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EPA Will Propose Updates to New Chemicals Regulations to Improve Efficiency, Remove LVE and LoREX Exemptions for PFAS and Certain PBTs
Thursday, May 25, 2023

The U.S. Environmental Protection Agency (EPA) announced on May 16, 2023, that it will propose amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to the pre-publication version of the proposed rule, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act [Lautenberg],” improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposal includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” EPA will also propose several amendments to the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions, and providing that certain persistent, bioaccumulative, and toxic (PBT) chemical substances are ineligible for these exemptions, consistent with EPA’s 1999 PBT policy. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Amendments to Conform Regulations to Lautenberg

EPA will propose changes to the premanufacture notice (PMN) procedural regulations at 40 C.F.R. Part 720 to align them with the notice review and determination requirements in TSCA Section 5, as amended by Lautenberg. EPA notes that these procedural regulations also generally apply to significant new use notices (SNUN) under 40 C.F.R. Part 721. EPA will also propose similar changes to the microbial commercial activity notice (MCAN) procedural regulations at 40 C.F.R. Part 725 to align them with the same notice review and determination requirements added by Lautenberg. EPA states that it has been implementing the amended statutory requirements but has not yet codified these updates into the new chemicals procedural regulations. EPA will propose to amend the regulations to specify that EPA must make a determination on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing (which includes importing) or processing and to list the five possible determinations and the actions required in association with those determinations. EPA will also propose to add definitions for new terms and to update existing terminology introduced by Lautenberg.

Commencement of Manufacture or Processing

EPA will propose to amend 40 C.F.R. Section 720.75(d) by removing the “outdated language allowing the submitter to commence manufacture of a chemical substance when the review period expires and adding new language specifying that EPA must issue a determination and take any required action on each PMN before manufacture may commence.” EPA will also propose to amend 40 C.F.R. Section 721.25(d) to state that any person submitting a SNUN shall not manufacture or process a chemical substance for a significant new use until EPA has issued a determination with respect to the significant new use and taken the actions required in association with that determination. Likewise, EPA will propose to amend 40 C.F.R. Section 725.170(b) and (c) by removing similar outdated language allowing the submitter to commence manufacture of a new microorganism or manufacture or processing of a microorganism for a significant new use when the review period expires and adding new language specifying that EPA must issue a determination and take any required action on each MCAN before manufacture may commence.

Required Determinations and Associated Actions

EPA states that to improve clarity and help inform the regulated community about EPA’s statutory obligations under TSCA Section 5(a)(3), it will propose to amend further 40 C.F.R. Sections 720.75(d) and 725.170 by listing the five possible determinations for each PMN, SNUN, or MCAN.

EPA will also propose to add language to 40 C.F.R. Sections 720.75(d) and 725.170(b) to describe the actions that EPA must take in association with its determination for a PMN, SNUN, or MCAN. EPA will propose to codify those actions, which EPA has been implementing, as applicable, for every PMN, SNUN, and MCAN since Lautenberg, “to be clear about EPA’s review process to the public.” The five possible determinations and associated actions are:

  • When EPA makes a determination for a PMN, SNUN, or MCAN according to TSCA Section 5(a)(3)(C), that the new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use, EPA issues a determination document to the submitter of the PMN, SNUN, or MCAN. The submitter may commence manufacturing or processing of the chemical substance after receiving the determination document. As required by TSCA Section 5(g), EPA also submits for publication in the Federal Register a statement of the “not likely” finding.
     
  • When EPA makes a determination for a PMN, SNUN, or MCAN according to TSCA Section 5(a)(3)(B), that:
     

    • The information available to EPA is insufficient to permit a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use,
       
    • In the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA, or
       
    • The chemical substance is or will be produced in substantial quantities and may either enter the environment in substantial quantities or result in significant or substantial human exposure,

EPA must issue an order pursuant to TSCA Section 5(e). The order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use. EPA may issue an order under TSCA Section 5(e) that requires testing to be conducted and presented to EPA after the applicable review period has concluded.

  • When EPA makes a determination for a PMN, MCAN, or SNUN according to TSCA Section 5(a)(3)(A) that the chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by EPA under the conditions of use, EPA must take one of the following actions described in TSCA Section 5(f) to the extent necessary to protect against such risk:
     

    • Issue an immediately effective proposed rule to limit the amount of such substance that may be manufactured, processed, or distributed in commerce or to impose other requirements described in TSCA Section 6(a); or
       
    • Issue an order to prohibit or limit the manufacture, processing, or distribution in commerce of the substance to take effect on the expiration of the applicable review period.

