[Federal Register Volume 80, Number 154 (Tuesday, August 11, 2015)]
[Proposed Rules]
[Pages 48051-48053]
[FR Doc No: 2015-19723]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0384; FRL-9932-22-Region 4]

Approval and Promulgation of Implementation Plans; Kentucky: New
Sources in or Impacting Nonattainment Areas

AGENCY: Environmental Protection Agency

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve the Commonwealth of Kentucky's September 23, 2011, State
Implementation Plan (SIP) revision, submitted through the Kentucky
Division for Air Quality (KY DAQ), which modifies the SIP by making
changes to Kentucky regulation, ``Review of new sources in or impacting
upon nonattainment areas.'' EPA has preliminarily determined that
Kentucky's requested SIP revision meets the applicable provisions of
the Clean Air Act (CAA or Act) and EPA regulations regarding
Nonattainment New Source Review (NNSR) permitting.

DATES: Written comments must be received on or before September 10,
2015.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R04-OAR-2015-0384 by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2015-0384'', Air Regulatory Management
Section, Air Planning and Implementation Branch, Air, Pesticides and
Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Ms. Lynorae Benjamin, Chief, Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air, Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Such

deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2015-0384. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information may not be publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
www.regulations.gov or in hard copy at the Air Regulatory Management
Section, Air Planning and Implementation Branch, Air, Pesticides and
Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA
requests that if at all possible, you contact the person listed in the
FOR FURTHER INFORMATION CONTACT section to schedule your inspection.
The Regional Office's official hours of business are Monday through
Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Zuri Farngalo of the Air Regulatory
Management Section, in the Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Farngalo may be reached by phone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On September 23, 2011, KY DAQ submitted a SIP revision to EPA for
approval that makes several changes to Kentucky's regulations at 401
Kentucky Administrative Regulations (KAR) 51:052, Review of new sources
in or impacting nonattainment areas. These regulations establish air
quality permitting requirements for the construction or modification of
major stationary sources located within, or impacting upon, areas
designated nonattainment for any primary national ambient air quality
standard. To ensure improvement of air quality in those areas, the
emissions resulting from construction or modification of a major
stationary source must be offset with compensating emission reductions.
    Kentucky's requested SIP revision would revise 401 KAR 51:052 by:
(1) Changing Section 5, paragraph (6)(b) to authorize new or modified
sources to offset their emission increases with emission reductions
achieved by shutting down an existing unit or curtailing production or
operating hours prior to the new source application date (if specified
conditions are met), (2) adding new and more comprehensive language to
Section 5, paragraph (6)(b) describing how to calculate offsetting
emission reductions obtained from a source shutdown or curtailment (3)
amending Section 4, paragraph (3)(a) to establish an offset ratio of at
least 1:1 for pollutants other than volatile organic compounds (VOCs)
and nitrogen oxides (NOx), and (4) making changes to the introductory
paragraph to 401 KAR 51:052 and Section 5, paragraph (3)(e) that update
and clarify these provisions.

II. Analysis of Kentucky's Submittal

    EPA has reviewed Kentucky's requested changes to 401 KAR 51:052,
Review of new sources in or impacting nonattainment areas, and
preliminarily concluded that these changes are consistent with the
applicable CAA provisions and EPA's NNSR permitting regulations at 40
CFR 51.165. Specifically, the changes to Section 5, paragraph (6)(b) of
401 KAR 51:052 authorizing new or modified sources to offset emission
increases with emission reductions generated by source shutdowns or
curtailments occurring before the filing of a permit application for a
new project are consistent with 40 CFR 51.165(a)(3)(ii)(C)(1).
Likewise, the new regulatory language in Section 5, paragraph (6)(b) of
401 KAR 51:052 describing how to calculate emission offsets generated
from source shutdowns or permanent curtailments also is consistent with
40 CFR 51.165(a)(3)(ii)(C)(1). The change to Section 4, paragraph
(3)(a) of 401 KAR 51:052 specifying that increases in emissions shall
be offset by reductions in emissions using a ratio of emission
decreases to emission increases of at least 1:1 is required by 40 CFR
51.165(a)(9)(i). Finally, the changes to the introductory paragraph to
401 KAR 51:052 and Section 5 paragraph (3)(e) simply update and clarify
these provisions and do not affect the consistency of these provisions
with federal law. EPA has preliminarily determined that these changes
are approvable pursuant to CAA section 110 and EPA's NNSR permitting
regulations at 40 CFR 51.165.

II. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Kentucky Rule 401 KAR 51:052, Review of new sources in or
impacting nonattainment areas. EPA has made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the appropriate EPA office
(see the ADDRESSES section of this preamble for more information).

III. Proposed Action

    EPA is proposing to approve the Commonwealth of Kentucky's
September 23, 2011, SIP revision. EPA has preliminarily determined that
the changes to Kentucky's Rule 401 KAR 51:052, Review of new sources in
or impacting nonattainment areas, are approvable because they are
consistent with CAA section 110 and EPA's

regulations regarding NNSR permitting at 40 CFR 51.165.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011)
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements and
Volatile organic compounds.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: July 30, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2015-19723 Filed 8-10-15; 8:45 am]
 BILLING CODE 6560-50-P


OIRA_ DOCKET@ omb. eop. gov 07/ 23/ 2001 02: 57 PM NOTICE OF OFFICE OF MANAGEMENT AND BUDGET ACTION Sandy Farmer 07/ 23/ 2001 Environmental Protection Agency Office of Environmental Information Collection Strategies Division ( 2822) Washington, DC 20460 In accordance with the Paperwork Reduction Act, OMB has taken the following action on your request for the extension of approval of an information collection received on 05/ 17/ 2000.

TITLE: Pre Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances.

