Document ID: EPA-HQ-OPP-2015-0658-0011
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Flumioxazin
Posted Date: 2016-12-19T05:00Z

[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91846-91852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30467]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0658; FRL-9955-45]

Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
flumioxazin in or on multiple commodities which are identified and 
discussed later in this document. The Inter-Regional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 19, 2016. Objections and 
requests for hearings must be received on or before February 17, 2017, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0658, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; Main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

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

[[Page 91847]]

identify docket ID number EPA-HQ-OPP-2015-0658 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 February 17, 2017. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0658, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of November 23, 2015 (80 FR 72941) (FRL-
9936-73), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition 
(PP#5E8399) by Interregional Research No. 4 (IR-4), Rutgers, The State 
University of New Jersey, 500 College Road East, Suite 201-W, 
Princeton, NJ 08540. The Agency inadvertently republished this notice 
on March 16, 2016 (81 FR 14030) (FRL-9942-86). The petition requested 
that 40 CFR 180.568 be amended by establishing tolerances for residues 
of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-
propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, in or on berry, low growing, subgroup 13-07G at 0.07 
parts per million (ppm); caneberry, subgroup 13-07A at 0.4 ppm; citrus, 
group 10-10 at 0.02 ppm; citrus oil at 0.1 ppm; clover, forage at 0.02 
ppm; clover, hay at 0.15 ppm; fruit, pome, group 11-10 at 0.02 ppm; 
fruit, small vine climbing, except for fuzzy kiwifruit, subgroup 13-07F 
at 0.02 ppm; fruit, stone, group 12-12 at 0.02 ppm; head and stem 
brassica, subgroup 5A at 0.02 ppm; nut, tree, group 14-12 at 0.02 ppm; 
onion, bulb subgroup 3-07A at 0.02 ppm; and vegetable, fruiting, group 
8-10 at 0.02 ppm.
    The petitioner also requested the removal of the following 
established tolerances based on the establishment of tolerances for the 
commodities established in this action: Cabbage at 0.02 ppm; cabbage, 
Chinese, napa at 0.02 ppm; fruit, pome group 11 at 0.02 ppm; fruit, 
stone, group 12 at 0.02 ppm; garlic at 0.02 ppm; grape at 0.02 ppm; 
nut, tree group 14 at 0.02 ppm; okra at 0.02 ppm; onion, bulb at 0.02 
ppm; pistachio at 0.02 ppm; shallot bulb at 0.02 ppm; strawberry at 
0.07 ppm; and vegetable, fruiting group 8 at 0.02 ppm. That document 
referenced a summary of the petition prepared by Valent USA 
Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on these notices of 
filings. EPA's response to these comments is discussed 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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 flumioxazin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flumioxazin 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.
    Toxicity associated with flumioxazin includes anemia and effects on 
the cardiovascular system and liver. Specifically, alterations in 
hemoglobin parameters were observed in rats, as well as increased renal 
toxicity in male rats, and increased absolute and relative liver 
weights and increased alkaline phosphate values were seen in dogs. No 
evidence of neurotoxicity was seen in male or female rats in the acute 
or subchronic neurotoxicity studies. The oral and dermal developmental 
rat studies showed evidence of increased quantitative susceptibility of 
fetuses, as cardiovascular anomalies (ventral septal defects) were 
found. These developmental effects in the offspring were more severe 
and seen at doses lower than those that caused parental and systemic 
toxicity. The regulatory endpoints for flumioxazin are protective of 
this increased susceptibility, however, so there is low concern and no 
residual uncertainties for these effects. Flumioxazin was negative for 
mutagenicity in most of the available studies, however, there were 
aberrations in a chromosomal aberration assay. The lack of 
carcinogenicity in mice and rats permits flumioxazin to be classified 
as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by flumioxazin 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 Flumioxazin: Human Health Risk 
Assessment for the New Uses on Clover Grown for Seed; Citrus Group 10-
10; Caneberry Subgroup 13-07A; Head and Stem Brassica Subgroup 5A; and 
Crop Group Expansion for Fruiting Vegetable Group 8-10; Low Growing 
Berry Subgroup 13-07G; Nut Tree Group 14-12; Onion Bulb Subgroup 3-07A; 
Pome

[[Page 91848]]

