[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Rules and Regulations]
[Pages 50284-50288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21746]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0333; FRL-9984-01]


Flumioxazin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances with regional 
registrations for residues of flumioxazin in or on Grass, forage and 
Grass, hay. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective October 5, 2018. Objections and 
requests for hearings must be received on or before December 4, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0333, 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 L. 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-2017-0333 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 4, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0333, 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,

[[Page 50285]]

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 October 23, 2017 (82 FR 49020) (FRL-
9967-37), 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 
7E8565) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.568(c) be amended by establishing tolerances 
with regional registrations for residues of the herbicide flumioxazin, 
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-
4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)-dione, including its 
metabolites and degradates, determined by measuring only flumioxazin, 
in or on Grass, forage at 0.4 parts per million (ppm) and Grass, hay 
0.05 ppm. That document referenced a summary of the petition prepared 
by Valent, U.S.A. Corporation, the registrant, which is available in 
the docket, http://www.regulations.gov. This petition request is 
associated with an application to allow use of flumioxazin on grass in 
the States of Washington, Idaho, and Oregon. Although comments were 
submitted to the docket, none were relevant to the safety of the 
tolerances being established in this action.
    Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is 
issuing a tolerance that varies from what the petitioner sought. The 
reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for flumioxazin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with flumioxazin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Toxicity associated with flumioxazin includes anemia and effects on 
the cardiovascular system and liver. Specifically, alterations in 
hemoglobin parameters were observed in rats, as well as increased renal 
toxicity in male rats, and increased absolute and relative liver 
weights and increased alkaline phosphate values were seen in dogs.
    No evidence of neurotoxicity was seen in male or female rats in the 
acute or subchronic neurotoxicity studies. The oral and dermal 
developmental rat studies showed evidence of increased quantitative 
susceptibility of fetuses, as cardiovascular anomalies (ventral septal 
defects) were found. These developmental effects in the offspring were 
more severe and seen at doses lower than those that caused parental and 
systemic toxicity. The regulatory endpoints for flumioxazin are 
protective of this increased susceptibility, however, so there is low 
concern and no residual uncertainties for these effects.
    Flumioxazin was negative for mutagenicity in most of the available 
studies, however, there were aberrations in a chromosomal aberration 
assay. The lack of carcinogenicity in mice and rats permits flumioxazin 
to be classified as ``not likely to be carcinogenic to humans.''
    Specific information on the studies received and the nature of the 
adverse effects caused by flumioxazin as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document titled, ``SUBJECT: Flumioxazin. Human 
Health Risk Assessment for the Proposed New Uses on Grass (Seed Crop)'' 
at page 24 in docket ID number EPA-HQ-OPP-2017-0333.

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-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
    A summary of the toxicological endpoints for flumioxazin used for 
human risk assessment is discussed in Unit III. B of the final rule 
published in the Federal Register of September 21, 2012 (77 FR 58493) 
(FRL-9358-3). One additional endpoint has since been identified, i.e., 
the selection of an adult oral endpoint for assessing the aggregate 
risks from short-term and intermediate-term oral exposure: An oral 
NOAEL of 3 mg/kg/day based on cardiovascular effects in fetuses seen at 
the LOAEL of 10 mg/kg/day in the rat developmental study was used, 
along with a 10X interspecies uncertainty factor, a 10X intraspecies 
uncertainty factor, and a 1X FQPA safety factor. Long-term exposures 
(greater than 6 months) are not expected based on the existing 
flumioxazin use pattern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary

[[Page 50286]]

exposure to flumioxazin, EPA considered exposure under the petitioned-
for tolerances as well as all existing flumioxazin tolerances in 40 CFR 
180.568. EPA assessed dietary exposures from flumioxazin in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for flumioxazin for females 13-49. In 
estimating acute dietary exposure, EPA used food consumption 
information from the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This 
software uses 2003-2008 food consumption data from the United States 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA; 2003-2008). 
As to residue levels in food, EPA assumed tolerance-level residues, 
100% crop treated (PCT) for all commodities and DEEM-FCID version 3.16.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID Version 3.16 software which 
incorporates 2003-2008 food consumption data from USDA's NHANES/WWEIA. 
As to residue levels in food, EPA incorporated tolerance-level residues 
and/or 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that flumioxazin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for flumioxazin. Tolerance-level residues and/or 100 
PCT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for flumioxazin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of flumioxazin. The estimated drinking water 
concentrations (EDWCs) are based on hydrolysis and the residues of 
concern for flumioxazin and its major degradates (482-HA, and APF), 
expressed as flumioxazin equivalents. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the First Index Reservoir Screening Tool (FIRST) model, 
the EDWCs in surface water for acute exposures are 400 parts per 
billion (ppb) for flumioxazin and for chronic exposures are estimated 
to be 9.4 ppb, 21.6 ppb, and 110.1 ppb for flumioxazin, 482-HA and APF 
degradates, respectively, for a total concentration of 141 ppb. Based 
on the Screening Concentration in Ground Water (SCI-GROW) model, for 
both acute and chronic (non-cancer) exposures, the EDWCs of 482-HA and 
APF are estimated to be 45.27 ppb and 2.66 ppb, respectively, for 
ground water. EDWCs of flumioxazin are estimated to be negligible in 
ground water for chronic exposures. Estimates of drinking water 
concentrations were directly entered into the dietary exposure model as 
follows. The peak day zero of 400 ppb for flumioxazin (degradates 482-
HA and APF were not detected) was used to assess the contribution to 
drinking water for the acute dietary risk assessment, and the day 30 
total of 141 ppb for flumioxazin, 482-HA and APF degradates was used to 
assess the contribution to drinking water for the chronic dietary risk 
assessment.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Flumioxazin is currently registered for the following uses that 
could result in residential exposures: Turf grass, residential lawns, 
ornamentals, and aquatic weeds. EPA assessed residential exposure under 
the assumption that homeowner handlers wear shorts, short-sleeved 
shirts, socks, and shoes, and that they complete all tasks associated 
with the use of a pesticide product including mixing/loading, if 
needed, as well as the application. Residential handler exposure 
scenarios for both dermal and inhalation are considered to be short-
term only, due to the infrequent use patterns associated with homeowner 
products.
    EPA uses the term ``post-application'' to describe exposure to 
individuals that occur as a result of being in an environment that has 
been previously treated with a pesticide. Flumioxazin can be used in 
many areas that can be frequented by the general population including 
residential areas, lakes, and ponds. As a result, individuals can be 
exposed by entering these areas if they have been previously treated. 
Therefore, short-term and intermediate-term dermal and oral post-
application exposures and risks were assessed for adults and children. 
In addition, oral post-application exposures and risks were assessed 
specifically for children to be protective of possible hand-to-mouth, 
object-to-mouth, and soil ingestion activities that may occur on 
treated turf areas. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found flumioxazin to share a common mechanism of 
toxicity with any other substances, and flumioxazin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
flumioxazin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable

[[Page 50287]]

