[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Rules and Regulations]
[Pages 70143-70149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28973]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0812; FRL-8851-7]


Acequinocyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acequinocyl in or on bean, edible podded; hop, dried cones; okra and 
vegetable, fruiting, group 8. 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 November 17, 2010. Objections and 
requests for hearings must be received on or before January 18, 2011, 
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-2009-0812. 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: <a href="/cdn-cgi/l/email-protection#a4cec5c7cfd7cbca8ad7cdc0cac1dde4c1d4c58ac3cbd2"><span class="__cf_email__" data-cfemail="107a71737b637f7e3e6379747e7569507560713e777f66">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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

[[Page 70144]]

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 site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 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-2009-0812 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 18, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0812, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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. Summary of Petitioned-for Tolerance

    In the Federal Register of January 6, 2010 (75 FR 868) (FRL-8801-
5), 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 
9E7598) by IR-4 Project Headquarters, 500 College Road East, Suite 
201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.599 
be amended by establishing tolerances for residues of the insecticide 
acequinocyl, 2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione, and its 
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the 
stoichiometric equivalent of acequinocyl and by establishing a 
tolerance for the residues of acequinocyl, including its metabolites 
and degradates in or on vegetable, fruiting, group 8 at 0.7 parts per 
million (ppm); okra at 0.7 ppm; bean, edible podded at 0.25 ppm and 
hop, dried cone at 3.5 ppm. That notice referenced a summary of the 
petition prepared on behalf of IR-4 by Arysta LifeScience North America 
LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance for hop dried cones from 3.5 ppm to 4.0 
ppm as available data submitted support the higher tolerance. The 
reason(s) 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 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 acequinocyl including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with acequinocyl 
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.
    Acequinocyl exhibits low acute toxicity in oral, dermal and 
inhalation routes of exposure, as well as, primary eye and primary skin 
irritation studies. It is not a dermal sensitizer.
    In rat studies including a subchronic oral toxicity study, a 28-day 
dermal toxicity study, and a chronic feeding/oncogenicity study, 
acequinocyl increased prothrombin and activated partial thromboplastin. 
Internal hemorrhages were observed in both a rat and rabbit 
developmental toxicity study, a mouse subchronic/chronic toxicity 
study, and in a 2-generation reproduction rat study. In a combined 
chronic toxicity/oncogenicity study in rats, enlarged eyeballs were 
observed. Hepatotoxicity in the mouse was evidenced by histopathology 
and increased liver enzymes.
    In both rat and rabbit developmental toxicity studies, acequinocyl 
increased the number of resorptions. Developmental effects (i.e., 
resorptions) occurred at a dose that was higher than or the same as the 
dose that caused maternal toxicity. In the 2-generation reproduction 
toxicity study in the rat, there was no evidence of reproductive 
toxicity, though there were notable toxic effects observed in offspring 
that were not observed in adults including swollen body parts, 
protruding eyes, clinical signs, delays in pupil development and 
increased mortality occurring mainly after weaning.
    There was no evidence of carcinogenic potential in either the rat 
or mouse carcinogenicity study, indicating that acequinocyl is ``not 
likely'' to be carcinogenic to humans. There was no concern for 
mutagenic activity as indicated by several

[[Page 70145]]

mutagenicity studies. Acequinocyl is classified as ``Not likely to be 
Carcinogenic to Humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by acequinocyl 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, ``Acequinocyl; Human-Health Risk 
Assessment for Proposed Section 3 Uses on Fruiting Vegetables, Hops, 
Okra, and Edible-Podded Beans'' dated August 26, 2010, at pp. 32-35 in 
docket ID number EPA-HQ-OPP-2009-0812-0004.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). 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 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 acequinocyl used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/Scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary......................  N/A...................  N/A...................  An endpoint attributable to
(General population including                                                         a single dose was not
 infants and children).                                                               identified in the
                                                                                      database.
Chronic dietary....................  NOAEL = 2.7 mg/kg/day.  Chronic RfD = 0.027 mg/ Carcinogenicity study in
(All populations)..................  UFA = 10x.............   kg/day.                 mice (18 month); LOAEL =
                                     UFH = 10x.............  cPAD = 0.027 mg/kg/day   7.0 mg/kg/day based on the
                                     FQPA SF = 1x..........                           clinical chemistry and
                                                                                      microscopic nonneoplastic
                                                                                      lesions (brown pigmented
                                                                                      cells and perivascular
                                                                                      inflammatory cells in
                                                                                      liver).
Short-term.........................  Dermal NOAEL = 200 mg/  LOC (occupational/      28-day dermal study in
(1 to 30 days) and intermediate-      kg/day.                 residential) for MOE    rats;
 term (1-6 months) dermal.                                    = <100.                LOAEL = 1000 mg/kg/day
                                                                                      based on increased
                                                                                      clotting factor times.
Short-term (1 to 30 days)            Oral NOAEL = 60 mg/kg/  LOC (occupational/      Developmental toxicity
 inhalation.                          day (inhalation         residential) = MOE      study in rabbits;
                                      absorption rate =       <100.                  Maternal LOAEL = 120 mg/kg/
                                      100%).                                          day based on clinical
                                     UFA = 10x.............                           signs (hematuria, reduced
                                     UFH = 10x.............                           fecal output, body weight
                                                                                      loss, and reduced food
                                                                                      consumption) and gross
                                                                                      necropsy findings (pale
                                                                                      lungs and liver,
                                                                                      hemorrhaging uterus, fluid
                                                                                      in the cecum, fur in the
                                                                                      stomach, blood stained
                                                                                      vaginal opening, blood-
                                                                                      stained urinary bladder
                                                                                      contents/urine).
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)..          Classification: ``Not likely to be Carcinogenic to Humans.''
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
RfD = reference dose.
MOE = margin of exposure.
LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acequinocyl, EPA considered exposure under the petitioned-
for tolerances as well as all existing acequinocyl tolerances in 40 CFR 
180.599. EPA assessed dietary exposures from acequinocyl 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 
acequinocyl; 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 U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 and the Nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII). As to residue levels in 
food, EPA conducted a chronic dietary exposure analysis of acequinocyl 
based on the assumption of tolerance level residues and 100 percent 
crops treated (PCT) for all existing and proposed uses.

