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.

On June 24, 2020, Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Four Years Later.”  A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA), and comments by the Hon. John Shimkus U.S. Representative, 15th District of Illinois, is available to watch now.
 
This complimentary all-day virtual seminar marked the fourth Toxic Substances Control Act (TSCA) Annual Conference, with top EPA officials and industry leaders reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists covered “TSCA Implementation: Where Are We Now?,” “Science Policy Issues,” and “Regulatory and Policy Issues” while offering unique insights into the decision-making process of EPA.
 
Building on the timely information shared during this event, B&C’s All Things Chemical ™ podcast has released an exclusive interview with Alexandra Dunn focusing on the current state of TSCA, “TSCA at Four — A Conversation with Alexandra Dunn, OCSPP AA.” Lynn L. Bergeson and Alexandra Dunn focused their discussion on the implementation of the amendments to TSCA, which Congress enacted in 2016.  As pollution prevention is an integral part of EPA’s mission, this episode also focuses on initiatives under way to introduce safer and greener chemicals.  Finally, the discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce petitioned the U.S. Environmental Protection Agency (EPA) to develop a risk management procedural rule under the Toxic Substances Control Act (TSCA).  According to ACA’s June 15, 2020, press release, ACA “believes that a procedural rule would provide guard rails to ensure consistency, transparency and effective public communication in developing risk mitigation requirements for companies following EPA completion of a Risk Evaluation under TSCA.”  ACA states that a procedural rule “is needed to establish a central point of reference for all requirements and considerations involved in crafting a risk management rule regulating a specific chemical.”  The petitioners ask EPA to implement an updated risk management procedural rule addressing considerations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).  According to the press release, the petition lists and describes various risk mitigation considerations under the Lautenberg Act’s framework that should be addressed in a procedural rule, including considerations related to transparency, deadlines for compliance, notice, effective dates, exemptions for critical or essential use, coordination with and/or delegation to other agencies, and processes to amend a risk mitigation rule.  ACA states that EPA has 90 days from filing to grant or deny the petition.  If EPA grants the petition, EPA can enter into a public rulemaking process, as requested by petitioners, though it is not required to do so.  ACA notes that while the Administrative Procedure Act (APA) provides that “rules of agency organization, procedure, or practice” are exempt from notice and comment requirements, “petitioners believe that EPA should publish the requested section 6 risk management procedural rule for notice and comment because the information and opinions supplied by the public will inform the Agency’s views.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 12, 2020, that it is opening a public comment period for a manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4), a chemical used to make other silicone chemicals and as an ingredient in some personal care products.  EPA states that the manufacturer-requested risk evaluation of D4 is the third evaluation of this kind to be requested under the amended Toxic Substances Control Act (TSCA).  EPA will publish a notice in the Federal Register announcing the public comment period and beginning a 45-day comment period.  EPA “welcomes all public comments on this request, particularly on the following”:

  • Any information not included in the manufacturer request that the commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use the Agency is proposing to include in the risk evaluation; and
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA is proposing to include in the risk evaluation.

After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  EPA has opened Docket ID EPA-HQ-OPPT-2018-0443 for the request.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory.  EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  EPA plans the next regular update of the Inventory for early 2021.  According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in U.S commerce.  Other updates to the TSCA Inventory include updates to commercial activity data and updated regulatory flags, such as consent orders and significant new use rules (SNUR).

Tags: Inventory,

 

By Lynn L. Bergeson and Carla N. Hutton

On May 29, 2020, the U.S. Environmental Protection Agency (EPA) released updated data collected during the 2016 Chemical Data Reporting (CDR) period.  EPA notes that the updated 2016 CDR data now include information that was previously classified as confidential business information (CBI), such as aggregate production volumes and site-specific production volumes.  EPA published an initial release of the 2016 CDR data in May 2017.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA) were signed into law during the 2016 CDR submission period and changed CDR CBI reporting requirements.  EPA states that as a result, it conducted “a thorough substantiation and verification process with companies that submitted 2016 CDR data.”  According to EPA, this process allowed it to determine which claims met the new legal standard and ensure that valid CBI claims remained protected.

Background

On March 17, 2020, EPA announced the availability of a final rule amending the CDR rule.  EPA states that some of the key revisions include simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD); updating requirements for asserting confidentiality claims to align with the requirements in amended TSCA; and adding reporting exemptions for specific types of byproducts manufactured in certain equipment.  Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool.  More information is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” notes that EPA has changed the way that toll manufacturing must be reported.  In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals.  In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company.  This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.

