82_FR_57382 82 FR 57151 - Ethofumesate; Pesticide Tolerances

82 FR 57151 - Ethofumesate; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

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

Page Range57151-57158
FR Document2017-25828

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 In addition, this regulation eliminates tolerances for residues of ethofumesate that are superseded by the tolerances established by this final rule.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 Issue 231 (Monday, December 4, 2017)
[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ethofumesate that are superseded by the tolerances established by this 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
----------------------------------------------------------------------------------------------------------------
                                    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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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

[[Page 57155]]

(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



                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                                   57151

                                             required by FFDCA section 408(b)(4).                    responsibilities established by Congress              § 180.586 Clothianidin; tolerances for
                                             The Codex Alimentarius is a joint                       in the preemption provisions of FFDCA                 residues.
                                             United Nations Food and Agriculture                     section 408(n)(4). As such, the Agency                *       *    *         *     *
                                             Organization/World Health                               has determined that this action will not                  (b) * * *
                                             Organization food standards program,                    have a substantial direct effect on States
                                             and it is recognized as an international                or tribal governments, on the                                                    Parts per      Expiration/
                                             food safety standards-setting                           relationship between the national                          Commodity                            revocation
                                                                                                                                                                                       million          date
                                             organization in trade agreements to                     government and the States or tribal
                                             which the United States is a party. EPA                 governments, or on the distribution of                Fruit, citrus, group
                                             may establish a tolerance that is                       power and responsibilities among the                    10–10 ................     0.07         12/31/20
                                             different from a Codex MRL; however,                    various levels of government or between
                                             FFDCA section 408(b)(4) requires that                   the Federal Government and Indian                     ■ 3. In § 180.668, revise the table in
                                             EPA explain the reasons for departing                   tribes. Thus, the Agency has determined               paragraph (b) to read as follows:
                                             from the Codex level.                                   that Executive Order 13132, entitled
                                                The Codex has established MRLs for                   ‘‘Federalism’’ (64 FR 43255, August 10,               § 180. 668     Sulfoxaflor; tolerances for
                                             clothianidin in/on citrus fruits at 0.07                1999) and Executive Order 13175,                      residues.
                                             ppm. These MRLs are the same as the                     entitled ‘‘Consultation and Coordination              *       *    *         *     *
                                             tolerance established for clothianidin                  with Indian Tribal Governments’’ (65 FR                   (b) * * *
                                             in/on fruit, citrus, group 10–10 in the                 67249, November 9, 2000) do not apply
                                             United States. The Codex has not                        to this action. In addition, this action                                                        Expiration/
                                                                                                                                                                                      Parts per
                                             established any MRLs for sulfoxaflor in/                does not impose any enforceable duty or                    Commodity              million       revocation
                                             on sorghum commodities.                                                                                                                                    date
                                                                                                     contain any unfunded mandate as
                                             IV. Statutory and Executive Order                       described under Title II of the Unfunded              Sorghum, forage ...                 0.4     12/31/20
                                             Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                  Sorghum, grain .....                0.3     12/31/20
                                                                                                     1501 et seq.).                                        Sorghum, stover ...                 0.9     12/31/20
                                                This action establishes tolerances
                                             under FFDCA section 408(d) in                              This action does not involve any
                                                                                                     technical standards that would require                *        *     *       *     *
                                             response to petitions submitted to the
                                             Agency. The Office of Management and                    Agency consideration of voluntary                     [FR Doc. 2017–25826 Filed 12–1–17; 8:45 am]
                                             Budget (OMB) has exempted these types                   consensus standards pursuant to section               BILLING CODE 6560–50–P
                                             of actions from review under Executive                  12(d) of the National Technology
                                             Order 12866, entitled ‘‘Regulatory                      Transfer and Advancement Act
                                             Planning and Review’’ (58 FR 51735,                     (NTTAA) (15 U.S.C. 272 note).                         ENVIRONMENTAL PROTECTION
                                             October 4, 1993). Because this action                                                                         AGENCY
                                                                                                     V. Congressional Review Act
                                             has been exempted from review under
                                                                                                                                                           40 CFR Part 180
                                             Executive Order 12866, this action is                     Pursuant to the Congressional Review
                                             not subject to Executive Order 13211,                   Act (5 U.S.C. 801 et seq.), EPA has                   [EPA–HQ–OPP–2016–0314; FRL–9969–13]
                                             entitled ‘‘Actions Concerning                           submitted a report containing this rule
                                             Regulations That Significantly Affect                   and other required information to the                 Ethofumesate; Pesticide Tolerances
                                             Energy Supply, Distribution, or Use’’ (66               U.S. Senate, the U.S. House of                        AGENCY:  Environmental Protection
                                             FR 28355, May 22, 2001) or Executive                    Representatives, and the Comptroller                  Agency (EPA).
                                             Order 13045, entitled ‘‘Protection of                   General of the United States prior to
                                             Children from Environmental Health                                                                            ACTION: Final rule.
                                                                                                     publication of the rule in the Federal
                                             Risks and Safety Risks’’ (62 FR 19885,                  Register. This action is not a ‘‘major                SUMMARY:   This regulation establishes
                                             April 23, 1997). This action does not                   rule’’ as defined by 5 U.S.C. 804(2).                 tolerances for residues of ethofumesate
                                             contain any information collections                                                                           in or on beet, sugar, molasses and beet,
                                             subject to OMB approval under the                       List of Subjects in 40 CFR Part 180
                                                                                                                                                           sugar, roots. In addition, this regulation
                                             Paperwork Reduction Act (PRA) (44                                                                             eliminates tolerances for residues of
                                             U.S.C. 3501 et seq.), nor does it require                 Environmental protection,
                                                                                                     Administrative practice and procedure,                ethofumesate that are superseded by the
                                             any special considerations under                                                                              tolerances established by this final rule.
                                             Executive Order 12898, entitled                         Agricultural commodities, Pesticides
                                                                                                     and pests, Reporting and recordkeeping                Interregional Research Project Number 4
                                             ‘‘Federal Actions to Address                                                                                  (IR–4) requested these tolerances under
                                             Environmental Justice in Minority                       requirements.
                                                                                                                                                           the Federal Food, Drug, and Cosmetic
                                             Populations and Low-Income                               Dated: October 20, 2017.                             Act (FFDCA).
                                             Populations’’ (59 FR 7629, February 16,                 Michael L. Goodis,
                                                                                                                                                           DATES: This regulation is effective
                                             1994).
                                                Since tolerances and exemptions that                 Director, Registration Division, Office of            December 4, 2017. Objections and
                                             are established on the basis of a petition              Pesticide Programs.                                   requests for hearings must be received
                                             under FFDCA section 408(d), such as                       Therefore, 40 CFR chapter I is                      on or before February 2, 2018, and must
                                             the tolerances in this final rule, do not               amended as follows:                                   be filed in accordance with the
                                             require the issuance of a proposed rule,                                                                      instructions provided in 40 CFR part
                                             the requirements of the Regulatory                      PART 180—[AMENDED]                                    178 (see also Unit I.C. of the
                                                                                                                                                           SUPPLEMENTARY INFORMATION).
ethrower on DSK3G9T082PROD with RULES




