[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29023-29028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13459]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0235; FRL-9976-41]


Acetochlor; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
acetochlor in or on alfalfa and related animal commodities which are 
identified and discussed later in this document. Monsanto Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective June 22, 2018. Objections and 
requests for hearings must be received on or before August 21, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2017-0235, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
<a href="/cdn-cgi/l/email-protection#3e6c7a786c70514a575d5b4d7e5b4e5f10595148"><span class="__cf_email__" data-cfemail="20726466726e4f5449434553604550410e474f56">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0235 in the subject line on the first 
page of your submission. All objections and requests for a hearing

[[Page 29024]]

must be in writing, and must be received by the Hearing Clerk on or 
before August 21, 2018. Addresses for mail and hand delivery of 
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2017-0235, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
    <bullet> 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 February 27, 2018 (83 FR 8408) (FRL-
9972-17), 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 
6F8533) by Monsanto Company, 1300 I Street NW, Suite 450 East, 
Washington, DC 20005. The petition requested that 40 CFR 180.470 (a) 
General., be amended by establishing tolerances for residues of the 
herbicide acetochlor, (2-chloro-2'-methyl-6'-ethyl-N-
ethoxymethylacetanilide), and its metabolites containing either the 2-
ethyl-6-methylaniline (EMA) or the 2-(1-hydroxyethyl)-6-methyl-aniline 
(HEMA) moiety, to be expressed as acetochlor equivalents, resulting 
from applications to soil or growing crops, in or on Alfalfa, forage at 
8 parts per million (ppm), Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 
ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat 
byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, 
kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, 
except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 
ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat 
byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 
0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, 
meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 
180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an 
exception in the description of the commodities as follows: Animal 
feed, nongrass, group 18, except alfalfa, forage, and Animal feed, 
nongrass, group 18, except alfalfa, hay. That document referenced a 
summary of the petition prepared by Monsanto Company, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed 8 ppm tolerance for alfalfa forage to 8.0 ppm. The 
reason for this change is 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 acetochlor including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with acetochlor follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Acetochlor has low acute toxicity by the oral, dermal, and 
inhalation routes of exposure and is minimally irritating to the eyes. 
A dermal irritation study indicates that it is a severe skin irritant. 
Acetochlor is also a strong dermal sensitizer. Evidence of 
neurotoxicity was observed in acute and subchronic neurotoxicity 
screening studies in rats, developmental toxicity studies in rats, and 
subchronic and chronic studies in dogs. In addition to the nervous 
system, the major target organs affected in subchronic and chronic 
studies in rats, dogs, and mice exposed to acetochlor are the liver, 
thyroid (secondary to liver), kidney, testes, and erythrocytes. 
Species-specific target organs include the nasal olfactory epithelium 
in rats and the lungs in mice.
    There is no evidence of increased qualitative or quantitative 
susceptibility of fetuses or offspring to acetochlor exposure in the 
developmental and reproduction toxicity studies in rats and rabbits. In 
two developmental toxicity studies in rats, fetal effects (increased 
early resorptions, post-implantation loss, and decreased fetal weight) 
occurred at doses that also resulted in maternal toxicity (mortality, 
clinical signs of toxicity, and decreased maternal body weight). In two 
rabbit developmental toxicity studies, there were no adverse fetal 
effects at the highest doses tested (190 mg/kg/day and 300 mg/kg/day); 
whereas maternal toxicity (body weight loss) was seen at 190 mg/kg/day 
in one study. In three reproduction toxicity studies in rats, offspring 
effects (decreased pup weights in the first two studies; decreased pup 
weights, decreased F2 litter size at birth, and focal hyperplasia and 
polypoid adenomata in nasal epithelium of adult F1 offspring at study 
termination in the third study) occurred at the same or higher doses 
than those resulting in parental toxicity (decreased body weight or 
weight gain in the first two studies; focal hyperplasia and polypoid 
adenomata in nasal epithelium of adult F1 offspring at study 
termination in the third study). There was no evidence of reproductive 
toxicity observed at any

