cell gene 
mutation studies showed no mutagenic effects. Therefore, a dietary 
exposure assessment to evaluate cancer risk was not performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue or PCT information in the dietary 
assessment for fenpyroximate. Tolerance level residues and/or 100% CT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for fenpyroximate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpyroximate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on proposed application rates and the environmental fate 
properties of fenpyroximate, some surface and ground water 
contamination may occur. However, the risk of water contamination from 
parent compound is relatively low, based on its high sorption 
potential. Unlike its parent compound, the sorption of the M-3 
metabolite is much less, and it may move into water resources more 
readily. Environmental fate data indicate that parent and its Z-isomer 
are stable to photolysis in soil and immobile in soil. Major degradates 
formed in the aqueous layer were M-3 (50%), M-8 (36%), M-16 (4-
hydroxymethylbenzoic acid, 58%) and M-11 (25 to 30%), and M-3 (>10%), 
M-11 (25 to 30%) and M8 (16 to 19%) in the soil. However, data from a 
field dissipation study showed M3 (32%) being the only significant 
degradate found in the field.
    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWC) of fenpyroximate, and 
its degradates, M1 and M3, for acute exposures are estimated to be 8.74 
parts per billion (ppb) for surface water and 0.001 ppb for ground 
water. For chronic exposures for non-cancer assessments the EDWCs are 
estimated to be 0.51 ppb for surface water and 0.001 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 8.74 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 0.51 ppb was used to 
assess 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). Fenpyroximate is not 
registered for any specific use patterns 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.''
    EPA has not found fenpyroximate to share a common mechanism of 
toxicity with any other substances, and fenpyroximate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fenpyroximate does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is no concern for 
prenatal and/or postnatal toxicity resulting from exposure to 
fenpyroximate. There is no evidence (qualitative or quantitative) of 
increased susceptibility following prenatal and postnatal exposure in 
adequate developmental toxicity studies in the rat and rabbit and a 2-
generation reproduction study in the rat.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for fenpyroximate is adequate to 
characterize potential prenatal and postnatal risk for infants and 
children. Acceptable/guideline studies for developmental toxicity in 
rats and rabbits and reproduction toxicity in rats are available for 
FQPA assessment.
    EPA began requiring functional immunotoxicity testing of all food 
and non-food use pesticides on December 26, 2007. Since this 
requirement went into effect relatively recently, these studies are not 
yet available for fenpyroximate. In the absence of an immunotoxicity 
study, EPA evaluated the available fenpyroximate toxicity data to 
determine whether an additional database uncertainty factor (UF) is 
needed to account for potential toxicity. No evidence of immunotoxicity 
was found in studies conducted with fenpyroximate. Due to the lack of 
evidence of immunotoxicity for fenpyroximate, EPA does not believe that 
conducting an immunotoxicity study with fenpyroximate will result in a 
NOAEL less than the chronic Reference dose (cRfD) NOAEL of 0.97 
milligram/kilogram/day (mg/kg/day) already established for 
fenpyroximate, and an additional database UF is not

[[Page 63078]]

needed to account for potential immunotoxicity.
    Acute and subchronic neurotoxicity testing in rats is also required 
as a result of the changes to the pesticide data requirements in 
December of 2007 (40 CFR part 158). Although neurotoxicity studies in 
rats have not yet been submitted, there is no evidence of neurotoxicity 
in any study in the toxicity database for fenpyroximate. Therefore, EPA 
has concluded that an additional UF is not needed to account for the 
lack of these data.
    ii. There is no indication that fenpyroximate is a neurotoxic 
chemical in available studies, and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fenpyroximate results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary exposure assessments were 
performed based on 100% CT and tolerance-level residues for existing 
and proposed uses. EPA made conservative (protective) assumptions in 
the ground and surface water modeling used to assess exposure to 
fenpyroximate in drinking water. These assessments will not 
underestimate the exposure and risks posed by fenpyroximate.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
fenpyroximate will occupy 7.6% of the aPAD for females 13-49 years old, 
the only population subgroup of interest.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fenpyroximate from food and water will utilize 42% of the cPAD for 
children 1-2 years old, the population subgroup receiving the greatest 
exposure. There are no residential uses for fenpyroximate.
    3. Short-term and intermediate-term risk. Short-term aggregate 
exposure takes into account short-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level). Similarly, intermediate-term aggregate exposure takes 
into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Fenpyroximate is not registered for any use patterns that would 
result in residential exposure. Therefore, the short- and intermediate-
term aggregate risk is the sum of risk from exposure to fenpyroximate 
through food and drinking water and will not be greater than the 
chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. There was no evidence 
of carcinogenicity in mouse studies or in combined chronic/
carcinogenicity studies in the rat. In addition, bacterial reverse 
mutation and in vitro mammalian cell gene mutation studies showed no 
mutagenic effects. Therefore, fenpyroximate is not expected to pose a 
cancer risk.
    5. 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 fenpyroximate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An acceptable enforcement method, gas chromatography with nitrogen-
phosphorus detector (GC/NPD) method DFG S19, is available for 
enforcement of tolerances for residues in or on plant commodities. This 
method has undergone a petition method validation and is listed in the 
U.S. EPA Index of Residue Analytical Methods under fenpyroximate, 
Method ID 2000--109M, ``Quantification of Fenpyroximate Residues in Raw 
Agricultural and Processed Commodities.'' Method S19 has a limit of 
quantitation of 0.02 ppm for the combined residues of fenpyroximate and 
its Z-isomer in strawberries.
    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

    Codex and Mexican maximum residue limits (MRLs) are established for 
residues of fenpyroximate per se in or on several crop commodities but 
not for the crops requested. Harmonization with the other Codex and 
Mexican MRLs is not possible because the U.S. tolerance expressions 
include additional metabolites/isomers. There are currently no 
established Canadian MRLs.

V. Conclusion

    Therefore, a tolerance is established for combined residues of the 
insecticide fenpyroximate parent and its Z-isomer, (E)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl] benzoate, and its Z-isomer, (Z)-1,1-
dimethylethyl 4-[[[[(1,3-dimethyl-5-phenoxy-1H-pyrazol-4-
yl)methylene]amino]oxy]methyl] benzoate, in or on berry, low growing, 
subgroup 13-07G at 1.0 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled 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

[[Page 63079]]

require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final 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: November 13, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.566 is amended by alphabetically adding the following 
commodity to the table in paragraph (a)(1) to read as follows:

Sec.  180.566  Fenpyroximate; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Berry, low growing, crop subgroup 13-07G.............                1.0
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-28676 Filed 12-01-09; 8:45 am]

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