2019-09538. Availability of Draft Toxicological Profiles

AGENCY:

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

ACTION:

Notice with comment period.

SUMMARY:

The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on Draft Toxicological Profiles for Dinitrophenols, 2-Butanone, Mirex and Chlordecone, 1,2-Diphenylhydrazine, 1,2,3-Trichloropropane, Lead, and Endrin. ATSDR has updated these profiles based on availability of new health effects information since their initial release. On March 21, 2016 ATSDR announced that it was preparing to develop Draft Toxicological Profiles for public comment release (81 FR 15110), which include those profiles mentioned above. All toxicological profiles issued as “Drafts for Public Comment” represent the result of ATSDR's evidence-based evaluations to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of dinitrophenols, 2-butanone, mirex and chlordecone, 1,2-diphenylhydrazine, 1,2,3-trichloropropane, lead, and endrin for review and potential inclusion in the profiles. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.

DATES:

Written comments must be received on or before August 7, 2019.

ADDRESSES:

You may submit comments, identified by docket number ATSDR-2019-0006, 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, Mail Stop S102-1, Atlanta, GA, 30329-4027. Attn: Docket No. ATSDR-2019-0006.

Instructions: All submissions must include the agency name and Docket Number. All relevant comments received will be posted without change to http://regulations.gov,, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

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:

Public Participation

Interested persons or organizations are invited to participate by submitting written views, information, and data.

Please note that comments received, including attachments and other supporting materials, are part of the public record and are subject to public disclosure. Comments will be posted on https://www.regulations.gov. Therefore, do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. If you include your name, contact information, or other information that identifies you in the body of your comments, that information will be on public display. ATSDR will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. ATSDR will carefully consider all comments submitted in preparation of the final Toxicological Profiles and may revise the profiles as appropriate.

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.

Availability

These Draft Toxicological Profiles will be available online at http://www.atsdr.cdc.gov/​ToxProfiles and at www.regulations.gov,, Docket No. ATSDR-2019-0006.

Pamela I. Protzel Berman,

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