By Lynn L. Bergeson and Margaret R. Graham
On February 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its notice extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018. 84 Fed. Reg. 2851. The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3). The duration of the extension period is a total of 33 days, but the notice states that because the extension is less than 90 days, EPA reserves the right under TSCA Section 5(c) to issue, for good cause, future additional extensions for individual cases up to a total of 90 days.
More information on why EPA has chosen to do this is in our blog item regarding the pre-publication version of this notice “EPA Extends Review Periods for TSCA Section 5 PMNs, SNUNs, MCANs and Exemption Notices Due to Lack of Authorized Funding and Shutdown.”
By Lynn L. Bergeson
On February 5, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced the launch of its Twitter account, @EPAChemSafety. EPA states that this account will post the latest news on chemicals and pesticides including updates on its chemical review initiatives under the Toxic Substances Control Act (TSCA) and information on upcoming webinars and public meetings.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On February 1, 2019, Lynn Vendinello, Acting Director, Chemical Control Division, of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) signed the pre-publication version of a notice announcing that, due to the recent lapse of appropriations and the Agency shutdown, EPA is extending the review periods for all Toxic Substances Control Act (TSCA) Section 5 Premanufacture Notices (PMN), Significant New Use Notices (SNUN), Microbial Commercial Activity Notices (MCAN), and exemption notices that were submitted to the Agency under TSCA Section 5 before December 29, 2018, and for which the review period had not expired as of December 29, 2018.
Due to a lack of authorized funding, from December 29, 2018, until EPA operations for the TSCA New Chemicals operations fully resumed on January 31, 2019, certain EPA functions were suspended including the processing of submissions made through the Central Data Exchange (CDX), e-PMN, or other methods. Further, no review work was performed on the TSCA section 5 notifications received by EPA on or before December 29, 2018, and for which the review period had not yet expired as of December 29, 2018. Consequently, the review period for any TSCA Section 5 notice submitted during the shutdown did not begin until TSCA New Chemical operations fully resumed on January 31, 2019.
EPA states that the duration of the extension period will be a total of 33 days, which is equivalent to the duration of the time period from December 29, 2018 (the date on which certain EPA operations shutdown) and the date on which EPA operations for the TSCA New Chemicals Program fully resumed (January 31, 2019). The notice states that EPA requires an extension of the review periods to complete its risk assessments, to examine its regulatory options, and to prepare the necessary documents associated with the relevant determination under TSCA Section 5(a)(3).
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On January 31, 2019, the U.S. Environmental Protection Agency (EPA) was petitioned by the Attorneys General of 14 states (Massachusetts, Pennsylvania, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Rhode Island, Vermont, and Washington) and the District of Columbia under Toxic Substances Control Act (TSCA) Section 21(a) to issue an asbestos reporting rule to require reporting under TSCA Section 8(a) of information necessary for EPA to administer TSCA as to the manufacture (including importation), processing, distribution in commerce, use, and disposal of asbestos. Specifically, the petition states that the Attorneys General are petitioning EPA’s Administrator to:
- [I]nitiate a rulemaking and issue a new asbestos reporting rule to: (i) eliminate any applicability of the “naturally occurring substance” (NOCS) exemption in the [Chemical Data Reporting (CDR)] for asbestos reporting; (ii) apply the CDR reporting requirements to processors of asbestos, as well as manufacturers, including importers, of the chemical substance; (iii) ensure that the impurities exemption in the CDR does not apply to asbestos; and (iv) require reporting with respect to imported articles that contain asbestos.
In support of their requests in the petition, the Attorneys General state the following:
- NOCS Exemption: “The identified uses of imported raw asbestos represent pathways of exposure that present risks to health and the environment that EPA must consider in conducting its risk evaluation and regulating asbestos, and accordingly EPA should promulgate an asbestos reporting rule to require reporting of such information. Moreover, the required asbestos reporting must capture information with respect to the quantities imported, and these potential exposure pathways so this information can be made available to inform the states’ and the public’s knowledge regarding asbestos exposure risks.”
- Reporting from Processors: “[T]o enable EPA to carry out its responsibility to impose requirements on processors to eliminate unreasonable risks of injury to health or the environment arising from exposures to asbestos, EPA must promulgate new regulations to apply the reporting requirements of the CDR to processors of asbestos notwithstanding that the current CDR does not expressly require such reporting. Should EPA fail to do so, EPA would be violating TSCA, acting arbitrarily and capriciously, and abusing its discretion in implementing TSCA.”
- Exemptions for “Impurities” and “Articles”: “[W]hile the CDR exempts reporting with respect to ‘impurities’ and for chemical substances imported as ‘part of an article,’ neither of these exceptions should be applied to reporting with respect to the presence of asbestos if EPA is to satisfy TSCA’s mandate to prevent unreasonable risks associated with exposures to this highly toxic chemical.”
