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 and Margaret R. Graham

On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory

The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements “for applicable persons to provide information to assist in the preparation of an ‘inventory of mercury supply, use, and trade in the United States,’ where ‘mercury’ is defined as ‘elemental mercury’ and ‘a mercury compound.’  The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process.”

More information on the proposed rule issued in October 2017 is available in our blog item “EPA Issues Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA.”


 

By Lynn L. Bergeson and Margaret R. Graham

On April 26, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt was grilled by Members of the U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Environment at a hearing titled The Fiscal Year 2019 U.S. Environmental Protection Agency Budget.  The budget was plainly not the primary topic as the House Committee Members covered a lot of ground.  Pruitt fielded many questions and comments from House Democrats on his alleged ethical lapses regarding spending, security details, retaliation towards EPA employees who reportedly questioned his practices, and concerns about a hostile work environment.  Lawmakers from both sides of the aisle expressed concern over the installation of a secure phone booth in his office.  His opening statement addressed these criticisms only vaguely, stating that they are merely a distraction and an attempt to “attack and derail the President’s agenda and these administration’s priorities.”  There were also questions concerning the delay of the proposed rule banning the use of methylene chloride, and criticism regarding EPA’s recent proposed rule to strengthen transparency in regulatory science (the “secret” Science Rule). 

No attempt is made here to summarize the lengthy hearing.

Pruitt’s testimony statement is available here.  It does not contain information on the Science Rule, but it briefly references the implementation of the Toxic Substances Control Act (TSCA) in a section entitled “Ensuring the Safety of Chemicals in Commerce.”

More information on the many TSCA implementation initiatives is available on our TSCA Reform News & Information webpage, as well as the TSCAblogTM.  A summary of Pruitt’s testimony before the Senate Committee on Environment and Public Works is available in our blog item “Pruitt Addresses Legacy Issues, TSCA Implementation in Oversight Hearing.” 


 

By Lynn L. Bergeson and Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) announced that it would be presenting a webinar to assist processors with reporting under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule, published in the Federal Register on August 11, 2017.  This webinar, scheduled for May 23, 2018, from 1:00 p.m. to 4:00 p.m. (EDT) will “include an overview of reporting requirements for processors, a demonstration of the electronic reporting application (Central Data Exchange, or CDX), and will provide time for questions and answers.”  Registration for the webinar is not required.  The webinar will be available through the following link on May 23: http://epawebconferencing.acms.com/tsca_inventory/.  A link to access the TSCA Inventory is available here.  The upcoming deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

More information on TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and in our memorandum “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Carla N. Hutton

On March 22, 2018, U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt appointed 11 additional members to the Science Advisory Committee on Chemicals.  Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the purpose of the Committee is to provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of the Act.  According to EPA, these additional members “will increase the balance of scientific perspectives and add experts with experience in labor, public interest, animal protection and chemical manufacturing and processing to the committee.”  The additional 11 members -- three from non-governmental organizations (NGO), four from industry, and four from academia or governmental organizations -- will supplement the 18 expert members that were appointed on January 19, 2017.  The Committee will meet three to four times a year for two years, and its charter can be extended.  EPA has not yet scheduled the Committee’s first meeting.

Two of the members have reportedly declined the appointment.  Dr. Michael Wilson, National Director for Occupational and Environmental Health at the BlueGreen Alliance, “notified EPA that he was unable to accept the appointment,” according to a spokesperson for the BlueGreen Alliance.  Dr. Jennifer McPartland, Senior Scientist at the Environmental Defense Fund, has also declined the appointment.  Ruthann Rudel, Director of Research at the Silent Spring Institute, stated that she is “collecting some advice and information” and has not decided whether to accept the appointment. 


 

By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham

On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people.  Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop.  The draft guidance documents are:

EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI.  In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA.  In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA.  A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.

On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice.  83 Fed. Reg. 10719.  Comments on the ICR are due May 11, 2018.  EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.

