Federal Register / Vol. 83, No. 132 / Tuesday, July 10, 2018 / Rules and Regulations 31893 

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 

above. 

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 and Commandant 

Instruction M16475.1D, which guide 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 establishes a 

temporary safety zone. It is categorically 

excluded from further review under 

paragraph L60(a) 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 § 165.T09–0630 to read as 

follows: 

§ 165.T09–0630 Safety Zone; Hamburg 

Beach Blast Fireworks Display; Lake Erie, 

Hamburg, NY. 

(a) Location. The safety zone will 

encompass all waters of Lake Erie; 

Hamburg, NY contained within a 280- 

foot radius of: 42°45′59.21′′ N, 

078°52′41.51′′ W. 

(b) Enforcement period. This 

regulation will be enforced from 9:45 

p.m. until 10:45 p.m. on July 28, 2018. 

(c) Regulations. (1) In accordance with 

the general regulations in § 165.23, entry 

into, transiting, or anchoring within this 

safety zone is prohibited unless 

authorized by the Captain of the Port 

Buffalo or his designated on-scene 

representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Buffalo or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port Buffalo is any 

Coast Guard commissioned, warrant or 

petty officer who has been designated 

by the Captain of the Port Buffalo to act 

on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone must 

contact the Captain of the Port Buffalo 

or his on-scene representative to obtain 

permission to do so. The Captain of the 

Port Buffalo or his on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port Buffalo, or his on-scene 

representative. 

Dated: July 5, 2018. 

Joseph S. Dufresne, 

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

Port Buffalo. 

[FR Doc. 2018–14740 Filed 7–9–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0227; FRL–9978–15] 

Pyroxsulam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

existing tolerances for residues of 

pyroxsulam in or on teff forage, teff 

grain, teff hay, and teff straw. 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: This regulation is effective July 

10, 2018. Objections and requests for 

hearings must be received on or before 

September 10, 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–2017–0227, 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, 


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31894 Federal Register / Vol. 83, No. 132 / Tuesday, July 10, 2018 / Rules and Regulations 

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 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–2017–0227 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 September 10, 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– 

2017–0227, 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 October 23, 

2017 (82 FR 49020) (FRL–9967–37), 

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 7E8551) by IR–4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the herbicide pyroxsulam, 

N-(5,7-dimethoxy[1,2,4]triazolo[1,5- 

a]pyrimidin-2-yl)-2-methoxy-4- 

(trifluoromethyl)-3-pyridinesulfonamide 

in or on the raw agricultural 

commodities teff, forage at 0.06 ppm; 

teff, grain at 0.01 ppm; teff, straw at 0.03 

ppm; and teff, hay at 0.01 ppm. That 

document referenced a summary of the 

petition prepared by Dow Agrosciences, 

the registrant, which is available in the 

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

comment was received on the notice of 

filing but was related to the impact of 

wind turbines on bats and therefore not 

relevant to this action. 

In between the submission of the 

petition and the publication of this 

document, tolerances were established 

in the Federal Register of July 5, 2017 

(82 FR 30987) (FRL–9962–60) for 

residues in teff forage, teff grain, teff 

hay, and teff straw at the levels 

requested in this petition to cover 

residues of pyroxsulam in or on imports 

of those commodities since there was no 

domestic registration for that use at the 

time. 

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 consistent with 

FFDCA section 408(b)(2). 

In the Federal Register of July 5, 2017 

(82 FR 30987), EPA established 

tolerances for residues of pyroxsulam in 

or on teff forage, teff grain, teff hay, and 

teff straw at the same levels as those 

requested in this action. Because there 

was no domestic use of pyroxsulam 

registered on those commodities at the 

time, the tolerances included a footnote 

noting the lack of U.S. registrations for 

use of pyroxsulam on teff. Due to 

changes in the status of domestic 

registrations for use of pyroxsulam in or 

on teff, this footnote is no longer 

accurate and needs to be removed. 

The U.S. registration of teff on 

pyroxsulam does not change the 

Agency’s previous conclusions about 

drinking water exposure or residential 

exposure; therefore, the previous 

aggregate risk assessment supports the 

amendment of the teff tolerances. Based 

on this assessment of potential exposure 


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Federal Register / Vol. 83, No. 132 / Tuesday, July 10, 2018 / Rules and Regulations 31895 

from use of pyroxsulam on teff and the 

findings supporting the July 5, 2017 

tolerances established for teff 

commodities, 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 pyroxsulam residues. 

For a detailed discussion of the 

aggregate risk assessments and 

determination of safety for the proposed 

tolerances, please refer to the July 5, 

2017 Federal Register document and its 

supporting documents available at 

http://www.regulations.gov in docket ID 

numbers EPA–HQ–OPP–2006–0785 and 

EPA–HQ–OPP–2017–0227. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology, Method GRM 04.17, a 

liquid chromatography with tandem 

mass spectrometry (LC/MS/MS) 

method, is available to enforce the 

tolerance expression. 

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 pyroxsulam. 

V. Conclusion 

Therefore, the tolerances for teff 

commodities in 40 CFR 180.638 are 

amended by removing the footnote 

stating ‘‘There are no U.S. registrations 

on teff as of May 8, 2017’’. 

VI. Statutory and Executive Order 

Reviews 

This action modifies 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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). This action 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), nor does 

it require any special considerations 

under Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

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

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

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

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 15, 2018. 

Michael Goodis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.638, revise the table in 

paragraph (a) to read as follows: 

§ 180.638 Pyroxsulam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

Teff, forage ................................. 0.06 

Teff, grain ................................... 0.01 

Teff, hay ...................................... 0.01 

Teff, straw ................................... 0.03 

Wheat, forage ............................. 0.06 

Wheat, grain ............................... 0.01 

Wheat, hay ................................. 0.01 

Wheat, straw ............................... 0.03 

* * * * * 

[FR Doc. 2018–14735 Filed 7–9–18; 8:45 am] 

BILLING CODE 6560–50–P 


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