Lynn L. Bergeson, “Feeling The Pinch: Who Pays TSCA Risk Evaluation Fees?,” Financier Worldwide, September 2020: Ordinarily, government fees command little interest in corporate finance and board-level business circles. Newly imposed fees to defray the U.S. Environmental Protection Agency’s (EPA) risk evaluation of high-priority chemical substances under TSCA Section 6 are extraordinary, however, and are commanding significant interest. This article explains why.
OIG Concludes That Lack Of Planning Risks EPA’s Ability To Meet TSCA Deadlines: On August 17, 2020, EPA’s Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended TSCA, and has the staff, resources, and management controls in place to meet future statutory deadlines. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG recommends that the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP): publish the annual existing chemical plan including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement the TSCA amendments; and specify what skill gaps must be filled in fiscal year (FY) 2021 to meet the TSCA requirements. More information is available in our August 18, 2020, blog item.
EPA Calls For Nominations For 2021 Green Chemistry Challenge Awards: On August 17, 2020, EPA announced that it is accepting nominations for the 2021 Green Chemistry Challenge Awards. EPA intends these awards to recognize innovation by American businesses and researchers that redesign chemical products and processes to reduce or eliminate the use and manufacture of hazardous substances. The 2021 Green Chemistry Challenge Awards nomination package is now available, and nominations are due December 4, 2020. EPA states that it anticipates giving awards to “outstanding green chemistry technologies” in five categories in June 2021. EPA will host a webinar on September 23, 2020, for those interested in applying. During the webinar, EPA will provide an overview of the requirements, criteria, and tips for submitting a nomination package.
EPA Issues Final SNURs For Certain Chemical Substances: On August 21, 2020, EPA published final significant new use rules (SNUR) for certain chemical substances that are the subject of premanufacture notices (PMN). 85 Fed. Reg. 51657. The final SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use. The required notification initiates EPA’s evaluation of the chemical under the conditions of use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required as a result of that determination. The SNURs will be effective on October 20, 2020.
Jeff Morris, Former OPPT Director, Describes Community-Based Exposures And Susceptibilities As A Social Justice Challenge For TSCA Implementation: On August 18, 2020, Jeff Morris, former Director of EPA’s OPPT, wrote a column published by Chemical Watch. In the column, “Expert Focus: Community-based exposures and susceptibilities -- a social justice challenge for TSCA implementation,” Morris discusses how risk evaluations conducted under TSCA provide an opportunity to address community exposures and susceptibilities that are not otherwise covered in assumptions made about exposures in the general population. Morris proposes ways that TSCA stakeholders can take “leadership roles in discussion, and action, on understanding potential exposures and susceptibilities of communities near chemical facilities and, where they exist, how they can be incorporated into TSCA risk evaluations.”
EPA Announces Proposal To Add Chitosan To The List Of Active Ingredients Permitted In Exempted Minimum Risk Pesticide Products: On August 20, 2020, EPA announced that it is seeking to add chitosan to the list of active ingredients allowed for in minimum risk pesticides exempted from pesticide registration requirements under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25(b). 85 Fed. Reg. 51394. A minimum risk product must meet six specific conditions to be exempted from pesticide registration. One of those conditions is that the active ingredient in the minimum risk pesticide be one that is listed specifically by EPA. If added to the list of minimum risk pesticide active ingredients, pesticide products containing chitosan could qualify as minimum risk pesticides provided the other conditions are also satisfied (e.g., using inert ingredients approved by EPA for use in minimum risk pesticides, not making any public health claims). EPA states that it has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document concerning “Pesticides; Addition of Chitosan to the List of Active Ingredients Allowed in Exempted Minimum Risk Pesticides Products.” EPA will not make this draft regulatory document available to the public until after it has been signed. When it is available, that document and additional information will be available in docket EPA-HQ-OPP-2019-0701. More information is available in our August 21, 2020, blog.
EPA Revokes SNUR For Certain Chemical Substance: On August 25, 2020, EPA revoked the SNUR for the chemical substance identified generically as alpha 1-, 3-polysaccharide, which was the subject of PMN P-16-581. 85 Fed. Reg. 52274. EPA issued a SNUR based on this PMN, which designated certain activities as significant new uses. EPA is revoking the SNUR based on new test data for the chemical substance. This rule will be effective September 24, 2020.
EPA Proposes SNURs For Certain Chemical Substances: On August 25, 2020, EPA proposed SNURs under TSCA for chemical substances that are the subject of PMNs. 85 Fed. Reg. 52294. This action would require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use by this proposed rule. This action would further require that persons not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination. Comments are due September 24, 2020.
Alexandra Dapolito Dunn Encourages Stakeholders To Engage In Public Engagement Opportunities: On September 2, 2020, EPA posted a blog item by Alexandra Dapolito Dunn, Assistant Administrator for OCSPP, entitled “Advancing Chemical Safety by Listening to You.” Dunn describes how EPA will move from risk evaluation to risk management.
EPA Publishes Final Scope Documents And List Of Manufacturers Subject To Fees For Risk Evaluations Of High-Priority Chemicals: On September 4, 2020, EPA published two Federal Register notices regarding the risk evaluations for the 20 high-priority chemicals designated in December 2019. In the first notice, EPA announced the availability of the final scope documents for the risk evaluations to be conducted under TSCA for the 20 high-priority substances. 85 Fed. Reg. 55281. The scope document for each chemical substance includes the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA plans to consider in conducting the risk evaluation for the chemical substance. In the second notice, EPA announced the availability of the final list identifying manufacturers subject to fee obligations for EPA-initiated risk evaluations under TSCA Section 6. 85 Fed. Reg. 55283. For more information, please read the full memorandum.
EPA Webinars Will Kick Off Public Engagement And Outreach On Risk Management Under TSCA: On September 8, 2020, EPA announced a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final TSCA chemical risk evaluations. After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust process to gain important feedback from stakeholders on the options for managing those risks.” EPA will hold two public webinars to kick off this outreach effort: the first webinar, scheduled for September 16, 2020, will feature a discussion of the findings from the final risk evaluation for methylene chloride; and the second webinar, scheduled for September 30, 2020, will include a discussion of the findings from the final risk evaluation for 1-bromopropane. More information is available in our September 9, 2020, blog item.
EPA’s OCSPP Reorganization Will Include New Risk Evaluation And Risk Management Divisions: EPA’s OCSPP will be reorganizing at the end of September 2020. OCSPP currently consists of OPPT, the Office of Pesticide Programs (OPP), and the Office of Science Coordination and Policy (OSCP). According to reporting in Bloomberg Environmental, EPA is reorganizing within OPPT and OPP, as well as reorganizing at the OCSPP level. EPA has recently completed its first risk...