[[Page 29025]]

dose tested in two of the three reproductive toxicity studies in rats. 
The third reproduction study in rats showed a decreased number of 
implantations at the highest dose tested of 216 mg/kg/day.
    There was evidence of carcinogenicity in studies conducted with 
acetochlor in rats and mice. A 23-month mouse carcinogenicity study 
showed weak evidence for increased benign lung tumors in females, and a 
78-week study showed weak evidence for increased benign lung tumors in 
males. The increases were considered equivocal, based on increases in 
benign tumors only, inconsistent dose-responses between the two 
studies, inconsistencies in the responses of males and females between 
the two studies, lack of pre-neoplastic lung lesions in the 23-month 
study (while the 78-week study showed an increase in bronchiolar 
hyperplasia), and the variable incidence of lung tumors known to occur 
in older mice.
    Two carcinogenicity studies in rats showed an increase in nasal 
epithelial tumors and thyroid follicular cell tumors. Thyroid tumor 
incidence was relatively low, and there was evidence that the tumors 
were due to disruption of thyroid-pituitary homeostasis. There are 
acceptable mode of action data for the rat tumors (nasal olfactory 
epithelial tumors and thyroid follicular cell tumors) which are 
adequate to support a non-linear, margin of exposure (MOE), approach 
for assessment of cancer risk. The data show that, like the related 
compounds, alachlor and butachlor, tumor formation is dependent upon 
local cytotoxicity secondary to oxidative damage by a reactive quinone 
imine intermediate. The mechanistic data on nasal tumorigenesis of 
acetochlor in the rat, when considered together with the mutagenicity 
data on acetochlor and consistent findings in mechanistic and 
mutagenicity studies on the closely related compound alachlor, are 
considered adequate to demonstrate a cytotoxic, non-mutagenic mode of 
tumor induction.
    Because a clear mode of action was demonstrated for the rat tumors, 
EPA based the cancer classification on the data from the mouse. EPA 
classified acetochlor as ``Suggestive Evidence of Carcinogenic 
Potential'' based on weak evidence for benign lung tumors in male and 
female mice and histiocytic sarcomas in female mice, and determined 
that linear quantification of carcinogenic potential would not be 
appropriate for the mouse tumors. The rat nasal tumors, with a point of 
departure (POD) of 10 mg/kg/day, are the most sensitive effect for 
cancer risk. The chronic population adjusted dose (cPAD), based on the 
no observed adverse effect level (NOAEL) of 2.0 mg/kg/day from the 
chronic dog study, will be protective of both non-cancer and cancer 
effects, including rat nasal tumors, thyroid tumors, and mouse tumors.
    Specific information on the studies received and the nature of the 
adverse effects caused by acetochlor 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 Acetochlor: Human Health Risk 
Assessment for Proposed New Use on Alfalfa and Related Animal 
Commodities at [insert page number] in docket ID number EPA-HQ-OPP-
2017-0235.

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/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for acetochlor used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of January 22, 2014 (79 FR 3512) 
(FRL-9904-19).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to acetochlor, EPA considered exposure under the petitioned-
for tolerances as well as all existing acetochlor tolerances in 40 CFR 
180.470. EPA assessed dietary exposures from acetochlor in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for acetochlor. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed tolerance level residues except for 
livestock commodities where anticipated residues were used, and 100 
percent crop treated (PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA. As to residue levels in food, anticipated residues from field 
trial data and livestock feeding studies were used, while 100% crop 
treated assumptions (including feed items) were made for all 
commodities.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice summarized in Unit III.A., EPA classified acetochlor as 
having ``Suggestive Evidence of Carcinogenic Potential'' but determined 
that the chronic risk assessment will be protective of both non-cancer 
and cancer effects. Therefore, a separate exposure assessment to 
evaluate cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are

[[Page 29026]]

