82 FR 45730 - Fluoxastrobin; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 189 (October 2, 2017)

Page Range		45730-45736
FR Document		2017-21113
This regulation establishes tolerances for residues of fluoxastrobin in or on multiple commodities which are identified and discussed later in this document. Arysta LifeScience North America, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Federal Register, Volume 82 Issue 189 (Monday, October 2, 2017)
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Rules and Regulations]
[Pages 45730-45736]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-21113]



[[Page 45730]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0727; FRL-9966-09]


Fluoxastrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluoxastrobin in or on multiple commodities which are identified and 
discussed later in this document. Arysta LifeScience North America, LLC 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective October 2, 2017. Objections and 
requests for hearings must be received on or before December 1, 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-2015-0727, 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
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-2015-0727 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 
December 1, 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-2015-0727, 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 March 16, 2016 (81 FR 14030) (FRL-9942-
86), 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 
5F8406) by Arysta LifeScience North America, LLC, 15401 Weston Parkway, 
Suite 150, Cary, North Carolina, 27513. The petition requested that 40 
CFR 180.609 be amended by establishing tolerances for residues of the 
fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4- 
pyrimydinyl]oxy]phenyl] (5,6-dihydro-l,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z isomer, (1Z)-[2-[[6-(2chlorophenoxy)-5-fluoro-4-
pyrimydinyl]oxy]phenyl] (5,6-dihydro-l,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on avocado at 0.9 parts per million (ppm); barley, 
grain at 0.4 ppm; barley, hay at 15 ppm; barley, straw at 15 ppm; 
rapeseed subgroup 20A at 0.8 ppm; and dried shelled pea and bean 
(except soybean) subgroup 6C at 0.2 ppm. No comments were submitted on 
this notice of filing. Based on data submitted with the petition, the 
tolerances established by the Agency in this action differ slightly 
from what the petitioner requested. The reasons for these deviations 
are 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

[[Page 45731]]

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 fluoxastrobin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fluoxastrobin 
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.
    In mammals, the liver and kidney were the main target organs. Liver 
effects (cholestasis) were observed in dogs following subchronic and 
chronic oral exposures. Dogs were the more sensitive species, with 
liver effects in dogs occurring at a 35-fold lower dose than elicited 
adverse effects in other species. Kidney effects were observed in rats 
and dogs following subchronic exposures, but not following chronic 
exposures. In rats, effects were also observed in the adrenal glands, 
urinary bladder, and urethra. There were dose-related changes in the 
liver and kidneys of mice, however, the changes were not considered to 
be adverse.
    There was no evidence of increased quantitative or qualitative 
fetal or offspring susceptibility in the developmental toxicity studies 
in rats or rabbits or the two-generation reproduction toxicity study in 
rats. There were no maternal or developmental effects in the rat 
developmental study. In the developmental toxicity study in rabbits, 
maternal effects (cold ears, transient body-weight loss, and decreased 
food consumption) occurred in the absence of fetal toxicity. In the 
two-generation reproduction study in rats, offspring effects (decreased 
body weights, delayed preputial separation, and incomplete 
ossification) occurred at the same dose as parental toxicity (decreased 
premating absolute body weight and body-weight gain).
    Fluoxastrobin has low acute toxicity via the oral, dermal, and 
inhalation routes of exposure. Overall, it is mildly irritating to the 
eyes, but is neither a dermal irritant nor a dermal sensitizer. There 
were no signs of neurotoxicity or immunotoxicity in the database. 
Fluoxastrobin is classified as ``Not Likely to be Carcinogenic to 
Humans'' based on the absence of treatment-related tumors in two 
adequate rodent carcinogenicity studies. There was no concern for 
mutagenicity.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluoxastrobin 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 Human Health Risk Assessment in Support 
of Application to Avocado, Barley, Rapeseed subgroup 20A, and Dried 
Shelled Pea and Bean on pages 14 and 15 in docket ID number EPA-HQ-OPP-
2015-0727.

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 fluoxastrobin used for 
human risk assessment is shown in the Table of this unit.

