81 FR 774 - Notice of Availability of Draft Guidelines for Human Exposure Assessment

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 4 (January 7, 2016)

Page Range		774-775
FR Document		2016-00077

The Environmental Protection Agency (EPA) is announcing a 45- day public comment period for the External Review Draft of the ``Guidelines for Human Exposure Assessment.'' EPA is seeking public comment prior to external peer review. The document will undergo review during an expert peer review meeting, which will be convened, organized, and conducted by an independent contractor. The date and location of the peer review meeting will be announced in a subsequent Federal Register notice. All comments received in the docket by the closing date February 22, 2016 will be shared with the peer review panel for their consideration. Comments received after the close of the comment period may be considered by EPA when it finalizes the document. Members of the public may obtain the draft guidance at http:// www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure- assessment or from Dr. Michael Broder via the contact information below.

Federal Register, Volume 81 Issue 4 (Thursday, January 7, 2016)

[Federal Register Volume 81, Number 4 (Thursday, January 7, 2016)]
[Notices]
[Pages 774-775]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00077]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0684; FRL-9940-77-ORD]


Notice of Availability of Draft Guidelines for Human Exposure 
Assessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability for public comment.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing a 45-
day public comment period for the External Review Draft of the 
``Guidelines for Human Exposure Assessment.'' EPA is seeking public 
comment prior to external peer review. The document will undergo review 
during an expert peer review meeting, which will be convened, 
organized, and conducted by an independent contractor. The date and 
location of the peer review meeting will be announced in a subsequent 
Federal Register notice. All comments received in the docket by the 
closing date February 22, 2016 will be shared with the peer review 
panel for their consideration. Comments received after the close of the 
comment period may be considered by EPA when it finalizes the document. 
Members of the public may obtain the draft guidance at http://www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure-assessment or from Dr. Michael Broder via the contact information 
below.

DATES: All comments received in the docket by February 22, 2016 will be 
shared with the external peer review panel for their consideration. 
Comments received beyond that time may be considered by EPA when it 
finalizes the document.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
ORD-2015-0684 by one of the following methods:
     http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Email: [email protected].
     Mail: ORD Docket, Environmental Protection Agency, 
Mailcode: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA 
West Building, 1301 Constitution Avenue NW., Washington, DC 20460, 
Attention Docket ID No EPA-HQ-ORD-2015-0684. Deliveries are only 
accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. Special arrangements should be made for deliveries of 
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2015-0684. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available online at 
http://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected by statute through http://www.regulations.gov or email. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an email comment directly to EPA, without 
going through http://www.regulations.gov, your email address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, EPA recommends that you include your name 
and other contact information in the body of your comment and with any 
disk or CD-ROM you submit. If EPA cannot read your comment due to 
technical difficulties and cannot contact

[[Page 775]]

you for clarification, EPA may not be able to consider your comment. 
Electronic files should avoid the use of special characters, any form 
of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. 
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 
ORD Docket is (202) 566-1752.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Broder, Office of the 
Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number 
(202) 564-3393; fax number (202) 564-2070; or email: 
[email protected].

SUPPLEMENTARY INFORMATION: The current guidance document for human 
exposure assessment, Guidelines for Exposure Assessment, was published 
in 1992, reflecting the state-of-the-science in the 1970s and 1980s. 
Since its publication, the field of exposure science has undergone 
significant transformation in methods and approaches, which EPA has 
incorporated into its policies and practices to better align with the 
current state-of-the-science. The 1992 guidelines are being updated to 
reflect the updated methods and approaches.
    The draft guidelines benefit from over two decades of experience 
with EPA assessments conducted by Agency programs under their 
respective authorities and constraints, and from input from external 
panels, including the National Academy of Sciences and EPA's Science 
Advisory Board. This draft document builds on topics covered in the 
1992 exposure guidelines including planning and scoping for an 
assessment, data acquisition and use, modeling, and considerations of 
uncertainty in exposure assessment. It also includes new material on 
planning and conducting an observational human exposure measurement 
study and considerations of lifestages and sensitive populations in 
exposure assessments. These draft guidelines present the most current 
science used in EPA exposure assessments and incorporates information 
about the Agency's current policies.

    Dated: December 22, 2015.
Thomas Burke,
EPA Science Advisor.
[FR Doc. 2016-00077 Filed 1-6-16; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 4 / Thursday, January 7, 2016 / Notices 775