After EPA issues an order under TSCA Section 5(e) or (f) and the applicable review period concludes, the submitter may submit studies, tests, reports, or other additional information. If EPA concludes from an assessment of the additional information that one or more of the prohibitions or limitations contained in the order are no longer necessary to protect against an unreasonable risk of injury to health or the environment, EPA may modify or revoke the prohibitions or limitations of the order. If EPA determines that none of the order terms are warranted after assessment of the additional information, EPA may revoke all the requirements of the order. EPA states that it will propose amendments to 40 C.F.R. Sections 720.75(d) and 725.170 to state that EPA may modify or revoke the prohibitions and limitations in an order after the applicable review period has ended if the submitter submits to EPA additional testing, studies, reports, or other information that EPA determines, upon review, demonstrates that such prohibitions or limitations are no longer necessary to protect against an unreasonable risk of injury to health or the environment.

Other Proposed Revisions

EPA will propose to replace the terms “notice period,” “notification period,” “statutory review period,” and “notice review period” with the term “applicable review period” throughout 40 C.F.R. Part 720 to conform to the new terminology in TSCA Section 5 added by Lautenberg. EPA will propose to add a definition for “applicable review period” to 40 C.F.R. Section 720.3, which EPA would define as “the period starting on the date EPA receives a complete notice under section 5(a)(1) of the Act and ending 90 days after that date or on such date as is provided for in sections 5(b)(1) or 5(c) of the Act.” EPA states that this proposed definition is based on the TSCA Section 5(i)(3) definition for “applicable review period.”

EPA will also propose to add a definition for “potentially exposed or susceptible subpopulation” to 40 C.F.R. Section 720.3, a term added to TSCA by Lautenberg. Based on the definition in TSCA Section 3(12), EPA would define “potentially exposed or susceptible subpopulation” as “a group of individuals within the general population identified by EPA who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, the elderly, or overburdened communities.”

EPA will also propose to update 40 C.F.R. Section 720.70(b) by revising paragraph (b)(3). According to EPA, the language in paragraph (b) describes the content of the document that EPA routinely publishes in the Federal Register under TSCA Section 5(d)(2) to announce the receipt of PMNs submitted to EPA. EPA notes that although not required by TSCA Section 5(d)(2), the first sentence in 40 C.F.R. Section 720.70(b)(3) specifies that the document EPA publishes in the Federal Register pursuant to TSCA Section 5(d)(2) will also include a list of data submitted with the PMN in accordance with 40 C.F.R. Section 720.50(a). EPA notes that its transparency goal is now better achieved through other more efficient and effective mechanisms that negate the need to publish that information in the Federal Register. To provide streamlined access to information EPA receives and develops about chemicals, EPA has built and is constantly expanding content in ChemView and currently makes the PMN itself, including test data submitted with it, available on ChemView (subject to confidentiality claims). In addition, EPA is making the list of new chemical submissions received available in one place on its website to increase transparency and make information on new chemicals easier to find.

Amendments Related to Notice Information Requirements

EPA will propose changes to the notice information requirements at 40 C.F.R. Section 720.45, as well as corresponding changes to the reporting form in its Central Data Exchange (CDX), to clarify the level of detail expected for information that must be submitted to EPA in the PMN, SNUN, and certain exemption notices.

Proposed Changes to 40 C.F.R. Section 720.45 and the PMN Form

EPA will propose to amend 40 C.F.R. Section 720.45 and the PMN form in CDX to clarify the information requirements for a notice. Specifically, EPA states that it will propose to add details to certain information requirements already contained in 40 C.F.R. Section 720.45 and to add additional reporting fields to the PMN form to reflect these details.

EPA notes that consistent with TSCA Section 5(d)(1), for all information requirements under 40 C.F.R. Section 720.45, submitters are only required to provide information to the extent that it is known to or reasonably ascertainable by the submitter, as defined at 40 C.F.R. Section 720.3(p). Under the proposed changes to 40 C.F.R. Section 720.45, a submitter would be required to include in the PMN form the detailed information proposed in this action, along with all other information already required, to the extent the information is known to or reasonably ascertainable by the submitter. EPA states that “[t]his is an important point because a submitter may not know or be able to reasonably ascertain certain details about the chemical substance that is the subject of the notice, such as details about manufacturing, processing, or use sites out of the submitter’s control. In those situations, EPA would make conservative assumptions and use conservative default values for any information that is not known to or reasonably ascertainable by the submitter and therefore not provided in the PMN form.”

