Regulatory Developments

Industry Associations Petition EPA to Develop Risk Management Procedural Rule under TSCA Section 6

July 10, 2020 PRINT

On June 3, 2020, the American Coatings Association (ACA), National Association of Manufacturers, Toy Association, National Association of Home Builders, and U.S. Chamber of Commerce filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) requesting that the U.S. Environmental Protection Agency (EPA) develop a risk management procedural rule under TSCA Section 6. According to the petition, such a rule is necessary to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The Petitioners note that the prioritization and risk evaluation framework rules “serve an essential role to guide affected stakeholders through these new processes.” The Petitioners request a TSCA Section 6 rulemaking to establish a similar degree of procedural consistency, guidance, and transparency for EPA’s risk management process. EPA has 90 days from filing to grant or deny the petition. If EPA grants the petition, EPA must promptly commence an appropriate proceeding in accordance with TSCA Section 6. If EPA denies the petition, it must publish its reasons for the denial in the Federal Register and Petitioners can challenge that decision in accordance with TSCA Section 21(b)(4).

The petition notes that in December 2016, EPA repealed the TSCA Section 6 procedural rules at 40 C.F.R. Part 750 because they did not conform with the Lautenberg Act amendments. The petition asserts that procedural guardrails are necessary to guide EPA and affected stakeholders so that risk management is “consistently applied and appropriately tailored.” According to the petition, a framework rule will establish a central point of reference for all of the requirements and considerations involved in the crafting of a risk management rule. In addition, the petition asserts, a risk management procedural rule is consistent with EPA’s strategic goal to provide greater regulatory certainty and improve risk communication to the public. The petition suggests a blueprint to design a rule that includes all the features required by TSCA and its corresponding regulations. The petition asks that EPA undertake notice and comment rulemaking in developing the requested rule “because the information and opinions supplied by the public will inform the Agency’s views.” The petition notes that such a process is not necessary for rules of agency practice and procedure under the Administrative Procedure Act (APA).

The Selection of One or More Risk Management Approach(es) Enumerated in Section 6(a) Should Be Guided by a Transparent Process

The petition specifically seeks to identify certain essential elements of a risk management framework for chemicals that have been in commerce for many years. The petition argues that the selection of one or more risk management approaches enumerated in TSCA Section 6(a) should be guided by a transparent process that organizes and directs EPA’s use of the Section 6(a) options in a stepwise approach, and that a rule is needed for stakeholders to understand how EPA will select among the options, including:

  • Prohibiting or otherwise restricting the chemical or limiting the amount of the chemical;
     
  • Prohibiting or otherwise restricting the chemical for a particular use or a particular use in a concentration in excess of a specified level;
     
  • Requiring that a chemical or any article containing that chemical be marked with or accompanied by clear and adequate minimum warnings and instructions;
     
  • Requiring that manufacturers and processors of a chemical make and maintain records of the processes used to manufacture or process the chemical, or monitoring or conducting reasonable and necessary tests to assure compliance;
     
  • Prohibiting or otherwise regulating any manner or method of commercial use of such chemical; and
     
  • Prohibiting or otherwise regulating any manner or method of disposal of such chemical or any article containing such chemical.
     

Such a rule would require EPA to explain why particular options will or will not address the unreasonable risk and to apply risk management options “to the extent necessary so that the chemical substance or mixture no longer presents an unreasonable risk.” The petition argues that the risk management rule for a specific chemical should “demonstrate that the provisions do not apply to conditions of use that meet the TSCA safety standard by listing those conditions as exempt.” The petition notes that TSCA Section 6 does not identify how EPA will provide adequate notice to regulated entities and the public with respect to this “important delineation on conditions of use.”

The petition states that, as part of the procedures envisioned, Section 6 risk management regulations should recognize and be consistent with established Occupational Safety and Health Administration (OSHA) workplace standards and requirements, such as the Hazard Communication Standard. Under TSCA Sections 6 and 9, in cases where EPA finds workplace controls inadequate, it can recommend that OSHA take action to address the unreasonable risk.

Procedures to Coordinate with Section 18, Codify Section 6(c) Deadlines, and Consider Section 6(c)(2) Effects Associated with Risk Management Rules Are Important

The petition asks that the risk management procedural rule address the preemption provisions in TSCA Section 18, including how the process for state waivers would work. The petition argues that TSCA Section 6(c) provisions should be included in a risk management rule and that these provisions should be reflected in requirements in the procedural rule, including:

  • Proceeding in accordance with Section 553 of the APA;
     
  • Publishing a proposed rule with reasons for the action;
     
  • Allowing interested persons to submit data, views, and arguments and to make all such submission publicly available;
     
  • Requiring that the final rule be based on the rulemaking record; and
     
  • Including the unreasonable risk determination.
     

The petition asks that the procedural rule address the deadlines for issuing risk management rules, i.e., propose a rule within one year of publication of the final risk evaluation and issue a final rule within two years of publication of the final risk evaluation, with the opportunity for a two year-extension. Regarding the extension, the petition argues that the risk management procedural rule should include the conditions EPA will consider when determining whether to extend the deadlines.

The petition asks that the procedural rule codify the requirements in TSCA Section 6(c)(2) to issue a statement of effects, asserting that it would ensure that EPA gives due consideration to these effects, while providing affected stakeholders and the public with a clear understanding of the information these statements need to contain. The petition states that EPA must publish this statement “based on reasonably available information” with respect to:

  • The effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture;
     
  • The effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture;
     
  • The benefits of the chemical substance or mixture for various uses; and
     
  • The reasonably ascertainable economic consequences of the rule, including consideration of:
     
    • The likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health;
       
    • The costs and benefits of the proposed regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator; and
       
    • The cost effectiveness of the proposed regulatory action and of the one or more primary alternative regulatory actions considered by the Administrator.
       

The petition asks that EPA include in the rule how it will address consideration of alternatives, replacement parts, and substances in articles, including how it will define “complex consumer goods” and “complex durable goods,” which are terms used in the exemption for replacement parts. The petition requests that EPA consider exempting de minimis levels of chemicals in mixtures and imported articles.

A Risk Management Rule Must Specify Effective Dates and Provide for Sufficient Notice to Affected Entities

The petition asks that EPA include provisions in the risk management procedural rule that address how the effective, compliance, and sell-through dates identified in TSCA Section 6(d)(1) will be established. The petition states that EPA should explain in the procedural rule the conditions under which it would declare a proposed Section 6(a) rule immediately effective.

The Risk Management Procedural Rule Should Codify the Critical or Essential Use Exemption and Establish Procedures for Routine Consideration of These Exemptions

The petition notes that the Lautenberg Act gives EPA the authority to grant exemptions for uses that the Administrator finds to be critical or essential. The petition states that EPA “should anticipate and provide the ability to routinely consider the need for these exemptions when issuing risk management rules.” Accordingly, the petition states that the risk management procedural rule should codify and include procedures for the critical or essential use exemptions and should define specific terms, such as “critical” and “essential” for the purpose of those exemptions.

To Conserve Limited Resources and Ensure Consistent Federal Regulations, a Risk Management Procedural Rule Should Establish a Process by Which the Agency Delegates to Other Federal Agencies and Other Laws It Administers -- Wherever Possible and Appropriate

The petition notes that TSCA Section 9 includes a process by which EPA may delegate risk management actions to other federal agencies. The petition asks that the risk management procedural rule go further, however, “and codify the statute’s affirmative directive that EPA ensure its regulations are not duplicative of another agency’s jurisdiction or regulations.” According to the petition, the procedural rule should require EPA to determine whether other federal agencies can prevent or reduce the identified unreasonable risk and, if so, initiate the process outlined in TSCA Section 9(a).

A Risk Management Framework Should Include a Process to Petition the Agency to Amend or Repeal a Section 6(a) Rule

The petition asks that the risk management procedural rule include a provision for petitions to amend or repeal a TSCA Section 6 risk management rule, notwithstanding the existence of the process available in TSCA Section 21. The petition states that a Section 6 risk management procedural rule should identify the type of information and/or data that EPA will generally need to amend or repeal an existing Section 6(a) risk management rule, the menu of available risk management measures, and the procedures to modify these rules where warranted. According to the petition, given the relatively short time frame for EPA to decide whether to grant a TSCA Section 21 petition, “it is vital that affected stakeholders and the general public know what information and/or data must be submitted with the petition.”

Commentary

We note that Section 21 petitions have now been submitted by non-governmental organizations (NGOs) and industry under amended TSCA, and applaud this fact. We believe that the actions requested by the Petitioners, namely, that EPA develop a risk management procedural rule under TSCA Section 6, is not without merit, as it would likely have the benefits expressed by the Petitioners (e.g., that risk management actions are “consistently applied and appropriately tailored”). A rulemaking of this magnitude would, however, be a broad and complex undertaking by EPA, potentially occurring at the same time that EPA is developing Section 6(a) rules for persistent, bioaccumulative, and toxic (PBT) chemicals under Section 6(h) and for some number of the first ten risk evaluation chemicals. Given resource constraints and the press of its statutory obligations for timely completing required risk management rules, EPA may wish to delay consideration of the need for the development of such a rule until such time as it gains experience and identifies efficiencies in undertaking its mandated requirements under amended TSCA, including on prioritization, risk evaluation, and risk management. Furthermore, experience in developing and implementing risk management actions under amended TSCA would help inform the development of any risk management procedural rule.

We note that TSCA Section 21(b)(4)(B) includes standards a court must use to decide whether to order EPA to initiate rulemaking in the event a lawsuit is filed by the Petitioner after the denial by EPA of a petition to issue a TSCA Section 6 rulemaking, among certain other actions for which an entity may petition.  With regard to petitions for the issuance of TSCA Section 6 rules, however, TSCA Section 21(b)(4)(B) only addresses petitions for the issuance of TSCA Section 6(a) rules. If a petition for the issuance of a TSCA Section 6 rule other than a Section 6(a) is denied and the Petitioner challenges the denial in court, it is not clear what standard the court would use in deciding whether to order EPA to initiate the rulemaking.  If the standard in TSCA Section 21(b)(4)(B)(ii) that is applicable to TSCA Section 6(a) rules applies, the Petitioner would need to demonstrate to the court in a de novo proceeding by a preponderance of the evidence that “the chemical substance or mixture to be subject to such rule … presents an unreasonable risk …” As there is no chemical substance or mixture specifically addressed in the subject petition for a TSCA Section 6 risk management procedural rule, it may be difficult for the Petitioner successfully to challenge a denial of the petition under that standard.

At the same time, we recognize that as structured in amended TSCA, all Section 6(a) rules will involve needed mitigation of unreasonable risks found by EPA in its risk evaluations, so perhaps this point can be successfully argued. We question, however, whether, as a general matter TSCA Section 21 envisions a petition for the issuance of a TSCA Section 6 procedural rule. In this light, it is interesting that the petition was not also submitted as an APA petition for a rulemaking. Under 5 U.S.C. Section 553(e), federal agencies must give interested persons “the right to petition for the issuance, amendment, or repeal of a rule.” Although there is no specific deadline for an Agency response for such a petition as with the 90-day deadline for a response to a TSCA Section 21 petition, there are requirements that agencies respond within a reasonable time, that Petitioners are given prompt notice of a denial, and that a brief statement of the grounds for denial be included.


 
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