Monthly Update for September 2020


Register Now For 4-Part “TSCA Fundamentals” Course: Bergeson & Campbell, P.C. (B&C®) is pleased to join Chemical Watch to provide in-depth training on the very latest Toxic Substances Control Act (TSCA) regulatory and policy developments, their impact, and how to anticipate their requirements. Staying on top of TSCA changes is critically important, and training on current regulatory requirements is vital for a company to comply with the law and remain commercially competitive. Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and Kathleen M. Roberts, Senior Regulatory Consultant, will teach the courses over four two-hour live virtual training sessions on October 19, 21, 26, and 29, 2020. Register now!

CDR Cross-CheckTM: As you gather your company’s information for Chemical Data Reporting (CDR), let The Acta Group (Acta®) assist with the search of the TSCA Inventory and particular TSCA actions. CDR Cross-Check is a low-cost, straightforward way to have Acta search Chemical Abstracts Service (CAS) Registry Numbers (RN) and TSCA Accession Numbers and provide the output that you need to know whether a particular TSCA action changes a reporting exemption or the reporting threshold.

You do not have to be a current Acta client, simply go to https://cdr-cross-check.actagroup.com/, follow the instructions to upload your list of CAS RNs, and pay the search fee.

You have enough to worry about in CDR reporting, let Acta help with the database searching!

The PSX 2020 Virtual Conference Has Begun: PSX 2020, presented by the Product Stewardship Society (PSS), is designed to support professional growth by providing education relevant to current, emerging, and future issues in product stewardship. This year’s virtual event remains the premier venue to enhance your stewardship skill sets and learn how to become a Certified Professional Product Steward (CPPS), the first-ever product stewardship credential that the PSS is proud to offer with the Board for Global EHS Credentialing. On September 16, 2020, B&C professionals Karin F. Baron, MSPH, Senior Regulatory Consultant, and Richard E. Engler, Ph.D., Director of Chemistry, will present “Evaluating New Chemicals and Disconnects in Hazard Communication.” Single day registrations for September 16 and 17, 2020, are still available!

TSCA/FIFRA/TRI

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 evaluations under TSCA and begun to concentrate on risk management activities. The reorganization reflects this by taking the current risk management divisions, the National Program Chemicals Division (NPCD) and the Chemical Control Division (CCD), and the Risk Assessment Division (RAD) and reorganizing them to focus separately on existing chemicals and new chemicals. Read the full memorandum for B&C’s commentary on the reorganization.

COVID-19

OSHA And FDA Develop Checklist Intended To Protect Food Industry Employees Amid Coronavirus Pandemic: On August 19, 2020, the Occupational Safety and Health Administration (OSHA) announced that together with the U.S. Food and Drug Administration (FDA), it developed a checklist for human and animal food manufacturers to consider when continuing, resuming, or reevaluating operations due to the coronavirus pandemic. According to OSHA, the checklist is useful for persons growing, harvesting, packing, manufacturing, processing, or holding human and animal food regulated by FDA. The checklist includes the following considerations: ensure employee health and a safe workplace; investigate exposure and determine when an employee should be tested for the coronavirus; and configure the work environment to help minimize the risk of spreading the coronavirus among workers. OSHA states that food manufacturers can use this checklist in conjunction with other sector-specific information, such as guidance from the Centers for Disease Control and Prevention (CDC) and OSHA for agriculture and meat and poultry processing workers and employers.

FDA Provides COVID-19 Consumer Update: FDA, on September 9, 2020, announced the availability of updated information for consumers that includes guidance related to questions about nutrition, food safety, dietary supplements, and cosmetics. 85 Fed. Reg. 55678. FDA notes that within the first half of 2020, more than 15,000 inquiries were received by the Food and Cosmetic Information Center (FCIC). The FCIC answers include many useful links for consumers and food businesses related to various issues surrounding the COVID-19 pandemic. Documents that have been updated recently include:

  • Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (updated August 7, 2020);
     
  • Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (updated August 7, 2020); and
     
  • Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (updated August 7, 2020).
     

