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 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.


 

By Lynn L. Bergeson and Kathleen M. Roberts

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423. 

During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary.  EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes.  The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.

The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:

The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.

During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020.  To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings.   While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements. 

It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle. 

More information on the negotiated rulemaking process as related to inorganic byproducts is available on our blog under key phrases negotiated rulemaking and inorganic byproducts.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 20, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating that it is extending the compliance date by which submitters of Toxic Substances Control Act (TSCA) submissions containing information claimed as Confidential Business Information (CBI) and filed between June 22, 2016, and March 21, 2017, had to submit to EPA the substantiation required by TSCA Section 14(c)(3) for all information claimed as confidential, other than information exempt from substantiation pursuant to TSCA Section 14(c)(2).  82 Fed. Reg. 43964.  The new deadline for substantiation of these claims is October 19, 2017.  EPA states that this extension is in response to “concerns raised by industry stakeholders regarding the ability for companies to meet the previous September 19, 2017, deadline due to recent severe weather events,” and that it is “providing this additional flexibility for stakeholders because of the impacts of hurricanes Harvey and Irma.”  Further, “because EPA published its interpretation that TSCA section 14(c)(3) requires up front substantiation after some companies had already asserted confidentiality claims subject to TSCA section 14(c)(3), the Agency set a future deadline for submission of substantiations pertaining to those submissions.” 

More information on the CBI substantiation process is available in our memorandum The September 19th CBI Substantiation Deadline Fast Approaching.

Also on September 20, 2017, EPA announced it was scheduling three webinars to assist the regulated community with reporting under the TSCA Inventory Notification (Active-Inactive) rule.  The webinars, scheduled for September 27, 2017, October 25, 2017, and November 29, 2017, from 1:00 p.m. - 3:00 p.m. (ET), will be identical and will include an overview of reporting requirements, a demo of the electronic reporting application (Central Data Exchange (CDX)), and will provide time for questions and answers.  Registration for the webinars is not required.  EPA’s TSCA Inventory webpage contains the information on how to access the webinar.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 
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