Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Rules and Regulations 42947 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the CAA; and 

• Does not provide the EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this action does not apply 

on any Indian reservation land or in any 

other area where the EPA or an Indian 

tribe has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications and will not impose 

substantial direct costs on tribal 

governments or preempt tribal law as 

specified by Executive Order 13175 (65 

FR 67249, November 9, 2000). 

B. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action 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. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

C. Petitions for Judicial Review 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by July 11, 2016. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this action for the purposes of 

judicial review nor does it extend the 

time within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Attainment 

determination, Incorporation by 

reference, Sulfur dioxide. 

Dated: August 24, 2017. 

Edward H. Chu, 

Acting Regional Administrator, Region 7. 

For the reasons stated in the 

preamble, EPA amends 40 CFR part 52 

as set forth below: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart AA—Missouri 

■ 2. Add § 52.1343 to read as follows: 

§ 52.1343 Control strategy: Sulfur Dioxide. 

(a) Determination of attainment. EPA 

has determined, as of September 13, 

2017, that the Jefferson County 2010 

SO2 nonattainment has attained the 

2010 SO2 1-hr NAAQS. This 

determination suspends the 

requirements for this area to submit an 

attainment demonstration, associated 

reasonably available control measures, 

reasonable further progress, contingency 

measures, and other plan elements 

related to attainment of the standards 

for as long as the area continues to meet 

the 2010 SO2 1-hr NAAQS. 

(b) [Reserved] 

[FR Doc. 2017–19339 Filed 9–12–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0308; FRL–9965–71] 

EPTC; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of EPTC, S-ethyl 

dipropylthiocarbamate in or on grass, 

forage at 0.60 ppm and grass, hay at 0.50 

ppm. Gowan Company requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 13, 2017. Objections and 

requests for hearings must be received 

on or before November 13, 2017, 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–2015–0308, is 

available at https://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 


sradovich on DSK3GMQ082PROD with RULES
42948 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Rules and Regulations 

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. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to https://

www.epa.gov/test-guidelines-pesticidesand-toxic-substances. 

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–2015–0308 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 November 13, 2017. 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– 

2015–0308, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at https://www.epa.gov/ 

dockets. 

II. Summary of Petitioned-For 

Tolerances 

In the Federal Register of Friday, July 

17, 2015 (80 FR 42462) (FRL–9929–13), 

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 5F8355) by 

Gowan Company, P.O. Box 5569, Yuma, 

AZ 85366. The petition requested that 

40 CFR part 180 be amended by 

establishing tolerances for residues of 

the herbicide EPTC, S-ethyl 

dipropylthiocarbamate, in or on grass 

grown for seed, forage at 0.6 parts per 

million (ppm) and grass grown for seed, 

hay at 0.5 ppm. That document 

referenced a summary of the petition 

prepared by Gowan Company, the 

registrant, which is available in the 

docket, https://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for EPTC, including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with EPTC 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. 

On an acute exposure basis, EPTC is 

highly toxic via inhalation and is 

moderately toxic via the oral and dermal 

routes of exposure. It is slightly 

irritating to eyes and minimallyirritating to skin. It is a weak skin 

sensitizer. 

EPTC is an S-alkylthiocarbamate, 

which consistently produced 

cardiomyopathy and neuronal cell 

necrosis in studies of varying length of 

treatment and in different species. 

Cardiotoxicity was observed in 

subchronic and long-term studies, and 

in general, the severity and incidence of 

the lesion increased with increasing 

doses of EPTC. In 90-day feeding and 

inhalation studies and in two chronic 

feeding/oncogenicity studies, 

histopathological evaluation revealed 

myocardial degeneration. Myocardial 

degeneration in adult rats was also 

observed in two separate two-generation 

reproduction studies. In two chronic 

dog studies, degenerative changes in the 

cardiac muscle were observed when 

EPTC was administered in a capsule, 

but not when administered (at 

comparable doses) in the diet. In both 

dog studies, electrocardiograms were 

taken, but only one high-dose male in 

the capsule study had changes which 

were described as ‘‘potentially’’ 

treatment-related. 

