[Federal Register Volume 77, Number 85 (Wednesday, May 2, 2012)]
[Rules and Regulations]
[Pages 25904-25910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10346]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0449; FRL-9346-4]


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 multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
several established individual tolerances, as they will be superseded 
by inclusion in crop subgroup tolerances or by updated commodity 
terminology. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective May 2, 2012. Objections and 
requests for hearings must be received on or before July 2, 2012, 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-2011-0449. 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email 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 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

[[Page 25905]]

site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2011-0449 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 
July 2, 2012. 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-2011-0449, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online 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. Summary of Petitioned-For Tolerances

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), 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 
1E7864) by IR-4, 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 miticide acequinocyl, [2-
(acetyloxy)-3-dodecyl-1,4-naphthalenedione] and its metabolite, 2-
dodecyl-3-hydroxy-1,4-naphthoquinone, expressed as acequinocyl 
equivalents, in or on bean, succulent shelled at 0.15 parts per million 
(ppm); caneberry subgroup 13-07A at 4.5 ppm; cherry at 0.8 ppm; cowpea, 
forage at 9.0 ppm; cucumber at 0.15 ppm; melon subgroup 9A at 0.06 ppm; 
soybean, vegetable, succulent at 0.25 ppm; fruit, small vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 1.6 ppm; and berry, low 
growing, subgroup 13-07G at 0.4 ppm. The petition additionally 
requested that 40 CFR 180.599 be amended by removing the established 
tolerances for residues of acequinocyl in or on grape at 1.6 ppm and 
strawberry at 0.4 ppm, as they will be superseded by inclusion in 
subgroup 13-07F and 13-07G, respectively. 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 levels for several commodities. 
Additionally, the Agency has determined that tolerances should be 
established on the meat byproducts of livestock commodities and the 
previously established tolerances on the liver of livestock commodities 
should be removed. The Agency also determined that a tolerance is 
necessary on cowpea, hay. Finally, EPA determined that the proposed 
tolerance on cherry should be established as two tolerances on sweet 
and tart cherry. The reasons for these changes are explained in Unit 
IV.C.

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 its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Acequinocyl exhibits low acute toxicity via the oral, dermal and 
inhalation routes of exposure, as well as in primary eye and primary 
skin irritation studies. It is not a dermal sensitizer. Acequinocyl is 
a known Vitamin K antagonist; therefore, it is thought to produce 
adverse effects by disrupting the blood coagulation system, as 
indicated by increased prothrombin time, increased activated partial 
thromboplastin time, and internal hemorrhages.
    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 noted. 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

[[Page 25906]]

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 studies. There was also no concern for 
mutagenic activity as indicated by several mutagenicity studies. 
Therefore, 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 Succulent Soybean Vegetable; 
Succulent Shelled Beans; Cowpea Forage; Caneberry Subgroup 13-07A; 
Melon Subgroup 9A; Cucumber, Cherry; Low-Growing Berry Subgroup 13-07G; 
and Small Fruit Vine Climbing, Except Fuzzy Kiwifruit, Subgroup 13-
07F,'' pp. 31-33 in docket ID number EPA-HQ-OPP-2011-0449.

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 
the Table of this unit.

   Table--Summary of Toxicological Doses and Endpoints for Acequinocyl for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario              uncertainty/safety   RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                 effects
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Acute dietary (General population    N/A...................  N/A...................  An endpoint attributable to
 including infants and children).                                                     a single dose was not
                                                                                      identified in the
                                                                                      database.
Chronic dietary (All populations)..  NOAEL = 2.7 mg/kg/day.  Chronic RfD = 0.027 mg/ Carcinogenicity study in
                                     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 non-neoplastic
                                                                                      lesions (brown pigmented
                                                                                      cells and perivascular
                                                                                      inflammatory cells in
                                                                                      liver).
Dermal, short-term.................  Dermal study NOAEL =    LOC (occupational/      28-day dermal study in
(1 to 30 days).....................   200 mg/kg/day.          residential) for MOE    rats;
                                                              = 100.                 LOAEL = 1,000 mg/kg/day
                                                                                      based on increased
                                                                                      clotting factor times.
Inhalation, short-term (1 to 30      Oral NOAEL = 60 mg/kg/  LOC (occupational/      Developmental toxicity
 days).                               day (inhalation         residential) = MOE      study in rabbits; Maternal
                                      absorption rate =       <100.                   LOAEL = 120 mg/kg/day
                                      100%).                                          based on clinical signs
                                     UFA = 10x.............                           (hematuria, reduced fecal
                                     UFH = 10x.............                           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.''
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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. mg/kg/day = milligram/kilogram/day.

