82 FR 57151 - Ethofumesate; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 231 (December 4, 2017)

This regulation establishes tolerances for residues of ethofumesate in or on beet, sugar, molasses and beet, sugar, roots. In addition, this regulation eliminates tolerances for residues of ethofumesate that are superseded by the tolerances established by this final rule. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)]
[Rules and Regulations]
[Pages 57151-57158]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-25828]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0314; FRL-9969-13]


Ethofumesate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
ethofumesate in or on beet, sugar, molasses and beet, sugar, roots. In 
addition, this regulation eliminates tolerances for residues of 
ethofumesate that are superseded by the tolerances established by this 
final rule. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective December 4, 2017. Objections and 
requests for hearings must be received on or before February 2, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0314, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket)

[[Page 57152]]

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, Director, 
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-2016-0314 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 
February 2, 2018. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0314, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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 
6E8472) by IR-4, IR-4 Project Headquarters, 500 College Road East, 
Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 
180.345 be amended by increasing the existing tolerance for the 
combined residues of the herbicide ethofumesate (2-ethoxy-2,3-dihydro-
3,3-dimethyl-5-benzofuranyl methanesulfonate) and its metabolites (2-
hydroxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate and 
2,3-dihydro-3,3-dimethyl-2-oxo-5-benzofuranyl methanesulfonate) both 
calculated as the parent compound, in or on beet, sugar, molasses from 
0.5 to 2.5 parts per million (ppm); beet, sugar, refined sugar from 0.2 
to 1.0 ppm; beet, sugar, roots from 0.3 to 1.5 ppm; and beet, sugar, 
tops from 4.0 to 30.0 ppm. That document referenced a summary of the 
petition prepared by Willowood USA, LLC, the registrant, which is 
available in the docket, http://www.regulations.gov. One comment was 
received on the notice of filing. EPA's response to the comment is 
found in Unit IV.C.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances that differ from what the petitioner requested. 
The reasons for these changes are explained in Unit IV.D.

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 ethofumesate including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with ethofumesate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database 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.

[[Page 57153]]

    The liver is the main target organ in rats and dogs, and the major 
critical effects seen in oral studies are decreased body weight/body 
weight gain and hepatic toxicity in the rat, dog and/or rabbit. Mice 
are relatively insensitive to ethofumesate up to the limit dose 
following subchronic and chronic dietary exposure.
    Ethofumesate did not demonstrate the potential to cause 
neurotoxicity in four species (rats, mice, dogs and rabbits).
    Rats did not show evidence of developmental, maternal, or offspring 
toxicity or susceptibility in a three-generation reproduction study or 
any developmental or maternal toxicity in the developmental toxicity 
study. Although increased prenatal quantitative sensitivity (increased 
resorptions, increased post-implantation loss and incomplete 
ossification of the vertebral arches) was observed in the rabbit 
developmental toxicity study, the developmental toxicity no observed 
adverse effect levels (NOAELs) and lowest observed adverse effect 
levels (LOAELs) are well characterized. In maternal rabbits, effects 
included decreased body weight, increased mortality, abortions and 
complete litter resorption at levels in excess of the limit dose.
    Ethofumesate is classified as ``Not Likely to be Carcinogenic to 
Humans'', based on bioassays in the rat and the mouse, combined with a 
lack of in vitro or in vivo mutagenicity supported by a battery of 
mutagenicity studies that showed no evidence of a mutagenic effect.
    Specific information on the studies received and the nature of the 
adverse effects caused by ethofumesate 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, ``Ethofumesate. Human Health Risk 
Assessment for an Amended Use on Sugar Beets'' dated October 4, 2017 at 
pages 33-36 in docket ID number EPA-HQ-OPP-2016-0314.