                                             Flexibility Act (RFA) (5 U.S.C. 601 et
                                             seq.), do not apply.                                    ■ 1. The authority citation for part 180              ADDRESSES: The docket for this action,
                                                This action directly regulates growers,              continues to read as follows:                         identified by docket identification (ID)
                                             food processors, food handlers, and food                                                                      number EPA–HQ–OPP–2016–0314, is
                                                                                                         Authority: 21 U.S.C. 321(q), 346a and 371.
                                             retailers, not States or tribes, nor does                                                                     available at http://www.regulations.gov
                                             this action alter the relationships or                  ■ 2. In § 180.586, revise the table in                or at the Office of Pesticide Programs
                                             distribution of power and                               paragraph (b) to read as follows:                     Regulatory Public Docket (OPP Docket)


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                                             57152            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations

                                             in the Environmental Protection Agency                  OPP–2016–0314 in the subject line on                  from 0.2 to 1.0 ppm; beet, sugar, roots
                                             Docket Center (EPA/DC), West William                    the first page of your submission. All                from 0.3 to 1.5 ppm; and beet, sugar,
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 tops from 4.0 to 30.0 ppm. That
                                             Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       document referenced a summary of the
                                             20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   petition prepared by Willowood USA,
                                             is open from 8:30 a.m. to 4:30 p.m.,                    before February 2, 2018. Addresses for                LLC, the registrant, which is available in
                                             Monday through Friday, excluding legal                  mail and hand delivery of objections                  the docket, http://www.regulations.gov.
                                             holidays. The telephone number for the                  and hearing requests are provided in 40               One comment was received on the
                                             Public Reading Room is (202) 566–1744,                  CFR 178.25(b).                                        notice of filing. EPA’s response to the
                                             and the telephone number for the OPP                      In addition to filing an objection or               comment is found in Unit IV.C.
                                             Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                   Based upon review of the data
                                             the visitor instructions and additional                 as described in 40 CFR part 178, please               supporting the petition, EPA is
                                             information about the docket available                  submit a copy of the filing (excluding                establishing tolerances that differ from
                                             at http://www.epa.gov/dockets.                          any Confidential Business Information                 what the petitioner requested. The
                                             FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            reasons for these changes are explained
                                             Michael L. Goodis, Director,                            Information not marked confidential                   in Unit IV.D.
                                             Registration Division (7505P), Office of                pursuant to 40 CFR part 2 may be
                                                                                                                                                           III. Aggregate Risk Assessment and
                                             Pesticide Programs, Environmental                       disclosed publicly by EPA without prior
                                                                                                                                                           Determination of Safety
                                             Protection Agency, 1200 Pennsylvania                    notice. Submit the non-CBI copy of your
                                                                                                     objection or hearing request, identified                 Section 408(b)(2)(A)(i) of FFDCA
                                             Ave. NW., Washington, DC 20460–0001;                                                                          allows EPA to establish a tolerance (the
                                             main telephone number: (703) 305–                       by docket ID number EPA–HQ–OPP–
                                                                                                     2016–0314, by one of the following                    legal limit for a pesticide chemical
                                             7090; email address: RDFRNotices@                                                                             residue in or on a food) only if EPA
                                             epa.gov.                                                methods:
                                                                                                       • Federal eRulemaking Portal: http://               determines that the tolerance is ‘‘safe.’’
                                             SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                Section 408(b)(2)(A)(ii) of FFDCA
                                                                                                     instructions for submitting comments.                 defines ‘‘safe’’ to mean that ‘‘there is a
                                             I. General Information
                                                                                                     Do not submit electronically any                      reasonable certainty that no harm will
                                             A. Does this action apply to me?                        information you consider to be CBI or                 result from aggregate exposure to the
                                                You may be potentially affected by                   other information whose disclosure is                 pesticide chemical residue, including
                                             this action if you are an agricultural                  restricted by statute.                                all anticipated dietary exposures and all
                                             producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   other exposures for which there is
                                             pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 reliable information.’’ This includes
                                             list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 exposure through drinking water and in
                                             Classification System (NAICS) codes is                  NW., Washington, DC 20460–0001.                       residential settings, but does not include
                                             not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    occupational exposure. Section
                                             provides a guide to help readers                        arrangements for hand delivery or                     408(b)(2)(C) of FFDCA requires EPA to
                                             determine whether this document                         delivery of boxed information, please                 give special consideration to exposure
                                             applies to them. Potentially affected                   follow the instructions at http://                    of infants and children to the pesticide
                                             entities may include:                                   www.epa.gov/dockets/contacts.html.                    chemical residue in establishing a
                                                • Crop production (NAICS code 111).                    Additional instructions on                          tolerance and to ‘‘ensure that there is a
                                                • Animal production (NAICS code                      commenting or visiting the docket,                    reasonable certainty that no harm will
                                             112).                                                   along with more information about                     result to infants and children from
                                                • Food manufacturing (NAICS code                     dockets generally, is available at http://            aggregate exposure to the pesticide
                                             311).                                                   www.epa.gov/dockets.                                  chemical residue. . . .’’
                                                • Pesticide manufacturing (NAICS                     II. Summary of Petitioned-For
                                                                                                                                                              Consistent with FFDCA section
                                             code 32532).                                                                                                  408(b)(2)(D), and the factors specified in
                                                                                                     Tolerance
                                                                                                                                                           FFDCA section 408(b)(2)(D), EPA has
                                             B. How can I get electronic access to                      In the Federal Register of July 20,                reviewed the available scientific data
                                             other related information?                              2016 (81 FR 47150) (FRL–9948–45),                     and other relevant information in
                                                You may access a frequently updated                  EPA issued a document pursuant to                     support of this action. EPA has
                                             electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    sufficient data to assess the hazards of
                                             regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                and to make a determination on
                                             the Government Printing Office’s e-CFR                  pesticide petition (PP 6E8472) by IR–4,               aggregate exposure for ethofumesate
                                             site at http://www.ecfr.gov/cgi-bin/text-               IR–4 Project Headquarters, 500 College                including exposure resulting from the
                                             idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Road East, Suite 201W, Princeton, NJ                  tolerances established by this action.
                                             40tab_02.tpl.                                           08540. The petition requested that 40                 EPA’s assessment of exposures and risks
                                                                                                     CFR 180.345 be amended by increasing                  associated with ethofumesate follows.
                                             C. How can I file an objection or hearing               the existing tolerance for the combined
                                             request?                                                residues of the herbicide ethofumesate                A. Toxicological Profile
                                               Under FFDCA section 408(g), 21                        (2-ethoxy-2,3-dihydro-3,3-dimethyl-5-                   EPA has evaluated the available
                                             U.S.C. 346a, any person may file an                     benzofuranyl methanesulfonate) and its                toxicity database and considered its
                                             objection to any aspect of this regulation              metabolites (2-hydroxy-2,3-dihydro-3,3-               validity, completeness, and reliability as
                                             and may also request a hearing on those                 dimethyl-5-benzofuranyl                               well as the relationship of the results of
ethrower on DSK3G9T082PROD with RULES




                                             objections. You must file your objection                methanesulfonate and 2,3-dihydro-3,3-                 the studies to human risk. EPA has also
                                             or request a hearing on this regulation                 dimethyl-2-oxo-5-benzofuranyl                         considered available information
                                             in accordance with the instructions                     methanesulfonate) both calculated as                  concerning the variability of the
                                             provided in 40 CFR part 178. To ensure                  the parent compound, in or on beet,                   sensitivities of major identifiable
                                             proper receipt by EPA, you must                         sugar, molasses from 0.5 to 2.5 parts per             subgroups of consumers, including
                                             identify docket ID number EPA–HQ–                       million (ppm); beet, sugar, refined sugar             infants and children.