- Reporting for Asbestos: “EPA must account for the many tons of asbestos that are imported into the U.S., whether as a raw material or processed, to evaluate adequately the current and likely future risks of exposure to asbestos, and must also account for asbestos in consumer products, whether or not the asbestos is intentionally included in those products. These data … are needed for EPA to be able to make informed technically complex decisions regarding the regulation of asbestos. Without these data to rely on, the agency will be unable to meet its obligations under TSCA to make its decisions based on the weight of the scientific evidence and using the best available science …. Accordingly, EPA must issue an asbestos reporting rule to ensure that the NOCS, the impurities, and the articles exemptions do not apply to asbestos, and that processors of asbestos are required to report.”
The petition cites EPA’s denial of a petition submitted by a group of non-governmental organizations (NGO) seeking similar action that the Attorneys General are requesting, but does not address the many reasons that EPA denied the first petition. Why the Attorneys General would follow up EPA’s well-reasoned denial with a petition of their own with very similar requests and only marginal additional facts, is unclear. More information on the NGO petition is available in our blog item "EPA Denies Section 21 Petition Seeking Increased Asbestos Reporting."
By Lynn L. Bergeson and Carla N. Hutton
On January 28, 2019, the U.S. Environmental Protection Agency (EPA) published its Year in Review: 2018 (YIR). The YIR lists the following accomplishments:
- Issued major proposals, including the Affordable Clean Energy Rule, the Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule, and the new waters of the U.S. definition;
- Provided greater regulatory certainty to states, tribes, localities, and the regulated community;
- Streamlined the effectiveness and efficiency of EPA;
- Launched cross-agency initiatives to improve risk communication on emerging contaminants and vulnerable populations;
- Initiated multiple actions to reduce lead exposure, including releasing the Federal Lead Action Plan;
- Improved enforcement compliance and assistance;
- Held EPA’s first-ever Per- and Polyfluoroalkyl Substances (PFAS) National Leadership Summit and Inaugural Recycling Day Summit;
- Led international environmental efforts, including first-ever articles to prevent and reduce marine litter; and
- Ensured comprehensive and coordinated responses to multiple natural disasters.
The YIR provides the following “by the numbers” summary:
- Regulatory Reform: EPA issued 13 final deregulatory actions in 2018. To date, under President Trump, EPA has issued 33 final major deregulatory actions, “saving Americans almost $2 billion”;
- Air: EPA reported that, during President Trump’s first year in office, greenhouse gas emissions from major industrial sources decreased by 2.7 percent;
- Water: By the end of 2018, EPA closed seven Water Infrastructure Finance and Innovation Act (WIFIA) loans totaling nearly $2 billion to help finance over $4 billion for water infrastructure projects and create up to 6,000 jobs;
- Land: EPA deleted all or part of 22 sites from Superfund’s National Priorities List in fiscal year (FY) 2018 -- “the largest number of deletions in one year since FY 2005”;
- Chemicals: After inheriting a “backlog” of 672 new chemical submissions pending review in January 2017, under President Trump, EPA “aggressively worked to improve the review of new chemical submissions and, as a result, eliminated the initial backlog and reduced the number of cases pending review to 475 submissions by August 2018.” EPA completed 99.7 percent of the 2,199 pesticide registration actions on-time, and registered 23 new active ingredients and 147 new uses of existing pesticides, “providing new tools to growers to meet their pest management needs”;
- Enforcement: In FY 2018, EPA enforcement actions required the treatment, disposal, or elimination of 809 million pounds of pollutants and waste -- almost twice as much as FY 2017. EPA also entered into the largest settlement in the history of its enforcement of the Risk Management Program with the responsible party spending $150 million on major safety improvements; and
- Grants: EPA awarded $4,451,520,905 in grants in FY 2018, including more than $63 million under the General Assistance Program, benefiting nearly all federally recognized tribes through awards to 500 tribal governments and approximately 25 intertribal consortia, $4.344 million in State and Tribal Assistance Grants, and 37 environmental education grants totaling $3,306,760 in 32 states to 13 colleges and universities, 23 stakeholder organizations, and one tribal community.
Further information on the YIR and our commentary is available in the full Bergeson & Campbell, P.C. (B&C®) memorandum.