Physical and Chemical Properties and Environmental Fate Characteristics

To ensure that the regulations are clear about what information fields are included in the PMN form itself, EPA states that it believes that the information requirements in 40 C.F.R. Section 720.45 should reflect the PMN form fields. EPA will therefore propose to add relevant physical and chemical property information requirements in a new provision at 40 C.F.R. Section 720.45(j)(1) that are already specified within the PMN form.

EPA notes that it will propose several information requirements at 40 C.F.R. Section 720.45(j)(1) that are not already specified within the PMN form for physical and chemical properties. EPA will propose to require in 40 C.F.R. Section 720.45(j)(1) that data on surface tension and ultraviolet-visible (UV-VIS) absorption, as well as any particle size distribution analysis, be submitted as part of the PMN form, to the extent it is known to or reasonably ascertainable by the submitter. Additionally, EPA will propose to require at 40 C.F.R. Section 720.45(j)(1) information for aspect ratio, thickness, and number of layers or walls for nanomaterials. According to EPA, requiring data for these properties will allow EPA to offer additional clarity to submitters providing notices for nanomaterials, “since submitters might otherwise omit such data.”

EPA will also propose to add information requirements for the environmental fate characteristics of the chemical substance to 40 C.F.R. Section 720.45(j)(2). EPA notes that environmental fate characteristics test data are already required by 40 C.F.R. Section 720.50, but notes that this provision does not describe in detail what these relevant characteristics include.

Categories of Use

The next set of information requirements that EPA will propose to add to 40 C.F.R. Section 720.45 relate to the categories of use of the chemical substance. According to EPA, the proposed requirements will include detailed information on commercial and consumer uses, which already have form fields in the PMN form in CDX specifying in greater detail the broader information requirement in the regulations at 40 C.F.R. Section 720.45(f) regarding categories of use. Additionally, EPA will propose to add to 40 C.F.R. Section 720.45(f) a requirement to designate applicable consumer and commercial product categories using Organization for Economic Cooperation and Development (OECD)-based functional use codes, which EPA states would create consistency with TSCA Section 8(a) Chemical Data Reporting (CDR) requirements in 40 C.F.R. Part 711. EPA will also propose corresponding changes to the PMN form fields in CDX.

Details Concerning Manufacture, Processing, and Use

The third set of information requirements that EPA will propose to add to 40 C.F.R. Section 720.45 is information related to each site where the chemical substance will be manufactured, processed, or used. According to EPA, these requirements apply to sites controlled by submitters, as well as sites controlled by others, and although the information requirements that EPA will propose are similar for both, “different types of activities (e.g., manufacturing versus processing) often occur at submitter-controlled sites versus those at sites controlled by others.”

For both sites controlled by submitters and sites controlled by others, EPA will propose to add information requirements for site addresses. For submitter-controlled sites, EPA will also propose to add requirements for whether a particular chemical substance is manufactured or processed via batch or continuous production, as well as the amount of the chemical substance manufactured or processed in a given batch and/or timeframe. According to EPA, these proposed information requirements already have a corresponding form field in the PMN form in CDX because they are each covered by the existing information requirements in 40 C.F.R. Section 720.45(g)(1)-(2) and (h) for a process description of operations at such sites. EPA states that since these proposed information requirements are not yet specified in the regulations, it will propose to add them at 40 C.F.R. Section 720.45(g)(1) and (2) for sites controlled by the submitter and 40 C.F.R. Section 720.45(h)(1) and (2) for sites not controlled by the submitter.

EPA will also propose to add requirements for detailed information about the process diagram or description for each site controlled by the submitter and for each site not controlled by the submitter. According to EPA, these requirements include descriptions of the identity, approximate weight per batch or per day for continuous production, and entry point of all starting materials and feedstocks; the identity, approximate weight per batch or per day for continuous production, and entry point of all products, recycle streams, and wastes, including frequency of any equipment cleaning; the type of containers used for interim storage and transport of the chemical substance; and identification, by number, of any points of release.

Worker Exposure

EPA will also propose to add requirements for detailed information about the possible worker exposure at each site controlled by the submitter and at each site not controlled by the submitter. These requirements include types of potential worker exposure (e.g., dermal, inhalation), descriptions of any protective equipment and engineering controls in place, the moisture content of the chemical substance (if a solid), and the percentage of the chemical substance in the formulation at the time of exposure. In addition, according to EPA, for sites controlled by others, these requirements also include worker activities and descriptions of the physical form of the chemical substance.

