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 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 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, Kathleen M. Roberts, and Carla N. Hutton

On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers.  84 Fed. Reg. 17692.  The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters.  Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR.  EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small.  Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.  Comments are due by June 24, 2019.  More information on the proposed rule is available in our full memorandum.


 

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019See the full memorandum for more information on the proposed rule. 


 

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

On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA), specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT)Registration is required.  The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”

The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAM) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances.  EPA states that these webinars on the use of New Approach Methodologies (NAMs) in Risk Assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.


 

By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 5, 2019, the U.S. Environmental Protection Agency (EPA) issued a final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 13531. The final rule is significant because the 13 chemical substances are not also subject to consent orders.  During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs.  The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk.  The final rule will become effective on June 4, 2019.  Please see our full memorandum for more information on this final rule.


 

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

On March 22, 2019, the U.S. Environment Protection Agency (EPA) issued a memorandum stating that it was releasing 24 studies in the Colour Index (C.I.) Pigment Violet (PV) 29 docket (Docket No. EPA-HQ-OPPT-2018-0604) that were reviewed by EPA to develop its Draft Risk Evaluation for C.I. PV 29.  EPA states that these studies are being made available to the public prior to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) expert panel peer review of the draft risk evaluation.  That entirety of the reports was originally erroneously claimed to be confidential business information (CBI), therefore, the reports were not included in the public docket previously.   Fifteen of the study reports have been released without any redactions while nine reports were partially redacted.  EPA provides a full list of the studies and their confidential status in the memorandum.  The 24 study reports represent the following disciplines:  #1-17 Human Health; #18-20 Environmental Hazard; #21-22 Environmental Fate, and #23-24 Physical Chemical properties.  Twenty of the 29 studies made available in the dockets were summarized in the European Chemicals Agency’s (ECHA) registration dossier for C.I. PV 29; EPA refers to them as “robust summaries” and states that it has compared the information contained in the robust summaries against the information contained in the study reports for accuracy.  They were posted to the docket in November 2018. 


 

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

On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include:

  • Seven chlorinated solvents;
  • Six phthalates;
  • Four flame retardants;
  • Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
  • A fragrance additive; and
  • A polymer pre-curser.

EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates.  The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria. 

Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however.  EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.”  EPA is scheduled to publish the notice regarding this list in the Federal Register on March 21, 2019.  The pre-publication notice is available here.  Comments will be due 90 days after publication in the Federal Register.  EPA is opening a docket for each of the 40 chemicals.  EPA is then directed to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority. 

Please be on the lookout for our memorandum that will contain more information regarding EPA’s list.  It will be posted on our Regulatory Developments webpage.


 

By Lynn L. Bergeson and Carla N. Hutton

On March 18, 2019, the U.S. Environmental Protection Agency (EPA) released new tools intended to help companies, organizations, and individuals fulfill their reporting requirements under the mercury reporting requirements rule.  Those required to report under the mercury rule can now do so online through the Mercury Electronic Reporting (MER) application accessed through EPA’s Central Data Exchange (CDX).  EPA states that it designed this reporting tool “to be user-friendly, with drop-down menus and lists of check-box options, to help make reporting easy and efficient.”  As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury 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 the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides).  EPA will use data from the 2018 reporting year for the 2020 mercury inventory.  The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.  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.  More information is available in our memorandum.


 
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