AGENCY FORM NUMBER( S): 7710 25, 7710 56, 574.11 ACTION : APPROVED OMB NO.: 2070 0012 EXPIRATION DATE: 07/ 31/ 2004 BURDEN RESPONSES BURDEN HOURS BURDEN COSTS Previous 218 226,547 0 New 1,674 184,608 0 Difference 1,456  41,939 0 Program Change 0 0 Adjustment  41,939 0 TERMS OF CLEARANCE: This ICR is approved for three years. When EPA resubmits the ICR for renewal, it should include a discussion and quantification of any non labor costs associated with the reporting and recordkeeping requirements, e. g. testing costs.

NOTE: The agency is required to display the OMB control number and inform respondents of its legal significance ( see 5 CFR 1320.5( b)).

_____________________________________________________________ OMB Authorizing Official Title Donald R. Arbuckle Deputy Administrator, Office of Information and Regulatory Affairs _____________________________________________________________


Note to EPA-HQ-OAR-2007-0225

EPA used the Environmental Benefits Mapping and Analysis Program
(BenMAP) to estimate the human health benefits of alternate ozone
standards. The health impact functions and valuation functions used to
estimate these benefits are specified in BenMAP configuration files
located at:

http://www.epa.gov/ttnecas1/benmodels.html


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Andrew Ertman,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4)

PP #1E7878

	21 U.S.C. 346 EPA has received a pesticide petition (PP #1E7878) from IR-4 Project Headquarters, Rutgers, The State University of NJ, 500 College Road East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.361 by establishing a tolerance for the combined residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine, and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347) in or on the raw agricultural commodities lettuce, leaf at 3.0 parts per million (ppm), Brassica, leafy greens, subgroup 5B at 0.2 ppm, turnip greens at 0.2 ppm, melons subgroup 9A at 0.1 ppm, vegetable, soybean, succulent at 0.1 ppm, and small fruit vine climbing subgroup 13-07E, except grape at 0.1 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.  The qualitative nature of the residues of pendimethalin in plants is understood based on adequate studies conducted with 14 C pendimethalin on various crops.  Pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite (CL202347) are the residues of concern.

	2. Analytical method. Section 408 (b)(3) of the amended FDCA requires EPA to determine that there is a practical method for detecting and measuring levels of the pesticide chemical residue in or on food and that the tolerance be set at a level at or above of the limit of detection of the designated method.  In plants the method is aqueous organic solvent extraction, column clean up, and quantitation by GC.  The method has a limit of quantitation (LOQ) of 0.05 ppm for pendimethalin and the alcohol metabolite.

	3. Magnitude of residues. Field trials in major growing areas were carried out in order to determine the magnitude of residues in the leaf lettuce, Brassica leafy greens, melons, and small fruit vining commodities. No field trial data were generated in order to determine the magnitude of residues in turnip greens and vegetable soybean commodities, as EPA has determined that the tolerance these crop commodities may be safely extrapolated from the proposed tolerances on leafy Brassica greens (subgroup 5B) and from the established tolerances on beans for turnip green and vegetable soybean (edamame), respectively. EPA has determined that the petition contains data or information regarding the above aforementioned crops.  Field trials were conducted for the representative crops of Brassica leafy greens subgroup 5B (mustard greens), melons subgroup 9A (cantaloupe), and small fruit vine climbing subgroup 13-07E (kiwifruit) spread across the US.  Field trials were carried out using the maximum number of applications, the maximum label rate and shortest pre-harvest interval (PHI).

B. Toxicological Profile

	1. Acute toxicity.  Pendimethalin technical demonstrates low acute toxicity via the oral, dermal, and inhalation routes of exposure.  The acute toxicity studies place technical pendimethalin in toxicity category III for the acute oral, category IV for acute dermal, and category IV for acute inhalation.  Technical pendimethalin is category IV for skin irritation and category III for eye irritation. Pendimethalin did not cause skin sensitization in guinea pigs.  Two formulated end use products are registered for use on crops, an Emulsifiable Concentrate (EC) and an Encapsulated Suspension (CS).  The EC has an acute oral category of III, acute dermal category of III, an acute inhalation category of III, eye and skin irritation of III, and is not a dermal sensitizer.  The CS has an acute oral category of IV, an acute dermal category of IV, an acute inhalation category of IV, eye and skin irritation category of IV, and is not a dermal sensitizer.

	2. Genotoxicty. Extensive mutagenicity studies conducted to investigate point and gene mutations, DNA damage and chromosomal aberration, both using in vitro and in vivo test systems demonstrate pendimethalin to be non-genotoxic.

Pendimethalin has been classified as a Group C "possible human carcinogen," based on a statistically significantly increased incidence of benign follicular cell adenomas of the thyroid gland in male and female rats at 5000 ppm (250 mg/kg b.w./day) (highest concentration tested).  For risk assessment, OPP recommends using the RfD (non-linear) approach for quantification of human risk.  The Agency Committee has determined that the hypothesis, that benign thyroid tumors associated with pendimethalin are due to a thyroid-pituitary imbalance, can be supported.  Finally, pendimethalin's mechanism of threshold oncogenic activity only occurs at high doses in rats, a mammalian species that is expected to be much more sensitive than humans to the induction of thyroid tumors via conditions which result in hypothyroidism.

	3. Reproductive and developmental toxicity. Pendimethalin is not a selective developmental toxicant.  There is no indication of increased susceptibility following prenatal/postnatal exposure to pendimethalin.

In a developmental (teratology) toxicity study in the rat, the results demonstrated that the NOAELs for both maternal toxicity and fetal (prenatal)/developmental toxicity were 500 mg/kg b.w./day (highest dose tested) (HDT).  In addition, there were no indications of any teratogenic effects in the rat fetuses at 500 mg/kg b.w./day (HDT).  Therefore, pendimethalin is considered to be neither a developmental toxicant nor a teratogenic agent in the rat.

In a developmental (teratology) toxicity study in the rabbit, the results demonstrated the NOAEL for maternal toxicity was 30 mg/kg b.w./day, based on increased clinical signs of toxicity and decreased body weight gain during the treatment period at 60 mg/kg b.w./day (HDT).  The NOAEL for fetal (prenatal)/developmental toxicity was 60 mg/kg b.w./day (HDT).  In addition, there were no indications of any teratogenic effects in the rabbit fetuses at 60 mg/kg b.w./day.  Therefore, pendimethalin is considered to be neither a developmental toxicant nor a teratogenic agent in the rabbit.

