Federal Development Update for July 2020


We announce with sadness that our colleague, Dr. Joseph E. Plamondon, passed away on July 7, 2020. As many in the Toxic Substances Control Act (TSCA) community know well, Joe was renowned in the industrial chemical community for his work on TSCA matters, his presentations at professional events, his extensive writing on chemical regulatory matters, and his wealth of experience across this regulatory arena. For those clients and friends who knew Joe or had occasion to work with him, you had the opportunity to appreciate that his commitment to excellence and passion for TSCA and chemistry were without limit. All of us at Bergeson & Campbell respected Joe’s skill, his professionalism, his enthusiasm for complicated TSCA issues, and his many technical writings on the subject.

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CDR Cross-Check™: Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold.

CDR Cross-Check will identify:

  • Whether the chemical is listed as active or inactive;
     
  • Whether the chemical was subject to specific TSCA regulatory actions in 2016;
     
  • Whether the chemical is exempt; and
     
  • What the reporting thresholds are based on the updated data released by the U.S. Environmental Protection Agency (EPA) on May 29, 2020.
     

Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.

TSCA Tutor® Complimentary Enrollment: Clients and friends who have enrolled in TSCA Tutor courses have confirmed their usefulness and value. There are online/on-demand courses with in-depth training on all of the provisions of TSCA applicable to companies making and using chemicals, including courses on CDR, Confidential Business Information (CBI), and Section 6 Risk Evaluations -- three topics of high current interest.

To give our clients and friends an opportunity to enroll in a full class and preview all 12 courses, during July, B&C is offering complimentary registration for “An Overview of TSCA,” the first course in the series. Visit https://tscatutor.thinkific.com/courses/t101-an-overview-of-tsca to enroll, using the coupon code “FreeJuly2020” at checkout. This coupon code must be used by July 31, 2020.

TSCA/FIFRA/TRI

Available On-Demand: “TSCA Reform -- Four Years Later” Virtual Seminar: On June 24, 2020, B&C, The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Four Years Later.” A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA), and comments by the Hon. John Shimkus, U.S. Representative, 15th District of Illinois, is available to watch now.

This complimentary all-day virtual seminar marked the fourth TSCA Annual Conference, with top EPA officials and industry leaders reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists covered “TSCA Implementation: Where Are We Now?,” “Science Policy Issues,” and “Regulatory and Policy Issues” while offering unique insights into the decision-making process of EPA.

Building on the timely information shared during this event, B&C’s All Things Chemical™ podcast has released an exclusive interview with Alexandra Dunn focusing on the current state of TSCA, “TSCA at Four — A Conversation with Alexandra Dunn, OCSPP AA.” Lynn L. Bergeson and Alexandra Dunn focused their discussion on the implementation of the amendments to TSCA, which Congress enacted in 2016. As pollution prevention is an integral part of EPA’s mission, this episode also focuses on initiatives under way to introduce safer and greener chemicals. Finally, the discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.

Lynn L. Bergeson, Charles M. Auer, And Richard E. Engler, Ph.D., “What Lies Ahead for The Next Four Years Of TSCA?,” Chemical Watch, July 14, 2020: The Frank R Lautenberg Chemical Safety for the 21st Century Act is four years old. While to some June 22, 2016, seems like yesterday, the past four years have been transformational. EPA has worked hard, been timely, and done well in thoughtfully implementing the changes. Rather than look back, this article looks forward to the next four years and speculates on some of the many challenging topics EPA and other TSCA stakeholders are likely to address. A PDF of this article is available for download here.

Industry Associations Petition EPA To Develop Risk Management Procedural Rule Under TSCA: On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce filed a petition under TSCA Section 21 requesting that EPA develop a risk management procedural rule under TSCA Section 6. According to the petition, such a rule is necessary to implement the Lautenberg Act amendments. The petitioners note that the prioritization and risk evaluation framework rules “serve an essential role to guide affected stakeholders through these new processes.” The petitioners request a TSCA Section 6 rulemaking to establish a similar degree of procedural consistency, guidance, and transparency for EPA’s risk management process. EPA has 90 days from filing to grant or deny the petition. If EPA grants the petition, EPA must promptly commence an appropriate proceeding in accordance with TSCA Section 6. If EPA denies the petition, it must publish its reasons for the denial in the Federal Register and petitioners can challenge that decision in accordance with TSCA Section 21(b)(4). More information is available in our July 10, 2020, memorandum.

Trial Concludes In Challenge To EPA’s Denial Of Fluoride Petition: During the week of June 15, 2020, the U.S. District Court for the Northern District of California heard from EPA’s final three witnesses: Dr. Joyce Tsuji, Dr. Ellen Chang, and Dr. Tala Henry. Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162-EMC. Plaintiffs’ closing argument asserted that EPA failed to quantify what fluoride levels were dangerous to humans. EPA responded in its closing that studies relied on by plaintiffs are limited by confounding variables, lack of comparison groups, and double-blind methodologies. Additionally, EPA noted inconsistencies among the reports plaintiffs cited. After hearing closing arguments, Judge Chen noted that the evidence presented by both parties was not confined to the administrative record and that he allowed both parties to use evidence that was available after plaintiffs filed their petition in 2016. Judge Chen asked plaintiffs and EPA to consider how to reach an agreement, including plaintiffs submitting a new petition or EPA reconsidering its denial of the petition. Pending Judge Chen’s request for additional briefing, there was no ruling on what could potentially be the first half of a bifurcated trial. A status conference is tentatively scheduled for August 6, 2020, at 10:30 a.m. (PDT). More information is available in our June 22, 2020, blog item.

EPA Begins Public Comment Period For Manufacturer-Requested Risk Evaluation For D4: On June 17, 2020, EPA requested public comment on a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in personal care products. 85 Fed. Reg. 36586. EPA encourages commenters to identify any information not included in the request that the commenters believe would be needed to conduct a risk evaluation, and to provide any other information relevant to EPA’s possible additional conditions of use, such as information on other conditions of use of the chemical substance than those included in the request or in EPA’s possible additional conditions of use. Comments are due August 3, 2020.

EPA Publishes Receipt And Status Information For Certain New Chemicals: On June 18, 2020, EPA published a notice pertaining to submissions under TSCA Section 5, including notice of receipt of a premanufacture notice (PMN), significant new use notice (SNUN), or microbial commercial activity notice (MCAN), including an amended notice or test information; an exemption application (Biotech exemption); an application for a test marketing exemption (TME), both pending and/or concluded; a notice of commencement (NOC) of manufacture (including import) for new chemical substances; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review. 85 Fed. Reg. 36844. The notice covers the period from May 1, 2020, to May 31, 2020. Comments identified by the specific case number provided in the notice are due July 20, 2020.

EPA Adds 172 PFAS To List Of TRI Chemicals: On June 22, 2020, EPA published a final rule that adds 172 per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA). 85 Fed. Reg. 37354. EPA also set a manufacture, processing, and otherwise use reporting threshold of 100 pounds for each PFAS being added to the list. The rule was effective immediately.

