Workshop: Cumulative Mixtures Risk of Six Selected Phthalates in Support of Summary Information on the Integrated Risk Information System (IRIS)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of Peer Consultation Workshop on the Cumulative Mixtures Risk of Six Selected Phthalates; Request for Public Comments.

SUMMARY:

EPA is announcing that ICF International, an EPA contractor for external scientific peer consultation, will convene a panel of independent experts and conduct an external peer consultation workshop to: (1) Review the recommendations for evaluation of the cumulative mixtures risk of phthalates as set forth in the National Academies of Science (NAS) report “Phthalates and Cumulative Risk Assessment: The Tasks Ahead” (2008); and (2) propose additional methods and approaches, not already captured in the 2008 NAS report, that may facilitate the assessment of risk(s) associated with exposure to cumulative mixtures of the six selected phthalates.

ICF International invites all interested public parties to register to attend this workshop as observers. Space is limited, and reservations will be accepted on a first-come, first-served basis. In addition, ICF International invites the public to give brief oral comments at the conclusion of each workshop day. Furthermore, there is an opportunity to provide written comments regarding the subject matter under discussion; for more information please see below. In conceptualizing and preparing a draft of the “Toxicological Review of the Cumulative Mixtures Risk of Six Selected Phthalates,” EPA will consider ICF's report of the comments and recommendations from individuals participating in the external peer consultation workshop and any written public comments that EPA receives in accordance with this notice.

DATES:

The peer consultation workshop on the Cumulative Mixtures Risk of Six Selected Phthalates will be held on December 8 and 9, 2010, beginning at 8 a.m. and ending at 5 p.m. Eastern Standard Time. Please note that a public comment period begins November 15, 2010 and ends January 4, 2011. Technical comments should be in writing and must be received by the EPA by January 4, 2011.

ADDRESSES:

The peer consultation workshop on the Cumulative Mixtures Risk of Six Selected Phthalates will be held at the Double Tree Crystal City, located at 300 Army Navy Drive in Arlington, VA. To attend the workshop, register no later than December 3, 2010, preferably via the workshop Web site page at http://epa.phthalatesworkshop.icfi.com. Alternatively, you may register by calling ICF International at 1-703-934-3173, sending a facsimile to 1-703-934-3470, or sending an e-mail to Ms. Ami Parekh Gordon at AGordon3@icfi.com.

Additional Information: EPA welcomes public attendance at the “Peer Consultation Workshop on Cumulative Mixtures Risk of Six Selected Phthalates” and will make every effort to accommodate persons with disabilities. For information on access or services for individuals with disabilities, or if you have any other questions related to this workshop please contact Ms. Ami Parekh Gordon of ICF International at AGordon3@icfi.com or by phone at 1-703-934-3173.

SUPPLEMENTARY INFORMATION:

I. Information About IRIS

EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. Through the IRIS Program, EPA provides the highest quality science-based human health assessments to support the Agency's regulatory activities. The IRIS database contains information for more than 550 chemical substances that can be used to support the first two steps (hazard identification and dose-response evaluation) of the risk assessment process. When supported by available data, IRIS provides oral reference doses (RfDs) and inhalation reference concentrations (RfCs) for chronic noncancer health effects and cancer assessments. 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.

The IRIS cumulative assessment will address the specific recommendations presented in the NAS report on cumulative risk for phthalates and expand the discussion to other approaches that may also be applicable. The 2008 NAS report recommended that:

○ EPA group chemicals that cause common adverse outcomes and not focus exclusively on structural similarity or on similar mechanisms of action, and

○ Phthalates and other agents that cause androgen insufficiency or block androgen-receptor signaling, and are thus capable of inducing effects that characterize components of the phthalate syndrome, should be considered in a cumulative risk assessment.

In response to NAS recommendations, EPA is conducting research to: (1) Determine whether prenatal exposures to phthalates are associated with adverse effects in male and female offspring; (2) determine how phthalates interact in mixtures with other phthalates, toxic substances, and pesticides to induce adverse effects, in particular disruption of reproductive development in males and females; and (3) determine approaches to integrate new data on multiple phthalates into a cumulative mixtures assessment.

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

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2010-0927, by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.
• E-mail: ORD.Docket@epa.gov.
• Facsimile: 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 telephone number is 202-566-1752. If you provide comments by mail, 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.
• 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. 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 by hand delivery, 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-2010-0927. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all comments it receives in the public docket without change and to make the comments available online at http://www.regulations.gov,, including any personal information provided, unless comments include 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 comments. If you send e-mail comments directly to EPA without going through http://www.regulations.gov,, your e-mail address will be automatically captured and included as part of the comments that are placed in the public docket and made available on the Internet. If you submit electronic comments, EPA recommends that you include your name and other contact information in the body of your comments and with any disk or CD-ROM you submit. If EPA cannot read your comments due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comments. Electronic files should avoid the use of special characters and 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 are available either electronically at http://www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.