2013-15523. Availability of Draft Toxicological Profiles

AGENCY:

Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS).

ACTION:

Notice of availability, and request for comments.

SUMMARY:

This notice announces the availability of Set 25 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 25 substances. Although ATSDR considered key studies for each of these substances during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 25 Toxicological Profile is available online at http://www.atsdr.cdc.gov/​toxprofiles/​index.asp and www.regulations.gov,, docket ATSDR-2013-0001.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 104(i)(3), [42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

DATES:

To be considered, comments on the draft toxicological profiles must be received not later than September 30, 2013. Comments received after close of the public comment period will be considered solely at the discretion of ATSDR, based upon what is deemed to be in the best interest of the general public.

ADDRESSES:

You may submit comments, identified by docket number ASTDR-2013-0001, by any of the following methods:

• Federal eRulemaking Portal: http://www.reguations.gov. Follow the instructions for submitting comments.
• Mail: Division of Toxicology and Health and Human Sciences, 1600 Clifton Rd. NE., MS F57, Atlanta, GA. 30333.

Instructions: All submissions received must include the agency name and docket number for this notice. All relevant comments will be posted without change. Because all public comments regarding ATSDR toxicological profiles are available for public inspection, no confidential business information or other confidential information should be submitted in response to this notice. Refer to the section Submission of Nominations (below) for specific information required.

FOR FURTHER INFORMATION CONTACT:

Ms. Delores Grant, Division of Toxicology and Human Health Sciences, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA 30333. Phone: [phone].

SUPPLEMENTARY INFORMATION:

The Superfund Amendments and Reauthorization Act (SARA) (Pub. L. 99-499) amends the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) (42 U.S.C. 9601 et seq.) by establishing certain responsibilities for ATSDR and the U.S. Environmental Protection Agency (U.S. EPA) with regard to hazardous substances most commonly found at facilities on the CERCLA National Priorities List (NPL). As part of these responsibilities, the ATSDR administrator must prepare toxicological profiles for substances enumerated on the priority list of hazardous substances. This list identifies 275 hazardous substances which, according to ATSDR and U.S. EPA, pose the most significant potential threat to human health. The availability of the revised priority list of 275 hazardous substances was announced in the Federal Register on March 6, 2008 (73 FR 12178). In addition, ATSDR has the authority to prepare toxicological profiles for substances not found at sites on the National Priorities List, in an effort to “. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances” under CERCLA Section 104(i)(1)(B). This is also to respond to requests for consultation under section 104(i)(4), and as otherwise necessary to support the site-specific response actions conducted by ATSDR.

Each profile will include an examination, a summary, and an interpretation of available toxicological information and epidemiological evaluations. This information and these data identify the levels of significant human exposure for the substance and for the associated health effects. The profiles must also include a determination of whether adequate information on the health effects of each substance is available or is in the process of development. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of a program of research to determine such health effects.

All toxicological profiles issued as “Drafts for Public Comment” represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances.

Set 25 toxicological profiles:

	Name	CAS
1	Hexachlorobenzene (UPDATE)	118-74-1
2	Endosulfan (UPDATE)	115-29-7
	Endosulfan sulfate	1031-07-8
	Endosulfan-alpha	95-99-98
	Endosulfan-beta	33213-65-9
3	1,1-Dichloroethane (UPDATE)	75-34-3
4	Dinitrotoluenes (DNT) (UPDATE)
	2,3-DNT	602-01-7
	2,4-DNT	121-14-2
	2,5-DNT	619-15-8
	2,6-DNT	606-20-2
	3,4-DNT	610-39-9
	3,5-DNT	618-85-9

Dated: June 21, 2013.

Sascha Chaney,

Acting Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry.