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

On June 11-13, 2019, the American Chemical Society (ACS) Green Chemistry Institute® will host the 23rd Annual Green Chemistry and Engineering Conference and the 9th International Conference on Green and Sustainable Chemistry.  The Conference will be held right outside of Washington D.C. in Reston, Virginia, and will focus on the theme of “Closing the Loop” in the chemical life cycle.  With over three days of programming, the Conference offers more than 40 technical sessions in seven concurrent tracks and multiple opportunities to network with hundreds of attendees from around the world.  This year’s featured keynote speakers are:

  • Udit Batra, Ph.D., Chief Executive Officer, MilliporeSigma;
  • Lee Cronin, Ph.D., Regis Professor of Chemistry, University of Glasgow; and
  • Dana Kralisch, Ph.D., Professor of Pharmaceutical Technology and Biopharmacy, Institute of Pharmacy, Faculty of Biological Sciences, Friedrich Schiller University of Jena, and Chief Technical Officer, JeNACell GmbH.

Richard E. Engler, Ph.D., Director of Chemistry for Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), will be presenting Regulatory Barriers to a Circular Economy on June 13, 2019, and Ligia Duarte Botelho, M.A., a Regulatory Associate with B&C and Acta and Manager with B&C® Consortia Management, L.L.C. (BCCM), will be presenting Role of Regulations in Circular Economy: Challenge of New Chemical Bias on June 13, 2019.

Reduced rates for advanced registration are available until May 31, 2019.  Registration is available online


 

By Lynn L. Bergeson

On June 10, 2019, at 5:00 p.m., the American Chemical Society (ACS) will hold the 2019 Green Chemistry Challenge Awards ceremony in Washington, D.C.  Sponsored by the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), in partnership with the ACS Green Chemistry Institute® and members of the chemical community, these prestigious annual awards recognize chemical technologies that incorporate the principles of green chemistry into chemical design, manufacture, and use. 

EPA usually presents one Green Chemistry Challenge Award in each award category.  For the 2019 competition, there are five award categories:

  • Focus Area 1:  Greener Synthetic Pathways;
  • Focus Area 2:  Greener Reaction Conditions;
  • Focus Area 3:  The Design of Greener Chemicals;
  • Small Business (for a technology in any of the three focus areas developed by a small business); and
  • Academic (for a technology in any of the three focus areas developed by an academic researcher).

If you are interested in attending this event, please RSVP to .(JavaScript must be enabled to view this email address) for more information.


 

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

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process.

EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.”  EPA Assistant Administrator Alexandra Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed. Reg. 20354.  The meeting may also be available via webcast.

EPA states that the purpose of the SACC meeting is for EPA “to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment, and risk characterization.”  Additionally, this meeting will include an orientation on TSCA and how EPA is evaluating chemicals in commerce as prescribed in amended TSCA.  EPA states that it will use the scientific advice, information, and recommendations from the SACC, as well as public comments, to inform the final risk evaluation.  Comments are still being collected on the PV29 risk assessment until May 17, 2019, in Docket No. EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

More information about the June SACC meeting and peer review of PV29 is available on EPA’s website.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder responses to this candidate list proposal and follow up actions with EPA related to risk evaluation work optimally will be conducted under existing or potentially newly formed chemical consortia.  But what if your chemical is not on the list of 20?  If you want to protect or even increase your business market advantage, consider inviting your commercial rivals to join an industry advocacy group anyway.  This is particularly important if you have a chemical of commercial interest on the TSCA Work Plan Chemicals list.  For more information on this issue, please see our full memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  The pre-publication version of the notice is available here.  Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive.  Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.  

Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.

For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 1, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) sent a memorandum to Alexandria Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, announcing that it “plans to begin preliminary research on the Office of Pollution Prevention and Toxics processes to implement the work to meet statutory deadlines of the Lautenberg Act.”  OIG’s objectives are to determine whether EPA has met the deadlines imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines.

As reported in our March 6, 2019, memorandum, “GAO Reviews EPA’s IRIS Assessment Efforts and Implementation of TSCA Reforms,” the U.S. Government Accountability Office (GAO) recently assessed whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA) as amended by the Lautenberg Act.  In its report, Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act, GAO found that while EPA has responded to the initial statutory deadlines in TSCA, as amended by the Lautenberg Act, challenges remain.  As stated in our memorandum, the report draws attention to the challenges facing EPA, including:

  • Pending litigation by environmental groups against many of the final rules;
  • Ensuring appropriate resources and staffing to meet the increased workload required under amended TSCA;
  • Need for development of internal guidance documents to ensure consistency in EPA’s approaches;
  • Ensuring that new chemical review is efficient and predictable, and
  • Attempting to move forward with a major reorganization of the Office of Pollution Prevention and Toxics.

More information is available in our memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 30, 2019, the U.S. Environmental Protection Agency (EPA) announced it would be hosting two webinars for companies, organizations, and individuals required to report under the Mercury Inventory Reporting Rule of the Toxic Substances Control Act (TSCA).  The final rule applies to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).

The first webinar, Mercury Inventory Reporting Rule, will provide background on reporting requirements under the final rule.  It will take place on May 21, 2019, at 2:00 p.m. (EDT).  The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is coming up on July 1, 2019.  Reporters are required to submit their information to EPA using the Mercury Electronic Reporting (MER) application for the first time on July 1, 2019, and then every three years thereafter.  Based on the information collected, EPA will identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use.  Following EPA’s presentation, webinar participants will have an opportunity to ask questions on reporting requirements under the final rule.  Registration is available online.

The second webinar, Mercury Electronic Reporting (MER) Application, will demonstrate how to use the online MER application through EPA’s Central Data Exchange (CDX), which is organized as a fill-in-the-blanks form with drop-down menus and lists of check-box options.  It will take place on May 23, 2019, at 2:00 p.m. (EDT).  Registration is available online.

More information on the Mercury Inventory Reporting Rule is available in our June 25, 2018, memorandum “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” and in our March 19, 2019, memorandum “EPA Releases New Tools to Help Companies Meet July 1 Mercury Reporting Requirements.”


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 

The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered” in the final rule.  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.”

Regarding the other four claims that it denied, EPA made the following statements:

  1. “EPA acted well within its discretion in concluding that, as part of the Inventory update, any manufacturer or processor of a chemical substance can file a claim to maintain the chemical substance’s confidentiality”;
  2. “There is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation”;
  3. “Agencies need not address all regulatory obligations ‘in one fell swoop’ … nothing in [TSCA] requires the EPA to develop and implement the unique identifier system alongside its Inventory review process”; and
  4. “EPA’s decision [to exclude export-only chemicals from the final rule’s requirement that chemical companies notify EPA of chemical substances being manufactured or processed] reflected a reasonable interpretation of [TSCA].”

 
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