Monthly Update for May 2020
Join Bergeson & Campbell, P.C., The Environmental Law Institute, And George Washington University Milken Institute School Of Public Health For “TSCA Reform — Four Years Later” Virtual Seminar: From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform — Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Confirmed speakers include:
- Lynn L. Bergeson, Managing Partner, B&C
- Yvette T. Collazo, Director, Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
- Thomas M. Connelly, Jr., Executive Director and CEO, American Chemical Society (ACS)
- Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA
- Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund (EDF)
- Scott Fulton, President, ELI
- Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
- Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, GWU
- Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC)
Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. – 4:30 p.m. (EDT),to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.
Register Now For “Eurasia REACH: Achieving Timely Compliance With New Chemicals Requirements”: In 2017, the Eurasian Economic Union (EAEU) issued in final a regional chemical framework, Technical Regulation (TR) on the Safety of Chemical Products EAEU 041/2017. The implementation date for the chemicals framework was June 1, 2021, but several factors have resulted in delays. In spite of these delays, the Russian Federation is moving forward with its own chemicals management program. B&C affiliate The Acta Group (Acta®) and EPPA are pleased to present “Eurasia REACH: Achieving Timely Compliance with New Chemicals Requirements,” a complimentary presentation covering technical, legal, and policy matters affecting compliance by expert global and in-country regulatory and legal professionals, on Wednesday May 27, 2020, from 2:00 p.m. – 3:00 p.m. (EDT). Register online.
Available On-Demand: “Navigating The Jurisdictional Tightrope Between Biopesticides, Biostimulants, And Related Emerging Technologies,” Webinar And Podcast: “Navigating the Jurisdictional Tightrope Between Biopesticides, Biostimulants, and Related Emerging Technologies” complimentary webinar is available to stream now. This webinar deconstructs the jurisdictional boundaries distinguishing pesticides, biopesticides, plant regulators, biostimulants, and related technologies by reviewing the draft EPA guidance intended to clarify the lines between and among those products that are subject to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration as plant regulators and those biostimulant products not subject to FIFRA registration. The webinar also focuses on new and evolving chemistry and technology issues that may blur some jurisdictional lines or potentially move products from one category to another. Lynn L. Bergeson, Managing Partner, B&C; Lisa R. Burchi, Of Counsel, B&C; and Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C, present.
The latest episode of B&C’s Podcast All Things Chemical™, “What Is the Difference between a Biostimulant and a Pesticide?” is available at the B&C website, iTunes, or wherever you listen to podcasts.
TSCA New Chemicals Webinar Available On-Demand; Save $100 On GlobalChem Webinar Series: GlobalChem Webinar Series Part 3, “TSCA New Chemicals,” is now available on-demand. Sign up by Wednesday, May 20, 2020, for the 10-Part GlobalChem Webinar Series and save $100 on the cost of the series ($299 for American Chemistry Council (ACC) members, $399 for non-members) by using the code LAWBC during registration.
Richard E. Engler, Ph.D., Director of Chemistry, B&C; Lynn Dekleva, Ph.D., Associate Deputy Assistant Administrator for New Chemicals, EPA OCSPP; Tala Henry, Ph.D., Deputy Director, EPA OPPT; Mike Walls, Vice President, Regulatory and Technical Affairs, ACC; and Ritesh Tiwari, Chemical Engineer, EPA, offered updates on the key changes to the TSCA Section 5 rulemaking. Visit www.globalchem.org for more information.
Lynn L. Bergeson, “Effectively Managing Supply Chain Communications Under TSCA,” Bloomberg Environment Insights, April 28, 2020: The EPA’s amendments to TSCA reporting requirements have increased the need for chemical stakeholders to manage actively supply chain communications. Lynn L. Bergeson, owner and managing partner of B&C, explores the upsides to be realized through these communications and the perils of failing to seize them. Download a PDF of this article here.
EPA Convenes Call On Plan To Reduce Burden For Certain Stakeholders Subject To TSCA Fees Rule Requirements For EPA-Initiated Risk Evaluations: On April 16, 2020, EPA hosted a call on its recently announced plan to reduce the burden for certain stakeholders subject to the TSCA fees rule requirements for EPA-initiated risk evaluations. The call covered:
- How EPA’s plan to initiate a rulemaking to consider proposing exemptions to the current rule’s requirements impacts manufacturers and other businesses;
- What the “No Action Assurance” means for importers of articles and producers of byproducts and impurities; and
- Reporting obligations during the current comment period, which will close May 27, 2020.
More information is available in our April 17, 2020, blog item.
EPA Releases Second Set Of Draft Scope Documents For Remaining High-Priority Substances: EPA published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the remaining seven of the 20 chemicals designated as high-priority substances for risk evaluation under TSCA. 85 Fed. Reg. 22733. The draft scope documents include the proposed conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations EPA expects to consider in the risk evaluations. The documents also include: a description of the reasonably available information and the science approaches that EPA plans to use; a conceptual model that outlines the potential hazards and exposures throughout the life cycle of the chemical; an analysis plan to identify the approaches and methods that EPA plans to use to assess health and environmental factors; and a potential plan for peer review. Comments are due June 8, 2020. For more information, please read the full memorandum.
B&C Frequently Asked Questions (FAQ) On TSCA Fees For EPA-Initiated Risk Evaluations, Preliminary Lists For 20 High-Priority Chemicals, And Self-Identification Requirements: Under the amended TSCA, EPA has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with implementation efforts. The EPA fees rule, which became effective on October 18, 2018, required payment of fees for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6. For more information, please read the full memorandum.
EPA Will Award Cooperative Agreement To Support National Tribal Toxics Council: EPA announced on April 29, 2020, that is seeking applications from states, federally-recognized tribes, Native American organizations, and non-governmental organizations (NGO) to provide technical support for the National Tribal Toxics Council (NTTC). The NTTC works collaboratively with EPA to represent tribal interests in the development and implementation of chemical risk assessment, risk management, and pollution prevention programs. EPA states that it anticipates awarding one cooperative agreement for approximately $800,000 over a five-year period that will focus on the following activities:
- Assist federally-recognized tribes, Alaska Native Villages, and intertribal organizations in selecting and maintaining a geographically diverse membership with a diversity of relevant and technical expertise in the NTTC;
- Assist the NTTC in maintaining a viable charter that covers activities eligible for EPA funding and fulfilling the objectives of that charter; and
- Provide professional and technical support to the NTTC to conduct its meetings and other activities.
Applications are due June 15, 2020.
EPA Approves Experimental Use Permit For Field Testing Of Genetically Modified Aedes aegypti Mosquitoes: On May 1, 2020, EPA granted an experimental use permit (EUP) to Oxitec Ltd. (Oxitec) to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce populations that serve as a vector for a variety of diseases, including Zika virus. The EUP is designed to test the effectiveness of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations in specific locations with monitoring and sampling of the resultant mosquito populations. These field tests will proceed only after state and local approval, and they are intended as a first step toward potential wider use of genetically modified mosquitoes in the U.S. EPA’s decision and the approved permit are available here. For more information, see our blog.
EPA Publishes Draft Risk Evaluation Of Perchloroethylene: On May 4, 2020, EPA published a Federal Register notice announcing the availability of the draft risk evaluation of perchloroethylene. 85 Fed. Reg. 26464. According to EPA, it reviewed 68 conditions of use and preliminarily found unreasonable risk to workers, occupational non-users (ONUs), consumers, bystanders, and the environment from certain uses. EPA notes that if its final risk evaluation finds there are unreasonable risks associated with perchloroethylene under the specific conditions of use, EPA will propose actions to address those risks within the timeframe required by TSCA. EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable. Comments are due July 6, 2020. EPA will also hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation on May 26-29, 2020. Please consult the Federal Register notice for more details on the virtual peer review meeting deadlines. For our commentary on this risk evaluation, please read the full memorandum.
SACC Will Peer Review Draft Risk Evaluation For Asbestos In June: EPA announced in a May 15, 2020, Federal Register notice, that the TSCA SACC will meet from June 8-11, 2020, to peer review the draft risk evaluation for asbestos. 85 Fed. Reg. 29446. The public meeting will be virtual, with participation by phone and webcast only. There will be no in-person gathering for this meeting. EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review. Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting. Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting. Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020. More information on EPA’s draft risk evaluation is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”
New Reporting Procedure For Co-Manufacturers Under TSCA CDR Rule May Catch Certain Manufacturers Off Guard: One of several changes to the TSCA Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR Rule and instead relied on the contracting company to do so. EPA stated in the preamble to the final CDR Rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U. More information is available in our May 13, 2020, blog item.
EPA’s Updated Small Manufacturer Definition Will Apply To CDR Reporting Period Beginning June 1: On May 12, 2020, EPA released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3. EPA notes that the updated definitions will apply to the CDR Rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.
EPA Will Hold Webinar On CDR Requirements On May 19: EPA will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The 2020 CDR submission period is from June 1, 2020, to November 30, 2020. The webinar will include information about the revised reporting requirements, including:
- New requirements for making confidential business information (CBI) claims;
- Reporting refinements related to byproducts, including exemptions;
- Phasing in certain processing and use data codes; and
- Process improvements for reporting co-manufacturing.
The webinar will also introduce the updated e-CDRweb reporting tool. EPA states that although registration is not required, it is preferred.
NGOs Ask EPA To Revise Draft Scope Documents To Comply With TSCA And EPA Regulations: EDF, Earthjustice, NRDC, and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that EPA’s 20 draft scope documents released on April 9 and April 23, 2020, fail to meet TSCA and EPA regulatory requirements. According to EDF’s May 14, 2020, blog item, the NGOs called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require be included, and then make the revised draft scopes available for public comment. More information is available in our May 15, 2020, blog item.
Find B&C’s Updates And Analysis Of Chemical Regulatory Impacts Of COVID-19 In One Place: From new product or new use approvals, to impact on chemical supply chains, B&C monitors key federal and international chemical legislative and regulatory initiatives to keep firm clients and friends informed. We have compiled a comprehensive and frequently updated listing of our content related to the coronavirus crisis that we hope will serve as a useful, one-click source of information: www.lawbc.com/uploads/docs/COVID-19.pdf.
Chemical Distribution In The Time Of COVID-19 — A Conversation With Eric R. Byer, NACD: B&C is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic. Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, TSCA implementation initiatives, and the impact of tariffs on imports from China on NACD member companies. Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD. The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell.”
Special Episode Of NEN Podcast Addresses Resources For Small Businesses Impacted By COVID-19: The Nanotechnology Entrepreneurship Network (NEN) aired a special episode of its podcast on March 31, 2020, “Resources for Small Businesses Impacted by COVID-19: A Conversation with Jennifer Shieh.” The episode features a conversation between Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office (NNCO), and Dr. Jennifer Shieh, Chief Scientist and Program Manager at the U.S. Small Business Administration (SBA). Dr. Shieh discusses the resources available to small businesses impacted by the COVID-19 pandemic.
OSHA Issues Alert Intended To Keep Manufacturing Workers Safe During Coronavirus Pandemic: On April 16, 2020, the Occupational Safety and Health Administration (OSHA) issued an alert listing safety tips employers can follow to help protect manufacturing workers from exposure to coronavirus. According to OSHA, the safety measures include:
- Practicing sensible social distancing and maintaining six feet between co-workers, where possible;
- Establishing flexible work hours (e.g., staggered shifts), if feasible;
- Training workers on how to put on, use/wear, take off, and maintain properly protective clothing and equipment;
- Allowing workers to wear masks over their nose and mouth to prevent spread of the virus;
- Monitoring public health communications about coronavirus recommendations for the workplace and ensuring that workers have access to and understand that information;
- Promoting personal hygiene. If workers do not have access to soap and water for handwashing, provide alcohol-based hand rubs containing at least 60 percent alcohol. Provide disinfectants and disposable towels workers can use to clean work surfaces; and
- Encouraging workers to report any safety and health concerns.
OSHA Will Consider Employer’s Good Faith Efforts When Enforcing Compliance During Coronavirus Pandemic: On April 16, 2020, OSHA announced that it issued interim guidance to advise compliance safety and health officers to evaluate an employer’s good faith efforts to comply with safety and health standards during the coronavirus pandemic. OSHA states that during an inspection, compliance safety and health officers should assess an employer’s efforts to comply with standards that require annual or recurring audits, reviews, training, or assessments. Officers should evaluate if the employer:
- Explored all options to comply with applicable standards (e.g., use of virtual training or remote communication strategies);
- Implemented interim alternative protections, such as engineering or administrative controls; and
- Rescheduled required annual activity as soon as possible.
According to OSHA, employers unable to comply with OSHA requirements because local authorities required the workplace to close should demonstrate a good faith attempt to meet applicable requirements as soon as possible following the re-opening of the workplace. OSHA will take employers’ attempts to comply in good faith into “strong consideration” when determining whether it cites a violation. OSHA may issue a citation if it finds an employer cannot demonstrate any efforts to comply. OSHA states that to ensure corrective actions employers have taken once normal activities resume, it will develop a program to conduct monitoring inspections from a randomized sampling of cases where the agency noted, but did not cite, violations. The interim guidance took effect immediately, and remains in effect until further notice.