Environmental Releases

Finally, EPA will propose to add detailed information requirements about the potential environmental releases at each site controlled by the submitter and at each site not controlled by the submitter. According to EPA, these requirements include descriptions of the type of release (e.g., transport, interim storage, disposal, equipment cleaning); the amount of the chemical substance released directly to the environment or into control technology; the amount of the chemical substance released to the environment after control technology; for equipment cleaning releases, frequency of equipment cleaning and what is used to clean equipment; for transport and storage releases, how the chemical substance or the product containing the chemical substance is transported from the site and stored and information about the containers used; for releases into air, Clean Air Act (CAA) operating permit numbers and a description of any leak detection and repair program the site has implemented; for releases into water, National Pollutant Discharge Elimination System (NPDES) permit numbers and information on the navigable waterways and other destinations into which the release occurs; and for releases into wastewater treatment plants, information on the publicly owned treatment works (POTW) into which the release occurs. In addition, for sites controlled by others, these requirements also include a description of the media of release.

EPA notes that if the information is not known to or reasonably ascertainable by the submitter for one or more sites, it makes conservative assumptions and uses default values to replace the missing information whether the site is controlled by the submitter or not. Therefore, EPA states that it believes that the level of detail in the regulations for process description, worker exposure, and environmental release information for sites controlled by the submitter at 40 C.F.R. Section 720.45(g) should mirror the level of detail in the regulations for process description, worker exposure, and environmental release information for sites not controlled by the submitter at 40 C.F.R. Section 720.45(h). EPA will propose to amend 40 C.F.R. Section 720.45(g) and (h) to make them consistent.

Additionally, EPA will propose clarifying amendments to 40 C.F.R. Sections 720.45(g)(3) and (4) and 720.45(h)(3) and (4) to ensure that submitters include worker exposure and environmental release information from exempt manufacture or related use of the chemical substances under 40 C.F.R. Section 720.30 (e.g., a chemical substance manufactured under the byproduct or impurity exemptions) at each site where the chemical substance will be manufactured, processed, or used, if known or reasonably ascertainable. EPA will also propose clarifying amendments to 40 C.F.R. Section 721.25(c) to ensure that submitters of SNUNs include in their notices a description of both the significant new use for which they are submitting a SNUN and all other known or intended categories of use.

Pollution Prevention Information

Lastly, EPA will propose to add optional pollution prevention information at 40 C.F.R. Section 720.45(k). EPA notes that the PMN form in CDX currently includes an optional text field and attachment function for submitters who wish to provide pollution prevention information about the chemical substance, such as information about using alternative fuel sources, reducing the use of water and chemical inputs, modifying a production process to produce less waste, implementing water and energy conservation practices, or substituting for riskier existing products.

EPA states that it estimates that the proposed amendments, which are intended to clarify the level of detail required for existing data requirements under 40 C.F.R. Sections 720.45 and 720.50, “would have a very minor impact on submitter burden because they are largely reflected in existing fields in the PMN form in CDX that submitters already are prompted to complete” and are also already included in the PMN Points to Consider document. EPA’s estimate of the burden impacts of these proposed information requirement amendments are presented in an Information Collection Request (ICR) document, which will be placed in the online docket when the proposed rule is published in the Federal Register.

EPA states that it seeks comment “specifically on its burden estimate and on the general pros and cons of clarifying these information requirements in the regulations and making corresponding changes to the PMN form.” EPA also seeks comment from the public, including those who have submitted a notice to EPA in the past, on any information requirement details that are not clearly explained in the PMN form or the regulations.

Other Modifications to the PMN Form in CDX

EPA states that it is considering adding statements with accompanying check boxes to certain screens of the PMN form (such as when transitioning between the various worksheets completed by the submitter) that indicate that information fields can only be left blank if such information is not known to or reasonably ascertainable by the submitter. If a submitter leaves information fields blank, they would have to check a box on the screen to affirm that the information is not known to or reasonably ascertainable by the submitter before advancing to the next screen. Additionally, a statement would warn the submitter of the potential consequences of leaving the field blank and later amending the field. If a field is left blank, EPA would make conservative assumptions and use conservative default values when assessing risk, which could result in more stringent risk management requirements. If a field that has been left blank is later amended during the review process, EPA may declare the original submission incomplete. According to EPA, this check box approach would not have a corresponding regulatory change, as it is consistent with the existing requirements to provide all information that is known to or reasonably ascertainable by the submitter and EPA’s long-standing practice to use conservative assumptions and default values in the absence of information. The ICR document describes the potential modifications to each screen of the PMN form.