A two-generation reproductive toxicity study in the rat demonstrated an absence of increased sensitivity for the developing offspring to pendimethalin.  The NOAEL for parental toxicity was 500 ppm (approximately 38.5 mg/kg b.w./day), based on reduced food consumption and decreased body weight/weight gain at 2500 ppm (mid-dietary concentration).  The NOAEL for pup/offspring toxicity was also 500 ppm, based on decreased pup body weight gain at 2500 ppm.  Lastly, the NOAEL for reproductive toxicity was 2500 ppm (approximately 194 mg/kg b.w./day), based on reduced mean live litter size at 5000 ppm (highest concentration tested) (HCT).  These reductions in mean live litter size and pup body weight gain were only observed at dietary concentrations that were parentally toxic.  As such, there is no evidence that prenatal or postnatal exposure to pendimethalin results in an increased sensitivity to developing offspring.

	4. Sub-chronic toxicity. Sub-chronic (90-day) feeding studies were conducted in rats and dogs.  For the rat, the NOAEL for systemic toxicity was 500 ppm (41 mg/kg b.w./day), based on slightly decreased body weight, increased absolute and relative liver weights, and liver histopathology (hepatocellular hypertrophy) in males and females at 5000 ppm (HCT).  For the dog, the NOAEL for systemic toxicity was 2500 ppm (62.5 mg/kg b.w./day), based on decreased body weight at 10000 ppm (250 mg/kg b.w./day).

	5. Chronic toxicity. The chronic Reference Dose (RfD) was established based on the results of sub-chronic special studies demonstrating the thyroid hormone related endpoint in rats.  The NOAEL of 10 mg/kg b.w./day was established from the collective results of the sub-chronic oral 92-day thyroid function study, the sub-chronic oral 56-day thyroid function study, and the 14-day intrathyroidal metabolism study.  A LOAEL of 31 mg/kg b.w./day was based on hormonal and histopathological changes in the thyroid gland.  The chronic RfD was calculated to be 0.03 mg/kg b.w./day using an Uncertainty Factor (UF) of 30X (3X for interspecies extrapolation and 10X for intraspecies variability) and a 10X database uncertainty factor (UFDB) retained pending receipt of a developmental thyroid toxicity study.  EPA/HED currently recommends a FQPA Safety Factor of 1X.  Therefore, the chronic Population Adjusted Dose (PAD) is 0.03 mg/kg b.w./day.

Chronic toxicity studies were conducted in rats, mice, and dogs.  For the 2-year rat feeding study, the NOAEL for systemic toxicity was 500 ppm (25 mg/kg b.w./day), based on decreased body weight gain (approximately 20-30%), increased clinical signs of toxicity, increased relative liver weights, and slight but statistical increase in the incidence of benign follicular cell adenomas of the thyroid gland in males and females at 5000 ppm (250 mg/kg b.w./day) (HCT).  For the 18-month mouse feeding study, the NOAEL for systemic toxicity was 500 ppm (75 mg/kg b.w./day), based on slightly decreased mean body weights and reduced survival at 5000 ppm (750 mg/kg b.w./day) (HCT).  There were no oncogenic effects up to 5000 ppm (750 mg/kg b.w./day) (HCT).  Lastly, for the 1-year oral (via gelatin capsules) chronic dog study, the NOAEL for systemic toxicity was 200 mg/kg b.w./day, the highest dose tested.

	6. Animal metabolism. Adequate goat and poultry metabolism studies are available for pendimethalin. The Agency has determined that there is no reasonable expectation of finite pendimethalin residues of concern in animal commodities as a result of use on multiple crops.

In the rat, pendimethalin is metabolized mainly through oxidation of the 4-methyl group attached to the benzene ring as well as oxidation of the alkyl side chain of the N-substituted dinitroaniline compound.  When C14-pendimethalin is administered to rates, about 70% of the radioactivity is excreted in feces and 20% is in the urine within 24 hours.  Within 96 hours, the radioactivity found in the tissues was 0.3 ppm or less, except fat which is 0.9 ppm.  The major portion of the radioactivity that was excreted in the feces was identified as the parent compound.

	7. Metabolite toxicology. The main pendimethalin plant metabolite, CL 202347, has been tested for toxicity.  The acute oral toxicity in mice was determined to be 2140 mg/kg bw.  An Ames assay showed the metabolite to be non-mutagenic.

	8. Endocrine disruption. It is known that pendimethalin affects the hypothalamus-pituitary-thyroid axis.  However, as the chronic RfD (0.03 mg/kg b.w./day) is based on the thyroid hormone related endpoint in rats, as noted in the sub-chronic special studies in Section 5 above, which additionally demonstrated reversibility of the thyroid effects in the oral 56-day thyroid function study, these effects are already taken into consideration in the characterization of potential risks to humans.

C. Aggregate Exposure

	1. Dietary exposure. Pendimethalin is a pre-emergent herbicide used to control broadleaf and grass weeds in food and non-food crops, as well as non-agricultural use sites including residential lawns. In examining aggregate exposure, FQPA directs EPA to consider available information concerning exposures from the pesticide residue in food and water (dietary) and all other non-occupational exposures. The primary non-food sources of exposure are through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). The potential for aggregate exposure from all registered and proposed uses is discussed below.

	i. Food. An assessment was conducted to evaluate the potential risk due to chronic dietary exposure of the U.S. population to residues of pendimethalin.  The current tolerance values are listed in the U.S. 40 CFR § 180.361.

This analysis included all the crops with established tolerance values as of April 2011, and the proposed new tolerances for lettuce, leaf at 4.0 ppm, Brassica leafy greens (subgroup 5B) at 0.2 ppm, turnip greens at 0.2 ppm, melons (subgroup 9A) at 0.1 ppm, vegetable, soybean, succulent at 0.1 ppm, and small fruit vine climbing (subgroup 13-07E, except grape) at 0.1 ppm.

