Document ID: EPA-HQ-ORD-2007-1141-0001
Agency: epa
Document Type: Notice
Title: Draft Toxicological Review of Acrylamide: In Support of Summary Information on the Integrated Risk Information System (IRIS)
Posted Date: 2007-12-28T05:00Z

[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Notices]               
[Page 73813-73814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-90]                         

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8511-8; Docket ID No. EPA-HQ-ORD-2007-1141]

 
Draft Toxicological Review of Acrylamide: In Support of Summary 
Information on the Integrated Risk Information System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Public Comment Period.

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SUMMARY: The EPA is announcing a public comment period to review the 
final draft document titled, ``Toxicological Review of Acrylamide: In 
Support of Summary Information on the Integrated Risk Information 
System (IRIS)'' (EPA/635/R-07/009), related to the human health 
assessment for acrylamide. The document was prepared by the National 
Center for Environmental Assessment (NCEA) within EPA's Office of 
Research and Development.
    EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality 
guidelines. This document has not been formally disseminated by EPA. It 
does not represent and should not be construed to represent any Agency 
policy or determination. EPA will consider any public comments 
submitted in accordance with this notice when revising the document.

DATES: The 60-day public comment period begins on December 28, 2007 and 
ends February 26, 2008. Technical comments should be in writing and 
must be received by EPA by February 26, 2008.

ADDRESSES: The draft ``Draft Toxicological Review of Acrylamide: In 
Support of Summary Information on the Integrated Risk Information 
System (IRIS)'' (EPA/635/R-07/009) is available primarily via the 
Internet on NCEA's home page under the Recent Additions menu at 
http://www.epa.gov/ncea. A limited number of paper copies are available by 

contacting the IRIS Hotline at (202) 566-1676, (202) 566-1749 
(facsimile), or hotline.iris@epa.gov. If you are requesting a paper 
copy, please provide your name, mailing address, the document title, 
and the EPA number of the requested publication.
    Technical comments may be submitted electronically via 
http://www.regulations.gov, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions provided in the 
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the public comment 
period, contact the Office of Environmental Information Docket; 
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: 
ORD.Docket@epa.gov.

    For general information about the IRIS assessment process, terms, 
and existing values go to NCEA's home page via the Internet and click 
on ``IRIS'' in the Quick Finder section at http://www.epa.gov/ncea (or go to 

http://www.epa.gov/iriswebp/iris/index.html ). For information on the 

status and estimated completion dates of the Toxicological Review of 
Acrylamide go to the IRIS home page and click on ``IRIS Track'' in the 
left hand column (or go to: http://cfpub.epa.gov/iristrac/index.cfm).

    If you have questions or need information regarding communications 
and outreach, contact Linda Tuxen, National Center for Environmental 
Assessment; telephone: 703-347-8609; facsimile: 703-347-8699; e-mail: 
tuxen.linda@epa.gov.

    For technical and scientific questions concerning the draft 
Toxicological Review of Acrylamide, contact the Chemical Manager, 
Robert DeWoskin, National Center for Environmental Assessment; 
telephone: 919-541-1089; facsimile: 919-541-0248; e-mail: 
dewoskin.rob@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Information About the Document

    Acrylamide is a monomer used primarily in the production of 
polyacrylamide polymers. Polyacrylamides are used as a flocculent in 
water purification, oil recovery, and soil stabilization; and in the 
manufacturing of a wide range of products as a coating, matrix, 
additive, or stabilizer. Human exposure to acrylamide occurs primarily 
in the workplace from dermal contact and inhalation of dust and vapor 
during processing or use. The public may be exposed to acrylamide 
through emissions from production facilities, use in consumer products, 
contaminated drinking water, and cigarette smoke. In early 2002, 
Swedish scientists reported high concentrations of acrylamide in 
certain fried, baked, and deep-fried foods. Subsequent research 
demonstrated that acrylamide forms ``de novo'' (i.e., newly formed, not 
present as an environmental contaminant) during high temperature 
cooking of carbohydrate-rich foods that contain asparagine and in a few 
other food processes. Considerable research is on-going to assess the 
level of and the potential risk from exposure to

[[Page 73814]]

acrylamide in food (additional information is available on the U.S. 
FDA's Internet site for acrylamide: http://www.cfsan.fda.gov/lrd/pestadd.html#acrylamide
).

    This public review draft of ``Toxicological Review of Acrylamide'' 
is an update and reassessment of the human health effects that may 
result from exposure to acrylamide. The acrylamide oral and inhalation 
reference values and carcinogenicity classification have been revised 
based upon new data and changes in guidance that have occurred since 
the previous assessment in 1988.
    IRIS is a database of human health effects that may result from 
exposure to various chemical substances found in the environment. The 
database (available on the Internet at http://www.epa.gov/iris) 

contains qualitative and quantitative health effects information for 
more than 540 chemical substances that may be used to support the first 
two steps (hazard identification and dose response evaluation) of the 
risk assessment process. When supported by available data, the database 
provides oral reference doses (RfDs) and inhalation reference 
concentrations (RfCs) for health effects, and oral slope factors and 
inhalation unit risks for carcinogenic effects. Combined with specific 
exposure information, government and private entities use IRIS to help 
characterize public health risks of chemical substances in a site-
specific situation and thereby support risk management decisions 
designed to protect public health.

II. How to Submit Technical Comments to the Docket at 
http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-
1141 by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for 

submitting comments.
     E-mail: ORD.Docket@epa.gov.
     Fax: 202-566-1753.
     Mail: Office of Environmental Information (OEI) Docket 
(Mail Code: 2822T).
    U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. The phone number is 202-566-1752.
     Hand Delivery: The OEI Docket is located in the EPA 
Headquarters Docket Center, EPA West Building, Room 3334, 1301 
Constitution Ave., NW., Washington, DC. The EPA Docket Center 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. Such deliveries are only accepted during 
the docket's normal hours of operation, and special arrangements should 
be made for deliveries of boxed information.
    If you provide comments in writing, please submit one unbound 
original with pages numbered consecutively, and three copies of the 
comments. For attachments, provide an index, number pages consecutively 
with the comments, and submit an unbound original and three copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2007-1141. 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 through http://www.regulations.gov or e-mail. 

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 e-
mail comment directly to EPA without going through http://www.regulations.gov, 

your e-mail 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. For additional 
information about EPA's public docket visit the EPA Docket Center 
homepage at http://www.epa.gov/epahome/dockets.htm.

    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 can be accessed either 
electronically in http://www.regulations.gov or in hard copy from the OEI 

Docket in the EPA Headquarters Docket Center.

    Dated: December 18, 2007.
Rebecca M. Clark,
Acting Director, National Center for Environmental Assessment.
[FR Doc. E7-25282 Filed 12-27-07; 8:45 am]

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