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased quantitative susceptibility of fetuses in the oral and dermal 
developmental rat studies, where cardiovascular abnormalities occurred 
in the absence of maternal toxicity. The rat reproduction study also 
showed evidence of qualitative and quantitative post-natal 
susceptibility since reproductive effects in offspring were more severe 
and were seen at lower doses than those that caused parental/systemic 
toxicity. Even with this observed increased susceptibility, the Agency 
has concluded there is a low concern and no residual uncertainties for 
pre- and/or postnatal toxicity because the developmental toxicity 
NOAELs/LOAELs are well-characterized after oral and dermal exposure, 
and the offspring toxicity NOAEL and LOAEL are well characterized in 
the reproduction study. Furthermore, the doses and endpoints have been 
selected from the developmental and reproductive toxicity studies for 
risk assessment of the relevant exposed populations (e.g., pregnant 
females and children), with the exception of the chronic dietary 
endpoint, for which a chronic study was selected. Therefore, regulatory 
endpoints for flumioxazin are protective of the increased 
susceptibility and there are no residual concerns for these effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for oral and dermal exposures, but retained 
the 10X FQPA database uncertainty factor (UF) for inhalation exposure 
and risk assessment due to the lack of an inhalation study. That 
decision is based on the following findings:
    i. The toxicity database for flumioxazin is incomplete but 
sufficient for assessing the toxicity and characterizing the hazard of 
flumioxazin due to the absence of an acceptable inhalation study. 
Therefore, the Agency is retaining the 10X FQPA safety factor for 
assessing inhalation risk.
    ii. There is no indication that flumioxazin is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is evidence that flumioxazin may result in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The Agency concluded that while there is an increased 
susceptibility, there is a low concern and no residual uncertainties 
for pre-and/or postnatal toxicity because the developmental toxicity 
NOAELs/LOAELs are well characterized after oral and dermal exposure; 
the offspring toxicity NOAEL and LOAEL are well characterized in the 
reproduction study; and the doses and endpoints have been selected from 
the developmental and reproductive toxicity studies for the relevant 
populations, except for the chronic dietary endpoint, for which a 
chronic study was chosen. Therefore, the regulatory endpoints for 
flumioxazin are protective of the increased susceptibility seen in the 
developmental and reproduction studies, and there are no residual 
concerns for these effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments were 
performed based on tolerance-level residues, default processing 
factors, and assuming 100 PCT. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to flumioxazin in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
flumioxazin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to flumioxazin will occupy 76% of the aPAD for females 13-49 years old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
flumioxazin from food and water will utilize 44% of the cPAD for all 
infants <1 year old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
flumioxazin is not expected.
    3. Short-term and intermediate-term risks. Short-term and 
intermediate-term aggregate exposure takes into account short-term and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Flumioxazin 
is currently registered for uses that could result in short-term and 
intermediate residential exposures, and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term and intermediate-term residential exposures to 
flumioxazin. Since the Agency has determined that the short-term and 
intermediate-term points of departure are the same, the aggregate risks 
are the same for both short-term and intermediate-term exposures.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term and 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 110 for adult females 13-49 years and MOE of 200 for 
children less than 2 years. Because EPA's level of concern for 
flumioxazin is a MOE of 100 or below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, flumioxazin is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to flumioxazin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/nitrogen-
phosphorus detection (GC/NPD) method, Valent Method RM30-A-1), is 
available to enforce the tolerance expression. The reported method 
limits of quantitation and detection (LOQ and LOD) for flumioxazin in/
on plant commodities are 0.02 and 0.01 ppm, respectively.
    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;

[[Page 50288]]

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 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 flumioxazin in/on grass, 
therefore there are no international harmonization issues.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance for Grass, forage at 0.40 ppm, 
rather than 0.4 ppm, to be consistent with its practice to provide 
greater precision about the levels of residues that are permitted by a 
tolerance. This is intended to avoid the situation where residues may 
be higher than the tolerance level, but as a result of rounding would 
be considered non-violative. For example, Grass, forage tolerance 
proposed at 0.4 ppm was established at 0.40 ppm, to avoid an observed 
hypothetical tolerance at 0.44 ppm being rounded to 0.4 ppm.

V. Conclusion

    Therefore, tolerances with regional registrations are established 
for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-
propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-
1,3(2H)-dione, including its metabolites and degradates determined by 
measuring only flumioxazin, in or on raw agricultural commodities, in 
or on Grass, forage at 0.40 ppm and Grass, hay at 0.05 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); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not 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: September 21, 2018.
Michael L. 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.  180.568, add alphabetically the commodities ``Grass, 
forage'' and ``Grass, hay'' to the table in paragraph (c) to read as 
follows:


Sec.  180.568  Flumioxazin; tolerances for residues.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
Grass, forage...............................................        0.40
Grass, hay..................................................        0.05
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-21746 Filed 10-4-18; 8:45 am]
BILLING CODE 6560-50-P


