[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Rules and Regulations]
[Pages 5307-5312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02346]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0650; FRL-9972-75]


Isoxaben; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isoxaben in or on apple, the bushberry subgroup 13-07B, the tree nut 
group 14-12, and the small vine climbing fruit (except fuzzy kiwifruit) 
subgroup 13-07F. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective February 7, 2018. Objections and 
requests for hearings must be received on or before April 9, 2018, 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-2016-0650, 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 identify 
docket ID number EPA-HQ-OPP-2016-0650 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 
April 9, 2018. 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-2016-0650, 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 April 10, 2017 (82 FR 17175) (FRL-9959-
61), 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 
6E8516) by Interregional Research Project No. 4 (IR-4) Project 
Headquarters, Rutgers, The State University of NJ, 500 College Road 
East, Suite 201, W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.650 be amended by establishing tolerances for residues of the 
herbicide isoxaben, N-[3-(1-ethyl-1-methylpropyl)-5-isoxazolyl]-2, 6-
dimethoxybenzamide, in or on the raw agricultural commodities apple at 
0.01 parts per million (ppm); the bushberry subgroup 13-07B at 0.01 
ppm; the fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 
13-07F at 0.01 ppm; and the nut, tree, group 14-12 at 0.02 ppm. The 
petition also requested to remove the tolerances in 40 CFR 180.650 in 
or on the raw agricultural

[[Page 5308]]

commodities grape at 0.01 ppm; nut, tree, group 14 at 0.02 ppm; and 
pistachio at 0.02 ppm. That document referenced a summary of the 
petition prepared by Dow AgroSciences, the registrant, which is 
available in the docket, http://www.regulations.gov. Comments were 
received on the notice of filing. 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 isoxaben including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isoxaben 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.
    Isoxaben shows low acute toxicity by all routes. In chronic oral 
studies, the liver (mouse) and kidney (rat) were target organs, and 
decreased body weight was observed in the rat, mouse, and dog. There 
was no indication of neurotoxicity or immunotoxicity. No evidence of 
increased susceptibility was observed in the rat or rabbit 
developmental toxicity studies, but was observed in the rat 
reproductive toxicity study only at the limit dose.
    Isoxaben is currently classified as having ``suggestive evidence of 
carcinogenic potential,'' based on the presence of liver tumors in male 
and female mice. Because the tumors were benign and observed at dose 
levels exceeding the limit dose of 1,000 mg/kg/day and there was low 
concern for genotoxicity, the cRfD is considered protective of 
potential carcinogenicity and a quantitative assessment of cancer risk 
was not conducted.
    Specific information on the studies received and the nature of the 
adverse effects caused by isoxaben 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 the document title ``Isoxaben. Aggregate Human 
Health Risk Assessment to Support Proposed New Uses on Bushberry 
Subgroup 13-07B and Apple, Crop Group Conversion (Tree Nut Group 14-
12), and Crop Group Expansion (Small Vine Climbing Fruit Except Fuzzy 
Kiwifruit Subgroup 13-07F)'' on pages 26-31 in docket ID number EPA-HQ-
OPP-2016-0650.

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 isoxaben used for 
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Isoxaben for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..         An appropriate endpoint for a single exposure was not identified
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 5.0 mg/kg/    Chronic RfD = 0.05   Chronic combined toxicity/
                                    day.                  mg/kg/day.           Carcinogenicity (oral)--rat.
                                   UFA = 10x...........  cPAD = 0.05 mg/kg/   LOAEL = 50.7 mg/kg/day, based on
                                   UFH = 10x...........   day..                renal toxicity in males.
                                   FQPA SF = 1x........

