By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 16, 2023, that the latest Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available on its website. The TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States. According to EPA, this update to the public TSCA Inventory is part of its biannual posting of non-confidential Inventory data. EPA plans the next regular update of the TSCA Inventory for summer 2023.
 
EPA states that the TSCA Inventory contains 86,685 chemicals, of which 42,170 are active in U.S. commerce. Other updates to the Inventory include new commercial activity data, unique identifier data, and regulatory flags (e.g., significant new use rules and test orders). EPA notes that additionally, several hundred substances are now listed with their specific chemical identities after having been moved from the confidential portion of the Inventory to the public portion as part of EPA’s TSCA confidential business information (CBI) review efforts.
 
Lastly, EPA reminds TSCA submitters to check regularly for any correspondence relating to their submissions in EPA’s Central Data Exchange (CDX). EPA states that it sends “critical and time-sensitive information regarding confidentiality claims through CDX, and failing to open this correspondence can delay the Agency’s processing of those claims.”

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) released on June 30, 2022, a report entitled “Additional Internal Controls Would Improve the EPA’s System for Electronic Disclosure of Environmental Violations.” OIG conducted the evaluation to determine whether EPA’s process for screening self-reported violations through its electronic disclosure, or eDisclosure, system is effective and ensures that significant concerns, such as criminal conduct and potential imminent hazards, are addressed by the Office of Enforcement and Compliance Assurance (OECA). According to OIG’s report, the goal of the eDisclosure system is to provide an efficient mechanism for regulated entities to self-disclose violations of federal environmental laws and regulations. Self-disclosed violations are automatically processed under the EPA’s audit policies. EPA subsequently screens certain eDisclosure submissions to ensure that significant concerns, such as criminal conduct and potential imminent hazards, are properly addressed.
 
OIG states that the eDisclosure system does not have adequate internal controls in place to ensure that EPA’s screening process is effective and that significant concerns, such as criminal conduct and potential imminent hazards, are identified and addressed by OECA and the EPA regions. OIG notes that there is no formal, written national guidance or eDisclosure-specific training available on how EPA staff should conduct screening or delineate staff responsibilities. According to OIG, as a result, most regions inconsistently screen for significant concerns or do not screen at all because they believe OECA is responsible for that task, do not have access to the eDisclosure system, or have other resource limitations. Further, EPA does not have performance measures and does not systematically track eDisclosure system data. Finally, OIG states the eDisclosure system’s reporting tool “does not allow staff to effectively or robustly use or track eDisclosure submissions.” OIG concluded that without national screening guidance, training, effective monitoring, and Central Data Exchange improvements, there is a risk that significant concerns are not being addressed and that the impacts of the EPA’s eDisclosure system will remain limited and unknown.
 
OIG recommends that the OECA Assistant Administrator develop national guidance that includes a process for screening eDisclosure submissions for significant concerns; provide eDisclosure-specific training to EPA headquarters and regions to clarify expectations, establish staff responsibilities, and communicate best practices; develop performance measures for the eDisclosure system, as well as a monitoring plan to track its effectiveness; and assess eDisclosure system functionality to identify and implement improvements. According to OIG, OECA agreed with all four of its recommendations and proposed acceptable corrective actions and estimated completion dates. All recommendations are resolved with corrective actions pending. Where appropriate, OIG revised the report based on technical comments provided by OECA.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2021, that it has launched a new application in the Central Data Exchange (CDX), EPA’s electronic reporting site, that will allow users to submit electronically certain communications under the Toxic Substances Control Act (TSCA).  According to EPA, the new application provides users with a faster, secure, and more convenient way to comply with TSCA reporting requirements and is “expected to be used for hundreds of individual communications every year.”
 
EPA states that the application is located within the Chemical Safety and Pesticide Programs (CSPP) data flow and supports numerous types of communications, including General Confidential Correspondence, Requests for Chemical Information, Pre-manufacture Notice (PMN) Corrections for Submissions made Prior to 2016, and Copy of Record Requests.  Previously, these types of communications were required to be sent to EPA in hard copy.  EPA will continue to accept paper documents, but recommends submitting TSCA communications electronically when possible “since paper communications could take longer to process.”

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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.”

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

As the U.S. Environmental Protection Agency (EPA) is currently closed due to the lapse in appropriations, EPA has ceased all work reviewing new and existing chemicals under the Toxic Substances Control Act (TSCA).  Regarding new chemicals, although the Central Data Exchange (CDX) may still accept submissions, EPA will not process any information submitted via CDX until EPA reopens and it is not clear how EPA will set “Day 1” for TSCA Section 5 notices submitted during the shutdown.  

We are unaware of EPA publishing a formal notice that it is suspending the review period of new chemical notices, but EPA will not be making any determinations on such notices during the shutdown.  Submitters should continue to submit any required information (e.g., Notices of Commencement) even though EPA will not process or review such submissions. 

EPA actions on existing chemicals (including risk evaluations and publication of the updated TSCA Inventory with active/inactive status) will be delayed.  As previously reported, the first preparatory meeting on the Colour Index (C.I.) Pigment Violet 29 risk evaluation (scheduled for January 8, 2019) will be cancelled if the shutdown continues through January 4, 2019, at 5:00 p.m., which appears probable.

