[Federal Register Volume 74, Number 144 (Wednesday, July 29, 2009)]
[Rules and Regulations]
[Pages 37612-37618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17942]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0556; FRL-8420-6]
Fenpyroximate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of fenpyroximate in or on raw agricultural commodities (RAC):
Vegetables, fruiting, group 8 at 0.20 ppm; okra at 0.20 ppm; melon
subgroup 9A at 0.10 ppm; and cucumber at 0.10 ppm. The Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 29, 2009. Objections and
requests for hearings must be received on or before September 28, 2009,
and must be filed in accordance with the instructions
[[Page 37613]]
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-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: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-7610; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural 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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents 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 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 September 28, 2009.
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 August 13, 2008 (73 FR 47186) (FRL-8375-
8), 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
8E7365) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.566 be amended by
establishing tolerances for 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 food commodities vegetables,
fruiting, group 08 at 0.20 ppm; okra at 0.20 ppm; melon subgroup 09A at
0.03 ppm; and cucumber at 0.05 ppm. That notice referenced a summary of
the petition prepared by Nichino America, Inc., of Wilmington, DE
19808, 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.
Based upon review of available field trial residue data supporting
the petition, EPA determined that the proposed tolerance levels for
certain crops should be revised as follows: Melon subgroup 9A increased
from 0.03 ppm to 0.10 ppm and cucumber increased from 0.05 ppm to 0.10
ppm. The reasons for these changes are explained in Unit IV.D.
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
[[Page 37614]]
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
tolerances for combined residues of fenpyroximate and its Z-isomer in
or on food commodities vegetables, fruiting, group 8 at 0.20 ppm; okra
at 0.20 ppm; melon subgroup 9A at 0.10 ppm; and cucumber at 0.10 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 their
validity, 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 by the maximization test method.
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. 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 maternal 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 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.
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 the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Fenpyroximate. Petition for the
Establishment of Permanent Tolerances for Residues on Fruiting
Vegetable (crop Group 8), Okra. Human Health Risk Assessment, dated 12/
23/2008, page 14 in docket ID number EPA-HQ-OPP-2008-0556-0004.
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-, intermediate-
, 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. Petition for the Establishment of Permanent
Tolerances for Residues on Fruiting Vegetable (Crop Group 8), Okra.
Human Health Risk Assessment, dated 12/23/2008, page 12 in docket ID
number EPA-HQ-OPP-2008-0556-0004.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenpyroximate, EPA considered exposure under the
petitioned-for tolerances 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
[[Page 37615]]
performed for subgroups other than females 13-49 years old.
In estimating acute dietary exposure, EPA used food consumption
information from the United States 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 percent crop treated
(PCT) and existing and proposed tolerance-level residues for all
commodities. DEEM (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 (1.0x) 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 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. Available
data support processing factors presented in Unit C.1. for stated
commodities.
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 PCT and
existing and proposed tolerance-level residues for all commodities.
DEEM (ver. 7.81) default processing factors were assumed with the
exceptions listed in Unit C.1.
iii. Cancer. Fenpyroximate is classified as ``not likely to be a
human carcinogen.'' There was no evidence of carcinogencity in mice
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 cancer
dietary exposure assessment was not performed.
The assumption of 100 PCT and tolerance level residues was made for
all registered and proposed commodity uses of fenpyroximate.
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.
The nature of fenpyroximate residues in plants and animals is
understood. The residues of concern for plants are fenpyroximate and
its Z-isomer (also referred to as M-1). The residues of concern for
livestock milk, fat, meat and meat by-products are parent and multiple
metabolites. Livestock residues, however, are not relevant to this
petition. EPA determined that the residues in plants and livestock raw
agricultural commodities for the purposes of tolerance enforcement and
risk assessment are the parent compound, fenpyroximate, plus its Z-
isomer and metabolites and that parent, Z-isomer and metabolite M-3
should be considered as residues of concern in drinking water. Based on
the 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 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
structural similarity between parent and M-3, the Agency concluded that
parent and M-3 should be included in the risk assessment.
The EDWCs were Tier 1 estimates for ground water using the
Screening Concentration in Ground Water (SCI-GROW) model and surface
water using the First Index Reservoir Screening Tool (FIRST) model for
fenpyroximate and its metabolites. The models utilized an application
rate of 0.2 lb ai/A with 2 applications per season.
Based on the FIRST, and SCI-GROW models, the EDWCs of fenpyroximate
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 are estimated to be 0.51 ppb for surface
water and 0.001 ppb for ground water. Parent, Z-isomer and metabolite
M-3 are of concern in 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 of value 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
[[Page 37616]]
data are available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. There is no concern for pre-
and/or post-natal toxicity resulting from exposure to fenpyroximate.
There is no evidence (qualitative or quantitative) of increased
susceptibility following pre- and post-natal exposure in adequate
developmental toxicity studies in the rat and rabbit and a two-
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 pre-natal and post-natal 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 specific
immunotoxicity studies, EPA has evaluated the available fenpyroximate
toxicity database to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity.
