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, Susan M. Kirsch, and Margaret R. Graham

On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt.  In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.”  In opening remarks, Senator Tom Carper (Ranking Member of the EPW Committee) (D-DE)) challenged Pruitt’s record on implementing TSCA reform, stating that EPA has not truly used the authority bestowed on it through TSCA to declare that products being sold on the market are safe, therefore, consumers do not have the confidence that they deserve and that Congress intended in passing TSCA.  Pruitt did not respond to this comment, and did not go on to address TSCA implementation in his brief opening remarks.  Instead, Pruitt devoted the bulk of his opening statement to highlighting specific areas where EPA’s environmental protection goals dovetail well with opportunities for economic growth.  These issues/economic opportunities included:  investment in infrastructure to eradicate lead from drinking water within a decade; advancing initiatives that incentivize private companies to take on clean-up projects at abandoned mines; and remediation activities at “Superfund” sites -- hazardous waste sites regulated under the  Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

Senator Jeff Merkley (D-OR) expressed concern that EPA’s chemical reviews under TSCA were only focusing on new “items” (chemicals) being made, but overlooking “legacy” chemicals already in the environment (e.g., asbestos).  Merkley cited a report that claimed that review of the ten chemicals on the priority list were being “slow-walked.”  In response, Pruitt stated “it is an absolute priority during [EPA’s] first year,” the three TSCA final rules were issued consistent with the implementation schedule in the first year, and the backlog of chemical reviews has been addressed through the addition of resources. 

Senator Kirsten Gillibrand (D-NY) expressed her concerns regarding the toxic levels of perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) that have been found throughout New York State, stating that EPA was not using its TSCA authority to regulate these chemicals, as the implementation final rules “ignored the public’s exposure to the past uses of chemicals called legacy uses” that could still have the potential to contaminate groundwater.  She also stated her concern that due to this oversight, EPA will not likely study the health risks of widespread exposure to chemicals such as PFOS/PFOS.  She requested of Pruitt to revise the TSCA implementation rules to address legacy issues, so that “all uses of a chemical, including legacy uses, are studied.”  Pruitt stated that as PFOA and PFOS have not been manufactured since early 2000, they are in fact legacy uses, and that EPA was “very much going to focus” on this issue.  Gillibrand appeared to be content with his answer, as she did not demand a further commitment from him.  In regards to the Hudson River, Gillibrand requested that data from the sediment sampling be integrated into EPA’s five year review plan regarding the effectiveness of dredging for removing polychlorinated biphenyl (PCB) from the Hudson River.  Pruitt stated that EPA was reviewing the samples currently and that there is more work to be done to get clarity on this issue.  Gillibrand requested Pruitt to personally review the final report to ensure that all issues have been addressed and Pruitt confirmed that he would.

Near the close of the hearing, Senator Carper further stated that EPA has failed to follow through on its proposed ban of three highly toxic chemicals that Congress gave it the authority to ban when it enacted TSCA reform:  specifically methylene chloride, tricholoroethylene (TCE), and methylpyrrolidone (NMP), and asked Pruitt to commit to using EPA’s authority to ban them within the next 30 days.  Pruitt responded that they are on the priority list and that he will confirm this with the agency (that they are priorities, not that they will be banned in 30 days).  EPA’s delay in finalizing the bans was among the failures cited in the Senate EPW Minority Staff report, released January 29, 2018, “Basically Backward:  How the Trump Administration is Erasing Decades of Air, Water and Land Protections and Jeopardizing Public Health.”

Several Senators indicated their intention to submit additional questions for the record.  Pruitt has until February 13, 2018, to submit written responses, which will be made available on the EPW Committee website.  The full hearing is available on the EPW Committee’s website.  


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of chemical substances on the TSCA Inventory.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.  Specific information on the upcoming reporting deadline and changes in the CDX system is available in our blog items EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline and EPA Updates eNOA Template in CDX System.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 18, 2018, the U.S. Environmental Protection Agency (EPA) posted additional documents on its website, specifically materials from two webinars, designed to assist manufacturers reporting for the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule that became effective on August 11, 2017.  The rule, which established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, requires manufacturers to report to EPA by February 7, 2018, for the retrospective reporting period that began on August 11, 2017 (180 days after the final rule was published in the Federal Register).  The webinar slides and transcripts posted have three general sections:  (1) an overview of the new reporting requirements; (2) a demonstration of the electronic reporting application in CDX; and (3) a question and answer session, where technical questions related to the reporting requirements and the electronic reporting application were addressed.  These materials are:

An additional helpful development for manufacturers is the recent launch of the American Chemistry Council’s (ACC) TSCA Inventory Reset CDX Receipt Database.  The database allows manufacturers, importers, and processers under TSCA to upload and share Central Data Exchange (CDX) receipts.  Further, it is being reported that EPA will also be providing and updating a list of frequently asked questions prior to the February 7 deadline. 