required by FFDCA section 408(b)(2)(E) and authorized under FFDCA 
section 408(f)(1). Data will be required to be submitted no later than 
5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for acetochlor in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of acetochlor. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of acetochlor 
for acute exposures are estimated to be 74.9 parts per billion (ppb) 
for surface water and 129 ppb for ground water. EDWCs for chronic 
exposures for non-cancer assessments are estimated to be 4.84 ppb for 
surface water and 82.6 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 129.0 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value of 82.6 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). Acetochlor is not 
registered for any specific use patterns that would result in 
residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    The chloroacetanilides have been evaluated by the Agency and the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific 
Advisory Panel (SAP) as a related group of chemicals for this purpose. 
Acetochlor is included in a Cumulative Assessment Group of 
chloroacetanilide pesticides. For purposes of a cumulative risk 
assessment, it was determined that the common mechanism of toxicity 
group consists of alachlor, acetochlor, and butachlor. Butachlor is 
excluded from the group for risk assessment purposes at present because 
there are no registered uses or tolerances for this chemical in the 
U.S. The group was selected based on common endpoints of:
    i. Nasal turbinate tumors in rats, and a known mechanism of 
toxicity for development of these tumors.
    ii. Induction of hepatic uridine diphosphate-glucuronosyl 
transferase (UDPGT), which results in increased incidence of thyroid 
follicular cell tumors secondary to disruption of pituitary-thyroid 
homeostasis.
    Thyroid effects were not included in the final cumulative 
assessment of the chloroacetanilide herbicides because they were 
determined to occur at excessively toxic dose levels, and therefore 
were not considered relevant to human risk assessment. Nasal tumors 
represent the most sensitive endpoint for both compounds.
    A cumulative risk assessment of the chloroacetanilide pesticides 
acetochlor and alachlor was conducted in April 2007 and did not 
identify any cumulative risks of concern. A revised quantitative 
cumulative assessment was not conducted because the proposed new use on 
alfalfa would not affect the cumulative risk results. The new use on 
alfalfa is not anticipated to affect the cumulative risk results for 
the following reasons: The major risk driver in the cumulative 
assessment was alachlor in drinking water, domestic alachlor uses are 
being phased out (tolerances are being maintained for imported foods), 
cumulative dietary exposure was not of concern when accounting for the 
contribution from alachlor, acetochlor is a very minor contributor to 
chloroacetanilide cumulative risk when compared to alachlor, and 
acetochlor is less toxic than alachlor. No further cumulative 
evaluation is necessary for acetochlor use on alfalfa.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No increase in 
susceptibility was seen in developmental toxicity studies in rats and 
rabbits or in three multi-generation reproductive toxicity studies in 
rats. Toxicity to offspring was observed at dose levels which were the 
same or greater than those causing maternal or parental toxicity. Based 
on the results of developmental and reproductive toxicity studies, 
there is no concern for increased qualitative and/or quantitative 
susceptibility of the young following exposure to acetochlor.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X for acute dietary, chronic dietary, and 
dermal. That decision is based on the following findings:
    i. The toxicity database for acetochlor is complete for the purpose 
of evaluating this tolerance petition.
    ii. Evidence of neurotoxicity from exposure to acetochlor was 
observed in several oral studies. However, these effects were typically 
observed at high doses. The points of departure selected for risk 
assessment are protective of the potential neurotoxicity observed in 
the database.
    iii. There is no evidence that acetochlor results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to acetochlor in 
drinking water. The acute dietary exposure analysis used tolerance 
level residues except for livestock commodities where anticipated 
residues were used and 100 PCT. The chronic dietary exposure analysis 
used anticipated residues from field trial data and livestock feeding 
studies, while 100% crop treated assumptions (including feed items) 
were made for all commodities and 100 PCT. These assessments will not 
underestimate the exposure and risks posed by acetochlor.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are

[[Page 29027]]

safe by comparing aggregate exposure estimates to the acute PAD (aPAD) 
and chronic PAD (cPAD). For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure. Short-, intermediate-, and chronic-term risks are evaluated 
by comparing the estimated aggregate food, water, and residential 
exposure to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. In examining acute aggregate risk, the only pathway 
of exposure relevant to the acute time frame is dietary exposure. 
Therefore, the acute aggregate risk is comprised of exposures to 
acetochlor residues in food and drinking water and is equivalent to the 
acute dietary risk estimates. Using the exposure assumptions discussed 
in this unit for acute exposure, the acute dietary exposure from food 
and water to acetochlor will occupy 1.6% of the aPAD for infants <1-
year old, the population group receiving the greatest exposure.
    2. Chronic risk. In examining chronic aggregate risk, the only 
pathway of exposure relevant to the chronic time frame is dietary 
exposure. Therefore, the chronic aggregate risk is comprised of 
exposures to acetochlor residues in food and drinking water and is 
equivalent to the chronic dietary risk. Using the exposure assumptions 
described in this unit for chronic exposure, EPA has concluded that 
chronic exposure to acetochlor from food and water will utilize 26% of 
the cPAD for all infants (<1 year old), the population group receiving 
the greatest exposure. There are no residential uses for acetochlor.
    3. Short- and intermediate-term aggregate risk. Short-term and 
intermediate-term aggregate exposure take into account short-term or 
intermediate-term residential exposure plus chronic exposure from food 
and water (considered to be a background exposure level). Acetochlor is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term or intermediate-term aggregate risk 
is the sum of the risk from exposure to acetochlor through food and 
water and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. The Agency has 
concluded that assessments using a non-linear approach (e.g., a chronic 
RfD-based approach) will adequately protect for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
acetochlor. Chronic aggregate risk estimates are below the Agency's 
level of concern; therefore, cancer risk is also below the Agency's 
level of concern.
    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 acetochlor residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An Enforcement Analytical Method is available to enforce the 
proposed tolerances. The method is a high performance liquid 
chromatography/oxidative coulometric electrochemical detector (HPLC/
OCED) method and is listed as Method I in the Pesticide Analytical 
Manual (PAM) Vol. II (Sec.  180.470).

