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 Carla N. Hutton
 

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.

 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims.  EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders.  Following the procedures set forth in the final rule, EPA states that it will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory.  These procedures and requirements are intended to help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA.
 
The final rule is a follow-on to EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision.  The final rule applies to manufacturers and processors who made CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory (Active-Inactive) Notification Rule.  The final rule describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing certain previously filed substantiations.
 
The final rule also describes EPA’s plan to review these CBI claims for “active” chemicals, including procedures for its publication of annual review goals and results.  Manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange.  According to EPA, providing this information electronically supports more efficient data transmittal, improves data quality, and minimizes respondent burden and EPA administrative costs associated with information submission and recordkeeping.
 
More information on the final rule will be available in a forthcoming memorandum that will be posted on our website.  Information on EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

 

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Tags: CBI, Inventory

 

By Lynn L. Bergeson and Carla N. Hutton

On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 60363.  EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for certain CBI claims.  Specifically, EPA is proposing two additional questions that manufacturers and processors would be required to answer to substantiate certain CBI claims for specific chemical identities and is proposing procedures for manufacturers and processors to use in amending certain previously submitted substantiations to include responses to the additional questions.  Comments on the supplemental notice are due December 9, 2019.

EPA notes that these proposed revisions supplement the proposed rule issued in the April 23, 2019, Federal Register and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated on August 11, 2017.  More information on the proposed rule is available in our April 11, 2019, memorandum, “EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory,” and more information on the final rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 30, 2019, the U.S. Environmental Protection Agency (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 “[‌i]t 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.

Tags: CBI, Inventory,

 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information.  EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity.  When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID to other information or submissions concerning the same substance; and ensures that any non-confidential information received by EPA identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure.
 
EPA notes that this is the first time that the public version of the TSCA Inventory includes both a field containing a UID for those chemical substances with approved confidentiality claims for specific chemical identity and a field containing the ten-year expiration date from the assertion of such approved claims.  EPA states that the UIDs provide the public with a way to connect the specific chemical identity previously listed on the confidential portion of the TSCA Inventory with other relevant information in EPA’s holdings. 

Commentary

EPA’s goal is to publish an up-to-date version of the TSCA Inventory about every six months.  With the version published on September 19, 2019, EPA has taken another positive step in implementing its obligations under TSCA.  The Inventory now includes two new fields: UI (for the unique identifier or UID) and EX (indicating the expiration date of the CBI claim).  EPA continues to work through CBI identities, so only a few of the CBI substances have a UID.  We expect that EPA will begin to assign UIDs to CBI substances that are newly added to the Inventory (e.g., through a Notice of Commencement submitted going forward).  We also expect that EPA will assign UIDs to substances that were claimed as CBI on a Form A as EPA works through reviewing the almost 8,000 substances listed as active on the confidential portion of the Inventory.  A more detailed commentary is available in our September 20, 2019, memorandum, “EPA Includes Unique Identifier Information on Updated TSCA Inventory.”

Tags: Inventory, UID, CBI,

 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 15, 2019, announcing the availability of a signed action identifying chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  84 Fed. Reg. 21772.  The signed action, dated May 6, 2019, initiated a 90-day period after which substances identified as inactive will be designated as inactive.  Inactive designations for chemical substances on the TSCA Chemical Substance Inventory are effective on Monday, August 5, 2019.  Beginning August 5, 2019, manufacturers and processors will be required to notify EPA before reintroducing into commerce a substance currently identified as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity (NOA) Form B, found in EPA’s Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.  Our July 31 2019, memorandum, “EPA Posts NOA Form B Materials before TSCA Inventory Inactive Designations Take Effect August 5,” provides links to EPA materials intended to help manufacturers and processors prepare for the inactive designations taking effect, as well as a detailed commentary.  Companies with additional questions should contact .(JavaScript must be enabled to view this email address) or .(JavaScript must be enabled to view this email address)., for assistance.