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                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                           57153

                                                The liver is the main target organ in                   Ethofumesate is classified as ‘‘Not                of reference values for risk assessment.
                                             rats and dogs, and the major critical                   Likely to be Carcinogenic to Humans’’,                PODs are developed based on a careful
                                             effects seen in oral studies are decreased              based on bioassays in the rat and the                 analysis of the doses in each
                                             body weight/body weight gain and                        mouse, combined with a lack of in vitro               toxicological study to determine the
                                             hepatic toxicity in the rat, dog and/or                 or in vivo mutagenicity supported by a                dose at which no adverse effects are
                                             rabbit. Mice are relatively insensitive to              battery of mutagenicity studies that                  observed (the NOAEL) and the lowest
                                             ethofumesate up to the limit dose                       showed no evidence of a mutagenic                     dose at which adverse effects of concern
                                             following subchronic and chronic                        effect.                                               are identified (the LOAEL). Uncertainty/
                                             dietary exposure.                                          Specific information on the studies
                                                                                                                                                           safety factors are used in conjunction
                                                Ethofumesate did not demonstrate the                 received and the nature of the adverse
                                                                                                                                                           with the POD to calculate a safe
                                             potential to cause neurotoxicity in four                effects caused by ethofumesate as well
                                             species (rats, mice, dogs and rabbits).                 as the no-observed-adverse-effect-level               exposure level—generally referred to as
                                                Rats did not show evidence of                        (NOAEL) and the lowest-observed-                      a population-adjusted dose (PAD) or a
                                             developmental, maternal, or offspring                   adverse-effect-level (LOAEL) from the                 reference dose (RfD)—and a safe margin
                                             toxicity or susceptibility in a three-                  toxicity studies can be found at http://              of exposure (MOE). For non-threshold
                                             generation reproduction study or any                    www.regulations.gov in document,                      risks, the Agency assumes that any
                                             developmental or maternal toxicity in                   ‘‘Ethofumesate. Human Health Risk                     amount of exposure will lead to some
                                             the developmental toxicity study.                       Assessment for an Amended Use on                      degree of risk. Thus, the Agency
                                             Although increased prenatal                             Sugar Beets’’ dated October 4, 2017 at                estimates risk in terms of the probability
                                             quantitative sensitivity (increased                     pages 33–36 in docket ID number EPA–                  of an occurrence of the adverse effect
                                             resorptions, increased post-implantation                HQ–OPP–2016–0314.                                     expected in a lifetime. For more
                                             loss and incomplete ossification of the                                                                       information on the general principles
                                             vertebral arches) was observed in the                   B. Toxicological Points of Departure/
                                                                                                                                                           EPA uses in risk characterization and a
                                             rabbit developmental toxicity study, the                Levels of Concern
                                                                                                                                                           complete description of the risk
                                             developmental toxicity no observed                         Once a pesticide’s toxicological                   assessment process, see http://
                                             adverse effect levels (NOAELs) and                      profile is determined, EPA identifies                 www.epa.gov/pesticide-science-and-
                                             lowest observed adverse effect levels                   toxicological points of departure (POD)               assessing-pesticide-risks/assessing-
                                             (LOAELs) are well characterized. In                     and levels of concern to use in                       human-health-risk-pesticides.
                                             maternal rabbits, effects included                      evaluating the risk posed by human
                                             decreased body weight, increased                        exposure to the pesticide. For hazards                   A summary of the toxicological
                                             mortality, abortions and complete litter                that have a threshold below which there               endpoints for ethofumesate used for
                                             resorption at levels in excess of the limit             is no appreciable risk, the toxicological             human risk assessment is shown in the
                                             dose.                                                   POD is used as the basis for derivation               Table of this unit.

                                                 TABLE SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHOFUMESATE FOR USE IN HUMAN HEALTH RISK
                                                                                           ASSESSMENT
                                                                                      Point of departure        RfD, PAD, LOC for
                                                    Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                                 risk assessment
                                                                                        safety factors

                                             Acute dietary (Females 13–49           NOAEL = 30 mg/kg/          Acute RfD = 0.30           Developmental toxicity study in rabbit.
                                               years of age).                         day.                       mg/kg/day.               Developmental LOAEL = 300 mg/kg/day based on increased
                                                                                    UFA = 10x                  aPAD = 0.30 mg/kg/           resorptions, post-implantation loss and incomplete ossifica-
                                                                                    UFH =10x                     day                        tion of the vertebral arches.
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Acute Dietary General popu-                    No appropriate acute endpoint identified for the general population including infants and children.
                                               lation including infants and
                                               children.

                                             Chronic dietary (Females 13–49         NOAEL = 30 mg/kg/          Chronic RfD = 0.30         Developmental toxicity study in rabbit.
                                               years of age).                         day.                       mg/kg/day.               Developmental LOAEL = 300 mg/kg/day based on increased
                                                                                    UFA = 10x                  cPAD = 0.30 mg/kg/           resorptions, post-implantation loss and incomplete ossifica-
                                                                                    UFH = 10x                    day.                       tion of the vertebral arches.
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Chronic Dietary, General popu-         NOAEL= 127 mg/kg/          cRfD = 1.3 mg/kg/          Chronic oral toxicity/carcinogenicity study (rat).
                                               lation including infants and           day.                       day.                     LOAEL = 469 mg/kg/day based on decreased body weight gain
                                               children.                            UFA=10                     cPAD = 1.3 mg/kg/            in females.
                                                                                    UFH=10                       day.
                                                                                    FQPA SF = 1X
                                                                                    Total UF = 100
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                                                 TABLE SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHOFUMESATE FOR USE IN HUMAN HEALTH RISK
                                                                                      ASSESSMENT—Continued
                                                                                      Point of departure        RfD, PAD, LOC for
                                                    Exposure/scenario                  and uncertainty/                                                    Study and toxicological effects
                                                                                                                 risk assessment
                                                                                        safety factors