Acute Dietary Exposure Assessment

An acute assessment was not needed since the U.S. EPA Toxicological Endpoint Selection (TES) Committee had previously evaluated the pendimethalin toxicity data and determined there was no relevant toxicological endpoints for acute dietary exposure and that a risk assessment was not required.

Chronic Dietary Exposure Assessment

The chronic dietary exposure estimates were based on established and proposed tolerance values, and 100% CT values. Default process factors were used with consumption data from the USDA Continuing Survey of Food Intake by Individuals (CSFII 1994 - 1996, 1998).  The EPA Food Commodity Ingredient Database (FCID) was also used in Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software.

Dietary exposure estimates were compared against the worst-case pendimethalin chronic Population Adjusted Dose (cPAD) of 0.03 mg/kg b.w./day for all populations subgroups.  Results of the chronic dietary assessments are listed in the table below.  The estimated chronic dietary exposure from crops (both established and proposed tolerances) was less than 20% of the cPAD for all subpopulations.  Additional refinements such as the use of anticipated residues and percent crop treated values for the established crop uses would further reduce the estimated chronic dietary exposure.  The results in Table 1 below demonstrate there are no safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

Table 1.	Summary of chronic dietary exposure assessment considering crops with established and proposed tolerances for pendimethalin.

Population

Subgroups	Exposure Estimate

(mg/kg b.w./day)	%cPAD

US Population	0.001857	5.57

All infants (< 1 year)	0.003139	9.42

Children 1-2	0.006097	18.29

Children 3-5	0.00481	14.43

Children 6-12	0.002925	8.78

Youth 13-19	0.001735	5.21

Adults 20-49	0.001354	4.06

Adults 50+ yrs	0.001217	3.65

Females 13 - 49 yrs	0.001326	3.98

%cPAD = percent of chronic population adjusted dose

Exposure estimates based on tolerance values and 100 % CT values

	ii. Drinking Water. There are no established maximum contaminant levels or health advisory levels for residues of pendimethalin in drinking water.  The drinking water exposure values used in this assessment were obtained from the most recent pendimethalin assessment conducted by EPA published on October 27, 2009.  The pendimethalin water values were calculated using PRZM-EXAMS and SCI-GROW2.  The modeled chronic surface water concentrations were 6.0 ug/L, while the modeled groundwater concentration was 0.036 ug/L.

Drinking water contributions were assessed based on the a pendimethalin water concentration of 6.0 ug/L for chronic exposure and water consumption and body weights reported in CSFII, using DEEM-FCID software.  The chronic estimated water exposure values are summarized in Table 2.

Table 2.  	Summary of chronic dietary exposure assessment for drinking water considering direct and indirect sources.

Population

Subgroups	Exposure Estimate

(mg/kg b.w./day)	%cPAD

U.S. Population	0.000126	0.4

All Infants (< 1 year)	0.000415	1.2

Children 1-2 years	0.000188	0.6

Children 3-5 years	0.000176	0.5

Children 6-12 years	0.000121	0.4

Youth 13-19 years	0.000091	0.3

Adults 20-49 years	0.000118	0.4

Adults 50+ years	0.000124	0.4

Females 13 – 49 years	0.000118	0.4

%cPAD = percent of chronic population adjusted dose

Exposure based on the maximum estimated water concentration of 6.0 ug/L

Acute Aggregate Exposure and Risk (Food and water)

An acute assessment was not needed since the U.S. EPA Toxicological Endpoint Selection (TES) Committee had previously evaluated the pendimethalin toxicity data and determined there was no relevant toxicological endpoints for acute dietary exposure and that a risk assessment was not required.

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and residential)

Short-term aggregate risk from pendimethalin takes into account exposures from dietary consumption (food and water) and residential exposure from turf use.  Post application exposure from the turf use is considered short-term.  The aggregate MOE from food, water, and residential exposure are 1174 (children 1-2 years) and 3883 (US population) for the EC formulation and 693 (children 1-2 years) and 2487 (US population) for the CS formulation, respectively.  These MOEs are greater than the target MOE of 300, which indicates there is no safety concern from the aggregate exposure from pendimethalin.  The results of the analysis are shown in Tables 3 and 4.

Table 3. 	Estimated short/intermediate term aggregate exposure and risk of pendimethalin for the EC formulation.

Population	NOAEL (mg/kg/day)	Target MOE1	Food Exposure (mg/kg/d

ay)	Water Exposure (mg/kg/day)	Residential Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	MOE2

US	10	300	0.001857	0.00012625	0.000592	0.00257525	3883

Child

1-2 yr old	10	300	0.006097	0.0001875	0.002235	0.0085195	1174

1 Target MOE is 300.

2 Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure)

Table 4. 	Estimated short/intermediate term aggregate exposure and risk of pendimethalin for the CS formulation.

Population	NOAEL (mg/kg/day)	Target MOE1	Food Exposure (mg/kg/day)	Water Exposure (mg/kg/day)	Residential Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	MOE2

US	10	300	0.001857	0.00012625	0.002038	0.00402125	2487

Child

1-2 yr old	10	300	0.006097	0.0001875	0.008148	0.0144325	693

1 Target MOE is 300.

2 Aggregate MOE = (NOAEL / (Food + Water + Residential Exposure)

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of pendimethalin from food and water (Table 5). Exposures from residential uses are not included in the chronic aggregate assessment.  The results demonstrate there are no safety concerns for any subpopulation based on established and new uses, and that the results clearly meet the FQPA standard of reasonable certainty of no harm.