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 USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA utilized tolerance level 
residues and 100 percent crop treated (PCT) information for all 
registered and proposed uses. The assessment also used Dietary Exposure

[[Page 25907]]

Evaluation Model (DEEM-FCIDTM) ver. 7.81 default processing 
factors, with the exception of those for grape juice and raisins.
    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 and/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 6.69 parts per billion (ppb) for surface water and 
0.0036 ppb 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 6.69 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 use by commercial applicators 
and homeowners that could result in residential exposure: Landscape 
ornamentals in residential and public areas. Residential handlers are 
expected to complete all tasks associated with the use of acequinocyl 
including mixing and loading (if needed), and application of 
acequinocyl with either a low-pressure hand wand or with a hose-end 
sprayer. EPA assessed potential short-term dermal and inhalation 
exposures to residential handlers from these scenarios. Residential 
handler exposure scenarios are considered to be short-term only, due to 
the infrequent use patterns associated with homeowner products. 
Postapplication exposure was not anticipated for the registered 
residential uses; therefore, a quantitative postapplication assessment 
was not conducted. 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 Web site 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. The acequinocyl toxicity 
database is adequate to evaluate potential increased susceptibility of 
infants and children, and includes developmental toxicity studies in 
rats and rabbits and a 2-generation reproduction study in rats. 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 2-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 males, the study noted increased qualitative susceptibility of 
pups (swollen body parts, protruding eyes, clinical signs, delays in 
pupil development and increased mortality). These effects occurred 
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. The toxicity database for acequinocyl is complete except for 
immunotoxicity and acute and subchronic neurotoxicity testing. Recent 
changes to 40 CFR part 158 imposed new data requirements for 
immunotoxicity testing (OPPTS Guideline 870.7800) and acute and 
subchronic neurotoxicity testing (OPPTS Guideline 870.6200) for 
pesticide registration. The toxicology database for acequinocyl does 
not show any evidence of treatment-related effects on the immune 
system, and the overall weight-of-evidence suggests that this chemical 
does not directly target the immune system. Therefore, the Agency does 
not believe that conducting a functional immunotoxicity study will 
result in a lower POD than that currently in use for overall risk 
assessment, and additional UFs are not needed to account for a lack of 
this study.
    Previously, EPA concluded that exposure to acequinocyl does not 
pose a neurotoxicity concern. Acequinocyl is a known Vitamin K 
antagonist; neurotoxic compounds of similar structure were not 
identified. While there is potential evidence of neurotoxicity or 
neuropathology in the 2-generation reproduction study as well as the 
rat subchronic oral toxicity study, these toxicities are not considered 
to be primary effects because they were observed at very high doses and 
in the presence of more severe systemic effects

[[Page 25908]]

in both studies. The Agency does not believe that conducting the acute 
and subchronic neurotoxicity studies will result in a lower POD than 
that currently used for overall risk assessment; therefore, additional 
UFs to account for neurotoxicity are not necessary.
    ii. There is no evidence of increased susceptibility of rat or 
rabbit fetuses to in utero exposure to acequinocyl. In the 2-generation 
reproduction study in rats, increased qualitative susceptibility was 
observed in offspring. However, EPA determined that the degree of 
concern is low for the noted effects because the effects were observed 
at the same doses as parental effects, and there is a clear NOAEL 
established which was 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 and surface water modeling used 
to assess exposure to acequinocyl in drinking water. Residential uses 
are not expected to result in postapplication 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 55% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, 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 the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2,500 for the 
general U.S. population, and 2,600 for females 13-49 years old. Because 
EPA's level of concern for acequinocyl 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). An intermediate-term adverse effect was identified; however, 
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 in two adequate rodent carcinogenicity 
studies, 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

    Morse Methods (Meth-135 and Meth-133, revision 
3), two high-performance liquid chromatography methods with 
tandem mass-spectroscopy detection (HPLC/MS/MS), are adequate 
enforcement methodologies available to enforce the tolerance 
expression.
    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; email address: 
[email protected].