EPA Announces Approval Of First-Ever Long-Lasting Antiviral Product For Use Against COVID-19: On August 24, 2020, EPA announced the issuance of a FIFRA Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days. EPA states that after carefully reviewing the available data and information, it “determined that the product helps to address the current national emergency.” According to EPA, the product is “expected to provide longer-lasting protection in public spaces, increasing consumer confidence in resuming normal air travel and other activities.” For more information, see our August 26, 2020, blog.

CDC Publishes Industry-Specific Resources: CDC has published six industry-related fact sheets to provide employees and employers with information to prevent the spread of COVID-19: offshore oil and gas employees and employers; utility employees and employers; and warehousing employees and employers.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Proposes GHG Emission Standards And Test Procedures For Control Of Air Pollution From Airplanes And Airplane Engines: On August 20, 2020, EPA published a proposed rule that would establish greenhouse gas (GHG) emission standards applicable to certain classes of engines used by certain civil subsonic jet airplanes with a maximum takeoff mass greater than 5,700 kilograms (kg) and by certain civil larger subsonic propeller-driven airplanes with turboprop engines having a maximum takeoff mass greater than 8,618 kg. 85 Fed. Reg. 51556. According to EPA, the proposed standards are equivalent to the airplane carbon dioxide (CO2) standards adopted by the International Civil Aviation Organization (ICAO) in 2017 and would apply to both new type design airplanes and in-production airplanes. Comments are due October 19, 2020. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are “best assured of consideration” if received by the Office of Management and Budget (OMB) by September 21, 2020. EPA announced on August 26, 2020, that it will hold a public hearing on September 17, 2020, on the proposed emission standards. 85 Fed. Reg. 52514.

EPA Seeks Comment On Proposed Consent Decree Concerning SIPs Addressing RACT For VOCs From Sources Covered By The 2016 Oil And Gas CTG: On August 21, 2020, EPA published a notice of a proposed consent decree that would fully resolve a lawsuit filed by the Center for Biological Diversity and the Center for Environmental Health. 85 Fed. Reg. 51698. The consent decree would require EPA to take action under the Clean Air Act (CAA) to make a finding of failure to submit for state implementation plans (SIP) addressing reasonably available control technology (RACT) for volatile organic compounds (VOC) from sources covered by the 2016 Oil and Gas control techniques guideline (CTG) pursuant to 42 U.S.C. Section 7410(k)(1)(B) for the 2008 ozone National Ambient Air Quality Standards (NAAQS) for certain states and areas as listed in the proposed consent decree. The proposed consent decree would also require the Administrator, pursuant to CAA Section 110(k)(2)-(4), 42 U.S.C. Section 7410(k)(2)-(4), to take final action to approve or disapprove, in whole or in part SIP submissions addressing the 2016 Oil and Gas CTG for the 2008 and/or 2015 ozone NAAQS submitted by various states for the nonattainment areas and ozone transport region (OTR) states as listed in the proposed consent decree. Comments are due September 21, 2020.

EPA Posts Responses To Certain State Designation Recommendations For The 2010 SO2 Primary NAAQS: On August 21, 2020, EPA announced that it has posted its responses to certain state designation recommendations for the 2010 Sulfur Dioxide (SO2) Primary NAAQS on its website and in the electronic docket, Docket ID EPA-HQ-OAR-2020-0037. 85 Fed. Reg. 51694. EPA states that these responses include its intended designations for the affected areas, specifically all remaining undesignated areas for the 2010 SO2 NAAQS in the United States. EPA also invites the public to review and provide input on the intended designations. According to the notice, EPA intends to make final designation determinations for the areas of the country addressed by these responses no later than December 31, 2020. Comments are due September 21, 2020.

