Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” 82 Fed. Reg. 22452.  The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed at the nanoscale as described in the January 12, 2017, final Toxic Substances Control Act (TSCA) Section 8(a) rule.  The final rule requires one-time reporting for existing discrete forms of certain nanoscale materials, and a standing one-time reporting requirement for new discrete forms of certain nanoscale materials.  More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”  EPA states that it will accept comments regarding the draft guidance, but not regarding the rule itself, “which has already been finalized.”  Comments are due June 15, 2017.

The 14-page draft guidance, in the form of questions and answers, addresses questions within the following categories:  what chemicals are reportable; who is required to report; information that is to be reported; when is reporting required; general questions; and confidentiality.  While the publication of draft guidance within four months of promulgation of the final rule is an achievement, the draft guidance does not significantly expand upon that which is already known, or make the rule clearer or easier with which to comply.  Companies subject to the reporting requirements of the final rule can expect to continue to struggle in sorting out what discrete forms are required to be reported.  More information regarding the draft guidance is available in our May 16, 2017, memorandum, “EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule.”


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The “key changes” that EPA notes are:

New Certification Requirement.  Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several statements.  The certification language is incorporated into electronic reporting tools for TSCA submissions requiring or permitting electronic reporting. Entities who make TSCA submissions on paper must now also include the following statements in the submission:

  • I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
  • I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that:
    • (i) My company has taken reasonable measures to protect the confidentiality of the information;
    • (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
    • (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
    • (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
  • Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.

Substantiation Requirements.  Existing substantiation requirements for certain types of CBI claims continue to remain in effect.  EPA notes that it may develop further guidance and require additional requirements in the future.

Generic Names.  A structurally descriptive generic name is now required where specific chemical identity is claimed as CBI.  EPA will be relying on existing generic name guidance for the creation and approval of generic names until updated guidance is developed.

EPA’s Review of Claims.  EPA will be reviewing and approving or denying a CBI claim for specific chemical identity and a proportion of CBI claims for other types of information in accordance with TSCA § 14.  EPA states that it may contact submitters of CBI to corroborate their CBI claims to the extent that substantiation has not already been provided.

While the guidance is welcomed and useful, it sheds no light on how best to corroborate a claim of CBI and how best to respond to an EPA allegation that the CBI claim is lacking.  These questions will continue to be debated; when in doubt, consult legal counsel.

More information is available on EPA’s website.  Please also join Bergeson & Campbell, P.C. (B&C®) and Chemical Watch on September 12, 2016, for the third complementary webinar in the series on “‘The New TSCA -- What You Need to Know,” featuring information on the TSCA Inventory, Chemical Data Reporting (CDR), and CBI.   

Tags: CBI, EPA, guidance, TSCA