EPA Proposes Rule Intended To Protect Children From Exposure To Lead-Contaminated Dust: On June 24, 2020, EPA published a proposed rule intended to protect children better from the harmful effects of lead exposure after lead removal activities. 85 Fed. Reg. 37810. The proposed rule would lower the amount of lead that can remain in dust on floors and windowsills after lead removal activities (the dust-lead clearance levels (DLCL)) from 40 micrograms (µg) of lead in dust per square foot (ft2) to 10 µg/ft2 for floor dust and from 250 µg/ft2 to 100 µg/ft2 for window sill dust. EPA notes that it has not proposed to revise the DLCL for window troughs at this time and that the proposed revisions would not apply retroactively. Comments on the proposed rule are due August 24, 2020.

EPA NAM Work Plan Intends To Reduce Use Of Animals In Chemical Testing: On June 24, 2020, EPA released a New Approach Methods (NAM) Work Plan that will “serve [] as a roadmap for meeting its animal testing reduction goals set forth in Administrator Andrew Wheeler’s 2019 Directive.” According to EPA’s June 24, 2020, press release, the Work Plan describes how EPA plans to develop, test, and apply chemical safety testing approaches that reduce or replace the use of animals. EPA states that compared to traditional animal testing, NAMs allow researchers better to predict potential hazards for risk assessment purposes without the use of traditional methods that rely on animal testing. The objectives of the Work Plan include: evaluating regulatory flexibility for the use of NAMs; establishing baselines and metrics for assessing progress; developing NAMs that fill critical information gaps; establishing scientific confidence in NAMs; demonstrating NAMs application to regulatory decisions; and engaging with stakeholders to incorporate their knowledge and address their concerns regarding EPA’s phaseout of mammalian testing.

Final Risk Evaluation For Methylene Chloride Is First Completed Under Lautenberg Act Amendments: On June 24, 2020, EPA announced the availability of the final TSCA risk evaluation for methylene chloride. 85 Fed. Reg. 37942. This is the first risk evaluation that EPA has completed under the Lautenberg Act amendments to TSCA. After evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk. EPA also determined that methylene chloride does not present an unreasonable risk to the environment under the conditions of use. In its June 19, 2020, press release, EPA notes that the next step in the process required by TSCA is addressing the identified risks. According to EPA, there are several actions it could take to address these risks, including regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical substance, as applicable. EPA will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions. EPA states that as with any chemical product, it “strongly recommends that users continue to carefully follow all instructions on the product’s label/safety data sheet.” More information on the final risk evaluation for methylene chloride is available in our June 25, 2020, memorandum.

EPA Unconditionally Registers New Nanosilver Product For Antimicrobial Use On Textiles: On July 2, 2020, EPA announced that it has registered NSPW Nanosilver (a new nanosilver formulation) to suppress odor-causing bacteria and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles. Textiles that may be treated with NSPW Nanosilver include fabrics, sportswear, footwear, linens, and awnings. NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard). The same type of nanosilver was the active ingredient in another product that EPA previously conditionally registered under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(7)(C) in 2015. The U.S. Court of Appeals for the Ninth Circuit issued a decision vacating that conditional registration because the court concluded that the mandatory public interest finding by EPA was not adequately supported by the administrative record. See our blog entitled “Appellate Court Vacates Conditional Nanosilver Registration.” According to EPA, the new registration for NSPW Nanosilver involves a modified use pattern that will limit exposures compared to the product that received the previously vacated conditional registration. Based on additional data that the applicant has submitted to support the use pattern as modified, EPA has prepared an updated risk assessment for NSPW Nanosilver and has determined based on that risk assessment that the product as modified meets the standard for an unconditional registration under FIFRA Section 3(c)(5). Materials supporting this action will be posted in Docket ID EPA-HQ-OPP-2020-0043. More information and our commentary on the new registration for NSPW Nanosilver is available in our July 6, 2020, Pesticide Law and Policy Blog®.

EPA Will Hold Public Workshop On Laminated Products-Formaldehyde Emission Standards For Composite Wood Products: On July 7, 2020, EPA announced that it will hold a public workshop on September 8, 2020, to discuss the laminated product provisions and the rulemaking petition for exemption from the definition of hardwood plywood in the 2016 formaldehyde emission standards for composite wood products final rule. 85 Fed. Reg. 40643. According to EPA, the workshop will aid with informing potential development of future guidance for petitioning EPA for an exemption under the final rule. EPA states that the primary audience is Third Party Certifiers (TPC), panel producers, and fabricators or laminated product producers who contract with TPCs to certify composite wood products under the 2016 final rule. The workshop is also open to the general public. Registration is now open and must be completed by August 31, 2020. Written comments that participants would like to be considered during the workshop should be submitted by August 24, 2020. EPA will also accept written comments and materials submitted after the conclusion of the workshop until November 4, 2020.

2019 TRI Preliminary Data Coming “Soon”: On July 8, 2020, EPA announced that it plans to publish the initial preliminary Toxics Release Inventory (TRI) data for calendar year 2019 later in July 2020. The data will be about chemical releases, waste management, and pollution prevention activities that took place during 2019 at more than 20,000 federal and industrial facilities across the country. According to EPA, stakeholders can use these data to identify how many facilities that report to TRI operate in a certain geographic area and where they are located; and learn which chemicals facilities are managing and in what quantities. These preliminary data will be available in two ways: by going to EPA’s Envirofacts website and searching for a specific location, industry sector, or facility; and by downloading data files that can be opened using Excel or another spreadsheet application.

EPA Corrects TRI Reporting Requirements: EPA published a final rule on July 14, 2020, that corrects existing regulatory language for the TRI Program. 85 Fed. Reg. 42311. EPA states that it is making corrections that update identifiers, formulas, and names for certain TRI-listed chemicals, and updating the text that identifies the chemicals to which the 0.1 percent de minimis concentration applies to remedy a cross-reference to a no-longer accurate Occupational Safety and Health Administration (OSHA) regulatory citation. EPA notes that the corrections maintain previous regulatory actions and do not alter existing reporting requirements or impact compliance burdens or costs. The final rule was effective July 14, 2020.

COVID-19

OSHA Issues Guidance As Non-Essential Businesses Reopen And Employees Return To Work: On June 18, 2020, OSHA announced that it issued guidance intended to assist employers reopening non-essential businesses and their employees returning to work during the evolving coronavirus pandemic. OSHA states that non-essential businesses should reopen as state and local governments lift stay-at-home or shelter-in-place orders and follow public health recommendations from the Centers for Disease Control and Prevention (CDC) and other federal requirements or guidelines. According to OSHA, employers should continue to consider ways to use workplace flexibilities, such as remote work and alternative business operations, to provide goods and services to customers. OSHA recommends that employers continually monitor federal, state, and local government guidelines for updated information about ongoing community transmission and mitigation measures, as well as for evolving guidance on disinfection and other best practices for worker protection.