EPA Proposes Amendments To NESHAP For Industrial, Commercial, And Institutional Boilers And Process Heaters: On August 24, 2020, EPA published a proposed rule that would amend the 2013 National Emission Standards for Hazardous Air Pollutants (NESHAP) for Industrial, Commercial, and Institutional Boilers and Process Heaters. 85 Fed. Reg. 52198. The 2013 rule established emission standards for categories of boilers based on the maximum achievable control technologies (MACT). The proposed amendments address deficiencies identified by the U.S. Court of Appeals for the D.C. Circuit in a July 2016 decision that remanded several of the emission standards to EPA. In response to the remands, EPA proposes to amend several numeric emission limits for new and existing boilers and process heaters consistent with the court’s opinion and set compliance dates for these new emission limits. The court also remanded for further explanation EPA’s use of carbon monoxide (CO) as a surrogate for organic hazardous air pollutants (HAP) and, in a subsequent decision in March 2018, remanded for further explanation EPA’s use of a CO threshold to represent the application of MACT for organic HAP. Comments are due October 23, 2020. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives a copy by September 23, 2020.

EPA Issues Final Regulations Implementing Court’s Vacatur Of 2015 CCR Provisions: On April 17, 2015, EPA promulgated national minimum criteria for existing and new coal combustion residuals (CCR) landfills and existing and new CCR surface impoundments. The criteria were challenged in court, and on August 21, 2018, the U.S. Court of Appeals for the D.C. Circuit issued its opinion in the case of Utility Solid Waste Activities Group v. EPA, 901 F.3d 414 (per curiam). On August 28, 2020, EPA issued final regulations to implement the court’s vacatur of the 2015 provisions. 85 Fed. Reg. 53516. The court vacated provisions that allowed unlined impoundments to continue receiving coal ash unless they leak, and classified “clay-lined” impoundments as lined, thereby allowing such units to operate indefinitely. In addition, EPA states that it is establishing a revised date by which unlined surface impoundments must cease receiving waste and initiate closure, following its reconsideration of those dates in light of the court’s decision. Lastly, EPA adopted final amendments to the requirements for the annual groundwater monitoring and corrective action report and the requirements for the publicly accessible CCR Internet sites. This final rule will be effective on September 28, 2020.

EPA Issues Proposed And Direct Final Rules To Correct Flex-Fuel Vehicle Provisions In CAFE Regulations: On August 31, 2020, EPA issued proposed and direct final rules to correct an error in EPA’s regulations for test procedures used in the Corporate Average Fuel Economy (CAFE) program issued in a 2012 rulemaking. 85 Fed. Reg. 53722 and 85 Fed. Reg. 53676. The correction clarifies the method for how flex-fuel vehicles are accounted for in manufacturer fuel economy calculations in model years 2020 and later. This correction allows the program to be implemented as originally intended in the 2012 rule. The direct final rule will be effective November 30, 2020, unless EPA receives adverse comment by October 15, 2020. If EPA receives adverse comment, it will publish a timely withdrawal in the Federal Register.

EPA Announces 2030 Vision And Goals For RCRA Cleanups: On September 1, 2020, EPA announced the 2030 Vision and Goals for the Resource Conservation and Recovery Act (RCRA) Corrective Action hazardous waste facility cleanup program. According to EPA, “[t]he new vision provides inspiration and overall direction for the program.” EPA has laid out five goals for the program for the next ten years related to: ensuring that RCRA Corrective Action cleanups are initiated and completed expeditiously; eliminating or controlling adverse impacts beyond the facility boundaries; ensuring land within the facility boundaries will be safe for continued use or reasonably foreseeable new uses; identifying and implementing the key elements of effective Long-Term Stewardship for Corrective Action; and regularly adjusting the universe of facilities in the cleanup pipeline to reflect current program priorities.

EPA Denies Petitions For Reconsideration Of Final Revisions To The Accidental Release Prevention Requirements: On September 4, 2020, EPA provided notice that it is denying three petitions for reconsideration of the final revisions to the Accidental Release Prevention Requirements: Risk Management Programs under CAA. 85 Fed. Reg. 55286. EPA set out the basis for its action in separate letters addressed to each petitioner, available in the rulemaking docket, Docket ID EPA-HQ-OEM-2015-0725.