                                             Incidental oral short-term (1 to       NOAEL= 190 mg/kg/          Residential LOC for        90-day oral toxicity study (rats).
                                               30 days) & intermediate-term           day.                       MOE = 100.               LOAEL = 1900 mg/kg/day based on based on reduced body
                                               (1 to 6 months) Infants and          UFA = 10x                                               weight gain, microscopic lesions in the liver and kidney in
                                               children only.                       UFH = 10x                                               male rats and reduced body weight/weight gain in females.
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Dermal short-term (1 to 30             NOAEL = 30 mg/kg/          LOC for MOE = 100          Developmental toxicity study (rabbits).
                                               days) Females 13–49 years              day.                                                Developmental LOAEL = 300 mg/kg/day based on increased
                                               of age.                              Dermal absorption                                       resorptions, post-implantation loss and incomplete ossifica-
                                                                                      rate (DAF) = 27%                                      tion of the vertebral arches.
                                                                                    UFA = 10x
                                                                                    UFH = 10x
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Dermal short-term General pop-         NOAEL= 190 mg/kg/          LOC for MOE = 100          90-day oral toxicity study (rats).
                                               ulation including infants and         day.                                                 LOAEL = 1900 mg/kg/day based on reduced body weight gain,
                                               children.                            DAF rate = 27%                                          microscopic lesions in the liver and kidney in male rats and
                                                                                    UFA = 10x                                               reduced body weight/weight gain in females.
                                                                                    UFH = 10x
                                                                                    FQPA SF = 1x

                                             Inhalation (short and inter-           NOAEL= 30 mg/kg/           LOC for MOE = 100          Developmental toxicity study (rabbits).
                                               mediate) Females 13–49                 day.                                                Developmental LOAEL = 300 mg/kg/day based on increased
                                               years of age.                        Inhalation & oral tox-                                  resorptions, post-implantation loss and incomplete ossifica-
                                                                                      icity considered                                      tion of the vertebral arches.
                                                                                      equivalent
                                                                                    UFA = 10x
                                                                                    UFH = 10x
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Inhalation (short and inter-           NOAEL = 190 ..........     LOC for MOE = 100          90-day oral toxicity study (rats).
                                               mediate term) General popu-          Inhalation & oral tox-                                LOAEL = 1900 mg/kg/day based on reduced body weight gain,
                                               lation including infants and           icity considered                                      microscopic lesions in the liver and kidney in male rats and
                                               children.                              equivalent                                            reduced body weight/weight gain in females.
                                                                                    UFA = 10x
                                                                                    UFH = 10x
                                                                                    FQPA SF = 1x
                                                                                    Total UF = 100

                                             Cancer (Oral, dermal, inhala-                                        Classification: ‘‘Not likely to be carcinogenic to humans’’.
                                               tion).
                                               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                                  exposure. Because no appropriate                      food, EPA used an unrefined
                                                                                                     endpoint was identified for the general               determination based on tolerance-level
                                                1. Dietary exposure from food and
                                                                                                     population including infants and                      residues, 100 percent crop treated (PCT)
                                             feed uses. In evaluating dietary
                                                                                                     children, a quantitative acute dietary                information for all commodities, and
                                             exposure to ethofumesate, EPA
                                             considered exposure under the                           exposure assessment was not conducted                 Dietary Exposure Evaluation Model
                                             petitioned-for tolerances as well as all                for these populations. Such effects were              (DEEM) 7.81 default processing factors,
                                             existing ethofumesate tolerances in 40                  observed for the population subgroup                  where available.
                                             CFR 180.345. EPA assessed dietary                       females 13–49 years of age.                              ii. Chronic exposure. In conducting
                                             exposures from ethofumesate in food as                    In estimating acute dietary exposure                the chronic dietary exposure assessment
                                             follows:                                                for females 13–49 years, EPA used food                EPA used the food consumption data
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                                                i. Acute exposure. Quantitative acute                consumption information from the                      from the USDA’s 2003–2008 NHANES/
                                             dietary exposure and risk assessments                   United States Department of Agriculture               WWEIA. As to residue levels in food,
                                             are performed for a food-use pesticide,                 (USDA’s) National Health and Nutrition                EPA used an unrefined determination
                                             if a toxicological study has indicated the              Examination Survey, What We Eat in                    based on 100 PCT, tolerance-level
                                             possibility of an effect of concern                     America (NHANES/WWEIA) from 2003                      residues for all commodities, and
                                             occurring as a result of a 1-day or single              through 2008. As to residue levels in                 Dietary Exposure Evaluation Model


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                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                        57155

                                             (DEEM) 7.81 default processing factors,                 ornamental turf. Although registered                  mechanism of toxicity and to evaluate
                                             where available.                                        products are labeled for use on home                  the cumulative effects of such
                                                iii. Cancer. Based on the data                       lawns, residential handler exposures are              chemicals, see EPA’s Web site at http://
                                             summarized in Unit III.A., EPA has                      not anticipated because the label                     www.epa.gov/pesticide-science-and-
                                             concluded that ethofumesate does not                    language requiring personal protective                assessing-pesticide-risks/cumulative-
                                             pose a cancer risk to humans. Therefore,                equipment (PPE) and prohibiting the                   assessment-risk-pesticides.
                                             a dietary exposure assessment for the                   use of handheld equipment indicate that
                                             purpose of assessing cancer risk is                                                                           D. Safety Factor for Infants and
                                                                                                     the product is not intended for                       Children
                                             unnecessary.                                            homeowner use. Therefore, the Agency
                                                iv. Anticipated residue and percent                  has not conducted a residential handler                 1. In general. Section 408(b)(2)(C) of
                                             crop treated (PCT) information. The                     assessment.                                           FFDCA provides that EPA shall apply
                                             Agency did not use anticipated residue                     There is potential for ethofumesate                an additional tenfold (10X) margin of
                                             data or percent crop treated estimates.                 residential post-application exposure for             safety for infants and children in the
                                                2. Dietary exposure from drinking                    individuals exposed as a result of being              case of threshold effects to account for
                                             water. The Agency used screening level                  in an environment that has been                       prenatal and postnatal toxicity and the
                                             water exposure models in the dietary                    previously treated. Residential post-                 completeness of the database on toxicity
                                             exposure analysis and risk assessment                   application dermal (adults and children)              and exposure unless EPA determines
                                             for ethofumesate in drinking water.                     and incidental oral (children only)                   based on reliable data that a different
                                             These simulation models take into                       exposures are anticipated from the                    margin of safety will be safe for infants
                                             account data on the physical, chemical,                 registered turf uses. EPA conducted                   and children. This additional margin of
                                             and fate/transport characteristics of                   screening level calculations on the                   safety is commonly referred to as the
                                             ethofumesate. Further information                       scenarios most likely to result in highest            Food Quality Protection Act Safety
                                             regarding EPA drinking water models                     possible exposure. These scenarios are:               Factor (FQPA SF). In applying this
                                             used in pesticide exposure assessment                      • For children 1 to <2 years old:                  provision, EPA either retains the default
                                             can be found at http://www.epa.gov/                     incidental ingestion (hand-to-mouth),                 value of 10X, or uses a different
                                             pesticide-science-and-assessing-                                                                              additional safety factor when reliable
                                                                                                     incidental ingestion (turf-to-mouth),
                                             pesticide-risks/about-water-exposure-                                                                         data available to EPA support the choice
                                                                                                     incidental ingestion (soil-to-mouth), and
                                             models-used-pesticide.                                                                                        of a different factor.
                                                Based on the Tier I: First Index                     dermal exposure
                                                                                                                                                             2. Prenatal and postnatal sensitivity.
                                             Reservoir Screening Tool (FIRST) and                       • for adults and youths (11 to <16
                                                                                                                                                           There are no concerns or uncertainties
                                             Tier II: Pesticide Root Zone Model                      years old: dermal exposure (golfing,
                                                                                                                                                           for pre- and/or post-natal toxicity
                                             Ground Water (PRZM GW)/PWC, the                         lawn mowing, etc.).                                   resulting from exposure to
                                             estimated drinking water concentrations                 Post-application exposures were                       ethofumesate. There is no evidence that
                                             (EDWCs) of ethofumesate (parent                         calculated by considering the potential               ethofumesate results in increased
                                             compound only) for acute exposures are                  sources of exposure then calculating                  susceptibility in in utero exposure to
                                             estimated to be 416 parts per billion                   dermal and/or incidental oral exposure                ethofumesate in the prenatal
                                             (ppb) for surface water and 750 ppb for                 and risks. Further information regarding              developmental study in rats. Increased
                                             ground water. For chronic exposures for                 EPA standard assumptions and generic                  pre-natal quantitative susceptibility was
                                             non-cancer assessments are estimated to                 inputs for residential exposures may be               observed in the rabbit developmental
                                             be 123 ppb for surface water and 695                    found at http://www.epa.gov/pesticide-                toxicity study. The Agency concluded,
                                             ppb for ground water.                                   science-and-assessing-pesticide-risks/                however, that there is no concern that
                                                Modeled estimates of drinking water                  standard-operating-procedures-                        the risk assessment will not adequately
                                             concentrations of ethofumesate for                      residential-pesticide.                                safeguard against potential pre- and
                                             parent compound only, were directly                        4. Cumulative effects from substances              post-natal toxicity because the
                                             entered into the dietary exposure model.                with a common mechanism of toxicity.                  developmental toxicity NOAELs/
                                             For acute dietary risk assessment, the                  Section 408(b)(2)(D)(v) of FFDCA                      LOAELs are well characterized and are
                                             water concentration value of 750 ppb                    requires that, when considering whether               used as endpoints for risk assessment
                                             was used to assess the contribution to                  to establish, modify, or revoke a                     for the appropriate population
                                             drinking water. For chronic dietary risk                tolerance, the Agency consider                        subgroups.
                                             assessment, the water concentration                     ‘‘available information’’ concerning the                3. Conclusion. EPA has determined
                                             value of 695 ppb was used to assess the                 cumulative effects of a particular                    that reliable data show the safety of
                                             contribution to drinking water.                         pesticide’s residues and ‘‘other                      infants and children would be
                                                3. From non-dietary exposure. The                    substances that have a common                         adequately protected if the FQPA SF
                                             term ‘‘residential exposure’’ is used in                mechanism of toxicity.’’                              were reduced to 1X. That decision is
                                             this document to refer to non-                             Unlike other pesticides for which EPA              based on the following findings:
                                             occupational, non-dietary exposure                      has followed a cumulative risk approach                 i. The toxicity database for
                                             (e.g., for lawn and garden pest control,                based on a common mechanism of                        ethofumesate is sufficiently complete
                                             indoor pest control, termiticides, and                  toxicity, EPA has not made a common                   and adequate for characterizing
                                             flea and tick control on pets).                         mechanism of toxicity finding as to                   potential pre- and/or post-natal risks to
                                                Ethofumesate is currently registered                 ethofumesate and any other substances                 infants and children. Available studies
                                             for the following uses that could result                and ethofumesate does not appear to                   supporting this decision include
                                             in residential exposures: ornamental                    produce a toxic metabolite produced by                developmental toxicity studies in rats
                                             lawns and turf (including golf courses,                 other substances. For the purposes of
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                                                                                                                                                           and rabbits, and a three-generation
                                             parks, cemeteries, and homeowner/                       this tolerance action, therefore, EPA has             reproduction study in rats.
                                             commercial lawns). EPA assessed                         assumed that ethofumesate does not                      Based on all available hazard and
                                             residential exposure using the following                have a common mechanism of toxicity                   exposure data for ethofumesate, the
                                             assumptions: All ethofumesate products                  with other substances. For information                Agency determined that the subchronic
                                             are intended for either agricultural use                regarding EPA’s efforts to determine                  inhalation, acute and subchronic
                                             or require professional application for                 which chemicals have a common                         neurotoxicity, and the immunotoxicity


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                                             57156            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations

                                             studies for ethofumesate were not                       tolerance-level residues, and Dietary                 residential exposure plus chronic
                                             necessary and waived those                              Exposure Evaluation Model (DEEM)                      exposure to food and water (considered
                                             requirements. The existing ethofumesate                 7.81 default processing factors where                 to be a background exposure level).
                                             database is extensive and adequately                    available. The dietary exposure analyses                 Ethofumesate is currently registered
                                             sufficient to permit a full assessment of               also assumed that all drinking water                  for uses that could result in short-term
                                             risks associated with proposed new uses                 will contain ethofumesate at the highest              residential exposure. Residential
                                             under consideration.                                    EDWC levels modeled by EPA. The                       exposure to ethofumesate is not
                                                ii. There is no indication that                      Agency used similarly conservative                    anticipated from the amended uses that
                                             ethofumesate is a neurotoxic chemical.                  assumptions to assess post-application                are the subject of this regulatory action;
                                             Ethofumesate did not cause clear                        exposure of adults and children. The                  however, it is anticipated from currently
                                             clinical or histopathological signs of                  residential exposure estimates are based              registered residential uses of
                                             neurotoxicity in four species tested                    on EPA’s 2012 Residential Standard                    ethofumesate. Residential exposures are
                                             (rats, rabbits, mice and dogs) as                       Operations Procedures (SOPs). These                   only expected to be short-term in
                                             evaluated by the current studies within                 assessments will not underestimate the                duration; however, since the point of
                                             the database. In addition, there was no                 exposure and risks posed by                           departure is the same for short and
                                             evidence of neurotoxicity observed in                   ethofumesate.                                         intermediate-term exposures, the short-
                                             the toxicity databases of chemicals in                                                                        term aggregate is protective of any
                                             the same class as ethofumesate.                         E. Aggregate Risks and Determination of
                                                                                                     Safety                                                longer-term exposures.
                                             Therefore, EPA is not requiring a                                                                                Aggregate risk estimates (MOEs) were
                                             developmental neurotoxicity study nor                      EPA determines whether acute and                   derived using recommended exposure
                                             incorporating an additional UFs to                      chronic dietary pesticide exposures are               scenarios including: For adults, dermal
                                             account for neurotoxicity.                              safe by comparing aggregate exposure                  post-application exposure from high
                                                iii. There is no evidence that                       estimates to the acute population-                    contact activities on treated turf; for
                                             ethofumesate results in increased                       adjusted dose (aPAD) and chronic                      children, including ages 11 to <16 years
                                             susceptibility in in utero exposure to                  population-adjusted dose (cPAD). For                  and 6 to <11 years, dermal post-
                                             ethofumesate in the prenatal                            linear cancer risks, EPA calculates the               application exposure from golfing on
                                             developmental study in rats. No rat                     lifetime probability of acquiring cancer              treated turf; and for children (1 to <2
                                             developmental effects were seen at the                  given the estimated aggregate exposure.               years), combined dermal plus hand-to-
                                             highest dose tested (limit dose of 1000                 Short-, intermediate-, and chronic-term               mouth post-application exposure from
                                             mg/kg). There is, however, quantitative                 risks are evaluated by comparing the                  high contact activities on treated turf.
                                             evidence for increased susceptibility                   estimated aggregate food, water, and                     EPA short-term aggregate risk
                                             following in utero exposure to                          residential exposure to the appropriate               calculations of aggregate MOEs,
                                             ethofumesate in an adequate                             PODs to ensure that an adequate MOE                   combining average food and drinking
                                             developmental toxicity study in the                     exists.                                               water, plus residential exposures (total
                                             rabbit. At 300 mg/kg/day, no maternal                      1. Acute risk. Using the exposure
                                                                                                                                                           exposure), ranged from 120 for females
                                             toxicity was reported, but                              assumptions discussed in this unit for
                                                                                                                                                           13–49 years; to 430 for children 1 to <2
                                             developmental toxicity was observed as                  acute exposure, the acute dietary
                                                                                                                                                           years; to 770 for adults, 20–49 years and
                                             increased resorptions, post-implantation                exposure from food and water to
                                                                                                                                                           significantly higher for population
                                             loss and skeletal abnormalities                         ethofumesate will occupy 14% of the
                                                                                                                                                           subgroups, children 6 to 11 years and
                                             (incomplete ossification of vertebral                   aPAD at the 95th percentile for females
                                                                                                                                                           youth 11 to <16 years. These short-term
                                             arches). However, the developmental                     13–49 years old, the only population
                                                                                                                                                           aggregate risk estimates are not of
                                             toxicity NOAELs and LOAELs are well                     subgroup for which an acute dietary
                                                                                                                                                           concern to EPA (i.e., MOEs are ≥ 100).
                                             characterized and are used as endpoints                 endpoint attributable to a single
                                                                                                                                                              4. Aggregate cancer risk for U.S.
                                             for risk assessment for the appropriate                 exposure was identified.
                                                                                                        2. Chronic risk. Using the exposure                population. Based on the lack of
                                             population subgroups.
                                                                                                     assumptions described in this unit for                evidence of carcinogenicity in two
                                                There was no quantitative or
                                                                                                     chronic exposure from food and                        adequate rodent carcinogenicity studies,
                                             qualitative evidence of increased
                                             susceptibility in the three-generation                  drinking water only as chronic exposure               ethofumesate is not expected to pose a
                                             reproduction study in rats with                         from residential uses of ethofumesate is              cancer risk to humans.
                                                                                                     not expected, EPA identified separate                    5. Determination of safety. Based on
                                             ethofumesate since maternal,
                                             reproductive and offspring toxicity were                chronic dietary endpoints for the                     these risk assessments, EPA concludes
                                             not observed at any dose tested up to                   general population, including infants                 that there is a reasonable certainty that
                                             5000 ppm (397 and 463 mg/kg/day,                        and children, as well as for the                      no harm will result to the general
                                             males and females, respectively).                       population subgroup of females 13–49                  population, or to infants and children
                                             Although a limit dose was not achieved                  years of age. Based on the input                      from aggregate exposure to ethofumesate
                                             and no maternal toxicity reported, a                    parameters and assumptions, the                       residues.
                                             new study was not required because the                  chronic dietary risk estimate for the U.S.            IV. Other Considerations
                                             highest dose tested was similar to the                  population was determined to be 1.2%
                                             dose level that caused toxicity to rats in              of the cPAD with the population                       A. Analytical Enforcement Methodology
                                             the chronic/carcinogenicity dietary                     subgroup of females 13–49 years having                   Adequate enforcement methodology
                                             study.                                                  the highest risk estimate at 5.2% of the              (Method I in PAM Vol. II is listed as an
                                                iv. There are no residual uncertainties              cPAD. EPA concluded that                              adequate tolerance enforcement method
                                             identified in the exposure databases.
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                                                                                                     ethofumesate risk estimates for all                   for plants) is available to enforce the
                                             The dietary exposure analyses are                       population subgroups were below the                   tolerance expression.
                                             unlikely to underestimate exposure. The                 level of concern of <100% of the cPAD.                   The method may be requested from:
                                             acute and chronic dietary food and                         3. Short- and intermediate-term                    Chief, Analytical Chemistry Branch,
                                             drinking water exposure assessments                     aggregate risk. Short- and intermediate-              Environmental Science Center, 701
                                             were performed based on 100 PCT                         term aggregate exposures take into                    Mapes Rd., Ft. Meade, MD 20755–5350;
                                             information for all commodities,                        account short- and intermediate-term                  telephone number: (410) 305–2905;


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                                                              Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations                                         57157

