E6-7648. Integrated Risk Information System (IRIS); Announcement of 2006 Program

AGENCY:

Environmental Protection Agency.

ACTION:

Notice; correction.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) published a document in the Federal Register of February 23, 2006 (71 FR 9333), announcing the IRIS 2006 program agenda. EPA is correcting errors in the list of substances.

The Integrated Risk Information System (IRIS) is an EPA database that contains the Agency's scientific positions on human health effects that may result from exposure to chemical substances in the environment. On March 4, 2005, EPA announced the 2005 IRIS agenda (70 FR 10616), with solicitation of scientific information from the public for consideration in assessing health effects from specific chemical substances. All assessments currently in progress are listed in this notice. EPA is not initiating new assessments in 2006 in order to focus on completion of existing assessments. This notice also provides an update on EPA' efforts to improve the IRIS health assessment development and review processes.

DATES:

While EPA is not expressly soliciting comments on this notice, the Agency will accept information related to the substances included herein. Please submit any information in accordance with the instructions provided at the end of this notice.

ADDRESSES:

Please submit relevant scientific information identified by docket ID number EPA-HQ-ORD-2003-0016, online at http://www.regulations.gov (EPA' preferred method); by e-mail to [e-mail]; mailed to EPA Docket Center, Environmental Protection Agency, Mail Code: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or as an ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

FOR FURTHER INFORMATION CONTACT:

For information on the IRIS program, contact Dr. Abdel-Razak Kadry, IRIS Program Director, National Center for Environmental Assessment, (mail code: 8601D), Office of Research and Development, U.S. Environmental Protection Agency, Washington, DC 20460; telephone: [phone], facsimile: [phone]; or e-mail: [e-mail].

For general questions about access to IRIS, or the content of IRIS, please call the IRIS Hotline at [phone] or send electronic mail inquiries to [e-mail].

SUPPLEMENTARY INFORMATION:

Background

IRIS is an EPA database containing Agency scientific positions on potential adverse human health effects that may result from exposure to chemical substances found in the environment. (EPA notes that information in the IRIS database has no preclusive effect and does not predetermine the outcome of any rulemaking. When EPA uses such information to support a rulemaking, the scientific basis for, and the application of, that information are subject to comment.) IRIS currently provides information on health effects associated with more than 500 chemical substances.

The database includes chemical-specific summaries of qualitative and quantitative health information in support of the first two steps of the risk assessment process, i.e., hazard identification and dose-response evaluation. Combined with specific situational exposure assessment information, the information in IRIS is an important source in evaluating potential public health risks from environmental contaminants.

EPA's overall process for developing IRIS assessments consists of: (1) An annual Federal Register announcement of EPA's IRIS agenda and call for scientific information from the public on selected chemical substances; (2) a search of the scientific literature; (3) development of IRIS Summaries and support documents; (4) EPA-wide review; (5) external peer review; (6) management review and approval; and (7) entry of IRIS Summaries and support documents into the IRIS database (http://www.epa.gov/​iris).

The IRIS Annual Agenda

Each year, EPA develops an annual agenda for the IRIS program and announces new assessments under review. A focus of the IRIS Program for 2006 is to move forward the 75 assessments already in progress. In light of this focus, EPA will not initiate any new assessments in 2006. This notice provides: (1) A list of IRIS assessments in progress; (2) an update on improvements made to the IRIS program and preliminary notice of further improvements under consideration.

Assessments in Progress

The following assessments are underway. Each was listed in the 2005 IRIS agenda. The status and planned milestone dates for each assessment can be found on the IRIS Track system, accessible from the IRIS database. All health endpoints due to chronic exposure, cancer and noncancer, are being assessed unless otherwise noted. For all endpoints assessed, both qualitative and quantitative assessments are being developed where information is available. Those substances denoted with an asterisk (*) may require additional time for analysis or peer review due to their large databases or complex assessment issues. Substances denoted with a double asterisk (**) are being evaluated for effects from acute and/or other less-than-lifetime exposure durations. These substances are part of a pilot test to evaluate the application of methods, procedures, and resource needs for adding health effects information for less-than-lifetime exposure durations to IRIS. Additional less-than-lifetime durations may be added to ongoing chronic assessments as needs arise and resources permit.

