FRIDAY, January 15, 10 a.m. – 12:30 p.m. Please note the date change for this roundtable.
Via Microsoft Teams Meeting
The next U.S. Small Business Administration Office of Advocacy Environmental Roundtable will meet virtually to discuss the following topics beginning at 10 a.m. on Friday, January 15, 2021. The meeting will be held using the Microsoft Teams platform.
Send your RSVP to david.rostker@sba.gov. A meeting link will be provided to you when you RSVP.
Agenda
10:00 AM – 10:20 AM Introductions and Update on Chemicals Designated as High Priority under TSCA
Tabby Zeb, SBA Office of Advocacy
10:20 AM – 11:20 AM EPA’s Final Risk Evaluation for Perchloroethylene
Tyler Lloyd, Office of Pollution Prevention and Toxics, EPA
11:20 AM – 12:30 PM ORD Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments
Andrew Kraft, Office of Research and Development, EPA
Small Business Perspectives on the IRIS Handbook
Kevin Bromberg, Bromberg Regulatory Strategy LLC
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 david.rostker@sba.gov. 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
Issues for Discussion
January 15, 2021
EPA’s Final Risk Evaluations for Perchloroethylene (PCE)
EPA recently published its final risk evaluation for the sixth of its 10 high-priority chemicals under the amended Toxic Substance Control Act (TSCA). EPA completed the final risk evaluation for perchloroethylene in December 2020. Perchloroethylene is a colorless liquid used primarily in industrial settings in the production of fluorinated compounds and as a solvent in dry cleaning. This chemical is also used commercially in lubricants, adhesives, and sealants. Perchloroethylene has a limited number of consumer uses in products like adhesives for arts and crafts and stainless steel polish. After evaluating 61 conditions of use, EPA has determined that perchloroethylene presents an unreasonable risk under 59 conditions of use, including all consumer uses and all but two occupational uses. A final determination that a condition of use presents an unreasonable risk of injury to health or the environment means that the agency will have to regulate those risks, which can include use-restrictions or bans, among other options.
The agency is currently in the process of developing ways to address the identified unreasonable risks and has up to one year to propose and take public comments on any risk management actions. Within this time frame, the agency will also have to consider whether any potential regulations for the identified risks will have a significant economic impact on a substantial number of small entities and if so, the agency will need to convene a small business advocacy review panel to seek advice and recommendations from representatives of affected small entities on the potential impact of the proposed rule. For this reason, it is important for small business stakeholders to be informed of the conditions of use that have been determined to pose an unreasonable risk and the basis for those determinations. At this roundtable, EPA will be providing an overview of this final risk evaluation, with time for discussion and questions.
ORD Staff Handbook for Developing IRIS Assessments
The “ORD Staff Handbook for Developing Integrated Risk Information System (IRIS) Assessments,” or “IRIS Handbook,” provides operating procedures for developing assessments to the scientists in the IRIS Program, including operating procedures for developing assessments including problem formulation approaches and methods for conducting systematic review, dose response analysis, and developing toxicity values. IRIS chemical assessments are an important source providing toxicity information used by EPA and other agencies, including federal, state, and local, to characterize potential public health risk. On November 30, 2020, EPA announced a 90-day public comment period for its latest iteration of the IRIS Handbook, which addresses recommendations and input from the National Academy of Sciences, Engineering, and Medicine (NASEM); EPA Agency reviewers; other Federal Agencies; EPA’s Science Advisory Board; and workshops involving input from experts in systematic review. The steps in the overall IRIS process have not changed. The comment period ends on March 1, 2021.
Kevin Bromberg
Kevin Bromberg, Principal of Bromberg Regulatory Strategy LLC, retired from the Office of Advocacy in January 2020 after 40 years of government service working on environmental regulatory issues. He continues to represent small businesses, including the Small Business Low Risk Coalition, which seeks regulatory relief from the requirements of the current draft general stormwater industrial permit. Until he retired, Mr. Bromberg was the Advocacy representative on the federal interagency IRIS task group beginning in 2012, where he made multiple recommendations on EPA IRIS risk assessments and procedures.
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