Following this retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory.  EPA will publish the draft Inventory with the active designations “as soon as is practicable” following the close of the 180-day submission period.  The draft Inventory will not have the legal effect of actually designating any chemical substance as inactive, however, and EPA does not construe it as the list with “designations of active substances and inactive substances” from which forward-looking reporting commences.  EPA states that it concludes that new TSCA is referring to the completed product of the initial cycle of sorting between active and inactive substances, not the preliminary product of the initial cycle of such sorting.

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.


 

By Lynn L. Bergeson

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, "Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018," is now available.  In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal, scientific, and regulatory issues expected to be hot topics in 2018.  This 38-page document is chock-full of insights, predictions, and useful information.

Happy New Year and enjoy reading our predictions!


 

By Lynn L. Bergeson and Margaret R. Graham

On January 3, 2018, the U.S. Environmental Protection Agency announced it would be hosting two webinars to support Third-Party Certifiers (TPC) in generating and entering annual report information into the Central Data Exchange (CDX).  Registration is available online through the following links: the webinars will be held on January 9, 2018, from 1:00 p.m. to 3:00 p.m. (EST); and on February 1, 2018, from 9:00 a.m. to 11:00 a.m. (EST).  Both webinar presentations will provide an overview of the TPC annual report requirements and a live demonstration of the reporting process through CDX.

As required under the Toxic Substances Control Act (TSCA) Title VI final rule that implemented the Formaldehyde Standards for Composite Wood Products Act, EPA-recognized TPCs must submit an annual report to EPA through CDX on or before March 1, 2018.  The required information includes the name and location of the mill(s), the types of products certified for them, and quarterly test data on each product.  Providing certification services for multiple mills and submitting that information to the CDX database may take a considerable amount of time, therefore, EPA strongly suggests for TPCs to start entering the required information and existing testing data for each panel producer as soon as possible to ensure that they meet the deadline.  Basic information on each panel producer, such as name(s), product type(s), and testing information that is available now can be entered into CDX immediately. 

EPA also stated the importance of retaining the password; the password created for the annual report will be required later to amend, finalize, and submit the report to the EPA.  If this password is lost, it cannot be recovered, and a new annual report submission would need to be created.

More information is available on EPA’s website.


 

By Christopher R. Bryant and Lynn L. Bergeson

On December 27, 2017, a three-judge panel of the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) ordered the U.S. Environmental Protection Agency (EPA) to revise its nearly 17-year-old standard for levels of lead in paint and dust within one year.  A Cmty. Voice v. EPA, No. 16-72816.  The Ninth Circuit held that “EPA was under a duty stemming from the Toxic Substances Control Act and the Residential Lead-Based Paint Hazard Reduction Act of 1992 to update lead-based paint and dust-lead hazard standards in light of the obvious need, and a duty under the Administrative Procedure Act to fully respond to petitioners’ rulemaking petition.”  The decision stems from a petition filed in June 2016 by environmental and health groups seeking this action.  The order came in the form of a writ of mandamus, an unusual court order and extraordinary judicial remedy that requires an official or agency to perform a certain duty, in this case for EPA to issue a proposed rule within 90 days of this decision and to promulgate the final rule within a year of when the proposed rule is issued.  The court stated that in doing so, it was mindful of the Agency’s arguments that officials needed more time to deliberate a complex new standard.

Commentary

While not entirely surprising given the Circuit, the decision relies on a seldom used remedy that rarely succeeds in judicial settings.  It reflects the court’s sharp rebuff of the Administration’s apparent decision to delay action on the lead standard.  Given the many challenges EPA’s Office of Pollution Prevention and Toxics will face in the New Year, complying with the court’s order will not be easy.  


 

By Lynn L. Bergeson and Margaret R. Graham

On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018.  The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders additional time to assess the impacts of the proposal, review technical documents in the docket, and prepare comments.  The 2016 amendments TSCA require EPA to establish periodic mercury reporting requirements for any person that manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process to assist in the development of an inventory of mercury and other recommended actions.  EPA’s proposed rule, issued on October 26, 2017 (82 Fed. Reg. 49564), specifically requires reporting on the manufacture, import, distribution in commerce, storage, and export of mercury.  