Tags: CBI, EPA, guidance, TSCA

 

By Lynn L. Bergeson and Margaret R. Graham

On March 9, 2018, as a first step in developing a proposed rule regulating certain persistent, bioaccumulative, and toxic (PBT) chemicals, the U.S. Environmental Protection Agency (EPA) announced that it is seeking nominations for individuals who represent small businesses, small governments, and small non-for-profit organizations to serve as Small Entity Representatives (SER) to provide input on potential impacts of PBT regulation.  EPA states the role of a SER is “to provide advice and recommendations to ensure that the Panel carefully considers small entity concerns regarding the impact of the potential rule on their organizations and to communicate with other small entities within their sector who do not serve as SERs,” and will ask the SERs to provide comments on behalf of their company, community, or organization and advise a soon to be created Small Business Advocacy Review (SBAR) panel regarding potential impacts to small businesses that could result from the regulation of certain identified PBTs.  The SBAR panel will include federal representatives from EPA, the Small Business Administration, and the Office of Management and Budget (OMB).  After collecting input from the small entities, the panel will make recommendations to the Agency on the development of a proposed rule to regulate these PBT chemicals.

Under Section 6(h) of the Toxic Substances Control Act (TSCA), EPA is required, not later than three years after the date of enactment (June 22, 2019), to propose rules regarding the regulation of certain PBTs selected from the 2014 update of the TSCA Work Plan for Chemical Assessments that:  (1) EPA has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other have been identified; and (2) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator.  The PBT chemicals that EPA has selected are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics, wiring insulation, and building and construction materials;
  • Hexachlorobutadiene (HCBD), used as a solvent in the manufacture of rubber compounds and as hydraulic, heat transfer or transformer fluid;
  • Pentachlorothiophenol (PCTP), used as a mercaptan (sulfur) cross-linking agent to make rubber more pliable in industrial uses;
  • Phenol, isopropylated, phosphate (3:1), used as a flame retardant in consumer products and as lubricant, hydraulic fluid, and other industrial uses; and
  •  2,4,6-Tris(tert-butyl) phenol, an antioxidant that can be used as a fuel, oil, gasoline or lubricant additive. 

The Regulatory Flexibility Act requires agencies to establish a SBAR panel for rules that may have a significant economic impact on a substantial number of small entities.  EPA states that the panel process will offer “an opportunity for small businesses, small governments and small not-for-profit organizations … to provide advice and recommendations to ensure that the EPA carefully considers small entity concerns regarding the impact of the potential rule on their organizations.” 

EPA states eligible SERs are small entities that manufacture, process, distribute in commerce, use, or dispose any of the five selected PBT chemicals.  EPA is seeking self-nominations directly from entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted through the instructions outlined on EPA’s Potential SBAR Panel website and must be received by March 22, 2018.  More information about the SBAR process is available online. 


 

By Lynn L. Bergeson and Margaret R. Graham

On March 7, 2018, the U.S. Environmental Protection Agency (EPA) released a draft Strategic Plan to Promote the Development and Implementation of Alternative Test Methods to reduce the use of vertebrate animals in chemical testing, fulfilling another milestone under the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA).  Under amended TSCA, EPA is required to develop a strategy to promote the development and implementation of alternative test methods and strategies to reduce, refine or replace vertebrate animal testing by June 22, 2018.  EPA states the draft document incorporates input from a November 2017 public meeting held on the development of the draft strategy, as well as written comments submitted after the meeting, and draws upon EPA research on test methods.

The draft strategy outlines EPA’s Strategic Plan for the reduction of testing in vertebrates for chemicals regulated under TSCA. The organizing framework for the EPA’s strategy to reduce vertebrate animal testing relies heavily on what have been termed new approach methodologies (NAM) -- a broadly descriptive reference to any nonanimal technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment.  The strategy describes a multi-year process with incremental steps for adoption and integration of NAMs that are appropriate and fit-for-purpose for making TSCA decisions, and has three core components:

  • Identifying, developing, and integrating NAMs for TSCA decisions;
  • Building confidence that the NAMs are scientifically reliable and relevant for TSCA decisions; and
  • Implementing the reliable and relevant NAMs for TSCA decisions. The EPA has identified seven current/near-term (less that three years) needs and activities.

EPA states that completing these activities will result in moving towards four intermediate-term (three to five years) objectives and these time frames, needs, and activities provide the basis for developing NAMs, establishing reliability and relevance criteria for the NAMs, and implementing NAMs to inform decisions made under TSCA.

