Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29023 

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 8, 2018. 

Michael Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.675: 

■ a. Revise the table in paragraph (a)(1); 

and 

■ b. Remove the entries for ‘‘Vegetable, 

fruiting, group 8–10’’ and 

‘‘Watermelon’’ in the table in paragraph 

(b). 

The revision reads as follows: 

§ 180.675 Tolfenpyrad; tolerance for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

Almond hulls ............................... 6.0 

Apple, wet pomace ..................... 3.0 

Brassica, leafy greens, subgroup 

4–16B ...................................... 40 

Commodity Parts per 

million 

Citrus, dried pulp 1 ...................... 8.0 

Citrus, dried pulp ........................ 4.0 

Citrus, oil 1 .................................. 70.0 

Citrus, oil ..................................... 30 

Cotton, gin byproducts ............... 15.0 

Cotton, undelinted seed ............. 0.70 

Fruit, citrus, group 10–10 1 ......... 1.5 

Fruit, citrus, group 10–10 ........... 0.80 

Fruit, pome, group 11–10 ........... 1.0 

Fruit, stone, group 12–12 ........... 2.0 

Grape .......................................... 2.0 

Grape, raisin ............................... 6.0 

Nuts, tree, group 14–12 ............. 0.05 

Persimmon .................................. 2.0 

Plum, prune ................................ 3.0 

Pomegranate .............................. 2.0 

Potato ......................................... 0.01 

Tea .............................................. 30.0 

Vegetable, Brassica, head and 

stem, group 5–16 .................... 5.0 

Vegetable, cucurbit, group 9 ...... 0.70 

Vegetable, fruiting, group 8–10 .. 0.70 

Vegetable, leafy, except Brassica, group 4 ........................... 30.0 

1This tolerance expires on December 24, 

2018. 

* * * * * 

[FR Doc. 2018–13456 Filed 6–21–18; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&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 


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29024 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

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: 

• 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 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-Nethoxymethylacetanilide), 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 


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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-observedadverse-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 


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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 noncancer 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 nonoccupational, 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 


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Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 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 

(§ 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 


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29028 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 

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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.470, 

■ 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 

■ 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: 

§ 180.470 Acetochlor; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

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) * * * 

Commodity Parts per 

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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0448; FRL–9978–50] 

Thiencarbazone-methyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of thiencarbazonemethyl in or on wheat forage. Bayer 

CropScience requested this tolerance 

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–2017–0448, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW, Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael L. Goodis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 


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