Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Allegations of Significant Adverse Reactions to Human Health or the Environment (Renewal)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), “Allegations of Significant Adverse Reactions to Human Health or the Environment” (EPA ICR Number 1031.12 and OMB Control Number 2070-0017) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR which is currently approved through October 31, 2021. Public comments were previously requested via the Federal Register on March 29, 2021 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

DATES:

Additional comments may be submitted on or before November 24, 2021.

ADDRESSES:

Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OPPT-2015-0688, online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.

Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

Virginia Lee, Data Gathering and Analysis Division (7401M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-4142; email address: lee.virginia@epa.gov.

SUPPLEMENTARY INFORMATION:

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Abstract: Under section 8(c) of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2607(c), companies that manufacture, process, or distribute chemicals are required to maintain records of significant adverse reactions to health or the environment alleged to have been caused by such chemicals. Since TSCA section 8(c) includes no automatic reporting provision, EPA can obtain and use the information contained in company files only by inspecting those files or requiring reporting of records that relate to specific substances of concern. Therefore, under certain conditions, and using the provisions found in 40 CFR part 717, EPA may require companies to report such allegations to the Agency. EPA uses such information on a case specific basis to corroborate suspected adverse health or environmental effects of chemicals already under review by EPA. The information is also useful to identify trends of adverse effects across the industry that may not be apparent to any one chemical company. This ICR addresses the information reporting and recordkeeping requirements found in 40 CFR part 717. Respondents may claim all or part of a notice confidential.

Form Numbers: None.

Respondents/Affected Entities: Companies that manufacture, process, import, or distribute in commerce chemical substances or mixtures.

Respondent's obligation to respond: Mandatory (40 CFR part 717).

Estimated number of respondents: 13,160 (total).

Frequency of response: 1.

Total Estimated burden: 25,527 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total Estimated cost: $4,701,622 (per year) includes $0 annualized capital or operation and maintenance costs.

Changes in the Estimates: There is no change in the estimated annual burden compared with the ICR currently approved by OMB. There is, however, an increase in the estimated total burden cost from $1,987,487 to $4,701,622 that is related to an adjustment in the burden cost calculation associated with projected compliance determination activities. This change is an adjustment.