46394 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 

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 will not call for a new 

collection of information under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). 

D. Federalism and Indian Tribal 

Governments 

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. If you 

believe this rule has implications for 

federalism or Indian tribes, please 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section. 

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 rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, which guides the 

Coast Guard in complying with the 

National Environmental Policy Act of 

1969 (42 U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves 

establishing a temporary safety zone 

extending 150 yards around a bridge to 

complete emergency repairs to the S99 

Alford Street Bridge during a sevenmonth period when boating traffic is 

minimal on the Mystic River. It is 

categorically excluded from further 

review under paragraph L60(b) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 01. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket where indicated 

under ADDRESSES. 

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 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add a new § 165.T01–0343 to read 

as follows: 

§ 165.T01–0343 Safety zone, S99 Alford 

Street Bridge—Emergency grid replacement 

project, Mystic River, Charlestown and 

Everett, MA. 

(a) Location. The following area is a 

safety zone: All navigable waters of the 

Mystic River between Charlestown and 

Everett, Massachusetts from surface to 

bottom, within 150-yards of the S99 

Alford Street Bridge, at mile 1.4 on the 

Mystic River between Charlestown and 

Everett, Massachusetts. 

(b) Definitions. As used in this 

section: 

(1) Designated representative means 

any Coast Guard commissioned, 

warrant, petty officer, or any federal, 

state, or local law enforcement officer 

who has been designated by the Captain 

of the Port (COTP) Boston, to act on his 

or her behalf. The designated 

representative may be on an official 

patrol vessel or may be on shore and 

will communicate with vessels via 

VHF–FM radio or loudhailer. In 

addition, members of the Coast Guard 

Auxiliary may be present to inform 

vessel operators of this regulation. 

(2) Official patrol vessel means any 

Coast Guard, Coast Guard Auxiliary, 

state, or local law enforcement vessel 

assigned or approved by the COTP 

Boston to enforce this section. 

(c) Enforcement Periods. This section 

is enforceable 24 hours a day from 12:01 

a.m. on October 1, 2018, through 11:59 

p.m. on April 30, 2019. When enforced 

as deemed necessary by the COTP 

Boston, vessels will be prohibited from 

entering this safety zone during the 

emergency grid replacement on the 

bridge. 

(d) Regulations. The general 

regulations contained in 33 CFR 165.23, 

as well as the following regulations, 

apply: 

(1) No person or vessel may enter or 

remain in this safety zone without the 

permission of the COTP Boston or the 

COTP’s designated representatives. 

However, any person or vessel 

permitted to enter the safety zone must 

comply with the directions and orders 

of the COTP Boston or the COTP’s 

designated representatives. 

(2) To obtain permission required by 

this regulation, individuals may reach 

the COTP Boston or a COTP designated 

representative via Channel 16 (VHF– 

FM) or 617–223–5757 (Sector Boston 

Command Center). 

(3) Penalties. Those who violate this 

section are subject to the penalties set 

forth in 33 U.S.C. 1232. 

Dated: September 6, 2018. 

Eric J. Doucette, 

Captain, U.S. Coast Guard, Captain of the 

Port Boston. 

[FR Doc. 2018–19746 Filed 9–12–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0416; FRL–9976–65] 

Afidopyropen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of afidopyropen, 

[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3- 

[(cyclopropylcarbonyl)oxy]- 

1,3,4,4a,5,6,6a,12,12a,12b-decahydroVerDate Sep<11>2014 17:40 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\13SER1.SGM 13SER1

daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46395 

6,12-dihydroxy-4,6a,12b-trimethyl-11- 

oxo-9-(3-pyridinyl)-2H,11Hnaphtho[2,1-b]pyrano[3,4-e]pyran-4- 

yl]methyl cyclopropanecarboxylate, 

including its metabolites and 

degradates, in or on multiple 

commodities which are identified and 

discussed later in this document. BASF 

Corporation requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

September 13, 2018. Objections and 

requests for hearings must be received 

on or before November 13, 2018, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2016–0416, 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 Building, Room 3334, 

1301 Constitution Avenue 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 

Avenue 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–2016–0416 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, 2018. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2016–0416, 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 

