Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA

The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to the rule consist of the 20 designated by EPA as high-priority substances and the 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). EPA states that it is taking this action because the TSCA Interagency Testing Committee (ITC) added these chemical substances to the TSCA Section 4(e) Priority Testing List through its 69th and 74th Reports. EPA will use the submitted information to inform the risk evaluations currently underway for 20 high-priority substances and for future prioritization. The final rule will be effective July 29, 2021. Requests to withdraw a chemical substance from the final rule pursuant to 40 C.F.R. Section 716.105(c) must be received by July 13, 2021.

Substances Added to the TSCA Section 8(d) Health and Safety Data Reporting Rule

EPA states that the 20 high-priority substances identified in the rule were designated high-priority under TSCA Section 6(b) because EPA found that each of the chemical substances may present an unreasonable risk of injury to health or the environment. According to the final rule, EPA is seeking unpublished health and safety studies to ensure that such studies are available to EPA to inform its risk evaluation findings of whether any of these high-priority substances present an unreasonable risk of injury to health or the environment. EPA will also consider this information, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals.

According to the final rule, EPA requests information regarding the identified organohalogen flame retardants to help support prioritization and evaluation activities under TSCA. EPA states that it will also consider this information, as appropriate, when reviewing potential analogue data for read across and/or category development in assessing new chemicals. Additionally, CPSC, a representative member of the ITC, needs information on a group of organohalogen flame retardants because CPSC voted to grant a petition to begin rulemaking for this class of chemicals under the FHSA.

The table below lists the high-priority substances and organohalogen flame retardants included in the final rule.

The Reporting Requirements

Listed below are the reporting requirements for chemical substances added by the final rule to the TSCA Health and Safety Data Reporting rule:

• Persons who, in the ten years preceding the date a chemical substance is listed, either have proposed to manufacture (including import) or have manufactured (including imported) the listed chemical substance must submit to EPA a copy of each specified type of health and safety study that is in their possession at the time the chemical substance is listed.
   
• Persons who, at the time the chemical substance is listed, propose to manufacture (including import) or are manufacturing (including importing) the listed chemical substance must submit to EPA:
  
  • A list of the specified types of health and safety studies known to them but not in their possession at the time the chemical substance is listed;
     
  • A list of the specified types of health and safety studies that are ongoing at the time the chemical substance is listed and are being conducted by or for them;
     
  • A list of the specified types of health and safety studies that are initiated after the date the chemical substance is listed and will be conducted by or for them;
     
  • A copy of each specified type of health and safety study that is in their possession at the time the chemical substance is listed; and
     
  • A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated and is now complete, regardless of completion date.
     
• Persons who, after the time the chemical substance is listed, propose to manufacture (including import) the listed chemical substance must submit to EPA:
  
  • A list of the specified types of health and safety studies known to them but not in their possession at the time they propose to manufacture (including import) the listed chemical substance;
     
  • A list of the specified types of health and safety studies that are ongoing at the time they propose to manufacture (including import) the listed chemical substance and are being conducted by or for them;
     
  • A list of the specified types of health and safety studies that are initiated after the time they propose to manufacture (including import) the listed chemical substance and will be conducted by or for them;
     
  • A copy of each specified type of health and safety study that is in their possession at the time they propose to manufacture (including import) the listed chemical substance; and
     
  • A copy of each specified type of health and safety study that was previously listed as ongoing or subsequently initiated and is now complete, regardless of the completion date.
     

The information listed above is due to EPA by September 27, 2021. Any person who manufactures (including imports) or who proposes to manufacture (including import) listed chemical substances from July 29, 2021, to September 27, 2021, must inform EPA by submitting a list of any studies initiated during the period from July 29, 2021, to September 27, 2021, within 30 days of their initiation, but in no case later than October 27, 2021. In addition, if any such person has submitted lists of studies that were ongoing or initiated during the period from July 29, 2021, to September 27, 2021, to EPA, such person must submit a copy of each study within 30 days after its completion, regardless of the study’s completion date.