Fruit Group 11-10; Small Fruit, Vine Climbing, Except Fuzzy Kiwifruit 
Subgroup 13-07F; and Stone Fruit Group 12-12 at pages 15-22 and 42-55 
in docket ID number EPA-HQ-OPP-2015-0658.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for flumioxazin used for 
human risk assessment is discussed in Unit III, B of the final rule 
published in the Federal Register of September 21, 2012 (77 FR 58493) 
(FRL-9358-3).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR 
180.568. EPA assessed dietary exposures from flumioxazin 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.
    Such effects were identified for flumioxazin for females 13-49. In 
estimating acute dietary exposure, EPA used food consumption 
information from the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This 
software uses 2003-2008 food consumption data from the U.S. Department 
of Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA incorporated tolerance-level residues, 100 percent crop 
treated (PCT) for all commodities and DEEM-FCID version 3.16.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID Version 3.16. This software uses 
2003-2008 food consumption data from USDA's NHANES/WWEIA. As to residue 
levels in food, EPA incorporated tolerance-level residues, 100 PCT for 
all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flumioxazin 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 percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for flumioxazin. Tolerance level residues and/or 
100% CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for flumioxazin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flumioxazin. The estimated drinking water 
concentrations (EDWCs) are based on aquatic rates of the residues of 
concern for flumioxazin and its major degradates (482-HA, and APF), 
expressed as flumioxazin equivalents. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) model, 
the EDWCs in surface water for acute exposures are 400 parts per 
billion (ppb) for flumioxazin only and for chronic exposures are 
estimated to be 9.4 ppb, 21.6 ppb, and 110.1 ppb for flumioxazin, 482-
HA and APF degradates, respectively, for a total concentration of 141 
ppb. Based on the Screening Concentration in Ground Water (SCI-GROW) 
model, for both acute and chronic (non-cancer) exposures, the EDWCs of 
482-HA and APF are estimated to be 45.27 ppb and 2.66 ppb, 
respectively, for ground water. EDWCs of flumioxazin are estimated to 
be negligible in ground water for chronic exposures.
    Estimates of drinking water concentrations were directly entered 
into the dietary exposure model as follows. The peak day zero of 0.400 
ppm for flumioxazin (degradates 482-HA and APF were not detected) was 
used to assess the contribution to drinking water for the acute dietary 
risk assessment, and the day 30 total of 0.141 ppm for flumioxazin, 
482-HA and APF degradates was used to assess the contribution to 
drinking water for the chronic dietary risk assessment.
    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). Flumioxazin is 
currently registered for the following uses that could result in 
residential exposures: Turf, gardens and trees, and aquatic weeds. EPA 
assessed residential exposure with the assumption that homeowner 
handlers wear shorts, short-sleeved shirts, socks, and shoes, and that 
they complete all tasks associated with the use of a pesticide product 
including mixing/loading, if needed, as well as the application. 
Residential handler exposure scenarios for both dermal and inhalation 
are considered to be short-term only, due to the infrequent use 
patterns associated with homeowner products.
    EPA uses the term ``post-application'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Flumioxazin can be used in 
many areas that can be frequented by the general population including 
residential areas, lakes, and ponds. As a result, individuals can be 
exposed by entering these areas if they have been previously treated. 
Therefore, short-term and intermediate-term dermal post-application 
exposures and risks were assessed for adults and children. In addition, 
oral post-application exposures and risks were assessed for children to 
be protective of possible hand-to-mouth, object-to-mouth, and soil 
ingestion activities that may occur on treated turf areas. Further 
information regarding EPA standard assumptions and generic inputs for

[[Page 91849]]

residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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 flumioxazin to share a common mechanism of 
toxicity with any other substances, and flumioxazin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
flumioxazin 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased quantitative susceptibility of fetuses in the oral and dermal 
developmental rat studies, where cardiovascular abnormalities occurred 
in the absence of maternal toxicity. The rat reproduction study also 
showed evidence of qualitative and quantitative post-natal 
susceptibility since reproductive effects in offspring were more severe 
and were seen at lower doses than those that caused parental/systemic 
toxicity. Even with this observed increased susceptibility, the Agency 
has concluded there is a low concern and no residual uncertainties for 
pre- and/or postnatal toxicity because the developmental toxicity 
NOAELs/LOAELs are well-characterized after oral and dermal exposure, 
and the offspring toxicity NOAEL and LOAEL are well characterized in 
the reproduction study.
    Furthermore, the doses and endpoints have been selected from the 
developmental and reproductive toxicity studies for risk assessment of 
the relevant exposed populations (e.g., pregnant females and children), 
with the exception of the chronic dietary endpoint, for which a chronic 
study was selected. Therefore, regulatory endpoints for flumioxazin are 
protective of the increased susceptibility and there are no residual 
concerns for these effects.
    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 for oral and dermal exposures, but retained 
at 10X for inhalation exposures due to the lack of an inhalation study. 
That decision is based on the following findings:
    i. The toxicity database for flumioxazin is sufficient for 
assessing the toxicity and characterizing the hazard of flumioxazin. An 
inhalation study is needed to characterize more completely the 
potential for adverse effects associated with the inhalation route of 
exposure; therefore, in order to account for any uncertainty attending 
the use of the dose and endpoint from an oral rat developmental 
toxicity study with an estimated 100% default absorption factor, the 
Agency is retaining the 10X FQPA safety factor for assessing inhalation 
risk.
    ii. There is no indication that flumioxazin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is evidence that flumioxazin may result in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The Agency concluded that while there is an increased 
susceptibility, there is a low concern and no residual uncertainties 
for pre-and/or postnatal toxicity because the developmental toxicity 
NOAELs/LOAELs are well characterized after oral and dermal exposure; 
the offspring toxicity NOAEL and LOAEL are well characterized in the 
reproduction study; and the doses and endpoints have been selected from 
the developmental and reproductive toxicity studies for the relevant 
populations, except for the chronic dietary endpoint, for which a 
chronic study was chosen. Therefore, the regulatory endpoints for 
flumioxazin are protective of the increased susceptibility seen in the 
developmental and reproduction studies, and there are no residual 
concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to flumioxazin in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by flumioxazin.