NIOSH Publishes Hazard Communication For Disinfectants Used Against Viruses: On June 23, 2020, the National Institute for Occupational Safety and Health (NIOSH) published a web page entitled “Hazard Communication for Disinfectants Used Against Viruses: Health Hazards and Protective Measures.” The page provides information about the health hazards that could be caused by cleaning products and disinfectants and the recommended barrier and respiratory protection workers can use to protect themselves from these hazards. The information, focusing on worker safety, supplements existing CDC guidance for disinfection of viruses. CDC intends the information to be used by employers and workers who use cleaning products and disinfectants, specifically those identified as effective against viruses, including avian (bird) flu, Ebola, and SARS-CoV-2 (the virus that causes COVID-19).

Senate Committee Holds Hearing On Impact Of COVID-19 On Mineral Supply Chains: On June 24, 2020, the Senate Committee on Energy and Natural Resources held a hearing to examine the impact of COVID-19 on mineral supply chains, the role of those supply chains in economic and national security, and challenges and opportunities to rebuild America’s supply chains. Witnesses included: Dr. Nedal Nassar, Chief, Materials Flow Analysis Section, National Minerals Information Center, U.S. Geological Survey (USGS); Mr. Joe Bryan, Senior Fellow, Atlantic Council Global Energy Center; Mr. Mark Caffarey, President, Umicore USA, Inc.; Dr. Thomas J. Duesterberg, Senior Fellow, Hudson Institute; and Mr. Simon Moores, Managing Director, Benchmark Mineral Intelligence.

EPA’s Temporary Enforcement Policy Will End August 31: On June 29, 2020, EPA issued a memorandum announcing an “addendum on termination” to its March 26, 2020, COVID-19 temporary enforcement policy. The memorandum notes that as states and businesses begin to reopen, there will be a period of adjustment as regulated entities plan how to comply with environmental legal obligations and with public health guidance from CDC and other agencies regarding actions intended to stem the transmission and spread of COVID-19. The memorandum states “it is now appropriate to expressly include a provision in the temporary policy that covers termination of the temporary policy, and to make such changes to the policy as are needed to reflect the impact of the changing circumstances on facility operations, worker shortages, and other constraints caused by the public health emergency.” For more information, please read the full memorandum.

OSHA Publishes FAQs Intended To Keep Workers Safe During Coronavirus Pandemic: On July 2, 2020, OSHA published frequently asked questions (FAQ) intended to provide guidance to employers and employees about topics such as the best practices to prevent the spread of infection during the coronavirus pandemic, workers’ rights to express concerns about workplace conditions, testing for the coronavirus, worker training, and returning to work.

EPA Announces Approval Of First Surface Disinfectant Products Tested On SARS-CoV-2: On July 6, 2020, EPA announced that it approved amended labels for two products, Lysol Disinfectant Spray (EPA Reg. No. 777-99) and Lysol Disinfectant Max Cover Mist (EPA Reg. No. 777-127), based on laboratory testing that shows the products are effective against SARS-CoV-2. These are the first products for which EPA has reviewed laboratory testing data and approved label claims against SARS-CoV-2. EPA updated the entries for the two Lysol products on List N to indicate they have now been tested directly against SARS-CoV-2. This is significant since they are the first List N products for which EPA has reviewed laboratory testing data specifically against SARS-CoV-2, and not listed based on EPA’s determination that a product can be used against SARS-CoV-2 because of the product’s effectiveness against a harder-to-kill virus. EPA states that it expects to approve such claims for additional List N products in the coming weeks. More information is available in our July 7, 2020, blog.

EPA Announces Research Studying The Potential Long-Lasting Effectiveness Of Disinfectants Against SARS-CoV-2: On July 7, 2020, EPA announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19. This research is being conducted at EPA’s Office of Research and Development’s (ORD) Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the high touch points in mass transit trains and stations. EPA states that it is working directly with New York’s Metropolitan Transportation Authority, North America’s largest transportation network, on evaluating EPA-registered antimicrobial products across New York City Transit to determine their ability to provide effective anti-virus protection over time. EPA states that it will make the results of this research available to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time. Additional information on EPA’s research on COVID-19 in the environment is available here. More information is available in our blog.

EPA Releases Financial Impact Tool Intended To Help Water Utilities: On July 8, 2020, EPA announced that it released a new tool to help water utilities assess the financial impact of COVID-19 on operations. EPA notes that throughout the COVID-19 national health emergency -- and as communities across the country reopen -- water utilities have reliably provided safe drinking water and critical wastewater services. Developed by EPA’s Water Infrastructure and Resiliency Finance Center, the Water Utility COVID-19 Financial Impact Tool leads water utilities through a series of questions that can determine how their revenues, expenses, and cash flow have been affected. EPA states that the tool will help water utilities understand their own financial health as they plan for ongoing operation and maintenance and capital infrastructure needs, including implementing plans to repair, replace, and modernize aging infrastructure.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Grants Petitions To Add 1-BP To List Of HAPs: On June 18, 2020, EPA announced that it is granting petitions to add n-propyl bromide (nPB), commonly known as 1-bromopropane (1-BP), to the list of hazardous air pollutants (HAP) contained in the Clean Air Act (CAA). 85 Fed. Reg. 36851. EPA states that it is taking final action to grant these petitions based on the petitioners Halogenated Solvents Industry Alliance and New York State Department of Environmental Conservation having met the requirements contained in CAA Section 112(b)(3), which allows any person to petition the Administrator to add a substance to the list of HAPs. EPA notes that this is the first occasion on which it is granting petitions to add a substance to the list of HAPs that Congress created in 1990. According to the notice, EPA will take a separate regulatory action to add 1-BP to the list of HAPs under CAA Section 112(b)(1). The petitions were granted as of June 18, 2020.

EPA Issues Final Action For Perchlorate In Drinking Water: On June 18, 2020, EPA announced that it issued a final action regarding the regulation of perchlorate under the Safe Drinking Water Act (SDWA). Considering the best available science and the proactive steps that EPA, states, and public water systems have taken to reduce perchlorate levels, EPA states that it determined that perchlorate does not meet the criteria for regulation as a drinking water contaminant under the SDWA. Therefore, EPA withdrew the 2011 regulatory determination and has made a final determination not to issue a national regulation for perchlorate. According to EPA, the main factors contributing to the decrease in perchlorate levels include drinking water regulations for perchlorate in Massachusetts and California; federal and state remediation activities at perchlorate contaminated sites, particularly the ongoing remediation efforts in the state of Nevada to address perchlorate contamination in groundwater adjacent to the lower Colorado River upstream of Lake Mead; and improved procedures for storage and handling of hypochlorite solutions used as drinking water disinfectants. EPA notes that it also performed a new health impact analysis based on recommendations from the Science Advisory Board (SAB). The new analysis shows that the concentrations at which perchlorate may present a public health concern are higher than the concentrations considered in the 2011 regulatory determination.