Amendments Related to Pre-Screen, Incomplete Submissions, Correcting Errors, and New Information

EPA will propose amendments to the regulations regarding how EPA acknowledges the receipt of a notice to account for EPA’s pre-screen process and to clarify the start of the applicable review period, particularly when a notice contains errors or is incomplete. EPA will also propose amendments to align the process for correcting errors in the notice with the existing process for incomplete submissions. EPA states that it will also clarify that a notice is not considered complete at the time of the initial notice submission if the submitter submits additional information at any time during the review period that was known to or reasonably ascertainable by the submitter at the time of initial notice submission. Finally, EPA will propose amendments to clarify that new information about a chemical substance under EPA review must be submitted electronically via CDX and that certain notifications to EPA of new information may be made by e-mail.

Pre-Screening Procedures

EPA will propose to amend 40 C.F.R. Section 720.65(a) to codify the pre-screen process that EPA conducts prior to moving forward to the risk assessment process. If through the pre-screen process EPA finds that the initial notice submission is complete, Day 1 of the applicable review period is the day the notice was received by EPA via CDX, consistent with the existing regulations at 40 C.F.R. Section 720.75(a). If the pre-screen process finds that the initial submission is incomplete, the applicable review period will not begin until EPA receives a complete notice, consistent with the existing regulation at 40 C.F.R. Section 720.65(c)(2)(i). EPA notes that after the pre-screen, it may still determine within 30 days of receipt of the submission, once the risk assessment is underway and the information submitted more thoroughly evaluated, that the notice is incomplete, as currently described at 40 C.F.R. Section 720.65(c)(2)(i). EPA will also propose an amendment to 40 C.F.R. Section 720.70 to clarify that a notice of receipt will be published in the Federal Register after EPA receives a complete notice, “rather than merely receiving the notice, to accommodate the pre-screening procedures.”

Correcting Errors in Notices

EPA will propose amendments to 40 C.F.R. Section 720.65(a) and (b) to state that if EPA receives a notice with errors and EPA requests (as part of the pre-screen process or, at latest, within 30 days of receipt of the notice) that the submitter remedy such errors, the applicable review period will not begin until EPA receives a corrected notice. EPA states that while the current regulations and the proposed amendment give EPA discretion to request remedy of errors, “EPA now believes that if the Agency exercises that discretion to request that the submitter remedy an error, review of the notice should not move forward until the error is corrected.”

Notice Amendments Indicating Original Notice Was Incomplete

EPA states that it intends to change its “longstanding practice of accepting amendments that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period” under 40 C.F.R. Section 720.75(b). According to EPA, it would continue to accept amendments and, as necessary, refine risk assessments based on these amendments, “but believes that the shift to restart the applicable review period would create a more transparent and predictable review process for submitters.”

To communicate clearly this intended change in long-standing practice, EPA will propose to amend 40 C.F.R. Section 720.65(c) by adding a paragraph (2), which would state that a notice submission may be declared incomplete if the submitter submits additional or revised information at any time during the review period without demonstrating to EPA’s satisfaction that such information was not known to or reasonably ascertainable by the submitter at the time of initial notice submission. Additionally, EPA will propose an amendment at 40 C.F.R. Section 720.65(d)(5)(iii) to clarify that if EPA obtains additional information during the review period that leads EPA to declare the initial notice submission incomplete, in accordance with 40 C.F.R. Section 720.65(d)(2) (proposed to be redesignated from current 40 C.F.R. Section 720.65(c)(2)(ii)), the applicable review period would restart at Day 1 upon receipt of the complete notice.

EPA seeks comment on the proposed new provision at 40 C.F.R. Section 720.65(c)(2) and the proposed amendment to 40 C.F.R. Section 720.65(c)(5)(iii) (proposed to be redesignated as Section 720.65(d)(5)(iii)), which clarify that EPA may deem an original notice incomplete and restart the review period at Day 1 upon completion of the notice if a submitter provides required information during the applicable review period without demonstrating that it was not known to or reasonably ascertainable by the submitter at the time of the initial notice submission. EPA seeks comment on situations when this interpretation may not be appropriate.

