Document ID: EPA-HQ-OPP-2019-0135-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Ethalfluralin
Posted Date: 2020-07-28T04:00Z

[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Pages 45336-45341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16266]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0135; FRL-10008-20]

Ethalfluralin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation decreases the tolerance for residues of 
ethalfluralin in or on potato. Gowan Company requested this tolerance 
modification under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 28, 2020. Objections and 
requests for hearings must be received on or before September 28, 2020, 
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-2019-0135, 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: 
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 
Publishing 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-2019-0135 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 
September 28, 2020. 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-2019-0135, 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.

[[Page 45337]]

     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/where-send-comments-epa-dockets.
    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 May 9, 2019 (84 FR 20320) (FRL-9992-36), 
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 8F8721) 
by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition requested 
that the tolerance in 40 CFR 180.416 for residues of the herbicide 
ethalfluralin in or on potato be reduced from 0.05 parts per million 
(ppm) to 0.01 ppm. That document referenced a summary of the petition 
prepared by Gowan Company, the registrant, which is available in the 
docket, http://www.regulations.gov. No relevant comments were received 
on 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 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 ethalfluralin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with ethalfluralin 
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.
    Ethalfluralin has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure. It is moderately irritating to the eye 
and produces moderate to severe skin irritation. It is a dermal 
sensitizer.
    The hazard database for ethalfluralin indicates that the liver is 
the primary target organ in rats and mice, with hematological effects 
also observed in rats and dogs. No systemic toxicity up to the limit 
dose was seen in the 21-day dermal toxicity study in rabbits. There 
were no signs of immunotoxicity or neurotoxicity in the database.
    No reproductive or developmental effects were observed in rats, and 
although there were developmental effects (sternal variations, 
incomplete cranial development and resorptions) in rabbits, these were 
seen in the presence of maternal toxicity.
    Ethalfluralin has been classified as a possible human carcinogen 
(Group C) based on positive genotoxicity assays (two positive 
Salmonella assays and a positive assay for chromosomal aberrations) and 
the findings from a two-year chronic carcinogenicity study in rats 
(showing an increased incidence of mammary gland fibroadenomas and 
combined adenomas/fibroadenomas in female rats).
    Specific information on the studies received and the nature of the 
adverse effects caused by ethalfluralin 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 Ethalfluralin. Human Health Risk 
Assessment for the Section 3 Registration on Potato in docket ID number 
EPA-HQ-OPP-2019-0135.

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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for ethalfluralin used for 
human risk assessment is shown in Table 1 of this unit.

[[Page 45338]]

