E7-25282. 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.

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 www.epa.gov/​ncea. A limited number of paper copies are available by contacting the IRIS Hotline at [phone], [phone] (facsimile), or [e-mail]. 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 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: [phone]; facsimile: 202-566-1753; or e-mail: [e-mail].

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 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: [phone]; facsimile: 703-347-8699; e-mail: [e-mail].

For technical and scientific questions concerning the draft Toxicological Review of Acrylamide, contact the Chemical Manager, Robert DeWoskin, National Center for Environmental Assessment; telephone: [phone]; facsimile: 919-541-0248; e-mail: [e-mail].

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 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 www.regulations.gov

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2007-1141 by one of the following methods:

• www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: [e-mail].
• Fax: [phone].
• 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 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 www.regulations.gov or e-mail. The 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 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 www.epa.gov/​epahome/​dockets.htm.

Docket: All documents in the docket are listed in the 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 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.