Table 5. 	Estimated chronic aggregate exposure and risk of pendimethalin

Population Subgroup	cPAD (mg/kg/day)	Food Exposure (mg/kg/day)	Water Exposure (mg/kg/day)	Total Exposure (mg/kg/day)	% cPAD

U.S. Population	0.03	0.001857	0.00012625	0.00198325	5.9

All Infants (< 1 yr old)	0.03	0.003139	0.000415	0.003554	10.7

Children 1-2 years	0.03	0.006097	0.0001875	0.0062845	18.9

Children 3-5 years	0.03	0.00481	0.00017625	0.00498625	15.0

Children 6 – 12 years	0.03	0.002925	0.00012125	0.00304625	9.1

Youth 13-19 years	0.03	0.001735	0.00009125	0.00182625	5.5

Females 13-49 years	0.03	0.001326	0.0001175	0.0014435	4.3

Adults 20-49 years	0.03	0.001354	0.0001175	0.0014715	4.4

Adults + 50	0.03	0.001217	0.00012375	0.00134075	4.0

	2. Non-dietary exposure. The systemic exposure from the use of pendimethalin on residential turf was calculated following the current EPA Standard Operating Procedures (SOPs) for residential exposure assessment (EPA 1997b; EPA 1999a), as revised by EPA Policy 12 (EPA, 2001), and using the Residential Exposure Assessment Spreadsheet Tool (REx), Version 4.0G.  Exposure values were derived from the use of a product-specific hand press study to estimate hand-to-mouth transfer in children and a formulation-specific turf transferable residue study to determine dermal exposure to adults and children.  Residential exposure to both the Pendulum® 3.3 EC herbicide and Pendulum® AquaCap™ herbicide are presented below.

The following table provides the route specific and aggregate exposure assessment results for each population subgroup, along with the percentage of the cPAD (0.03 mg kg BW/day) utilized, and MOE (NOAEL/Aggregate systemic Exposure).

Table 6.	Summary of residential exposure to pendimethalin following the use of the Pendulum® 3.3 EC herbicide formulation including the route specific and aggregate exposure assessment results for the population subgroups.

Population subgroup	Route of Exposure	Route Specific

Systemic Exposure

(mg/kg BW/day) 1	Aggregate

Systemic Exposure

(mg/kg BW/day)	%cPAD	MOE

Adult

(20-49)	Post-application dermal	0.000592	0.000592	1.8	16892

Child

(1-6)	Post-application dermal	0.000990	0.002235	6.7	4474

	Post-application

(Hand to Mouth ingestion)	0.001245

	1 Based 3% dermal absorption

Table 7.	Summary of residential exposure to pendimethalin following the use of the Pendulum® AquaCap™ herbicide formulation including the route specific and aggregate exposure assessment results for the population subgroups.

Population subgroup	Route of Exposure	Route Specific

Systemic Exposure

(mg/kg BW/day) 1	Aggregate

Systemic Exposure

(mg/kg BW/day)	%cPAD	MOE

Adult

(20-49)	Post-application dermal	0.002038	0.002038	6.1	4907

Child

(1-6)	Post-application dermal	0.003411	0.008148	24.4	1227

	Post-application

(Hand to Mouth ingestion)	0.004737

	1 Based 3% dermal absorption

D. Cumulative Effects

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imethalin does not appear to produce a toxic metabolite produced by other substances.  For the purposes of this tolerance action, therefore, it is assumed that pendimethalin does not have a common mechanism of toxicity with other substances.

E. Safety Determination

	1. U.S. population. Based on these risk assessments, there is a reasonable certainty that no harm will result to the general population or any subpopulation from aggregate exposure to pendimethalin residues.

	2. Infants and children. Based on these risk assessments, there is a reasonable certainty that no harm will result to infants or children, or any subpopulation from aggregate exposure to pendimethalin residues.

F. International Tolerances

	There are no CODEX, Canadian or Mexican International Maximum Residue Levels (MRL's) established for residues of pendimethalin in these crops at this time.


Docket ID #:  EPA-HQ-OPP-2009-0812

COMPANY NOTICE OF FILING

EPA Registration Division contact: Sidney Jackson,<PHONE_NUMBER>

Interregional Research Project Number 4 (IR-4) and Arysta LifeScience
North America LLC

PP# 9E7598

EPA has received a pesticide petition (9E7598) from Interregional
Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W,
Princeton, NJ 08540, in cooperation with Arysta LifeScience North
America LLC, 15401 Weston Parkway, Suite l50, Cary, N.C., 27513
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.599 by
revising the tolerance expression to read tolerances are established for
the residues of the insecticide acequinocyl, including its metabolites
and degradates. 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 and by establishing a tolerance for the
residues of acequinocyl, including its metabolites and degradates in or
on fruiting, vegetables, 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.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.

A.	Residue Chemistry

Plant metabolism. The nature of the residues of acequinocyl in plants is
adequately understood based on three crops; apples, oranges and
eggplant. The major residue in all plant metabolism studies is
acequinocyl. A minor but significant metabolite is acequinocyl-OH
(2-dodecyl-3-hydroxy-l,4-naphthoquinone). The proposed tolerance
expression is the parent, acequinocyl and its hydroxy metabolite,
acequinocyl-OH.

Analytical method. The analytical method to quantitate residues of
acequinocyl and acequinocyl-OH in/on fruit crops utilizes high pressure
liquid chromatography-mass spectrometry/mass spectrometry (HPLC-MS/MS)
detection for fruiting vegetables crop group 8 (tomatoes and peppers)
and LC/MS/MS for snap-bean, edible podded and hop, dried cones. The
lowest level for method validation (LLMV) was 0.01 ppm for acequinocyl
and 0.025 ppm for acequinocyl-OH.

Magnitude of residues. The proposed use of acequinocyl calls for a
maximum of 2 applications per season at 0.3 lb a.i. per acre per
application (maximum 0.6 lb a.i. per acre per season), with a 21-day
interval between applications. The pre-harvest interval is 7 days. The
maximum residue for each commodity is shown in the following table.

1

Sample Type	Acequinocyl

Maximum Residue (ppm)	Acequinocyl-OH

Maximum Residue (ppm)

Tomato Fruit	0.20	< 0.025

Tomato Paste	0.05	< 0.025

Tomato Puree	0.04	< 0.025

Non-Bell Peppers	0.2950	0.0429

Bell Peppers	0.564	0.0430

Snap Beans	0.19	0.03

Hops	2.53	0.735

The crop field trial data are adequate to support the proposed
tolerances requested in Section F of the petition.

B.	Toxicological Profile

1. Acute toxicity. Acequinocyl technical has low acute, dermal and
inhalation toxicity

in laboratory animals. The oral lethal dose (LD)50 male/female (M/F) in
the rat and mouse was > 5000 milligram per kilogram (mg/kg). The dermal
LD50 (M/F) was > 2000 mg/kg. The inhalation lethal concentration (LC)50
was reported as > 0.84 mg/1. In the eye and dermal irritation studies,
acequinocyl technical was not an eye or skin irritant to rabbits and was
not a skin sensitizer in guinea pigs.

Genotoxicty. Acequinocyl was found to be negative in the Ames reverse
mutation, mouse lymphoma, Chinese hamster lung (CHL) chromosome
aberration and mouse micronucleus assays.

Reproductive and developmental toxicity. i. Rat teratology. Acequinocyl
technical was administered by oral gavage to pregnant Sprague Dawley
rats at dose levels of 0, 50,150, 500 or 750 mg/kg/day on gestation days
7-17. Common signs in the descendants included vaginal discharge,
pallor, pale eyes, hypoactivity, piloerection, slow or irregular
breathing, intra-uterine hemorrhage and blood stained stomach and/or
intestinal contents. Maternal no-observed adverse effect level
(NOAEL)=150 mg/kg/day based on these signs. Developmental NOAEL=500
mg/kg/day based on an increase in certain skeletal variants that may be
attributed to the observed maternal toxicity.

2

ii. Rabbit teratology. Groups of New Zealand white rabbits received
acequinocyl technical by gavage at doses of 0, 30, 60 or 120 mg/kg/day.
Maternal NOAEL=60 mg/kg/day based on reduction in maternal body weight
and 5 females were sacrificed at 120 mg/kg/day. Fetal NOAEL=60 mg/kg/day
due to skeletal variations in the thoracic-lumbar ribs.

iii. Rat reproduction study. Acequinocyl technical was fed to two
generations of male and female Sprague Dawley rats at dietary
concentrations of 0,100, 800, or 1500 ppm (0, 7.3, 59 or 111 mg/kg/day
for males and 0, 8.7, 69 or 134 mg/kg/day for females). Systemic and pup
NOAEL=100 ppm (7.3 and 8.7 mg/kg/day). Systemic: Hemorrhage and swollen
body parts were seen at 800 and 1500 ppm in Fl males. At 800 and 1500
ppm, treatment related clinical signs, hemorrhagic effects, subcutaneous
bleeding on body parts and/or cranium and/or brain were seen in the Fl
pups. At 800 and 1500 ppm toxicity seen in F2 pups included subcutaneous
bleeding on body parts and/or cranium and/or brain at weaning.

Subchronic toxicity. i. Rat feeding study. Fischer rats received
acequinocyl technical

at dietary concentrations of 0, 100, 400, 1600 or 3200 ppm (0, 7.57,
30.4, 120, 253 mg/kg/day,

respectively for males and 0, 8.27, 32.2,129, 286 mg/kg/day,
respectively for females) for 13

consecutive weeks. Treatment related yellow brown urine in all animals
of both sexes at 400

ppm suggested the presence of a metabolite of the test material.
Macroscopic examination

on the surviving animals revealed no treatment related abnormalities. At
3200 and 1600

ppm, macroscopic and microscopic examination of the mortalities revealed
hemorrhaging of

muscle and other organs. NOAEL = 400 ppm (30.4 mg/kg/day for males and
32.2 mg/kg/day for

females).

 ii. Mouse feeding study. Groups of CD-I (ICR) BR mice received
acequinocyl

technical by oral route at concentrations of 0, 100, 500, 1000 or 1500
ppm (0,16,81,151, 295

mg/kg/day respectively for males and 0, 21, 100, 231, 342 mg/kg/day
respectively for females)

for 13 weeks. At 100 ppm, there were hepatic histopathological lesions
and an increase in

relative liver weight. A clear NOAEL for both sexes was not determined.

iii. Dog feeding study. Acequinocyl technical was administered via
gelatin capsule to male and female beagle dogs at dose levels of 0, 40,
160, 640 or 1000 mg/kg/day once a day 7 days a week for 13 weeks. At 40,
160 and 640 mg/kg/day colored feces were observed in both sexes.  At 160
and 640 mg/kg/day, treatment related decrease in body weight gain in
males and an increase platelet count for females was observed.
Macroscopic and microscopic examinations on the surviving animals
revealed no treatment related abnormalities. A clear NOAEL was not
determined.

iv. 28-day dermal toxicity. Groups of Sprague Dawley rats received daily
dermal applications of acequinocyl technical at doses of 0, 40, 200 or
1000 mg/kg/day for 6 hours/day for 28 days followed by a 14 day
treatment free period only in the high dose group. There were no
macroscopic findings. Red staining occurred on the back of the animals
and was only seen in the morning after dosing. There was no evidence of
systemic toxicity. NOAEL=1000 mg/kg/day.

3

Chronic toxicity. i. Dog feeding study. Beagle dogs were dosed by
capsule at 0,5,20,

80 or 320 mg/kg/day for 1 year with acequinocyl technical. Minor
disturbances in platelet

counts were observed in both sexes at 80 and 320 mg/kg/day. There were
no treatment

related macroscopic histopathological findings. Colored feces and/or
abnormally stained

sawdust were observed for all treatment groups. Varying degrees of
discoloration of the

urine was observed for animals receiving 20 mg/kg/day or more. The
discoloration was

considered to be attributable to a colored metabolite of the test
substance. NOAEL = 20

mg/kg/day.

