50084 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 1980 

(RFA), 5 U.S.C. 601–612, as amended, 

requires federal agencies to consider the 

potential impact of regulations on small 

entities during rulemaking. The term 

‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard received zero 

comments from the Small Business 

Administration on this rule. The Coast 

Guard certifies under 5 U.S.C. 605(b) 

that this rule will not have a significant 

economic impact on a substantial 

number of small entities. While some 

owners or operators of vessels intending 

to transit the bridge may be small 

entities, for the reasons stated in section 

V.A above, this rule will not have a 

significant economic impact on any 

vessel owner or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT, above. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). 

D. Federalism and Indian Tribal 

Government 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. We 

received zero comments on this rule. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this 

proposed rule will not result in such an 

expenditure, we do discuss the effects of 

this proposed rule elsewhere in this 

preamble. We received zero comments 

on this rule. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a determination that this 

action is one of a category of actions 

which do not individually or 

cumulatively have a significant effect on 

the human environment. This rule 

simply promulgates the operating 

regulations or procedures for 

drawbridges. This action is categorically 

excluded from further review, under 

figure 2–1, paragraph (32)(e), of the 

Instruction. A preliminary Record of 

Environmental Consideration and a 

Memorandum for the Record are not 

required for this rule. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to contact the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Revise § 117.243(b) to read as 

follows: 

§ 117.243 Nanticoke River. 

* * * * * 

(b) The draw of the SR 13 Bridge, mile 

39.6, in Seaford shall: 

(1) Open on signal, except from 6 p.m. 

to 8 a.m., from April 1 through October 

31; from November 1 through March 31, 

Monday to Friday and on Saturday and 

Sunday from 3:30 p.m. to 7:30 a.m., if 

at least four hours notice is given. 

(2) Open on signal, on Saturday and 

Sunday, from 7:31 a.m. through 3:29 

p.m., from November 1 through March 

31, if at least 24 hours notice is given. 

Dated: October 10, 2017. 

M.L. Austin, 

Rear Admiral, U.S. Coast Guard, Commander, 

Fifth Coast Guard District. 

[FR Doc. 2017–23559 Filed 10–27–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0155; FRL–9968–12] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

existing tolerance for residues of the 

ovicide/miticide hexythiazox in/on hop, 

dried cones, by increasing the current 

tolerance from 2.0 parts per million 

(ppm) to 20 ppm. Gowan Company 

requested modification of this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 30, 2017. Objections and 

requests for hearings must be received 


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on or before December 29, 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–2017–0155, 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, P.E., Director, 

Registration Division (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

main telephone number: (703) 305– 

7090; email address: 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–2017–0155 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 December 29, 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– 

2017–0155, 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 June 8, 2017 

(82 FR 26641) (FRL–9961–14), EPA 

issued a document pursuant to the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP #6F8489) by 

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

AZ 85366–5569. This petition requested 

that 40 CFR 180.448 be amended by 

establishing a tolerance for residues of 

hexythiazox in or on hop, dried cones 

at 20 ppm. This document referenced a 

summary of the petition prepared by 

Gowan Company, the registrant, which 

is available in the docket, http://

www.regulations.gov. No comments 

were received in response to the 

referenced 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 hexythiazox 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with hexythiazox 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. 

Hexythiazox has low acute toxicity by 

the oral, dermal, and inhalation routes 

of exposure. It produces mild eye 

irritation and is not a skin irritant or 

skin sensitizer. Hexythiazox is 

associated with toxicity of the liver and 


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adrenals following subchronic and 

chronic exposure to dogs, rats, and 

mice, with the dog being the most 

sensitive species. The prenatal 

developmental studies in rabbits and 

rats and the two-generation 

reproduction study in rats showed no 

indication of increased susceptibility to 

in utero or postnatal exposure to 

hexythiazox. Reproductive toxicity was 

not observed. There is no concern for 

immunotoxicity or neurotoxicity 

following exposure to hexythiazox. The 

toxicology database for hexythiazox 

does not show any evidence of 

treatment-related effects on the immune 

system. 

Hexythiazox is classified as ‘‘Likely to 

be Carcinogenic to Humans’’ based on a 

treatment-related increase in benign and 

malignant liver tumors in female mice 

and the presence of mammary gland 

tumors (fibroadenomas) in male rats; 

however, the evidence as a whole was 

not strong enough to warrant the use of 

a linear low dose extrapolation model 

applied to the animal data (Q1*) for a 

quantitative estimation of human risk 

because the common liver tumors 

(benign and malignant) were only 

observed in high-dose female mice, and 

benign mammary gland tumors were 

only observed in high-dose male rats. 

Since the effects seen in the study that 

serves as the basis for the chronic 

reference dose (cRfD) occurred at doses 

substantially below the lowest dose that 

induced tumors (and there is no 

mutagenic concern for hexythiazox), the 

cRfD is considered protective of all 

chronic effects, including potential 

carcinogenicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by hexythiazox 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 within the 

document entitled ‘‘Hexythiazox. 

