2023-02754. Availability of Four 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 drafts of four updated toxicological profiles: Cobalt, Hexachlorocyclohexanes, 1,1,1-Trichloroethane, and Vinyl Chloride.

DATES:

Written comments must be received on or before May 10, 2023.

ADDRESSES:

You may submit comments, identified by Docket Number ATSDR-2022-0006, by either of the following methods:

• Federal eRulemaking Portal:www.regulations.gov. Follow the instructions for submitting comments.

• Mail: Toxicology Section, Office of Innovation and Analytics, Agency for Toxic Substances and Disease Registry, 4770 Buford Highway, Mail Stop S102-1, Atlanta, GA 30341-3717. Attn: Docket No. ATSDR-2022-0006.

Instructions: All submissions must include the Agency name and Docket Number. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. Do not submit comments by email. ATSDR does not accept comments by email. For access to the docket to read background documents or comments received, go to www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

N. Roney, Agency for Toxic Substances and Disease Registry, 4770 Buford Highway, Mail Stop S102-1, Atlanta, GA 30329-4027; Email: [e-mail]; Telephone: [phone].

SUPPLEMENTARY INFORMATION:

ATSDR has prepared drafts of four updated toxicological profiles based on current understanding of the health effects and availability of new studies and other information since their initial release. 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 to the public and health professionals. ATSDR considers key studies for these substances during the profile development process, using a systematic review approach. To that end, ATSDR is seeking public comments and additional information or reports on studies about the health effects of these four substances for review and potential inclusion in the profiles. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile.

Public Participation

Interested persons or organizations are invited to participate by submitting written views, information, and data. 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 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. Do not submit comments by email. ATSDR does not accept comments by email. 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 review and 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 the hazardous substances most commonly found at facilities on the CERCLA National Priorities List. 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 has determined pose the most significant potential threat to human health. The SPL is available online at www.atsdr.cdc.gov/​spl. ATSDR is also mandated to revise and publish updated toxicological profiles, as necessary, to reflect updated health effects and other information.

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 (CERCLA Section 104(i)(6); 42 U.S.C. 9604(i)(6)). Public nominations for substances from the SPL (or other substances) for toxicological profile development were requested on April 18, 2018 (83 FR 17177).

ATSDR has now prepared drafts of four updated toxicological profiles based on current understanding of the health effects and availability of new studies and other information since their initial release.

Availability

The Draft Toxicological Profiles are available online at www.regulations.gov, Docket No. ATSDR-2022-0006 and at www.atsdr.cdc.gov/​ToxProfiles.

Donata Green,

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