EPA Extends Comment Period For Proposed Rulemaking “Increasing Consistency And Transparency In Considering Benefits And Costs In The Clean Air Act Rulemaking Process”: On June 19, 2020, EPA extended the comment period on its June 11, 2020, proposed rulemaking “Increasing Consistency and Transparency in Considering Benefits and Costs in the Clean Air Act Rulemaking Process.” 85 Fed. Reg. 37057. Comments are due August 3, 2020. EPA held a virtual public hearing on the proposed rulemaking on July 1, 2020, to provide interested parties the opportunity to present data, views, or arguments concerning EPA's proposed requirements for benefits and costs analyses for CAA rulemakings. According to EPA’s June 4, 2020, press release, the final rule “will codify best practices for benefit-cost analysis in rulemaking, and provide clarity for states, local communities and industry regarding EPA’s rulemaking considerations.” The fact sheet states that the proposed regulation consists of three main requirements: EPA will prepare a benefit-cost analysis (BCA) for all future significant proposed and final regulations under the CAA; the BCA should be developed in accordance with best practices from the economic, engineering, physical, and biological sciences; and EPA must increase transparency in the presentation of the benefits resulting from significant CAA regulations.

EPA Publishes Final Rule For NESHAP For Cellulose Products Manufacturing: On July 2, 2020, EPA published a final rule regarding the residual risk and technology review (RTR) conducted for the Miscellaneous Viscose Processes and Cellulose Ether Production source categories regulated under the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Cellulose Products Manufacturing. 85 Fed. Reg. 39980. EPA states that it is adopting as final its proposed determination that the risks from both source categories are acceptable and that the current NESHAP provides an ample margin of safety to protect public health. EPA identified no new cost-effective controls under the technology review to achieve further emissions reductions. The final amendments address emissions during startup, shutdown, and malfunction (SSM) events; add electronic reporting requirements; add provisions for periodic emissions performance testing for facilities using non-recovery control devices; add a provision allowing more flexibility for monitoring of biofilter control devices; and make technical and editorial changes. The final rule was effective July 2, 2020.

EPA Publishes Final Rule For NESHAP For OLD Source Category: On July 7, 2020, EPA published a final rule regarding the RTR conducted for the Organic Liquids Distribution (Non-Gasoline) (OLD) source category regulated under NESHAP. 85 Fed. Reg. 40740. EPA is issuing final amendments to the storage tank requirements as a result of the RTR; taking final action to correct and clarify regulatory provisions related to emissions during periods of SSM; add requirements for electronic reporting of performance test results and reports, performance evaluation reports, compliance reports, and Notification of Compliance Status (NOCS) reports; add operational requirements for flares; and make other minor technical improvements. The final rule was effective July 7, 2020. EPA published corrections in a July 10, 2020, Federal Register notice. 85 Fed. Reg. 41411.

EPA Calls For Information For Integrated Science Assessment For Lead: On July 7, 2020, EPA announced that it is preparing an Integrated Science Assessment (ISA) as part of the review of the primary and secondary National Ambient Air Quality Standards (NAAQS) for lead. 85 Fed. Reg. 40641. ORD’s Center for Public Health and Environmental Assessment (CPHEA) will complete the ISA. EPA states that when final, the ISA is intended to update the previous lead ISA (EPA/600/R-10/075F), published on June 26, 2013. EPA invites interested parties to assist in developing and refining the scientific information base for the review of the lead NAAQS by submitting research studies and data that have been published, accepted for publication, or presented at a public scientific meeting since January 1, 2011. Information is due to EPA by September 8, 2020.

EPA Proposes Amendments To The 2013 NESHAP For Industrial, Commercial, And Institutional Boilers And Process Heaters: On July 9, 2020, EPA announced that it will propose amendments to the 2013 NESHAP for Industrial, Commercial, and Institutional Boilers and Process Heaters. According to EPA, these amendments would further reduce toxic emissions from certain types of units and represent continued clean air progress made by the Trump Administration. The 2013 rule established emission standards for categories of boilers based on the maximum achievable control technologies (MACT). EPA notes that the proposed updated standards address deficiencies identified by the U.S. Court of Appeals for the D.C. Circuit and align them with CAA requirements. In response to the three remands, EPA is proposing: to revise 34 (of 90) emission limits for certain types of new and existing boilers; an updated rationale for using carbon monoxide (CO) as a surrogate for controlling organic HAPs; and an updated rationale for its original determination that setting a CO standard below 130 parts per million (ppm) would not provide any additional organic HAP reduction. EPA states that the proposed amendments would continue to reduce emissions of HAPs, including mercury, formaldehyde, benzene, and polycyclic organic matter. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

EPA Publishes Final Rule For Site Remediation NESHAP: On July 10, 2020, EPA published a final rule regarding the RTR conducted for the Site Remediation NESHAP source category. 85 Fed. Reg. 41680. EPA is issuing a final determination that risks due to emissions of air toxics from site remediation sources are acceptable and that no revision to the standards is required to provide an ample margin of safety to protect public health. EPA states that based on the results of its technology review, it is promulgating the proposed changes to the leak detection and repair (LDAR) program. In addition, EPA is making final amendments to revise regulatory provisions pertaining to emissions during periods of SSM, including final work practice requirements for pressure relief devices (PRD) and the 240-hour maintenance period for control devices on tanks. The final rule includes requirements for electronic submittal of semiannual reports and performance test results. Finally, it makes minor clarifications and corrections. The final rule was effective immediately.

EPA Publishes CWA Section 401 Certification Rule: EPA published a final rule on July 13, 2020, to update and clarify the substantive and procedural requirements for water quality certification under Section 401 of the Clean Water Act (CWA). 85 Fed. Reg. 42210. EPA notes that CWA Section 401 is a direct grant of authority to states (and Tribes that have been approved for “treatment as a State” status) to review for compliance with appropriate federal, state, and Tribal water quality requirements any discharge into a water of the United States that may result from a proposed activity that requires a federal license or permit. According to EPA, the final rule is intended to increase the predictability and timeliness of CWA Section 401 certification actions by clarifying timeframes for certification, the scope of certification review and conditions, and related certification requirements and procedures. The final rule will be effective on September 11, 2020.

EPA Publishes Final Rule For Integrated Iron And Steel Manufacturing Facilities NESHAP: EPA published a final rule on July 13, 2020, regarding the RTR conducted for the Integrated Iron and Steel Manufacturing Facilities NESHAP source category. 85 Fed. Reg. 42074. EPA states that it found that risks due to emissions of air toxics from this source category are acceptable and that the current NESHAP provides an ample margin of safety to protect public health. Under the technology review, EPA found no developments in practices, processes, or control technologies that necessitate revision of the standards. According to EPA, it is taking final action to establish emission standards for mercury in response to a 2004 administrative petition for reconsideration that minimizes emissions by limiting the amount of mercury per ton of metal scrap used. EPA is also removing exemptions for periods of SSM consistent with a 2008 court decision, and clarifying that the emissions standards apply at all times; adding electronic reporting of performance test results and compliance reports; and making minor corrections and clarifications for a few other rule provisions. The final rule was effective immediately.