More information on this proposed rule is available in our memorandum December 26, 2017, Deadline Approaching for Comments on EPA’s Proposed Reporting Requirements for TSCA Mercury Inventory.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals.  EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  The deadline to submit comments is fast approaching:  December 9, 2017.  The five chemicals and their corresponding dockets are:

In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents which provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical.  Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed. 

More information on the PBTs is available on our blog under keyword PBTs.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
  • New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.  EPA states that this document includes EPA’s general decision framework for new chemicals and a breakdown of how EPA intends to approach each of the five types of new-chemical determinations required.
  • Points to Consider When Preparing TSCA New Chemical Notifications (Draft).  This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice.  EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
  • Overview of Comments Received on the Draft "Points to Consider" Document.  This document summarizes 151 comments received on the draft Points to Consider document.  It organizes them by topic.  The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings.  These comments have not been posted in the docket for this meeting.
  • New Chemicals Decision Guidelines Manual – Detailed Outline.  EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5.  It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.

The December 6, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 20, 2018.

More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.


 

By Lynn L. Bergeson and Margaret R. Graham

On October 26, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory.  82 Fed. Reg. 49564.  Under TSCA Section 8(b)(10)(B), the mercury inventory, which includes mercury “supply, use, and trade” in the United States, is required to be published every three years.  Information on the 2017 mercury inventory report is available in our blog item "EPA Releases Inventory Report of Mercury Supply, Use, and Trade in the U.S."

Through this proposed rule, EPA is on its way to delivering timely on its mandate under TSCA Section 8(b)(10)(D) to promulgate a rule within two years of the enactment of new TSCA (by June 22, 2018) that will require “any person who manufactures [including import] mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process” to make periodic reports to EPA to assist in the preparation of the mercury inventory. 

TSCA Section 8(b)(10)(C) further directs to “identify any manufacturing processes or products that intentionally add mercury; and … recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  The proposed rule, however, states that “[a]t this time, EPA is not making such identifications or recommendations.” 

The proposed rule requests comments on several changes, including:

  • On the proposed limited data collection requirements, such as the identification of countries that manufacture, import, or export mercury-added products (i.e., countries of origin and destination), as well as the identification of purchasing or receiving industry sectors via North American Industrial Classification System (NAICS) codes, to inform activities under the Minamata Convention on Mercury;
  • On whether to require one-time reporting for exports of the mercury compounds prohibited from export under TSCA Section 12(c)(7);
  • On its proposal to apply the proposed reporting requirements to any person who manufactures (including imports) mercury, mercury-added products or otherwise intentionally uses mercury in a manufacturing process regardless of the amount of mercury at issue;
  • On its proposal that because of the similarities in the intentional addition of mercury to manufacture a product and otherwise intentional use of mercury in a manufacturing process, all quantities of mercury used in both activities should be reported without a reporting threshold;
  • On what kinds of information would be particularly important to address for small entities if EPA were to develop compliance guides tailored to small entities that will be required to comply with the reporting requirements;
  • On whether the proposed reporting requirements should apply to persons who do not manufacture or import mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, but engage in the supply, use, and trade of mercury in the United States; and
  • On its proposal to require mandatory electronic reporting.

EPA also requests comments on the proposed timelines and reporting deadlines; and on the proposed interpretations of activities to be considered as part of supply, use, and trade of mercury in the United States -- as described below.

For those who will need to report, EPA proposes the following reporting periods and deadlines:

  • The 2020 reporting year will be from January 1 to December 31, 2018; subsequent recurring reporting years will be from January 1 to December 31 at three-year intervals beginning in 2021;
  • All information reported for an applicable reporting year must be submitted on or before the first day of July following the reporting year.  The 2020 submission deadline is July 1, 2019; subsequent recurring submission deadlines are from July 1, in three-year intervals, beginning in 2022.

EPA’s proposed interpretations of activities to be considered as part of the supply, use, and trade of mercury in the United States are as follows:

  • Import of mercury or a mercury added product with the purpose of obtaining an immediate or eventual commercial advantage for the importer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity.
  • Manufacture (other than import) of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity. In this context, EPA considers manufacture to be the intentional production of mercury, a mercury compound, or a mercury-added product.
  • Otherwise intentional use of mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, with the purpose of obtaining an immediate or eventual commercial advantage for the user, except where such mercury is generated as a byproduct not used for commercial purposes.
  • Distribution in commerce, including domestic sale or transfer, of mercury or a mercury-added product.
  • Storage of mercury after manufacture (including import).
  • Export of mercury or a mercury-added product, including the determining and controlling the sending of mercury (unless specifically prohibited) or a mercury-added product to a destination out of the customs territory of the United States.

Comments on the proposed rule are due by December 26, 2017.


 
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