Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA.  Some of the highlights from EPA’s announcement are:

  • A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce; EPA states that this information will help it focus risk evaluation efforts on chemicals that are still on the market.
  • As recently as 2018, the TSCA Inventory showed over 86,000 chemicals available for commercial production and use in the U.S.  Until this update, EPA states that it was not known which of these chemicals on the TSCA Inventory were actually in commerce.
  • More than 80 percent (32,898) of the chemicals in commerce have identities that are not Confidential Business Information (CBI), increasing public access to additional information about them.  
  • For the less than 20 percent of the chemicals in commerce that have confidential identities, EPA states that it is developing a rule outlining how it will review and substantiate all CBI claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory. 
  • From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported or processed in the U.S. over the past ten years, the period ending June 21, 2016.  EPA received more than 90,000 responses, a significant reporting effort by manufacturers, importers and processors.

Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments webpage.  

On March 13, 2019, EPA will host a webinar to assist manufacturers (including importers) and processors with future reporting requirements.  Under the final TSCA Inventory notification (active-inactive) rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive.  EPA states that manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days to file a Notice of Activity (NOA) Form B so that they can continue their current activity.  Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.

The webinar is scheduled for 1:00 p.m. - 4:00 p.m. (EDT) on Wednesday, March 13, 2019.  The webinar will include an overview of filing a NOA Form B, a demonstration of the electronic reporting application, and time for questions and answers.  Registration for the webinar is not required.

More information about the TSCA Inventory update and the webinar is available on EPA’s TSCA Chemical Substance Inventory webpage.


 

 

 

 

 

 

Bergeson & Campbell, P.C. (B&C®) is pleased to announce an exciting and important new component to our suite of Toxic Substances Control Act (TSCA) offerings. Our TSCA Tutor training platform provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.

B&C developed TSCA Tutor in recognition that TSCA awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.

B&C is now scheduling its TSCA Tutor sessions. The full TSCA Tutor program includes 18 hours of training.  More information on the sessions is available on the B&C website.  

Companies interested in finding out more, or those ready to sign-up for TSCA Tutor sessions, should contact .(JavaScript must be enabled to view this email address) for pricing and scheduling information.


 

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. 

Tags: EPA, OCSPP, twitter

 

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:

  1. 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.”
  2. 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.”
  3. 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.”
  4. 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 and Margaret R. Graham

On January 16, 2019, a group of global companies from the plastics and consumer goods value chain announced the launch of the Alliance to End Plastic Waste (AEPW), which will advance solutions to eliminate plastic waste in the environment, especially in the ocean.  AEPW membership, currently at 30 member companies, represents global companies located throughout North and South America, Europe, Asia, Southeast Asia, Africa, and the Middle East.  APEW has committed over $1.0 billion with the goal of investing $1.5 billion over the next five years.  The announcement of the launch states that APEW will “develop and bring to scale solutions that will minimize and manage plastic waste and promote solutions for used plastics by helping to enable a circular economy.”  AEPW is a not-for-profit organization that includes companies that make, use, sell, process, collect, and recycle plastics including chemical and plastic manufacturers, consumer goods companies, retailers, converters, and waste management companies.  The following companies are the founding members:  BASF, Berry Global, Braskem, Chevron Phillips Chemical Company LLC, Clariant, Covestro, Dow, DSM, ExxonMobil, Formosa Plastics Corporation, U.S.A., Henkel, LyondellBasell, Mitsubishi Chemical Holdings, Mitsui Chemicals, NOVA Chemicals, OxyChem, PolyOne, Procter & Gamble, Reliance Industries, SABIC, Sasol, SUEZ, Shell, SCG Chemicals, Sumitomo Chemical, Total, Veolia, and Versalis (Eni).

As part of its roll-out, APEW also announced an initial set of projects and collaborations that reflect a range of solutions to help end plastic waste:

  1. Partnering with cities to design integrated waste management systems in large urban areas where infrastructure is lacking.  This work will include engaging local governments and stakeholders and generating economically sustainable and replicable models that can be applied across multiple cities and regions.
  2. Funding The Incubator Network by Circulate Capital to develop and promote technologies, business models, and entrepreneurs that prevent ocean plastic waste and improve waste management and recycling, with the intention of creating a pipeline of projects for investment, with an initial focus on Southeast Asia.
  3. Developing an open source, science-based global information project to support waste management projects globally with reliable data collection, metrics, standards, and methodologies to help governments, companies, and investors focus on and accelerate actions to stop plastic waste from entering the environment.
  4. Creating a capacity building collaboration with intergovernmental organizations such as the United Nations to conduct joint workshops and trainings for government officials and community-based leaders to help them identify and pursue the most effective and locally-relevant solutions in the highest priority areas.
  5. Supporting Renew Oceans to aid localized investment and engagement.  The program is designed to capture plastic waste before it reaches the ocean from the ten major rivers shown to carry the vast majority of land-based waste to the ocean.

The global internet broadcast that aired on January 16, 2019, is available at www.endplasticwaste.org/live.  More information is available on APEW’s website.


 

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.

Background

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.

Commentary

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. 


 
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