EPA Proposes To Retain Existing NAAQS For Ozone: EPA announced on July 13, 2020, its proposal to retain, without changes, the 2015 NAAQS for ozone. EPA states that this proposal comes after careful review and consideration of the most current available scientific evidence and risk and exposure information, and with consultation of EPA’s independent science advisors. EPA notes that from 2017 to 2019, ozone concentrations fell four percent and since the beginning of the Trump Administration, EPA has re-designated 13 nonattainment areas for the 2008 eight-hour ozone standards to attainment, meaning these communities are now breathing cleaner air. According to EPA, as a result of CAA programs and efforts by state, local, and tribal governments, from 1990-2019, U.S. emissions of nitrogen oxides and volatile organic compounds have dropped by 65 percent and 47 percent, respectively. During that same time, national average ozone concentrations have dropped 25 percent.

EPA Will Hold Webinar On Resource Roadmapping For Revitalization: On July 21, 2020, EPA will hold a webinar on “Resource Roadmapping for Revitalization: Tools for Leveraging Funding & Other Resources for Brownfields & Land Revitalization.” EPA will host a webcast to present and explain how EPA brownfields grantees and local community leaders can use the “resource roadmapping” approach to match project costs and needs with sources of funding and finance, and to implement practical strategies for securing grants, low-cost funding, incentives, and innovative finance sources for brownfields and community revitalization.

FDA

Vitamin D2 Mushroom Powder Approved As Food Additive: The U.S. Food and Drug Administration (FDA), on July 13, 2020, approved use of vitamin D2 mushroom powder, produced using ultraviolet (UV) light treatment in a variety of food types in response to a food additive petition (FAP) originally filed by Oakshire Naturals LP in 2018. 85 Fed. Reg. 41916. The Federal Food, Drug, and Cosmetic Act (FFDCA) will be amended to include 21 Code of Federal Regulations (C.F.R.) Section 172.382, which will list manufacturing details, maximum use levels, and other pertinent information for safe use of the food additive. The rule was effective July 13, 2020. FDA is accepting objections and requests for a hearing on the final rule until August 12, 2020.

FDA Warns Consumers About Contaminated Hand Sanitizers: FDA, on July 2, 2020, posted an update warning related to several hand sanitizer products that were found to contain methanol. FDA warns consumers and health care providers that these products are toxic when absorbed through the skin or ingested and can be life-threatening when ingested. FDA notes that methanol is not an acceptable active ingredient for hand sanitizers and must not be used due to its toxic effects. FDA has issued several warning letters and advises consumers to not use hand sanitizer from the companies or products noted on the FDA website. FDA continues to address concerns related to various issues that have arisen due to the increased marketing of hand sanitizers in the United States as a result of the ongoing pandemic. FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose.

NANOTECHNOLOGY

Video And Slides Available From National Academies Briefing Webinar On Quadrennial Review Of NNI: On June 9, 2020, the National Academies of Sciences, Engineering, and Medicine (National Academies) held a briefing webinar featuring its report, A Quadrennial Review of the National Nanotechnology Initiative. During the webinar, members of the ad hoc National Academies committee discussed how U.S. nanotechnology programs compare to those in other nations, whether coordination under the National Nanotechnology Initiative (NNI) should continue, and how to improve the NNI’s research and development (R&D) strategy to enhance further U.S. economic prosperity and security. The National Academies has posted the public briefing video and public briefing slides.

EUON Nanopinion Addresses Pigments, “The Oldest Nanomaterials In Human History”: On June 12, 2020, the European Union (EU) Observatory for Nanomaterials (EUON) posted a Nanopinion entitled “Pigments: The oldest nanomaterials in human history facing modern day challenges.” Dr. Heike Liewald, Managing Director, Eurocolour e.V., and Giuliana Beck, Advisor, German association of producers of pigments and fillers, describe how the introduction of nano-specific requirements in statutes has significantly increased the regulatory burden. More information is available in our June 16, 2020, blog item.

NIOSH Publishes Program Performance One-Pager For Nanotechnology Research Center: On June 25, 2020, NIOSH published a Nanotechnology Research Center (NTRC) Program Performance One-Pager (PPOP). NTRC conducts research to understand the potential effects on human health of exposure to engineered nanomaterials and develops methods to control or eliminate exposures. According to the PPOP, NTRC’s accomplishments include conducting a survey to gather information about companies’ safety and health practices surrounding the use of ENMs to assess the impact of the NIOSH guidance. More information is available in our June 26, 2020, blog item.

EC Amends REACH Annex II To Include SDS Requirements For Nanoforms: On June 26, 2020, the European Commission (EC) published a regulation in the Official Journal of the European Union that amends Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Annex II describes the requirements for compiling safety data sheets (SDS). The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be provided in SDSs. The Annex II amendments include provisions regarding nanoforms. More information is available in our July 1, 2020, blog item.

EU NanoSafety Cluster Holds Webinar On Immune Response From Occupational Exposure To Carbon Nanotubes And Carbon Nanofibers: On June 30, 2020, the EU NanoSafety Cluster held a webinar on “Immune response from occupational exposure to CNTs and nanofibres.” The following speakers discussed work at NIOSH on the association of occupational exposure with ex vivo functional immune response in workers handling carbon nanotubes and carbon nanofibers (CNT/F): Matthew Dahm -- CNT/F exposure assessment; Aaron Erdely -- Occupational exposure and immune effects; and Mary K. Schubauer-Berigan -- Cross-sectional evaluation of CNT/F workers. More information is available in our June 25, 2020, blog item.

EUON Publishes Nanopinion On Polymer-Based Nanocomposites: On July 1, 2020, EUON published a Nanopinion entitled “Polymer based nanocomposites – enabling innovation, resource efficiency and helping to fight climate change” by Dr. Sabine Lindner, Consumer and Environmental Affairs, PlasticsEurope Deutschland e.V. Dr. Lindner notes how the addition of nanoscale particles to plastic matrices can improve the properties of products such as plastic packaging for food. Dr. Lindner describes the work that PlasticsEurope is doing with different stakeholders, such as the International Nano Authorities Dialogue, and its participation on the advisory board of RiskGONE, a project aimed “at providing solid procedures for science-based risk governance of nanomaterials, based on a clear understanding of risks and risk management practices.” More information is available in our July 6, 2020, blog item.

EPA Registers NSPW Nanosilver As A Materials Preservative: On July 2, 2020, EPA announced that it registered NSPW Nanosilver as a new active ingredient that helps suppress odor-causing bacteria, and algae, fungus, mold, and mildew that can cause deterioration or staining in textiles. NSPW Nanosilver is the active ingredient in the pesticide product POLYGUARD-NSPW MASTER BATCH (Polyguard). According to EPA, Polyguard will be formulated as a master batch, meaning that NSPW Nanosilver will be embedded within plastic beads or pellets. EPA states that based on its human health and ecological risk assessment, it has determined that the new active ingredient, NSPW Nanosilver, meets the regulatory standard under FIFRA for use as a materials preservative in textiles in Polyguard. More information is available in our July 2, 2020, blog item.