  Table--Summary of Toxicological Doses and Endpoints for Fluoxastrobin for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (All Populations)..  No appropriate toxicological effect attributable to a single dose was
                                    observed. Therefore, a dose and endpoint were not identified for this risk
                                    assessment.
                                  ------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 1.5 mg/kg/    Chronic RfD = 0.015  Chronic Toxicity Study in Dogs.
                                    day.                  mg/kg/day.          LOAEL = M/F 8.1/7/7 mg/kg/day
                                   UFA = 10x...........  cPAD = 0.015 mg/kg/   based on body weight reductions
                                   UFH = 10x...........   day.                 and hepatocytomegaly and
                                   FQPA SF = 1x........                        cytoplasmic changes associated
                                                                               with increased serum liver
                                                                               alkaline phosphatase indicative
                                                                               of cholestasis.
Incidental oral short-term (1-30   NOAEL = 3.0 mg/kg/    LOC for MOE = <100.  90-Day Toxicity in Dogs.
 days) and Intermediate-term (1-6   day.                                      LOAEL = 24 mg/kg/day based on
 months).                          UFA = 10x...........                        reductions in body-weight gain
                                   UFH = 10x...........                        and food efficiency, liver
                                   FQPA SF = 1x........                        effects (cholestasis), and kidney
                                                                               effects (increased relative
                                                                               weights in females, degeneration
                                                                               of proximal tubular epithelium in
                                                                               males).

[[Page 45732]]

 
Dermal short-term (1-30 days) and  Oral study NOAEL =    Residential LOC for  90-Day Toxicity in Dog.
 intermediate-term (1-6 months).    3.0 mg/kg/day         MOE = <100.         LOAEL = 24 mg/kg/day based on
                                    (dermal absorption   Occupational LOC      reductions in body-weight gain
                                    rate = 2.3%.          for MOE = <100.      and food efficiency, liver
                                   UFA = 10x...........                        effects (cholestasis), and kidney
                                   UFH = 10x...........                        effects (increased relative
                                   FQPA SF = 1x........                        weights in females, degeneration
                                                                               of proximal tubular epithelium in
                                                                               males).
Inhalation short and Intermediate- Oral study NOAEL =    Residential LOC for  90-Day Toxicity in Dogs.
 Term.                              3.0 mg/kg/day         MOE = <100.         LOAEL = 24 mg/kg/day based on
                                    (inhalation          Occupational LOC      reductions in body-weight gain
                                    toxicity is           for MOE = <100.      and food efficiency, liver
                                    considered                                 effects (cholestasis), and kidney
                                    equivalent to oral                         effects (increased relative
                                    toxicity).                                 weights in females, degeneration
                                   UFA = 10x...........                        of proximal tubular epithelium in
                                   UFH = 10x...........                        males).
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: Fluoxastrobin is classified as ``not likely to be
                                    carcinogenic to humans'' based on the absence of treatment-related tumors in
                                    two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
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 fluoxastrobin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fluoxastrobin 
tolerances in 40 CFR 180.609. EPA assessed dietary exposures from 
fluoxastrobin 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 fluoxastrobin; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, Version 3.16, food consumption data 
from the 2003-2008 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 assumed tolerance-
level residues for livestock commodities, average field trial residues 
for some crop commodities, and percent crop treated (PCT) and percent 
crop treated for new use (PCTn) estimates for some commodities. DEEM 
version 7.81 default processing factors were assumed, except for 
tolerances that were established for processed commodities or when 
processing studies showed no concentration.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fluoxastrobin 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. 
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by FFDCA section 408(b)(2)(F), EPA may require registrants to submit 
data on PCT.
    The Agency estimated the PCT for existing uses as follows: corn, 
1.0%; peanuts, 2.5%; peppers, 2.5%; potatoes, 1.0%; soybeans, 1.0%; and 
wheat, 2.5%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), and proprietary market surveys for the chemical/crop 
combination for the most recent 6-7 years. EPA uses an average PCT for 
chronic dietary risk analysis and maximum PCT for acute dietary risk 
analysis. The average PCT figure for each existing use is derived by 
combining available public and private market survey data for that use, 
averaging across all observations, and rounding to the nearest 5%, 
except for those situations in which the average PCT is less than 2.5%. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 6 years of available public and private market 
survey data for the