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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.”

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By Charles M. Auer and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency (EPA) has updated its eNOA upload template that was initially released in 2017 to assist filers with the Central Data Exchange (CDX) system.  The eNOA, or electronic Notice of Activity (NOA) Form, is used for retrospective reporting under the amended Toxic Substances Control Act’s (TSCA) Inventory notification requirements.  The eNOA template, available for download from within the eNOA system on CDX, assists users to upload many substance identities in a batch.  The template file is a comma separated value (CSV) file, CSV-NAA.csv, that is readable by most spreadsheet and database programs.  The change means that if submitters attempt to use the old template, the CSV file will not upload properly and will generate errors in CDX. 

The template was updated by adding a new field name.  The new field name that will be added to the CSV file is “Isjoint,” and the field explanation is “NOA is joint with another submitter;” which permits filers to upload and start multiple joint submissions in a batch.  The field names required, along with their field explanations, are: 

• Isjoint: NOA is joint with another submitter.
• CASRN:  CASRN with our without dashes; after upload, dashes will be present.  Must be “TRUE” or “FALSE”;
• Accession Number:  Accession number for substances listed on the confidential portion of the Inventory;      
• Chemical Cbi:  Submitter seeking to maintain CBI claim for substance identity.  Must be “TRUE” or “FALSE”;
• Submitter Cbi: Submitter claiming CBI for submitter identity.  Must be “TRUE” or “FALSE”;
• Company Details Cbi: Submitter claiming CBI for submitting company details.  Must be “TRUE” or “FALSE”;
• Technical [Contact] Cbi:  Submitter claiming CBI for technical contact identity.  NB: “Contanct” is misspelled in the template.  Must be “TRUE” or “FALSE”;
• Substantiation CBI:  Submitter claiming CBI for substantiation statement(s).  Must be “TRUE” or “FALSE”; and
• ShowCbiQuestions:  Set to TRUE to substantiate CBI claims.  This is required for submitter, company, and technical contact claims.  Must be “TRUE” or “FALSE.” 

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By Lynn L. Bergeson and Margaret R. Graham

On January 3, 2018, the U.S. Environmental Protection Agency announced it would be hosting two webinars to support Third-Party Certifiers (TPC) in generating and entering annual report information into the Central Data Exchange (CDX).  Registration is available online through the following links: the webinars will be held on January 9, 2018, from 1:00 p.m. to 3:00 p.m. (EST); and on February 1, 2018, from 9:00 a.m. to 11:00 a.m. (EST).  Both webinar presentations will provide an overview of the TPC annual report requirements and a live demonstration of the reporting process through CDX.

As required under the Toxic Substances Control Act (TSCA) Title VI final rule that implemented the Formaldehyde Standards for Composite Wood Products Act, EPA-recognized TPCs must submit an annual report to EPA through CDX on or before March 1, 2018.  The required information includes the name and location of the mill(s), the types of products certified for them, and quarterly test data on each product.  Providing certification services for multiple mills and submitting that information to the CDX database may take a considerable amount of time, therefore, EPA strongly suggests for TPCs to start entering the required information and existing testing data for each panel producer as soon as possible to ensure that they meet the deadline.  Basic information on each panel producer, such as name(s), product type(s), and testing information that is available now can be entered into CDX immediately. 

EPA also stated the importance of retaining the password; the password created for the annual report will be required later to amend, finalize, and submit the report to the EPA.  If this password is lost, it cannot be recovered, and a new annual report submission would need to be created.

More information is available on EPA’s website.

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By Lynn L. Bergeson and Margaret R. Graham

On March 10, 2017, the U.S. Environmental Protection Agency (EPA) announced that its Office of Pollution Prevention and Toxics (OPPT) would be hosting two webinars covering the use of the Central Data Exchange (CDX) for upfront confidential business information (CBI) substantiation.  Per EPA’s notice on January 19, 2017, the statutory requirements for substantiation of CBI claims will change effective March 21, 2017, for Toxic Substances Control Act (TSCA) submissions.  In preparation for this change, OPPT revised the CDX TSCA reporting applications to allow for upfront substantiation of CBI claims.

OPPT’s first webinar will be March 15, 2017, at 1:00 p.m. (EDT) and the second will be on March 21, 2017, at 1:00 p.m. (EDT).  EPA states that these webinars will cover technical aspects of making upfront substantiations within the CDX reporting applications, and that OPPT would appreciate help in identifying participants that currently use CDX reporting applications or will do so under the new requirements to participate in these events.

Registration is available online.  The webinars will be limited to the first 1,000 registrants and registration will close at 11:00 a.m. (EDT) on the date of each webinar.  After the webinar, OPPT will post the webinar materials on its Confidential Business Information under TSCA webpage.  More information on the statutory requirements for substantiation of CBI claims is available in our blog item EPA Issues Guidance On Substantiation Requirements For CBI Claims Under TSCA.

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