Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations 46685 

EPA-APPROVED FLORIDA REGULATIONS—Continued 

State citation 

(section) Title/subject 

State 

effective 

date 

EPA 

approval 

date 

Explanation 

*******

Chapter 62–296 Stationary Sources—Emission Standards 

62–296.100 ............. Purpose and Scope .................... 10/6/08 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–296.405 ............. Fossil Fuel Steam Generators 

with More Than 250 Million Btu 

Per Hour Heat Input.

3/2/99 10/6/17, [Insert Federal Register 

citation].

62–296.406 ............. Fossil Fuel Steam Generators 

with Less Than 250 Million Btu 

Per Hour Heat Input, New and 

Existing Emissions Units.

3/2/99 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–296.412 ............. Dry Cleaning Facilities ................ 3/11/10 10/6/17, [Insert Federal Register 

citation].

62–296.414 ............. Concrete Batching Plants ........... 1/10/07 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–296.418 ............. Bulk Gasoline Plants ................... 3/11/10 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–296.500 ............. Reasonably Available Control 

Technology (RACT)—Volatile 

Organic Compounds (VOC) 

and Nitrogen Oxides (NOX) 

Emitting Facilities.

3/11/10 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–296.508 ............. Petroleum Liquid Storage ........... 10/6/08 10/6/17, [Insert Federal Register 

citation].

Amendments effective 10/6/08 

* * * * * * * 

Chapter 62–297 Stationary Sources—Emissions Monitoring 

62–297.310 ............. General Emissions Test Requirements.3/9/15 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

62–297.450 ............. EPA VOC Capture Efficiency 

Test Procedures.

3/2/99 10/6/17, [Insert Federal Register 

citation].

* * * * * * * 

* * * * * 

[FR Doc. 2017–21504 Filed 10–5–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0560; FRL–9963–66] 

Florpyrauxifen-Benzyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

florpyrauxifen-benzyl in or on rice 

grain, freshwater fish, shellfish 

crustacean, and mollusc. Dow 

AgroSciences LLC requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 6, 2017. Objections and 

requests for hearings must be received 

on or before December 5, 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–2016–0560, 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 


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46686 Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations 

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, Director, 

Registration Division (7505P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460–0001; 

Main telephone number: (703) 305– 

7090; email address: RDFRNotices@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2016–0560 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 5, 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– 

2016–0560, 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 5F8403) by Dow 

AgroSciences LLC, 9330 Zionsville 

Road, Indianapolis, IN 46268. The 

petition requested that 40 CFR part 180 

be amended by establishing tolerances 

for residues of the herbicide 

florpyrauxifen-benzyl (2- 

Pyridinecarboxylic acid, 4-amino-3- 

chloro-6-(4-chloro-2-fluoro-3- 

methoxyphenyl)-5-fluoro-, 

phenylmethyl ester) and florpyrauxifen 

(metabolite; 2-Pyridinecarboxylic acid, 

4-amino-3-chloro-6-(4-chloro-2-fluoro-3- 

methoxyphenyl)-5-fluoro-), in or on the 

raw agricultural commodities rice, grain 

(dehulled) at 0.01 parts per million 

(ppm); rice, grain at 0.2 ppm; fish, 

freshwater at 2 ppm; shellfish, 

crustacean at 0.5 ppm; and shellfish, 

mollusk at 9 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 tolerance levels that vary 

from the petitioned-for levels for certain 

crops and is correcting commodity 

definitions, as needed, to be consistent 

with current EPA policy. These changes 

are explained further 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 florpyrauxifenbenzyl including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with 

florpyrauxifen-benzyl follows. 

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. 

Florpyrauxifen-benzyl is not 

genotoxic and there were no treatmentrelated findings up to the limit dose 

(1,000 milligrams/kilogram (mg/kg)/day) 

or highest doses tested in the acute, 

short-term, sub-chronic, or chronic oral 

toxicity studies, two-generation 


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Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations 46687 

reproduction or developmental toxicity 

studies or in the neurotoxicity study. 

Chronic administration of 

florpyrauxifen-benzyl did not show any 

carcinogenicity potential and did not 

cause any adverse effects in mice, rats 

or dogs even up to the highest doses 

tested. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by florpyrauxifen-benzyl 

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

from the toxicity studies can be found 

at http://www.regulations.gov in 

document ‘‘Florpyrauxifen-benzyl: New 

Active Ingredient, First Food Use. 

Human Health Risk Assessment for the 

Establishment of Permanent Tolerances 

on Rice, Fish, and Shellfish and 

Registration for Uses on Rice and 

Freshwater Aquatic Weed Control’’ 

dated December 1, 2016 in docket ID 

number EPA–HQ–OPP–2016–0560. 

