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By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals.  EPA states that it is also proposing changes to regulations based on issues that it identified, as well as issues raised by public commenters, for significant new use rules (SNUR) previously proposed and issued under these regulations.  Additionally, EPA claims to propose a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices.  EPA states that it expects the changes “to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment.”  Comments are due September 26, 2016.

The revisions include:

  • Proposed Changes to 40 C.F.R. Section 721.63, Protection in the Workplace;
  • Proposed Changes to 40 C.F.R. Section 721.72, Hazard Communication Program;
  • Clarification of the Use of 40 C.F.R. Section 721.80, Industrial Commercial and Consumer Activities;
  • Proposed Changes to 40 C.F.R. Section 721.91, Computation of Estimated Surface Water Concentrations:  Instructions;
  • Proposed Changes to 40 C.F.R. Section 721.11, Determining Whether a Chemical Substance or a Specific Use Is Subject to This Part When the Chemical Substance Identity or Significant New Use Is Confidential;
  • Proposed Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVE), Low Release and Exposure Exemptions (LoREX), and Test Marketing Exemption (TME) Applications; and
  • Fixing Typographical Errors and Other Non-Substantive Changes.

Commentary

Although the notice downplays them, the proposal raises significant and complex issues.  There may well be good reasons for several of the proposed changes.  The minimal discussion provided in the notice and the lack of adequate public debate having occurred prior to its issuance raise troubling questions about the legal basis for, scope of, and complexity of the proposed changes, some of which may apply retroactively. The confusion the proposal can be expected to cause could have been avoided had adequate discussion preceded its publication, or at the least EPA could have raised these issues in the proposed rule’s preamble to focus stakeholders’ attention appropriately.

More information is available in our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.


 

By Lynn L. Bergeson

On July 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register soliciting a second round of comments on the burdens and value of information it periodically collects addressing significant new use rules (SNUR) for existing chemicals.  Specifically, EPA submitted a request to renew the approval of an existing information collection request (ICR), Toxic Substances Control Act (TSCA) Section 5(a)(2) SNURs for Existing Chemicals, to the Office of Management and Budget (OMB).  This notice provides chemical manufacturers and other interested parties a second opportunity to comment on certain questions, specifically:  whether the agency accurately estimated the burden of responding to SNURs that it issues for chemicals in commerce; whether the agency could minimize the burden; and whether the information it collects is necessary. 

The first ICR was issued on September 2, 2015, and comments were due November 2, 2015.  Only two comments were filed in response to the initial ICR, by the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA), two trade associations.  ACC and SOCMA stated in their comments that EPA underestimated the burdens its SNURs impose on chemical manufacturers and their customers.

This renewed ICR states that EPA estimated that six companies would be affected by its new use rules for existing chemicals, creating an estimated total burden of 1,025 hours per year and a cost of $100,595.

Comments are due August 25, 2016.

Commentary

SNURs are deeply unpopular to some in the chemical community and welcomed outcomes of the premanufacture notice (PMN) or significant new use notification (SNUN) process to others.  Most would agree that the cost of compliance with a SNUR can be difficult to estimate with any degree of precision.  Some of us are also of the view that TSCA, as recently amended, may result in many more SNURs given the new “determination” requirements under TSCA Section 5(a).  The comment period opened by today’s Federal Register notice provides an excellent opportunity to provide comment to EPA and thus help to ensure that EPA has an accurate and current basis upon which to estimate the cost.


 
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