 Table 1--Summary of Toxicological Doses and Endpoints for Ethalfluralin for Use in Human Health Risk Assessment
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                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
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Acute dietary (Females 13-50 years   NOAEL = 75 mg/kg/day..  Acute RfD = 0.75 mg/kg/ Rabbit Developmental
 of age).                            UFA = 10x.............   day.                    Toxicity Study.
                                     UFH = 10x.............  aPAD = 0.75 mg/kg/day.  MRID: 00129057, 00250596.
                                     FQPA SF = 1x..........                          Developmental LOAEL = 150
                                                                                      mg/kg/day based on
                                                                                      increased number of
                                                                                      resorptions and increased
                                                                                      sternal and cranial
                                                                                      variations.
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Acute dietary......................      A single dose effect relevant to the general US population including
(General population including          infants and children was not identified in the toxicity studies conducted
 infants and children).                                           with ethalfluralin.
                                    ----------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 4 mg/kg/day....  Chronic RfD = 0.04 mg/  Dog Chronic Oral Toxicity
                                     UFA = 10x.............   kg/day.                 Study.
                                     UFH = 10x.............  cPAD = 0.04 mg/kg/day.  MRID: 00153371, 92062014.
                                     FQPA SF = 1x..........                          LOAEL = 20 mg/kg/day based
                                                                                      on increased urinary
                                                                                      bilirubin, variations in
                                                                                      erythrocyte morphology,
                                                                                      increased thrombocyte
                                                                                      count, and increased
                                                                                      erythroid series of the
                                                                                      bone marrow.
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Cancer (Oral, dermal, inhalation)..   Ethalfluralin has been classified as a possible human carcinogen (Group C)
                                      based on increased mammary gland fibro-adenomas & combined adenomas/fibro-
                                               adenomas in female rats. Q1* = 8.9 x 10-2 (mg/kg/day)-1.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligram/kilogram/day. 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 ethalfluralin, EPA considered exposure under the 
petitioned-for tolerance as well as all existing ethalfluralin 
tolerances in 40 CFR 180.416. EPA assessed dietary exposures from 
ethalfluralin 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 ethalfluralin. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA used tolerance-level residues and assumed 100 percent crop 
treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level 
residues and assumed 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that ethalfluralin should be classified as a ``Possible human 
carcinogen (Group C)'' and a linear approach has been used to quantify 
cancer risk.
    A refined ethalfluralin chronic cancer dietary (food and drinking 
water) analysis was conducted using half the field trial limit of 
detection (LOD) value for all potato commodities, monitoring data 
generated by USDA's Pesticide Data Program (PDP) for most commodities 
(soybean grain; soy infant formula; canned black, kidney, pinto, and 
garbanzo beans; cantaloupe; watermelon; cucumber; summer squash; winter 
squash; and peanut butter), average PCT data for some commodities, and 
tolerance-level residues and 100 PCT for remaining commodities.
    iv. Anticipated residues 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:
    Canola/rapeseed (2.5%); cantaloupe (5%); cucumber (55%); peanut 
(15%); pumpkin (20%); squash (20%); sunflower (5%); and watermelon 
(15%). The remaining commodities assumed 100% CT.
    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

[[Page 45339]]

chronic dietary risk analysis and a 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 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 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 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 ethalfluralin 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 ethalfluralin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of ethalfluralin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Surface Water Concentration Calculator (SWCC) and the 
Pesticide Root Zone Model for GroundWater (PRZM-GW) models, the 
estimated drinking water concentrations (EDWCs) of ethalfluralin for 
acute exposures are estimated to be 26.1 parts per billion (ppb) for 
surface water and <0.001 ppb for ground water. The EDWCs for chronic 
exposures are estimated to be 0.57 ppb for surface water and <0.001 ppb 
for ground water. The surface water EDWC for cancer exposure was 
estimated to be 0.36 ppb; the groundwater EDWC is the same as for acute 
and chronic exposures, <0.001 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 26.1 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.57 ppb was used to 
assess the contribution to drinking water. For cancer dietary risk 
assessment, the water concentration of value 0.36 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Ethalfluralin is not 
registered for any specific use patterns that would result in 
residential exposure.
    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 ethalfluralin to share a common mechanism of 
toxicity with any other substances, and ethalfluralin does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
ethalfluralin 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://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10x) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. As summarized in Unit 
III.A., no reproductive or developmental effects were observed in rats, 
and although there were developmental effects (sternal variations, 
incomplete cranial development and resorptions) in rabbits, these were 
seen in the presence of maternal toxicity. The resorptions are 
considered a maternal and developmental effect and the skeletal effects 
are minor, so these are not considered evidence of qualitative 
susceptibility.
    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 ethalfluralin is adequate to 
characterize potential prenatal and postnatal risk for infants and 
children.
    ii. There is no indication that ethalfluralin 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 ethalfluralin results in increased 
susceptibility in in utero rats in the prenatal developmental study or 
in young rats in the 2-generation reproduction study. Although there 
were developmental effects (sternal variations, incomplete cranial 
development and resorptions) seen in the rabbit prenatal study, there 
is low concern for increased susceptibility, as these effects were seen 
in the presence of maternal toxicity. Additionally, the dose and 
endpoints chosen for risk assessment are protective of the 
developmental effects observed in the rabbit developmental toxicity 
studies.