[[Page 5309]]

 
Incidental oral intermediate-term  NOAEL = 200 mg/kg/    LOC for MOE = 100..  Reproductive toxicity (oral)--rat.
 (1 to 6 months).                   day.                                      Offspring LOAEL = 1,000 mg/kg/day,
                                   UFA = 10x...........                        based on decreased body weight
                                   UFH = 10x...........                        gain in F1 females on day 70,
                                   FQPA SF = 1x........                        decreased F2 pup weights,
                                                                               gestation survival, live pups/
                                                                               litter, and increased incidence
                                                                               of malformations.
                                                                              One-year dietary study (co-
                                                                               critical supporting study)--rat.
                                                                              LOAEL = 625 mg/kg/day, based on
                                                                               decreased body weight gain in
                                                                               females during the first six
                                                                               months, with a NOAEL of 62.5 mg/
                                                                               kg/day.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     NOAEL = 200 mg/kg/    LOC for MOE = 100..  Reproductive toxicity (oral)--rat.
 days).                             day (inhalation                           Offspring LOAEL = 1,000 mg/kg/day,
                                    toxicity assumed to                        based on decreased body weight
                                    be equivalent to                           gain in F1 females on day 70,
                                    oral toxicity).                            decreased F2 pup weights,
                                   UFA = 10x...........                        gestation survival, live pups/
                                   UFH = 10x...........                        litter, and increased incidence
                                   FQPA SF = 1x........                        of malformations.
----------------------------------------------------------------------------------------------------------------
Inhalation intermediate-term (1    NOAEL = 200 mg/kg/    LOC for MOE = 100..  Reproductive toxicity (oral)--rat.
 to 6 months).                      day (inhalation                           Offspring LOAEL = 1,000 mg/kg/day,
                                    toxicity assumed to                        based on decreased body weight
                                    be equivalent to                           gain in F1 females on day 70,
                                    oral toxicity).                            decreased F2 pup weights,
                                   UFA = 10x...........                        gestation survival, live pups/
                                   UFH = 10x...........                        litter, and increased incidence
                                   FQPA SF = 1x........                        of malformations.
                                                                              One-year dietary study (co-
                                                                               critical supporting study)--rat.
                                                                              LOAEL = 625 mg/kg/day, based on
                                                                               decreased body weight gain in
                                                                               females during the first six
                                                                               months, with a NOAEL of 62.5 mg/
                                                                               kg/day.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)      ``Suggestive Evidence of Carcinogenic Potential,'' based on increased
                                     incidence of hepatocellular adenomas in male and female mice. Quantitative
                                    assessment of cancer risk using a cancer potency factor is not required. The
                                                 chronic RfD is protective of potential cancer risk.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isoxaben, EPA considered exposure under the petitioned-for 
tolerances as well as all existing isoxaben tolerances in 40 CFR 
180.650. EPA assessed dietary exposures from isoxaben in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
isoxaben; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the US 
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 assumed tolerance-level residues and 100 
percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to isoxaben. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
isoxaben. Tolerance-level residues and 100 PCT were assumed for all 
food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for isoxaben in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of isoxaben. 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 Surface Water Concentration Calculator (SWCC v1.106) 
and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of isoxaben for chronic exposures 
are estimated to be 43.6 parts per billion (ppb) for surface water and 
909 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration value of 909 ppb was used to assess 
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).

[[Page 5310]]

    Isoxaben is currently registered for the following uses that could 
result in residential exposures: Residential turf. EPA assessed 
residential exposure using the following assumptions: Isoxaben 
residential uses constitute short- and intermediate-term exposure 
scenarios. For residential handlers, since a dermal endpoint was not 
selected, the only route of exposure quantitatively assessed for adult 
handlers is through inhalation. For post-application exposures, only 
intermediate-term incidental oral exposures for children were assessed 
due to the persistence of isoxaben residues in soil. Neither a short-
term dermal nor short-term incidental oral endpoint was selected for 
children. Although there is potential for post-application inhalation 
exposure of both adults and children, the estimated exposure is 
anticipated to be negligible; therefore, a quantitative post-
application inhalation assessment was not required.
    For the purpose of performing an aggregate assessment, the Agency 
selected only the most conservative, or worst-case, residential adult 
and child scenarios to be included in the aggregate, based on the 
lowest overall MOE (highest exposure estimates). For adults, handler 
inhalation exposure resulting from the application of a granular 
formulation of isoxaben to residential lawns via push-type spreader has 
been used to estimate adult aggregate exposure. (The inhalation 
exposure was added to background exposure from food and water, and 
compared to the short-term inhalation POD.) Post-application risks for 
adults in residential settings were not assessed due to the lack of a 
dermal endpoint.
    For children, an intermediate-term aggregate assessment was 
conducted by adding the incidental soil ingestion exposure, and average 
food and water exposure (chronic dietary exposure). The incidental oral 
residential exposure value selected for the aggregate analysis is based 
on children ingesting soil particles containing pesticide residues 
while playing on treated turf. Due to the persistence of isoxaben in 
the soil, the Agency used a conservative approach by using the maximum 
seasonal application rate for estimating soil ingestion by children 
rather than the standard maximum single application rate. This scenario 
resulted in the highest calculated exposure levels; therefore, it is 
protective for all other oral post-application exposure and risk for 
children in residential settings.
    Further information regarding EPA standard assumptions and generic 
inputs for 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 isoxaben to share a common mechanism of toxicity 
with any other substances, and isoxaben does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that isoxaben does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's website at http://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. No evidence of increased 
susceptibility was observed in the rat or rabbit developmental toxicity 
studies, but was observed in the rat reproductive toxicity study only 
at the limit dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for isoxaben is adequately complete to 
allow the Agency to assess the toxicological profile of isoxaben.
    ii. There is no indication that isoxaben is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. No evidence of increased susceptibility was observed in the 
rat or rabbit developmental toxicity studies, but was observed in the 
rat reproductive toxicity study only at the limit dose; however, this 
risk assessment is protective of the susceptibility observed at the 
limit dose in the reproductive toxicity study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to isoxaben in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
isoxaben.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
isoxaben is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
isoxaben from food and water will utilize 98% of the cPAD for all 
infants less than 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 
isoxaben is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account

[[Page 5311]]

short-term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Isoxaben is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to isoxaben.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in an aggregate MOE of 6,700 for 
females 13-49 years old. Because EPA's level of concern for isoxaben is 
a MOE of 100 or below, this MOE is not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Isoxaben is currently registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to isoxaben.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 7,200 for children 1-2 years old. Because EPA's level 
of concern for isoxaben is a MOE of 100 or below, this MOE is not of 
concern.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA considers the chronic aggregate risk 
assessment to be protective of any aggregate cancer risk. As there is 
no chronic risk of concern, EPA does not expect any cancer risk to the 
U.S. population from aggregate exposure to isoxaben.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to isoxaben residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate residue analytical method (RAM) utilizing liquid 
chromatography with tandem mass spectrometric detection (LC/MS/MS), GRM 
02.26.S.1 (a revision of GRM 02.26), is available for enforcement of 
isoxaben residues in crop commodities.
    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 isoxaben.

C. Response to Comments

    Seven comments were received in response to the notice of filing. 
All of the comments were general in nature, not specific to the 
chemical isoxaben. They included statements such as ``I am not in favor 
of relaxing requirements on pesticides,'' ``I am opposed to this 
proposal,'' and ``My body doesn't live well on pesticides.''
    The Agency recognizes that some individuals believe that pesticides 
should be banned on agricultural crops; however, the existing legal 
framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) states that tolerances may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. These 
citizens' comments appear to be directed at the underlying statute and 
not EPA's implementation of it; the citizens have made no contention 
that EPA has acted in violation of the statutory framework nor have 
they provided any specific information or allegation that would support 
a finding that these tolerances are unsafe.

V. Conclusion

    Therefore, tolerances are established for residues of isoxaben 
including its metabolites and degradates, in or on apple at 0.01 ppm; 
the bushberry subgroup 13-07B at 0.01 ppm; the fruit, small, vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; and the 
nut, tree, group 14-12 at 0.02 ppm. In addition, the following existing 
tolerances are removed since they are superseded by the new tolerances: 
Grape, nut, tree, group 14; and pistachio.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This 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

[[Page 5312]]

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: January 19, 2018.
Donna S. Davis,
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. In Sec.  180.650, revise the table in paragraph (a) to read as 
follows:


Sec.  180.650   Isoxaben; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Almond, hulls...........................................            0.40
Apple...................................................            0.01
Bushberry subgroup 13-07B...............................            0.01
Fruit, small, vine climbing, except fuzzy kiwifruit,                0.01
 subgroup 13-07F........................................
Nut, tree, group 14-12..................................            0.02
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-02346 Filed 2-6-18; 8:45 am]
 BILLING CODE 6560-50-P