Teratology Society Preparing Comments on EPA Draft Guidelines for Human Exposure Assessment

The Teratology Society is preparing to submit comments in response to the request below. Members who wish to contribute to these comments should contact Heather Carskaddan (hcarskaddan@teratology.org) as soon as possible. The deadline to contribute to the Society's comments is 9 am ET on Monday, March 14, 2016.

Notice of Availability of Draft Guidelines for Human Exposure Assessment: Extension of Public Comment Period

For more information, go to: https://federalregister.gov/a/2016-03110


On January 7, 2016 the U.S. Environmental Protection Agency (EPA) announced the release of the external review draft of “Guidelines for Human Exposure Assessment” for public review and comment (81 FR 774-775). With this notice EPA is announcing the extension of the comment period to March 22, 2016. 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 March 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 Members of the public may obtain the draft guidance at http://www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure-assessment or from Dr.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.


All comments received in the docket by March 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.


Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2015-0684 by one of the following methods:

Internet: http://www.regulations.gov: Follow the on-line instructions for submitting comments.

Email: ord.docket@epa.gov.

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 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.


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: broder.michael@epa.gov.


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 Academies 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.


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