2019-13980. Availability of Toxicological Profiles for Tetrachloroethylene and Trichloroethylene

AGENCY:

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

ACTION:

Notice of availability.

SUMMARY:

The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the release of the final Toxicological Profiles for Tetrachloroethylene and Trichloroethylene. The present profiles supersede any previously released drafts.

FOR FURTHER INFORMATION CONTACT:

Susan Ingber, Agency for Toxic Substances and Disease Registry, Division of Toxicology and Human Health Sciences, 1600 Clifton Rd., NE, Mail Stop S102-1, Atlanta, GA, 30329-4027, Email: [e-mail]; Phone: [phone].

SUPPLEMENTARY INFORMATION:

Legislative Background

The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601 et seq.] amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) [42 U.S.C. 9601 et seq.] by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) regarding hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the priority list of hazardous substances [also called the Substance Priority List (SPL)]. This list identifies 275 hazardous substances that ATSDR and EPA have determined pose the most significant potential threat to human health. The SPL is available online at www.atsdr.cdc.gov/​spl.

In addition, CERCLA provides ATSDR with the authority to prepare toxicological profiles for substances not found on the SPL. CERCLA authorizes ATSDR to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances (CERCLA Section 104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B))); to respond to requests for health consultations (CERCLA Section 104(i)(4)); 42 U.S.C. 9604(i)(4)); and to support the site-specific response actions conducted by the agency.

Public Comment

ATSDR released the draft Toxicological Profiles for Tetrachloroethylene and Trichloroethylene for public comment December 15, 2014(79 FR 74093). The comment period ended on March 16, 2015. ATSDR received multiple comments on the draft Tetrachloroethylene profile from a professional association and multiple comments on the draft Trichloroethylene profile from three professional associations and one law firm. ATSDR carefully reviewed and considered all comments in the preparation of the final profiles.

The Toxicological Profile for Tetrachloroethylene received comments related to the use of specific studies for the profile, potential omission of studies, and derivation of the minimal risk level (MRL). ATSDR addressed these comments by correcting, clarifying, or updating data in the final toxicological profiles.

The Toxicological Profile for Trichloroethylene received comments centered on the methods and data used for deriving the MRLs, as well as suggestions for inclusion of additional studies. ATSDR clarified areas of scientific uncertainty and modeling techniques used to derive the MRLs. ATSDR updated the profile with several additional studies.

For both profiles, ATSDR also conducted a second peer review of the epidemiological carcinogenicity sections of the profile by external peer reviewers. A list of peer reviewers and the peer review comments are available at ATSDR's Peer Review Agenda web page at (https://www.atsdr.cdc.gov/​sites/​peer_​review/​index.html).

Availability

The Final Toxicological Profiles for Tetrachloroethylene and Trichloroethylene are available online at www.regulations.gov,, Docket No. ATSDR-2014-0001 and http://www.atsdr.cdc.gov/​ToxProfiles.

Pamela I. Protzel Berman,

Director, Office of Policy, Partnerships and Planning, Agency for Toxic Substances and Disease Registry.