EPA Revises Reporting Requirements For Mercury And Air Toxics Standards For Power Plants: On September 9, 2020, EPA amended the electronic reporting requirements for the NESHAP: Coal- and Oil-Fired Electric Utility Steam Generating Units (also known as the Mercury and Air Toxics Standards (MATS)). 85 Fed. Reg. 55744. According to EPA, this action revises and streamlines the electronic data reporting requirements of MATS, increases data transparency by requiring use of one electronic reporting system instead of two separate systems, and provides enhanced access to MATS data. The rule was effective immediately.

EPA Publishes Final RTR For Iron and Steel Foundries Source: EPA published on September 10, 2020, a final rule regarding the final residual risk and technology review (RTR) conducted for the major source Iron and Steel Foundries source category and the technology review for the area source Iron and Steel Foundries source category regulated under NESHAP. 85 Fed. Reg. 56080. In addition, EPA is taking final action to remove exemptions for periods of startup, shutdown, and malfunction (SSM) and to specify that emissions standards apply at all times. The final amendments also require electronic reporting of performance test results and compliance reports and make minor corrections and clarifications to a few other rule provisions for major sources and area sources. The rule was effective immediately.

EPA Amends NSPS For Oil And Natural Gas Sector: On September 15, 2020, EPA amended the new source performance standards (NSPS) for the oil and natural gas sector. 85 Fed. Reg. 57398. EPA granted reconsideration on the fugitive emissions requirements, well site pneumatic pump standards, requirements for certification of closed vent systems (CVS) by a professional engineer (PE), and the provisions to apply for the use of an alternative means of emission limitation (AMEL). EPA states that the final rule includes amendments as a result of its reconsideration of the issues associated with the above mentioned four subject areas and other issues raised in the reconsideration petitions for the NSPS, as well as amendments to streamline the implementation of the rule. The final rule also includes technical corrections and additional clarifying language in the regulatory text and/or preamble where EPA concludes further clarification is warranted. This final rule will be effective on November 16, 2020.

FDA

FDA Updates Docket Regarding Cosmetic Products Containing Talc: FDA, on August 19, 2020, announced the availability of a statement added to the docket for the meeting titled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” 85 Fed. Reg. 51035. The statement and related content on FDA’s web page for cosmetics and talc (available at the link here) are intended to clarify that the Executive Summary from the meeting and related presentations were meant solely to solicit scientific feedback on the issues raised and do not represent proposed or preliminary recommendations or policies of FDA or any other federal agency.

FDA Withdraws Color Additive Petition: FDA, on August 24, 2020, announced the withdrawal, without prejudice to a future filing, of a color additive petition proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide as a color additive in contact lenses. 85 Fed. Reg. 52081. The color additive petition was withdrawn on June 15, 2020.

NANOTECHNOLOGY

EPA Proposes To Extend ICR Regarding TSCA Section 8(a) Reporting And Recordkeeping Requirements For Certain Nanoscale Materials: On August 27, 2020, EPA announced that it submitted an information collection request (ICR), “Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials” to OMB for review and approval in accordance with PRA. 85 Fed. Reg. 52995. The ICR covers reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials. Comments are due September 28, 2020. More information is available in our August 27, 2020, blog item.

EUON Publishes Nanopinion On Nanosilver In Healthcare: On August 31, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Nanosilver in healthcare -- does the silver bullet exist?” by Dr. Dorota Napierska, Chemicals Policy and Projects Officer, Health Care Without Harm Europe (HCWH Europe). Napierska examines how beneficial the properties of nanosilver are in clinical settings and the risks involved.