Notifying EPA of the Receipt of New Information on a Chemical Substance under Review

EPA states that it “acknowledges that in some cases new information can become available about a chemical substance during the course of its review.” When this occurs, submitters are required to inform EPA in writing and provide the new information within ten days of receiving the new information, but no later than five days before the end of the notice review period. EPA will propose to amend 40 C.F.R. Sections 720.40(f) and 720.50(a)(4)(ii) to clarify that new information about a chemical substance under EPA review must be submitted electronically via CDX, consistent with the general electronic submission requirements in 40 C.F.R. Section 720.40(a). In addition, when submitters receive new information within five days of the end of the review period, EPA will propose to allow them to notify EPA by e-mail of the receipt of new information.

Amendments to LVEs and LoREXs

EPA will propose several amendments to the current LVE and LoREX regulations. Specifically, EPA will propose that: (1) submitters may not commence manufacture until EPA has approved the LVE or LoREX notice; (2) EPA may proactively inform LVE and LoREX holders if the chemical substance that is the subject of the LVE or LoREX becomes subject to a SNUR and the chemical identity is confidential business information (CBI); (3) PFAS will be categorically ineligible for these exemptions; and (4) the regulations codify the ineligibility for exemptions of certain PBTs as described in EPA’s 1999 PBT policy.

Amendments to Expiration of LVE and LoREX Review Period

EPA will propose to amend the regulations that allow submitters to begin manufacture or processing of chemical substances for which a PMN, MCAN, or SNUN was submitted upon expiration of the review period so that those regulations would require a determination from EPA prior to commencement of manufacture or processing of such substances. EPA will propose similar amendments to the LVE and LoREX regulations at 40 C.F.R. Section 723.50 to align with the proposed amendments to the PMN, SNUN, and MCAN regulations and with the statutory framework and to ensure better that chemical substances manufactured under LVEs and LoREXs will not present an unreasonable risk. EPA will propose to amend the LVE and LoREX regulations at 40 C.F.R. Section 723.50(g) to require a notification of approval of an LVE or LoREX from EPA prior to commencement of manufacture of the chemical substance under the exemption.

Notification of LVE and LoREX Holders If the Chemical Substance Is Subject to a SNUR

EPA will propose to add language to 40 C.F.R. Section 723.50 to allow EPA to inform an LVE or LoREX holder whenever the chemical substance that is the subject of that LVE or LoREX becomes subject to a proposed or final SNUR that describes the chemical substance by a generic chemical name due to a confidentiality claim for its specific chemical identity. EPA states that “[t]his proposed amendment would, as a courtesy, help inform LVE and LoREX holders of regulatory requirements that they may have otherwise been unable to determine on their own without submitting an inquiry to EPA (also known as a bona fide)” pursuant to 40 C.F.R. Section 721.11. EPA will propose to amend the regulations at 40 C.F.R. Section 723.50 to establish that a granted LVE or LoREX notice demonstrates a bona fide intent to manufacture the substance, such that a disclosure to an LVE or LoREX holder that the substance is the subject of a proposed or final rule under 40 C.F.R. Part 721 will not be considered public disclosure of CBI under TSCA Section 14.

EPA states that it does not intend to inform proactively current LVE and LoREX holders about SNURs that predate this rule. EPA seeks comment on its proposal to allow EPA to inform proactively an LVE or LoREX holder whenever the chemical substance that is the subject of that LVE or LoREX becomes subject to a proposed or final SNUR that describes the chemical substance by a generic chemical name. EPA notes that it would only start the practice of notifying LVE and LoREX holders subject to this proposed amendment after the date of the final rule.

Making PFAS Categorically Ineligible for LVEs and LoREXs

EPA will propose amendments to make PFAS categorically ineligible for LVEs and LoREXs going forward and will propose a structural definition of PFAS for purposes of the LVE and LoREX regulations. EPA will propose to define PFAS as a chemical substance that contains at least one of these three structures:

(1) R-(CF2)-CF(R′)Rʺ, where both the CF2 and CF moieties are saturated carbons;

(2) R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; or

(3) CF3C(CF3)R′Rʺ, where R′ and Rʺ can either be F or saturated carbons.

Manufacturers of substances that do not meet this structural definition would remain eligible to submit an LVE or LoREX notice. EPA notes that the proposed chemical structure definition for PFAS is the same definition proposed in its January 26, 2023, rule entitled “Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule.” 88 Fed. Reg. 4937.