Substance name	CAS No.
acetaldehyde	75-07-0.
acrolein**	107-02-8.
acrylamide	79-06-1.
acrylonitrile	107-13-1.
aldicarb/aldicarb sulfoxide	116-06-3/1646-87-3.
aldicarb sulfone	1646-88-4.
arsenic	7440-38-2.
asbestos*	1332-21-4.
benzene**	71-43-2.
benzo(a)pyrene	50-32-8.
beryllium (cancer effects)	7440-41-7.
bromobenzene	108-86-1.
butyl benzyl phthalate	85-68-7.
cadmium	7440-43-9.
carbon tetrachloride	56-23-5.
cerium	1306-38-3.
chloroethane	75-00-3.
chloroform (inhalation route)	67-66-3.
chloroprene	126-99-8.
cobalt	7440-48-4.
copper	7440-50-8.
dibutyl phthalate (chronic; less-than-lifetime** exposures)	84-74-2.
1,2-dichlorobenzene	95-50-1.
1,3-dichlorobenzene	541-73-1.
1,4-dichlorobenzene	106-46-7.
1,2-dichloroethylene	540-59-0.
di(2-ethylhexyl)adipate (DEHA)	103-23-1.
di(2-ethylhexyl)phthalate	117-81-7.
1,4-dioxane	123-91-1.
ethanol	64-17-5.
ethyl tertiary butyl ether	637-92-3.
ethylbenzene	100-41-4.
ethylene dichloride	107-06-2.
ethylene glycol monobutyl ether (cancer effects)	111-76-2.
ethylene oxide (cancer effects; noncancer acute** exp.)	75-21-8.
formaldehyde*	50-00-0.
hexachlorobutadiene	87-68-3.
hexachloroethane	67-72-1.
hexachlorocyclopentadiene**	77-47-4.
hexahydro-1,3,5-trinitro-triazine (RDX)	121-82-4.
2-hexanone	591-78-6.
hydrogen cyanide	74-90-8.
hydrogen sulfide**	7783-06-4.
isopropanol	67-63-0.
kepone	43-50-0.
methanol	67-56-1.
methyl tert-butyl ether (MTBE)	1634-04-4.
methylene chloride (dichloromethane)	75-09-2.
mirex	2385-85-5.
naphthalene (inhalation route)*	91-20-3.
nickel (soluble salts)	[n.a.-various].
nitrobenzene	98-95-3.
PAH mixtures*	[n.a.-various].
pentachlorophenol	87-86-5.
perfluorooctanoic acid-ammonium salt (PFOA)	3825-26-1.
perfluorooctane sulfonate-potassium salt (PFOS)	2795-39-3.
phosgene (acute** exposure)	75-44-5.
platinum	7440-06-4.
polybrominated diphenyl ethers (tetra, penta, hexa, deca-BDEs)	[n.a.-various].
polychlorinated biphenyls (PCBs) (noncancer endpoints)	1336-36-3.
propionaldehyde	123-38-6.
refractory ceramic fibers	[n.a.].
styrene	100-42-5.
2,3,7,8-TCDD (dioxin)*	1746-01-6.
1,1,2,2-tetrachloroethane (chronic; less-than-lifetime** exp.)	79-34-5.
tetrachloroethylene (perchloroethylene)	127-18-4.
tetrahydrofuran	109-99-9.
thallium	7440-28-0.
trichloroacetic acid	76-03-9.
1,1,1-trichloroethane (chronic; less-than-lifetime** exp.)	71-55-6.
trichloroethylene*	79-01-6.
1,2,3-trichloropropane	96-18-4.
2,2,4-trimethylpentane	540-84-1.
uranium compounds	[n.a.-various].
vinyl acetate	108-05-4.

Note that the asbestos noncancer assessment has been expanded to include cancer effects. Also note that the following assessments are being withdrawn from the IRIS agenda: Bromodichloromethane, bromoform, and dibromochloromethane are drinking water disinfection byproducts with criteria documents currently available from EPA's Office of Water. Cryptosporidium is withdrawn from the IRIS agenda pending completion of a microbial risk assessment approach. These are the only substantive changes to the IRIS agenda.

IRIS Summaries and support documents for all substances listed as on-going assessments in 2006 will be provided on the IRIS Web site at http://www.epa.gov/​iris as they are completed. This publicly available Web site is EPA's primary location for IRIS documents. In addition, external peer review drafts of IRIS assessments are posted for public information and comment. These drafts will continue to be accessible via the IRIS and NCEA Web sites. Note that these drafts are intended for public information only, and do not represent the Agency's final position.

Other Improvements to the IRIS Program—Update

As discussed in the Federal Register notice announcing the 2005 agenda, EPA is improving the IRIS program and its products through a series of program reforms. EPA has expanded its central IRIS Staff to better manage the program and promote scientific quality and consistency. In addition, external scientific peer reviews are being conducted routinely by panel meetings rather than by mail reviews. This step is being taken to provide the best possible scientific evaluation of each assessment. Further, EPA now conducts each external peer review at the end of each IRIS assessment review process, strengthening the role of peer review in informing the outcome of the process. A public comment period prior to panel peer review meetings is now standard practice, and the meetings are open to the public for observation. These program reforms facilitate scientific input from the public and make the peer review process more transparent.

Further enhancements to the IRIS assessment development and review process are currently under consideration. A follow-up notice will be published in the Federal Register to announce a public workshop on proposed additions to the IRIS process in 2006.

General Information

As of Monday, November 28, 2005, EPA's EDOCKET was replaced by the Federal Docket Management System (FDMS), the new Federal government-wide system. FDMS was created to provide a single point of access to all Federal rulemaking activities. All materials previously found in EDOCKET are now available on the Internet at http://www.regulations.gov.

A. How Can I Get Copies of Related Information?

EPA has established an official public docket for this action under Docket ID No. EPA-HQ-ORD-2003-0016. The official public docket is the collection of materials that is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room B102, 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 [phone], and the telephone number for the OEI Docket is [phone].

An electronic version of the public docket is available through EPA's electronic public docket and comment system. EPA Dockets at http://www.regulations.gov may be used to submit or view public submissions, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search”, then key in the appropriate docket identification number.

It is important to note that EPA's policy is that public submissions, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the submission contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute are not included in the official public docket or in EPA's electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

B. How and To Whom Do I Submit Information?

Information on chemical substances listed in this notice may be submitted as provided in the ADDRESSES section. If you submit electronic information, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your submission and with any disk or CD-ROM you submit. This ensures that you can be identified as the submitter of the information and allows EPA to contact you in case EPA cannot read your information due to technical difficulties or needs further information on the substance of your submission. Any identifying or contact information provided in the body of submitted information will be included as part of the submission information that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your information due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your information.

Your use of EPA's electronic public docket to submit information to EPA electronically is EPA's preferred method for receiving submissions. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your submission. In contrast to EPA's electronic public docket, EPA's electronic mail (e-mail) system is not an “anonymous access” system. If you send e-mail directly to the docket without going through EPA's electronic public docket, your e-mail address is automatically captured and included as part of the submission that is placed in the official public docket, and made available in EPA's electronic public docket.

Dated: May 8, 2006.

Peter W. Preuss,

Director, National Center for Environmental Assessment.