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 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 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.


 

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

On January 31, 2019, the U.S. Environmental Protection Agency (EPA) was petitioned by the Attorneys General of 14 states (Massachusetts, Pennsylvania, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Rhode Island, Vermont, and Washington) and the District of Columbia under Toxic Substances Control Act (TSCA) Section 21(a) to issue an asbestos reporting rule to require reporting under TSCA Section 8(a) of information necessary for EPA to administer TSCA as to the manufacture (including importation), processing, distribution in commerce, use, and disposal of asbestos.  Specifically, the petition states that the Attorneys General are petitioning EPA’s Administrator to:

  •  [‌I]nitiate a rulemaking and issue a new asbestos reporting rule to:  (i) eliminate any applicability of the “naturally occurring substance” (NOCS) exemption in the [Chemical Data Reporting (CDR)] for asbestos reporting; (ii) apply the CDR reporting requirements to processors of asbestos, as well as manufacturers, including importers, of the chemical substance; (iii) ensure that the impurities exemption in the CDR does not apply to asbestos; and (iv) require reporting with respect to imported articles that contain asbestos.

 In support of their requests in the petition, the Attorneys General state the following:

  1. NOCS Exemption:  “The identified uses of imported raw asbestos represent pathways of exposure that present risks to health and the environment that EPA must consider in conducting its risk evaluation and regulating asbestos, and accordingly EPA should promulgate an asbestos reporting rule to require reporting of such information.  Moreover, the required asbestos reporting must capture information with respect to the quantities imported, and these potential exposure pathways so this information can be made available to inform the states’ and the public’s knowledge regarding asbestos exposure risks.”
  2. Reporting from Processors:  “[T]o enable EPA to carry out its responsibility to impose requirements on processors to eliminate unreasonable risks of injury to health or the environment arising from exposures to asbestos, EPA must promulgate new regulations to apply the reporting requirements of the CDR to processors of asbestos notwithstanding that the current CDR does not expressly require such reporting.  Should EPA fail to do so, EPA would be violating TSCA, acting arbitrarily and capriciously, and abusing its discretion in implementing TSCA.”
  3. Exemptions for “Impurities” and “Articles”:  “[W]hile the CDR exempts reporting with respect to ‘impurities’ and for chemical substances imported as ‘part of an article,’ neither of these exceptions should be applied to reporting with respect to the presence of asbestos if EPA is to satisfy TSCA’s mandate to prevent unreasonable risks associated with exposures to this highly toxic chemical.”
  4. Reporting for Asbestos:  “EPA must account for the many tons of asbestos that are imported into the U.S., whether as a raw material or processed, to evaluate adequately the current and likely future risks of exposure to asbestos, and must also account for asbestos in consumer products, whether or not the asbestos is intentionally included in those products.  These data … are needed for EPA to be able to make informed technically complex decisions regarding the regulation of asbestos.  Without these data to rely on, the agency will be unable to meet its obligations under TSCA to make its decisions based on the weight of the scientific evidence and using the best available science ….  Accordingly, EPA must issue an asbestos reporting rule to ensure that the NOCS, the impurities, and the articles exemptions do not apply to asbestos, and that processors of asbestos are required to report.”

The petition cites EPA’s denial of a petition submitted by a group of non-governmental organizations (NGO) seeking similar action that the Attorneys General are requesting, but does not address the many reasons that EPA denied the first petition.  Why the Attorneys General would follow up EPA’s well-reasoned denial with a petition of their own with very similar requests and only marginal additional facts, is unclear.  More information on the NGO petition is available in our blog item "EPA Denies Section 21 Petition Seeking Increased Asbestos Reporting."


 

By Lynn L. Bergeson and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA).  EPA lists the following milestones that it has completed at the two-year anniversary:

In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.”  Speakers will include:

  • Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
  • Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
  • Michael Gould, EH&S Committee Chairman, RadTech North America; and
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available.  For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:

  • Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
  • Notices of Commencement received by EPA since June 21, 2006; and
  • Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.

EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule.  EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018.  According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date.  Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent.  The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

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 the key phrase TSCA Inventory and on our TSCA Reform News & Information web page.  More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.”  Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”


 

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.


 
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