No evidence of immunotoxicity was found. Due to the lack of evidence of
immunotoxicity for fenpyroximate, EPA does not believe that conducting
immunotoxicity testing will result in a NOAEL less than the cRfD NOAEL
of 0.97 mg/kg bw/day already established for fenpyroximate, and an
additional factor (UFDB) for database uncertainties is not
needed to account for potential immunotoxicity.
Acute and subchronic neurotoxocity testing in rats is also required
as a result of changes made to the pesticide data requirements in
December of 2007. 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 uncertainty factor is not needed to account for the
lack of these data.
The residue chemistry and environmental fate databases are
complete.
ii. There is no indication that fenpyroximate is a neurotoxic
chemical 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 dietary food exposure assessments were performed based
on 100 PCT 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-, intermediate-, 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 6.6% of the aPAD for (females 13-49 years)
the only population group 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 38% of the cPAD for
(children 1-2 years old) the population group receiving the greatest
exposure. There are no residential uses for fenpyroximate.
3. Short-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).
Fenpyroximate is not registered for any use patterns that would
result in residential exposure. Therefore, the short-term aggregate
risk is the sum of the risk from exposure to fenpyroximate through food
and water and will not be greater than the chronic aggregate risk.
4. Intermediate-term risk. 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 intermediate-term residential exposure. Therefore, the
intermediate-term aggregate risk is the sum of the risk from exposure
to fenpyroximate through food and water, which has already been
addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. Fenpyroximate is
classified as not likely to be carcinogenic to humans. Therefore,
fenproximate is not expected to pose a cancer risk.
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 fenpyroximate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate enforcement method is available for determination of
fenpyroximate residues of concern in plants. A gas chromatography
method with nitrogen/phosphorus detection (GC/NPD), Method S19, has
passed an Agency validation. Method S19 has a limit of quantitation of
0.10 ppm for the combined residues of fenpyroximate and its Z-isomer.
Adequate enforcement methodology (gas chromatography (GC/NPD) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; e-mail address: [email protected].
B. International Residue Limits
Codex and Mexican maximum residue limits (MRLs) are established for
residues of fenpyroximate per se in/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.
[[Page 37617]]
C. Revisions to Petitioned-For Tolerances
Based upon available data supporting petitioned-for tolerances, the
Agency revised and/or modified the petitions as proposed in the notice
of filing, as follows:
1. Proposed tolerance level for melon subgroup 9A at 0.03 ppm was
increased to 0.10 ppm. Available residue data for cantaloupe, the
representative crop, are adequate to fulfill data requirements. The
number and locations of field trials conducted are in accordance with
EPA Guideline 860.1500, and the trials reflect the proposed use
pattern. The residue data were not entered into the Agency's tolerance
spreadsheet because all treated samples bore combined residues below
the limit of quantitation (LOQ) of <0.10 ppm. The available data for
cantaloupe will support a tolerance of 0.10 ppm (the combined LOQs of
the enforcement method for the parent compound and the Z-isomer) for
fenpyroximate residues in/on melon subgroup 9A.
2. The Agency modified the proposed tolerance for residues in/on
cucumber from 0.05 ppm to 0.10 ppm based on available residue data.
Residue data include field trials where a single foliar application of
fenpyroximate at maximum proposed seasonal rate was made. Results show
that the maximum combined residues of fenpyroximate and its Z-isomer
in/on cucumbers was <0.03 ppm at 7-day PHI.
These data were entered into the Agency's tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP to determine an appropriate tolerance level. The
Agency determined that the appropriate RAC tolerance for cucumber is
0.10 ppm (the combined LOQs of the enforcement method for the parent
compound and the Z-isomer).
V. Conclusion
Therefore, tolerances are established for combined residues of
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 food commodities:
vegetables, fruiting, group 8 at 0.20 ppm; okra at 0.20 ppm; melon
subgroup 9A at 0.10 ppm; and cucumber at 0.10 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 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: July 20, 2009.
G. Jeffrey Herndon,
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 180.566 is amended by revising the term ``residues'' to read
``combined residues'' in introductory paragraphs (a)(1), (a)(2) and
(a)(3); and by alphabetically adding the following commodities to the
table in paragraph (a)(1) to read as follows:
Sec. 180.566 Fenpyroximate; tolerances for residues.
(a) General. (1) * * *
[[Page 37618]]
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Cucumber.............................................. 0.10
* * * * *
Melon subgroup 9A..................................... 0.10
* * * * *
Okra.................................................. 0.20
* * * * *
Vegetable, fruiting, group 8.......................... 0.20
----------------------------------------------------------------------------------------------------------------
* * * * *
[FR Doc. E9-17942 Filed 7-28-09; 8:45 am]
BILLING CODE 6560-50-S