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Integrated Risk Information System (IRIS); Request for Chemical Substance Nominations for 2011 Program

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Environmental Protection Agency (EPA).


Request for chemical substance nominations for the IRIS 2011 Program.


EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to specific chemical substances found in the environment. EPA is soliciting public nominations for chemical substances for its 2011 agenda. EPA invites the public to submit nominations for substances to be considered for an assessment or reassessment in its IRIS Program in accordance with the instructions provided at the end of this notice.


Nominations must be submitted within 60 days of the publication of this notice. The 60-day period begins October 18, 2010, and ends December 17, 2010.

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Nominations may be submitted electronically via, by e-mail, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions provided in the SUPPLEMENTARY INFORMATION section of this notice.

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For information on the IRIS Program, contact Abdel Kadry, PhD, Program Director, National Center for Environmental Assessment (mail code 8601PY), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; or send electronic mail inquiries to: For general questions about access to IRIS or the content of IRIS, please call the IRIS Hotline at (202) 566-1676 or send electronic mail inquiries to

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I. Background

EPA's IRIS is a human health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to specific 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 540 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, as well as assessments of potential carcinogenic effects resulting from chronic exposure. Combined with specific exposure information, government and private entities use IRIS to help characterize public health risks of chemical substances in site-specific situations and thereby support risk management decisions designed to protect public health.

From FY2008 to the present, the following IRIS assessments were completed and posted on the IRIS database:

carbon tetrachloride56-23-5
cerium oxide and cerium compounds1306-38-3
chlordecone (kepone)143-50-0
decabromodiphenyl ether1163-19-5
1,4-dioxane (oral)123-91-1
ethylene glycol monobutyl ether (EGBE)111-76-2
hexabromodiphenyl ether68631-49-2
hydrogen cyanide74-90-8
pentabromodiphenyl ether60348-60-9
tetrabromodiphenyl ether5436-43-1

The assessments listed below are currently on the IRIS agenda. The status and planned milestone dates can be found on the IRIS track system, accessible on the IRIS Web site (​iris). All cancer and noncancer health endpoints due to chronic exposure are being assessed unless otherwise noted. Not all of the assessments on the IRIS agenda have been started, but most are in the various review steps of the IRIS process. The remainder will start draft development as resources become available.

tert-amyl methyl ether (TAME)994-05-8
arsenic, inorganic (cancer)7440-38-2
arsenic, inorganic (noncancer)7440-38-2
beryllium (cancer)7440-41-7
bisphenol A80-05-7
butyl benzyl phthalate85-68-7
carbonyl sulfide463-58-1
chromium VI18540-29-9
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di-n-butyl phthalate84-74-2
1,2-dichloroethane (ethylene dichloride)107-06-2
dichloromethane (methylene chloride)75-09-2
diethyl phthalate84-66-2
di(2-ethylhexyl) phthalate117-81-7
diisobutyl phthalate84-69-5
diisononyl phthalate58033-90-2
diisopropyl ether (DIPE)108-20-3
4,4'-dimethyl-3-oxahexane (TAEE)919-94-8
1,4-dioxane (inhalation)123-91-1
dipentyl phthalate131-18-0
ethyl tertiary butyl ether (ETBE)637-92-3
ethylene oxide (cancer)75-21-8
hexabromocyclododecane (mixed stereoisomers)3194-55-6, 25637-99-5
hexahydro-1,3,5-trinitro-triazine (RDX)121-82-4
Libby amphibole asbestos1332-21-4
methyl tert-butyl ether (MTBE)1634-04-4
nickel (soluble salts)various
halogenated platinum salts and platinum compoundsvarious
polychlorinated biphenyls (PCBs) (noncancer)various
polycyclic aromatic hydrocarbon (PAH) mixturesvarious
refractory ceramic fibersnot applicable
2,3,7,8-tetrachlorodibenzo-p-dioxin and related compounds1746-01-6, various
tetrachloroethylene (perchloroethylene)127-18-4
trichloroacetic acid76-03-9
tungsten and related compounds7440-33-7, various
uranium (natural)7440-61-1
vanadium pentoxide1314-62-1
vinyl acetate108-05-4

The alkylates, listed above, are a distillation fraction of petroleum and are present in gasoline. Common alkylates found in gasoline for which IRIS assessments have not been recently completed include n-heptane, methylcyclohexane, 2-methylbutane, 2-methylpentane, 3-methylpentane, n-octane, 2,3,3-trimethylpentane, 2,3,4-trimethylpentane, and 2,2,5-trimethylhexane. EPA will evaluate the feasibility of conducting an assessment of alkylates, the approach to be taken in the assessment, and the identities of the compounds that will be assessed.