ISO Publishes Standards Regarding Measurements Of Nanoparticle Size And Shape Distribution And Polymeric Nanocomposite Films For Food Packaging With Barrier Properties: The International Organization for Standardization (ISO) has published two nanotechnology standards: ISO 21363:2020, “Nanotechnologies — Measurements of particle size and shape distributions by transmission electron microscopy”; and ISO/TS 21975:2020, “Nanotechnologies — Polymeric nanocomposite films for food packaging with barrier properties — Specification of characteristics and measurement methods.” More information is available in our July 8, 2020, blog item.

EFSA Consults On Draft Guidance On Technical Requirements For Regulated Food And Feed Product Applications To Establish The Presence Of Small Particles, Including Nanoparticles: The European Food Safety Authority (EFSA) has begun a public consultation on a draft document entitled “EFSA Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles Including Nanoparticles.” The draft Guidance sets out information requirements for applications in the regulated food and feed product areas and establishes criteria for assessing the presence of a fraction of small particles. Comments are due September 9, 2020. More information is available in our July 13, 2020, blog item.

ANSI Nanotechnology Standards Panel Will Hold Virtual Workshop On Advanced Materials In August: On August 19 and 20, 2020, the American National Standards Institute Nanotechnology Standards Panel (ANSI-NSP) will hold a virtual workshop on advanced materials. The workshop will focus on whether existing nanotechnology standards bodies should address advanced materials and how the gaps and needs relative to advanced materials standards can best be identified and prioritized. Panelists will include representatives from the National Nanotechnology Coordination Office (NNCO), EPA, the U.S. Consumer Product Safety Commission (CPSC), The Chemours Company, the Society of Toxicology, and the Organization for Economic Cooperation and Development (OECD). ANSI-NSP invites interested stakeholders, including industry, government representatives, representatives from non-governmental organizations, and academics, to participate. Online registration is now open.

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

Senate Passes Great American Outdoors Act: On June 17, 2020, the Senate passed the Great American Outdoors Act (H.R. 1957) by a vote of 73-25. The legislation would provide full and permanent funding for the Land and Water Conservation Fund (LWCF) and, according to the Senate Committee’s Democratic June 17, 2020, press release, “finally address the approximately $20 billion deferred maintenance backlog in our Country’s public lands.” The Great American Outdoors Act would provide $9.5 billion over five years for the National Park Service (NPS), U.S. Forest Service (USFS), Bureau of Land Management (BLM), U.S. Fish and Wildlife Service (USFWS), and Bureau of Indian Education maintenance backlog. The press release states that the current maintenance backlog is over $20 billion.

House Passes Moving Forward Act: On June 18, 2020, the House Committee on Transportation and Infrastructure passed the Investing in a New Vision for the Environment and Surface Transportation (INVEST) in America Act (H.R. 2). The Committee’s June18, 2020, press release states that the INVEST in America Act marks a significant departure from previous surface transportation reauthorization bills by addressing the maintenance needs and building smarter, safer infrastructure while putting the United States on a path toward zero emissions from the transportation sector. When the INVEST in America Act moved to the House floor, House Democrats combined the INVEST in America Act with a number of other clean energy, infrastructure, and education funding proposals to create the Moving Forward Act. The June 22, 2020, press release issued by the Committee states that the Moving Forward Act “marks a transformational investment in American infrastructure that will create millions of jobs, take bold action on the climate crisis, and address disparities in urban, suburban, and rural communities across our country.” On July 1, 2020, the House passed the bill by a vote of 233-188. According to a July 1, 2020, press release issued by Representative Frank Pallone, Jr. (D-NJ), Chair of the Energy and Commerce Committee, the bill “will help us rebuild our economy and combat climate change with a more than $126 billion investment in clean energy, energy efficiency and deep decarbonization,” including $20 billion for a clean energy and sustainability fund and a major investment in clean transportation and the development of an electric vehicle charging network. The bill also provides more than $47 billion for drinking water programs and infrastructure to remove pollutants like PFAS and lead from water. The Office of Management and Budget (OMB) issued a Statement of Administration Policy on June 29, 2020, stating that the Trump Administration opposes passage of the bill because it “is heavily biased against rural America,” “appears to be entirely debt-financed,” and “fails to tackle the issue of unnecessary permitting delays, which are one of the most significant impediments to improving our infrastructure.”

Ernst Blocks EPA Deputy Administrator Nomination: On June 26, 2020, Senator Joni Ernst (R-IA) announced her opposition to the nomination of Doug Benevento to be EPA Deputy Administrator. Ernst’s June 26, 2020, press release states that without her vote, Benevento’s nomination will not be brought before the Senate Environment and Public Works Committee and therefore a path forward on his nomination no longer exists. In her press release, Ernst cites issues that Iowa’s ethanol and biodiesel producers have had with EPA’s “gap year” waivers.

Bipartisan, Bicameral PFAS-Free Military Purchasing Act Introduced: On June 29, 2020, Senators Jeanne Shaheen (D-NH) and Richard Blumenthal (D-CT) and Representatives Elissa Slotkin (D-MI) and Mike Turner (R-OH) introduced the PFAS-Free Military Purchasing Act to reduce exposure of service members and their families to PFAS chemicals. The bill prohibits the U.S. Department of Defense (DOD) “from acquiring items that contain these dangerous and toxic chemicals commonly found in food service ware, carpets and rugs, cosmetics, and many other everyday items.” Shaheen’s June 29, 2020, press release states that PFAS exposure “has been linked to a number of serious health conditions, including cancer, liver damage, decreased fertility, and increased risk of asthma and thyroid disease.” The Environmental Working Group and the Green Science Policy Institute have endorsed the legislation.

Democrats On House Select Committee On Climate Crisis Release Roadmap For Climate Action: On June 30, 2020, Democratic members of the House Select Committee on the Climate Crisis released a majority staff report entitled “Solving the Climate Crisis: The Congressional Action Plan for a Clean Energy Economy and a Healthy, Resilient, and Just America.” The June 30, 2020, press release states that the report lays out the Climate Crisis Action Plan, “full of detailed, ambitious and actionable climate solutions that Congress should enact to benefit American families in communities across the nation.” The Climate Crisis Action Plan calls on Congress to grow the economy and put Americans back to work in clean energy jobs; protect the health of all families; make sure communities and farmers can withstand the impacts of climate change; and protect America’s land and waters for the next generation. According to the press release, an independent analysis found that the Climate Crisis Action Plan would save more than 60,000 American lives every year by 2050 by reducing air pollution, as well as nearly $8 trillion saved through 2050 thanks to health and climate benefits.