you for clarification, EPA may not be exposure measurement study and B. New Business
able to consider your comment. considerations of lifestages and • Farmer Mac Investment Eligibility—
Electronic files should avoid the use of sensitive populations in exposure Proposed Rule
special characters, any form of assessments. These draft guidelines
encryption, and be free of any defects or present the most current science used in C. Reports
viruses. EPA exposure assessments and • Auditor’s Report on FCA FY 2015/
Docket: All documents in the docket incorporates information about the 2014 Financial Statements
are listed in the http:// Agency’s current policies.
www.regulations.gov index. Although Closed Session*
Dated: December 22, 2015.
listed in the index, some information is Thomas Burke, • Executive Meeting with Auditors
not publicly available, e.g., CBI or other
EPA Science Advisor. Dated: January 5, 2016.
information whose disclosure is
[FR Doc. 2016–00077 Filed 1–6–16; 8:45 am] Dale L. Aultman,
restricted by statute. Certain other
material, such as copyrighted material, BILLING CODE 6560–50–P Secretary, Farm Credit Administration Board.
will be publicly available only in hard *Session Closed-Exempt pursuant to 5
copy. Publicly available docket U.S.C. Section 552b(c)(2).
materials are available either FARM CREDIT ADMINISTRATION [FR Doc. 2016–00200 Filed 1–5–16; 4:15 pm]
electronically in http:// BILLING CODE 6705–01–P
www.regulations.gov or in hard copy at Farm Credit Administration Board;
the ORD Docket, EPA/DC, EPA West, Sunshine Act; Regular Meeting
Room 3334, 1301 Constitution Ave. AGENCY: Farm Credit Administration. FEDERAL TRADE COMMISSION
NW., Washington, DC. The Public SUMMARY: Notice is hereby given,
Reading Room is open from 8:30 a.m. to [File No. 151–0215]
pursuant to the Government in the
4:30 p.m., Monday through Friday, Sunshine Act, of the regular meeting of Rangers Renal Holdings LP; Analysis
excluding legal holidays. The telephone the Farm Credit Administration Board To Aid Public Comment
number for the Public Reading Room is (Board).
(202) 566–1744, and the telephone DATES: Date and Time: The regular
AGENCY: Federal Trade Commission.
number for the ORD Docket is (202) meeting of the Board will be held at the ACTION: Proposed Consent Agreement.
566–1752. offices of the Farm Credit
FOR FURTHER INFORMATION CONTACT: Dr. SUMMARY: The consent agreement in this
Administration in McLean, Virginia, on
Michael Broder, Office of the Science matter settles alleged violations of
January 14, 2016, from 9:00 a.m. until
Advisor, Mail Code 8105R, U.S. federal law prohibiting unfair methods
such time as the Board concludes its
Environmental Protection Agency, 1200 of competition. The attached Analysis to
business.
Pennsylvania Ave. NW., Washington, Aid Public Comment describes both the
ADDRESSES: Farm Credit allegations in the draft complaint and
DC 20460; telephone number (202) 564–
Administration, 1501 Farm Credit Drive, the terms of the consent order—
3393; fax number (202) 564–2070; or
McLean, Virginia 22102–5090. Submit embodied in the consent agreement—
email: broder.michael@epa.gov.
attendance requests via email to that would settle these allegations.
SUPPLEMENTARY INFORMATION: The
VisitorRequest@FCA.gov. See DATES: Comments must be received on
current guidance document for human SUPPLEMENTARY INFORMATION for further
exposure assessment, Guidelines for or before January 29, 2016.
information about attendance requests.
Exposure Assessment, was published in ADDRESSES: Interested parties may file a
FOR FURTHER INFORMATION CONTACT: Dale
1992, reflecting the state-of-the-science comment at https://
L. Aultman, Secretary to the Farm ftcpublic.commentworks.com/ftc/
in the 1970s and 1980s. Since its
Credit Administration Board, (703) 883– rangersrenalconsent online or on paper,
publication, the field of exposure
4009, TTY (703) 883–4056. by following the instructions in the
science has undergone significant
transformation in methods and SUPPLEMENTARY INFORMATION: Parts of Request for Comment part of the
approaches, which EPA has this meeting of the Board will be open SUPPLEMENTARY INFORMATION section
incorporated into its policies and to the public (limited space available), below. Write ‘‘Rangers Renal Holding,
practices to better align with the current and parts will be closed to the public. LP; US Renal Care, Inc.; Dialysis Parent,
state-of-the-science. The 1992 Please send an email to VisitorRequest@ LLC; and Dialysis HoldCo, LLC.,—
guidelines are being updated to reflect FCA.gov at least 24 hours before the Consent Agreement; File No. 151–0215’’
the updated methods and approaches. meeting. In your email include: name, on your comment and file your
The draft guidelines benefit from over postal address, entity you are comment online at https://
two decades of experience with EPA representing (if applicable), and ftcpublic.commentworks.com/ftc/
assessments conducted by Agency telephone number. You will receive an rangersrenalconsent by following the
programs under their respective email confirmation from us. Please be instructions on the web-based form. If
authorities and constraints, and from prepared to show a photo identification you prefer to file your comment on
input from external panels, including when you arrive. If you need assistance paper, write ‘‘Rangers Renal Holding,
the National Academy of Sciences and for accessibility reasons, or if you have LP; US Renal Care, Inc.; Dialysis Parent,
EPA’s Science Advisory Board. This any questions, contact Dale L. Aultman, LLC; and Dialysis HoldCo, LLC.,—
draft document builds on topics covered Secretary to the Farm Credit Consent Agreement; File No. 151–0215’’
rmajette on DSK2TPTVN1PROD with NOTICES

in the 1992 exposure guidelines Administration Board, at (703) 883– on your comment and on the envelope,
including planning and scoping for an 4009. The matters to be considered at and mail your comment to the following
assessment, data acquisition and use, the meeting are: address: Federal Trade Commission,
modeling, and considerations of Open Session Office of the Secretary, 600
uncertainty in exposure assessment. It Pennsylvania Avenue NW., Suite CC–
also includes new material on planning A. Approval of Minutes 5610 (Annex D), Washington, DC 20580,
and conducting an observational human • December 10, 2015 or deliver your comment to the

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Document Created: 2016-01-07 00:12:53
Document Modified: 2016-01-07 00:12:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability for public comment.
Dates		All comments received in the docket by February 22, 2016 will be shared with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA when it finalizes the document.
Contact		Dr. Michael Broder, Office of the Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number (202) 564-3393; fax number (202) 564-2070; or email: [email protected]
FR Citation		81 FR 774