The following phthalates have been added to the IRIS agenda: Diisobutyl phthalate, diisononyl phthalate, and dipentyl phthalate. These additions to the IRIS agenda are in response to recommendations made by the National Academy of Sciences in the report, “Phthalates and Cumulative Risk Assessment—The Tasks Ahead” (NAS, 2008).

Perfluorooctanoic acid—ammonium salt (PFOA) and perfluorooctane sulfonate—potassium salt (PFOS) have been withdrawn from the IRIS agenda. In December 2009, EPA published the “Long-Chain Perfluorinated Chemicals (PFCs) Action Plan Summary” (​opptintr/​existingchemicals/​pubs/​actionplans/​pfcs.html), part of EPA Administrator Lisa Jackson's comprehensive approach to enhance the Agency's current chemicals management program under the Toxic Substances Control Act. PFOA and PFOS are included in the Agency's action plan for this class of chemicals. The listing of asbestos in the IRIS agenda has been revised to specify Libby amphibole asbestos. EPA is focusing on the Libby amphibole in order to respond to needs of the Agency and the Libby community. The assessment for weathered toxaphene has been withdrawn because of lack of data to support an IRIS assessment.

Today's notice invites voluntary public nominations for chemical substances not already listed in this notice. Today's notice also invites comments on assessments on the current IRIS agenda. To nominate a substance, please complete the form below and submit it to EPA by one of the methods detailed below. A fill-and-print version of this form can be found on the IRIS Web site,​iris, under IRIS Agenda. Nominations and comments are most Start Printed Page 63830useful if they identify the nominator (including full name, title, affiliation, mailing address, e-mail address, and telephone number) and provide information on the criteria EPA uses to evaluate the priority of the chemicals:

Identification of nominator:

Nominator's name:



Telephone No.:


e-mail address:

Chemical Substance Name:

Common Synonym(s), if any:

CAS No.:

Information for Prioritizing Nominations

1. What is the potential public health impact for this chemical?

2. Is this assessment needed to fulfill a chemical-specific EPA mandate or program need (e.g., statutory, regulatory, or court-ordered deadline)? Please describe the mandate or program need. When is the assessment needed?

3. Is this assessment a priority for stakeholders outside of EPA (e.g., states, tribes, local governments, environmental organizations, industries, or other IRIS users)? Why is it a priority?

4. Are you aware of other assessments of this substance that may be available to EPA (e.g., an EPA program has assessed this substance, but it has not received Agency-wide IRIS review, a state or other federal agency has an assessment, or another government or private organization has assessed this substance)? If possible, please provide specific information to allow EPA to locate and obtain the assessment.

5. For substances being nominated for IRIS reassessment, what, if any, significant new scientific data or risk assessment methodology is available that you believe would be likely to appreciably change the existing IRIS assessment? Please provide specific citations and other information that would allow EPA to locate and obtain the papers or data.

6. Are you aware of other factors that would make this substance a priority for IRIS assessment (e.g., widespread exposure, expected toxicity, or potentially susceptible populations)?

II. How To Submit Nominations and Comments to the Docket at Follow the on-line instructions for submitting comments.


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., Eastern Standard Time, Monday through Friday, excluding federal 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. Consult EPA's Web site at​epahome/​dockets.htm for current information on docket operations, locations and telephone numbers.

Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-2010-0744. Please ensure that your comments are submitted within the specified nomination period. Nominations received after the closing date will be marked “late,” and may be considered only 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, 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 or e-mail. The 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, 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, 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​epahome/​dockets.htm.

Docket: Documents in the docket are listed in the 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 materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

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Dated: October 12, 2010.

Darrell Winner,

Acting Director, National Center for Environmental Assessment.

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[FR Doc. 2010-26159 Filed 10-15-10; 8:45 am]