Human Health Risk Assessment for 

Amended Use on Hops,’’ dated 

September 5, 2017, which can be found 

in docket ID number EPA–HQ–OPP– 

2017–0155. 

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 hexythiazox 

used for human risk assessment is 

shown in the Table of this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX 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) No risk is expected from this exposure scenario as no hazard was identified in any toxicity study for this duration of exposure. 

Chronic Dietary (All populations).NOAEL= 2.5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.025 

mg/kg/day.

cPAD = 0.025 

One-Year Feeding Toxicity Study—Dogs. 

LOAEL = 12.5 mg/kg/day based on increased absolute and relative adrenal weights, and associated adrenal 

histopathology. 

Incidental Oral Short-Term (1 to 

30 days) and IntermediateTerm (1 to 6 months).

NOAEL= 30 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

2-Generation Reproduction Study—Rat. 

LOAEL = 180 mg/kg/day, based on decreased pup body 

weight during lactation and delayed hair growth and/or eye 

opening, and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal 

weights. 

Dermal Short- and Intermediate-term.A quantitative dermal risk assessment is not necessary since no dermal hazard is anticipated. There is no evidence of increased quantitative or qualitative susceptibility of the young following in utero and pre-and postnatal exposure to hexythiazox. 

Inhalation Short-Term (1 to 30 

days) and Intermediate-Term 

(1 to 6 months).

Oral NOAEL= 30 

mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE = 100.

2-Generation Reproduction Study—Rat. 

LOAEL = 180 mg/kg/day, based on decreased pup body 

weight during lactation and delayed hair growth and/or eye 

opening, and decreased parental body-weight gain and increased absolute and relative liver, kidney, and adrenal 

weights. 


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TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX 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 

Cancer (oral, dermal, and inhalation).Classification: ‘‘Likely to be Carcinogenic to Humans.’’ A quantification of risk using a non-linear approach; i.e., 

RfD, for hexythiazox will adequately account for all chronic toxicity, including carcinogenicity, that could result 

from exposure to hexythiazox. 

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

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

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to hexythiazox, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing hexythiazox tolerances in 40 

CFR 180.448. EPA assessed dietary 

exposures from hexythiazox 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. No toxic effects attributable to 

a single dose of hexythiazox were 

observed in the toxicology database; 

therefore, a quantitative acute dietary 

exposure and risk assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary (food and drinking 

water) exposure assessment, EPA used 

the Dietary Exposure Evaluation Model 

(DEEM–FCID), Version 3.16, which uses 

food consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America 

(NHANES/WWEIA) from 2003–2008. As 

to residue levels in food, EPA used 

tolerance-level residues, assumed 100 

percent crop treated (PCT), and 

incorporated DEEM 7.81 default 

processing factors when processing data 

were not available. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to hexythiazox. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii., 

Chronic exposure. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for hexythiazox. Tolerance-level 

residues and/or 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 hexythiazox in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

hexythiazox. 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. 

Surface water and groundwater 

estimated drinking water concentrations 

(EDWCs) do not result in any change to 

the existing EDWCs determined from a 

recent drinking water assessment 

derived on hops. Specifically, since 

hops is already a registered use that was 

recently assessed during registration 

review, no new drinking water scenarios 

were identified with this proposed 

increase in application rates that would 

require a new drinking water 

assessment to be conducted. In fact, the 

highest EDWCs associated with all uses 

of hexythiazox continue to be from use 

on sorghum in the Western U.S., using 

the Pesticide Root Zone Model (PRZM) 

surface water modeling scenario. 

Furthermore, based on the Agency’s 

previous assessment, the EDWCs of 

hexythiazox for chronic exposures are 

estimated to be 4.3 parts per billion 

(ppb) for surface water and 2.4 ppb for 

ground water (DP 433290, 5/9/2016; DP 

404023, 1/17/2012), and the higher of 

these values was used in the dietary 

exposure model to assess chronic 

dietary risk. 

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). 

Hexythiazox is currently registered for 

the following residential uses, including 

ornamental landscape plantings, turf, 

and fruit and nut trees in residential 

sites. 

EPA assessed residential exposure 

using the following assumptions: 

Residential handler exposures are 

expected to be short-term (1 to 30 days) 

via either the dermal or inhalation 

routes of exposures. Since a quantitative 

dermal risk assessment is not needed for 

hexythiazox, handler MOEs were 

calculated for the inhalation route of 

exposure only. EPA uses the term ‘‘postapplication’’ to describe exposure to 

individuals that occur as a result of 

being in an environment that has been 

previously treated with a pesticide. 

There is potential for post-application 

for individuals exposed as a result of 

being in an environment that has been 

previously treated with hexythiazox. 

Adult residential post-application 

dermal exposures were not assessed 

since no dermal hazard was identified 

for hexythiazox. The residential postapplication exposure assessment for 

children included incidental oral 

exposure resulting from transfer of 

residues from the hand-to-mouth, object 

to- mouth, and from incidental ingestion 

of soil. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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.’’ 

EPA has not found hexythiazox to 

share a common mechanism of toxicity 

with any other substances, and 

hexythiazox does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action; therefore, EPA has 

assumed that hexythiazox does not have 

a common mechanism of toxicity with 

other substances. For information 


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regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

data base indicates no increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

hexythiazox. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1x. That decision is 

based on the following findings: 

i. The toxicity database for 

hexythiazox is complete. 

ii. There is no indication that 

hexythiazox is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

hexythiazox results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

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 hexythiazox in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by hexythiazox. 

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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No toxic effects attributable to a 

single dose of hexythiazox were 

observed in the toxicology database; 

therefore, a quantitative acute aggregate 

risk assessment for hexythiazox is not 

required. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to hexythiazox 

from food and water will utilize 93% of 

the cPAD for children 1–2 years of age, 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

hexythiazox is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Hexythiazox is currently registered for 

uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to hexythiazox. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, drinking water, and residential 

inhalation exposures result in an 

aggregate MOE for adults (7,500) that 

greatly exceeds the LOC of 100, and is 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Hexythiazox is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to hexythiazox. Using the exposure 

assumptions described in this unit for 

intermediate-term exposures, EPA has 

concluded the combined intermediateterm food, drinking water, and 

residential oral exposures result in an 

aggregate MOE for children (1,150) that 

greatly exceeds the LOC of 100, and is 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. As discussed in Unit III. 

C.1.iii., EPA concluded that regulation 

based on the cRfD will be protective for 

both chronic and carcinogenic risks. As 

noted in this unit, there are no chronic 

risks of concern; therefore, the Agency 

concludes that aggregate exposure to 

hexythiazox will not pose a cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the U.S. general 

population, or to infants and children 

from aggregate exposure to hexythiazox 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate High performance liquid 

chromatography using ultra-violet 

detection (HPLC/UV) analytical method 

is available for the enforcement of 

tolerances for residues of hexythiazox 

and its metabolites containing the PT– 

1–3 moiety in crop and livestock 

commodities. This method is listed in 

the U.S. EPA Index of Residue 

Analytical Methods under hexythiazox 

as method AMR–985–87. The limit of 

quantification (LOQ) for hexythiazox 

residues is 0.02 ppm. 

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 Federal Food, Drug and 

Cosmetic Act (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, 


nlaroche on DSK9F9SC42PROD with RULES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50089 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

Codex has established an MRL for 

residues of hexythiazox on hops at 3 

ppm. The U.S. tolerance for residues of 

hexythiazox on hops cannot be 

harmonized based on approved label 

instructions. Based on available residue 

data, compliance with label instructions 

would result in exceedances of a 

tolerance harmonized with the Codex 

MRL. 

V. Conclusion 

Therefore, the existing tolerance for 

residues of the ovicide/miticide 

hexythiazox and its metabolites 

containing the (4-chlorophenyl)-4- 

methyl-2-oxo-3-thiazolidine moiety in/ 

on hop, dried cones is increased from 

2.0 ppm to 20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action amends an existing 

tolerance under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993). Because 

this action has been exempted from 

review under Executive Order 12866, 

this action is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

This action does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.), nor does it require any special 

considerations under Executive Order 

12898, entitled ‘‘Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: October 6, 2017. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.448 is amended by 

revising the entry ‘‘Hop, dried cones’’ in 

the table in paragraph (a) to read as 

follows: 

§ 180.448 Hexythiazox; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Hop, dried cones ........................ 20 

* * * * * 

* * * * * 

[FR Doc. 2017–23439 Filed 10–27–17; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2015–0056] 

RIN 2127–AL78 

Motor Vehicle Safety Standards; 

Electronic Stability Control Systems 

for Heavy Vehicles 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation. 

ACTION: Final rule; response to petition 

for reconsideration. 

SUMMARY: This final rule addresses a 

petition for reconsideration of the final 

rule for FMVSS No. 136, Electronic 

stability control systems for heavy 

vehicles. The petitioner, Truck and 

Engine Manufacturers Association 

(EMA), requested that NHTSA amend 

the test conditions for the agency’s 

performance test by allowing a larger 

lane width for long wheelbase truck 

tractors. After a careful technical review 

of the petition and the issues raised by 

the petitioner, the agency has decided to 

grant the petition because there is 

sufficient evidence to indicate that a 

larger lane width is needed for testing 

of long wheelbase truck tractors. 

DATES: The effective date of this final 

rule is November 29, 2017. 

Petitions for reconsideration: Petitions 

for reconsideration of this final rule 

must be received not later than 

December 14, 2017. 

ADDRESSES: Petitions for reconsideration 

of this final rule must refer to the docket 

and notice number set forth above and 

be submitted to the Administrator, 

National Highway Traffic Safety 

Administration, 1200 New Jersey 

Avenue SE., Washington, DC 20590. 

FOR FURTHER INFORMATION CONTACT: For 

technical issues, you may contact 


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