NGOs Challenge EPA’s Temporary Enforcement Discretion Policy: On April 16, 2020, a coalition of environmental justice, public health, and public interest NGOs filed suit in the U.S. District Court for the Southern District of New York, challenging EPA’s temporary enforcement discretion policy. The complaint states that EPA’s policy “creates a serious and immediate risk that industrial facilities and other regulated entities will stop monitoring and reporting for compliance with pollution limits, with no contemporaneous notice to EPA or to the public.” According to the complaint, promptly after EPA’s announcement of its new policy, plaintiffs petitioned EPA to publish a rule, on an emergency basis, requiring any entity that stops monitoring and reporting for environmental pollution to provide written notice and justification to EPA, which EPA would then make available to the public. Plaintiffs’ petition requested that EPA publish the rule within seven days and make it effective immediately. Plaintiffs asked EPA to provide public notice and comment on the rule at the same time and amend the rule as appropriate in response to comments. Plaintiffs state that EPA has not responded to the petition to date. Plaintiffs ask the court to order EPA to respond to their petition as soon as possible, and no later than five days from the court’s entry of judgment.
EPA Announces Availability Of COVID-19 Resources For State, Local, And Tribal Governments: On April 17, 2020, EPA announced that it is updating its coronavirus website to include new resources for state, local, and tribal agencies and intergovernmental associations. The update includes important information on grants, enforcement and compliance programs, water infrastructure, and a host of other issues important to effective environmental program delivery. According to EPA, it will update the web page regularly with new information. EPA states that it is also continuing to update resources on its website and add to the list of surface disinfectant products that are effective against SARS-CoV-2.
FDA Issues Emergency Authorized Use For Manufacturers Of Face Masks: The U.S. Food and Drug Administration (FDA) issued on April 18, 2020, an Emergency Use Authorization (EUA) for manufacturers and distributors of face masks in response to the ongoing efforts for prevention of the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In issuing this EUA, FDA is effectively allowing manufacturers and distributors to address well-publicized concerns relating to national personal protective equipment (PPE) shortages for face masks, but only for the general public and health care personnel (HCP) within a specified scope. For more information, please read the full memorandum.
SAB Reviews EPA Research On Large Scale Disinfection Of COVID-19 Virus: On April 20, 2020, EPA announced that EPA Administrator Wheeler requested that the Science Advisory Board (SAB) provide feedback on research needs concerning SARS-CoV-2 (the virus that causes COVID-19). This research is intended to help EPA understand and mitigate the environmental and human health impacts from COVID-19, and identifies EPA research that is already underway as well as new EPA research that has been proposed. EPA issued detailed charge questions for consideration by the SAB on April 21, 2020. EPA requested that any comments on the charge questions be submitted by April 26, 2020. The SAB hosted a public teleconference and audio webcast of the presentation by EPA and the review by SAB on April 30, 2020. For more information, please see our blog.
PHMSA Issues Notices Of Enforcement Discretion: On April 20, 2020, due to the COVID-19 pandemic, the U.S. Department of Transportation (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued the following notices of enforcement discretion:
- Notice of Enforcement Discretion for the Manufacturing of Packaging Designs Beyond Periodic Retesting Dates: PHMSA will not take enforcement action against any company that continues to manufacture a United Nations (UN) performance oriented packaging conforming to a tested design that is not more than 90 days beyond its periodic retest date. Specifically, the relief applies to manufacturers of non-bulk packagings, as well as intermediate bulk containers (IBC), large packagings, and flexible bulk containers. This relief applies only to designs tested and certified for Packing Group (PG) II (Y-marked) or PG III (Z-marked) hazardous materials. PG I (X-marked) designs are not eligible for this enforcement discretion; and
- Notice of Enforcement Discretion for Sanitizing and Disinfecting Products: PHMSA intends to provide temporary relief from certain Hazardous Materials Regulation (HMR) requirements for persons transporting sanitizing and disinfecting materials on a motor vehicle for the purposes of protecting the health and safety of employees (defined herein to include contractors) directly supporting the logistical operations of the carrier. The relief provided is for the highway (motor vehicle) transportation of materials only. Shipments by other modes of transportation must meet all requirements of the HMR unless relief has been provided elsewhere.
EPA Issues Interim Health And Safety Guidelines Related To COVID-19 For Conducting Superfund Site Work: In an April 21, 2020, memorandum, EPA recommends that its field contractor personnel follow the listed practices when conducting site work. The memorandum provides a consolidated list of safety and health best practices developed by EPA’s Office of Land and Emergency Management (OLEM) workgroup members to provide “accurate, timely and consistent safety and health information on topics that may not be adequately addressed in other guidance but could substantially adversely affect agency operations and employees, while responding to incidents and conducting work on Superfund sites or responding to incidents.” EPA notes that the guidelines are not official Agency policy.
EPA Issues Interim Rule Amending Quality-Assurance Requirements For Continuous Emission Monitoring During The COVID-19 National Emergency: On April 22, 2020, EPA issued an interim final rule amending the emissions reporting regulations applicable to sources that monitor and report emissions under the Acid Rain Program, the Cross-State Air Pollution Rule (CSAPR), and/or the Nitrogen Oxides (NOX) State Implementation Plan (SIP) Call. 85 Fed. Reg. 22362. The amendments provide that if an affected unit fails to complete a required quality-assurance, certification or recertification, fuel analysis, or emission rate test by the applicable deadline under the regulations because of travel, plant access, or other safety restrictions implemented to address the current COVID-19 national emergency and if the unit’s actual monitored data would be considered valid if not for the delayed test, the unit may temporarily continue to report actual monitored data instead of substitute data. Sources must maintain documentation, notify EPA when a test is delayed and later completed, and certify to EPA that they meet the criteria for using the amended reporting procedures. EPA states that substitute data must be reported if those criteria are not met or if monitored data are missing or are invalid for any non-emergency-related reason. Units are required to complete any delayed tests as soon as practicable after relevant emergency-related restrictions no longer apply, and the emergency period for which a unit can report valid data under the amendments is limited to the duration of the COVID-19 national emergency plus a grace period of 60 days to complete delayed tests, but no later than the date of expiration of the amendments. According to EPA, this action is necessary to protect on-site power plant operators and other essential personnel from unnecessary risk of exposure to the coronavirus. The amendments do not suspend emissions monitoring or reporting requirements or alter emissions standards under any program, and EPA states that it expects the amendments not to cause any change in emissions levels. The interim rule was effective April 22, 2020. Comments on the interim rule are due May 22, 2020.
EPA Remarks That Requirements To Notify EPA Of Certain Changes To Disinfectants During COVID-19 May Be Retained: On April 22, 2020, Assistant Administrator Alexandra Dapolito Dunn stated, on prerecorded remarks posted by the American Bar Association, that EPA, after the coronavirus crisis subsides, will review whether some of the current requirements to submit notifications or label amendments are necessary. Some of these requirements have been suspended as part of EPA’s efforts to hasten the process for disinfectants approved for use against SARS-CoV-2, which causes COVID-19. EPA modified the requirements to submit a notification or label amendment to increase quickly the number of disinfectants available to fight the novel coronavirus that causes COVID-19. These steps include a temporary policy EPA updated on April 14, 2020, describing situations in which manufacturers producing disinfectants for use against SARS-CoV-2 can change certain ingredients or sources of those ingredients without the normal requirement to notify EPA. EPA will proceed with formal rulemaking or another process if EPA decides to modify the requirements to keep the flexibility currently used during the COVID-19 crisis. More information is available in our blog.
EPA Announces Its Continued Efforts To Provide Critical Information On Safe Disinfectant Use During COVID-19 Crisis: On April 23, 2020, EPA announced it is continuing efforts to provide critical information on surface disinfectant products that can be used against SARS-CoV-2, which causes COVID-19. EPA states that it now has nearly 400 products that have qualified to be effective against SARS-CoV-2. EPA also published an overview of its actions and resources related to disinfection against the novel coronavirus. Additional information on EPA’s disinfectant safety messages is available on EPA’s twitter feeds, @EPA and @ChemSafety. These channels will be updated with new materials throughout the COVID-19 crisis. EPA states it is also continuing to add additional chemicals to its list of common inert ingredients. These actions are intended to help address supply chain issues for EPA-registered disinfectants and other pesticides. It allows manufacturers of already-registered EPA products to change the source of listed inert ingredients. More information is available here.
SAB Convenes COVID-19 Review Panel: On April 23, 2020, EPA announced in a Federal Register notice that the EPA SAB will convene a panel of experts drawn from the Chartered SAB, the SAB Chemical Assessment Advisory Committee (CAAC), and the SAB Drinking Water Committee (DWC) to provide “rapid advice on scientific and technical issues related to the COVID-19 Pandemic and opportunities for current and future EPA research activities that might enhance and inform EPA’s current and any future responses to SARS-CoV-2.” 85 Fed. Reg. 22737. The SAB COVID-19 Review Panel held a public teleconference on April 30, 2020, to conduct a review of EPA’s research activities in response to SARS-CoV-2. The Chartered SAB will hold a public teleconference on May 20, 2020, to review the draft report of the SAB COVID-19 Review Panel.
EPA And CBP Announce The Prevention Of Shipments Of Unregistered “Virus Shut Out” Product Imported Into California: On April 24, 2020, EPA and U.S. Customs and Border Protection (CBP) announced that the agencies prevented a significant number of shipments of illegal health products from entering the Los Angeles International Airport (LAX) and the San Francisco International Airport (SFO). The products at issue were not registered with EPA, including Virus Shut Out products. EPA previously announced on March 25, 2020, that EPA and CBP had prevented several shipments of Virus Shut Out from entering U.S. Pacific Ports. The announcement noted that because the product is not registered, EPA had not evaluated its safety and efficacy against viruses. Additionally, its label does not contain directions for its use in English as required by law, and on-line advertisements for the product contain misleading claims about its safety and effectiveness. Additional information on EPA’s efforts to discover and protect against fraudulent products is available in our blog.
EPA And CDC Release Updated Guidance For Cleaning And Disinfecting Spaces: On April 29, 2020, EPA and the Centers for Disease Control and Prevention (CDC) released updated guidance to give assistance to facility operators and families on how to clean and disinfect spaces properly. Developed in cooperation with the White House, the updated guidance provides step-by-step instructions for public spaces, workplaces, businesses, schools, and homes, and falls in line with the Opening up America Again guidelines, the three-phased approach, based on the advice of public health experts, to help state and local officials when reopening their economies, getting people back to work, and continuing to protect American lives. The comprehensive plan was developed in consultation with EPA’s expertise on the safe and effective use of disinfectants against the SARS-CoV-2, the virus that causes COVID-19. EPA’s guidance documents are available here. For more information, please read our blog.
U.S. District Court Issues Temporary Restraining Order For Silver Products Fraudulently Promoted As A Treatment For COVID-19: On April 29, 2020, the U.S. District Court for the District of Utah issued a temporary restraining order (TRO) to halt the sale of a fraudulent coronavirus (COVID-19) treatment. The U.S. Department of Justice (DOJ) announced the court’s decision in an effort to halt the sale of silver products fraudulently claimed to prevent and cure COVID-19. DOJ filed a civil complaint on April 27, 2020, against defendants Gordon Pedersen of Cedar Hills, Utah, and his companies, My Doctor Suggests LLC and GP Silver LLC. The complaint alleges that defendants began fraudulently promoting and selling various silver products in early 2020 with claims that the silver products would treat and prevent COVID-19. Some of the alleged false and misleading claims made by defendants include that having silver particles in the bloodstream would block the virus from attaching to cells, that silver would “usher” the virus out of the body, and that silver would destroy all forms of viruses and protect against COVID-19.
In another case, DOJ announced on April 17, 2020, that the United States District Court for the Southern District of Florida issued a TRO to halt the sale of an unapproved and potentially dangerous industrial bleach product being marketed as a “miracle” treatment for COVID-19. FDA and the U.S. Federal Trade Commission (FTC) had issued a warning letter to the defendant, Genesis II Church of Health and Healing, on April 8, 2020. FDA and FTC have issued nearly 40 separate warning letters in 2020 to companies selling unapproved or misbranded products with claims to prevent or to treat COVID-19. For more information on these two cases and our commentary, please see our blog.
AIHA Releases “Back-To-Work Safely” Guidelines And Resources: The American Industrial Hygiene Association (AIHA) announced on May 1, 2020, the availability of industry-specific guidelines and resources intended to help employers and employees get back to work safely. Guidelines are available for at-home service providers, retail, restaurant, hair and nail salon, and construction industries, general office settings, gyms and workout facilities, and rideshare, taxi, limo, and other passenger driver-for hire. The guidelines include recommendations on ventilation, personal hygiene, physical distancing, and enhanced cleaning. The guidelines and other resources are available to download on a new website, http://www.backtoworksafely.org. Additionally, COVID-19 resources on PPE and re-entry into the workplace hazards can be found at the AIHA Media Outreach Center.
EPA OIG Will Research And Identify Topics For Potential Audits And Evaluations Related To EPA’s Response To The Coronavirus Pandemic: EPA’s Office of Inspector General (OIG) announced on May 8, 2020, that it plans to initiate a project to research and identify topics for potential audits and evaluations related to EPA’s response to the coronavirus pandemic. The Project Notification states that OIG plans to examine the impact of the coronavirus pandemic on EPA’s programs and operations, regulatory and enforcement missions, and mandated activities, as well as to review measures that EPA has taken to address the coronavirus pandemic. OIG will also assess how, in the face of these impacts, EPA has conducted and is conducting its oversight and programmatic responsibilities to protect public health and the environment. According to OIG, this research will include data gathering and inquiries into areas such as personnel management, EPA programs and operations, regulatory and enforcement missions, human capital, financial management, and information technology operations and security.
