Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 79333 

either call. Individuals or groups 

wishing to make brief oral comments to 

the HSRB on January 12–13, 2016 are 

strongly advised to submit their request 

(preferably via email) to Jim Downing, 

listed under FOR FURTHER INFORMATION

CONTACT no later than noon, Eastern 

Time, Wednesday, January 6, 2016 in 

order to be included on the meeting 

agenda and to provide sufficient time 

for the HSRB Chair and HSRB 

Designated Federal Official to review 

the meeting agenda to provide an 

appropriate public comment period. 

Individuals or groups wishing to make 

brief oral comments to the HSRB during 

the March 30, 2016 teleconference 

should submit their request by Noon 

Eastern Time on Wednesday, March 23, 

2016. The request should identify the 

name of the individual making the 

presentation and the organization (if 

any) the individual will represent. Oral 

comments before the HSRB are 

generally limited to five minutes per 

individual or organization. Please note 

that this includes all individuals 

appearing either as part of, or on behalf 

of, an organization. While it is our 

intent to hear a full range of oral 

comments on the science and ethics 

issues under discussion, it is not our 

intent to permit organizations to expand 

the time limitations by having 

numerous individuals sign up 

separately to speak on their behalf. If 

additional time is available, further 

public comments may be possible. 

2. Written comments. Submit your 

written comments prior to the meetings. 

For the Board to have the best 

opportunity to review and consider your 

comments as it deliberates, you should 

submit your comments by Noon Eastern 

Time on Wednesday, January 6, 2016 for 

the January 12–13, 2016 meeting, and by 

noon Eastern Time on Wednesday, 

March 23, 2016 for the March 30, 2016 

teleconference. If you submit comments 

after these dates, those comments will 

be provided to the HSRB members, but 

you should recognize that the HSRB 

members may not have adequate time to 

consider your comments prior to their 

discussion. You should submit your 

comments using the instructions in 

Section I., under subsection C., ‘‘What 

Should I Consider as I Prepare My 

Comments for the EPA?’’ In addition, 

the agency also requests that persons 

submitting comments directly to the 

docket also provide a copy of their 

comments to Jim Downing listed under 

FOR FURTHER INFORMATION CONTACT. 

There is no limit on the length of 

written comments for consideration by 

the HSRB. 

E. Background 

The HSRB is a Federal advisory 

committee operating in accordance with 

the Federal Advisory Committee Act 5 

U.S.C. App.2 9. The HSRB provides 

advice, information, and 

recommendations to the EPA on issues 

related to scientific and ethical aspects 

of human subjects research. The major 

objectives of the HSRB are to provide 

advice and recommendations on: (1) 

Research proposals and protocols; (2) 

reports of completed research with 

human subjects; and (3) how to 

strengthen EPA’s programs for 

protection of human subjects of 

research. The HSRB reports to the EPA 

Administrator through the Agency’s 

Science Advisor. 

1. Topics for discussion. On Tuesday, 

January 12–13, 2016, EPA’s Human 

Studies Review Board will consider 

seven scientific and ethical topics: (1) 

Assessing intermittent pesticide 

exposure from flea control collars 

containing the organophosphorus 

insecticide tetrachlorvinphos, authored 

by M. Keith Davis, J. Scott Boone, John 

E. Moran, John W. Tyler, and Janice E. 

Chambers. Journal of Exposure Science 

and Environmental Epidemiology (2008) 

18, 564–570; (2) Field Testing of SC 

Johnson Personal Mosquito Repellent 

Products to Support their Use of the 

EPA Repellency Awareness Graphic, 

GLP Study Number 865E1, J. Palm, 

September 24, 2015. Test Substance: 

MARK–3 OFF! Deep Woods Sportsmen 

Insect Repellent I (Maximum Strength 

Pump Spray Deep Woods OFF! EPA 

Reg. No. 4822–276); (3) Field Testing of 

SC Johnson Personal Mosquito 

Repellent Products to Support their Use 

of the EPA Repellency Awareness 

Graphic, GLP Study Number 864E1, J. 

Palm, September 24, 2015. Test 

Substance: MARK–2 OFF! Deep Woods 

Sportsmen Insect Repellent II 

(UNSCENTED DEEP WOODS OFF! EPA 

Reg. No. 4822–397); (4) Field Testing of 

SC Johnson Personal Mosquito 

Repellent Products to Support their Use 

of the EPA Repellency Awareness 

Graphic, GLP Study Number 867E1, E. 

Laznicka, October 21, 2015. Test 

Substance: MARK–5 OFF! Family Care 

Insect Repellent IV (Unscented) 

(UNSCENTED OFF! SKINTASTIC 

SPRAY INSECT REPELLENT, EPA Reg. 

