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 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 American Industrial Hygiene Association (AIHA) announced on May 1, 2020, the availability of industry-specific guidelines and resources intended to help employers and employees get back to work safely.  Guidelines are available for at-home service providers, retail, restaurant, hair and nail salon, and construction industries, general office settings, gyms and workout facilities and rideshare, taxi, limo, and other passenger driver-for hire.  The guidelines include recommendations on ventilation, personal hygiene, physical distancing, and enhanced cleaning.  The guidelines and other resources are available to download on a new website, http://www.backtoworksafely.org.  Additionally, COVID-19 resources on personal protective equipment (PPE) and re-entry into the workplace hazards can be found at the AIHA Media Outreach Center.
 
AIHA notes that the Back-to-Work Safely initiative is the most recent addition to a public relations campaign to clarify misinformation on PPE, ventilation, and disinfection and to educate employers and consumers about the hazards associated with re-entry into the workplace.

Tags: AIHA, Covid-19

 

The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain.  On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the "TSCA New Chemicals" webinar.  Other presenters include Lynn Dekleva, Ph.D., Associate Deputy Assistant Administrator for New Chemicals, EPA Office of Chemical Safety and Pollution Prevention (OCSPP), Tala Henry, Ph.D., Deputy Director, EPA Office of Pollution Prevention and Toxics (OPPT); Mike Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council; and Ritesh Tiwari, Chemical Engineer, EPA.  The webinar will address key changes in the Section 5 program and challenges faced by EPA and submitters, including information requirements, assessment of risks, and practical tips.  Register for the 10-part webinar series online.  B&C is a proud sponsor.


 

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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 29, 2020, that is seeking applications from states, federally-recognized tribes, Native American organizations, and non-governmental organizations (NGO) to provide technical support for the National Tribal Toxics Council (NTTC).  The NTTC works collaboratively with EPA to represent tribal interests in the development and implementation of chemical risk assessment, risk management, and pollution prevention programs.  EPA states that it anticipates awarding one cooperative agreement for approximately $800,000 over a five-year period that will focus on the following activities:

  • Assist federally-recognized tribes, Alaska Native Villages, and intertribal organizations in selecting and maintaining a geographically diverse membership with a diversity of relevant and technical expertise in the NTTC;
  • Assist the NTTC in maintaining a viable charter that covers activities eligible for EPA funding and fulfilling the objectives of that charter; and
  • Provide professional and technical support to the NTTC to conduct its meetings and other activities.

Applications are due June 15, 2020.

Tags: NTTC, Funding

 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The risk to consumers from perchloroethylene’s use in dry cleaning is from skin exposure to items cleaned with perchloroethylene.  EPA notes that it also found environmental risks to aquatic organisms.
 
EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation and will provide “frequent updates” on its progress throughout the process.  EPA notes that if its final risk evaluation finds there are unreasonable risks associated with perchloroethylene under the specific conditions of use, EPA will propose actions to address those risks within the time frame required by TSCA.  EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation, beginning a 60-day comment period.  EPA will also hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation May 26-29, 2020.  The virtual peer review meeting is open to the public to attend and provide comments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for that chemical substance.  EPA is also opening a 45-day comment period on these draft scope documents to allow for the public to provide additional data or information that could be useful to EPA in preparing the final scope documents.  Comments are due June 8, 2020.  More information on the draft scope documents is available in our April 21, 2020, memorandum, “EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances.”


 

Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.

Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies.  Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.

The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell”  Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:

All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.  All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music.  Subscribe so you never miss an episode. 


 
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