 

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

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced that it would soon be making available a signed action signed on May 6, 2019, that identifies chemical substances for inactive designation according to the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements rule.  The pre-publication version of the notice is available here.  Specifically, EPA states that the signed action is a companion to the first version of the TSCA Chemical Substance Inventory with all listings designated as active or identified as inactive, which was posted on the EPA TSCA Inventory web page on February 19, 2019, and it will initiate a 90-day period after which substances identified as inactive will be designated as inactive.  Because the action was signed on May 6, 2019, inactive designations will become effective on Monday, August 5, 2019.  

Starting on August 5, 2019, manufacturers and processors are required to notify EPA before reintroducing into commerce a substance designated as inactive on the TSCA Inventory.  Manufacturers and processors can notify EPA via a Notice of Activity Form B, found in EPA's Central Data Exchange (CDX).  Upon receiving such notification, EPA will change the designation of substances from inactive to active.

For more information, visit EPA’s TSCA Inventory Notification (Active-Inactive) Rule site.


 

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

On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim.  Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule:  (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements. 

The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.”  Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered” in the final rule.  The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.”

Regarding the other four claims that it denied, the court made the following statements:

  1. “EPA acted well within its discretion in concluding that, as part of the Inventory update, any manufacturer or processor of a chemical substance can file a claim to maintain the chemical substance’s confidentiality”;
  2. “There is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation”;
  3. “Agencies need not address all regulatory obligations ‘in one fell swoop’ … nothing in [TSCA] requires the EPA to develop and implement the unique identifier system alongside its Inventory review process”; and
  4. “EPA’s decision [to exclude export-only chemicals from the final rule’s requirement that chemical companies notify EPA of chemical substances being manufactured or processed] reflected a reasonable interpretation of [TSCA].”

 

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, Carla N. Hutton, and Margaret R. Graham

On February 19, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was releasing an update to the Toxic Substances Control Act (TSCA) Inventory listing the chemicals that are actively being manufactured, processed and imported in the United States, which is required under amended TSCA.  Some of the highlights from EPA’s announcement are:

  • A key result of the update is that less than half of the total number of chemicals on the current TSCA Inventory (47 percent or 40,655 of the 86,228 chemicals) are currently in commerce; EPA states that this information will help it focus risk evaluation efforts on chemicals that are still on the market.
  • As recently as 2018, the TSCA Inventory showed over 86,000 chemicals available for commercial production and use in the U.S.  Until this update, EPA states that it was not known which of these chemicals on the TSCA Inventory were actually in commerce.
  • More than 80 percent (32,898) of the chemicals in commerce have identities that are not Confidential Business Information (CBI), increasing public access to additional information about them.  
  • For the less than 20 percent of the chemicals in commerce that have confidential identities, EPA states that it is developing a rule outlining how it will review and substantiate all CBI claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory. 
  • From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported or processed in the U.S. over the past ten years, the period ending June 21, 2016.  EPA received more than 90,000 responses, a significant reporting effort by manufacturers, importers and processors.

Look for our memorandum on this important development tomorrow; it will be posted to our Regulatory Developments webpage.  

On March 13, 2019, EPA will host a webinar to assist manufacturers (including importers) and processors with future reporting requirements.  Under the final TSCA Inventory notification (active-inactive) rule, a substance is not designated as an “inactive substance” until 90 days after EPA publishes the initial version of the Inventory with all listings identified as active or inactive.  EPA states that manufacturers and processors should be aware that if there is a substance that is listed as “inactive” that is currently being manufactured or processed, they have 90 days to file a Notice of Activity (NOA) Form B so that they can continue their current activity.  Manufacturers and processors that intend to manufacture or process an “inactive” substance in the future must submit an NOA Form B before they start their activity.

The webinar is scheduled for 1:00 p.m. - 4:00 p.m. (EDT) on Wednesday, March 13, 2019.  The webinar will include an overview of filing a NOA Form B, a demonstration of the electronic reporting application, and time for questions and answers.  Registration for the webinar is not required.

More information about the TSCA Inventory update and the webinar is available on EPA’s TSCA Chemical Substance Inventory webpage.


 
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