No. 4822–395); (5) Field Testing of SC 

Johnson Personal Mosquito Repellent 

Products to Support their Use of the 

EPA Repellency Awareness Graphic, 

GLP Study Number 866E1, E. Laznicka, 

October 21, 2015. Test Substance: 

MARK–4 OFF! Active Insect Repellent I 

(Unscented OFF! Insect Repellent, EPA 

Reg. No. 4822–380); 6.) Field Testing of 

SC Johnson Personal Mosquito 

Repellent Products to Support their Use 

of the EPA Repellency Awareness 

Graphic, GLP Study Number 873E1, C. 

Talbert, October 21, 2015. Test 

Substance: MARK–8 OFF! Deep Woods 

Insect Repellent V (OFF! Insect 

Repellent Formula, EPA Reg. No. 4822– 

167) 

On Wednesday, March 30, 2016 the 

HSRB will approve its Final Report of 

the January 12–13, 2016 meeting. 

2. Meeting minutes and reports. 

Minutes of these meetings, summarizing 

the matters discussed and 

recommendations, if any, made by the 

advisory committee regarding such 

matters, will be released within 90 

calendar days of the meeting. Such 

minutes will be available at http://

www2.epa.gov/osa/human-studiesreview-board and http://

www.regulations.gov. In addition, 

information regarding the HSRB’s Final 

Report, will be found at http://

www2.epa.gov/osa/human-studiesreview-board or from the person listed 

under FOR FURTHER INFORMATION

CONTACT. 

Dated: December 14, 2015. 

Thomas A. Burke, 

EPA Science Advisor. 

[FR Doc. 2015–32021 Filed 12–18–15; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FLR–9940–43–Region 10] 

Proposed Reissuance of NPDES 

General Permit for Discharges From 

Federal Aquaculture Facilities and 

Aquaculture Facilities Located in 

Indian Country Within the Boundaries 

of Washington State (Permit Number 

WAG130000) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of proposed reissuance of 

NPDES General Permit and request for 

public comment. 

SUMMARY: The Director, Office of Water 

and Watersheds, Environmental 

Protection Agency (EPA) Region 10, is 

proposing to reissue a National 

Pollutant Discharge Elimination System 

(NPDES) General Permit for Federal 

Aquaculture Facilities and Aquaculture 

Facilities Located in Indian Country 

within the Boundaries of Washington 

State (General Permit). The draft 

General Permit contains effluent 

limitations, along with administrative 

reporting and monitoring requirements, 

as well as standard conditions, 

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79334 Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 

prohibitions, and management 

practices. A fact sheet is available that 

explains the draft General Permit in 

detail. 

Section 401 of the Clean Water Act, 

33 U.S.C. 1341, requires EPA to seek a 

certification from the State of 

Washington, and Indian Tribes with 

Treatment as a State for Water Quality 

Standards, that the conditions of the 

General Permit are stringent enough to 

comply with State water quality 

standards. The Washington Department 

of Ecology (Ecology) and the Lummi, 

Makah, Spokane, and Tulalip Tribes 

have provided draft certification that the 

draft General Permit complies with 

applicable Water Quality Standards. 

EPA will seek final certification from 

Ecology and tribes prior to issuing the 

General Permit. This is also notice of the 

draft § 401 certification provided by 

Ecology and tribes. Persons wishing to 

comment on the draft § 401 

certifications should send written 

comments to the contacts in the fact 

sheet. 

DATES: The public comment period for 

the draft General Permit will be from the 

date of publication of this Notice until 

March 31, 2016. Comments must be 

received or postmarked by no later than 

midnight Pacific Standard Time on 

March 31, 2016. All comments related 

to the draft General Permit and Fact 

Sheet received by EPA Region 10 by the 

comment deadline will be considered 

prior to issuing the General Permit. 

Submitting Comments: You may 

submit comments by any of the 

following methods. All comments must 

include the name, address, and 

telephone number of the commenter. 

Mail: Send paper comments to 

Catherine Gockel, Office of Water and 

Watersheds; USEPA Region 10; 1200 6th 

Ave., Suite 900, OWW–191; Seattle, 

Washington 98101. 

Email: Send electronic comments to 

gockel.catherine@epa.gov. Write 

‘‘Comments on the Draft Aquaculture 

General Permit’’ in the subject line. 

Fax: Fax comments to the attention of 

Catherine Gockel at (206) 553–1280. 

Hand Delivery/Courier: Deliver 

comments to Catherine Gockel, EPA 

Region 10, Office of Water and 

Watersheds, Mail Stop OWW–191, 1200 

6th Avenue, Suite 900, Seattle, WA 

98101–3140. Call (206) 553–0523 before 

delivery to verify business hours. 

Viewing and/or Obtaining Copies of 

Documents. A copy of the draft General 

Permit and the Fact Sheet, which 

explains the proposal in detail, may be 

obtained by contacting EPA at 1 (800) 

424–4372. 