ECHA Publishes Final Evaluation Of MWCNTs, Synthetic Graphite In Tubular Shape And Tangled: The European Chemicals Agency (ECHA) has posted the German Federal Institute for Occupational Safety and Health’s (BAuA) substance evaluation conclusion document for multi-walled carbon nanotubes (MWCNT), synthetic graphite in tubular shape and tangled. The conclusion provides a summary of how the information on the substance can be used for the purposes of regulatory risk management. More information is available in our September 3, 2020, blog item.

September Webinar Will Review How OECD Develops Test Guidelines: The EU-funded projects NanoHarmony and NANOMET-Organization for Economic Cooperation and Development (OECD) have jointly organized a September 16, 2020, webinar on “The Pathway to Test Guidelines: from science to standards for nanomaterials.” Participants will learn how OECD develops Test Guidelines, using case studies from the Test Guidelines that are supported through the projects for expansion into nanomaterials.

2020 NanoEHS U.S.-EU COR Workshop Will Be Held September 16-17: The U.S. National Nanotechnology Initiative (NNI) and European Commission (EC) have organized the ninth annual meeting of the environmental, health, and safety effects of nanomaterials (nanoEHS) Communities of Research (COR) as a virtual workshop on September 16-17, 2020. The draft agenda is available. Registration is free.

2020-2021 NNI NanoEHS Webinars Will Begin In November 2020: According to the Summer 2020 edition of the National Nanotechnology Coordination Office (NNCO) Quarterly Newsletter, the 2020-2021 NNI nanoEHS webinars will begin in November 2020. According to the Newsletter, the Nanotechnology Environmental and Health Implications (NEHI) Working Group is planning nanoEHS webinars to present progress in the following areas: nanomaterial measurement infrastructure; human exposure assessment; human health; environment; risk assessment and risk management methods; and informatics and modeling. NNI will post more information at https://www.nano.gov/publicwebinars as it becomes available.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.

LEGISLATIVE

House Subcommittee Chairs Request GAO Examination Of Federal PFAS R&D Efforts: On August 13, 2020, Representatives Lizzie Fletcher (D-TX), Chair of the House Science, Space, and Technology Subcommittee on Energy, Mikie Sherrill (D-NJ), Chair of the Science, Space, and Technology Subcommittee on Environment, and Haley Stevens (D-MI), Chair of the House Science, Space, and Technology Subcommittee, sent a letter to Comptroller Gene Dodaro requesting the U.S. Government Accountability Office (GAO) examine how the federal government has coordinated research and development (R&D) activities on per- and polyfluoroalkyl substances (PFAS) across different agencies. The Committee Chairs also called for an examination of the current state of PFAS science and how federal programs and investments are currently aligned to address any remaining scientific and technological gaps.

Bipartisan Group Of Lawmakers Call On EPA To Withdraw New Methane Rules: A bipartisan group of lawmakers has called on EPA to withdraw the Trump Administration’s final rule that will allow more methane to be released into the atmosphere. In an August 25, 2020, letter sent to EPA Administrator Andrew Wheeler and signed by 87 members of Congress, the lawmakers urged Wheeler to withdraw the Administration’s changes to EPA’s 2012 and 2016 NSPS for the Oil and Natural Gas Industry.

Senate Democrats’ Climate Committee Releases New Report On Climate Action: On August 25, 2020, the Senate Democrats’ Climate Committee announced the release of a report entitled The Case for Climate Action: Building a Clean Economy for the American People. The new report details how action from Congress can create millions of new jobs, grow the American economy, and improve people’s lives across the country. The Committee’s report calls on Congress to: reduce U.S. emissions rapidly to achieve 100 percent global net-zero emissions no later than 2050; stimulate economic growth by increasing federal spending on climate action to at least two percent of gross domestic product (GDP) annually -- and ensure that at least 40 percent of the benefits from these investments help communities of color and low-income, deindustrialized, and disadvantaged communities; and create at least ten million new jobs.

