EPA Updates TSCA CBI Requirements
The U.S. Environmental Protection Agency (EPA) published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 37155. The final rule notes that amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and treatment of confidentiality claims. The final rule includes procedures for submitting such claims in TSCA submissions. It addresses issues such as substantiation requirements, exemptions, electronic reporting enhancements (including expanding electronic reporting requirements), maintenance or withdrawal of confidentiality claims, and provisions in current rules that are inconsistent with amended TSCA. The rule also addresses EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims. The final rule will be effective August 7, 2023.
Summary of the Final Rule
Existing Regulations Governing Confidentiality under TSCA
The final rule centralizes most CBI-related procedures in a new part of the TSCA regulations, 40 C.F.R. Part 703. EPA notes that this new part also largely replaces TSCA-specific CBI regulations in 40 C.F.R. Section 2.306, though a few provisions remain regarding, e.g., the applicability of EPA’s public information rules to TSCA CBI in general and procedures for disclosure of information under special circumstances described in TSCA Section 14(d)(2) through (7). Section 2.306 has been updated in some provisions to conform to the timeframes specified for notice under TSCA Section 14(g).
EPA states that in some cases, such as the regulations implementing TSCA Section 14(d)(2) and (7), the final rule retains a notice requirement that is not required by TSCA “but which has historically been a feature” of EPA’s 40 C.F.R. Part 2, Subpart B, regulations. According to EPA, it received comments about the proposal to retain these notice requirements, “but notes that TSCA does not prohibit providing such notice and that especially in the case of rarely used disclosure provisions, providing notice to the person who asserted the CBI claim does not tend to significantly increase Agency burden or diminish the public availability of information.” Providing notice would also tend to reduce confusion for the person who asserted the CBI claim and reduce the possibility of unnecessary conflict over the handling of the information.
Purpose and Applicability
EPA states that it “somewhat revised” 40 C.F.R. Section 703.1 in response to public comment but retained the proposed provisions concerning the scope of information that is considered “reported to or otherwise obtained by EPA pursuant to TSCA or its implementing regulations,” particularly that data need not have been submitted pursuant to an exercise of TSCA authority in order for it to be considered obtained under TSCA.
EPA states that it modified the text of the proposed regulation in response to comments. The final rule clarifies and reconciles the applicable provisions of TSCA and the other laws by which EPA may have received data that is later used for TSCA purposes. According to EPA, even where TSCA excludes certain data from eligibility for business confidentiality protection, “there are very limited circumstances where the statute requires affirmative disclosure of that same data by EPA.” Instead, data used under TSCA might have originally been submitted under and remain protected or restricted from disclosure for reasons other than business confidentiality under another statute. EPA states that an example is Section 10(g) of the Federal Fungicide, Insecticide, and Rodenticide Act (FIFRA), which limits disclosure of certain pesticide data to persons who can certify they are not acting on behalf of an entity engaged in the production, sale, or distribution of pesticides in countries other than the United States. EPA notes that where certain data are not entitled to business confidentiality protections under TSCA but are protected from disclosure under another statute for other reasons (e.g., FIFRA Section 10(g)), “EPA does not believe there is a conflict between the two statutory provisions.” It therefore does not violate TSCA for EPA to withhold or restrict disclosure of such data pursuant to the requirements of the other law. EPA replaced the proposed language concerning resolution of conflicts with language in the final rule clarifying that information that was originally submitted under a statute other than TSCA may be protected from disclosure under the provisions of the other statute for reasons other than claims of business confidentiality, even if the information is subsequently used under TSCA and would not be eligible for business confidentiality protections under TSCA.
In the final rule, EPA declined to add exclusions beyond those originally proposed but modified the proposed text to combine similar exclusions and to clarify the intended scope of the exclusions. EPA states that it considers some types of information that may be included in or with a study document as not part of the “health and safety study” as defined in TSCA Section 3(8), which states that the term “health and safety study” means “any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this chapter.” According to EPA, this definition does not seek to provide an exclusive list of what is or is not “included” in the health and safety study but instead clarifies that all “underlying” information must be considered part of the study.
Requirements for Asserting a Confidentiality Claim
TSCA Section 14(c) governs assertion of confidentiality claims for TSCA submissions, requiring that persons submitting information under TSCA substantiate most confidentiality claims at the time of submission. It also includes additional certification and generic name requirements. EPA states that the final rule retains most of the proposed provisions, with some modifications to clarify the regulatory provisions, or in response to public comment.
Assertion of Confidentiality Claim upon Submission of Information to EPA
The final rule requires that confidentiality claims be asserted (and substantiated as necessary) at the time of submission (limited exceptions may apply in the case that such information is collected during an in-person TSCA enforcement inspection). EPA notes that this includes confidentiality claims for specific chemical identity, which must be asserted as specified in existing reporting rules (e.g., Chemical Data Reporting (CDR) rule, 40 C.F.R. Part 711). According to EPA, several commenters expressed concern regarding language in the preamble to the proposed rule clarifying that failing to assert a CBI claim for a specific chemical identity submitted under those existing regulations would lead to the specific chemical identity being moved from the confidential to the public portion of the Inventory. The concern pertains to instances where the chemical identity is reported by accession number (a non-confidential identifier) and no chemical identity CBI claim is asserted, with the result that the specific chemical identity is moved to the public Inventory. Existing rules require that the reporter assert and substantiate confidentiality claims for the specific identity if they wish for that substance to remain on the confidential portion of the TSCA Inventory. EPA states that commenters expressed concerns that downstream customers or processors of a specific chemical would report under TSCA by accession number and, “ignorant of specific chemical identity, could accidentally or intentionally waive the confidentiality claim and cause the substance to lose confidential status.”