[[Page 70146]]

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that acequinocyl does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
acequinocyl. Tolerance level residues and 100 PCT 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 acequinocyl in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acequinocyl. 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 the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
acequinocyl for chronic exposures for non-cancer assessments are 
estimated to be 2.45 parts per billion (ppb) acequinocyl for surface 
water and 0.0036 ppb (acequinocyl and its metabolite, acequinocyl-OH) 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 2.45 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).
    Acequinocyl is currently registered for the following uses that 
could result in residential exposures: Landscape ornamentals in 
residential and public areas for use by commercial applicators and 
homeowners. EPA assessed residential exposure using the following 
assumptions: In assessing residential exposure/risk, the homeowner 
handlers are expected to complete all tasks associated with the use of 
a pesticide product including mixing and loading (if needed), and 
application. No chemical-specific data were available with which to 
assess potential exposure to pesticide handlers. The estimates of 
exposure to pesticide handlers are based upon surrogate study data 
available from the Outdoor Residential Exposure Task Force (ORETF) and 
the Pesticide Handlers Exposure Data (PHED). Homeowner handler 
assessments are based on the assumption that individuals are wearing 
shorts, short-sleeved shirts, socks, and shoes. Residential handler 
exposure scenarios are considered to be short-term only, due to 
infrequent use patterns associated with homeowner products.
    Based upon the proposed use pattern, the following residential 
handler scenarios have been assessed:
    (1) Mixing/loading/applying liquids with low-pressure handwand 
(ORETF-fruit trees and ornamentals).
    (2) Mixing/loading/applying liquids with hose-end sprayer (ORETF-
fruit trees and ornamentals).
    No significant dermal post-application exposure is expected from 
landscape ornamentals uses.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 acequinocyl to share a common mechanism of 
toxicity with any other substances, and acequinocyl does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
acequinocyl 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. In the rat prenatal 
developmental toxicity study, developmental toxicity was indicated by 
increased resorptions and fetal variations. The developmental toxicity 
study in rabbits identified an increased number of complete 
resorptions. In the rat two-generation reproductive toxicity study, 
both the maternal and reproductive toxicity LOAELs were not observed, 
however the LOAEL for parental males was 58.9/69.2 mg/kg/day based on 
hemorrhagic effects. The offspring systemic LOAEL was also 58.9 mg/kg/
day. Though the offspring LOAEL was similar to that of parental male's, 
there were effects specific to the pups which in addition to the 
hemorrhagic effects noted in both generations, included swollen body 
parts, protruding eyes, clinical signs, delays in pupil development and 
increased mortality occurring mainly after weaning.
    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. At this time, the Agency is making permanent registration of 
these new uses conditional pending resolution of toxicological issues 
and has identified the following studies needed, including: (1) A 28-
day inhalation study; (2) an immunotoxicity study; and (3) acute and 
subchronic neurotoxicity studies. Except for the 28-day inhalation 
study, the remaining studies are required under new EPA regulations. 
The toxicology database for acequinocyl does not show any evidence of 
treatment-related effects on the immune system. The overall weight of 
evidence suggests that this chemical does not directly target the 
immune system. An immunotoxicity study is required as a part of new 
data requirements in the 40 CFR part 158 for conventional pesticide 
registration; however, the Agency does not believe that conducting a 
functional immunotoxicity study will result in a lower point of 
departure (POD) than that currently in use for overall risk assessment, 
and therefore, a database uncertainty factor (UF<INF>DB</INF>) is not 
needed to account for lack of this study.