EPTC, as well as other thiocarbamates 

(molinate, cycloate, pebulate, vernolate 

and butylate), have toxic effects on the 

central and peripheral nervous systems. 

With EPTC, there was an increased 

incidence and severity of neuronal 

necrosis/degeneration in both the 

central and peripheral nervous systems 

of rats and dogs. In the rat neurotoxicity 

studies, dose-related increases in the 

incidence of neuronal necrosis were 

observed in the brains after acute and 

subchronic exposure to EPTC. In the rat 

developmental neurotoxicity study, a 


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marginal decrease in absolute (not 

relative) pup brain weight (4–6%) was 

observed in only one sex (male pups) 

and at only one time point (PND63). 

Furthermore, this marginal effect had no 

dose-response, was not seen after 

perfusion, and had no corresponding 

necrosis. Therefore, this effect was 

considered marginal at best and not 

robust. In both of the combined chronic 

toxicity/carcinogenicity studies in the 

rat and in the chronic (capsule) study in 

the dog, treatment-related 

neuromuscular lesions were observed. 

In all of these studies, hindquarter 

weakness with corresponding 

histopathology findings of atrophy and 

degeneration of the skeletal muscle were 

observed. In the dog study, the lesions 

were described as Wallerian-type 

degeneration in the spinal cords and 

various peripheral nerves. 

EPTC is a reversible 

acetylcholinesterase (AChE) inhibitor. 

Toxicology studies with EPTC did not 

show any consistent pattern of AChEinhibition between different species, 

length of treatment, or the type of AChE 

enzyme measured. In some studies, 

brain AChE activity was inhibited 

without any effect on either plasma or 

erythrocyte AChE activities. In other 

studies, erythrocyte AChE was inhibited 

with no inhibition of either plasma or 

brain AChE. AChE-inhibition was 

observed at comparable or higher doses 

than where cardiac/neuronal effects 

were observed. 

There is no evidence of increased 

susceptibility following in utero 

exposure to EPTC in either the rat or 

rabbit developmental toxicity study or 

following in utero and/or postnatal 

exposure in the 2-generation 

reproduction study in rats. EPTC is 

classified as ‘‘Not Likely to be 

Carcinogenic to Humans.’’ This is based 

on the lack of carcinogenic potential 

noted in the available studies. There are 

no concerns for mutagenicity or 

clastogenicity. There is also no concern 

for immunotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by EPTC as well as the 

no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies scan be found at https:// 

www.regulations.gov in document 

EPTC: Human Health Risk Assessment 

for the Proposed Section 3 Registration 

for Use on Grasses Grown for Seed 

Production in docket ID number EPA– 

HQ–OPP–2015–0308. 

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 https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for EPTC used for human risk 

assessment is shown in Table 1 of this 

unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR EPTC FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (all populations 

including infants and children).

LOAEL = 200 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF/UFL = 10x 

aRfD/aPAD = 0.2 

mg/kg/day.

Acute neurotoxicity rat study. 

NOAEL not established in males. 

LOAEL = 200 mg/kg/day based on neuronal cell necrosis in the 

brain in males. 

Chronic dietary (all populations 

including infants and children).

POD = 5 mg/kg/day

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

cRfD/cPAD = 0.05 

mg/kg/day.

Co-critical, chronic/carcinogenicity and 2-generation reproduction in rats. 

Incidental oral (short- and intermediate-term).POD = 5 mg/kg/day

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic toxicity/carcinogenicity rat study. 

NOAEL = 5 mg/kg/day. 

LOAEL = 25 mg/kg/day based on decreased body weight and 

increased incidences of myocardial and neuromuscular lesions. 

Dermal (short- and intermediated-term).POD = 5 mg/kg/day 

Dermal absorption 

factor= 5%.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 2-generation reproduction toxicity rat study. 

Parental NOAEL = 2.5 mg/kg/day. 

Parental LOAEL = 10 mg/kg/day based on decreased body 

weight and cardiomyopathy. 

Developmental NOAEL = 10 mg/kg/day. 