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for acetochlor on alfalfa 
commodities, but there are Codex MRLs established for livestock 
commodities at 0.02 ppm. The tolerances established in this rulemaking 
are harmonized with the Codex MRLs for livestock commodities, except 
for the U.S. kidney tolerances, which are being established at 0.03 
ppm.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the 8 ppm tolerance for alfalfa forage to 8.0 ppm, 
in accordance with policy. No other revisions were needed.

V. Conclusion

    Therefore, tolerances are established for residues of acetochlor, 
in or on Alfalfa, forage at 8.0 ppm, Alfalfa, hay at 20 ppm, Cattle, 
fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, 
Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 
ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat 
byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, 
fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, 
Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, 
Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 
ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 
CFR part 180.470 (d) Indirect or inadvertent residues., by adding 
alfalfa as an exception in the description of the commodities as 
follows: Animal feed, nongrass, group 18, except alfalfa, forage, and 
Animal feed, nongrass, group 18, except alfalfa, hay.

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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food

[[Page 29028]]

retailers, not States or tribes, nor does this action alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). As 
such, the Agency has determined that this action will not have a 
substantial direct effect on States or tribal governments, on the 
relationship between the national government and the States or tribal 
governments, or on the distribution of power and responsibilities among 
the various levels of government or between the Federal Government and 
Indian tribes. Thus, the Agency has determined that Executive Order 
13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and 
Executive Order 13175, entitled ``Consultation and Coordination with 
Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not 
apply to this action. In addition, this action does not impose any 
enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et 
seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 5, 2018.
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.  180.470,
0
i. Add alphabetically the entries ``Alfalfa, forage''; ``Alfalfa, 
hay''; ``Cattle, fat''; ``Cattle, kidney''; ``Cattle, meat''; ``Cattle, 
meat byproducts, except kidney''; ``Goat, fat''; ``Goat, kidney''; 
``Goat, meat''; ``Goat, meat byproducts, except kidney''; ``Hog, 
kidney''; ``Horse, fat''; ``Horse, kidney''; ``Horse, meat''; ``Horse, 
meat byproducts, except kidney''; ``Milk''; ``Sheep, fat''; ``Sheep, 
kidney''; ``Sheep, meat``; ``Sheep, meat byproducts, except kidney''; 
to the table in paragraph (a) and
0
ii. Revise the commodities ``Animal feed, nongrass, group 18, except 
alfalfa, forage'', and ``Animal feed, nongrass, group 18, except 
alfalfa, hay'' in the table in paragraph (d).
    The additions and revisions read as follows:


Sec.  180.470   Acetochlor; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................             8.0
Alfalfa, hay............................................              20
 
                                * * * * *
Cattle, fat.............................................            0.02
Cattle, kidney..........................................            0.03
Cattle, meat............................................            0.02
Cattle, meat byproducts, except kidney..................            0.02
 
                                * * * * *
Goat, fat...............................................            0.02
Goat, kidney............................................            0.03
Goat, meat..............................................            0.02
Goat, meat byproducts, except kidney....................            0.02
Hog, kidney.............................................            0.02
Horse, fat..............................................            0.02
Horse, kidney...........................................            0.03
Horse, meat.............................................            0.02
Horse, meat byproducts, except kidney...................            0.02
Milk....................................................            0.02
 
                                * * * * *
Sheep, fat..............................................            0.02
Sheep, kidney...........................................            0.03
Sheep, meat.............................................            0.02
Sheep, meat byproducts, except kidney...................            0.02
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, except alfalfa, forage.             1.3
Animal feed, nongrass, group 18, except alfalfa, hay....             3.5
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-13459 Filed 6-21-18; 8:45 am]
 BILLING CODE 6560-50-P


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