Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27711 

anchor within the safety zone unless 

authorized by the Captain of the Port 

Detroit (COTP), or his on-scene 

representative. 

(2) The safety zone is closed to all 

vessel traffic, except as may be 

permitted by the COTP or his on-scene 

representative. 

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

COTP is any Coast Guard 

commissioned, warrant or petty officer 

or a Federal, State, or local law 

enforcement officer designated by or 

assisting the Captain of the Port Detroit 

to act on his behalf. 

(4) Vessel operators shall contact the 

COTP or his on-scene representative to 

obtain permission to enter or operate 

within the safety zone. The COTP or his 

on-scene representative may be 

contacted via VHF Channel 16 or at 

(313) 568–9464. Vessel operators given 

permission to enter or operate in the 

regulated area must comply with all 

directions given to them by the COTP or 

his on-scene representative. 

Dated: June 6, 2018. 

Jeffrey W. Novak, 

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

Port Detroit. 

[FR Doc. 2018–12756 Filed 6–13–18; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0565; FRL–9977–75] 

Extract of Swinglea glutinosa; 

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 Extract of Swinglea 

glutinosa in or on all food commodities 

when used in accordance with label 

directions and good agricultural 

practices. Gowan Company LLC 

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 Extract of Swinglea 

glutinosa under FFDCA. 

DATES: This regulation is effective June 

14, 2018. Objections and requests for 

hearings must be received on or before 

August 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–2017–0565, 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/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(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–2017–0565 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 August 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– 

2017–0565, 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. Background 

In the Federal Register of January 26, 

2018 (83 FR 3658) (FRL–9971–46), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 6F8504) by 

Gowan Company LLC, P.O. Box 5569, 

Yuma, AZ 85366–5569. The petition 

requested that 40 CFR 180 be amended 

by establishing an exemption from the 


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27712 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 

requirement of a tolerance for residues 

of the biochemical fungicide Extract of 

Swinglea glutinosa in or on all food 

commodities. That document referenced 

a summary of the petition prepared by 

the petitioner, Gowan Company LLC, 

which is available in the docket via 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

III. Final Rule 

A. EPA’s Safety Determination 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 

tolerance or tolerance exemption 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 . . . .’’ Additionally, FFDCA 

section 408(b)(2)(D) requires that EPA 

consider ‘‘available information 

concerning the cumulative effects of [a 

particular pesticide’s] . . . residues and 

other substances that have a common 

mechanism of toxicity.’’ FFDCA section 

408(b)(2)(C) 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 evaluated the available toxicity 

and exposure data on Extract of 

Swinglea glutinosa and considered their 

validity, completeness, and reliability, 

as well as the relationship of this 

information to human risk. EPA also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Extract of Swinglea glutinosa is 

extracted from the leaves of Swinglea 

glutinosa. Commonly known as Tabog, 

the plant is found in southeast Asian 

and South American countries and is 

also commercially cultivated for 

ornamental purposes. As a pesticidal 

active ingredient, Extract of Swinglea 

glutinosa is intended for use as a 

fungicide on growing crops and 

ornamentals in agricultural, greenhouse, 

turf, recreational, and commercial 

landscape use sites to control fungal 

diseases such as powdery mildew and 

sour rot. The antifungal mode of action 

(MOA) of Extract of Swinglea glutinosa 

is likely cell membrane disruption, 

attributable to the terpene constituents 

in the essential oil of the extract. This 

mode of action is similar to that 

observed in other essential oils that are 

considered biopesticides, such as tea 

tree oil, rosemary oil and thyme oil. The 

constituent compounds in Extract of 

Swinglea glutinosa are ubiquitous in 

fruits and vegetables and are regularly 

consumed by humans as part of a 

normal diet. The constituent 

compounds are also biodegradable; and 

the active ingredient is highly soluble in 

water and will degrade rapidly in 

aqueous environments. 

Based on the data submitted in 

support of this petition and the dietary 

risk assessment conducted by the 

Agency, EPA concludes that there is a 

reasonable certainty of no harm from 

aggregate exposures to Extract of 

Swinglea glutinosa, including the 

consumption of food treated with this 

active ingredient in accordance with 

label directions and good agricultural 

practices. EPA has made this 

determination because available 

toxicology data indicate that the active 

ingredient is not acutely toxic, 

subchronically toxic, mutagenic, or 

developmentally toxic via repeat oral 

exposure. As such, the Agency has not 

identified any endpoints of concern for 

Extract of Swinglea glutinosa and has 

conducted a qualitative assessment of 

exposure. The Agency has also 

determined that residues Extract of 

Swinglea glutinosa in drinking water are 

not expected to be significant when 

products are used according to label 

instructions. The active ingredient is 

applied at low concentrations, is very 

soluble in water, and degrades rapidly 

in aqueous solutions. Non-occupational 

exposures are not expected since Extract 

of Swinglea glutinosa is only intended 

for commercial agricultural and 

landscaping use. A full explanation of 

the data upon which EPA relied and its 

dietary risk assessment based on those 

data can be found within the April 10, 

2018, document entitled ‘‘Federal Food, 

Drug, and Cosmetic Act (FFDCA) 

Considerations for Extract of Swinglea 

glutinosa.’’ This document, as well as 

other relevant information, is available 

in the docket for this action as described 

under ADDRESSES. 

