2015-26321. Availability of Draft Toxicological Profile; Set 27 Toxicological Profiles

AGENCY:

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

ACTION:

Notice of availability and request for comment.

SUMMARY:

The Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of Set 27 Toxicological Profiles for review and comment. 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.

Comments can include additional information or reports on studies about the health effects of Set 27 substances. Although ATSDR considered key studies for each of these substances during the profile development process, the Federal Register notice solicits any relevant, additional studies, particularly unpublished data.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 into 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.

DATES:

Written comments on this draft Toxicological Profile must be received on or before January 14, 2016.

ADDRESSES:

You may submit comments, identified by docket number ATSDR-2015-0002, by any of the following methods:

• Federal eRulemaking Portal: www.regulations.gov. Follow the instructions for submitting comments.
• Mail: Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA 30329. Attn: Docket No. ATSDR-2015-0002.

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.

FOR FURTHER INFORMATION CONTACT:

Ms. Delores Grant, Division of Toxicology and Human Health Sciences, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA 30329. Phone: [phone] or 770-488-3351.

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) regarding 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 May 28, 2014 (79 FR 30613). 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). ATSDR also prepares Toxicological Profiles in response 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 in the process of development) in order to identify levels of significant human exposure. 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 provide such information.

Set 27 Toxicological Profiles

	Name
1	Polybrominated Biphenyl Ethers (PBDEs) UPDATE.
2	N,N-Diethyl-meta-toluamide (DEET).
3	Toluene Diisocyanates (mixture).
	Methylenediphenyl Diisocyanates (NEW).
4	Nitrates/Nitrites (NEW).
5	Toluene (UPDATE).

The Set 27 Toxicological Profiles are available online at http://www.atsdr.cdc.gov/​toxprofiles/​index.asp and http://www.regulations.gov,, Docket No. ATSDR-2015-0002.

Donna B. Knutson,

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