House Members Urge EPA To Withdraw Proposed Revisions To Disposal Of CCR: On September 3, 2020, Representative Jamie Raskin (D-MD) announced that 55 members of the House sent a letter to EPA, urging it to “withdraw its dangerous proposal to weaken coal ash safety standards across America by gutting a 2015 rule mandating the closure of unprotected coal ash storage ponds.” Under the existing 2015 rule, coal ash storage ponds are required to close if they are leaking dangerous chemicals, structurally impaired, or located in hazardous geological areas. According to Raskin’s press release, EPA’s proposed rule “would permit operators to resume dumping millions of tons of toxic waste in unprotected coal ash storage ponds, endangering the health of communities downstream and ensuring the continued pollution of our nation’s waterways.”

House Energy And Commerce Committee Advances Energy Bills: The House Committee on Energy and Commerce advanced two energy bills on September 9, 2020:

  • The Expanding Access to Sustainable Energy Act of 2019 (H.R. 4447) would establish an energy storage and microgrid grant and technical assistance program at the Department of Energy (DOE). The bill was passed, as amended, by voice vote; and
     
  • The Department of Energy Organization and Management Improvement Act (H.R. 8159) would require the Secretary of Energy to review and report periodically on measures and recommendations to improve general management of DOE, and to implement reforms to ensure continuous improvement in management. The bill was passed by voice vote.
     

Senators Announce Agreement On HFCs Amendment To Energy Bill: On September 10, 2020, Senator John Barrasso (R-WY), Chair of the Senate Committee on Environment and Public Works, Committee Ranking Member Tom Carper (D-DE), and Senator John Kennedy (R-LA) announced a bipartisan agreement on changes to an hydrofluorocarbons (HFC) amendment to the American Energy Innovation Act (S. 2657). According to the Committee’s September 10, 2020, press release, the revised amendment will authorize a 15-year phasedown of HFCs at a national level for the first time, administered by EPA. The amendment requires EPA to implement an 85 percent phase down of the production and consumption of HFCs, so they reach approximately 15 percent of their 2011-2013 average annual levels by 2036. Under the agreement, the revised amendment will also:

  • Protect essential uses of HFCs, including ensuring there are sufficient supplies of HFCs for Congressionally-designated essential uses of HFCs that currently have no substitute chemicals, including defense sprays, medical inhalers, semiconductor manufacturing, and mission-critical military uses;
     
  • Preempt state and local governments from regulating HFCs for the Congressionally-designated essential uses for at least five years (which can be extended to ten if there remains no substitute chemical for a use); and
     
  • Provide protection for consumers from cost increases by ensuring EPA cannot accelerate the 15-year regulatory timeline faster than HFC consumption levels that the market is already achieving.
     

House Subcommittee Will Hold Hearing On Need For Climate-Focused Economic Recovery: The House Energy and Commerce Subcommittee on Environment and Climate Change will hold a hearing on September 16, 2020, on “Building a 100 Percent Clean Economy: Opportunities for an Equitable, Low-Carbon Recovery.” According to the House Energy and Commerce Committee’s September 9, 2020, press release, COVID-19 recovery measures “should put the United States on the path to a low-carbon future. Economic growth and climate action go hand-in-hand, and we look forward to discussing the benefits of fostering a low-carbon economic recovery.”

Senate Committee Will Hold Hearing On Stakeholder Reactions To The Navigable Waters Protection Rule Under The Clean Water Act: On September 16, 2020, the Senate Committee on Environment and Public Works will hold a full Committee hearing entitled “Stakeholder Reactions: The Navigable Waters Protection Rule under the Clean Water Act.”

MISCELLANEOUS

USDA Hosts Stakeholder Forum For Discussion And Feedback On AIA, Requests Stakeholder Input: On August 16, 2020, USDA held a forum on its Agriculture Innovation Agenda (AIA). The forum focused on science-informed policies and programs from government agencies with the shared aim of supporting environmentalism and enhanced productivity. AIA seeks to spur developments in biotechnology and support accessibility in response to modern industry challenges. Stakeholders were given a chance to hear from representatives and participate in a question and answer (Q&A) session. USDA anticipates hosting future discussion opportunities with stakeholders. For more information on what was discussed at the forum, please read the full memorandum.

On September 10, 2020, USDA requested comments and suggestions on the “most innovative technologies and practices” that can be deployed across U.S. agriculture to meet USDA’s goal of increasing agricultural production by 40 percent to meet the needs of the global population in 2050 while cutting the environmental footprint of U.S. agriculture in half. 85 Fed. Reg. 55812. USDA states that this effort is a part of AIA. Comments are due November 9, 2020.

EPA Extends Comment Period On Integrated Risk Information System (IRIS) Assessment Plan For Oral Exposure To Vanadium And Compounds: On August 20, 2020, EPA announced that it is extending the public comment period for the IRIS Assessment Plan for Oral Exposure to Vanadium and Compounds (Scoping and Problem Formulation Materials). 85 Fed. Reg. 51430. EPA convened a public science webinar on August 19, 2020. Comments are due September 23, 2020.

EPA Announces Almost $5 Million For New Research On Managing PFAS In Agricultural And Rural Communities: On August 20, 2020, EPA announced $4.8 million in research funding to three institutions to understand better the potential impacts of PFAS on water quality and availability in rural communities and agricultural operations across the United States. The grant recipients will look at major sources of PFAS contamination, fate, and transport in rural areas, including exposure risks from private drinking water wells and improved wastewater treatment methods to remove PFAS from water and biosolids that may be used for agricultural purposes.

EPA Launches Innovative Ways To Destroy PFAS Challenge: On August 25, 2020, during a PFAS roundtable hosted by Representative Richard Hudson (R-NC) in Fayetteville, N.C., EPA Administrator Andrew Wheeler launched an innovation challenge intended to identify solutions to destroy PFAS. According to EPA’s August 25, 2020, press release, the Innovative Ways to Destroy PFAS Challenge is a partnership between federal and state agencies seeking detailed plans for non-thermal technologies to destroy PFAS in concentrated aqueous film forming foam (AFFF), a type of firefighting foam. The goal of this challenge is to discover new non-thermal technologies and approaches that can remove at least 99 percent of PFAS in unused AFFF, without creating any harmful byproducts. EPA notes that although PFAS compounds can be found in various wastestreams, the challenge is focused on unused AFFF. EPA is offering up to $50,000 for the best design concept(s), with the added potential opportunity for field testing of the winning design concept(s) in partnership with EPA and the U.S. Department of Defense’s Environmental Security Technology Certification Program (ESTCP). Challenge details are available on EPA’s website. The challenge closes November 23, 2020. Winners are expected to be announced in early 2021.

EPA And USDA Announce Competition Intended To Advance Agricultural Sustainability In The United States: On August 26, 2020, EPA and USDA announced the Next Gen Fertilizer Challenges, a joint EPA-USDA partnership and competition intended to advance agricultural sustainability in the United States. The competition includes two challenges that seek proposals for new and existing fertilizer technologies to maintain or improve crop yields while reducing the impacts of fertilizers on the environment. Along with EPA and USDA, the competition is coordinated with The Fertilizer Institute, the International Fertilizer Development Center, the National Corn Growers Association, and The Nature Conservancy. The first challenge, the Enhanced Efficiency Fertilizers (EEF): Environmental and Agronomic Challenge, aims to identify existing enhanced efficiency fertilizers that meet or exceed certain environmental and agro-economic criteria. This challenge will not have a monetary prize, but winners will receive scientific evaluation of their product and recognition from EPA, USDA, and other collaborators and participants. The second challenge, the Next Gen Fertilizer Innovations Challenge, aims to generate new concepts for novel technologies that can help address environmental concerns surrounding agriculture practices while maintaining or increasing crop yields. A panel of expert judges will review the submissions. Each winner will receive at least $10,000. Registrants must submit their entries by October 30, 2020, for the EEFs: Environmental and Agronomic Challenge and by November 30, 2020, for the Next Gen Fertilizer Innovations Challenge. Winners will be announced in winter 2021. An informational webinar will be held on September 24, 2020, at 10:00 to 11:00 a.m. (EDT).