Copies of the documents are also 

available for viewing and downloading 

at: http://yosemite.epa.gov/R10/WATER.

NSF/NPDES+Permits/General+NPDES+

Permits#WA .Requests may also be 

made to Audrey Washington at (206) 

553–0523 or washington.audrey@

epa.gov. 

Public Hearing: Persons wishing to 

request a public hearing should submit 

their written request by March 31, 2016 

stating the nature of the issues to be 

raised as well as the requester’s name, 

address, and telephone number to 

Catherine Gockel at the address above. 

If a public hearing is scheduled, notice 

will be published in the Federal 

Register. Notice will also be posted on 

the Region 10 Web site, and will be 

mailed to all interested persons 

receiving letters of the availability of the 

draft General Permit. 

FOR FURTHER INFORMATION CONTACT: 

Additional information can be obtained 

by contacting Catherine Gockel, Office 

of Water and Watersheds, U.S. 

Environmental Protection Agency, 

Region 10. Contact information is 

included above. 

Other Legal Requirements 

Endangered Species Act [16 U.S.C. 

1531 et al.]. Section 7 of the Endangered 

Species Act (ESA) requires Federal 

agencies to consult with NOAA 

Fisheries (NMFS) and the U.S. Fish and 

Wildlife Service (USFWS) (the Services) 

if their actions have the potential 

to either beneficially or adversely 

affect any threatened or endangered 

species. EPA has analyzed the 

discharges proposed to be authorized by 

the draft General Permit, and their 

potential to adversely affect any of the 

threatened or endangered species or 

their designated critical habitat areas in 

the vicinity of the discharges. Based on 

this analysis, EPA has determined that 

the issuance of this permit is not likely 

to adversely affect any threatened or 

endangered species in the vicinity of the 

discharge. 

National Environmental Policy Act 

(NEPA) [42 U.S.C. 4321 et.seq.] and 

Other Federal Requirements. 

Regulations at 40 CFR 122.49, list the 

federal laws that may apply to the 

issuance of permits i.e., ESA, National 

Historic Preservation Act, the Coastal 

Zone Act Reauthorization Amendments 

(CZARA), NEPA, and Executive Orders, 

among others. The NEPA compliance 

program requires analysis of 

information regarding potential impacts, 

development and analysis of options to 

avoid or minimize impacts; and 

development and analysis of measures 

to mitigate adverse impacts. EPA 

determined that no Environmental 

Assessments (EAs) or Environmental 

Impact Statements (EISs) are required 

under NEPA. EPA also determined that 

CZARA does not apply. 

Essential Fish Habitat (EFH). The 

Magnuson-Stevens Fishery Management 

and Conservation Act requires EPA to 

consult with NOAA–NMFS when a 

proposed discharge has the potential to 

adversely affect a designated EFH. The 

EFH regulations define an adverse effect 

as ‘‘any impact which reduces quality 

and/or quantity of EFH . . . [and] may 

include direct (e.g. contamination or 

physical disruption), indirect (e.g. loss 

of prey, reduction in species’ fecundity), 

site-specific or habitat-wide impacts, 

including individual, cumulative, or 

synergistic consequences of actions.’’ 

NMFS may recommend measures for 

attachment to the federal action to 

protect EFH; however, such 

recommendations are advisory, and not 

prescriptive in nature. EPA has 

evaluated the Draft General Permit and 

has made the determination that 

issuance of the General Permit will is 

not likely to adversely affect EFH. 

Executive Order 12866: The Office of 

Management and Budget (OMB) 

exempts this action from the review 

requirements of Executive Order 12866 

pursuant to Section 6 of that order. 

Economic Impact [Executive Order 

12291]: The EPA has reviewed the effect 

of Executive Order 12291 on this Draft 

General Permit and has determined that 

it is not a major rule pursuant to that 

Order. 

Paperwork Reduction Act [44 U.S.C. 

3501 et seq.] The EPA has reviewed the 

requirements imposed on regulated 

facilities in the Draft General Permit and 

finds them consistent with the 

Paperwork Reduction Act of 1980, 44 

U.S.C. 3501 et seq. 

Regulatory Flexibility Act [5 U.S.C. 

601 et seq.] The Regulatory Flexibility 

Act (RFA) requires that EPA prepare an 

initial regulatory flexibility analysis for 

rules subject to the requirements of the 

Administrative Procedures Act [APA, 5 

U.S.C. 553] that have a significant 

impact on a substantial number of small 

entities. However, EPA has concluded 

that NPDES General Permits are not 

rulemakings under the APA, and thus 

not subject to APA rulemaking 

requirements or the RFA. 