[[Page 70147]]

    Although a 28-day inhalation study is not available, EPA has 
determined that the additional FQPA SF is not needed. Residential 
inhalation risk was estimated by calculating exposure using the 
Agency's Residential SOPs. For chemicals with low vapor pressure (7.5 x 
10<SUP>-5</SUP> mmHg or below for outdoor uses at 20-30 [deg]C), these 
standard assumptions are expected to overestimate the exposure via the 
inhalation route. Acequinocyl is such a compound (1.69 x 
10<SUP>-11</SUP> mmHg at 25 [deg]C) and exposure through the inhalation 
route is expected to be minimal. Therefore, the risk estimate is 
conservative and is considered protective and the additional FQPA SF is 
not needed. Since all calculated inhalation MOEs for residential 
handlers are significantly greater than the Agency's LOC (MOE >100), 
even retaining the FQPA SF would not affect EPA's conclusion on safety.
    There is potential evidence of neurotoxicity or neuropathology in 
the 2-generation reproduction study as well as the rat subchronic oral 
toxicity study, however these toxicities are not considered to be 
primary effects since they occur in the presence of more severe 
systemic effects in both studies. Therefore, although an acute and 
subchronic neurotoxicity studies are now required as a part of new data 
requirements in the 40 CFR part 158 for conventional pesticide 
registration, the agency does not believe that conducting these studies 
will result in a lower point of departure (POD) than that currently 
used for overall risk assessment.
    ii. There is no evidence that acequinocyl results in increased 
susceptibility in in utero rat or rabbit fetuses in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. In the 2-generation rat reproduction study, more severe effects 
were observed in the offspring, however these effects were observed at 
the same doses as parental effects, and a clear NOAEL was established 
which is being used in endpoint selection.
    iii. 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. EPA made conservative 
(protective) assumptions in the ground water and surface water modeling 
used to assess exposure to acequinocyl in drinking water. The 
residential use (ornamentals) is not expected to result in post-
application exposure to infants and children. These assessments will 
not underestimate the exposure and risks posed by acequinocyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
acequinocyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
acequinocyl from food and water will utilize 45% of the cPAD for 
children 1-2 years old the population group receiving the greatest 
exposure. Based on the use pattern, chronic residential exposure to 
residues of acequinocyl is not expected.
    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).
    Acequinocyl is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to acequinocyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
drinking water, and dermal and inhalation residential exposures result 
in aggregate MOE of 2,700 for adults 50+ years old, the highest exposed 
population. Because EPA's level of concern for chemical name is a MOE 
of 100 or below, these MOEs are not of concern.
    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). Acequinocyl is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for acequinocyl.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity, acequinocyl 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 acequinocyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available for enforcing 
tolerances for acequinocyl residues of concern in/on the proposed/
registered plant commodities. Methods include two high-performance 
liquid chromatography methods with tandem mass-spectroscopy detection 
(HPLC/MS/MS).
    The methods 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: 
<a href="/cdn-cgi/l/email-protection#542631273d3021313931203c3b3027143124357a333b22"><span class="__cf_email__" data-cfemail="6b190e18020f1e0e060e1f03040f182b0e1b0a450c041d">[email protected]</span></a>.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the U.S. is 
a party. EPA may establish a tolerance that is different from a Codex 
MRL; however, FFDCA section 408(b)(4) requires that EPA explain the 
reasons for departing from the Codex level.

[[Page 70148]]

    The Codex has not established MRLs for acequinocyl.

C. Revisions to Petitioned-for Tolerances

    The Agency revised the 3.5 ppm proposed tolerance on hop, dried 
cones to 4.0 ppm. The Agency's tolerance spreadsheet as specified by 
the Guidance for Setting Tolerances Based on Field Trial Data SOP 
(August 2009 version) was used to determine appropriate tolerance 
levels.
    EPA has revised the tolerance expression for acequinocyl to clarify
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of acequinocyl not specifically 
mentioned; and
    2. That compliance with the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of acequinocyl 
including its metabolites and degradates in or on bean, edible podded 
at 0.25 ppm, hop, dried cones at 4.0 ppm, okra at 0.70 ppm, and 
vegetable, fruiting, group 8 at 0.70 ppm. Compliance with the tolerance 
levels specified is to be determined by measuring only the sum of 
acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its 
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the 
stoichiometric equivalent of acequinocyl, in or on the commodity.

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) (Pub. L. 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 4, 2010.
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 180.599 is amended by revising paragraph (a) introductory 
text and alphabetically adding the following commodities to the table 
in paragraph (a) to read as follows:


Sec.  180.599  Acequinocyl; tolerance for residues.

    (a) General. Tolerances are established for residues of 
acequinocyl, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
acequinocyl [2-(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its 
metabolite, 2-dodecyl-3-hydroxy-1,4-naphthoquinone, calculated as the 
stoichiometric equivalent of acequinocyl, in or on the commodity.

[[Page 70149]]



------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
 
                                * * * * *
Bean, edible podded..................................               0.25
 
                                * * * * *
Hop, dried cones.....................................               4.0
 
                                * * * * *
Okra.................................................               0.70
 
                                * * * * *
Vegetable, fruiting, group 8.........................               0.70
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-28973 Filed 11-16-10; 8:45 am]
BILLING CODE 6560-50-P


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