Developmental LOAEL = 40 mg/kg/day based on decreased 

mean pup weight during lactation days 4 to 21. 

Reproductive NOAEL = 40 mg/kg/day. 

Reproductive LOAEL >40 mg/kg/day. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR EPTC FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Inhalation (short- and intermediated-term).BMDL10 = 5.05 mg/ 

m3 mg/kg/day.

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 30 .. 90-day inhalation toxicity study in rats. 

BMD10 = 10.84 mg/m3 based on brain cholinesterase inhibition 

in males. 

Residential bystander HEC = 2.288 mg/m3

Occupational Handler HEC = 9.609 mg/m3; 

HED = 0.91 mg/kg/day 

Cancer (oral, dermal, inhalation).Classified as ‘‘Not Likely to be Carcinogenic to Humans.’’ based on the lack of carcinogenic potential noted in 

the available studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram per kilogram per day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = 

acute, c = chronic). POD = point of departure. RfD = reference dose (a = acute, c = chronic). UF = uncertainty factor. UFA = extrapolation from 

animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a 

LOAEL to extrapolate a NOAEL. HEC = human equivalent concentration. HED = human equivalent dose. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to EPTC, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing EPTC 

tolerances in 40 CFR 180.117. EPA 

assessed dietary exposures from EPTC 

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 EPTC. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA 

incorporated tolerance-level residues 

(adjusted for metabolites at 15X, to 

estimate the concentration of residues of 

toxicological concern), 100 percent crop 

treated (PCT) for all commodities, and 

default processing factors for all 

processed commodities except for 

potato granules (1.4X) and for sugar 

beets (4X). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the same food consumption 

data and food residue level information 

as described above for acute dietary 

exposure. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that EPTC 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. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for EPTC. Tolerance-level residues and 

100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. 

The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for EPTC in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of EPTC. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Tier II Surface Water 

Concentration Calculator (SWCC) and 

Pesticide Root Zone Model Ground 

Water (PRZM–GW) model, the highest 

estimated drinking water concentration 

(EDWC) of EPTC for acute exposure is 

estimated to be 378 parts per billion 

(ppb) from ground water. For chronic 

exposure, the highest EDWC is 

estimated to be 335 ppb from ground 

water. These EDWCs were directly 

entered into the dietary exposure 

models for both acute and chronic 

dietary risk assessments to assess the 

contribution from 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). EPTC 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.’’ Although 

thiocarbamates share some chemical 

and toxicological characteristics, the 

toxicological database does not support 

a testable hypothesis for a common 

mechanism of action. Therefore, for the 

purposes of this tolerance action EPA 

has assumed that EPTC 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 https:// 

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-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 


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based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

As discussed in Unit III.A., there was no 

qualitative or quantitative evidence of 

increased susceptibility to developing 

fetuses following in utero exposure to 

EPTC in the rabbit and rat 

developmental toxicity studies, or to 

offspring in the rat two-generation 

reproduction toxicity study. Although 

there was evidence of increased 

qualitative and quantitative 

susceptibility of offspring observed in 

the rat developmental neurotoxicity 

study. The effect on a marginal 

decreased absolute brain weight was 

observed only in male pups at one timepoint on postnatal day 63. This effect 

was considered marginal and not robust 

since it had no dose-response, was not 

seen after perfusion, and had no 

corresponding necrosis. Therefore, there 

is low concern for susceptibility. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X for assessing 

chronic dietary exposure but retained at 

10X for assessing acute dietary exposure 

to account for extrapolating a NOAEL 

from a LOAEL. That decision is based 

on the following findings: 

i. The toxicity database for EPTC is 

complete and adequate to assess 

potential risk to infants and children. 

ii. There is indication that EPTC has 

toxic effects on the central and 

peripheral nervous systems. Neuronal 

necrosis and degeneration were 

observed in both the central and 

peripheral nervous systems of rats and 

dogs after acute and subchronic 

exposure. Treatment-related 

neuromuscular lesions were also 

observed in chronic rat and dog studies. 

