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 Carla N. Hutton
 
Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require be included, and then make the revised draft scopes available for public comment.  The NGOs maintain that under both TSCA and EPA regulations codifying the risk evaluation rule, the scope of a risk evaluation must identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate; and
     
  • The hazards to health and the environment that EPA plans to evaluate.

The scope document must also present the “reasonably available information” on which EPA relies to identify these required scope elements.  The NGOs note that EPA regulations make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  Instead, according to the NGOs, “EPA’s draft scopes repeatedly indicate that these required scope elements will be developed and provided later -- thereby denying the public an opportunity to provide comment on the specific hazards, exposures and potentially exposed or susceptible subpopulations EPA expects to consider, as required at this stage in the process.”
 
The NGOs state that EPA also repeatedly refers in each draft scope to “systematic review documentation” that has not yet been made public.  EPA will use this separate document to identify the required scope elements and the reasonably available information on which it relies.  While EPA plans to publish this second document prior to issuing the final scope document, and take public comment on it, “EPA has wholly divorced that process from the public comment process for the draft scopes.”  By doing so, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  The NGOs urge EPA to publish and take comment simultaneously on the systematic review documentation for each scope along with the revised draft scopes themselves.


 

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 Carla N. Hutton
 

On May 12, 2020, the U.S. Environmental Protection Agency (EPA) released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under the Toxic Substances Control Act (TSCA).  According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States.  The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition.  When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.”  The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.
 
EPA notes that the updated definitions will apply to the Chemical Data Reporting (CDR) rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules.  EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation.  The final rule will be effective 30 days after publication in the Federal Register.  EPA has posted the pre-publication version of the final rule on its website.
 
More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”


 

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

 
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