[[Page 45340]]

    iv. There are no residual uncertainties identified in the exposure 
databases. The acute and chronic dietary food exposure assessments were 
performed based on 100 PCT and tolerance-level residues. The refined 
cancer dietary exposure assessment was based on USDA PDP monitoring 
data, field trial data for potatoes, and average PCT estimates. EPA 
made conservative (protective) assumptions in the ground and surface 
water modeling used to assess exposure to ethalfluralin in drinking 
water. These assessments will not underestimate the exposure and risks 
posed by ethalfluralin.

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 ethalfluralin will occupy <1% of the aPAD for females 13 to 49 years 
old, the population group receiving the greatest exposure. There are no 
residential uses for ethalfluralin.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ethalfluralin from food and water will utilize <1% of the cPAD for all 
population subgroups. There are no residential uses for ethalfluralin.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because there are no residential uses, ethalfluralin is not 
expected to pose short- or intermediate-term risk.
    4. Aggregate cancer risk for U.S. population. The cancer aggregate 
risk assessment combines exposures to ethalfluralin in food and 
drinking water only. The most highly-exposed population subgroups in 
the dietary (food and drinking water) cancer assessment were adults 20 
to 49 years old and females 13 to 49 years old with a cancer risk 
estimate of <=8.8 x 10-7. EPA generally considers cancer 
risks (expressed as the probability of an increased cancer case) in the 
range of 1 in 1 million (or 1 x 10-6) or less to be 
negligible.
    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 ethalfluralin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology [gas chromatography (GC) with 
electron capture detection (ECD); Pesticide Analytical Manual (PAM, 
Vol. II, section 180.416 Methods I and II)] is available to enforce the 
tolerance expression. Method I and II are applicable for the analysis 
of ethalfluralin residues in/on plant and animal commodities, 
respectively.

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 an MRL for ethalfluralin on potato.

C. International Trade Considerations

    In this Final Rule, EPA is reducing the existing tolerance for 
residues of ethalfluralin on potato from 0.05 ppm to 0.01 ppm. 
Available residue data demonstrate that tolerances at 0.01 ppm are 
sufficient to cover residues on potato.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures (SPS) Agreement, EPA intends to notify the 
WTO of this revision in order to satisfy its obligation. In addition, 
the SPS Agreement requires that Members provide a ``reasonable 
interval'' between the publication of a regulation subject to the 
Agreement and its entry into force to allow time for producers in 
exporting Member countries to adapt to the new requirement. At this 
time, EPA is establishing an expiration date for the existing 
tolerances to allow those tolerances to remain in effect for a period 
of six months after the effective date of this final rule, in order to 
address this requirement. After the six-month period expires, residues 
of ethalfluralin on potato cannot exceed the new tolerance of 0.01 ppm.
    This reduction in tolerance levels is not discriminatory; the same 
food safety standard contained in the FFDCA applies equally to 
domestically produced and imported foods.

V. Conclusion

    Therefore, the tolerance is decreased for residues of ethalfluralin 
in or on potato from 0.05 ppm to 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action modifies an existing tolerance 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

[[Page 45341]]

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: June 7, 2020.
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.  180.416, amend the table in paragraph (a) as follows:
0
i. Add an entry for ``Potato'' after ``Pea, dry, seed'' and before the 
current entry for ``Potato''; and
0
ii. Revise the current entry for ``Potato''.
    The addition and revision read as follows:

Sec.  180.416  Ethalfluralin; tolerances for residues

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                              * * * * * * *
Potato..................................................            0.01
Potato \1\..............................................            0.05
 
                              * * * * * * *
------------------------------------------------------------------------
\1\ This tolerance expires on January 28, 2021.

* * * * *
[FR Doc. 2020-16266 Filed 7-27-20; 8:45 am]
BILLING CODE 6560-50-P