House Appropriations Committee Approves FY 2021 Interior-Environment Funding Bill: On July 10, 2020, the House Appropriations Committee approved the fiscal year (FY) 2021 Interior, Environment, and Related Agencies bill on a vote of 30 to 19. According to the Committee’s July 10, 2020, press release, the legislation includes funding for programs within the Department of the Interior, EPA, and other related agencies, including the Indian Health Service. In total, the draft bill includes $36.76 billion in regular appropriations, an increase of $771 million above the FY 2020 enacted level, and $5.11 billion over the President’s 2021 request. Additionally, the bill includes $15 billion in emergency supplemental appropriations for investments in critical infrastructure. The bill provides a total of $9.38 billion for EPA -- an increase of $318 million above the FY 2020 enacted level and $2.67 billion above the President’s budget request. Of this amount, the bill includes:

  • $3.58 billion for EPA’s core science and environmental program work, an increase of $210 million above the FY 2020 enacted level and $822 million above the President’s budget request. This amount includes $12.9 million in additional funding for scientific and regulatory work on PFAS needed to establish drinking water and cleanup standards;
     
  • $4.36 billion for state and Tribal Assistance Grants, an increase of $119 million above the FY 2020 enacted level and $1.52 billion above the President’s budget request;
     
  • $1.22 billion for Superfund, an increase of $37 million above the FY 2020 enacted level and $143 million above the President’s request;
     
  • $15 million for Environmental Justice activities, an increase of $4.8 million, or 47 percent, above the FY 2020 enacted level and more than five times above the President’s budget request; and
     
  • $45 million for the EPA Office of Inspector General (OIG), an increase of $3.6 million above the enacted level and $5.3 million above the request.
     

The Committee amended the bill to prohibit funding for EPA to issue in final its rule entitled “Strengthening Transparency in Regulatory Science.” The House is expected to consider the appropriations bill later in July 2020. EPA Administrator Andrew Wheeler issued a statement on July 9, 2020, recommending that President Trump (R) veto the bill. According to Wheeler’s statement, House Democrats “are trying to undo common-sense regulations put forth by the Trump Administration that update Section 401 of the Clean Water Act and make lawful methane adjustments that have saved taxpayers millions of dollars while protecting human health and the environment, and allowing American businesses to flourish.”

MISCELLANEOUS

EPA Announces Winners Of 2020 Green Chemistry Challenge Awards: On June 16, 2020, EPA announced the winners of the 2020 Green Chemistry Challenge Awards. EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.” EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year. EPA and the American Chemical Society co-sponsor the awards. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners. More information is available in our June 17, 2020, blog item.

California State Water Board Adopts Definition Of Microplastics In Drinking Water: The California State Water Board announced on June 16, 2020, that it adopted an official definition of microplastics in drinking water. “Microplastics in drinking water” are defined as solid polymeric materials to which chemical additives or other substances may have been added, which are particles that have at least three dimensions that are greater than one nanometer (nm) and less than 5,000 micrometers (μm). Polymers that are derived in nature that have not been chemically modified (other than by hydrolysis) are excluded from the definition. The Board states that the definition “sets the foundation for a long-term approach to studying this ubiquitous contaminant, which recently has come into mainstream awareness as a major environmental challenge.” According to the Board, researchers believe further monitoring and study of microplastics in drinking water supplies and their implications for public health and safety are imperative.

CISA Publishes Retrospective Analysis Of CFATS For Comment: On June 22, 2020, the Cybersecurity and Infrastructure Security Agency (CISA) announced the availability of a retrospective analysis of the data, assumptions, and methodology used to support the 2007 interim final rule for the Chemical Facility Anti-Terrorism Standards (CFATS) program. 85 Fed. Reg. 37393. According to the notice, the purpose of the retrospective analysis is to provide an updated assessment of the costs and burdens of the CFATS program. Based on data observed by the program for over ten years, CISA states that it estimates that the actual costs of the CFATS program is 83 percent lower than estimated in 2007. Comments are due September 21, 2020.

District Court Rules That Prop 65 Warning For Glyphosate Is Barred By The First Amendment And Grants Permanent Injunction Against Enforcement: On June 22, 2020, the U.S. District Court for the Eastern District of California granted summary judgment for the plaintiffs in National Association of Wheat Growers et. al. v. Becerra, and entered a permanent injunction against enforcement of a Proposition 65 (Prop 65) warning label for pesticide products containing glyphosate. The court found that requiring the registrants of glyphosate products to include such a warning could not be justified as a valid restriction on commercial speech and therefore is contrary to the First Amendment of the Constitution. The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect. (See our February 28, 2018, blog entitled “Eastern District of California Rules on Motion to Enjoin Prop 65 Listing and Warning on Glyphosate Products.”) EPA also has stated that it would not allow a Prop 65 warning to be added to the labeling for any registered glyphosate product because such a warning is misleading and would cause the product to be “misbranded” under FIFRA Section 2(q)(1)(A). (See our August 15, 2019, blog entitled “EPA Issues Guidance Regarding Prop 65 Labeling Requirements for Glyphosate Products and OEHHA Responds.”) For more information and our commentary on the District Court decision, please read our full blog.

EPA Will Not Appeal Court Decision Regarding Directive On Strengthening And Improving Federal Advisory Committees: On June 24, 2020, EPA announced that it will not appeal a recent U.S. District Court for the Southern District of New York decision that vacates and remands Section 1 of EPA’s October 31, 2017, directive entitled “Strengthening and Improving Membership on EPA Federal Advisory Committees.” According to EPA, the decision not to appeal the judgment was made in light of a related decision by the U.S. Court of Appeals for the District of Columbia Circuit issued in April 2020. Based on the subsequent decision, EPA states that it “has determined that any blanket prohibition on the participation of EPA grant recipients as special government employees in EPA advisory committees should be promulgated as a supplemental ethics regulation with the concurrence of the Office of Government Ethics.” EPA notes that the court’s decision does not prevent future actions by EPA to regulate the composition of its advisory committees, including policies or regulations governing the participation of committee members who receive grants from EPA.

OSHA Issues Guidance Intended To Ensure Uniform Enforcement Of Silica Standards: On June 26, 2020, OSHA announced that it recently issued a compliance directive designed to ensure uniformity in inspection and enforcement procedures when addressing respirable crystalline silica exposures in general industry, maritime, and construction. The new directive provides OSHA compliance safety and health officers with guidance on how to enforce the silica standards’ requirements and clarifies topics such as alternative exposure control methods when a construction employer does not fully and properly implement Table 1, variability in sampling, multi-employer situations, and temporary workers. OSHA began enforcing most provisions of the construction standard in September 2017, with enforcement of the requirements for sample analysis starting in June 2018. Enforcement of most of the general industry and maritime standards began in June 2018, with enforcement of some medical surveillance requirements commencing on June 23, 2020. On June 23, 2021, OSHA will begin enforcing requirements for engineering controls for hydraulic fracturing operations in the oil and gas industry.

EPA’s Spring 2020 Regulatory Agenda “Continues Commitment To Strong Environmental Protections And Regulatory Reform Into 2021”: EPA announced on June 30, 2020, that the spring 2020 Unified Agenda of Regulatory and Deregulatory Actions “continues to support President Trump’s commitment to regulatory reform, while simultaneously advancing the Agency’s core mission of protecting human health and the environment.” The press release states that EPA’s Unified Agenda “shows continued progress in reducing unnecessary regulatory burden as envisioned by President Trump’s Executive Order 13771,” and the spring 2020 Unified Agenda “includes 40 deregulatory actions under development.” In addition, the spring Unified Agenda contains 29 new actions expected to be issued over the next 12 months. These actions include updates to EPA’s procedures for the National Environmental Policy Act, review of NAAQS for lead, and proposed rules to improve consistency and transparency in EPA’s BCAs for hazardous waste and drinking water regulations.