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flumioxazin will occupy 76% of the aPAD for females 13-49 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
flumioxazin from food and water will utilize 44% of the cPAD for all 
infants <1 year 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 
flumioxazin is not expected.
    3. Short and intermediate-term risk. Short-term and intermediate-
term aggregate exposure takes into account short-term and intermediate 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Flumioxazin is 
currently registered for uses that could result in short-term and

[[Page 91850]]

intermediate residential exposures, and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term and intermediate-term residential exposures to 
flumioxazin. Since the Agency has determined that the short-term and 
intermediate-term points of departure are the same the aggregate risks 
are the same for both short-term and intermediate-term exposures.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short-term and intermediate-term food, water, and residential exposures 
result in aggregate MOEs of 110 for adult females 13-49 years and 200 
for children less than two years. Because EPA's level of concern for 
flumioxazin is a MOE of 100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flumioxazin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC) using a 
nitrogen phosphorous detector (NPD)) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

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 United Nations 
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 any MRLs for flumioxazin.

C. Response to Comments

    EPA received five comments to the two published Notice of Filings. 
Two comments stated, in part and without any supporting information, 
that EPA should deny this petition because it is a harmful and toxic 
chemical with no benefits. The Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops. The 
existing legal framework provided by section 408 of the FFDCA, however, 
states that tolerances may be set when persons seeking such tolerances 
or exemptions have demonstrated that the pesticide meets the safety 
stand imposed by that statute. EPA has assessed the effects of this 
chemical on human health and determined that aggregate exposure to it 
will be safe. These comments provide no information to support an 
alternative conclusion.
    Another comment submitted by the Center for Biological Diversity 
was primarily concerned about the environmental risks and Agency 
compliance with any relevant obligations under the Endangered Species 
Act. This comment is not relevant to the Agency's evaluation of safety 
of the flumioxazin tolerances; section 408 of the FFDCA focuses on 
potential harms to human health and does not permit consideration of 
effects on the environment. Additional comments were submitted in 
support of this petition by Interregional Research Project Number 4 
(IR-4) and Dr. A. Stanley Culpepper from the University of Georgia 
Cooperative Extension.

D. Revisions to Petitioned-For Tolerances

    The petitioner proposed a tolerance of flumioxazin on caneberries 
at 0.4 ppm. Both the petitioner and the Agency used the Organization 
for Economic Cooperation & Development (OECD) spreadsheet calculator; 
however, the Agency did not consider the two Oregon trials to be 
independent since they were conducted at the same location on the same 
variety of raspberries and applications were made within 30 days of 
each other. Therefore, the four samples were accounted as two, 
resulting in an Agency recommended tolerance of 0.5 ppm. All other 
tolerances are recommended to be at the same levels as petitioned.
    The petitioner proposed a tolerance for head and stem brassica, 
subgroup 5A at 0.02 ppm; however, the EPA is establishing a tolerance 
for Vegetable, brassica, head and stem, group 5-16 at 0.02 ppm. In the 
Federal Register of May 3, 2016 (81 FR 26471) (FRL-9944-87) 
establishing the Vegetable, brassica, head and stem, group 5-16, EPA 
indicated that, for existing petitions for which a Notice of Filing had 
been published, the Agency would attempt to conform these petitions to 
the rule. Therefore, consistent with this rule, EPA is establishing 
tolerances on Vegetable, brassica, head and stem, group 5-16 rather 
than head and stem brassica, subgroup 5A. EPA concludes it is 
reasonable to revise the petitioned-for tolerance so that they agree 
with the recent crop grouping revisions because (1) the new crop group 
includes the same commodities as the subgroup except two commodities 
are no longer in the group and (2) the representative commodities for 
the revised crop groups/subgroups have not changed.
    Finally, the Agency is establishing tolerances for clover, forage 
and clover, hay with regional registrations in (c) since residue field 
trial data were only submitted to support registration in Idaho, 
Washington, and Oregon.