[[Page 45733]]

existing use and rounded up to the nearest multiple of 5%, except for 
situations in which the maximum PCT is less than 2.5%. In cases where 
the estimated value is less than 2.5% but greater than 1%, the average 
and maximum PCT used are 2.5%. If the estimated value is less than 1%, 
1% is used as the average PCT and 2.5% is used as the maximum PCT.
    The Agency estimated the PCT for new uses as follows: avocado, 12%; 
barley, 16%; canola, 9%; and dry beans/peas, 14%.
    EPA estimates percent crop treated for new uses (PCTn) of 
fluoxastrobin based on the PCT of the dominant pesticide (i.e., the one 
with the greatest PCT) used on that crop over the three most recent 
years of available data. Comparisons are only made among pesticides of 
the same pesticide types (i.e., the dominant fungicide on the crop is 
selected for comparison with a new fungicide). The PCTs included in the 
analysis may be for the same pesticide or for different pesticides 
since the same or different pesticides may dominate for each year. 
Typically, EPA uses USDA/NASS as the source for raw PCT data because it 
is publicly available and does not have to be calculated from available 
data sources. When a specific use site is not surveyed by USDA/NASS, 
EPA uses proprietary market research data or other publicly available 
state data when 80% or more of the crop acreage is grown in that state 
and calculates the PCTn.
    This estimated PCTn, based on the average PCT of the market leader, 
is appropriate for use in the chronic dietary risk assessment. This 
method of estimating a PCT for a new use of a registered pesticide or a 
new pesticide produces a high-end estimate that is unlikely, in most 
cases, to be exceeded during the initial five years of actual use. The 
predominant factors that bear on whether the estimated PCTn could be 
exceeded are (1) the extent of pest pressure on the crops in question; 
(2) the pest spectrum of the new pesticide in comparison with the 
market leaders as well as whether the market leaders are well-
established for this use; and (3) resistance concerns with the market 
leaders. EPA has examined the relevant data and determined that it is 
unlikely that the actual PCT with fluoxastrobin on avocado, barley, 
canola (rapeseed subgroup 20A) and dried shelled pea and bean (crop 
subgroup 6C) will exceed the PCTn within the next five years.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT and PCTn 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. The Agency is reasonably 
certain that the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which fluoxastrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for fluoxastrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fluoxastrobin. 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.
    The estimated drinking water concentrations (EDWCs) in surface 
water resulting from the proposed fluoxastrobin uses were calculated 
using the pesticide water calculator (PWC). Groundwater EDWCs for 
fluoxastrobin were derived for the proposed and existing uses using 
PRZM-Groundwater (PRZM GW). Based on PRZM GW, the EDWCs of 
fluoxastrobin for chronic exposures for non-cancer assessments are 
estimated to be 47.8 ppb for surface water and 182 ppb for ground 
water. The more conservative modeled estimate of drinking water 
concentrations (182 ppb) was directly entered into the dietary exposure 
model to assess the contribution to drinking water and chronic dietary 
risk.
    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).
    Fluoxastrobin is currently registered for the following uses that 
could result in residential exposures: Broadcast control of diseases on 
turf, including lawns and golf courses. EPA assessed residential 
exposure using the following assumptions:
    i. Residential Handler Exposure: All registered fluoxastrobin 
product labels with residential use sites (e.g., turf and ornamentals) 
require that handlers wear specific clothing (e.g., long sleeve shirt/
long pants) and/or use personal-protective equipment (PPE). Therefore, 
the Agency has made the assumption that these products are not intended 
for homeowner use, and has not conducted a quantitative residential 
handler assessment.
    ii. Residential Post-Application Exposure: Adults and children 
performing physical activities on turf and ornamentals during post-
application activities (e.g., high-contact lawn activities, mowing, and 
gardening) may receive dermal exposure to fluoxastrobin residues. Young 
children 1 to <2 years old may also receive incidental oral post-
application exposure to fluoxastrobin from treated turf. Residential 
post-application exposure is expected to be short-term in duration. 
Intermediate-term exposures are not likely because of the intermittent 
nature of exposure to homeowners. Post-application dermal and hand-to-
mouth exposure scenarios were combined for children 1 <2 years old. 
This combination was considered a protective estimate of children's 
exposure. 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 fluoxastrobin to share a common mechanism of 
toxicity with any other substances, and fluoxastrobin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
fluoxastrobin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine

[[Page 45734]]

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 Food Quality 
Protection Act Safety Factor (FQPA 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. As discussed in Unit III.A., 
there is no evidence of quantitative or qualitative fetal or offspring 
susceptibility in the developmental toxicity studies in rats or rabbits 
nor in two-generation reproduction studies in rats.
    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 fluoxastrobin is complete.
    ii. There is no indication that fluoxastrobin is a neurotoxic 
chemical, and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluoxastrobin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the two-generation 
reproduction study.
    iv. There are no residual uncertainties identified in the exposure 
databases. A partially refined chronic aggregate dietary (food and 
drinking water) exposure and risk assessments were conducted. The 
assumptions of the dietary assessment include tolerance-level residues 
for livestock commodities, average field-trial residues for some crop 
commodities, and PCT and PCTn estimates for some commodities. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to fluoxastrobin 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 fluoxastrobin.