By Lynn L. Bergeson and Christopher R. Bryant
On January 16, 2019, the Senate Environment and Public Works (EPW) Committee held a hearing on the nomination of Andrew Wheeler to serve as Administrator of the U.S. Environmental Protection Agency (EPA). Mr. Wheeler currently serves as the Acting Administrator, having taken the reins of EPA after former Administrator Scott Pruitt resigned in July 2018. An archived webcast of the hearing is available online. In introducing Mr. Wheeler, Senator John Barrasso (R-WY), Chair of the EPW Committee, stated: “under Acting Administrator Wheeler’s leadership, the agency has taken a number of significant actions to protect our nation’s environment, while also supporting economic growth. Acting Administrator Wheeler has led efforts to: issue common-sense regulatory proposals, like the Affordable Clean Energy Rule, and the revised definition of ‘Waters of the United States’; implement this Committee’s 2016 bipartisan reform of the Toxic Substances Control Act [(TSCA)] in an effective and efficient manner; reduce lead exposure, including through the Federal Lead Action Plan; provide greater regulatory certainty to states, to Tribes, localities, and to the regulated community; and improve enforcement and compliance assistance. Acting Administrator Wheeler is very well qualified to run the [EPA].” Republicans on the EPW Committee were supportive of his nomination and actions while serving as the EPA Acting Administrator. They noted with praise his deregulatory efforts, the repeal and replacement of the Obama-era Clean Power Plan, the proposed replacement of the Waters of the United States rule and the proposed repeal of the Corporate Average Fuel Economy (CAFE) standards.
Democrats on the EPW Committee, however, expressed their disapproval of Mr. Wheeler, as he faced sharp questions from them. EPW Ranking Member Tom Carper (D-DE) expressed his concern that Mr. Wheeler failed “to moderate some of Scott Pruitt’s most environmentally destructive policies,” adding that “upon examination, Mr. Wheeler’s environmental policies appear to be almost as extreme as his predecessor’s.” When questioned on his views on climate change by Senator Bernie Sanders (I-VT), Mr. Wheeler admitted that he believed it was a “huge issue” that should be addressed internationally, but he stopped short of agreeing with it being “one of the greatest crises facing our planet.” Despite the seeming Democratic opposition to his nomination, Mr. Wheeler is expected to be approved by the EPW Committee and, eventually, the Senate, and likely soon.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On January 14, 2019, in the U.S. District Court for the District of Vermont, the Vermont Public Interest Group; Safer Chemicals, Health Families; and two individuals (plaintiffs) followed up on their earlier notice of intent to sue and filed a complaint against Andrew Wheeler and the U.S. Environmental Protection Agency (EPA) to compel EPA to perform its “mandatory duty” to “address the serious and imminent threat to human health presented by paint removal products containing methylene chloride.” Plaintiffs bring the action under Toxic Substances Control Act (TSCA) Section 20(a) which states that “any person may commence a civil action … against the Administrator to compel the Administrator to perform any act or duty under this Act which is not discretionary.” Plaintiffs allege that EPA has not performed its mandatory duty under TSCA Sections 6(a) and 7. TSCA Section 6(a) gives EPA the authority to regulate substances that present “an unreasonable risk of injury to health or the environment” and TSCA Section 7 gives EPA the authority to commence civil actions for seizure and/or relief of “imminent hazards.” Plaintiffs’ argument to direct EPA to ban methylene chloride is centered on the issue of risk to human health only, however, stating that it presents “an unreasonable risk to human health” as confirmed by EPA. Under TSCA Section 20(b)(2), plaintiffs are required to submit a notice of intent to sue 60 days prior to filing a complaint which they did on October 31, 2018.
On January 19, 2017, EPA issued a proposed rule under TSCA Section 6 to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal (82 Fed. Reg. 7464). EPA also proposed to prohibit the use of methylene chloride in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. EPA relied on a risk assessment of methylene chloride published in 2014, the scope of which EPA stated included “consumer and commercial paint and coating removal.” The proposed rule stated that in the risk assessment, EPA identified risks from inhalation exposure including “neurological effects such as cognitive impairment, sensory impairment, dizziness, incapacitation, and loss of consciousness (leading to risks of falls, concussion, and other injuries)” and, based on EPA’s analysis of worker and consumer populations' exposures to methylene chloride in paint and coating removal, EPA proposed “a determination that methylene chloride and NMP in paint and coating removal present an unreasonable risk to human health.” The comment period on the proposed rule was extended several times, ending in May 2017, and in September 2017 EPA held a workshop to help inform EPA’s understanding of methylene chloride use in furniture refinishing.
No further action was taken to issue the rule in final, however, until December 21, 2018, when EPA sent the final rule to the Office of Management and Budget (OMB) for review. On the same day, EPA also sent another rule to OMB for review titled “Methylene Chloride; Commercial Paint and Coating Removal Training, Certification and Limited Access Program,” which has not previously been included in EPA’s Regulatory Agenda; very little is known about this rule. Plaintiffs do not refer to it in the complaint but there is speculation, based on its title, that this second rule may allow for some commercial uses of methylene chloride.