EPA states that it recognizes that this issue might arise in specific contexts. The final rule addresses a wide variety of situations where the knowledge issue is not presented, however. EPA “believes that the best way to address commenters’ concerns is to include measures in specific TSCA reporting rules that take into account the reporting entity’s potential lack of knowledge, where such measures are necessary.” According to EPA, addressing the issue in the context of specific reporting rules will allow it to take into consideration the unique reporting context for the rule, such as the attributes of specific reporters. For example, a specific reporting rule might except all or a category of reporters from requirements to reassert chemical identity claims to maintain confidential Inventory status.
According to EPA, outside the final rule, it has already begun exploring options for addressing the knowledge concerns raised by the commenters. EPA states that for example, in the proposed rule TSCA Section 8(a)(7) “Reporting and Recordkeeping Requirements for the Perfluoroalkyl and Polyfluoralkyl (PFAS) Substances; Notice of Data Availability and Request for Comment,” it sought to clarify and add language to the proposed rule based in part on comments received during the public comment period for the CBI final rule and concerning an entity’s knowledge of a specific chemical identity.
Substantiation and Exemptions
According to EPA, the final rule includes substantiation questions in 40 C.F.R. Section 703.5(b) largely as set out in the proposed rule. EPA notes that as suggested in the proposed rule, the final rule “omits a patent-specific question in favor of including the issue of patents in another question.” The provisions concerning substantiation exemptions are as proposed.
EPA sates that the final rule omits a substantiation question exclusively concerned with patents, for the reasons discussed in the proposed rule and supported by public comment. Instead, according to EPA, where information claimed as confidential appears in some form in a patent or patent application, persons submitting those claims must address this public disclosure in their answer to the question on public disclosures more generally, 40 C.F.R. Section 703.5(b)(3)(iii). Failure to address such a patent disclosure in the substantiation increases the risk that EPA will determine the information not entitled to confidential treatment.
Consistent with the proposed rule, the final rule omits a substantiation question specifically concerning trade secrets.
Specificity of Competitive Harm
EPA states that it received several comments on the substantiation question concerning substantial competitive harm (40 C.F.R. Section 703.5(b)(3)(i)), several supporting the proposed question, some advocating instead for a version of the question currently used for CDR submissions, or clarification, elaboration, or other changes from the proposed question. The final rule uses the proposed version of the question. EPA notes that submitters “may continue to use existing guidance describing EPA’s expectations for substantiation and may contact EPA regarding case-specific substantiation questions.” Guidance and current staff contact information is available on EPA’s web page, “Confidential Business Information under TSCA.”
The final rule provisions at 40 C.F.R. Section 703.5(b)(5) concerning substantiation exemptions in TSCA Section 14(c)(2) are the same as proposed. EPA states that it received limited comment concerning the exemption at TSCA Section 14(c)(2)(G), for the specific identity of chemicals that have not yet been introduced into commerce, arguing that because the exemption may only be applied to claims made up until the substance is introduced into commerce, EPA has an obligation to revisit those pre-commerce claims once the substance has been introduced into commerce. According to EPA, there is nothing in the statute to suggest that EPA is required to revisit those prior claims. EPA notes that it generally only reviews CBI claims as required by TSCA Section 14(g) (within 90 days of submission) or as permitted or required pursuant to one of the provisions of TSCA Section 14(f). The filing of a Notice of Commencement (NOC), for example, does not trigger a mandatory review of prior CBI claims for the subject chemical substance by the same submitter.
Public Copies of Submissions
EPA states that 40 C.F.R. Section 703.5(c) of the final rule includes a requirement that TSCA submitters include a public copy (sometimes referred to as a “sanitized copy”) of their submission, though 40 C.F.R. Section 703.5(c)(1) limits this requirement to unfielded data, such as study reports and other documents that might be submitted as attachments to a reporting form. According to EPA, most TSCA submissions that are made on a standard reporting form include individual data fields that each have a checkbox-type indicator for confidentiality claims. In the case of these forms, a public copy is either already generated automatically, or the reporting tool could be updated to perform this function in future enhancements of the Central Data Exchange (CDX). EPA states that the Response to Comments document elaborates on its current and planned practices for making public copies of TSCA submissions available, “while noting that committing many of these practices to a rule is beyond the intended scope of this rulemaking activity except to the extent EPA finds the public copy to be deficient.”