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 United 
States 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.
    The Codex has not established MRLs for acequinocyl.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data supporting the 
petitions, EPA revised the proposed tolerances on berry, low growing, 
subgroup 13-07G from 0.4 ppm to 0.50 ppm; bean, succulent shelled from 
0.15 ppm to 0.30 ppm; cowpea, forage from 9.0 ppm to 6.0 ppm; caneberry 
subgroup 13-07A from 4.5 ppm to 4.0 ppm; and melon subgroup 9A from 
0.06 ppm to 0.15 ppm. The Agency revised these tolerance levels based 
on analysis of the residue field trial data using the Organization for 
Economic Co-operation and Development (OECD) tolerance calculation 
procedures. EPA also determined that the proposed tolerance on cherry 
at 0.8 ppm should be established as two separate tolerances on cherry, 
tart at 1.0 ppm; and cherry, sweet at 0.50 ppm because residues were 
generally higher in tart cherries than in sweet cherries. EPA 
determined

[[Page 25909]]

that a tolerance is necessary on cowpea, hay at 18 ppm. Based on the 
results of the data supporting the cowpea tolerance, the appropriate 
tolerance for residues of acequinocyl in or on cowpea, forage is 6.0 
ppm. Typically, forage is harvested before the plant has bloomed. 
Because it was not specified at what plant stage the product can be 
applied, EPA deemed it necessary to establish a tolerance on cowpea, 
hay as well. There is typically a 3-fold drying factor between forage 
and hay; therefore, EPA is establishing a tolerance for residues of 
acequinocyl in or on cowpea, hay at 18 ppm.
    Finally, because cowpea forage and hay are significant feedstuff 
commodities for livestock, the maximum reasonable dietary burdens of 
acequinocyl were recalculated for acequinocyl using the Agency's most 
recent guidance on constructing reasonably balanced livestock diets. 
The Agency determined that the currently established tolerance level of 
0.02 ppm for residues of acequinocyl in the fat of cattle, goat, horse, 
and sheep are still appropriate. Furthermore, the established 0.02 ppm 
tolerance level in the liver of cattle, goat, horse, and sheep is 
appropriate. However, EPA is revising the commodity definition to meat 
byproducts rather than liver in order to reflect the correct 
terminology. Therefore, EPA determined that tolerances should be 
established at 0.02 ppm for the meat byproducts of cattle, goat, horse, 
and sheep; and the established tolerances in the liver of cattle, goat, 
horse, and sheep should be removed.

V. Conclusion

    Therefore, tolerances are established for residues of acequinocyl, 
including its metabolites and degradates, in or on the commodities in 
the table in paragraph (a) of Sec.  180.599. Compliance with the 
tolerance levels specified in the table of paragraph (a) of Sec.  
180.599 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 soybean, vegetable, succulent at 
0.25 ppm; berry, low growing, subgroup 13-07G at 0.50 ppm; fruit, small 
vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 1.6 ppm; 
bean, succulent shelled at 0.30 ppm; cowpea, forage at 6.0 ppm; cowpea, 
hay at 18 ppm; caneberry subgroup 13-07A at 4.0 ppm; melon subgroup 9A 
at 0.15 ppm; cucumber at 0.15 ppm; cherry, tart at 1.0 ppm; cherry, 
sweet at 0.50; cattle, meat byproducts at 0.02 ppm; goat, meat 
byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, 
meat byproducts at 0.02 ppm. This regulation additionally removes 
established tolerances in or on grape at 1.6 ppm; strawberry at 0.40 
ppm; cattle, liver at 0.02 ppm; goat, liver at 0.02 ppm; horse, liver 
at 0.02 ppm; and sheep, liver at 0.02 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) (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: April 20, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    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, paragraph (a), the table is amended by removing the 
entries for ``Cattle, liver''; ``Goat, liver''; ``Grape''; ``Horse, 
liver''; ``Sheep, liver''; and ``Strawberry'' and by alphabetically 
adding the following commodities to read as follows:


Sec.  180.599  Acequinocyl; tolerances for residues.

    (a) General. * * *

[[Page 25910]]



------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bean, succulent shelled......................................       0.30
Berry, low growing, subgroup 13-07G..........................       0.50
Caneberry subgroup 13-07A....................................       4.0
 
                                * * * * *
Cattle, meat byproducts......................................       0.02
Cherry, sweet................................................       0.50
Cherry, tart.................................................       1.0
 
                                * * * * *
Cowpea, forage...............................................       6.0
Cowpea, hay..................................................      18
Cucumber.....................................................       0.15
 
                                * * * * *
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup        1.6
 13-07F......................................................
 
                                * * * * *
Goat, meat byproducts........................................       0.02
 
                                * * * * *
Horse, meat byproducts.......................................       0.02
Melon subgroup 9A............................................       0.15
 
                                * * * * *
Sheep, meat byproducts.......................................       0.02
Soybean, vegetable, succulent................................       0.25
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-10346 Filed 5-1-12; 8:45 am]
BILLING CODE 6560-50-P