Regulatory Developments

TSCA:  EPA Opens Docket for Proposed TSCA Section 8(a) Rule for Nanomaterials

April 8, 2015

The U.S. Environmental Protection Agency's (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing data concerning environmental and health effects. EPA also proposes to require any persons who intend to manufacture or process chemical substances as discrete nanoscale materials after the effective date of the final rule to notify EPA of the same information at least 135 days before the intended date of commencement of manufacture or processing. Comments on the proposed rule are due July 6, 2015. More information is available in our March 25, 2015, memorandum, "EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials."

With publication of the proposed rule in the Federal Register, EPA also opened the rulemaking docket. The docket includes 60 supporting documents, including the following materials of note:

  • Economic Analysis for the TSCA Section 8(a) Reporting Requirements for Certain Nanomaterials: EPA estimates that there are approximately 800 U.S. nanomaterials manufacturers and processors subject to TSCA. According to EPA, around 500 firms are small businesses with less than $4 million in revenue, and these firms would be exempt from the reporting requirements of the proposed rule. EPA states that each of the remaining 300 firms is expected to report on approximately five commercially-relevant nanoscale materials in the first year of the rule. While this analysis assumes that the number of nanoscale materials firms remains constant over the ten-year analysis period, the total number of regulated nanoscale materials is assumed to double. Under the proposed rule, EPA estimates industry to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately $13.9 million and $1.5 million, respectively, while EPA expects to use approximately 6,539 hours in the first year and 723 hours in subsequent years, with costs of approximately $0.51 million and $0.06 million, respectively. Discounted over a ten-year period at three and seven percent, EPA estimates total annualized costs to be approximately $2.80 million and $3.08 million, respectively.
     
  • List of Chemical Substances That Could Be Nanoscale Materials: The list is 85 pages long. The proposed rule does not include any information concerning how EPA compiled the list.
     
  • Proposed Data Submission Form for TSCA 8(a) Reporting for Chemical Substances Manufactured and Processed as Nanoscale Materials.
     
  • Documentation of Review under Executive Order 12866: Nano 8(a) Notice of Proposed Rulemaking: The docket includes a copy of the information that was submitted to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) for review; documentation of any substantive changes made to the draft document that was submitted for review; and documentation of those substantive changes made at the suggestion or recommendation of OMB.
     
  • Letter to the Small Business Administration (SBA): EPA consulted with SBA concerning the proposed modification involving the existing standards to identify which businesses qualify as a small chemical substance manufacturer and processor.

A number of materials are not available from the online docket because they are copyrighted publications and may not be reproduced without consent of the copyright holder. These materials may be obtained in person or requested in writing from the EPA Docket Center.


 
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