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

   Table Summary of Toxicological Doses and Endpoints for ethofumesate for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49       NOAEL = 30 mg/kg/day  Acute RfD = 0.30 mg/ Developmental toxicity study in
 years of age).                    UFA = 10x...........   kg/day.              rabbit.
                                   UFH =10x............  aPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
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Acute Dietary General population   No appropriate acute endpoint identified for the general population including
 including infants and children.                                infants and children.
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Chronic dietary (Females 13-49     NOAEL = 30 mg/kg/day  Chronic RfD = 0.30   Developmental toxicity study in
 years of age).                    UFA = 10x...........   mg/kg/day.           rabbit.
                                   UFH = 10x...........  cPAD = 0.30 mg/kg/   Developmental LOAEL = 300 mg/kg/
                                   FQPA SF = 1x........   day.                 day based on increased
                                   Total UF = 100......                        resorptions, post-implantation
                                                                               loss and incomplete ossification
                                                                               of the vertebral arches.
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Chronic Dietary, General           NOAEL= 127 mg/kg/day  cRfD = 1.3 mg/kg/    Chronic oral toxicity/
 population including infants and  UFA=10..............   day.                 carcinogenicity study (rat).
 children.                         UFH=10..............  cPAD = 1.3 mg/kg/    LOAEL = 469 mg/kg/day based on
                                   FQPA SF = 1X........   day.                 decreased body weight gain in
                                   Total UF = 100......                        females.
----------------------------------------------------------------------------------------------------------------

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Incidental oral short-term (1 to   NOAEL= 190 mg/kg/day  Residential LOC for  90-day oral toxicity study (rats).
 30 days) & intermediate-term (1   UFA = 10x...........   MOE = 100.          LOAEL = 1900 mg/kg/day based on
 to 6 months) Infants and          UFH = 10x...........                        based on reduced body weight
 children only.                    FQPA SF = 1x........                        gain, microscopic lesions in the
                                   Total UF = 100......                        liver and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
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Dermal short-term (1 to 30 days)   NOAEL = 30 mg/kg/day  LOC for MOE = 100..  Developmental toxicity study
 Females 13-49 years of age.       Dermal absorption                           (rabbits).
                                    rate (DAF) = 27%.                         Developmental LOAEL = 300 mg/kg/
                                   UFA = 10x...........                        day based on increased
                                   UFH = 10x...........                        resorptions, post-implantation
                                   FQPA SF = 1x........                        loss and incomplete ossification
                                   Total UF = 100......                        of the vertebral arches.
----------------------------------------------------------------------------------------------------------------
Dermal short-term General          NOAEL= 190 mg/kg/day  LOC for MOE = 100..  90-day oral toxicity study (rats).
 population including infants and  DAF rate = 27%......                       LOAEL = 1900 mg/kg/day based on
 children.                         UFA = 10x...........                        reduced body weight gain,
                                   UFH = 10x...........                        microscopic lesions in the liver
                                   FQPA SF = 1x........                        and kidney in male rats and
                                                                               reduced body weight/weight gain
                                                                               in females.
----------------------------------------------------------------------------------------------------------------
Inhalation (short and              NOAEL= 30 mg/kg/day.  LOC for MOE = 100..  Developmental toxicity study
 intermediate) Females 13-49       Inhalation & oral                           (rabbits).
 years of age.                      toxicity considered                       Developmental LOAEL = 300 mg/kg/
                                    equivalent.                                day based on increased
                                   UFA = 10x...........                        resorptions, post-implantation
                                   UFH = 10x...........                        loss and incomplete ossification
                                   FQPA SF = 1x........                        of the vertebral arches.
                                   Total UF = 100......
----------------------------------------------------------------------------------------------------------------
Inhalation (short and              NOAEL = 190.........  LOC for MOE = 100..  90-day oral toxicity study (rats).
 intermediate term) General        Inhalation & oral                          LOAEL = 1900 mg/kg/day based on
 population including infants and   toxicity considered                        reduced body weight gain,
 children.                          equivalent.                                microscopic lesions in the liver
                                   UFA = 10x...........                        and kidney in male rats and
                                   UFH = 10x...........                        reduced body weight/weight gain
                                   FQPA SF = 1x........                        in females.
                                   Total UF = 100......
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)           Classification: ``Not likely to be carcinogenic to humans''.
----------------------------------------------------------------------------------------------------------------
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 ethofumesate, EPA considered exposure under the petitioned-
for tolerances as well as all existing ethofumesate tolerances in 40 
CFR 180.345. EPA assessed dietary exposures from ethofumesate 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. Because no appropriate 
endpoint was identified for the general population including infants 
and children, a quantitative acute dietary exposure assessment was not 
conducted for these populations. Such effects were observed for the 
population subgroup females 13-49 years of age.
    In estimating acute dietary exposure for females 13-49 years, EPA 
used food consumption information from the United States Department of 
Agriculture (USDA's) National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to 
residue levels in food, EPA used an unrefined determination based on 
tolerance-level residues, 100 percent crop treated (PCT) information 
for all commodities, and Dietary Exposure Evaluation Model (DEEM) 7.81 
default processing factors, where available.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used an unrefined 
determination based on 100 PCT, tolerance-level residues for all 
commodities, and Dietary Exposure Evaluation Model