In all of these studies hindquarter 

weakness was noted, and at necropsy 

evaluation atrophy and degeneration of 

the skeletal muscle was observed. In the 

dog study, the lesions were described as 

Wallerian-type degeneration in the 

spinal cords and various peripheral 

nerves. AChE inhibition was also seen 

in a number of toxicology studies; 

however, no consistent pattern was 

witnessed across studies with respect to 

AChE inhibition between different 

species, length of treatment, or the type 

of AChE enzyme measured. All studies 

provide clear NOAELs and LOAELs, 

except the acute neurotoxicity study, 

and because the Agency is relying on 

that study for selection of the acute 

dietary exposure endpoint, EPA is 

retaining the 10X FQPA safety factor to 

account from the extrapolation from the 

LOAEL to the NOAEL. 

iii. There is no evidence that EPTC 

results in increased susceptibility in in 

utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the two-generation reproduction 

study. Evidence of increased 

susceptibility to offspring was observed 

in the developmental neurotoxicity 

study; however, this effect was 

considered marginal and not robust. 

Therefore, there is low concern for the 

susceptibility. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to EPTC in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by EPTC. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to EPTC 

will occupy 46% of the aPAD for 

children between 1–2 years old, the 

population subgroup receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to EPTC from 

food and water will utilize 65% of the 

cPAD for children between 1–2 years 

old, the population subgroup receiving 

the greatest exposure. There are no 

residential uses for EPTC. 

3. Short- and intermediate-term risks. 

Short- and intermediate-term aggregate 

exposures takes into account short-term 

(1 to 30 days) and intermediate-term (1 

to 6 months) residential exposure plus 

chronic exposure from food and water 

(considered to be a background 

exposure level). Short- and 

intermediate-term adverse effects were 

identified; however, EPTC is not 

registered for any use patterns that 

would result in residential exposure. 

Because there is no residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective PADs (which is 

at least as protective as the PODs used 

to assess short- and intermediate-term 

risks), no further assessment of shortand intermediate-term risks are 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating short- and intermediate-term 

risks for EPTC. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

EPTC 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 EPTC 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate gas chromatography with 

micro coulometric (GLC/MC) detection 

method (RR–50) listed under Method A 

in the Pesticide Analytical Manual 

(PAM Volume II, Section 180.117; is 

available for enforcing tolerances of 

EPTC per se in plant commodities. For 

the determination of hydroxylated 

metabolites (free or conjugated) of EPTC 

in or on plant commodities, an adequate 

gas chromatography with nitrogenphosphorus detection (GC/NPD) 

enforcement method (Method RR–96– 

089B) is also available. 

These methods may be requested 

from: Chief, Analytical Chemistry 

Branch, Environmental Science Center, 

701 Mapes Rd., Ft. Meade, MD 20755– 

5350; telephone number: (410) 305– 

2905; email address: residuemethods@

epa.gov. 

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 


sradovich on DSK3GMQ082PROD with RULES
42952 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Rules and Regulations 

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 any MRLs for EPTC. 

C. Revisions to Petitioned-For 

Tolerances 

The Agency is establishing tolerances 

for the forage and hay forms of ‘‘grass’’ 

rather than ‘‘grass grown for seed’’ as 

requested to conform with its food and 

feed commodity vocabulary. Also, the 

Agency is establishing the tolerance 

levels to conform with its policy of 

significant figures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of EPTC, S-ethyl 

dipropylthiocarbamate, including its 

metabolites and degradates, in or on 

grass, forage at 0.60 ppm and grass, hay 

at 0.50. 

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 tolerances 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. 

Dated: August 16, 2017. 

Michael L. 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 § 180.117, add alphabetically the 

commodities to the table in paragraph 

(a) to read as follows: 

§ 180.117 S-ethyl dipropylthiocarbamate; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Grass, forage ........................ 0.60 

Grass, hay ............................ 0.50 

* * * * * 

* * * * * 

[FR Doc. 2017–19452 Filed 9–12–17; 8:45 am] 

BILLING CODE 6560–50–P 


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