Avenue 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 August 12, 

2016 (81 FR 53380) (FRL–9949–53), 

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 6F8468) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709–3528. The petition requested that 

40 CFR part 180 be amended by 

establishing permanent tolerances in 

primary crops for residues of the 

insecticide afidopyropen, 

[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3- 

[(cyclopropylcarbonyl)oxy]- 

1,3,4,4a,5,6,6a,12,12a,12b-decahydro6,12-dihydroxy-4,6a,12b-trimethyl-11- 

oxo-9-(3-pyridinyl)-2H,11Hnaphtho[2,1-b]pyrano[3,4-e]pyran-4- 

yl]methyl cyclopropanecarboxylate, its 

metabolites, and degradates, in or on the 

following raw agricultural and 

processed commodities: Almond, hulls 

at 0.15 parts per million (ppm); Apple, 

wet pomace at 0.05 ppm; Citrus, oil at 

0.3 ppm; Cotton, gin byproducts at 2 

ppm; Cotton, undelinted seed at 0.1 

ppm; Fruit, citrus, group 10–10 at 0.15 

ppm; Fruit, pome, group 11–10 at 0.03 

ppm; Fruit, stone, group 12–12 at 0.03 

ppm; Nut, tree, group 14–12 at 0.01 

ppm; Plum, prune at 0.06 ppm; 

Soybean, aspirated grain fractions at 0.4 

ppm; Soybean, seed at 0.01 ppm; 

Vegetable, brassica, head and stem, 

group 5–13 at 0.5 ppm; Vegetable, 

cucurbit, group 9 at 0.7 ppm; Vegetable, 

fruiting, group 8–10 at 0.15 ppm; 

Vegetable, leaf petioles, subgroup 22B at 

3 ppm; Vegetable, leafy, subgroup 4– 

13A at 2 ppm; Vegetable, leafy, 

subgroup 4–13B at 5 ppm; and 

Vegetable, tuberous and corm, subgroup 

1C at 0.01 ppm. That document 

referenced a summary of the petition 

prepared by BASF Corporation, 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 and EPA policy, 

the Agency has revised some of the 

commodity definitions and tolerance 

levels from the petition, and concluded 

that the following tolerances are 

appropriate for afidopyropen in or on 

the following commodities: Almond, 

hulls at 0.15 ppm; Apple, wet pomace 

at 0.05 ppm; Brassica, head and stem, 

group 5–16 at 0.50 ppm; Brassica, leafy 

greens, subgroup 4–16B at 5.0 ppm; 

Citrus, oil at 0.40 ppm; Cotton, gin 


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46396 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 

byproducts at 2.0 ppm; Cotton, 

undelinted seed at 0.08 ppm; Fruit, 

citrus, group 10–10 at 0.15 ppm; Fruit, 

pome, group 11–10 at 0.02 ppm; Fruit, 

stone, group 12–12 at 0.03 ppm; Grain, 

aspirated fractions at 0.15 ppm; Leafy 

Greens, subgroup 4–16A at 2.0 ppm; 

Leaf petiole vegetable subgroup 22B at 

3.0 ppm; Nut, tree, group 14–12 at 0.01 

ppm; Soybean, seed at 0.01 ppm; 

Tomato, dried at 0.50 ppm; Vegetable, 

cucurbit, group 9 at 0.70 ppm; 

Vegetable, fruiting, group 8–10 at 0.20 

ppm; and Vegetable, tuberous and corm, 

subgroup 1C at 0.01 ppm. The reasons 

for these changes are explained in Unit 

IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for afidopyropen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with afidopyropen 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. 

Afidopyropen is classified as category 

III for acute oral and acute dermal, and 

category IV for acute inhalation, primary 

eye irritation, and dermal irritation. The 

toxicology database for afidopyropen is 

complete. The target organs identified 

following exposure to afidopyropen are 

the liver, heart, brain, spleen, and 

reproductive organs of both sexes. The 

liver is a main target organ in both 

subchronic and chronic oral toxicity 

studies in all three-species tested (i.e., 

mouse, rat, and dog). 

There was no evidence of 

neurotoxicity seen in the subchronic 

neurotoxicity study in rats up to the 

highest dose tested. Afidopyropen 

caused neurotoxic effects in the acute 

neurotoxicity study; however, only at 

the limit dose of 2,000 milligrams/ 

kilogram/day (mg/kg/day). 

There is evidence of increased 

susceptibility following pre- and or 

post-natal exposure to afidopyropen. In 

a prenatal developmental study in rats, 

adverse effects in fetuses included an 

increased incidence of skeletal 

variations (lumbar ribs), increased 

ossification of the metatarsi, and an 

altered sex ratio (increased percentage 

of male pups); however, maternal effects 

were not observed up to the highest 

dose tested. In a second developmental 

study in rats, adverse fetal effects 

(increased incidence of skeletal 

variations and supernumerary ribs) 

occurred at a lower dose as compared to 

maternal effects (mortality in one 

animal). In a developmental study in 

rabbits, fetal developmental and 

maternal effects occurred at the same 

dose level. Effects included a decreased 

number of live fetuses, increased early 

resorptions and completely resorbed 

litters, as well as increased postimplantation loss. Fetuses also 

exhibited an altered sex ratio (increased 

percentage of male pups) at this dose 

level. 

Quantitative susceptibility was also 

observed in two 2-generation rat studies. 

In the first study, no reproductive or 

parental effects were observed, while 

offspring effects were decreased 

absolute body weight in both sexes and 

F1 pup and litter deaths. In the second 

study, offspring effects included 

decreased absolute body weight and 

decreased spleen and thymus weights in 

both sexes. Reproductive effects 

included effects on ovary and uterus 

weight, decreased implantation sites, 

and an altered sex ratio (increased 

percentage of male pups). In this study, 

the parental and offspring effects 

occurred at the same dose level. 

Afidopyropen did not display 

systemic effects in the 28-day dermal 

study, even at the limit dose of 1,000 

mg/kg/day. There were no adverse 

effects observed in the route-specific 

dermal toxicity study up to the limit 

dose; however, there is evidence of 

increased susceptibility following preand/or post-natal exposure to 

afidopyropen. As a result, an oral point 

of departure was selected since the 

dermal toxicity study did not evaluate 

developmental or reproductive 

endpoints. A point of departure (POD) 

for dermal exposures (all durations) was 

selected from the 2-generation 

reproduction study in rats, this POD 

reflects the most sensitive endpoint in 

the database, and is protective of effects 

observed following subchronic 

exposure, including the fetal effects 

seen in the rat and rabbit developmental 

studies. This POD is also selected for 

inhalation exposures (all durations), and 

incidental oral and chronic dietary 

exposures. Chronic dietary was set 

using 2 co-critical studies (chronic dog 

study and 2-generation rat reproduction 

study). For acute dietary exposure, the 

POD is based on maternal and 

developmental effects (increased early 

resorptions of litters) observed in the 

rabbit developmental study and is 

applicable to females of childbearing 

age. An acute dietary POD was not 

identified for the general population 

because acute effects of concern for this 

population were not observed in the 

toxicology database. 

In an immunotoxicity study in the rat, 

there were no adverse effects noted up 

to the highest dose tested. 

Afidopyropen is classified as 

‘‘Suggestive Evidence of Carcinogenic 

Potential’’ based on benign 

hepatocellular adenomas in male rats 

and uterine adenocarcinomas and 

combined adenocarcinomas and 

adenomas in female rats. There is 

insufficient evidence to support the 

petition’s description of a uterine tumor 

mode-of action (MOA) in female rats. 

There is no concern for mutagenicity. 

Quantification of human cancer risk is 

not required. The chronic Reference 

Dose (RfD) will adequately account for 

all chronic toxicity, including 

carcinogenicity, which could result 

from exposure to afidopyropen. 

More detailed information on the 

studies received and the nature of the 

adverse effects caused by afidopyropen 

as well as the no-observed-adverseeffect-level (NOAEL) and the lowestobserved-adverse-effect-level (LOAEL) 

from the toxicity studies can be found 

in the document entitled 

‘‘Afidopyropen. Human Health Risk 

Assessment for Section 3 Requests for a 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46397 

New Active Ingredient,’’ dated April 4, 

2018, by going to http://

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES. Locate and 

double-click on the hyperlink for the 

referenced document to view the 

referenced information on pages 16–23 

of 112. 

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 afidopyropen used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR AFIDOPYROPEN 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 (General population) An endpoint was not identified because effects of concern for this population were not observed in the toxicology database. 

Acute Dietary (Females 13+) ........ NOAEL = 16 mg/kg/ 

day UFA = 10X

UFH = 10X

FQPA SF = 1X

Acute RfD = 0.16 

mg/kg/day 

aPAD = 0.16 mg/kg/ 

day 

Rabbit Prenatal Developmental Study: 

Maternal and developmental LOAEL = 32 mg/kg/day, based 

on increased early resorptions per litter. 

Chronic Dietary (All populations including females 13+).NOAEL = 8 mg/kg/ 

day 

UFA = 10X

UFH = 10X

FQPA SF = 1X

Chronic RfD = 0.08 

mg/kg/day 

cPAD = 0.08 mg/kg/ 

day 

2 Co-critical Studies: 

Chronic Dog Study: 

LOAEL = 20 mg/kg/day, based on hyaline droplet deposition in hepatocytes and vacuolation of the white matter 

and neuropil of the cerebrum of male dogs. 

2-Generation Rat Reproduction Study: 

Offspring LOAEL = 41 mg/kg/day, based on decreased absolute body weight, and decreased spleen and thymus 

weights of male rats. 

Dermal Short-term (1 to 30 days) NOAEL = 8 mg/kg/ 

day 

Dermal absorption = 

15% 

UFA = 10X

UFH = 10X

FQPA SF = 1X

LOC for MOE = 100 2-Generation Rat Reproduction Study: 

Offspring LOAEL = 41 mg/kg/day, based on decreased absolute body weight, and decreased spleen and thymus 

weights of male rats. 

Inhalation (All durations) ................ A point of departure (POD) used for inhalation exposures (all durations) was selected from the 2-generation 

rat reproduction study, is the most sensitive endpoint in the database, and is protective of effects observed 

following subchronic exposure, including the fetal effects seen in the rat and rabbit developmental studies. 

Cancer (Oral, dermal, inhalation) .. Classification: ‘‘Suggestive Evidence of Carcinogenic Potential’’. 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to afidopyropen, EPA 

considered exposure under the 

petitioned-for tolerances, and assessed 

dietary exposures from afidopyropen 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. In estimating acute dietary 

(food and drinking water) exposure, 

EPA used food consumption 

information from the Dietary Exposure 

Evaluation Model-Food Commodity 

Intake Database (DEEM–FCIDTM, 

Version 3.16), which incorporates 2003– 

2008 consumption data from the United 

States Department of Agriculture’s 

(USDA’s) National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). The acute 

dietary assessment was conducted using 

recommended tolerance-level residues 

and 100% crop treated assumptions. 

Empirical and default processing factors 

were used. Screening-level estimated 

drinking water concentrations (EDWCs) 


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46398 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 

were incorporated as point estimates, 

based on surface water modeling. The 

acute EDWC (7.1 ppb) was modeled 

using the Florida cabbage scenario. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used DEEM–FCIDTM, 

Version 3.16, which incorporates 2003– 

2008 consumption data from the 

USDA’s NHANES/WWEIA. The chronic 

dietary assessment was conducted using 

recommended tolerance-level residues 

and 100% crop treated assumptions. 

Empirical and default processing factors 

were used. Screening-level EDWCs were 

incorporated as point estimates, based 

on surface water modeling. The chronic 

EDWC (3.9 ppb) was modeled using the 

California lettuce scenario. 

iii. Cancer. As explained in unit III.A., 

quantification of risk using a non-linear 

approach (i.e., a cPAD) will adequately 

account for all chronic toxicity, 

including carcinogenicity, that could 

result from exposure to afidopyropen. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use any anticipated residue or PCT 

information in the dietary assessment 

for afidopyropen. 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 afidopyropen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

afidopyropen. 

Afidopyropen may be transported to 

surface water and groundwater via 

runoff, leaching, or spray drift. 

Afidopyropen is a new chemical; 

therefore, at this point, no monitoring 

data are available. Because the Agency 

does not have comprehensive 

monitoring data, drinking water 

concentration estimates are made by 

reliance on simulation or modeling, 

taking into account data on the physical 

and fate characteristics of afidopyropen. 

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 latest version of the 

Pesticides in Water Calculator (PWC 

1.52) and incorporating the Pesticide 

Root Zone Model for Ground Water 

(PRZM GW), the estimated drinking 

water concentrations (EDWCs) of 

afidopyropen for acute exposures are 

estimated to be 7.1 parts per billion 

(ppb) for surface water, and 3.8 × 10¥4

ppb for ground water. For chronic 

exposures for non-cancer assessments, 

the EDWCs are estimated to be 3.9 ppb 

for surface water and 1.1 × 10¥4 ppb for 

ground water. 

Modeled estimates for drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 7.1 ppb was used 

to assess the contribution to drinking 

water. For chronic and cancer dietary 

risk assessment, the water concentration 

value of 3.9 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). The 

proposed use of afidopyropen on 

ornamentals can be in residential or 

recreational settings. All afidopyropen 

product labels require users to wear 

specific clothing and PPE (i.e., gloves), 

and are assumed to be marketed for 

commercial use; therefore, a 

quantitative residential handler 

assessment was not conducted. 

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 afidopyropen to 

share a common mechanism of toxicity 

with any other substances. 

Afidopyropen and another pesticide, 

aminocyclopyrachlor, both produce the 

common toxic metabolite CPCA; 

however, co-exposure to CPCA from 

both pesticides are unlikely to occur. 

Drinking water is the only expected 

exposure pathway for CPCA for either 

pesticide. The likelihood of having 

ground water residues of both 

afidopyropen and aminocyclopyrachlor 

at the EDWC predicted in the screening 

ground water modeling in the same 

location is miniscule for the following 

reasons: Ground water modeling 

assumes application of a chemical at the 

maximum rate, and the maximum 

number of applications, every year for 

up to 100 years, and because lateral flow 

of chemicals away from the application 

site is relatively slow, both chemicals 

would have to be applied in 

approximately the same location every 

year at the maximum application rates, 

at maximum numbers of applications 

for each, for the exposures to be 

additive, and this is not a feasible 

scenario. For the purposes of this 

tolerance action; therefore, EPA has 

assumed that afidopyropen does not 

have a common mechanism of toxicity 

with other substances or cause a 

cumulative effect as a result of the 

common metabolite with 

aminocyclopyrachlor. 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 website 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 

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. Pre-natal and post-natal sensitivity. 

There is evidence of increased 

susceptibility following pre- and or 

post-natal exposure to afidopyropen. In 

a prenatal developmental study in rats, 

adverse effects in fetuses included an 

increased incidence of lumbar ribs, 

increased ossification of the metatarsi, 

and an increased percentage of male 

pups; however, maternal effects were 

not observed up to the highest dose 

tested. In a second developmental study 

in rats, adverse fetal effects (increased 

incidence of skeletal variations and 

supernumerary ribs) occurred at a lower 

dose as compared to maternal effects 

(mortality in one animal). In a 

developmental study in rabbits, fetal 

developmental and maternal effects 

(increased early resorptions and 

completely resorbed litters) were 

observed. 

Quantitative susceptibility was also 

observed in two 2-generation rat studies. 

In the first study, no reproductive or 

parental effects were observed, while 

offspring effects were decreased 

absolute body weight in both sexes and 

F1 pup and litter deaths. In the second 

study, offspring effects included 

decreased absolute body weight and 

decreased spleen and thymus weights in 

both sexes. Reproductive effects 

included effects on ovary and uterus 


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weight, decreased implantation sites, 

and an altered sex ratio (increased 

percentage of male pups). In this study, 

the parental and offspring effects 

occurred at the same dose level. 

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 all exposure 

scenarios. That decision is based on the 

following findings: 

i. The toxicology database for 

afidopyropen is considered complete for 

evaluating and characterizing toxicity, 

assessing children’s susceptibility under 

FQPA, and selecting endpoints for the 

exposure pathways of concern. 

ii. Acute oral (gavage) and subchronic oral (dietary) neurotoxicity 

studies were conducted in rats. No 

evidence of specific neurotoxicity was 

seen in the subchronic neurotoxicity 

study up to the highest dose tested (369/ 

438 mg/kg/day). Afidopyropen caused 

neurotoxic effects in the acute study; 

however, only at the limit dose. 

Indications of neurotoxicity in mice 

and dogs were limited to vacuolation of 

white matter and/or spinal cord. The 

Agency has low concern because the 

nervous tissues in the mouse and dog 

studies were not perfused in-situ; 

therefore, the vacuolation that was 

observed is more likely an artifact of not 

preparing the tissues properly. The 

nervous tissue vacuolation seen in the 

subchronic dog and mice (subchronic 

and chronic) studies occurred at doses 

7.5X–115X higher than the POD for the 

chronic dietary risk assessment. As a 

result, the effects are well-characterized 

with clearly established NOAEL/LOAEL 

values and the selected PODs are 

protective for the observed neurotoxic 

effects. 

Based on the weight of the evidence 

and taking into consideration the PODs 

selected for risk assessment, a 

developmental neurotoxicity study is 

not required at this time. Clear NOAELs 

have been established for all lifestages, 

the selected PODs are protective of all 

pre- and post-natal toxicity observed 

throughout the database, and no specific 

neuropathological effects were noted. 

The adverse neuropathological effects 

observed in the subchronic mouse and 

dog and the chronic mouse studies 

occurred at doses 7.5X–115X higher 

than the lowest POD, and the rat 

(species typically used in the DNT) is 

less sensitive than dogs and mice to 

afidopyropen’s putative neurotoxic 

effects. 

iii. There is evidence of increased 

susceptibility following pre- and/or 

post-natal exposure to afidopyropen. In 

pre-natal developmental studies in rats, 

adverse fetal effects occurred at lower 

doses as compared to the maternal 

generation. In the first 2-generation 

study, offspring effects were observed 

while no adverse reproductive or 

parental effects occurred. In the second 

2-generation study, offspring effects 

occurred at a lower dose as compared to 

the reproductive and parental effects. 

Clear NOAELs have been established for 

the developmental effects in rats and 

rabbits as well as the offspring effects in 

the two-generation reproduction 

studies. The NOAEL used for the 

chronic dietary risk assessment (8 mg/ 

kg/day), based on effects observed in the 

2-generation reproduction study in rats, 

is protective of all developmental and 

offspring effects seen in the database. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary assessment is based on 

high-end assumptions such as toleranceequivalent residue levels of the parent 

compound in foods, 100% CT, default 

processing factors, and modeled, highend estimates of residues in drinking 

water. All of the exposure estimates are 

based on high-end assumptions and are 

not likely to underestimate risk. In 

addition, the residential exposure 

assessment was conducted based on the 

Residential SOPs such that residential 

exposure and risk will not be 

underestimated. 

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 only to 

afidopyropen will occupy 3.6% of the 

aPAD for females, 13–49 years old. 

Since there was no acute endpoint 

identified for the general population, an 

acute dietary exposure assessment was 

not conducted for the U.S. general 

population and other population 

subgroups. 

2. 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). In estimating the shortterm aggregate risk, EPA has aggregated 

the total short-term residential exposure 

and average dietary (food and water) 

exposure. The selected residential 

exposure scenarios for aggregation, 

adults and children (6 to <11 years old) 

contacting treated ornamentals, 

represent the worst-case risk estimates 

and are protective of all other lifestages 

and exposure scenarios. The short-term 

aggregate MOEs for adults (2,000) and 

children (2,500) are above the LOC 

(100), and are not of concern. 

3. 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). 

Because no intermediate-term exposure 

is anticipated, afidopyropen is not 

expected to pose an intermediate-term 

aggregate risk. 

4. Chronic risk. Chronic aggregate risk 

assessments address exposures that are 

likely to occur continuously for greater 

than six months. Using the exposure 

assumptions discussed in this unit for 

chronic exposure, EPA has concluded 

that chronic dietary exposure to 

afidopyropen from food and water only 

will occupy 2.2% of the cPAD for the 

U.S. general population, and the 

population subgroup with the highest 

estimated risk was for children, 1–2 

years old at 4.4% of the cPAD. 

Residential exposures to afidopyropen 

are not expected to occur on a chronic 

basis; therefore, the chronic aggregate 

risk estimates are equivalent to the 

chronic dietary risk estimates, and are 

below EPA’s LOC. 

5. Aggregate cancer risk for U.S. 

population. Afidopyropen is classified 

as having ‘‘Suggestive Evidence of 

Carcinogenic Potential.’’ The cRfD 

(cPAD) is considered to be protective of 

all chronic toxicity, including 

carcinogenicity, that could result from 

exposure to afidopyropen. 

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 

afidopyropen residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Suitable tolerance enforcement 

methods for plants and livestock using 

liquid chromatography- mass 

spectrometer/mass spectrometer (LC– 

MS/MS) analyses were submitted for the 

analysis of afidopyropen. The reported 


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limit of quantitation (LOQ) of each 

method is 0.01 ppm for afidopyropen. 

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. Maximum residue 

limits (MRLs) for afidopyropen have not 

been established by Codex. 

For this pesticide, the U.S. EPA and 

Health Canada’s Pest Management 

Regulatory Agency (PMRA) have 

conducted a joint review of the available 

data. That review used the Organization 

for Economic Co-operation and 

Development (OECD) calculation 

procedures to determine the appropriate 

MRLs. Therefore, the EPA tolerance 

levels are harmonized with MRLs to be 

established by Health Canada’s PMRA. 

C. Revisions to Petitioned-For 

Tolerances 

Several of the tolerances requested by 

the petitioner are different from those 

established in this rule. EPA’s tolerance 

levels are expressed to provide 

sufficient precision for enforcement 

purposes, and this may include the 

addition of trailing zeros (such as 0.30 

ppm rather than 0.3 ppm). This is to 

avoid the situation where rounding of 

an observed violative residue to the 

level of precision of the tolerance 

expression would result in a residue 

considered non-violative (such as 0.34 

ppm being rounded to 0.3 ppm). This 

revision has been made for the 

following: Brassica, head and stem, 

group 5–16; Brassica, leafy greens, 

subgroup 4–16B; Cotton, gin 

byproducts; Leafy Greens, subgroup 4– 

16A; Leaf petiole vegetable subgroup 

22B; and Vegetable, cucurbit, group 9. 

For citrus oil and cotton, undelinted 

seed, the levels differ because of 

differences in rounding the values 

calculated from the residue data. The 

pome fruit tolerance is different because 

of differences in the MRL calculation for 

pear. Two pear field trials were 

concluded to be replicates for 

calculation and the petitioner also used 

an additional residue value which is 

believed to be a transcription error. A 

tolerance for the processed food prunes 

is not needed because residues are not 

expected to concentrate in prunes. For 

fruiting vegetables, these differences are 

attributable to the petitioner having 

combined both the bell and non-bell 

pepper data together for calculation. In 

addition, the petitioner did not request 

a tolerance for the dried tomato 

processed commodity, but EPA has 

concluded that the tolerance for the 

crop group will not be adequate to cover 

that commodity. Finally, regarding 

‘‘Soybean, aspirated grain fractions,’’ the 

tolerance level requested by the 

petitioner was not consistent with data 

submitted with the petition. EPA 

reviewed the requested use pattern and 

supporting data, corrected the proposed 

commodity definition, and has decided 

to establish a tolerance for commodity 

‘‘Grain, aspirated fractions.’’ 

V. Conclusion 

Therefore, tolerances are established 

for residues of afidopyropen, 

[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3- 

[(cyclopropylcarbonyl)oxy]- 

1,3,4,4a,5,6,6a,12,12a,12b-decahydro6,12-dihydroxy-4,6a,12b-trimethyl-11- 

oxo-9-(3-pyridinyl)-2H,11Hnaphtho[2,1-b]pyrano[3,4-e]pyran-4- 

yl]methyl cyclopropanecarboxylate, 

including its metabolites and 

degradates, in or on Almond, hulls at 

0.15 ppm; Apple, wet pomace at 0.05 

ppm; Brassica, head and stem, group 5– 

16 at 0.50 ppm; Brassica, leafy greens, 

subgroup 4–16B at 5.0 ppm; Citrus, oil 

at 0.40 ppm; Cotton, gin byproducts at 

2.0 ppm; Cotton, undelinted seed at 0.08 

ppm; Fruit, citrus, group 10–10 at 0.15 

ppm; Fruit, pome, group 11–10 at 0.02 

ppm; Fruit, stone, group 12–12 at 0.03 

ppm; Grain, aspirated fractions at 0.15 

ppm; Leafy Greens, subgroup 4–16A at 

2.0 ppm; Leaf petiole vegetable 

subgroup 22B at 3.0 ppm; Nut, tree, 

group 14–12 at 0.01 ppm; Soybean, seed 

at 0.01 ppm; Tomato, dried at 0.50 ppm; 

Vegetable, cucurbit, group 9 at 0.70 

ppm; Vegetable, fruiting, group 8–10 at 

0.20 ppm; and Vegetable, tuberous and 

corm, subgroup 1C at 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 


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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46401 

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: September 5, 2018. 

Richard P. Keigwin, Jr., 

Director, 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. Add § 180.700 to subpart C to read 

as follows: 

§ 180.700 Afidopyropen; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of 

afidopyropen, including its metabolites 

and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only afidopyropen, 

[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3- 

[(cyclopropylcarbonyl)oxy]- 

1,3,4,4a,5,6,6a,12,12a,12b-decahydro6,12-dihydroxy-4,6a,12b-trimethyl-11- 

oxo-9-(3-pyridinyl)-2H,11Hnaphtho[2,1-b]pyrano[3,4-e]pyran-4- 

yl]methyl cyclopropanecarboxylate, in 

or on the following food commodities: 

Commodity Parts per 

million 

Almond, hulls .............................. 0.15 

Apple, wet pomace ..................... 0.05 

Brassica, head and stem, group 

5–16 ........................................ 0.50 

Brassica, leafy greens, subgroup 

4–16B ...................................... 5.0 

Citrus, oil ..................................... 0.40 

Cotton, gin byproducts ............... 2.0 

Cotton, undelinted seed ............. 0.08 

Fruit, citrus, group 10–10 ........... 0.15 

Fruit, pome, group 11–10 ........... 0.02 

Fruit, stone, group 12–12 ........... 0.03 

Grain, aspirated fractions ........... 0.15 

Commodity Parts per 

million 

Leafy Greens, subgroup 4–16A 2.0 

Leaf petiole vegetable subgroup 

22B .......................................... 3.0 

Nut, tree, group 14–12 ............... 0.01 

Soybean, seed ............................ 0.01 

Tomato, dried ............................. 0.50 

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

Vegetable, fruiting, group 8–10 .. 0.20 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.01 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2018–19951 Filed 9–12–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0702; FRL–9983–18] 

Bacteriophage Active Against Erwinia 

amylovora; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of lytic 

bacteriophage active against Erwinia 

amylovora that are produced in Erwinia 

amylovora in or on apple and pear, 

when used in accordance with label 

directions and good agricultural 

practices. OmniLytics, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of bacteriophage active 

against Erwinia amylovora in or on 

apple and pear under FFDCA. 

DATES: This regulation is effective 

September 13, 2018. Objections and 

requests for hearings must be received 

on or before November 13, 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–2017–0702, 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: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; main telephone number: 

(703) 305–7090; email address: 

BPPDFRNotices@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://www.ecfr.

gov/cgi-bin/text-idx?&c=ecfr&tpl=/ 

ecfrbrowse/Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2017–0702 in the subject line on 


daltland on DSKBBV9HB2PROD with RULES