EPA OIG Finds Safer Choice Program Would Benefit From Formal Goals And Additional Oversight: On June 30, 2020, the EPA OIG released a report on its audit to determine whether the Safer Choice program effectively meets its goals and whether the program achieves quality standards through its product qualification, renewal, and required audit processes. OIG recommends that the OCSPP Assistant Administrator develop and publish adequate Safer Choice program goals and performance measures, establish and implement procedures for formal audit oversight of third-party profilers (TPP), amend its memorandums of understanding with TPPs to require performance reviews conducted by EPA, and collect and document TPP audit supporting information.

CPSC Holds Webinar On Improvements To Saferproducts.Gov: On July 1, 2020, CPSC held a public webinar to receive information from interested parties about changes to CPSC’s Publicly Available Consumer Product Safety Information Database, www.SaferProducts.gov, that are in development to improve the website’s usefulness and navigability. CPSC states in its June 18, 2020, Federal Register notice that based, in part, on input from a March 2019 public hearing, CPSC is holding the webinar to show the changes to the website that are in development. 85 Fed. Reg. 36838. According to CPSC, these changes seek to improve usability and navigability on the website; make the website more mobile friendly with other devices, including smartphones and tablets; and improve cross-browser compatibility.

CPSC Staff Recommend Organohalogen Flame Retardant Chemicals Be Assessed As A Class: CPSC staff prepared a July 1, 2020, CPSC briefing package recommending assessing the potential health risks of organohalogen flame retardants (OFR) in specified consumer products using a class approach. The briefing memorandum outlines the general process for performing class-based risk assessments and provides recommendations for specific approaches and tasks. In 2015, a number of organizations and individuals petitioned CPSC to ban the use of additive OFRs, as a class, in durable infant or toddler products, children’s toys, child care articles or other children’s products (other than car seats), residential upholstered furniture, mattresses and mattress pads, and the plastic casings of electronic devices. In 2017, CPSC voted to grant the petition, to direct staff to convene a Chronic Hazard Advisory Panel (CHAP), and to complete a scoping and feasibility study in cooperation with the National Academies. The National Academies published its report, A Class Approach to Hazard Assessment of Organohalogen Flame Retardants, in May 2019.

CDTSC Issues Notice Of Deficiency To Spray Foam Insulation Manufacturers: On July 1, 2020, the California Department of Toxic Substances Control (CDTSC) announced that it issued a Notice of Deficiency to manufacturers of spray polyurethane foam (SPF) insulation systems who claim there is no suitable alternative to a toxic chemical used in their wall and roof insulation products. According to CDTSC’s press release, CDTSC found the Abridged Alternatives Analysis reports from companies participating in the American Chemistry Council’s Spray Foam Coalition to be insufficient. CDTSC states that “[w]orkers who apply SPF insulation are at risk of harming their respiratory systems and developing asthma when exposed to unreacted methylene diphenyl diisocyanate (MDI). SPF is not harmful once it is installed and cured.” CDTSC is requiring spray foam manufacturers to submit more information in revised reports by August 31, 2020. CDTSC notes that if the revisions are not adequate, it can issue a second Notice of Deficiency.

USDA Publishes Final Guidance Documents For National Bioengineered Food Disclosure Standard: The U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) announced on July 2, 2020, that it has issued final guidance intended to assist regulated entities in complying with the National Bioengineered Food Disclosure Standard, including Guidance to Ensure Acceptable Validation of a Refining Process, Guidance on Testing Methods, and two FAQ documents, one pertaining to each final guidance document. AMS will publish a Federal Register notice announcing the availability of the final guidance “soon.” in the Federal Register. The documents are available on the AMS website at https://www.ams.usda.gov/rules-regulations/be/validation-process. AMS states that both guidance documents and their respective FAQ documents can be used by regulated entities to establish protocols for complying with the Standard by the mandatory compliance date of January 1, 2022.

Environmental Technologies Trade Advisory Committee Will Meet July 21: The U.S. Department of Commerce (DOC) International Trade Administration announced on July 7, 2020, that the Environmental Technologies Trade Advisory Committee (ETTAC) will meet July 21, 2020. 85 Fed. Reg. 40620. At this final meeting of the current (2018-2020) ETTAC charter, ETTAC will present its recommendations to senior DOC officials, then interagency representatives of the Trade Promotion Coordinating Committee’s Environmental Trade Working Group (TPCC ETWG) will respond to the recommendations that ETTAC presented. The meeting will be co-chaired by senior officials from the International Trade Administration and EPA. ETTAC’s recommendation letters can be found at https://www.export.gov/ettac. The recommendations were developed by the ETTAC's three subcommittees: Trade Policy and Trade Negotiations, Trade Promotion and Export Market Development, and Cooperation on Standards, Certifications, and Regulations.

EPA OIG Issues Report On FY 2020 CSB Challenges: On July 6, 2020, the EPA OIG issued a report on U.S. Chemical Safety and Hazard Investigation Board (CSB) management challenges in FY 2020. OIG states that based on its continuous audit, evaluation, and investigative work, it has determined that the two management challenges it identified in FY 2019 have not been addressed: accomplishment of CSB mission is impaired until new CSB members are selected; and CSB has not developed policy on CSB member responsibilities. OIG also identified a new challenge for FY 2020 related to the coronavirus pandemic: CSB must continue operations during the coronavirus pandemic. According to OIG, unaddressed management challenges will impede the ability of the CSB to function effectively.

EPA Corrects Technical Errors In SAFE Vehicles Rule: On July 8, 2020, EPA published a final rule correcting technical errors in the April 30, 2020, Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks. 85 Fed. Reg. 40901. The SAFE Vehicles Rule promulgated final standards for corporate average fuel economy (CAFE) and carbon dioxide emissions for passenger cars and light trucks (collectively, light-duty vehicles) to be manufactured in model years 2021-2026. The correcting document was effective July 8, 2020.

OSHA Amends Beryllium Standard For General Industry: OSHA published on July 14, 2020, a final rule amending the beryllium standard for general industry. 85 Fed. Reg. 42582. OSHA states that amendments “clarify certain provisions and simplify or improve compliance.” According to OSHA, it designed the revisions “to maintain or enhance worker protections overall by ensuring that the rule is well understood and compliance is more straightforward.” The compliance date of the final standard as modified is September 14, 2020.

CHPAC Will Meet Virtually July 24 And 27: EPA’s Children’s Health Protection Advisory Committee (CHPAC) meeting will be held virtually July 24 and 27, 2020. 85 Fed. Reg. 40287. CHPAC advises EPA on science, regulations and other issues relating to children’s environmental health.
 

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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