ii Rat feeding/oncogenicity study. Groups of F344 rats received
acequinocyl technical at dietary levels of 0, 50, 200, 800 or 1600 ppm
(0, 2.25, 9.02, 36.4, 74.0 mg/kg/day for males and 0, 2.92, 11.6, 46.3,
93.6 mg/kg/day for females) for 2 years. The NOAEL = 200 ppm (9.02 and
11.6 mg/kg/day for males and females, respectively). Corneal
abnormalities and hypertrophy of the eye were observed in 800 ppm and
1600 ppm males and 1600 ppm females. At 800 ppm and 1600 ppm, PT was
observed to be longer in males and shorter in females and APTT longer in
females. Reddish brown urine was observed in both males and females.
There was no incidence of tumors.

iii. Mouse oncogenicity study. Acequinocyl technical was administered in
the diet of Crl:CD-l(ICR)BR mice at 0, 20, 50, 150 or 500 ppm for 80
weeks. NOAEL=20 ppm (lowest dose tested equal to 2.7 and 3.5 mg/kg/day
in males and females respectively), based on brown pigmented cells. At
50 and 500 ppm in both sexes, there was an increase incidence of fatty
hepatocytes. Other associated findings were increased liver weight,
slight increase in pale livers or pale areas within livers. Glomerular
amyloidosis was statistically increased in the 150 and 500 ppm males.
Yellow brown urine was consistently found in both sexes at high dose.
There was no increase in the incidence of tumors.

6.	Animal metabolism. Sprague Dawley rats were dosed orally with
acequinocyl

labeled 14C-phenyl or 14C-dodecyl. Both labels were used in the single
low dose (10 mg/kg)

study. The high dose (500 mg/kg) and 14-day repeat dose studies (10
mg/kg/day) were

conducted with 14C-phenyl acequinocyl only. Excretion was rapid, with
most of the dose in

the feces. Less than 15% of the radioactivity was found in the urine.
Absorption was about

25-42% based on the bile duct cannulation studies, which found 20-33% of
the administered

dose in bile, plus 5-9% in urine plus cage wash. Acequinocyl was not
detected in urine and was only a minor component (1-2%) in the feces.
The major fecal metabolite (12-36%) was the 2-hydroxy-3-dodecyl-l,
4-naphthalenedione (acequinocyl-OH or designated Rl). Subsequent
oxidation of the dodecyl chain yielded butanoic and hexanoic acids, the
only measurable identified urinary metabolites. 2-(l,
2-dioxotetradecyl)-benzoic acid comprised 19-40% of the radioactivity in
the feces. There were no remarkable differences in metabolite
disposition due to gender and no effect of pre-dosing for 2 weeks. The
large dose slowed transit time and reduced absorption.

4

Endocrine disruption. A standard battery of toxicity tests have been
conducted on acequinocyl. No effects were seen to indicate that
acequinocyl has an effect on the endocrine system.

C. Aggregate Exposure

1. Dietary exposure. The tolerance of 0.7 ppm for fruiting vegetables
crop group 8 (tomatoes and peppers) and okra, 0.25 ppm for edible podded
beans and 3.5 ppm for hops along with the previously established
tolerances for acequinocyl were incorporated into the aggregate exposure
results presented below. An aggregate risk assessment was conducted to
include the potential chronic dietary exposure from applications of
acequinocyl on these crops. This chronic risk assessment was conducted
to assess dietary exposures from acequinocyl in food using DEEM FCIDTM
and the following input parameters: tolerance level residues;
consumption data from the USDA 1994-1996 and 1998 Continuing Survey of
Food Intakes by Individuals (CSFII); 100 percent crop treated for all
commodities; default processing factors for all commodities, if
applicable; and a chronic toxicological endpoint of 2.7 mg/kg body
weight(bw) (NOAEL); 0.027 mg/kg bw(chronic reference dose (cRfD)) from
the chronic mouse study. Tolerance values used in the new Tier I DEEM
analysis for current registered uses were obtained from the most recent
EPA human health assessments (FR Notice, April 2, 2008).  Please note
that EPA has determined that there is no endpoint of concern
attributable to a single dose and, therefore, an acute reference dose
(aRfD) was not established. Therefore, no acute exposure assessment is
necessary (FR, Vol. 69, No. 139, 7/21/04, page 43528).

i. Food. The previous chronic dietary food exposure estimates to
acequinocyl were all less than 100% of chronic RfD.  When the previous
risk assessment is revised to include tomatoes, peppers, okra,
snap-beans, and hops, the chronic dietary food exposure estimates to
acequinocyl are still not a concern for the US population as a whole or
for any population subgroup.  The new chronic dietary exposure estimate
for the US population is 12.4% of the cPAD, indicating that there is
plenty of room in the risk cup even with the addition of these proposed
new crops.  The previous DEEM analysis without these new proposed IR-4
uses indicated 7.4% of the cPAD for the total US population (Levy,
2007).  The most highly exposed population subgroup is children aged 1-2
years old at 52.6% of the cPAD; this compares to 41% of the cPAD without
the addition of the new proposed IR-4 uses.

In order to determine which of the registered and proposed commodities
were driving the revised dietary risk assessment, a critical commodity
contribution analysis was conducted for two subpopulation groups,
children 1-2 years old and children 3-5 years old.  This analysis
identified (a) crop groups with greater than 5% of the total exposure
contribution; and (b) those foods or food-forms within the crop groups
contributing more than 1% of the total exposure.  For both of these
subpopulations, the grape crop group (includes fresh grapes, grape juice
and raisins) was the largest contributor.  For children 1-2, this food
group contributed 33.7% of the total exposure; for children 3-5, the
contribution was 30.5% of the total exposure.  The next highest
contributor to the 1-2 year olds was the pome fruit grouping, with apple
juice being the highest

Individual contributor.  The pome fruit group contributed 31.8% and
26.9% of total exposure for children aged 1-2 and 3-5, respectively.
The third highest crop group contributor was the fruiting vegetables,
with fresh tomatoes, tomato sauce, and tomato puree being the highest
individual food contributors within that crop group.  This group
accounted for 21.9% and 28.3% of total exposure for children aged 1-2
and 3-5, respectively.

