Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By  Lynn L. Bergeson 

EPA has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.” The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to TSCA. Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5. According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.” EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”

According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances. Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A). Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5. The Compliance Advisory includes several questions and answers (Q&A), including:

Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?

No. Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical. Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements. If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties. PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50. TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.

EPA’s “compliance advisory” is disappointing. It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs. This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts. EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.

For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination. If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order. Neither option is commercially feasible or sustainable.

This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space. EPA’s compliance advisory is an unexpected and, to many, unwanted parting gift from the Trump Administration. The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.


 

By  Lynn L. Bergeson 

EPA announced on January 5, 2021, that it is reopening the reporting period under the TSCA Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule 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, with provision to also allow notification by processors. From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years. The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI). In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory. In its January 5, 2021, announcement, EPA states that it has since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period. EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity. The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 

By Lynn L. Bergeson

EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).


 

The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
     
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
     
  • Additional unique identifiers.
     

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On March 11, 2020, EPA announced the availability of the latest TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S. commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
  • Additional unique identifiers.

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision. EPA notes that the supplemental notice is limited in scope and that “it impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.


 

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

Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) and Chemical Watch have collaborated to present a series of complimentary webinars on the reformed Toxic Substances Control Act (TSCA). Webinar 3 -- Inventory, CDR, and CBI will cover:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition;
       
    • Reporting by Processors;
       
    • Byproduct Rulemaking and Reporting;
       
    • TSCA Inventory; and
       
    • 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; and
       
    • Criminal Penalties.

Previous webinars in the series:

Webinar 1 -- The New TSCA -- Overview and Summary of Major Changes: What to Expect and When to Expect It, June 13, 2016; and

Webinar 2 -- Impacts on New and Existing Chemicals Programs (TSCA Sections 4, 5, and 6), July 14, 2016.

To request materials from previous webinars, please contact .(JavaScript must be enabled to view this email address).


 

Biofuels Digest is running a "Thought Leadership" series of articles highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products. The articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., cover key points throughout the manufacturing and commercialization process at which biobased companies need to be aware of TSCA requirements.

"The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," published April 26, 2015, begins with some common misconceptions about TSCA:

When I meet people from bioeconomy companies, I ask them about their products' status under the Toxic Substances Control Act (TSCA). The most common answers I receive are: "TSCA doesn't apply because our product is not toxic," "TSCA doesn't apply because our product is naturally occurring," and "We are compliant with TSCA because we're making something that's already in commerce." This usually leads to a more in-depth discussion of how TSCA works and its idiosyncrasies with respect to biobased products. I do not ask this to be accusatory, rather I want to be sure that companies understand their obligations so that they do not run afoul of the law. TSCA penalties can add up quickly (maximum $37,500 per violation per day) and can threaten nascent companies if they are not diligent.

The article continues by detailing how the Chemical Abstracts Index name and identity of a substance is determined, how feedstock and production processes can affect identity, and the impact the name has on commercialization prospects since all chemicals in production must be listed on the TSCA Inventory.

"The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," published May 3, 2015, details when feedstocks, intermediates, and catalysts may be reportable under TSCA.

Importantly, in addition to final chemical products, TSCA also applies to the other chemicals used in the manufacturing process. Looking at the various stages of a typical manufacturing process allows us to examine how TSCA applies at each stage.

The article then discusses feedstocks, such as plants, sugars, and municipal wastes; isolated and non-isolated intermediates; and catalysts, such as metals, enzymes, and microoganisms; and how each of those is treated under TSCA.

The final article in the series will be published in Biofuels Digest on May 10, 2015, and we will feature excerpts in next week's BRAG Report.