Tags: CBI, CDR

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will host a webinar on May 19, 2020, from 1:00 to 3:00 p.m. (EDT) to provide an overview of the 2020 Chemical Data Reporting (CDR) requirements.  The 2020 CDR submission period is from June 1, 2020, to November 30, 2020.  The webinar will include information about the revised reporting requirements, including:

  • New requirements for making confidential business information (CBI) claims;
  • Reporting refinements related to byproducts, including exemptions;
  • Phasing in certain processing and use data codes; and
  • Process improvements for reporting co-manufacturing.

The webinar will also introduce the updated e-CDRweb reporting tool.  EPA notes that the presentation will be similar to the webinars EPA hosted on March 31 and April 9, 2020.
 
EPA states that although registration is not required, it is preferred.  Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com.  Participants should follow along with the webinar slides and use the following call-in number to access the audio:  (866) 609-6049; Conference ID:  2499985.  EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.

Tags: CDR, Webinar, CBI

 

By Lynn L. Bergeson and Christopher R. Blunck
 
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) Rule, issued in final on April 9, 2020, is that in the 2020 cycle, the U.S. Environmental Protection Agency (EPA) has changed the way that toll manufacturing must be reported.  In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals.  As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs.  Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer.  In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR Rule and instead relied on the contracting company to do so.

EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company.  EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies.  The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:

(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
 

In both cases, the producing company (toll manufacturer) must provide the manufacturing details.  There is no mechanism for the contracting company to submit the entire Form U.
 
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

Tags: CDR, Reporting

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos.  The public meeting will be virtual, with participation by phone and webcast only.  There will be no in-person gathering for this meeting.  EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting.  Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting.  Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 4, 2020, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of perchloroethylene.  85 Fed. Reg. 26464.  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be two virtual public meetings of the TSCA SACC, with participation by phone and webcast only, and no in-person gathering.  The first virtual public meeting, on May 5, 2020, will be a preparatory meeting for SACC to consider the scope and clarity of the draft charge questions for the peer review.  This meeting will be followed by the peer review public virtual meeting on May 26-29, 2020, for SACC to consider and review the draft risk evaluation.  EPA will provide any written comments submitted on the draft risk evaluation on or before May 20, 2020, to SACC for their consideration before the meeting.  Comments received after May 20, 2020, and prior to the oral public comment period during the May 26-29, 2020, meeting will be available to the SACC for their consideration during the meeting.  Comments on the draft risk evaluation are due July 6, 2020.  EPA will consider all comments received by the end of the comment period.  More information on EPA’s draft risk evaluation is available in our April 28, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Perchloroethylene.”


 

By Lynn L. Bergeson, Heather J. Blankinship, and Carla N. Hutton
 
The Ministry of Industry and Trade of the Russian Federation formally announced that the May 1, 2020, deadline to submit substances and mixtures to its chemical inventory is extended to August 1, 2020.
 
Entities exporting products to the Russian Federation should nominate their substances and mixtures to the Russian chemical inventory to ensure continued access to the Russian market.  New substance registration is required for substances or mixtures not on the inventory after the nomination process closes.
 
A company without a legal entity in Russia can appoint an Authorized Representative (AR) to submit information on its behalf and cover importation by its customers in the region.  The appointment of an AR and timely submission allow a non-Russian company to maintain an uninterrupted supply chain into the region and support its Russian customers.
 
More information is available in The Acta Group’s (Acta®) April 2, 2020, memorandum, “Russian Federation Accepting Nominations to New Chemical Inventory,” as well as Acta’s website.  Acta’s “Eurasia REACH:  Achieving Timely Compliance with New Chemicals Requirements” webinar on May 27, 2020, will provide an overview of the Eurasian Economic Union (EAEU) Technical Regulation (TR) EAEU 041/2017  (Eurasia REACH) and its implementation status, include insights into the Eurasian regional political dynamics and impacts to implementation, and cover the requirements for submitting substances and mixtures to the Russian chemical inventory.  Registration for the webinar is still open. Acta assists clients with AR appointment and provides broad-based, hands-on support in the Russian Federation to support its clients’ regulatory compliance and business success.


 
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