We recall the lawsuit filed by the Natural Resources Defense Counsel (NRDC) in 2018 challenging EPA’s draft New Chemicals Decision-Making Framework document as a final rule. The current action further reflects the commitment of detractors of EPA to use the courts and every other means available to oppose the Administration’s TSCA implementation efforts. Whether and when this court will respond is unclear. What is clear is that the case will be closely watched, as the outcome will be an important signal to the TSCA stakeholder community regarding the utility of TSCA Section 20(a)(2) to force non-discretionary EPA actions that the Administration may be disinclined to take.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
Following through on a commitment he made in November 2018, President Trump on January 9, 2019, formally nominated Andrew Wheeler to serve as the Administrator of the U.S. Environmental Protection Agency (EPA). Mr. Wheeler has served as EPA’s Acting Administrator since the resignation of Scott Pruitt in July 2018. Mr. Wheeler previously worked in the law firm of Faegre Baker Daniels and was chief counsel to the Senate’s Environment and Public Works (EPW) Committee. Before his time at the Senate EPW Committee, Mr. Wheeler served in a similar capacity for six years for the Subcommittee on Clean Air, Climate Change, Wetlands, and Nuclear Safety. Mr. Wheeler completed his law degree at Washington University in St. Louis, his MBA at George Mason University, and his undergraduate work at Case Western Reserve University in English and Biology. Mr. Wheeler’s confirmation hearing in front of the Senate EPW Committee is scheduled for 10:00 a.m. (EST) on January 16, 2019. It will be webcast on the EPW Committee website.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
In the last hours of the 115th Congress, the Senate on January 2, 2019, approved the nominations of three individuals to serve in key environmental posts:
- Alexandra Dapolito Dunn -- EPA Toxics Office: The Senate approved the nomination of Alexandra Dunn to serve as the Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Ms. Dunn had been serving as the administrator for EPA Region 1. She previously was executive director and general counsel for the Environmental Council of the States (ECOS). Prior to joining ECOS, Ms. Dunn served as executive director and general counsel for the Association of Clean Water Administrators. Ms. Dunn also has extensive experience in environmental education, having served as dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University. In addition, she has taught at the Columbus School of Law, Catholic University of America, and, most recently, as an adjunct associate professor of law at the American University’s Washington College of Law. Ms. Dunn received a B.A. in political science from James Madison University and a J.D. from the Columbus School of Law. More information on Ms. Dunn’s confirmation hearing is available in our blog item Senate EPW Committee Holds Hearing on Nomination of Alexandra Dunn to Lead OCSPP.
- Mary Neumayr -- CEQ: The Senate also approved the nomination of Mary Neumayr to head the White House’s Council on Environmental Quality (CEQ). Ms. Neumayr currently serves as chief of staff for the CEQ. Prior to joining CEQ in March of 2017, she served in a variety of positions with the Committee on Energy and Commerce in the U.S. House of Representatives, including Deputy Chief Counsel, energy and environment in 2017; Senior Energy Counsel from 2011 to 2017; and Counsel from 2009 to 2010. Ms. Neumayr also served as Deputy Counsel for environment and nuclear programs at the U.S. Department of Energy from 2006 to 2009, and Counsel to the Assistant Attorney General for the environment and natural resources division at the U.S. Department of Justice from 2003 to 2006. Prior to her government service, Ms. Neumayr was in private legal practice from 1989 to 2003. She received her B.A. from Thomas Aquinas College and her J.D. from the University of California, Hastings College of the Law.
- Kelvin Droegemeier -- OSTP: Finally, the Senate also approved Kelvin Droegemeier to serve as the director of the White House Office of Science and Technology Policy (OSTP). A meteorologist from the University of Oklahoma, Mr. Droegemeier previously served as Oklahoma Governor Mary Fallin’s secretary of science and technology. He was also previously on the National Science Board for 12 years during the George W. Bush and Barack Obama administrations.
By Richard E. Engler, Ph.D. and Margaret R. Graham
As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA). Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during the shutdown.
We are unaware of EPA publishing a formal notice that it is suspending the review period of new chemical notices, but EPA will not be making any determinations on such notices during the shutdown. Submitters should continue to submit any required information (e.g., Notices of Commencement) even though EPA will not process or review such submissions.
EPA actions on existing chemicals (including risk evaluations and publication of the updated TSCA Inventory with active/inactive status) will be delayed. As previously reported, the first preparatory meeting on the Colour Index (C.I.) Pigment Violet 29 risk evaluation (scheduled for January 8, 2019) will be cancelled if the shutdown continues through January 4, 2019, at 5:00 p.m., which appears probable.