FDA Announces Availability Of Guidance Related To Coronavirus Disease 2019: On May 12, 2020, FDA announced the availability of guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency. Due to the emergency, the guidance documents have been implemented immediately without a public comment period, but FDA will consider comments and will revise the documents as needed. In addition, Dr. Stephen M. Hahn, Commissioner of Food and Drugs, testified before the U.S. Senate Committee on Health, Education, Labor and Pensions on May 12, 2020, regarding COVID-19: Safely Getting Back to Work and Back to School.
EPA Announces Additional Procedures To Add New Disinfectant Products To List N And Creates New Web-Based Application Tool For Consumers To Find Disinfectant Products To Use Against SARS-CoV-2: On May 12, 2020, EPA announced additional procedures for registrants to add new disinfectant products to EPA’s List N: Disinfectants for Use Against SARS-CoV-2 that are considered to be safe and effective for use against SARS-CoV-2, the virus that causes COVID-19. EPA states that it intends to expedite reviews of certain Pesticide Registration Improvement Extension Act (PRIA 4) submissions for products intended for use against the SARS-CoV-2. These actions include requests to amend currently registered products that require a review of efficacy data and applications for new pesticide product registrations that would qualify for List N for use against SARS-CoV-2. This process does not replace the review process of all other submitted antimicrobial products. EPA states that it also may consider expedited review of new active ingredients (AI) or new uses for currently registered AIs (including higher application rates, new application methods such as fogging and electrostatic sprayers, or use sites such as porous surfaces). For more information, see our blog.
EPA Seeks Public Comment On Proposed Settlement Agreement Regarding NPDWRs: On April 16, 2020, EPA published a Federal Register notice announcing a proposed settlement agreement that would address several claims in a lawsuit filed by the Waterkeeper Alliance, Inc., Waterkeeper Chesapeake, Inc., and California Coastkeeper in the U.S. District Court for the Southern District of New York. 85 Fed. Reg. 21230. On January 30, 2019, the plaintiffs filed a complaint pursuant to the Safe Drinking Water Act (SDWA) and the Administrative Procedure Act (APA) seeking declaratory and injunctive relief to resolve the claims regarding EPA’s obligations to develop new and revised National Primary Drinking Water Regulations (NPDWR). Under the proposed settlement agreement, EPA would agree to deadlines with respect to certain actions under the SDWA. Under the proposed settlement agreement, EPA would agree to deadlines for: (1) publishing a proposed regulatory determination for at least five contaminants that are listed on the Fourth Contaminant Candidate List (CCL); (2) signing for publication in the Federal Register the Fifth and Sixth CCLs; (3) making a determination as to whether the existing NPDWR for chromium is appropriate for revision; (4) signing for publication in the Federal Register a proposal to revise the NPDWRs for the microbial and disinfection byproducts (MDBP) contaminants identified as candidates for revision in the EPA’s Six-Year Review 3, published on January 11, 2017; and (5) signing for publication in the Federal Register a notice of final action on the proposal to revise the NPDWRs for the MDBPs. If EPA fails to meet any of these deadlines, plaintiffs’ sole remedy under the agreement shall be to reopen this lawsuit after undertaking the informal dispute-resolution procedures. Comments are due May 18, 2020.
EPA Completes Final MATS Supplemental Cost Finding And “Risk And Technology Review”: On April 16, 2020, EPA announced that it completed a reconsideration of the appropriate and necessary finding for the Mercury and Air Toxics Standards (MATS), “correcting flaws in the 2016 supplemental cost finding while ensuring that power plants will emit no more mercury to the air than before.” After primarily considering compliance costs relative to the hazardous air pollutant (HAP) benefits of MATS, EPA states that it is concluding that it is not “appropriate and necessary” to regulate electric utility steam generating units under Section 112 of the Clean Air Act (CAA). EPA is also taking final action on the residual risk and technology review (RTR) required by CAA Section 112. According to EPA, “[t]he results from the RTR show that emissions of HAP have been reduced such that residual risk is at acceptable levels, that there are no developments in HAP emissions controls to achieve further cost-effective reductions beyond the current standards, and, therefore, no changes to the MATS rule are warranted.”
EPA Promulgates Navigable Waters Protection Rule: On April 21, 2020, EPA and the U.S. Department of the Army (Army) promulgated the final Navigable Waters Protection Rule, which defines “waters of the United States” and thereby establishes federal regulatory authority under the Clean Water Act (CWA). 85 Fed. Reg. 22250. In the final rule, the agencies interpret “waters of the United States” to encompass: the territorial seas and traditional navigable waters; perennial and intermittent tributaries that contribute surface water flow to such waters; certain lakes, ponds, and impoundments of jurisdictional waters; and wetlands adjacent to other jurisdictional waters. The final rule also details 12 categories of exclusions, features that are not “waters of the United States,” such as features that only contain water in direct response to rainfall (e.g., ephemeral features); groundwater; many ditches; prior converted cropland; and waste treatment systems. The Navigable Waters Protection Rule is the second step in a two-step process to review and revise the definition of “waters of the United States” consistent with the February 2017 Presidential Executive Order entitled “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the ‘Waters of the United States.’” The final rule will become effective on June 22, 2020, and will replace the Step One Rule published in October 2019.
EPA Amends Regulations For Light-Duty Vehicle GHG Program: On April 23, 2020, EPA published a final rule amending the light-duty vehicle greenhouse gas (GHG) emissions standards regulations that were first promulgated in the 2012 rulemaking that established standards for model years (MY) 2017-2025 light-duty vehicles. 85 Fed. Reg. 22609. First, EPA is correcting regulations pertaining to how auto manufacturers calculate credits for the GHG program’s optional advanced technology incentives. The final rule corrects an error to ensure that auto manufacturers receive the appropriate amount of credits for electric vehicles, plug-in hybrid electric vehicles, fuel cell electric vehicles, and natural gas fueled vehicles. Second, the rule corrects an error in the regulations regarding how manufacturers must calculate certain types of off-cycle credits. EPA states that the corrections “are not expected to result in any additional regulatory burdens or costs.” The rule was effective immediately.