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(DEEM) 7.81 default processing factors, where available.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that ethofumesate 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. 
The Agency did not use anticipated residue data or percent crop treated 
estimates.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for ethofumesate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of ethofumesate. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Tier I: First Index Reservoir Screening Tool (FIRST) 
and Tier II: Pesticide Root Zone Model Ground Water (PRZM GW)/PWC, the 
estimated drinking water concentrations (EDWCs) of ethofumesate (parent 
compound only) for acute exposures are estimated to be 416 parts per 
billion (ppb) for surface water and 750 ppb for ground water. For 
chronic exposures for non-cancer assessments are estimated to be 123 
ppb for surface water and 695 ppb for ground water.
    Modeled estimates of drinking water concentrations of ethofumesate 
for parent compound only, were directly entered into the dietary 
exposure model. For acute dietary risk assessment, the water 
concentration value of 750 ppb was used to assess the contribution to 
drinking water. For chronic dietary risk assessment, the water 
concentration value of 695 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).
    Ethofumesate is currently registered for the following uses that 
could result in residential exposures: ornamental lawns and turf 
(including golf courses, parks, cemeteries, and homeowner/commercial 
lawns). EPA assessed residential exposure using the following 
assumptions: All ethofumesate products are intended for either 
agricultural use or require professional application for ornamental 
turf. Although registered products are labeled for use on home lawns, 
residential handler exposures are not anticipated because the label 
language requiring personal protective equipment (PPE) and prohibiting 
the use of handheld equipment indicate that the product is not intended 
for homeowner use. Therefore, the Agency has not conducted a 
residential handler assessment.
    There is potential for ethofumesate residential post-application 
exposure for individuals exposed as a result of being in an environment 
that has been previously treated. Residential post-application dermal 
(adults and children) and incidental oral (children only) exposures are 
anticipated from the registered turf uses. EPA conducted screening 
level calculations on the scenarios most likely to result in highest 
possible exposure. These scenarios are:
     For children 1 to <2 years old: incidental ingestion 
(hand-to-mouth), incidental ingestion (turf-to-mouth), incidental 
ingestion (soil-to-mouth), and dermal exposure
     for adults and youths (11 to <16 years old: dermal 
exposure (golfing, lawn mowing, etc.).

Post-application exposures were calculated by considering the potential 
sources of exposure then calculating dermal and/or incidental oral 
exposure and risks. Further information regarding EPA standard 
assumptions and generic inputs for residential exposures may be found 
at http://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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to ethofumesate and any other 
substances and ethofumesate does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that ethofumesate 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 Web site 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 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. There are no concerns or 
uncertainties for pre- and/or post-natal toxicity resulting from 
exposure to ethofumesate. There is no evidence that ethofumesate 
results in increased susceptibility in in utero exposure to 
ethofumesate in the prenatal developmental study in rats. Increased 
pre-natal quantitative susceptibility was observed in the rabbit 
developmental toxicity study. The Agency concluded, however, that there 
is no concern that the risk assessment will not adequately safeguard 
against potential pre- and post-natal toxicity because the 
developmental toxicity NOAELs/LOAELs are well characterized and are 
used as endpoints for risk assessment for the appropriate population 
subgroups.
    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 ethofumesate is sufficiently complete 
and adequate for characterizing potential pre- and/or post-natal risks 
to infants and children. Available studies supporting this decision 
include developmental toxicity studies in rats and rabbits, and a 
three-generation reproduction study in rats.
    Based on all available hazard and exposure data for ethofumesate, 
the Agency determined that the subchronic inhalation, acute and 
subchronic neurotoxicity, and the immunotoxicity