                                             email address: residuemethods@                            Although the petitioner requested an                Populations and Low-Income
                                             epa.gov.                                                increase in the existing sugar, beet,                 Populations’’ (59 FR 7629, February 16,
                                                                                                     refined sugar tolerance, EPA has                      1994).
                                             B. International Residue Limits
                                                                                                     determined that the tolerance is not                     Since tolerances and exemptions that
                                                In making its tolerance decisions, EPA               needed because the limit established for              are established on the basis of a petition
                                             seeks to harmonize U.S. tolerances with                 the raw agricultural commodity (RAC)                  under FFDCA section 408(d), such as
                                             international standards whenever                        (beet, sugar, roots at 1.5 ppm) is                    the tolerance in this final rule, do not
                                             possible, consistent with U.S. food                     sufficient to cover residues in this                  require the issuance of a proposed rule,
                                             safety standards and agricultural                       processed commodity (at 1.0 ppm).                     the requirements of the Regulatory
                                             practices. EPA considers the                              In setting the sugar beet molasses                  Flexibility Act (RFA) (5 U.S.C. 601 et
                                             international maximum residue limits                    tolerance, EPA used the empirical                     seq.), do not apply.
                                             (MRLs) established by the Codex                         processing factor previously derived for
                                             Alimentarius Commission (Codex), as                     determining the concentration of                         This action directly regulates growers,
                                             required by FFDCA section 408(b)(4).                    residues in this processed commodity,                 food processors, food handlers, and food
                                             The Codex Alimentarius is a joint                       which results in a tolerance of 2.0 ppm               retailers, not States or tribes, nor does
                                             United Nations Food and Agriculture                     rather 2.5 ppm as requested.                          this action alter the relationships or
                                             Organization/World Health                                 The tolerance expressions at 180.345                distribution of power and
                                             Organization food standards program,                    paragraphs (a) and (c) for ethofumesate               responsibilities established by Congress
                                             and it is recognized as an international                are being revised to comply with current              in the preemption provisions of FFDCA
                                             food safety standards-setting                           EPA policies and to accommodate                       section 408(n)(4). As such, the Agency
                                             organization in trade agreements to                     updated tolerance enforcement methods                 has determined that this action will not
                                             which the United States is a party. EPA                 that convert the NC 20645 (2-(2-                      have a substantial direct effect on States
                                             may establish a tolerance that is                       hydroxy-5-methanesulfonyloxyphenyl)                   or tribal governments, on the
                                             different from a Codex MRL; however,                    methylpropanoic acid) metabolite to                   relationship between the national
                                             FFDCA section 408(b)(4) requires that                   NC9607 (3,3-dimethyl-5-                               government and the States or tribal
                                             EPA explain the reasons for departing                   [(methylsulfonyl)oxy]-2(3H)-                          governments, or on the distribution of
                                             from the Codex level.                                   benzofuranone) prior to quantitation.                 power and responsibilities among the
                                                There are no Codex MRLs established                                                                        various levels of government or between
                                                                                                     V. Conclusion
                                             for the residues of ethofumesate in/on                                                                        the Federal Government and Indian
                                             any sugar beet raw agricultural or                        Therefore, tolerances are established               tribes. Thus, the Agency has determined
                                             processed commodity.                                    for residues of the herbicide                         that Executive Order 13132, entitled
                                                                                                     ethofumesate in or on beet, sugar,                    ‘‘Federalism’’ (64 FR 43255, August 10,
                                             C. Response to Comments                                 molasses at 2.0 ppm and beet, sugar,                  1999) and Executive Order 13175,
                                               One commenter supported the                           roots at 1.5 ppm. Also, the tolerance for             entitled ‘‘Consultation and Coordination
                                             tolerance action but expressed concerns                 beet, sugar, refined is deleted because               with Indian Tribal Governments’’ (65 FR
                                             about the need for additional data to                   residues in that processed commodity                  67249, November 9, 2000) do not apply
                                             assess the toxicity of ethofumesate to                  are covered by the tolerance for beet,                to this action. In addition, this action
                                             bioaccumulate and to contribute to                      sugar, roots.                                         does not impose any enforceable duty or
                                             obesity and diabetes. To the extent the                 VI. Statutory and Executive Order                     contain any unfunded mandate as
                                             commenter is concerned about impacts                    Reviews                                               described under Title II of the Unfunded
                                             on aquatic life, earthworms, and other                                                                        Mandates Reform Act (UMRA) (2 U.S.C.
                                             non-human organisms, this comment is                       This action establishes tolerances                 1501 et seq.).
                                             outside the scope of review appropriate                 under FFDCA section 408(d) in
                                                                                                     response to a petition submitted to the                  This action does not involve any
                                             for a tolerance safety assessment under                                                                       technical standards that would require
                                             section 408 of the FFDCA. If the                        Agency. The Office of Management and
                                                                                                     Budget (OMB) has exempted these types                 Agency consideration of voluntary
                                             commenter is raising concerns about                                                                           consensus standards pursuant to section
                                             potential human harm, the Agency has                    of actions from review under Executive
                                                                                                     Order 12866, entitled ‘‘Regulatory                    12(d) of the National Technology
                                             considered all the available data and                                                                         Transfer and Advancement Act
                                             determined that the tolerances are safe;                Planning and Review’’ (58 FR 51735,
                                                                                                     October 4, 1993). Because this action                 (NTTAA) (15 U.S.C. 272 note).
                                             there is nothing in the toxicity database
                                             that would suggest toxicity concerns                    has been exempted from review under                   VII. Congressional Review Act
                                             related to diabetes or obesity.                         Executive Order 12866, this action is
                                               The octanol-water partition                           not subject to Executive Order 13211,                   Pursuant to the Congressional Review
                                             coefficient (log Kow) for ethofumesate is               entitled ‘‘Actions Concerning                         Act (5 U.S.C. 801 et seq.), EPA will
                                             2.8. Compounds with log Kow values                      Regulations That Significantly Affect                 submit a report containing this rule and
                                             less than three are unlikely to                         Energy Supply, Distribution, or Use’’ (66             other required information to the U.S.
                                             bioaccumulate substantially. Therefore,                 FR 28355, May 22, 2001) or Executive                  Senate, the U.S. House of
                                             further assessment of the                               Order 13045, entitled ‘‘Protection of                 Representatives, and the Comptroller
                                             bioaccumulation of ethofumesate is not                  Children from Environmental Health                    General of the United States prior to
                                             warranted at this time.                                 Risks and Safety Risks’’ (62 FR 19885,                publication of the rule in the Federal
                                                                                                     April 23, 1997). This action does not                 Register. This action is not a ‘‘major
                                             D. Revisions to Petitioned-For                          contain any information collections                   rule’’ as defined by 5 U.S.C. 804(2).
                                             Tolerances                                              subject to OMB approval under the
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                                                                                                                                                           List of Subjects in 40 CFR Part 180
                                                EPA is not increasing the existing                   Paperwork Reduction Act (PRA) (44
                                             tolerance for ‘‘Beet, sugar, tops’’ because             U.S.C. 3501 et seq.), nor does it require               Environmental protection,
                                             it is unnecessary due to the fact that this             any special considerations under                      Administrative practice and procedure,
                                             commodity is no longer a significant                    Executive Order 12898, entitled                       Agricultural commodities, Pesticides
                                             livestock feed item or a recognized                     ‘‘Federal Actions to Address                          and pests, Reporting and recordkeeping
                                             human food.                                             Environmental Justice in Minority                     requirements.