Supreme Court Finds CWA Applies To Some Discharges Into The Ground: On April 23, 2020, the U.S. Supreme Court issued its decision in a case concerning whether discharging a pollutant into the ground where it then travels through groundwater to the Pacific Ocean constitutes discharging a pollutant to navigable waters and requires a permit under the CWA. County of Maui v. Hawaii Wildlife Fund, No. 18-260. In a 6-3 decision, the Court states that a permit is required when there is a discharge from a point source directly into navigable waters or when there is the functional equivalent of a direct discharge. According to the Court, many factors may be relevant to determining whether a particular discharge is the functional equivalent of one directly into navigable waters. The Court states that time and distance will be the most important factors in most cases, but other relevant factors may include the nature of the material through which the pollutant travels and the extent to which the pollutant is diluted or chemically changed as it travels. Courts will provide additional guidance through decisions in individual cases. According to the Court, the underlying statutory objectives can also provide guidance, and EPA can provide administrative guidance. Although this interpretation does not present as clear a line as the other interpretations proffered, the Court notes that EPA “has applied the permitting provision to some discharges through groundwater for over 30 years, with no evidence of inadministrability or an unmanageable expansion in the statute’s scope.” More information is available in our blog entitled “Supreme Court Ruling Sets New Test for Clean Water Act Permitting.”
EPA CAAAC Will Meet May 20: On April 28, 2020, EPA published a Federal Register notice announcing that the Clean Air Act Advisory Committee (CAAAC) will meet May 20, 2020. 85 Fed. Reg. 23518. EPA established the CAAAC to provide independent advice and counsel to EPA on policy issues associated with implementation of the CAA. The CAAAC advises EPA on economic, environmental, technical, scientific, and enforcement policy issues.
EPA And DOT Promulgate Final SAFE Vehicles Rule: On April 30, 2020, EPA and DOT’s National Highway Traffic Safety Administration (NHTSA) published in the Federal Register the final Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule setting corporate average fuel economy (CAFE) and carbon dioxide (CO2) emissions standards for MYs 2021-2026 passenger cars and light trucks. 85 Fed. Reg. 24174. The final rule will increase stringency of CAFE and CO2 emissions standards by 1.5 percent each year through MY 2026, as compared with the standards issued in 2012 that would have required about five percent annual increases. Specifically, EPA is amending CO2 standards for MYs 2021 and later, and NHTSA is amending fuel economy standards for MY 2021 and setting new fuel economy standards for MYs 2022-2026. The final rule withdraws a waiver previously provided to California under the CAA. The final rule will take effect June 29, 2020.
EPA Highlights Enforcement Actions Against Those Who Violate The Defeat Device And Tampering Prohibitions Under The CAA: EPA issued a press release on April 30, 2020, announcing that it has identified numerous companies and individuals who have manufactured and sold both hardware and software specifically designed to defeat required emissions controls on vehicles and engines used on public roads, as well as on nonroad vehicles and engines. EPA states that it has resolved more than 50 cases addressing these types of violations since 2015. EPA highlighted the following cases that have been resolved administratively:
- Freedom Performance, LLC was a major web-based distributor of diesel defeat device products. On February 24, 2020, EPA’s Chief Administrative Law Judge (ALJ) issued a default judgment against Freedom Performance, LLC, ordering a $7.058 million penalty for 13,928 violations of the aftermarket defeat device prohibition of the CAA;
- Spartan Diesel was ordered to pay a $4.1 million penalty for 5,000 violations of the aftermarket defeat device prohibition of the CAA on October 30, 2018, by the ALJ; and
- KT Performance is a Florida-based company that sold and installed approximately 2,833 delete products for diesel-powered trucks between January 2013 and April 2018. EPA filed an administrative complaint against KT Performance for violations of the aftermarket defeat device and tampering prohibitions of the CAA on April 30, 2018. The parties resolved the matter on July 3, 2018. The company was assessed a civil penalty of $52,284 that was calculated based on a demonstrated inability to pay a higher amount.
EPA Extends Comment Period On Preliminary Regulatory Determination For Contaminants On Fourth CCL: EPA published a Federal Register notice on April 30, 2020, announcing that it is extending the comment period on its preliminary regulatory determinations for contaminants on the fourth CCL. 85 Fed. Reg. 23940. EPA is making preliminary determinations to regulate two contaminants (i.e., perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA)) and not to regulate six contaminants (i.e., 1,1-dichloroethane, acetochlor, methyl bromide, metolachlor, nitrobenzene, and Royal Demolition eXplosive (RDX)). EPA seeks comment on these preliminary determinations. Comments are due June 10, 2020.
EPA Proposes To Retain Current PM NAAQS: On April 30, 2020, EPA published a Federal Register notice announcing that based on its review of the air quality criteria and the national ambient air quality standards (NAAQS) for particulate matter (PM), the Administrator has reached proposed decisions on the primary and secondary PM NAAQS. 85 Fed. Reg. 24094. With regard to the primary standards meant to protect against fine particle exposures (i.e., annual and 24-hour PM2.5 standards), the primary standard meant to protect against coarse particle exposures (i.e., 24-hour PM10 standard), and the secondary PM2.5 and PM10 standards, EPA proposes to retain the current standards, without revision. Comments are due June 29, 2020. EPA published a Federal Register notice on May 5, 2020, announcing that it will hold a virtual public hearing on its proposed action on May 20-21, 2020. 85 Fed. Reg. 26634. EPA requests that participants planning to provide oral testimony, as well as those planning to listen to the hearing, register in advance.
PHMSA Amends HMR To Maintain Alignment With International Standards: PHMSA issued a final rule on May 11, 2020, to amend the HMR to maintain alignment with international regulations and standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. 85 Fed. Reg. 27810. According to PHMSA, these revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization’s Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations Recommendations on the Transport of Dangerous Goods — Model Regulations. Additionally, PHMSA is adopting several amendments to the HMR that would allow for increased alignment with the Transport Canada, Transportation of Dangerous Goods Regulations. The rule was effective May 11, 2020, except for instruction 17, which will be effective January 2, 2023.
EPA Will Hold Webinar On Air Quality And Healthy Hearts: Progress And Remaining Challenges: EPA will hold a webinar on May 28, 2020, on “Air Quality and Healthy Hearts: Progress and Remaining Challenges.” EPA states that the webinar will provide an overview of newly published research by EPA scientists and their colleagues that helps fill key knowledge gaps. According to EPA, the findings, published in leading scientific journals, offer new insights into the progress made to protect at-risk individuals with chronic health problems. The research also identifies remaining environmental health challenges, such as determining risks faced from sustained exposure to elevated PM2.5 from wildfire smoke, which is being observed due to more frequent and larger wildland fires in the United States.
Comment Period Extended For Food Standards; General Principles And Food Standards Modernization: FDA on April 20, 2020, announced that it was extending the comment period for the proposed rule entitled “Food Standards: General Principles and Food Standards Modernization” until July 20, 2020. 85 Fed. Reg. 21795. The U.S. Department of Agriculture (USDA) and FDA originally proposed the rule in 2005 as a mechanism to “establish general principles that FDA and USDA would consider when determining whether to establish, revise, or eliminate a food standard.” The comment period for the original rule expired in August of 2005. FDA re-opened the comment period on February 21, 2020.
Modernizing FDA’s Data Strategy Meeting Rescheduled: FDA on April 29, 2020, announced that the public meeting titled “Modernizing FDA’s Data Strategy” is rescheduled to June 30, 2020, and that the comment period has been extended to July 30, 2020. 85 Fed. Reg. 23832. FDA is seeking input on possible approaches for modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. Interested parties should register for the free public meeting by 5:00 p.m. (EDT) on June 26, 2020.
Color Additive Petition For Spirulina Extract: On May 8, 2020, FDA announced that a color additive petition, proposing to amend the color additive regulations in 21 C.F.R. Section 73.530 to expand use of spirulina (Arthrospira platensis) extract in alcoholic beverages, non-alcoholic beverages, condiments and sauces, dips, plant-based products, salad dressings, and seasoning mixes at levels consistent with good manufacturing practice has been submitted. 85 Fed. Reg. 27340. The petition was submitted by GNT USA, Inc.
EUON Publishes Nanopinion On Addition Of Carbon Nanotubes To SIN List: On April 7, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “Carbon Nanotubes — First nanomaterial of high concern on the SIN List.” According to Dr. Anna Lennquist, Senior Toxicologist, International Chemical Secretariat (ChemSec), “[t]he persistence of carbon nanotubes under realistic conditions has been proven,” and, for single-walled carbon nanotubes, “there is evidence of reprotoxic effects.” Lennquist states that with the addition of carbon nanotubes to the SIN List, “we want to show that nanoforms can and should be evaluated as any other chemical substance. Not all nanomaterials are safe, not all are hazardous, but it must be a case-by-case assessment.”
ISO Publishes Standard On Characterization Of Carbon Nanotube Samples Using Thermogravimetric Analysis: The International Organization for Standardization (ISO) has published standard ISO/TS 11308:2020, “Nanotechnologies — Characterization of carbon nanotube samples using thermogravimetric analysis.” The standard provides guidelines for the characterization of carbon nanotube-containing samples by thermogravimetric analysis (TGA), performed in either an inert or oxidizing environment. The standard offers guidance on the purity assessment of the carbon nanotube samples through a quantitative measure of the types of carbon species present, as well as the non-carbon impurities (e.g., metal catalyst particles) within the material.
ISO Publishes Standard On Characterization And Measurement Of Nano-Object-Assembled Layers For Electrochemical Bio-Sensing Applications: ISO has published standard ISO/TS 21412:2020, “Nanotechnologies — Nano-object-assembled layers for electrochemical bio-sensing applications — Specification of characteristics and measurement methods.” The standard specifies the characteristics to be measured of nano-object-assembled layers on electrodes by means of a solution process and of nano-objects constituting the layers for electrochemical applications such as nano-biosensor or diagnosis applications. It also provides measurement methods for determining the characteristics.
EPA Proposes SNUR For Carbon Nanotubes (Generic): On May 4, 2020, EPA published proposed significant new use rules (SNUR) under TSCA for chemical substances that were the subject of premanufacture notices (PMN) and are subject to orders issued by EPA pursuant to TSCA. 85 Fed. Reg. 26419. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. The substances subject to the proposed SNURs include carbon nanotubes (generic). Based on carbon nanotube analogues, data submitted for the PMN substance, and comparison to analogous respirable, poorly soluble particulates, EPA identified concerns for pulmonary toxicity and oncogenicity. The proposed SNUR would designate as a “significant new use” the absence of specified protective measures. Comments on the proposed SNURs are due June 3, 2020. More information is available in our May 4, 2020, blog item.
EUON Publishes Nanopinion On ECETOC’s NanoApp: On May 5, 2020, EUON published a Nanopinion Entitled “Nanoapp Helps Navigate Legal Obligations Under REACH.” Olivier de Matos, Secretary General of the European Center for Ecotoxicology and Toxicology (ECETOC), describes the web-based app that was designed to help registrants follow the European Chemicals Agency’s (ECHA) guidance on sets of nanoforms. According to de Matos, the app primarily covers the “Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification.” de Matos states that the app has established criteria and rules that systematically evaluate the similarity between nanoforms, and on that basis, conclude whether a set of nanoforms can be justified. More information is available in our May 8, 2020, blog item.
WHO Publishes Principles And Methods To Assess Risk Of Immunotoxicity Associated With Exposure To Nanomaterials: On April 12, 2020, the World Health Organization (WHO) published Environmental Health Criteria 244: Principles and methods to assess the risk of immunotoxicity associated with exposure to nanomaterials. WHO states that the document presents an overview of the current knowledge and evidence on principles and basic mechanisms of immunotoxicity caused by engineered nanomaterials (ENM). The document provides guidance on principles and methods for hazard and risk assessment of different ENMs and groups of ENMs on the immunological system in the body; describes the key cell types and elements and the functioning of the human immunological system; and provides information on the effects of various ENMs on these cells and elements of the immune system. It includes case studies on carbon nanotubes and silver nanoparticles to illustrate how the information derived from the application of currently available methods can be structured to assess the hazards in terms of their immunotoxic properties.
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 weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
Senate Committee Gathers Information On America’s Water Infrastructure Act Of 2020 And The Drinking Water Infrastructure Act Of 2020, Passes Bills: The Senate Committee on Environment and Public Works conducted an information-gathering process entitled “An Information-Gathering Process on Draft Legislation entitled, America’s Water Infrastructure Act of 2020 and The Drinking Water Infrastructure Act of 2020: Stakeholder Comments.” On April 21, 2020, the Committee posted drafts of the two bills on its Committee website:
- The America’s Water Infrastructure Act of 2020 (S. 3591) includes approximately $17 billion in new federal authorizations. It will support economic competitiveness by increasing water storage, providing protection from dangerous floodwaters, deepening nationally significant ports, and maintaining the navigability of inland waterways across the country. It will also repair aging wastewater and irrigation systems; and
- The Drinking Water Infrastructure Act of 2020 (S. 3590) includes approximately $2.5 billion in federal authorizations. It reauthorizes programs under the SDWA to provide resources and technical assistance to communities to help meet their drinking water needs.
On April 22, 2020, the Committee began electronically accepting written statements from five invited stakeholders. On May 1, 2020, the Committee accepted written responses to questions submitted by Committee members to five invited stakeholders. On May 1, 2020, the Committee began electronically accepting written comments submitted by other stakeholders. On May 6, 2020, the Committee unanimously passed the bills as amended. The amendments include language added to S. 3590 directing EPA to develop a national drinking water standard for perfluoroalkyl and polyfluoroalkyl substances (PFAS).
Legislation Would Prohibit Implementation Of Navigable Waters Protection Rule: On May 8, 2020, Chair of the House Committee on Transportation and Infrastructure Peter DeFazio (D-OR) introduced the Clean Water for All Act, which would prohibit the implementation of the Navigable Waters Protection Rule, “the most draconian rollback of clean water protections in the history of the Clean Water Act.” DeFazio’s May 8, 2020, press release states that in addition, the bill would require EPA and the U.S. Army Corps of Engineers to develop a new regulation to protect rivers, streams, and wetlands “that is based on the best available science, and whose implementation will not degrade water quality, contaminate drinking water, or increase local flood-related risks.”