Comments on the draft strategy will be due 45 days after the notice of availability is published in the Federal Register.  EPA has scheduled a public meeting to obtain input on the draft strategy for April 10, 2018, from 9:00 a.m. (EDT) to 5:00 p.m. (EDT) in Washington, D.C.  Registration is available online and is requested by April 3, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user fees applicable to any person required to submit information to EPA under TSCA Section 4 or a notice, including an exemption or other information, to be reviewed by the Administrator under TSCA Section 5, or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  Comments on the proposed rule are due April 27, 2018.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) is available in our memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

 


 

By Lynn L. Bergeson and Margaret R. Graham

On February 16, 2018, the U.S. District Court for the Northern District of California issued an order granting plaintiffs’, the Sierra Club and A Community Voice-Louisiana, motion for summary judgment.  The court determined that the U.S. Environmental Protection Agency’s (EPA) final rule delaying the compliance date for the formaldehyde emission standards for composite wood products (Delay Rule) exceeded EPA’s authority under the Formaldehyde Standards in Composite Wood Products Act (Formaldehyde Act) codified as Title VI of the Toxic Substances Control Act (TSCA), vacated the Delay Rule, and set aside the year-long extension to December 12, 2018, of the compliance deadlines set out by EPA in the Delay Rule.  Sierra Club v. Pruitt, Case No. 4:17-cv-06293.  The Delay Rule, issued on September 25, 2017 (82 Fed. Reg. 44533), sought to extend further the compliance dates set out in its December 12, 2016, final rule that implemented the Formaldehyde Act (Formaldehyde Rule) (81 Fed. Reg. 89674), specifically:  the December 12, 2017, manufactured-by date for emission standards, recordkeeping, and labeling provisions until December 12, 2018; the December 12, 2018, compliance date for import certification provisions until March 22, 2019; and the December 12, 2023, compliance date for provisions applicable to producers of laminated products until March 22, 2024.  

As stated in the order, the Formaldehyde Act set out emission standards for domestically manufactured and imported composite wood products and directed EPA, by no later than July 1, 2013, to promulgate implementing regulations that would ensure compliance with the new emission standards; based on the Delay Rule’s further extension of deadlines, which sets both the manufacturing and emission standards compliance dates to December 12, 2018, EPA would have delayed the implementation for more than three years after the Formaldehyde Act had originally directed EPA to require compliance.

The order also denies defendant EPA’s cross-motion for summary judgment in which EPA states three arguments against plaintiffs’ motion:  (1) plaintiffs’ challenge is waived, as plaintiffs did not comment on the proposed extension by raising the sole issue plaintiffs raise in their motion; (2) the statute upon which plaintiffs base their claim expressly provides for EPA to set the manufactured-by date more than 180 days from promulgation of the implementing regulations; and (3) EPA’s extension of the manufactured-by date was reasonable, supported by the record, and not arbitrary or capricious.

In its analysis, the court offered the following to support its holdings:

  1. The designation of a manufacturing date “no earlier than 180 days following promulgation of the regulations” found in the sell-through provision of the Formaldehyde Act must fall on the 180th day after the regulations take effect.   EPA’s interpretation to set the manufacture date beyond 180 days from promulgation of the regulations effectively resets the compliance date in violation of the Formaldehyde Act’s mandatory expedient compliance deadline and the prohibition against stockpiling.
  2. EPA’s interpretation that it can designate the manufacture date beyond the 180 days limit for compliance with the emission standards is contrary to law and beyond the grant of authority bestowed upon it by Congress in the Formaldehyde Act.
  3. EPA’s interpretation creates inconsistency within the full text of the Formaldehyde Act, renders the 180-day compliance deadline superfluous, leads to the “absurd” result of permitting the perpetual delay of the effectiveness of the Formaldehyde Rule, and fails to satisfy the stated purpose of the Formaldehyde Act. 

The court concluded that the issue of whether EPA should extend the deadline for compliance with the emission standards of the Formaldehyde Rule was adequately before it for consideration. The court stayed the order vacating the Delay Rule until the parties address the implementation of the compliance guidelines and the court directs them to provide, by March 9, 2018, a joint proposed submission or simultaneous briefing to address the timing for lifting the stay and expeditious implementation of the court’s order. 

The ruling is one of several expected that will inform stakeholders on the scope of EPA’s authority under the Administrative Procedure Act (APA) and the underlying Act at issue, here the Formaldehyde Act, in undoing Obama-era regulations and the extent of Agency discretion in deciding whether and to what extent such rules can be unilaterally delayed or eliminated entirely.  The Trump Administration has in unprecedented ways sought to roll back rules under a host of laws, environmental and otherwise, in ways that detractors claim are illegal and contrary to the APA and other laws.  Here, the court emphasized the Formaldehyde Act’s “expeditious” emission compliance standards and reasoned that the repeated delays were simply inconsistent with Congress’ intent.

More information on the Formaldehyde Act under TSCA is available on our blog.


 
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