Based upon its evaluation, EPA 

concludes that Extract of Swinglea 

glutinosa is not toxic. No toxic 

endpoints were established for oral 

toxicity, dermal toxicity or inhalation 

toxicity. Exposure to Extract of Swinglea 

glutinosa via pesticidal use is not 

expected to exceed any levels of 

concern. EPA also determined that 

retention of the Food Quality Protection 

Act (FQPA) safety factor was not 

necessary due to the lack of threshold 

effects. 

Therefore, EPA concludes that there is 

a reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of Extract of 

Swinglea glutinosa. Therefore, EPA is 

establishing an exemption from the 

requirement of a tolerance for residues 

of Extract of Swinglea glutinosa when 

applied pre-harvest in accordance with 

label directions and good agricultural 

practices. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes due to the 

lack of concern about safety for Extract 

of Swinglea glutinosa at any exposure 

level. 

IV. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

EPA. 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 


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Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Rules and Regulations 27713 

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 tolerance exemption in this action, 

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. As a result, 

this action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

EPA 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, EPA 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 

EPA’s 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). 

V. 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: May 29, 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 § 180.1356 to subpart D to read 

as follows: 

§ 180.1356 Extract of Swinglea glutinosa; 

exemption from the requirement of a 

tolerance. 

Residues of the biochemical pesticide 

Extract of Swinglea glutinosa are exempt 

from the requirement of a tolerance in 

or on all food commodities when 

applied pre-harvest in accordance with 

label directions and good agricultural 

practices. 

[FR Doc. 2018–12809 Filed 6–13–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 180209147–8509–02] 

RIN 0648–BH76 

Fisheries of the Northeastern United 

States; 2018–2020 Small-Mesh 

Multispecies Specifications 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS issues final 2018 and 

projected 2019–2020 specifications for 

the small-mesh multispecies fishery, 

and corrects an error from a previous 

action. The specifications are necessary 

to establish allowable catch limits for 

each stock within the fishery to control 

overfishing while allowing optimum 

yield, consistent with the MagnusonStevens Fishery Conservation and 

Management Act. The intent of this 

action is to inform the public of these 

specifications for the 2018 fishing year, 

projected specifications for 2019–2020, 

and the regulatory correction. 

DATES: Effective June 14, 2018, through 

April 30, 2019. 

ADDRESSES: Copies of these 

specifications, including the 

Environmental Assessment (EA), 

Regulatory Flexibility Act Analyses, and 

other supporting documents for the 

action, are available upon request from 

Thomas A. Nies, Executive Director, 

New England Fishery Management 

Council, Mid-Atlantic Fishery 

Management Council, 50 Water Street, 

Newburyport, MA 01950. These 

documents are also accessible via the 

internet at www.nefmc.org. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Hanson, Fishery Management 

Specialist, (978) 281–9180. 

SUPPLEMENTARY INFORMATION: 

Background 

The small-mesh multispecies fishery 

is managed by the New England Fishery 

Management Council within the 

Northeast Multispecies Fishery 

Management Plan (FMP). The fishery is 

composed of five stocks of three species 

of hakes: Northern silver hake; southern 

silver hake; northern red hake; southern 

red hake; and offshore hake. Southern 

silver hake and offshore hake are often 

grouped together and collectively 

referred to as ‘‘southern whiting.’’ 

Amendment 19 to the FMP (78 FR 

20260; April 4, 2013) established a 

process and framework for setting catch 

specifications for the small-mesh 

fishery. The FMP requires the 

specification of an overfishing limit 

(OFL), acceptable biological catch 

(ABC), annual catch limit (ACL), and 

total allowable landings (TAL) for each 

stock within the fishery for up to three 

years at a time, based on the most recent 

stock projections for upcoming years. 

This action implements the Council’s 

recommended small-mesh multispecies 

specifications for the 2018 fishing year, 

announces projected 2019 and 2020 

specifications as recommended by the 

Council, and makes a minor regulatory 

correction. 

The proposed rule for this action 

published in the Federal Register on 

April 12, 2018 (83 FR 15780), and 

comments were accepted through April 

27, 2018. Additional background 

information regarding the development 


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