2024-09662. Availability of Three 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 three updated toxicological profiles: acrolein, n-hexane, and naphthalene. This action is necessary as this is the opportunity for members of the public and organizations to submit comments on drafts of the profiles. The intended effect of this action is to ensure that the public can note any pertinent additional information or reports on studies about the health effects caused by exposure to the substances covered in these three profiles for review.

DATES:

Written comments must be received on or before May 3, 2024.

ADDRESSES:

You may submit comments, identified by Docket No. ATSDR-2024-0001 by either of the methods listed below. Do not submit comments by email. ATSDR does not accept comments by email.

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

• Mail: Agency for Toxic Substances and Disease Registry, Office of Innovation and Analytics, 4770 Buford Highway, Mail Stop S106-5, Atlanta, GA 30341-3717. Attn: Docket No. ATSDR-2024-0001.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to http://www.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:

Farhana Rahman, Agency for Toxic Substances and Disease Registry, Office of Innovation and Analytics, 4770 Buford Highway, Mail Stop S106-5, Atlanta, GA 30341-3717; Email: [e-mail]; Phone: [phone] or 1-800-232-4636.

SUPPLEMENTARY INFORMATION:

ATSDR has prepared drafts of three 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 of the available literature 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 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.

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 http://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)).

Availability

The draft toxicological profiles and interaction profile are available online at http://www.regulations.gov, Docket No. ATSDR-2024-0001 and at http://www.atsdr.cdc.gov/​ToxProfiles.

Public Participation

Interested persons or organizations are invited to participate by submitting written views, recommendations, 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. If you submit comments with reference to studies that are not publicly available such as unpublished research, those studies must be attached with your comment for review. Otherwise ATSDR may be unable to respond to portions of your comment referencing any material that is not publicly available. Do not submit comments by email. ATSDR does not accept comments by email.

Donata Green,

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