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                                             57158            Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations

                                               Dated: October 26, 2017.                              hydroxy-2,3-dihydro-3,3-dimethyl-5-                   available for download at https://
                                             Michael Goodis,                                         benzofuranyl methanesulfonate, and                    apps.fcc.gov/edocs_public/attachmatch/
                                             Director, Registration Division, Office of              2,3-dihydro-3,3-dimethyl-2-oxo-5-                     FCC-17-143A1.pdf. The complete text of
                                             Pesticide Programs.                                     benzofuranylmethanesulfonate,                         this document is also available for
                                               Therefore, 40 CFR chapter I is                        calculated as the stoichiometric                      inspection and copying during normal
                                             amended as follows:                                     equivalent of ethofumesate, in or on the              business hours in the FCC Reference
                                                                                                     raw agricultural commodities.                         Information Center, Portals II, 445 12th
                                             PART 180—[AMENDED]                                      *     *    *     *     *                              Street SW., Room CY–A257,
                                                                                                     [FR Doc. 2017–25828 Filed 12–1–17; 8:45 am]           Washington, DC 20554. To request
                                             ■ 1. The authority citation for part 180                BILLING CODE 6560–50–P                                materials in accessible formats for
                                             continues to read as follows:                                                                                 people with disabilities (Braille, large
                                                 Authority: 21 U.S.C. 321(q), 346a and 371.                                                                print, electronic files, audio format),
                                                                                                     FEDERAL COMMUNICATIONS                                send an email to FCC504@fcc.gov or call
                                             ■ 2. In § 180.345:                                                                                            the Consumer & Governmental Affairs
                                             ■ i. Revise the introductory text of                    COMMISSION
                                                                                                                                                           Bureau at 202–418–0530 (voice), 202–
                                             paragraph (a);                                                                                                418–0432 (TTY).
                                                                                                     47 CFR Parts 10 and 11
                                             ■ ii. Remove the entry for ‘‘Beet, sugar,
                                             refined sugar’’ from the table in                       [PS Docket No. 15–91; PS Docket No. 15–               Supplemental Regulatory Flexibility
                                             paragraph (a);                                          94; FCC 17–143]                                       Analysis
                                             ■ iii. Revise the entries for ‘‘Beet, sugar,                                                                    1. This Supplemental Final
                                             molasses’’ and ‘‘Beet, sugar, roots’’ in                Wireless Emergency Alerts;                            Regulatory Flexibility Analysis
                                             the table in paragraph (a): and                         Emergency Alert System                                (Supplemental FRFA) supplements the
                                             ■ iv. Revise the introductory text of                   AGENCY:  Federal Communications                       Final Regulatory Flexibility Analysis
                                             paragraph (c) to read as follows:                       Commission.                                           (FRFA) of the September 2016 WEA
                                                                                                     ACTION: Final rule.                                   Report and Order, 81 FR 75710 (WEA
                                             § 180.345 Ethofumesate; tolerances for                                                                        R&O) to reflect the actions taken in this
                                             residues.
                                                                                                     SUMMARY:   In this document, the Federal              Order on Reconsideration and conforms
                                               (a) General. Tolerance are established                Communications Commission                             to the RFA.
                                             for residues of the herbicide                           (Commission) grants the petition filed
                                             ethofumesate, including its metabolites                                                                       Need for, and Objective of, the Order
                                                                                                     by CTIA for reconsideration the
                                             and degradates, in or on the                            Commission’s recent decision to revise                  2. In the WEA R&O, we took
                                             commodities in the table below.                         its Wireless Emergency Alert (WEA)                    advantage of the significant
                                             Compliance with the tolerance levels                    rules and grants in part and denies in                technological changes and
                                             specified below is to be determined by                  part the Competitive Carrier                          improvements experienced by the
                                             measuring only the sum of                               Association’s (CCA) request for a waiver              mobile wireless industry since the
                                             ethofumesate, 2-ethoxy-2,3-dihydro-3,3-                 or extension of time. Specifically, the               passage of the Warning, Alert and
                                             dimethyl-5-benzofuranyl                                 Commission extends the timeframe for                  Response Network (WARN) Act, and
                                             methanesulfonate, and its metabolites 2-                compliance with the requirement in the                deployment of WEA to improve the
                                             hydroxy-2,3-dihydro-3,3-dimethyl-5-                     WEA Report and Order that                             utility of WEA as a life-saving tool. As
                                             benzofuranyl methanesulfonate, and                      Participating CMS Providers provide                   pertinent to the Order on
                                             2,3-dihydro-3,3-dimethyl-2-oxo-5-                       ‘‘clickable’’ embedded references in                  Reconsideration we adopt today, in the
                                             benzofuranylmethanesulfonate,                           WEA messages from 12 months to 30                     WEA R&O we adopted rules focused on
                                             calculated as the stoichiometric                        months except for AT&T, Verizon, T-                   improving WEA message content by
                                             equivalent of ethofumesate, in or on the                Mobile, Sprint and U.S. Cellular. This                narrowing the rules for the geo-targeting
                                             following food commodities.                             document also clarifies that the                      of alerts, requiring Participating
                                                                                                     requirement for ‘‘clickable’’ embedded                Commercial Mobile Service (CMS)
                                                                                        Parts per                                                          Providers to support embedded
                                                        Commodity                        million     references encompass phone numbers
                                                                                                     and other types of embedded references,               references (i.e., URLs and phone
                                                                                                     and that our embedded reference                       numbers) included in WEA Alert
                                                *         *           *               *        *     requirement applies to new devices as                 Messages. In doing so, we set a deadline
                                             Beet, sugar, molasses ................              2.0 well as existing devices capable of                   for compliance with the embedded
                                             Beet, sugar, roots .......................          1.5 supporting this feature through a                     reference requirement of one year (12
                                                                                                     software upgrade. Finally, this                       months).
                                                *         *           *               *        *     document denies CCA’s request for a                     3. In this Order on Reconsideration,
                                                                                                     waiver or an extension of time for                    we grant, to the extent described herein,
                                             *     *      *     *         *                          compliance with the geo-targeting                     CTIA’s Petition for Reconsideration of
                                               (c) Tolerances with regional                          requirements.                                         the WEA R&O and CCA’s Petition for
                                             registrations. Tolerances with a regional                                                                     Waiver, or in the Alternative, Extension
                                             registration, as defined in § 180.1(l) are              DATES: Effective December 4, 2017.                    of Time. In doing so, we deny CCA’s
                                             established for residues of the herbicide FOR FURTHER INFORMATION CONTACT:                                    request for a waiver or an extension of
                                             ethofumesate, including its metabolites                 Gregory Cooke of the Public Safety and                time for compliance with the WEA
                                             and degradates, in or on the                            Homeland Security Bureau, Policy and                  R&O’s best approximates geo-targeting
                                             commodities in the table below.                         Licensing Division, gregory.cooke@                    standard, as compliance with the best
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                                             Compliance with the tolerance levels                    fcc.gov, (202) 418–2351.                              approximate geo-targeting is well within
                                             specified is to be determined by                        SUPPLEMENTARY INFORMATION: This is a                  the capabilities of CCA’s members; and
                                             measuring only the sum of                               summary of the Commission’s Order on                  we reconsider the deadline for
                                             ethofumesate, 2-ethoxy-2,3-dihydro-3,3- Reconsideration in PS Docket No. 15–                                  compliance with the embedded
                                             dimethyl-5-benzofuranyl                                 91, No. 15–94, FCC 17–143, released on                reference requirement from one year (12
                                             methanesulfonate, and its metabolites 2- November 1, 2017. The document is                                    months) to 30 months for all


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Document Created: 2017-12-02 00:41:38
Document Modified: 2017-12-02 00:41:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael 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
FR Citation82 FR 57151 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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