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 February 7, 2018, manufacturers that manufactured (including imported) chemicals for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, will be required to report to the U.S. Environmental Protection Agency (EPA) for the retrospective reporting period that began on August 11, 2017, per the Toxic Substances Control Act (TSCA) Inventory Notification (Active/Inactive) Requirements final rule that established a retrospective electronic notification of chemical substances on the TSCA Inventory.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.  Specific information on the upcoming reporting deadline and changes in the CDX system is available in our blog items EPA Offers Assistance to Manufacturers Reporting for the TSCA Inventory February 7, 2018, Deadline and EPA Updates eNOA Template in CDX System.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 18, 2018, the U.S. Environmental Protection Agency (EPA) posted additional documents on its website, specifically materials from two webinars, designed to assist manufacturers reporting for the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements final rule that became effective on August 11, 2017.  The rule, which established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, requires manufacturers to report to EPA by February 7, 2018, for the retrospective reporting period that began on August 11, 2017 (180 days after the final rule was published in the Federal Register).  The webinar slides and transcripts posted have three general sections:  (1) an overview of the new reporting requirements; (2) a demonstration of the electronic reporting application in CDX; and (3) a question and answer session, where technical questions related to the reporting requirements and the electronic reporting application were addressed.  These materials are:

An additional helpful development for manufacturers is the recent launch of the American Chemistry Council’s (ACC) TSCA Inventory Reset CDX Receipt Database.  The database allows manufacturers, importers, and processers under TSCA to upload and share Central Data Exchange (CDX) receipts.  Further, it is being reported that EPA will also be providing and updating a list of frequently asked questions prior to the February 7 deadline. 

Following this retrospective reporting for manufacturers, EPA will include the active designations, determined by the notices received, on a draft of the Inventory.  EPA will publish the draft Inventory with the active designations “as soon as is practicable” following the close of the 180-day submission period.  The draft Inventory will not have the legal effect of actually designating any chemical substance as inactive, however, and EPA does not construe it as the list with “designations of active substances and inactive substances” from which forward-looking reporting commences.  EPA states that it concludes that new TSCA is referring to the completed product of the initial cycle of sorting between active and inactive substances, not the preliminary product of the initial cycle of such sorting.

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under key phrase TSCA Inventory and on our TSCA Reform News & Information webpage.


 

By Richard E. Engler, Ph.D. and Margaret R. Graham

On November 22, 2017, the U.S. Environmental Protection Agency (EPA) announced it was releasing a preliminary list of chemical substances reported under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) rule that includes substances reported to EPA through November 10, 2017, and that it will be updated approximately once per month.  EPA states that it is making this list available to help keep the stakeholder community informed of the status of reporting under the TSCA Inventory Notification (Active-Inactive) rule.  EPA is providing the list in a downloadable, searchable spreadsheet.  The total number of chemicals on the list is 10,730.  

This total adds substantially to the 13,209 substances that appear on EPA’s list of substances exempt from Form A reporting.  It is important to note that the new list is not an update to the list of interim active substances or to the list of substances exempt from Form A reporting; it is only a list of substances reported via Form A notices of activity through the specified date.  The new list of substances reported by Form As will be useful to processors, allowing them to ensure that key substances are reported as active, but it does not relieve manufacturers or importers from the Form A reporting obligations of the rule.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available on our blog item under key phrase TSCA Inventory


 

By Lynn L. Bergeson and Carla N. Hutton

On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA).  According to OIG’s Project Notification, the specific objectives for this evaluation are to determine:  (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to prioritize imported and manufactured chemicals for the purpose of identifying the potential for human health and environmental risks.  The Project Notification asks Wendy Cleland-Hamnett, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, and Lawrence Starfield, Acting Assistant Administrator for the Office of Enforcement and Compliance Assurance, to provide the following information:

  • Policies, procedures, and guidance on how CDR data are used in the prioritization of chemicals for TSCA risk evaluations and/or other assessments;
  • Policies, procedures, and guidance regarding the quality assurance/quality control of CDR data; and
  • Enforcement response policy and guidance for CDR violations.

The Project Notification states that the anticipated benefits of the project are “reduced risks to human health and the environment from the monitoring and oversight of TSCA chemicals subject to the CDR rule reporting requirements.”


 

By Lynn L. Bergeson and Carla N. Hutton

On August 14, 2017, as the final Toxic Substances Control Act (TSCA) Section 8(a) information gathering rule on nanomaterials took effect, the U.S. Environmental Protection Agency (EPA) published “working guidance” intended to assist stakeholders in complying with the rule.  The working guidance notes that it “will not provide answers to all of the potential questions that will arise as manufacturers and processors seek to comply with the rule.  Commenters to the draft guidance asked several questions that would require more details or information before EPA could respond to their question.”  If the guidance does not answer questions about the rule, companies are directed to contact Jim Alwood, Chemical Control Division, Office of Pollution Prevention and Toxics, .(JavaScript must be enabled to view this email address).  EPA states that it will answer questions on a case-by-case basis.  EPA intends to add further questions/answers and revisions to the guidance based on questions identified by persons who may be subject to the rule. 

As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale.  Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA.  The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.  Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule.  There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule.  These persons must report to EPA at least 135 days before manufacture or processing of that discrete form.  More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is effective as of August 11, 2017 (the date of publication).

As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016.  Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018.  The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.

More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a Section 8(a) of the Toxic Substances Control Act (TSCA) rule establishing reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.  According to a pre-publication version of the final rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA.  The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects.  Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule.  There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule.  These persons must report to EPA at least 135 days before manufacture or processing of that discrete form.  The final rule will be effective 120 days after publication in the Federal Register.  The final rule states that EPA has prepared a detailed response to public comments that will be available in the rulemaking docket.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase nanotechnology.


 

Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.

All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.

Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."

Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)

Speakers:

  • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
     
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
     
  • Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
     
  • Kelly Franklin, Chemical Watch
     
  • Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.

 

Topics Covered:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition
       
    • Reporting by Processors
       
    • Byproduct Rulemaking and Reporting
       
    • Toxic Substances Control Act (TSCA) Inventory
       
    • Nomenclature
       
  • Section 14 Confidential Business Information (CBI)
     
    • Information Not Protected
       
    • Asserting CBI
       
    • Presumptive CBI
       
    • Requirements for CBI Claims
       
    • Exemptions to Protection from Disclosure
       
    • Review and Resubstantiation
       
    • Duties of Administrator
       
    • Criminal Penalties

Register Online

 

Additional Webinars in "The New TSCA" Series:

 

Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.