Document YD9YgoDNYv83nEdODm58m4X9n

BERGES ON &CAMPB ELL PC The Effect of TSCA Reform on Mew and Existing Chemicals: EPA Review, Regulation, and Testing Requirements TSCA: Best Practices in Toxicology, Risk, and Chemical Management Strategies Fail 2017 Symposium October 13, 2017 h.D. Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00001 B EKGE S ON CAMPBELL PC I Disclaimer | | The views presented are solely the author's and do not necessarily represent Bergeson & | Campbell, P.C. or its clients Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00002 Key Provisions B E K G E S O N A: C A M P B E L L PC . Section 4 - Testing > New order authority Use tiered testing Minimize vertebrate testing . Section 5 - New Chemicals > Must make determinations . Must take regulatory action if potential for risk . Section 6 - Existing Chemicals > Must undertake prioritization, risk evaluation, risk management .- Tight deadlines Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00003 Key Terms B E S G E S O S k CAMPBELL PC Unreasonable risk Conditions of use Reasonably foreseeable Potentially exposed and susceptible subpopulations (PESS) Not likely to present Sound science Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00004 Challenges B E S G E S O S tx C A MP B E L L PC No phase-n ~ Effective immediately; policies, processes, and interpretation are still in flux Many short deadlines for rulemaking Brain drain - The U.S. Environmental Protection Agency (ERA) had been losing and continues to lose senior staff to retirements Staff shortages ~ Between hiring freeze and retirements, staff is stretched thin; ERA using "details" (temporary internai transfers) to fill the gaps Funding for contract support ~ Expanding capacity of contracts takes time Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00005 B EKGE S ON CAMPBELL PC Existing Chemicals issues . Stakeholders must take care not to pre-judge outcomes . ERA will have to require testing to fill gaps on existing chemicals . Prioritization and risk evaluation are resource intensive > If ERA cannot demonstrate low priority with sufficient information, must designate as high priority . Blurred lines between commercial and consumer use many "professional-grade" products available to consumers . Recognize that while in-place substances may contribute to exposure, the Toxic Substances Control Act (TSCA) may not be the best mechanism to protect against exposures . TSCA does not have authority to regulate non-TSCA uses Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00006 Expected Changes B EKGE S ON CAMPBELL PC . IVlore consent orders (CO) and more Significant New Use Rules (SNUR) . yore testing, especially on existing chemicals Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00007 Unexpected Changes . >90% new chemicals regulated . Polymer eligible for the Polymer Exemption being regulated . New chemicals bias worsened . 90-day clock "reset" Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00008 B EKGE S ON CAMPBELL PC Inhalation Categories . Surfactant default exposure limit of about 10~5 mg/m3, or about two sprays from a spray bottle . Water-proofing of lungs . Lung overload (due to high molecular weight polymers) . Cationic binding to lung tissue Notes: All known categories prior to Lautenberg; EPA routinely identified the potential hazard EPA says it has "insufficient information", but does not exercise testing authority over existing chemicals EPA spent 6 months doing a literature search, but did not search data in OPP EPA's initial finding is insufficient information; upfront inhalation testing; now require APF 1000 or APF of 50 after break-through testing If the surfactants on the SCIL were submitted without test data, EPA would require APF 1000 respiratory protection (fullface supplied air) Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00009 B E K G E S O N : C A M P B E L L PC Common EPA Responses If low/low - Not likely to present unreasonable risk; otherwise, 5e/SNUR IVlost common PESS: Workers IVlost common regulatory outcome: Required personal protective equipment (PPE); limits to water releases Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00010 Examples of Flawed Risk Evaluations . Mist concentrations equivalent of 16 L/m3 . Vapor concentration above the vapor pressure . Number of containers emptied corresponding to 250,000 kg in a Low Volume Exemption (LVE) Notes: Submitters need to scrutinize risk evaluations Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00011 COs and SNURs B EKGE S ON CAMPBELL PC . SNURs are a "black mark" in the market . Until more existing chemicals have SNUR-like burden (testing, restrictions, recordkeeping), many customers (especially unsophisticated far down the supply chain) will avoid CO/SNUR substances Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00012 Creative Solutions Exempt polymer flag Non-order SNURs B E S G E S O S tx C A MP B E L L PC Notes: Non-order SNURs as now envisioned require that EPA promulgate the SNUR, then EPA makes non-likely finding, after which submitter may commence Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00013 B EKGE S ON CAMPBELL PC Suggestions for Submitters . Detailed release and exposure data . Duplicate key information, make it less likely an assessor will miss it - Key information in the premanufacture notification (PMN) form, not just attachments . Equipment cleaning and maintenance . Specify medium of release . Specify treatment method ~ "appropriate WWT" is not enough . Pollution Prevention (P2) statements . Learn Sustainable Futures (SF) tools; use them before submitting . Request prenotice review meeting to identify weaknesses Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00014 B E K G E S O N : C A M P B E L L PC Suggestions for EPA . Can SNURs focus on critical portions of supply chain? . Issue test orders related to inhalation categories ~ spread the burden among new and existing chemical manufacturers . Must improve the quality and consistency of assessments . Prepare new chemical review reports to be ready to send upon request . Points to Consider must be more than just what to put in a PMN - Provide insight into ERA'S thinking and EPA's approaches to hazard, exposure, and risk assessments Explain role of P2 statements/risk reduction Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00015 B EKGE S ON CAMPBELL PC Questions for Stakeholders . Is EPA required to regulate for PPE? , Can PPE be reasonably assumed to be a "condition of use" in an industrial setting? ; Can PPE be reasonably assumed if there are other reasons to use PPE? . If EPA is not required to regulate for PPE, are COs/SNURs for PPE the best use of EPA's resources? . Is skin or eye irritation an "unreasonable risk" that requires EPA to regulate? . Is corrosion an endpoint that requires a 5NUR? Is a clear warning sufficient? . What is "reasonably foreseeable"? Is it the same as "someone could"? . How likely is "not iikely"? . Does it make sense to require confirmatory testing for substances with high aquatic toxicity? . Should there be a stakeholder group in which these and other issues can be discussed to provide EPA input? Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00016 Closing Thoughts B EKGE S ON CAMPBELL PC . Cooperation among stakeholders is vital to get TSCA implementation right . ERA needs to exercise its test authority for existing chemicals = Even the playing field between new and existing chemicals . Submitters must provide more complete data set ; Identify potential analogs . Have some patience Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00017 B E R G E S O N : C A M P B E L L F C Thank You Richard E,, Engler, PhD, Bergeson & Campbell, P.C. 2200 Pennsylvania Avenue, MM, Suite 10W Washington, DC 20037 Sierra Club v. EPA 18cv3472 NDCA Attachments Prod 1 ED 002061 00041278-00018