Murder Hornet Eradication Act Would Direct Funding To States For Eradication Programs, Impacted Bee Colony Restoration: On May 8, 2020, Representative Raúl M. Grijalva (D-AZ), Chair of the House Natural Resources Committee, introduced the Murder Hornet Eradication Act, which would direct new funding to states to eradicate the Asian giant hornet and restore bee populations the invasive species has already damaged. The bill would require the Secretary of the Interior to establish a grant program to provide financial assistance to states to eradicate the hornet. According to Grijalva’s May 8, 2020, press release, the bill is modeled on the Nutria Eradication and Control Act of 2003, which the House voted to update last year.
Energy Infrastructure Act Would Boost Protections For Critical Electric Infrastructure: On May 12, 2020, Senators Lisa Murkowski (R-AK), Chair of the Energy and Natural Resources Committee, and James Risch (R-ID) introduced the Energy Infrastructure Protection Act to boost protections for critical electric infrastructure. The bill would update provisions in the Federal Power Act and restrict federal disclosures of certain sensitive energy information. According to the Committee’s May 12, 2020, press release, the Department of Energy (DOE) and the Federal Energy Regulatory Commission (FERC) currently protect information received from utilities. The Energy Infrastructure Protection Act would enhance those protections through provisions that:
- Direct DOE and FERC to improve methods to protect critical energy information;
- Grant explicit authority to DOE and FERC to help energy companies improve security; and
- Allow federal, state, and local authorities to request that their own critical energy information be protected under special designation by DOE or FERC.
Senate Committee Will Hold EPA Oversight Hearing: On May 20, 2020, the Senate Committee on Environment and Public Works will hold a full committee hearing on“Oversight of the Environmental Protection Agency.”
EPA Extends Comment Period On Supplement To Proposed Rule On Strengthening Transparency In Regulatory Science: On April 17, 2020, EPA published a Federal Register notice extending the comment period on its supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule. 85 Fed. Reg. 21340. Comments are due May 18, 2020. More information on the SNPRM is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”
SAB Publishes Report On Proposed Rule On Strengthening Transparency In Regulatory Science: On April 24, 2020, SAB submitted a report to EPA on its consideration of the scientific and technical basis of the proposed rule on strengthening transparency in regulatory science. The report states that SAB finds that key considerations that could inform the proposed rule are not present or presented without analysis and explanation of scope. In addition, according to the report, certain key terms and implementation issues have not been adequately defined or described. To provide clarity on the procedures for conducting the proposed efforts, SAB “strongly encourages the development of additional policy and/or guidance documents.” In addition, SAB has concerns about the scientific and technical challenges of implementing some requirements of the proposed rule.
SAB Economic Guidelines Review Panel Will Meet In May And June: EPA published a Federal Register notice on May 1, 2020, announcing that the SAB’s Economic Guidelines Review Panel will meet May 18, 2020, May 21, 2020, May 26, 2020, and June 9, 2020. 85 Fed. Reg. 25435. The purpose of the meetings is to conduct a peer review of EPA’s revised document entitled “Guidelines for Preparing Economic Analyses” and to develop a report responsive to charge questions on the revised document. EPA relies on the Guidelines when evaluating the economic consequences of its regulations and policies. The Office of Policy, with input from other EPA economists, has been working to improve the Guidelines by updating and revising selected chapters as appropriate, many of which have not been revisited since 2010.
GAO Priority Recommendations For EPA Include Assessing And Controlling Toxic Chemicals: On May 5, 2020, the U.S. Government Accountability Office (GAO) released a report updating its open priority recommendations for EPA. According to GAO, in April 2019, it identified 17 priority recommendations for EPA. Since then, EPA has implemented three of those recommendations by, among other things, assessing established timeframes for each step in the Integrated Risk Information System (IRIS) process and publishing current information about chemicals being assessed. In its April 2020 report, GAO identified seven additional priority recommendations for EPA, concerning management of climate change risk and ensuring cybersecurity at EPA, bringing the total number of open priority recommendations to 21. GAO’s recommendations involve the following areas:
- Assessing and controlling toxic chemicals;
- Reducing pollution in the nation’s waters;
- Ensuring cybersecurity at EPA;
- Addressing data, funding, and cybersecurity issues for drinking water and wastewater infrastructure; and
- Managing climate change risks.
More information on GAO’s open priority recommendations for EPA is available in our full memorandum.
OEHHA Updates And Expands CalEcotox Database For Ecological Risk Assessments: The California Office of Environmental Health Hazard Assessment (OEHHA) announced on May 8, 2020, the availability of its newly updated and expanded CalEcotox database — a data retrieval tool for risk assessors conducting ecotoxicological risk assessments. Data contained in CalEcotox include physiological and ecological parameters and toxicity data for over 90 terrestrial mammals, birds, reptiles, and amphibians, as well as one fish species. According to OEHHA, these species were selected based on a variety of factors, with a focus on utility for risk assessments conducted in California. OEHHA states that the new user interface “allows for easy retrieval and export of data, filtered by species, toxicity or exposure endpoints, chemical, or location.”
EPA “Aggressively Working” To Increase Research And Understand PFAS: EPA announced on May 13, 2020, that it is building on the work outlined in its February 2019 PFAS Action Plan to expand its research efforts and capabilities by launching the PFAS Innovative Treatment Team (PITT). According to EPA, PITT “is a dedicated and full-time team that brings together a multi-disciplined research staff that will concentrate their efforts and expertise on a single problem: how to remove, destroy, and test PFAS-contaminated media and waste.” EPA states that PITT will operate in a work environment designed to break down administrative and procedural barriers in an effort to facilitate faster results. Over the next few months, PITT will work to achieve the following goals:
- Assess current and emerging destruction methods being explored by EPA, universities, other research organizations, and industry;
- Explore the efficacy of methods while considering byproducts to avoid creating new environmental hazards; and
- Evaluate methods’ feasibility, performance, and costs to validate potential solutions.
According to EPA, the results of the research project are expected later this year.
OECA Publishes Criminal Enforcement Case Bulletin Update For February Through March 2020: EPA published on May 14, 2020, the Environmental Crimes Case Bulletin for February 2020 through March 2020. The bulletin summarizes publicized investigative activity and adjudicated cases conducted by EPA’s Office of Criminal Enforcement, Forensics and Training (OCEFT) Criminal Investigation Division special agents, forensic specialists, and legal support staff. OCEFT investigates violations of environmental laws and provides a broad range of technical and forensic services for civil and criminal investigative support and council on legal and policy matters.
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.