Unfunded Mandates Reform Act 

Section 201 of the Unfunded 

Mandates Reform Act (UMRA), Public 

Law 104–4, generally requires Federal 

agencies to assess the effects of their 

regulatory actions (defined to be the 

same as rules subject to the RFA) on 

tribal, state, and local governments, and 

the private sector. However, General 

NPDES Permits are not rules subject to 

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Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices 79335 

the requirements of the APA, and are, 

therefore, not subject to the UMRA. 

Authority: This action is taken under the 

authority of Section 402 of the Clean Water 

Act as amended, 42 U.S.C. 1342. I hereby 

provide public notice of the Draft General 

Permit for Federal Aquaculture Facilities and 

Aquaculture Facilities Located in Indian 

Country within the Boundaries of 

Washington State in accordance with 40 CFR 

124.10. 

Dated: December 14, 2015. 

Daniel D. Opalski, 

Director, Office of Water and Watersheds, 

Region 10. 

[FR Doc. 2015–32026 Filed 12–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2015–0780; FRL–9939–68] 

Lead; Renovation, Repair and Painting 

Program; Lead Test Kit; Notice of 

Opening of Comment Period 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA is opening a comment 

period to allow for further public 

comment on lead test kits and other 

field testing options as suggested in 

EPA’s Fiscal Year 2015 Appropriations 

Act policy rider. Among other things, 

the 2008 Lead Renovation, Repair, and 

Painting rule (RRP) established 

performance recognition criteria for lead 

test kits for use as an option to 

determine if regulated lead-based paint 

is not present in target housing and 

child-occupied facilities. The use of an 

EPA-recognized lead test kit, when used 

by a trained professional, can reliably 

determine that regulated lead-based 

paint is not present by virtue of a 

negative result. The RRP rule also 

established negative response and 

positive response criteria for lead test 

kits recognized by EPA. No lead test kit 

has been developed that meets the 

positive response criterion. On June 4, 

2015, EPA hosted a public meeting and 

webinar to solicit input from 

stakeholders in an effort to understand 

the current state of the science for lead 

test kits and lead-based paint field 

testing alternatives, as well as the 

existing market and potential 

availability of additional lead test kits. 

To date, no company’s lead test kit has 

met both the negative response and 

positive response criteria outlined in the 

RRP rule. Based on stakeholder input, 

EPA is unaware of any lead test kit 

available now or in the foreseeable 

future that would meet both of the 

performance criteria. 

DATES: Comments must be received on 

or before February 19, 2016. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2015–0780, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 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. The docket for 

this action will remain open until 

February 19, 2016. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: 

The Agency’s lead information 

Contact Us form at http://www2.epa.

gov/lead/forms/contact-us or visit 

www2.epa.gov/lead. You may also 

contact Toiya Goodlow, National 

Program Chemicals Division (7404M), 

Office of Pollution Prevention and 

Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460; telephone 

number: (202) 566–2305; email address: 

goodlow.toiya@epa.gov. 

For general information contact: The 

National Lead Information Center, 

ABVI-Goodwill, 422 South Clinton 

Ave., Rochester, NY 14620; telephone 

number: 1–800–424–LEAD (5323); 

online information request form: http:// 

www2.epa.gov/lead/forms/lead-hotlinenational-lead-information-center. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This document is directed to 

stakeholders that develop, manufacture 

and/or sell lead test kits or other leadbased paint field testing instruments. 

You may be potentially affected by this 

action if you manufacture or sell lead 

test kits, or if you use lead test kits to 

determine if lead-safe work practices are 

required under the RRP rule to perform 

renovations for compensation in target 

housing or child-occupied facilities. 

Examples of child-occupied facilities 

are day-care centers, preschools, and 

kindergarten classrooms. 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

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

comments.html. 

II. What action is the Agency taking? 

On April 22, 2008, EPA published the 

Lead Renovation, Repair, and Painting 

rule. It requires contractors to use leadsafe work practices during renovation, 

repair, and painting activities that 

disturb lead-based paint in target 

housing and child-occupied facilities 

built before 1978 unless a determination 

can be made that no lead-based paint 

would be disturbed during the 

renovation or repair (Ref. 1). The use of 

an EPA-recognized lead test kit, when 

used by a trained professional, can 

reliably determine that regulated leadbased paint is not present by virtue of 

a negative result. The federal standards 

for lead-based paint in target housing 

and child-occupied facilities is a lead 

content in paint that equals or exceeds 

a level of 1.0 milligram per square 

centimeter (mg/cm2) or 0.5 percent by 

weight. If regulated lead-based paint is 

not present, there is no requirement to 

employ lead-safe work practices under 

the RRP rule. 

The RRP rule established negative 

response and positive response criteria 

outlined in 40 CFR 745.88(c) for lead 

test kits recognized by EPA. Lead test 

kits recognized before September 1, 

2010, must meet only the negative 

response criterion outlined in 40 CFR 

745.88(c)(1). The negative response 

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