EPA will propose that any LVE or LoREX notice for a PFAS that is submitted to EPA would be denied upon receipt without substantive review. EPA notes that this includes “any chemical substance where any of the reasonably anticipated metabolites, environmental transformation products, byproducts, or reasonably anticipated impurities are a PFAS.” Persons who wish to manufacture a PFAS not on the TSCA Inventory would instead be required to submit a PMN at least 90 days prior to commencing manufacture for a non-exempt commercial purpose.

Codifying EPA’s Policy Concerning PBT Chemicals and LVEs and LoREXs

EPA will propose amendments to 40 C.F.R. Section 723.50(d) that would codify EPA’s long-standing practice that, whenever EPA identifies a chemical substance under LVE or LoREX review (or any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the substance) as PBT with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms, that substance would be ineligible for the LVE or LoREX. According to EPA, the proposed amendments will clarify that PBT chemicals with anticipated environmental releases and potentially unreasonable human or environmental organism exposures would be ineligible for the LVE or LoREX but would not prevent companies from submitting an exemption notice for a given substance. EPA states that the finding that a substance is PBT would be made by EPA during its review of the notice. EPA notes that although it is ultimately responsible for assessing whether chemical substances are potentially PBT, “submitters who possess data indicating that their new chemical substances could be PBT and could be handled in such a way as to result in anticipated or unreasonable exposures may be less likely to expend the time and resources to submit an LVE or LoREX notice for EPA review of those substances if the outcome of the review would almost certainly be denial of the notice.”

EPA will propose to define “PBT chemical substance” for purposes of 40 C.F.R. Section 723.50 as “a chemical substance possessing characteristics of persistence (P) in the environment, accumulation in biological organisms (bioaccumulation (B)), and toxicity (T) resulting in potential risks to humans and ecosystems.”

Amendments Related to Suspensions of the Review Period

EPA will propose to amend 40 C.F.R. Section 720.75(b)(2) to allow PMN, SNUN, LVE, and LoREX submitters to request a suspension of the notice review period for up to 30 days orally or in writing, including by e-mail, without the need for a formal, written request submitted to EPA via CDX using e-PMN software. EPA will similarly propose to amend 40 C.F.R. Section 725.54(c) to permit MCAN submitters to request suspensions for up to 30 days orally or in writing, including by e-mail, without the need for a formal, written request submitted to EPA via CDX using e-PMN software. EPA states that it would continue to require that all requests for suspensions exceeding 30 days be submitted electronically to EPA via CDX using e-PMN software.

EPA seeks comment on its proposal to increase the number of days permissible for suspensions not requiring a formal, written request submitted to EPA via CDX using e-PMN software. Specifically, EPA requests comment on its proposal to permit requests for suspensions up to 30 days to be communicated orally or via e-mail, and to update the relevant regulations pertaining to suspension of microorganism-related submissions under 40 C.F.R Section 725.54 to mirror the proposed changes for suspension of PMNs, SNUNs, LVEs, and LoREXs. EPA states that it is not considering, proposing, or requesting comment on any additional changes to the regulations regarding suspensions at this time.

Commentary

EPA has been planning a long time to update the new chemical regulations to align those regulations with the new statutory language in Lautenberg. Many of EPA’s proposed changes are reasonable, but EPA’s justifications for these changes in some cases do not align with our understanding.

EPA’s narrative in the past and in this proposal is that submitters are not providing all information that is known or reasonably ascertainable to the submitter. We do not doubt that there are cases in which a submitter is aware of information and does not include that information in a submission. In our experience, amendments are often made in response to EPA’s assessment, often because EPA has expressed concerns that even a sophisticated submitter would be challenged to predict. EPA’s proposed regulations appear to give EPA carte blanche to reset the 90-day review period whenever a submitter provides additional information. Our view would be different if EPA could be more precise in what it seeks. Even in EPA’s engineering webinar series, EPA was challenged to define clearly what it sought and stated only that it seeks “more” information. “More” is too general to be a useful descriptor. It is especially troublesome that often, in our experience, EPA ignores, dismisses without justification, or simply minimizes the relevance of information provided by the submitter to justify EPA relying on its most conservative assumptions.