ii. Drinking water. The available environmental fate data indicate that
acequinocyl does not persist in the environment nor does it have the
ability to leach into groundwater resources. Acequinocyl degrades
rapidly in the environment. Aqueous photolyis, Tl/2 = 14 minutes, soil
photolyis, Tl/2 = 2 days, aerobic soil metabolism (4 soils) Tl/2 = <3
days, aerobic aquatic metabolism Tl/2 = 0.39 day in water and sediment,
hydrolysis Tl/2 = 74 days (pH4), = 2.2 days (pH7), =1.3 hours (pH9).
Acequinocyl shows low soil mobility.  Drinking water data was
incorporated directly into the DEEM dietary assessment under “drinking
water” for both direct and indirect sources using the chronic
concentration of parent-only (acequinocyl) residues modeled from surface
water using PRZM-EXAMS by EPA and used in their revised human health
risk assessment (Levy, S., 2007).  This was a very conservative estimate
because it was assumed that acequinocyl was stable to all routes of
degradation.  As a result, this model produced the highest estimated
drinking water concentration (EDWC), 2.73 part per billion (ppb), which
was considered to be the most protective.  Using these considerations,
exposures to acequinocyl in drinking water do not pose a significant
human health risk.

iii. Non-dietary exposure. The proposed expansion of the registration
for applications to fruiting vegetables crop group 8 (tomatoes,
peppers), okra, edible podded beans, and hops requires evaluation of
occupational handler and postapplication exposures and dietary exposures
for consumers.

a. Occupational Handler Exposure: The following handler scenarios were
evaluated:

1. Mix/load liquid open-pour for groundboom applications

2. Mix/load liquid open-pour for airblast applications

3. Application by groundboom, open-cab

4. Application by airblast, open-cab

Exposure data from PHED were used to assess dermal and inhalation risks.
 All short-term and intermediate-term occupational risks were acceptable
(margin of exposure (MOE)s exceeded 100; short-term MOEs ranged from
4,866 to 51,330 and intermediate-term MOEs ranged from 20,700 to
291,300).

Based on the anticipated occupational use patterns for acequinocyl
products, long-term (several months to lifetime) exposures are not
expected for occupational handlers of acequinocyl.

b. Occupational Postapplication Exposure: Since re-entry activities
occur after the sprays have dried, post-application inhalation exposures
are not assessed.  Post-application exposures to acequinocyl are
expected to be of short-term duration only (1 to 30 days) based on the
limited use pattern.  Short-term dermal post-application exposures were
assessed against the NOAEL for short-term dermal exposures (200
mg/kg/day).  For fruiting vegetables, okra, edible podded beans and
hops, the risks are not of concern (MOEs > 100) on day 0 for all
potential re-entry activities.  As such, the REI of 12 hours is
appropriately protective.  The highest exposure potential is in hops
with high contact activities such as training, stripping and harvesting;
the margin of exposure associated with these high contact activities is
942, well above the level of concern of 100.

6

c. Residential Handler exposure: Residential handler risks were
calculated by EPA in the 2007 Human Health Risk Assessment document
(Levy, S., 2007).  Two scenarios, mixing/loading and applying liquids by
low-pressure hand-wand and mixing/loading and applying liquids with a
hose-end sprayer, were identified and evaluated for short-term
residential risks.  Based on the EPA residential handler assessment,
there are no risks of concern for residential handlers (MOEs > 100).
The lowest MOE, 2,900, was associated with dermal exposure when using
the hose-end sprayer.

d. Residential Postapplication exposures: Current EPA policy indicates
that there is no significant post-application exposure to treated
residential ornamentals; therefore, no residential re-entry risk
assessment was performed.

In summary, all residential and occupational exposure scenarios are
associated with a reasonable certainty of no harm for the US population
and all subpopulations.

D.	Cumulative Effects

There is no information available to indicate that toxic effects
produced by acequinocyl are cumulative with those of any other compound.

E.	Safety Determination

U.S. population. . The chronic dietary food and drinking water exposure
(including all current and proposed uses) to acequinocyl was estimated
at 12.4% of the cPAD for the total US population. The calculated chronic
dietary risks included contributions of modeled residues from drinking
water (direct and indirect, all sources).  The groundwater EDWC for
acequinocyl was estimated to be 0.0036 ppb, while surface water EDWCs
were estimated to be 0.37 and 2.73 ppb, using two different approaches
(Levy, 2007).  The most conservative value, 2.73 ppb, was chosen for use
in the chronic dietary assessment. Acequinocyl concentrations in the
source surface water are not expected to exceed 2.73 ppb in chronic
scenarios due to the conservative high-end assumptions used in the
model. The Tier 1 chronic dietary risk assessment took into account
tolerance-level residues, 100% crop treated, and a drinking water
modeled concentration of 2.73 ppb. The result of this assessment
indicated exposures to the general US population were not of concern.

Infants and children. The chronic dietary food exposure to acequinocyl
was estimated at 22.5% of cPAD for all infants (<1 year), and 52.6% of
cPAD for children 1-2 years (most highly exposed). The calculated
chronic dietary risks included contributions of modeled residues from
drinking water (direct and indirect, all sources).  The most
conservative value, 2.73 ppb obtained from PRZM-EXAMS surface water
model, was chosen for use in the chronic dietary assessment. Acequinocyl
concentrations in the source surface water are not expected to exceed
the EDWC of 2.73 ppb in chronic scenarios due to the conservative
high-end assumptions used in the model.  The Tier 1 chronic dietary risk
assessment took into account tolerance-level residues, 100% crop
treated, and a drinking water modeled concentration of 2.73 ppb. The
result

7

of this assessment indicated exposures to the most exposed
subpopulation, children aged 1 to 2 years, were not of concern.

F.	International Tolerances

To date, no Codex, Canadian or Mexican tolerances exists for
acequinocyl.

REFERENCES:

Levy, Sarah.  Amendment to PP#s 6F7040 and #7F176.  Human Health Risk
Assessment for the Proposed Uses of Acequinocyl on Grapes, the Tree Nut
Crop Group, and Residential Sites (Ornamentals). December 12, 2007.

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