V. Conclusion

    Therefore, tolerances are established for residues of flumioxazin, 
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, in or on tolerances for 
residues of the herbicide flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-
(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, in or on, berry, low growing, subgroup 13-07G at 0.07 
parts per million (ppm); caneberry, subgroup 13-07A at 0.5 ppm; citrus, 
group 10-10 at 0.02 ppm; fruit, pome, group 11 at 0.02 ppm; fruit, 
stone, group 12 at 0.02 ppm; nut, tree, group 14-12 at 0.02 ppm; onion, 
bulb subgroup 3-07A at 0.02 ppm; small fruit, vine climbing, except for 
fuzzy kiwifruit, subgroup 13-07F at 0.02 ppm; vegetable, brassica, head 
and stem, group 5-16 at 0.02 ppm; and vegetable, fruiting, group 8-10 
at 0.02 ppm.
    Additionally, EPA is establishing tolerances with regional 
registrations for clover, forage at 0.02 ppm and clover, hay at 0.15 
ppm. Finally, the EPA is removing tolerances for Cabbage at 0.02 ppm; 
cabbage, Chinese, napa at 0.02 ppm; fruit, pome group 11 at 0.02 ppm; 
fruit, stone, group 12 at 0.02 ppm; garlic at 0.02 ppm; grape at 0.02 
ppm; nut, tree

[[Page 91851]]

group 14 at 0.02 ppm; okra at 0.02 ppm; onion, bulb at 0.02 ppm; 
pistachio at 0.02 ppm; shallot bulb at 0.02 ppm; strawberry at 0.07 ppm 
and vegetable, fruiting group 8 at 0.02 ppm since these will be 
superseded by this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerances 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: December 6, 2016.
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. Revise Sec.  180.568 to read as follows:

Sec.  180.568  Flumioxazin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-
benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only flumioxazin.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Alfalfa, forage..............................................        3.0
Alfalfa, hay.................................................        8.0
Almond, hulls................................................       0.70
Artichoke, globe.............................................       0.02
Asparagus....................................................       0.02
Berry, low growing, subgroup 13-07G..........................       0.07
Bushberry subgroup 13-07B....................................       0.02
Caneberry, subgroup 13-07A...................................       0.50
Citrus, group 10-10..........................................       0.02
Citrus, oil..................................................        0.1
Corn, field, forage..........................................       0.02
Corn, field, grain...........................................       0.02
Corn, field, stover..........................................       0.02
Cotton, gin byproducts.......................................       0.60
Cotton, undelinted seed......................................       0.02
Fish, freshwater.............................................        1.5
Fruit, pome, group 11-10.....................................       0.02
Fruit, small vine climbing, except for fuzzy kiwifruit,             0.02
 subgroup 13-07F.............................................
Fruit, stone, group 12-12....................................       0.02
Grain, aspirated fractions...................................        100
Hop, dried cones.............................................       0.05
Leaf petioles subgroup 4B....................................       0.02
Nut, tree, group 14-12.......................................       0.02
Olive........................................................       0.02
Onion, bulb subgroup 3-07A...................................       0.02
Pea and bean, dried shelled, except soybean, subgroup 6C.....       0.07
Peanut.......................................................       0.02
Peppermint, tops.............................................       0.04
Pomegranate..................................................       0.02
Prickly pear, fruit..........................................       0.07
Prickly pear, pads...........................................       0.06
Rapeseed subgroup 20A........................................       0.40
Soybean forage...............................................       0.03
Soybean hay..................................................       0.02
Soybean, seed................................................       0.02
Spearmint, tops..............................................       0.04
Sugarcane, cane..............................................       0.20
Sunflower subgroup 20B.......................................       0.50
Vegetable, brassica, head and stem, group 5-16...............       0.02
Vegetable, cucurbit, group 9.................................       0.03
Vegetable, fruiting, group 8-10..............................       0.02
Vegetable, tuberous and corm, subgroup 1C....................       0.02
Wheat, forage................................................       0.02
Wheat, grain.................................................       0.40
Wheat, hay...................................................       0.02
Wheat, straw.................................................        6.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances are 
established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-
4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only flumioxazin.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Clover, forage...............................................       0.02
Clover, hay..................................................       0.15
------------------------------------------------------------------------

[[Page 91852]]

    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2016-30467 Filed 12-16-16; 8:45 am]
 BILLING CODE 6560-50-P