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, 
fluoxastrobin 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 
fluoxastrobin from food and water will utilize 31% of the cPAD for the 
general U.S population and 77% 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 fluoxastrobin is not 
expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fluoxastrobin 
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 fluoxastrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 150 for adults 
and 100 for children (1-2 years old). The Agency does not have concern 
if the MOEs are equal to or greater than 100. Furthermore, many 
conservative assumptions were incorporated into the assessment, so the 
actual exposure and risk are likely to be considerably lower than the 
estimates in the Agency assessment.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
fluoxastrobin is not registered for any use patterns that would result 
in intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
fluoxastrobin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, fluoxastrobin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to fluoxastrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass 
spectrometry) is available to enforce the tolerance expression. Method 
No. 00604 is available for plant commodities and Method No. 00691 is 
available for livestock 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: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural

[[Page 45735]]

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 a MRL for fluoxastrobin.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerance levels for the following commodities 
that differ from what the petitioner requested: Avocado from 0.9 ppm to 
1.0 ppm; barley, grain from 0.4 ppm to 0.40 ppm; rapeseed subgroup 20A 
from 0.8 ppm to 0.70 ppm; pea and bean, dried shelled, except soybean, 
subgroup 6C from 0.2 ppm to 0.20 ppm. The tolerances for avocado and 
rapeseed subgroup 20A differ because the Agency used different inputs 
for determining those tolerance levels. Although the petitioner and the 
Agency both used the Organization for Economic Co-operation and 
Development (OECD) calculation procedures to obtain tolerance levels, 
the Agency determined that some of the trials were not independent. In 
addition, if a higher residue value was observed at a preharvest 
interval (PHI) longer than the minimum labeled PHI, then the Agency 
used the highest value.
    The Agency added a significant figure to the tolerances for barley, 
grain and pea and bean, dried shelled, except soybean to conform to 
current Agency policy on significant figures. In addition, the Agency 
has modified the commodity definition for dried shelled pea and bean 
(crop subgroup 6C) to pea and bean, dried shelled, except soybean, 
subgroup 6C in order for consistency with the Agency's food and feed 
commodity vocabulary.

V. Conclusion

    Therefore, tolerances are established for residues of 
fluoxastrobin, and its Z-isomer in or on avocado at 1.0 ppm; barley, 
grain at 0.40 ppm; barley, hay at 15 ppm; barley, straw at 15 ppm; 
rapeseed subgroup 20A at 0.70 ppm; and pea and bean, dried shelled, 
except soybean, subgroup 6C at 0.20 ppm.

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 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 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: August 31, 2017.
Michael Goodis,
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.  180.609, add alphabetically ``avocado'', ``barley, grain''; 
``barley, hay''; ``barley, straw''; ``pea and bean, dried shelled, 
except soybean, subgroup 6C''; and ``rapeseed, subgroup 20A'' to the 
table in paragraph (a)(1) to read as follows:


Sec.  180.609   Fluoxastrobin; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Avocado.....................................................         1.0
Barley, grain...............................................        0.40
Barley, hay.................................................          15
Barley, straw...............................................          15
 
                                * * * * *
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.20
 
                                * * * * *
Rapeseed, subgroup 20A......................................        0.70
 
                                * * * * *
------------------------------------------------------------------------


[[Page 45736]]

* * * * *
[FR Doc. 2017-21113 Filed 9-29-17; 8:45 am]
 BILLING CODE 6560-50-P
45730 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations

ENVIRONMENTAL PROTECTION determine whether this document delivery of boxed information, please
AGENCY applies to them. Potentially affected follow the instructions at http://
entities may include: www.epa.gov/dockets/contacts.html.
40 CFR Part 180 • Crop production (NAICS code 111). Additional instructions on commenting
• Animal production (NAICS code or visiting the docket, along with more
[EPA–HQ–OPP–2015–0727; FRL–9966–09]
112). information about dockets generally, is
Fluoxastrobin; Pesticide Tolerances • Food manufacturing (NAICS code available at http://www.epa.gov/
311). dockets.
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
Agency (EPA). code 32532). II. Summary of Petitioned-For
ACTION: Final rule. Tolerance
B. How can I get electronic access to
In the Federal Register of March 16,
SUMMARY: This regulation establishes other related information? 2016 (81 FR 14030) (FRL–9942–86),
tolerances for residues of fluoxastrobin You may access a frequently updated EPA issued a document pursuant to
in or on multiple commodities which electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
are identified and discussed later in this regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
document. Arysta LifeScience North the Government Printing Office’s e-CFR pesticide petition (PP 5F8406) by Arysta
America, LLC requested these tolerances site at http://www.ecfr.gov/cgi-bin/text- LifeScience North America, LLC, 15401
under the Federal Food, Drug, and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Weston Parkway, Suite 150, Cary, North
Cosmetic Act (FFDCA). 40tab_02.tpl. Carolina, 27513. The petition requested
DATES: This regulation is effective that 40 CFR 180.609 be amended by
October 2, 2017. Objections and C. How can I file an objection or hearing
establishing tolerances for residues of
requests for hearings must be received request?
the fungicide fluoxastrobin, (1E)-[2-[[6-
on or before December 1, 2017, and Under FFDCA section 408(g), 21 (2-chlorophenoxy)-5-fluoro-4-
must be filed in accordance with the U.S.C. 346a, any person may file an pyrimydinyl]oxy]phenyl] (5,6-dihydro-
instructions provided in 40 CFR part objection to any aspect of this regulation l,4,2-dioxazin-3-yl)methanone O-
178 (see also Unit I.C. of the and may also request a hearing on those methyloxime, and its Z isomer, (1Z)-[2-
SUPPLEMENTARY INFORMATION). objections. You must file your objection [[6-(2chlorophenoxy)-5-fluoro-4-
ADDRESSES: The docket for this action, or request a hearing on this regulation pyrimydinyl]oxy]phenyl] (5,6-dihydro-
identified by docket identification (ID) in accordance with the instructions l,4,2-dioxazin-3-yl)methanone O-
number EPA–HQ–OPP–2015–0727, is provided in 40 CFR part 178. To ensure methyloxime, in or on avocado at 0.9
available at http://www.regulations.gov proper receipt by EPA, you must parts per million (ppm); barley, grain at
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– 0.4 ppm; barley, hay at 15 ppm; barley,
Regulatory Public Docket (OPP Docket) OPP–2015–0727 in the subject line on straw at 15 ppm; rapeseed subgroup
in the Environmental Protection Agency the first page of your submission. All 20A at 0.8 ppm; and dried shelled pea
Docket Center (EPA/DC), West William objections and requests for a hearing and bean (except soybean) subgroup 6C
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be at 0.2 ppm. No comments were
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or submitted on this notice of filing. Based
20460–0001. The Public Reading Room before December 1, 2017. Addresses for on data submitted with the petition, the
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections tolerances established by the Agency in
Monday through Friday, excluding legal and hearing requests are provided in 40 this action differ slightly from what the
holidays. The telephone number for the CFR 178.25(b). petitioner requested. The reasons for
Public Reading Room is (202) 566–1744, In addition to filing an objection or these deviations are discussed in Unit
and the telephone number for the OPP hearing request with the Hearing Clerk IV.C.
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
III. Aggregate Risk Assessment and
the visitor instructions and additional submit a copy of the filing (excluding
Determination of Safety
information about the docket available any Confidential Business Information
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(i) of FFDCA
Information not marked confidential allows EPA to establish a tolerance (the
FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be legal limit for a pesticide chemical
Michael Goodis, Registration Division residue in or on a food) only if EPA
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your determines that the tolerance is ‘‘safe.’’
Environmental Protection Agency, 1200 Section 408(b)(2)(A)(ii) of FFDCA
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
by docket ID number EPA–HQ–OPP– defines ‘‘safe’’ to mean that ‘‘there is a
DC 20460–0001; main telephone reasonable certainty that no harm will
number: (703) 305–7090; email address: 2015–0727, by one of the following
methods: result from aggregate exposure to the
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// pesticide chemical residue, including
SUPPLEMENTARY INFORMATION: all anticipated dietary exposures and all
www.regulations.gov. Follow the online
I. General Information instructions for submitting comments. other exposures for which there is
Do not submit electronically any reliable information.’’ This includes
A. Does this action apply to me? information you consider to be CBI or exposure through drinking water and in
You may be potentially affected by other information whose disclosure is residential settings, but does not include
jstallworth on DSKBBY8HB2PROD with RULES

this action if you are an agricultural restricted by statute. occupational exposure. Section
producer, food manufacturer, or • Mail: OPP Docket, Environmental 408(b)(2)(C) of FFDCA requires EPA to
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ give special consideration to exposure
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. of infants and children to the pesticide
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. chemical residue in establishing a
not intended to be exhaustive, but rather • Hand Delivery: To make special tolerance and to ‘‘ensure that there is a
provides a guide to help readers arrangements for hand delivery or reasonable certainty that no harm will

