On December 10, 2019 USEPA held a public meeting to provide an update on implementation of the TSCA New Chemicals Program including the “Working Approach” for making Section 5 determinations (i.e., Premanufacture Notice (PMN) findings, the Confidential Business Information (CBI) process, and some new information delivery tools.
The “Working Approach” segment focused on the concepts of “Conditions of Use” (COU) and “Information Sufficiency” and specifically how these relate to the PMN assessment process and development of Significant New Use Rules (SNURs). The Agency has designated three types of COU:
They described the process for identifying Reasonably Foreseen Uses as including:
In the case of a “Not likely to present an unreasonable risk” finding that includes a SNUR a reasonably foreseen use can affect when the use is addressed in the review process, e.g.
Information sufficiency is critical in determining the outcome of the assessment. USEPA made it clear that “sufficient” information is not necessarily complete or perfect, and that analogue data may be acceptable. This suggests that it would be prudent to conduct a rigorous analogue search prior to PMN submission, as well as a patent search to address potential COUs. They also reiterated that uncertainty itself is a driver for consent orders to obtain additional data (e.g., the potential need for chronic data when only acute data is provided and the results are not favorable).
For COUs involving workers the Agency indicated that its initial assessment includes consideration of engineering controls described in notice, but not personal protective equipment (PPE). PPE is only considered if risks are identified, and may mitigate risk such that a “not likely” determination is possible. Although they made a point to mention that they do not mandate any particular hazard classification, USEPA does expect warnings for hazards they identify to be included in the Safety Data Sheet in some way.
The Agency intends to release an updated “Working Approach” document by the end of the year.
Regarding CBI the speaker mentioned the July 2019 Federal Register notice announcing that USEPA would no longer be sending out Notices of Deficiency for submissions which fail to properly substantiate CBI claims. Common deficiencies the Agency has seen include:
The remainder of the presentation involved the Agency’s efforts to make the new chemical process more transparent by providing tools for stakeholders to access information both on the USEPA website and another site called ChemView. Historically the Agency has made information pertaining to new chemical submissions available in the Federal Register via www.regulations.gov. The new webpage makes it easier to access information about new chemical submissions, such as the date the notice was received by USEPA, case number, chemical substance identity (to the extent that such information is not subject to a CBI claim), the status of submissions and the text of “not likely to present risk” findings. Statistics on the program will also be available, and the Agency intends to update this webpage monthly.
There is also a website for CBI information including CBI review statistics, final CBI determinations, and access to the new Unique Identifiers (UID) that are cross-referenced to generic names, P numbers, accession numbers and the expiration dates for CBI protection. USEPA plans to update this information quarterly.
The ChemView website now includes redacted versions of some PMNs along with all supporting documentation, as well as a summary of PMN review determinations with links to the Federal Register and Code of Federal Regulations citations and any TSCA Section 5 actions (e.g. consent orders or SNURs).