[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Rules and Regulations]
[Pages 38138-38143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16322]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0140; FRL-9996-79]


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 cotton, undelinted seed and cotton, gin 
byproducts. Bayer CropScience requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 6, 2019. Objections and 
requests for hearings must be received on or before October 7, 2019 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-2018-0140, 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-2018-0140 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 
October 7, 2019. 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-2018-0140, 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 June 14, 2018 (83 FR 27744) (FRL-9978-
29), 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 
7F8649) by Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, 
Research Triangle Park, NC 27709. 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-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on cotton, undelinted seed and cotton, gin 
byproducts at 0.01 parts per million (ppm). There were no comments 
received in response to the notice of filing.

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

[[Page 38139]]

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 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 study 
in the rats or rabbits and two-generation reproduction toxicity study 
in rats. In the two-generation reproduction study in rats, the only 
effects observed were in both the offspring and the parental animals at 
the same dose. No developmental effects were observed in the rat and 
rabbit developmental studies.
    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. 
Fluoxastrobin has been classified by the Cancer Assessment Review 
Committee (CARC) 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 the NOAEL and the LOAEL are identified. 
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 Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Fluoxastrobin 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)..  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/day  Chronic RfD = 0.015  Chronic Toxicity Study in Dogs.
                                   UFA = 10X...........   mg/kg/day           LOAEL = M/F 8.1/7/7 mg/kg/day
                                   UFH = 10X...........  cPAD = 0.015 mg/kg/   based on body weight reductions
                                   FQPA SF = 1X........   day.                 and hepatocytomegaly and
                                                                               cytoplasmic changes associated
                                                                               with increased serum liver
                                                                               alkaline phosphatase indicative
                                                                               of cholestasis.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1-30   NOAEL= 3.0 mg/kg/day  LOC for MOE = <100.  90-Day Toxicity in Dogs.
 days) and Intermediate-term (1-6  UFA = 10X...........                       LOAEL = 24 mg/kg/day based on
 months).                          UFH = 10X...........                        reductions in body-weight gain
                                   FQPA SF = 1X........                        and food efficiency, liver
                                                                               effects (cholestasis), and kidney
                                                                               effects (increased relative
                                                                               weights in females, degeneration
                                                                               of proximal tubular epithelium in
                                                                               males).
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1-30 days) and  Oral study NOAEL =    Residential LOC for  90 Day Toxicity in Dogs.
 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).

[[Page 38140]]

 
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.
----------------------------------------------------------------------------------------------------------------
Note: 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 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, 1.0%; peppers, 1.0%; 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), proprietary market surveys, and California Department of 
Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the 
chemical/crop combination for the most recent 10 years. EPA uses an 
average PCT for chronic dietary risk analysis and a maximum PCT for 
acute dietary risk analysis. The average PCT figures for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding up 
to the nearest 5%, except for those situations in which the average PCT 
is less than 1% or less than 2.5%. In those cases, the Agency would use 
less than 1% or less than 2.5% as the average PCT value, respectively. 
The maximum PCT figure is the highest observed maximum value reported 
within the most recent 10 years of available public and private market 
survey data for the existing use and rounded up to the nearest multiple 
of 5%, except where the maximum PCT is less than 2.5%, in which case, 
the Agency uses less than 2.5% as the maximum PCT.
    The Agency estimated the PCT for new uses as follows: Avocado, 12%; 
barley, 16%; canola, 9%; and dry beans/peas, 15%. EPA estimates PCTn of 
fluoxastrobin based on the PCT of the dominant pesticide (i.e., the one 
with the greatest PCT) used on that crop over

[[Page 38141]]

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 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 53.1 parts per billion 
(ppb) for surface water and 163 ppb for ground water. The more 
conservative modeled estimate of drinking water concentrations (163 
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: Turf and ornamentals. 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 to <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 https://www.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 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

[[Page 38142]]

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 uncertainty factors (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 2-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 this dietary assessment include tolerance-level residues 
for livestock and some crop commodities, average field-trial residues 
for some crop commodities, and PCT plus 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 
postapplication 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 28% of the cPAD for the 
general U.S. population and 71% 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 160 for adults 
and 100 for children (1-2 years old). Because EPA's level of concern 
for fluoxastrobin is an MOE below 100, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). 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 methods with 
tandem mass-spectroscopy detection (LC/MS/MS) is available to enforce 
the tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fluoxastrobin in/on cotton.

V. Conclusion

    Therefore, tolerances are established for residues of 
fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on cotton, undelinted seed and cotton, gin 
byproducts at 0.01 ppm.

[[Page 38143]]

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), nor is it considered a 
regulatory action under 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 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: July 23, 2019.
Donna 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.  180.609(a)(1), amend the table by adding alphabetically the 
commodities ``Cotton, gin byproducts'' and ``Cotton, undelinted seed'' 
to read as follows:


Sec.  180.609  Fluoxastrobin; tolerances for residues.

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

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cotton, gin byproducts......................................        0.01
Cotton, undelinted seed.....................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-16322 Filed 8-5-19; 8:45 am]
 BILLING CODE 6560-50-P