[[Page 57156]]

studies for ethofumesate were not necessary and waived those 
requirements. The existing ethofumesate database is extensive and 
adequately sufficient to permit a full assessment of risks associated 
with proposed new uses under consideration.
    ii. There is no indication that ethofumesate is a neurotoxic 
chemical. Ethofumesate did not cause clear clinical or 
histopathological signs of neurotoxicity in four species tested (rats, 
rabbits, mice and dogs) as evaluated by the current studies within the 
database. In addition, there was no evidence of neurotoxicity observed 
in the toxicity databases of chemicals in the same class as 
ethofumesate. Therefore, EPA is not requiring a developmental 
neurotoxicity study nor incorporating an additional UFs to account for 
neurotoxicity.
    iii. There is no evidence that ethofumesate results in increased 
susceptibility in in utero exposure to ethofumesate in the prenatal 
developmental study in rats. No rat developmental effects were seen at 
the highest dose tested (limit dose of 1000 mg/kg). There is, however, 
quantitative evidence for increased susceptibility following in utero 
exposure to ethofumesate in an adequate developmental toxicity study in 
the rabbit. At 300 mg/kg/day, no maternal toxicity was reported, but 
developmental toxicity was observed as increased resorptions, post-
implantation loss and skeletal abnormalities (incomplete ossification 
of vertebral arches). However, the developmental toxicity NOAELs and 
LOAELs are well characterized and are used as endpoints for risk 
assessment for the appropriate population subgroups.
    There was no quantitative or qualitative evidence of increased 
susceptibility in the three-generation reproduction study in rats with 
ethofumesate since maternal, reproductive and offspring toxicity were 
not observed at any dose tested up to 5000 ppm (397 and 463 mg/kg/day, 
males and females, respectively). Although a limit dose was not 
achieved and no maternal toxicity reported, a new study was not 
required because the highest dose tested was similar to the dose level 
that caused toxicity to rats in the chronic/carcinogenicity dietary 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary exposure analyses are unlikely to underestimate 
exposure. The acute and chronic dietary food and drinking water 
exposure assessments were performed based on 100 PCT information for 
all commodities, tolerance-level residues, and Dietary Exposure 
Evaluation Model (DEEM) 7.81 default processing factors where 
available. The dietary exposure analyses also assumed that all drinking 
water will contain ethofumesate at the highest EDWC levels modeled by 
EPA. The Agency used similarly conservative assumptions to assess post-
application exposure of adults and children. The residential exposure 
estimates are based on EPA's 2012 Residential Standard Operations 
Procedures (SOPs). These assessments will not underestimate the 
exposure and risks posed by ethofumesate.

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 population-adjusted dose (aPAD) and chronic population-adjusted 
dose (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 ethofumesate will occupy 14% of the aPAD at the 95th percentile for 
females 13-49 years old, the only population subgroup for which an 
acute dietary endpoint attributable to a single exposure was 
identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure from food and drinking water only as chronic 
exposure from residential uses of ethofumesate is not expected, EPA 
identified separate chronic dietary endpoints for the general 
population, including infants and children, as well as for the 
population subgroup of females 13-49 years of age. Based on the input 
parameters and assumptions, the chronic dietary risk estimate for the 
U.S. population was determined to be 1.2% of the cPAD with the 
population subgroup of females 13-49 years having the highest risk 
estimate at 5.2% of the cPAD. EPA concluded that ethofumesate risk 
estimates for all population subgroups were below the level of concern 
of <100% of the cPAD.
    3. Short- and intermediate-term aggregate risk. Short- and 
intermediate-term aggregate exposures take into account short- and 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ethofumesate is currently registered for uses that could result in 
short-term residential exposure. Residential exposure to ethofumesate 
is not anticipated from the amended uses that are the subject of this 
regulatory action; however, it is anticipated from currently registered 
residential uses of ethofumesate. Residential exposures are only 
expected to be short-term in duration; however, since the point of 
departure is the same for short and intermediate-term exposures, the 
short-term aggregate is protective of any longer-term exposures.
    Aggregate risk estimates (MOEs) were derived using recommended 
exposure scenarios including: For adults, dermal post-application 
exposure from high contact activities on treated turf; for children, 
including ages 11 to <16 years and 6 to <11 years, dermal post-
application exposure from golfing on treated turf; and for children (1 
to <2 years), combined dermal plus hand-to-mouth post-application 
exposure from high contact activities on treated turf.
    EPA short-term aggregate risk calculations of aggregate MOEs, 
combining average food and drinking water, plus residential exposures 
(total exposure), ranged from 120 for females 13-49 years; to 430 for 
children 1 to <2 years; to 770 for adults, 20-49 years and 
significantly higher for population subgroups, children 6 to 11 years 
and youth 11 to <16 years. These short-term aggregate risk estimates 
are not of concern to EPA (i.e., MOEs are >= 100).
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, ethofumesate 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 ethofumesate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method I in PAM Vol. II is listed 
as an adequate tolerance enforcement method for plants) 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;

[[Page 57157]]

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.
    There are no Codex MRLs established for the residues of 
ethofumesate in/on any sugar beet raw agricultural or processed 
commodity.

