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)

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 Members of the public may obtain the draft guidance at http:// www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure- assessment or from Dr.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, 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Members of the public may obtain the draft guidance at http://www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure-assessment or from Dr.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]
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