Regulatory Developments

TSCA:  EPA Holds Public Meeting on TSCA Section 8(a) Proposed Rule

June 24, 2015

On June 11, 2015, the U.S. Environmental Protection Agency (EPA) held a meeting on its 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. Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT Chemical Control Division, provided further insight into EPA's goals, directives, and expected results as related to the proposed rule. Morris stated that EPA is trying to ensure public confidence in the commercialization of nanomaterials, and this proposed rule, through its reporting requirements, will give EPA more information on whether this information is sufficient enough to instill confidence as well as whether further reporting will be necessary. Morris also stated that EPA's broader goal with these requirements is more understanding of nanomaterials, and that EPA is hopeful that the reporting will not be too burdensome so as to not achieve this goal. Alwood emphasized the importance of EPA knowing what is "feasible" in terms of what information can be reported, stating that the proposed rule requires information that is "known to or reasonably ascertainable by" persons subject to the rule; it does not require the development of specific data or a minimum data set. Alwood also stated that the small business exemption, that exempts manufacturers with company sales of less than $4 million, does not include a production volume component because if it did, then 85-90 percent of nanomaterials manufacturers would be exempt. Comments are due by July 6, 2015.

There were five commenters: (1) Steven Gordon, Ph.D., DABT, Staff Scientist at 3M Medical Department, on behalf of the American Chemistry Council; (2) Dan Russell, SVP, Manufacturing and Operations at Pixelligent Technologies, LLC; (3) Jo Anne Shatkin, President, Vireo Advisors; (4) Martha Marrapese, Partner at Keller and Heckman LLP, in capacity as General Counsel to the Nano Manufacturing Association; and (5) Vincent Caprio, Executive Director of the NanoBusiness Commercialization Association. Some of the concerns that the commenters voiced were regarding: (1) the 135-day waiting period; (2) the definition of "novel and unique" characteristics; (3) the definition of "trace amounts"; (4) the financial burden on the industry; and (5) lack of coordination with other governments, Canada for example.

Commentary

Below are some industry insights into the public meeting:

  • EPA made it clear that it is looking for input and that it is in fact vital that manufacturers provide that input; industry has an opportunity to shape the rule and it should take it. EPA did not comment on how it came up with the list of exempt substances (e.g., zinc oxide, nano clays), nor whether the manufacturers that have previously submitted voluntary reporting information through the Nanoscale Materials Stewardship Program would get credit for doing so.
     
  • For the definition of a small business, it seems justifiable to remove the production volume threshold for nanomaterials (as few are manufactured over 100,000 kg) but relying solely on the $4 million sales threshold, however, puts significant burden on companies with sales greater than $4 million and less than $40 million that are quite small and may be operating without a profit.
     
  • EPA has discretion on when the deadline for reporting should be; it would be helpful if this deadline were set to avoid other significant reporting deadlines (e.g., Toxics Release Inventory and Chemical Data Reporting deadlines) to avoid overloading company environmental health and safety staff, consultant/contract support, EPA staff, or EPA servers.
     
  • Finally, given the significant cooperation between U.S. and Canada through the U.S.-Canada Regulatory Cooperation Council, requirements under this rule should be substantially similar to the requirements in Canada. Unfortunately, there does not appear to be significant collaboration with Canada on this reporting issue.

More information on the proposed rule can be found in our April 8, 2015, memorandum, "EPA Opens Docket for Proposed TSCA Section 8(a) Rule for Nanomaterials," and in our March 25, 2015, memorandum, "EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials."


 
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