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45734 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations

which chemicals have a common and surface water modeling used to equal to or greater than 100.
mechanism of toxicity and to evaluate assess exposure to fluoxastrobin in Furthermore, many conservative
the cumulative effects of such drinking water. EPA used similarly assumptions were incorporated into the
chemicals, see EPA’s Web site at http:// conservative assumptions to assess post- assessment, so the actual exposure and
www2.epa.gov/pesticide-science-and- application exposure of children as well risk are likely to be considerably lower
assessing-pesticide-risks/cumulative- as incidental oral exposure of toddlers. than the estimates in the Agency
assessment-risk-pesticides. These assessments will not assessment.
underestimate the exposure and risks 4. Intermediate-term risk.
D. Safety Factor for Infants and
posed by fluoxastrobin. Intermediate-term aggregate exposure
Children
E. Aggregate Risks and Determination of takes into account intermediate-term
1. In general. Section 408(b)(2)(C) of residential exposure plus chronic
FFDCA provides that EPA shall apply Safety
exposure to food and water (considered
an additional tenfold (10X) margin of EPA determines whether acute and to be a background exposure level). An
safety for infants and children in the chronic dietary pesticide exposures are intermediate-term adverse effect was
case of threshold effects to account for safe by comparing aggregate exposure identified; however, fluoxastrobin is not
prenatal and postnatal toxicity and the estimates to the acute PAD (aPAD) and registered for any use patterns that
completeness of the database on toxicity chronic PAD (cPAD). For linear cancer would result in intermediate-term
and exposure unless EPA determines risks, EPA calculates the lifetime residential exposure. Intermediate-term
based on reliable data that a different probability of acquiring cancer given the risk is assessed based on intermediate-
margin of safety will be safe for infants estimated aggregate exposure. Short-, term residential exposure plus chronic
and children. This additional margin of intermediate-, and chronic-term risks dietary exposure. Because there is no
safety is commonly referred to as the are evaluated by comparing the intermediate-term residential exposure
Food Quality Protection Act Safety estimated aggregate food, water, and and chronic dietary exposure has
Factor (FQPA SF). In applying this residential exposure to the appropriate already been assessed under the
provision, EPA either retains the default PODs to ensure that an adequate MOE appropriately protective cPAD (which is
value of 10X, or uses a different exists. at least as protective as the POD used to
additional safety factor when reliable 1. Acute risk. An acute aggregate risk
assess intermediate-term risk), no
data available to EPA support the choice assessment takes into account acute
further assessment of intermediate-term
of a different factor. exposure estimates from dietary
risk is necessary, and EPA relies on the
2. Prenatal and postnatal sensitivity. consumption of food and drinking
chronic dietary risk assessment for
As discussed in Unit III.A., there is no water. No adverse effect resulting from
evaluating intermediate-term risk for
evidence of quantitative or qualitative a single oral exposure was identified
fluoxastrobin.
fetal or offspring susceptibility in the and no acute dietary endpoint was
5. Aggregate cancer risk for U.S.
developmental toxicity studies in rats or selected. Therefore, fluoxastrobin is not
population. Based on the lack of
rabbits nor in two-generation expected to pose an acute risk.
2. Chronic risk. Using the exposure evidence of carcinogenicity in two
reproduction studies in rats. adequate rodent carcinogenicity studies,
3. Conclusion. EPA has determined assumptions described in this unit for
chronic exposure, EPA has concluded fluoxastrobin is not expected to pose a
that reliable data show the safety of cancer risk to humans.
infants and children would be that chronic exposure to fluoxastrobin
from food and water will utilize 31% of 6. Determination of safety. Based on
adequately protected if the FQPA SF these risk assessments, EPA concludes
were reduced to 1X. That decision is the cPAD for the general U.S population
and 77% of the cPAD for all infants <1- that there is a reasonable certainty that
based on the following findings: no harm will result to the general
i. The toxicity database for year-old, the population group receiving
the greatest exposure. Based on the population, or to infants and children
fluoxastrobin is complete.
ii. There is no indication that explanation in Unit III.C.3., regarding from aggregate exposure to fluoxastrobin
fluoxastrobin is a neurotoxic chemical, residential use patterns, chronic residues.
and there is no need for a residential exposure to residues of IV. Other Considerations
developmental neurotoxicity study or fluoxastrobin is not expected.
additional UFs to account for 3. Short-term risk. Short-term A. Analytical Enforcement Methodology
neurotoxicity. aggregate exposure takes into account Adequate enforcement methodology
iii. There is no evidence that short-term residential exposure plus (liquid chromatography/mass
fluoxastrobin results in increased chronic exposure to food and water spectrometry) is available to enforce the
susceptibility in in utero rats or rabbits (considered to be a background tolerance expression. Method No. 00604
in the prenatal developmental studies or exposure level). Fluoxastrobin is is available for plant commodities and
in young rats in the two-generation currently registered for uses that could Method No. 00691 is available for
reproduction study. result in short-term residential livestock commodities. The method may
iv. There are no residual uncertainties exposure, and the Agency has be requested from: Chief, Analytical
identified in the exposure databases. A determined that it is appropriate to Chemistry Branch, Environmental
partially refined chronic aggregate aggregate chronic exposure through food Science Center, 701 Mapes Rd., Ft.
dietary (food and drinking water) and water with short-term residential Meade, MD 20755–5350; telephone
exposure and risk assessments were exposures to fluoxastrobin. number: (410) 305–2905; email address:
conducted. The assumptions of the Using the exposure assumptions residuemethods@epa.gov.
jstallworth on DSKBBY8HB2PROD with RULES

dietary assessment include tolerance- described in this unit for short-term
level residues for livestock exposures, EPA has concluded the B. International Residue Limits
commodities, average field-trial residues combined short-term food, water, and In making its tolerance decisions, EPA
for some crop commodities, and PCT residential exposures result in aggregate seeks to harmonize U.S. tolerances with
and PCTn estimates for some MOEs of 150 for adults and 100 for international standards whenever
commodities. EPA made conservative children (1–2 years old). The Agency possible, consistent with U.S. food
(protective) assumptions in the ground does not have concern if the MOEs are safety standards and agricultural

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45736 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations

* * * * * available electronically through http:// pursuant to 40 CFR 260.20 and 260.22.
[FR Doc. 2017–21113 Filed 9–29–17; 8:45 am] www.regulations.gov. Samsung does not believe that the
BILLING CODE 6560–50–P
FOR FURTHER INFORMATION CONTACT: For petitioned waste meets the criteria for
technical information regarding the which EPA listed it. Samsung also
Samsung Austin Semiconductor believes no additional constituents or
ENVIRONMENTAL PROTECTION factors could cause the waste to be
AGENCY petition, contact Michelle Peace at 214–
665–7430 or by email at hazardous. EPA’s review of this petition
peace.michelle@epa.gov. included consideration of the original
40 CFR Part 261 listing criteria and the additional factors
SUPPLEMENTARY INFORMATION: The
[EPA–R06–RCRA–2017–0254; FRL–9968– required by the Hazardous and Solid
61–Region 6] information in this section is organized Waste Amendments of 1984 (HSWA).
as follows: See section 3001(f) of RCRA, 42 U.S.C.
Hazardous Waste Management I. Overview Information 6921(f), and 40 CFR 260.22 (d)(1)–(4)
System; Identification and Listing of A. What action is EPA finalizing? (hereinafter all sectional references are
Hazardous Waste B. Why is EPA approving this delisting? to 40 CFR unless otherwise indicated).
C. What are the limits of this exclusion? In making the initial delisting
AGENCY: Environmental Protection D. How will Samsung Austin
Agency (EPA). determination, EPA evaluated the
Semiconductor manage the waste if it is
delisted? petitioned waste against the listing
ACTION: Final rule.
E. When is the final delisting exclusion criteria and factors cited in
SUMMARY: The Environmental Protection effective? § 261.11(a)(2) and (3). Based on this
Agency (EPA) is granting a petition F. How does this final rule affect states? review, EPA agrees with the petitioner
submitted by Samsung Austin II. Background that the waste is non-hazardous, with
Semiconductor (Samsung) to exclude A. What is a ‘‘delisting’’? respect to the original listing criteria. If
from hazardous waste control (or delist) B. What regulations allow facilities to EPA had found, based on this review,
delist a waste? that the waste remained hazardous
a certain solid waste. This final rule C. What information must the generator
responds to the petition submitted by based on the factors for which the waste
supply?
Samsung to have the copper filter cake was originally listed, EPA would have
III. EPA’s Evaluation of the Waste Data
from the electroplating process A. What waste and how much did proposed to deny the petition. EPA
excluded, or delisted from the definition Samsung Austin Semiconductor petition evaluated the waste with respect to
of a hazardous waste. The Copper filter EPA to delist? other factors or criteria to assess
cake is listed as F006, wastewater B. How did Samsung Austin whether there is a reasonable basis to
treatment sludges from electroplating Semiconductor sample and analyze the believe that such additional factors
operations. The basis of the listing is waste data in this petition? could cause the waste to be hazardous.
IV. Public Comments Received on the EPA considered whether the waste is