Because no single or repeated dose 

study performed by any route of 

exposure produced an adverse effect 

following florpyrauxifen-benzyl 

exposure, toxicity endpoints and points 

of departure were not selected for 

florpyrauxifen-benzyl exposure 

scenarios and a quantitative risk 

assessment was not conducted. Instead, 

a qualitative human health risk 

assessment has been conducted to 

support the proposed uses of 

florpyrauxifen-benzyl. 

Florpyrauxifen-benzyl is proposed for 

use on rice and aquatic sites. Humans 

could potentially be exposed to 

florpyrauxifen-benzyl residues in food 

(including fish and shellfish) because 

florpyrauxifen-benzyl may be applied 

directly to growing rice and aquatic 

sites. These applications can also result 

in florpyrauxifen-benzyl reaching 

surface and ground water, both of which 

can serve as sources of drinking water. 

There are no proposed uses in 

residential settings and there are no 

anticipated residential exposures. 

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. EPA considers the 

toxicity database to be complete and 

there are no residual uncertainties in the 

florpyrauxifen-benzyl exposure 

database. Because there are no threshold 

effects in the florpyrauxifen-benzyl 

database, the requirement to retain this 

safety factor is inapplicable to the 

current tolerance action. 

Based on the lack of toxicity from 

exposure to residues of florpyrauxifenbenzyl, 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 florpyrauxifen-benzyl. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate analytical enforcement 

methodology which uses highperformance liquid chromatography 

with tandem mass spectrometry (HPLC/ 

MS–MS) to quantitate residues of 

florpyrauxifen-benzyl and 

florpyrauxifen is available for 

enforcement. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for florpyrauxifen-benzyl. 

C. Revisions to Petitioned-For 

Tolerances 

Although a tolerance for rice, grain 

(dehulled) was requested, EPA 

determined that no such tolerance is 

required. Rice, grain (dehulled) is 

covered by the rice grain tolerance. 

Based on the Organization of Economic 

Cooperation and Development (OECD) 

statistical calculation applied to the 

field trial (U.S.) residue data, EPA 

determined that the appropriate 

tolerance level for rice, grain is 0.30 

ppm. The OECD calculation procedures 

are globally recognized for calculating 

MRLs to facilitate the harmonization of 

regulatory limits. 

For fish-shellfish, mollusc the 

tolerance level is established at 20 ppm, 

rather than the requested 9 ppm, based 

on the residue data. Also, to be 

consistent with current EPA policy, the 

commodity definitions were revised as 

fish-freshwater finfish; fish-shellfish, 

crustacean; and fish-shellfish, mollusc, 

and the Agency added a significant 

figure to the tolerances for rice, grain; 

fish-freshwater finfish; and fishshellfish, crustacean. 

V. Conclusion 

Despite the lack of toxicity, the EPA 

is establishing tolerances as requested 

by the petitioner for international trade 

purposes. Therefore, tolerances are 

established for residues of 

florpyrauxifen-benzyl, including its 

metabolites and degradates, in or on 

rice, grain at 0.30 ppm; fish-freshwater 

finfish at 2.0 ppm; fish-shellfish, 

crustacean at 0.50 ppm; and fishshellfish, mollusc at 20 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 


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46688 Federal Register / Vol. 82, No. 193 / Friday, October 6, 2017 / Rules and Regulations 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 8, 2017. 

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 § 180.695 to subpart C to read 

as follows: 

§ 180.695 Florpyrauxifen-benzyl; 

Pesticide Tolerances. 

(a) General. Tolerances are 

established for residues of 

florpyrauxifen-benzyl, 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 the sum of 

florpyrauxifen-benzyl (phenylmethyl 4- 

amino-3-chloro- 6-(4-chloro-2-fluoro-3- 

methoxyphenyl)-5-fluoro-2- 

pyridinecarboxylate) and its acid 

metabolite (4-amino-3-chloro-6-(4- 

chloro-2-fluoro-3-methoxyphenyl)-5- 

fluoropyridine-2-carboxylic acid) 

calculated as the stoichiometric 

equivalent of florpyrauxifen-benzyl, in 

or on the commodity. 

Commodity Parts per 

million 

Fish—freshwater finfish ........ 2.0 

Fish—shellfish, crustacean ... 0.50 

Fish—shellfish, mollusc ........ 20 

Rice, grain ............................ 0.30 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2017–21614 Filed 10–5–17; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Parts 1, 2, 15, 90, 95, and 97 

[ET Docket No. 15–26; FCC 17–94] 

Permitting Radar Services in the 76–81 

GHz Band 

Correction 

In rule document 2017–18463 

beginning on page 43865 in the issue of 

Wednesday, September 20, 2017, make 

the following correction: 

§ 2.106 [Corrected] 

■ In Part 2, in § 2.106, on page 43869, 

the table should appear as follows: 


asabaliauskas on DSKBBXCHB2PROD with RULES