Small Business Environmental Roundtable, Sept 7, 2018
TO: Interested Persons
FROM: Kevin Bromberg, Assistant Chief Counsel
David Rostker, Assistant Chief Counsel
Tabby Waqar, Assistant Chief Counsel
SUBJECT: Next SBA Environmental Roundtable Meeting, September 7, 2018
The next U.S. Small Business Administration, Office of Advocacy Environmental Roundtable will meet to discuss the following topics, beginning at 10 a.m. on Friday, September 7, 2018. Send your RSVP to email@example.com. Please indicate whether you are attending in person, or by teleconference. Information will be sent out to you when you RSVP. We have adopted a casual attire option for all Roundtable meetings.
10:00 – 10:30 AM Reviewing New Chemicals under the Amended Toxic Substances Control Act (TSCA)
Tala Henry and Greg Schweer, Office of Pollution Prevention and Toxics, EPA
10:30 – 10:50 AM An Industry Perspective on TSCA Section 5
Jared Rothstein, Society of Chemical Manufacturers and Affiliates
10:50 – 11:30 AM Discussion/ Q&A
Roundtable meetings are open to all interested persons, with the exception of the press, in order to facilitate open and frank discussion about the impacts of Federal regulatory activities on small entities. Agendas and presentations are available to all, including the press. Anyone who wants to receive roundtable agendas or presentations, or to be included in the distribution list, should forward such requests to firstname.lastname@example.org. The purpose of these Roundtable meetings is to exchange opinions, facts and information and to obtain the attendees’ individual views and opinions regarding small business concerns. The meetings are not intended to achieve or communicate any consensus positions of the attendees.
Small Business Environmental Roundtable
Issue for Discussion
September 7, 2018
In implementing section 5 of amended TSCA, EPA has been in the process of revising its procedures for reviewing new chemicals. Key statutory provisions require EPA to make one of four possible determinations on a Pre-Manufacture (PMN) notice:
- The chemical substance presents an unreasonable risk.
- There is insufficient information in the notice for EPA to make a risk determination.
- There is insufficient information and the PMN substance may present an unreasonable risk.
- The PMN substance is not likely to present an unreasonable risk.
Before a PMN substance can be manufactured commercially, EPA must make an affirmative determination within 90 days of a PMN submission (with a possible one-time 90-day extension). Amended Section 5 also requires that determinations must take into account risks to potentially exposed or susceptible subpopulations without consideration to cost or other non-risk factors. The agency must also consider reasonably foreseeable conditions of use, those being “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”
For the regulated community, it is essential that the New Chemicals program reduce delays, complete reviews within the statutory deadlines, and perform with greater predictability and transparency. Small businesses requiring significant research and development (R&D) and manufacturing lead-time need an EPA program that will allow them to meet customer demands, operate profitably, and bring innovative chemicals to market efficiently.
Speaker Bio: Jared Rothstein
Jared Rothstein is the Senior Manager of Regulatory Affairs at the Society of Chemical Manufacturers and Affiliates (SOCMA) overseeing the association’s advocacy efforts on environmental, health, and safety policies. He manages a broad range of regulatory issues including chemicals managements, accident prevention, process safety, and facility site security. SOCMA is the US-based trade association dedicated solely to the specialty and fine chemical industry. SOCMA members play an indispensable role in the global chemical supply chain, providing specialty chemicals to companies in markets ranging from aerospace and electronics to pharmaceuticals and agriculture. Over 70% of SOCMA’s manufacturer members are small businesses.