cadmium, hexavalent chromium, nickel, Proposed Exclusion
and cyanide (complexed). After careful acutely toxic, the concentration of the
Who submitted comments on the proposed constituents in the waste, their tendency
analysis and evaluation of comments rule?
submitted by the public, the EPA has to migrate and to bioaccumulate, their
V. Statutory and Executive Order Reviews
concluded that the petitioned wastes are persistence in the environment once
not hazardous waste when disposed of I. Overview Information released from the waste, plausible and
in Subtitle D landfills. This exclusion specific types of management of the
A. What action is EPA finalizing?
applies to the copper filter cake petitioned waste, the quantities of waste
The EPA is finalizing: generated, and waste variability. EPA
generated at Samsung Austin
(1) The decision to grant Samsung believes that the petitioned waste does
Semiconductor’s Austin, Texas facility.
Austin Semiconductor’s petition to have not meet the listing criteria and thus
Accordingly, this final rule excludes the
its copper filter cake excluded, or should not be a listed waste. EPA’s
petitioned waste from the requirements
delisted, from the definition of a proposed decision to delist waste from
of hazardous waste regulations under
hazardous waste, subject to certain Samsung is based on the information
the Resource Conservation and
continued verification and monitoring submitted in support of this rule,
Recovery Act (RCRA) when disposed of
conditions; and including descriptions of the wastes and
in Subtitle D landfills, but imposes (2) To use the Delisting Risk
testing conditions to ensure that the analytical data from the Austin, Texas
Assessment Software v.3.0.35 to facility.
future-generated wastes remain evaluate the potential impact of the
qualified for delisting. petitioned waste on human health and C. What are the limits of this exclusion?
DATES: This final rule is effective on the environment. The Agency used this This exclusion applies to the waste
October 2, 2017. model to predict the concentration of described in the petition only if the
ADDRESSES: The EPA has established a hazardous constituents released from requirements described in Table 1 of
docket for this action under Docket ID the petitioned waste, once it is part 261, appendix IX and the
No. EPA–R06–RCRA–2017–0254. All disposed. conditions contained herein are
documents in the docket are listed on After evaluating the petition, EPA satisfied. The conditional exclusion
the http://www.regulations.gov Web proposed a rule, on July 14, 2017, to applies to 750 cubic yards of copper
site. Although listed in the index, some exclude the Samsung Austin filter cake sludge generated annually
information is not publicly available, Semiconductor copper filter cake waste from the Samsung Austin
jstallworth on DSKBBY8HB2PROD with RULES

e.g., CBI or other information whose from the lists of hazardous wastes under Semiconductor facility in Austin, TX.
disclosure is restricted by statute. §§ 261.31 and 261.32. There were no
Certain other material, such as D. How will Samsung Austin
comments received on this rulemaking.
copyrighted material, is not placed on Semiconductor manage the waste if it is
the Internet and will be publicly B. Why is EPA approving this delisting? delisted?
available only in hard copy form. Samsung’s petition requests an Storage containers of the copper filter
Publicly available docket materials are exclusion from the F006 waste listing cake will be transported to an

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Document Created: 2017-09-30 04:40:47
Document Modified: 2017-09-30 04:40:47
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective October 2, 2017. Objections and requests for hearings must be received on or before December 1, 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).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		82 FR 45730
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements