47996 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

EPA-APPROVED GEORGIA REGULATIONS—Continued 

State citation Title/subject State effective 

date EPA approval date Explanation 

*******

391–3–1–.03 .................. Permits ......................... 8/1/2013 10/16/2017, [Insert citation of publication].Changes specifically to (8)—Permit Requirements at (d) (state effective August 1, 2013) 

and (g) (state effective September 13, 2011). 

* * * * * * * 

* * * * * 

[FR Doc. 2017–22250 Filed 10–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0392; FRL–9966–73] 

Fenpicoxamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fenpicoxamid 

(XDE 777) in or on banana, rye, and 

wheat. Dow AgroSciences LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

October 16, 2017. Objections and 

requests for hearings must be received 

on or before December 15, 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–2016–0392, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Michael L. Goodis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2016–0392 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 15, 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– 

2016–0392, 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 December 

20, 2016 (81 FR 92758) (FRL–9956–04), 

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 5E8440) by Dow 

AgroSciences LLC, 9330 Zionsville Rd, 

Indianapolis, IN 46268. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide fenpicoxamid 

(XDE- 777) in or on banana at 0.1 parts 

per million (ppm), rye, grain and wheat, 

grain at 0.7 ppm; and residues of 

fenpicoxamid and its metabolite 

X12326349 expressed as fenpicoxamid 


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equivalents in or on meat and fat from 

cattle, goats, and sheep at 0.01 ppm; and 

meat byproducts of cattle, goats, and 

sheep at 0.02 ppm. That document 

referenced a summary of the petition 

prepared by Dow AgroSciences LLC, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. Based 

upon review of the data supporting the 

petition, EPA is establishing tolerances 

as follows: 0.15 ppm for banana and 

0.60 ppm for rye, grain and wheat, 

grain. In addition, EPA has concluded 

that no tolerances are needed for 

livestock commodities at this time. The 

reason for these changes are explained 

in Unit IV.C. 

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 fenpicoxamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fenpicoxamid 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. Fenpicoxamid has 

no significant acute toxicity via oral, 

dermal or inhalation route of exposure. 

Moreover, it is not a skin irritant and 

does not cause skin sensitization. 

Liver effects were consistently 

observed in mice regardless of duration; 

however, the severity, magnitude, and 

diversity of the liver response 

progressed from adaptive in subchronic 

exposures to adverse in chronic 

exposures. Mice exposed to 

fenpicoxamid in the diet for 80 weeks 

experienced liver weight increase 

accompanied by microscopic changes 

including very slight to moderate 

centrilobular/midzonal hepatocellular 

hypertrophy with altered tinctorial 

properties (increased cytoplasmic 

eosinophilia), vacuolization consistent 

with fatty change, and very slight 

hepatocyte necrosis. These liver effects 

also coincided with an increased 

incidence of microscopic calculi within 

the gallbladder in both sexes. A 

treatment-related increase in liver 

tumors were seen in male mice and is 

the basis for the Agency’s classification 

of the chemical as ‘‘Suggestive Evidence 

of Carcinogenic Potential’’. The Agency 

determined that a non-linear approach 

adequately accounted for all chronic 

toxicity, including carcinogenicity, that 

could result from chronic exposure to 

fenpicoxamid and, therefore, 

quantification of carcinogenic potential 

was not required. This decision was 

based on the following considerations: 

(1) There was limited evidence of 

carcinogenicity in the fenpicoxamid 

toxicity database; (2) the concern for 

mutagenicity and genotoxicity is low; 

and (3) there was no evidence of 

carcinogenicity at doses at or below the 

chronic reference dose. 

Rats were likewise only adversely 

affected by treatment following chronic 

exposures. Chronic dietary exposure 

elicited treatment-related changes in the 

kidneys (increased severity of chronic 

progressive glomerulonephropathy) that 

were considered detrimental to the rat’s 

health. However, unlike mice, chronic 

exposure did not elicit an increase in 

neoplasms in any tissue. Rabbits and 

dogs tolerated oral exposure up to doses 

of 495 and 1,115 milligrams/kilogram/ 

day (mg/kg/day), respectively, without 

any signs of deteriorating health. There 

was no evidence of fetal susceptibility 

in rats or rabbits, or offspring 

susceptibility in rats. None of the 

available studies produced evidence of 

treatment-induced immunotoxicity or 

neurotoxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fenpicoxamid as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Fenpicoxamid (XDE–777): Human 

Health Risk Assessment to Establish 

Tolerances for Bananas, Wheat, and Rye 

Commodities Without U.S. 

Registration’’ at pages 10 through 20 in 

docket ID number EPA–HQ–OPP–2016– 

0392. 

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 fenpicoxamid used for 

human risk assessment is shown in the 

Table of this unit. 


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

ASSESSMENTS

Exposure/scenario Point of departure Uncertainty/FQPA 

safety factors 

RfD, PAD, level of 

concern for risk assessment Study and toxicological effects 

Acute Dietary (General Population, including Infants and 

Children).

There were no effects in the toxicity database that could be attributed to a single dose; therefore, an acute POD was 

not identified. 

Chronic Dietary (All 

Populations).

NOAEL = 40 mg/kg/ 

day.

UFA = 10x UFH = 10x 

FQPA SF = 1x.

cRfD = 0.40 mg/kg/ 

day cPAD = 0.40 

mg/kg/day.

Carcinogenicity study—mouse. MRID 

49731126. LOAEL = 156 and 388 mg/kg/ 

day for males and females, respectively, 

based on treatment-related adverse liver 

effects in males (increased liver weight, 

hypertrophy, hepatocyte necrosis and fatty 

change) and females (increased liver 

weight, hypertrophy and fatty change) and 

gall bladder calculi. 

Cancer (oral, dermal, 

inhalation).

‘‘Suggestive Evidence of Carcinogenic Potential’’ based on the presence of liver tumors in male mice only. The cRfD is 

protective of carcinogenic effects. 

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. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fenpicoxamid, EPA assessed 

dietary exposures from fenpicoxamid 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 such effects were 

identified in the toxicological studies 

for fenpicoxamid; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

2003–2008 food consumption data from 

the USDA’s National Health and 

Nutrition Examination Survey, What We 

Eat in America, (NHANES/WWEIA). As 

to residue levels in food, EPA used 

tolerance-level residues and 100% crop 

treated. 

iii. Cancer. As discussed in Unit 

III.A., EPA has concluded that a 

nonlinear RfD approach is appropriate 

for assessing cancer risk to 

fenpicoxamid. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residues and/or PCT 

information in the dietary assessment 

for fenpicoxamid. Tolerance-level 

residues and 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Because there are no domestic 

uses of fenpicoxamid registered in the 

United States, there will not be residues 

of fenpicoxamid in drinking water. 

Therefore, a drinking water assessment 

is not required. 

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). 

Fenpicoxamid is not registered for any 

specific use patterns that would result 

in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found fenpicoxamid to 

share a common mechanism of toxicity 

with any other substances, and 

fenpicoxamid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that fenpicoxamid does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 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. 

Developmental toxicity was not 

observed in the rat or rabbit 

developmental studies and, no 

reproductive or offspring effects were 

observed in the reproduction toxicity 

study. As a result, EPA concluded there 

is low concern for prenatal or postnatal 

sensitivity from fenpicoxamid exposure. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 


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adequately protected if the FQPA SF 

were reduced to 1X for all exposure 

scenarios. That decision is based on the 

following findings: 

i. The toxicity database for 

fenpicoxamid is complete. 

ii. There is no indication that 

fenpicoxamid 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 

fenpicoxamid 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. 

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 adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fenpicoxamid is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fenpicoxamid 

from food for the highest exposed 

population subgroup, children 1–2 years 

of age, is 0.002737 mg/kg/day or <1.0% 

of the cPAD. The chronic dietary 

exposure estimate for the general 

population is 0.001022 mg/kg/day or 

<1.0% of the cPAD. 

3. Short-term and intermediate-term 

risk. Because fenpicoxamid is not 

registered for any uses that may result 

in residential exposure, fenpicoxamid is 

not expected to cause any short-term or 

intermediate-term risk not already 

accounted for in the Agency’s 

assessment of chronic risk. 

4. Aggregate cancer risk for U.S. 

population. Based on the Agency’s 

assessment of chronic risk, the Agency 

concludes that fenpicoxamid is not 

expected to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to 

fenpicoxamid residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography method with tandem 

mass spectrometry detection (LC/MS/ 

MS), Method No. 120615) is available to 

enforce the tolerance expression. 

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. 

Codex has not established any MRLs 

for residues of fenpicoxamid. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is establishing tolerances for 

wheat, grain and rye, grain (at 0.60 ppm) 

that differ from what the petition 

requested (0.7 ppm). The petitioner 

included only wheat grain residues for 

individual growing season/area 

combinations. Including all residues for 

wheat grain in the OECD MRL 

calculator in accordance with Agency 

policy results in a tolerance level of 0.60 

ppm. Because the wheat grain data can 

be used to assess residues in rye grain, 

the Agency is establishing a tolerance at 

0.60 ppm for rye grain as well. Finally, 

although the notice of filing and the 

petition summary indicate that the 

petitioner was seeking tolerances for 

wheat and rye, the section of the 

petition that listed actual requested 

tolerances more narrowly sought only 

‘‘wheat, grain’’ and ‘‘rye, grain’’ 

tolerances because those are the forms 

in which the wheat and rye will be 

imported. Accordingly, EPA is 

establishing tolerances for the 

commodities ‘‘wheat, grain’’ and ‘‘rye, 

grain’’. 

EPA is establishing a different 

tolerance level for banana than what 

was requested based on available 

residue data and the OECD calculator, 

and in order to harmonize with 

Canada’s MRL. 

EPA is not establishing any of the 

petitioned-for tolerances for livestock 

commodities. Based on the results of the 

livestock feeding studies, the residues of 

concern for livestock commodities 

(fenpicoxamid and X12326349) would 

be below the limit of quantification 

(LOQ) of the enforcement analytical 

method. Therefore, the Agency 

concludes, as indicated in 40 CFR 

180.6(a)(3), that there is no reasonable 

expectation of finite residues and no 

tolerances are needed for livestock 

commodities at this time. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fenpicoxamid and its 

metabolites and degradates, in or on 

banana at 0.15 ppm, and rye and wheat 

grain at 0.60 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). 


jstallworth on DSKBBY8HB2PROD with RULES
48000 Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Rules and Regulations 

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: September 6, 2017. 

Richard P. Keigwin, Jr., 

Acting 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 § 180.109 to subpart C to read 

as follows: 

§ 180.109 Fenpicoxamid; Tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of fenpicoxamid 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels for fenpicoxamid is to 

be determined by measuring only 

fenpicoxamid ([[4-methoxy-2- 

[[[(3S,7R,8R,9S)-9-methyl-8-(2-methyl-1- 

oxopropoxy)-2,6-dioxo-7- 

(phenylmethyl)-1,5-dioxonan-3- 

yl]amino]carbonyl]-3- 

pyridinyl]oxy]methyl 2- 

methylpropanoate) in or on the 

commodity. 

Commodity Parts per 

million 

Banana* ................................ 0.15 

Wheat, grain* ........................ 0.60 

Rye, grain* ............................ 0.60 

*There are no U.S. registrations for use of 

fenpicoxamid on this commodity. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2017–22357 Filed 10–13–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0142; FRL–9966–13] 

Triflumezopyrim; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

triflumezopyrim in or on rice, grain and 

rice, hulls. E.I. Dupont de Nemours and 

Company requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 16, 2017. Objections and 

requests for hearings must be received 

on or before December 15, 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–2016–0142, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Michael L. Goodis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 


jstallworth on DSKBBY8HB2PROD with RULES