C. Response to Comments

    One commenter supported the tolerance action but expressed concerns 
about the need for additional data to assess the toxicity of 
ethofumesate to bioaccumulate and to contribute to obesity and 
diabetes. To the extent the commenter is concerned about impacts on 
aquatic life, earthworms, and other non-human organisms, this comment 
is outside the scope of review appropriate for a tolerance safety 
assessment under section 408 of the FFDCA. If the commenter is raising 
concerns about potential human harm, the Agency has considered all the 
available data and determined that the tolerances are safe; there is 
nothing in the toxicity database that would suggest toxicity concerns 
related to diabetes or obesity.
    The octanol-water partition coefficient (log Kow) for 
ethofumesate is 2.8. Compounds with log Kow values less than 
three are unlikely to bioaccumulate substantially. Therefore, further 
assessment of the bioaccumulation of ethofumesate is not warranted at 
this time.

D. Revisions to Petitioned-For Tolerances

    EPA is not increasing the existing tolerance for ``Beet, sugar, 
tops'' because it is unnecessary due to the fact that this commodity is 
no longer a significant livestock feed item or a recognized human food.
    Although the petitioner requested an increase in the existing 
sugar, beet, refined sugar tolerance, EPA has determined that the 
tolerance is not needed because the limit established for the raw 
agricultural commodity (RAC) (beet, sugar, roots at 1.5 ppm) is 
sufficient to cover residues in this processed commodity (at 1.0 ppm).
    In setting the sugar beet molasses tolerance, EPA used the 
empirical processing factor previously derived for determining the 
concentration of residues in this processed commodity, which results in 
a tolerance of 2.0 ppm rather 2.5 ppm as requested.
    The tolerance expressions at 180.345 paragraphs (a) and (c) for 
ethofumesate are being revised to comply with current EPA policies and 
to accommodate updated tolerance enforcement methods that convert the 
NC 20645 (2-(2-hydroxy-5-methanesulfonyloxyphenyl) methylpropanoic 
acid) metabolite to NC9607 (3,3-dimethyl-5-[(methylsulfonyl)oxy]-2(3H)-
benzofuranone) prior to quantitation.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
ethofumesate in or on beet, sugar, molasses at 2.0 ppm and beet, sugar, 
roots at 1.5 ppm. Also, the tolerance for beet, sugar, refined is 
deleted because residues in that processed commodity are covered by the 
tolerance for beet, sugar, roots.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


[[Page 57158]]


    Dated: October 26, 2017.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.345:
0
i. Revise the introductory text of paragraph (a);
0
ii. Remove the entry for ``Beet, sugar, refined sugar'' from the table 
in paragraph (a);
0
iii. Revise the entries for ``Beet, sugar, molasses'' and ``Beet, 
sugar, roots'' in the table in paragraph (a): and
0
iv. Revise the introductory text of paragraph (c) to read as follows:


Sec.  180.345  Ethofumesate; tolerances for residues.

    (a) General. Tolerance are established for residues of the 
herbicide ethofumesate, including its metabolites and degradates, in or 
on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-benzofuranyl 
methanesulfonate, and its metabolites 2-hydroxy-2,3-dihydro-3,3-
dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-3,3-dimethyl-
2-oxo-5-benzofuranylmethanesulfonate, calculated as the stoichiometric 
equivalent of ethofumesate, in or on the following food commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, molasses.......................................         2.0
Beet, sugar, roots..........................................         1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with a 
regional registration, as defined in Sec.  180.1(l) are established for 
residues of the herbicide ethofumesate, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels specified is to be determined by measuring 
only the sum of ethofumesate, 2-ethoxy-2,3-dihydro-3,3-dimethyl-5-
benzofuranyl methanesulfonate, and its metabolites 2-hydroxy-2,3-
dihydro-3,3-dimethyl-5-benzofuranyl methanesulfonate, and 2,3-dihydro-
3,3-dimethyl-2-oxo-5-benzofuranylmethanesulfonate, calculated as the 
stoichiometric equivalent of ethofumesate, in or on the raw 
agricultural commodities.
* * * * *
[FR Doc. 2017-25828 Filed 12-1-17; 8:45 am]
BILLING CODE 6560-50-P