Our concern is that these proposed regulations will require additional effort on submitters’ part to collect and submit information, but that the additional effort may well not change EPA’s seemingly reflexive rejection of information in favor of its reliance on conservative risk assumptions. We find it especially troublesome that EPA’s estimated level of effort for submitters is negative apparently because the only effort that is required to comply with the proposed rule is to not amend after submission. Inexplicably, EPA ignores the effort to comply with the proposed updated requirements. EPA’s view apparently is that amendments are only made to supplement submissions with information that was available, but not included, at the time of submission. Instead, our expectation is that it will require significant additional effort to provide data in new required fields in addition to attachments or descriptive text, to document that data were not available at the time of submission, and to be prepared to rebut assertions by EPA that the information should have been submitted.

We see little value in EPA updating the PMN data flow in CDX. CDX is designed to replicate the PMN form -- a form that is out of date. The form and CDX both need to be updated to reflect the reality of new TSCA. Adding data fields may be justified, and adding more granular CBI claims is certainly needed. We also acknowledge that some submitters do not take sufficient care to ensure that all information reasonably available to them is included in submissions, but we disagree that the lack of fulsome information in a PMN is the predominant reason for EPA re-reviews. We are especially concerned that submitters will undertake the additional effort to comply with the regulations and EPA will continue to ignore, dismiss, or minimize such information it its reviews. For EPA to require additional effort to submit information in a specified manner only for EPA to reach the same determination as if the information had not been provided in the proscribed manner is both frustrating and wasteful. EPA states that it fills data gaps with models, analogs, and worst-case assumptions, which is appropriate. In the proposal, EPA does explain what level of detailed data is required under this new process for EPA’s deliberative process to elicit a different determination. If EPA’s view is consistently that everything is reasonably foreseen, the data provided by the submitter, in EPA’s preferred format or not, will not move the needle as no amount of information can address an unlimited number of reasonably foreseen events. EPA could achieve the exact same outcome without the information provided.

EPA’s proposed changes to the regulations for exemption submissions (e.g., LVEs) are also seemingly reasonable. EPA is appropriately proposing changes to the regulations to conform with Lautenberg. On the other hand, some changes seem to give EPA unlimited authority to deny exemption notices even if EPA could not get around to reviewing notices in the 30-day time period. While we do not think this is what EPA intended, a literal reading of the proposed language suggests that EPA could simply lower the priority of a submission for 30 days and then deny it based on the fact that EPA was “not able” to review it timely.

We also question the wisdom of EPA’s view that certain classes of chemicals are entirely ineligible for LVEs. Some chemicals may be too complex to review in a 30-day timeframe, but a PBT can probably be granted timely in an LVE if the necessary release and exposure controls are described in the notice.

Also problematic is EPA’s view of suspensions. We support EPA extending the amount of time a case can be suspended by phone or e-mail. There is little, if any, value in speaking with a program manager every two weeks only to hear that there is no update on the case. Unfortunately, the proposed regulations treat the 90-day review period as if it were a meaningful deadline. As it stands, PMNs sit paused in some part of the review process for months or years. Submitters typically acquiesce to seriatim suspensions. Most of those cases are paused at or near day 89 of the review process. EPA’s proposed regulations about submitting new information that becomes available during the last five days of the review period may put some submissions on near-permanent hold, especially if the manufacturer is registering the same substance in, for example, Europe.

A submitter might perform the testing to support a REACH registration in the 1-10 ton band and include that information in a PMN. In the year-plus that the PMN sits at EPA, the submitter performs the testing for a 10-100 ton registration. When that information becomes available, it must be submitted to EPA, and EPA will, presumably, restart its review, deprioritizing the PMN because new information was submitted. The PMN sits unreviewed for another year, during which the submitter develops the data to support a 100-1,000 ton registration. Again, the new data must be submitted and again, EPA will reset its review. This pattern puts submitters in an unenviable position of choosing between seeking to commercialize in the United States or in other countries or regions. Parallel commercialization becomes impossible. A submitter either submits in the United States and forgoes any additional testing to support registrations elsewhere, or it forgoes the U.S. market until it has completed all testing for all other global markets. EPA’s policies and, importantly, regulations should accommodate the reality of commercializing on a global scale. Our view would be different if EPA could and did review submissions timely. Until that happens, EPA’s process should avoid punishing submitters for EPA’s delays.

In general, the proposed changes have a sensible basis and are reasonable. We would welcome EPA’s more focused review of information submitted with PMNs and greater clarity around perceived inadequacy before insisting submitters provide more information. Stakeholders are urged to review the proposal carefully and to assist EPA in making informed and good choices in revising the rules.

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