EPA states that persons reporting under the rule may also assert confidential business information (CBI) claims for certain information included in their submission. Submissions claiming CBI must meet the following requirements:

• CBI claims must be asserted at the time the information claimed as CBI is submitted to EPA. Information submitted with a confidentiality claim may be made public without further notice;
   
• Information claimed as CBI must be substantiated at the time of submission, with the exception of those types of information exempt from substantiation under TSCA Section 14(c)(2);
   
• All persons making a CBI claim must provide a standard statement concerning the need for the CBI claim and a certification that the statement of need is true and correct; and
   
• Where a specific chemical identity is claimed as CBI, a structurally descriptive generic name must be provided for disclosure to the public.
   

Types of Studies That Must Be Submitted

Under the final rule, manufacturers (including importers) of TSCA high-priority substances are required to submit the following:

• Lists and copies of unpublished health and safety studies for all high-priority substances specified in the rule on health effects, such as toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetics (absorption, distribution, metabolism, or elimination), including modeling studies, in humans or animals;
   
• All unpublished studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 C.F.R. Section 716.50 are also required under the rule;
   
• All unpublished studies on occupational (both users and non-users), general population, consumer, and environmental exposure, such as: unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modeling studies that estimate environmental concentrations or human exposures; and
   
• Studies showing any measurable content of the high-priority substance in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study.
   

Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter’s own accord and studies conducted or to be conducted pursuant to a TSCA Section 4 action are exempt from the submission of lists of health and safety studies required under 40 C.F.R. Section 716.35 and the submission of studies required under the rule.

Under the final rule, manufacturers (including importers) of organohalogen flame retardants are required to submit the following:

• Lists and copies of unpublished health and safety studies for all organohalogen flame retardants specified in the rule on health effects, such as toxicity studies (in vivo and in vitro) on carcinogenicity, reproductive and developmental effects, genotoxicity, neurotoxicity, immunotoxicity, endocrine effects, and other systemic toxicity and toxicokinetics (absorption, distribution, metabolism, or elimination), including modeling studies, in humans or animals;
   
• All unpublished studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 C.F.R. Section 716.50 are also required under the rule;
   
• All unpublished studies on occupational (both users and non-users), general population, consumer, and environmental exposure, such as unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modeling studies that estimate environmental concentrations or human exposures, must be submitted; and
   
• Studies showing any measurable content of the organohalogen flame retardant in the tested substance (single substances or mixture) must be reported. The composition and purity of test substances must be reported if included as part of the study.
   

Studies previously submitted to EPA pursuant to a requirement under TSCA or of the submitter’s own accord and studies conducted or to be conducted pursuant to a TSCA Section 4 action are exempt from the submission of lists of health and safety studies requirements under 40 C.F.R. Section 716.35 and the submission of studies requirements under the final rule.

Commentary

Bergeson & Campbell, P.C. (B&C^®) views the publication of this final rule as an indication of the procedures that EPA will likely employ in the future with meeting its obligations under TSCA Section 6(b). We anticipate that EPA will use a stepwise approach like this: the TSCA ITC adds substances to its Priority Testing List that EPA is considering for prioritization, followed by obtaining unpublished health and safety studies under Section 8(d) of TSCA. Thereafter, EPA will be better positioned to identify the types of information it determines are data needs. EPA can then exercise its testing authority, including test orders, under TSCA Section 4(a).

EPA has been criticized for not employing its data call-in authority under Section 8 in its review of existing chemicals. The argument is that without that data call-in, EPA cannot be sure it is using the best available science, as required under TSCA Section 26(h). Without the call-in, high-quality studies may be available to stakeholders, but not to EPA. Additionally, requiring the reporting helps ensure EPA uses “reasonably available information” as defined and required under EPA’s risk evaluation rule in its development of risk evaluations.

Of particular note, this action requires submission of studies “showing any measurable content of the High-Priority Substance in the tested substance (single substances or mixture).” We will be interested to see how EPA determines that effects seen in studies with minimal, but measurable quantities of one of the high-priority substances are due to that small quantity and not to the primary component(s).

EPA’s final rule will elicit potentially relevant health and safety studies for EPA’s ongoing risk evaluations and inform potential analogue data for read across and/or category development in assessing new chemical substances. EPA has not updated its new chemical categories document since August 2010. The submission of relevant health and safety studies may provide EPA with an opportunity to refine existing categories or to create new ones. EPA also intends to share the information received under the final rule, as appropriate, with the ITC and other agencies, such as the CPSC, as part of CPSC’s ongoing evaluation of organohalogen flame retardants under the FHSA.