OSHA Amends Construction And Shipyard Standards For Occupational Exposure To Beryllium And Beryllium Compounds: On August 31, 2020, OSHA amended its existing construction and shipyard standards for occupational exposure to beryllium and beryllium compounds to clarify certain provisions and simplify or improve compliance. 85 Fed. Reg. 53910. According to OSHA, the changes are designed to accomplish three goals: to tailor more appropriately the requirements of the construction and shipyards standards to the particular exposures in these industries in light of partial overlap between the beryllium standards’ requirements and other OSHA standards; to aid compliance and enforcement across the beryllium standards by avoiding inconsistency, where appropriate, between the shipyards and construction standards and recent revisions to the general industry standard; and to clarify certain requirements with respect to materials containing only trace amounts of beryllium.

EPA Publishes “First Ever” Rule Intended To Promote Transparency In Developing Regulatory Guidance Documents: On September 14, 2020, EPA released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.” The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance. EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document. EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents. The final rule will be effective 30 days after publication in the Federal Register. More information will be available in a forthcoming memorandum that will be posted on our website.

EPA Will Hold External Peer Review On Report On PBPK Modeling For Chloroprene And A Supplemental Analysis Of Metabolite Clearance: On October 5-6, 2020, EPA will hold a public meeting as a part of an independent peer review on the draft documents Physiologically Based Pharmacokinetic (PBPK) Modeling for Chloroprene and Supplement: Uncertainty Analysis of In Vitro Metabolic Parameters and of In Vivo Extrapolation (IVIVE) Used in a Physiologically Based Pharmacokinetic (PBPK) Model for Chloroprene. The meeting is intended to allow the public an opportunity to provide oral comments to the peer reviewers. Written comments will be solicited and will be provided to the external peer reviewers.

FSIS Will Host Food Safety Meeting: The USDA Food Safety and Inspection Service (FSIS) is hosting a virtual public meeting with participation from FDA, CDC, and the Partnership for Food Safety Education from 12:00 to 4:00 p.m. (EDT) on October 6, 2020. FSIS seeks to establish a comprehensive understanding of how consumers handle and prepare food today, by reviewing recent research and forthcoming research, and intends to discuss their consumer education efforts in the meeting. An agenda, to be published online before the public meeting, will be posted on the FSIS website. Interested parties are invited to pre-register for the meeting. Comments are due on or before October 9, 2020.

OEHHA’s CIC Will Consider Chemicals For Prioritization: During its November 17, 2020, meeting, the California Office of Environmental Health Hazard Assessment’s (OEHHA) Carcinogen Identification Committee (CIC) will consider the prioritization of seven chemicals or chemical groups for possible preparation of hazard identification materials: bisphenol A; chlorpyrifos; coal dust; decabromodiphenyl ether (DecaBDE); methyl bromide; perfluorooctane sulfonate (PFOS) and its salts and transformation and degradation precursors; and trifluralin. Comments on the prioritization document for these chemicals are due October 19, 2020. OEHHA will forward public comments to CIC members prior to the meeting. CIC will provide OEHHA with advice on the prioritization of these chemicals for possible preparation of hazard identification materials. At a later date, OEHHA will select chemicals for preparation of hazard identification materials and announce those decisions in a separate notice.

ELI Report Looks At Trump Administration’s Impact On Environmental Law And Policy And What Lies Ahead: The Environmental Law Institute (ELI) recently released Environment 2021: What Comes Next?, a report that looks at the Trump Administration’s impact on environmental law and policy and what lies ahead. ELI states that the report is “a response to growing demand for analysis of how deregulatory initiatives by the Trump Administration will affect environmental protection, governance, and the rule of law with a focus on what might happen in a second Trump administration or a new administration.”

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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