Supporting Statement and Certification
According to EPA, the final rule at 40 C.F.R. Section 703.5(a) includes certification and supporting statements as set out in TSCA Section 14, which are consolidated into one certification that is automatically incorporated into most TSCA reporting forms. EPA states that TSCA submitters who for unusual and case-specific reasons are not able to provide their submission via CDX must assure that the consolidated statement is included in their submission. This provision is unchanged from the proposal.
The final rule includes provisions specifying requirements for generic chemical names, which are used in place of specific chemical names in public documents mentioning substances with confidential specific chemical identities. According to EPA, the requirements cover when and how such generic names must be submitted, some basic requirements, and procedures for resolving disagreements about the adequacy of a given generic name. TSCA Section 14(c)(1)(C) requires the submission of a generic name any time a specific chemical identity is claimed as confidential. This provision further requires that the generic name be “structurally descriptive” and that it “describe the chemical structure […] as specifically as practicable” while also protecting the features of the chemical substance that are claimed confidential or where disclosure would likely cause substantial harm. The generic name must also be consistent with the generic name guidance developed in accordance with TSCA Section 14(c)(4)(A).
According to EPA, the generic name provisions in the final rule are the same as proposed. EPA states that it concluded that incorporation of elements of the generic name guidance into the rule “provides helpful clarification concerning minimum generic name requirements.” EPA notes that despite that clarification, “EPA’s experience is that, in some instances, disagreement regarding the sufficiency of a generic name may be unavoidable,” however. Therefore, the final rule sets forth a streamlined process for negotiating generic names in TSCA Section 5 NOCs and introduces a provision for EPA to provide an opportunity to correct deficient generic names in any TSCA submission. EPA states that the substantiation exemption for certain specific chemical identities contained in Section 14(c)(2)(G) and corresponding exclusions from routine CBI review under TSCA Section 14(g) “indicate that substantive review of the sufficiency of every generic name at the time of submission is both in excess of TSCA requirements and impractical (especially where the substantiation necessary to complete such a review is neither required nor provided).”
EPA states that “[t]he clear requirements in the final rule regarding assertion of CBI claims, combined with recent improvements to TSCA reporting tools including near-universal electronic reporting, should significantly reduce the incidence of procedural deficiencies. Nonetheless, EPA does not expect that these will prevent all such problems.” EPA is therefore retaining the proposed deficiency provisions in the final rule at 40 C.F.R. Section 703.5(e).
According to EPA, the final rule requires, with very limited exceptions, that all TSCA submissions that include CBI claims be submitted electronically. EPA states that this requirement “most notably” affects reporting under TSCA Section 8(e), export notifications under TSCA Section 12(b), and polymer exemption notices under TSCA Section 5, “for which electronic reporting is required for the first time in today’s final rule.” EPA notes that voluntary e-reporting was already available for TSCA Sections 8(e) and 12(b) notices, and EPA will update those existing reporting tools in accordance with the final rule and make them mandatory to use for reporting. EPA states that a new reporting tool will be available for submitting annual polymer exemption notices.
Requirement to Report Health and Safety Information Using Organization for Economic Cooperation and Development (OECD) Harmonized Templates
The final rule requires that health and safety information be provided using the appropriate OECD harmonized template (OHT), when such a template is available. EPA notes that as explained in the preamble to the proposed rule, this requirement would be in addition to existing requirements to provide a full study report. (Emphasis in original.) According to EPA, templated data will make CBI review of the submission more efficient (by aiding in identification of CBI claims) and aid in data sharing and dissemination within EPA and in public databases. EPA states that it intends to elaborate on instructions for including OHT files (e.g., currently acceptable file types and IUCLID software versions) as appropriate in individual reporting rules or orders, and/or in the applicable reporting tool instruction documents.
Maintenance of Company Contact Information and Communications Concerning Claims
According to EPA, the final rule provisions concerning maintenance of company contact information and reliance on electronic notices concerning CBI claims are as proposed. EPA states that “[m]aintaining contact information for individual submissions is an inescapable consequence of the Lautenberg amendments, particularly since most CBI claims now expire after ten years unless reasserted by the submitter.” The TSCA Section 14(f) CBI review provisions also call for submission-specific company contact maintenance, in that those types of CBI review almost always require some notice to the company, both that the review is taking place and for the purpose of permitting submission of substantiation. Such reviews can take place at any time after a submission is made. EPA notes that it has created new reporting tools that permit a company to request copies of records it may have lost access to by turnover in personnel or to provide updated contact information for one or more company submissions. EPA states that more broadly, it “strongly suggests that companies develop internal practices to assure that a current company contact is maintained for each of their submissions including CBI. This might include, for example, use of email addresses that more than one person can access to receive CBI notices, a limited-access internal list of submission passphrases, or other procedures to better assure that passphrases and TSCA submission-specific information is known to or available to more than one person and isn’t lost to the company when any one of its personnel are suddenly unavailable.”
According to EPA, the final rule adopts the proposed provisions on withdrawing claims, which provide instructions for withdrawing claims originally made in an electronic submission, and for withdrawing claims originally made on paper or in an electronic submission no longer accessible to the company.
Amending a Public Copy Following Claim Denial or Expiration
According to EPA, public commentary was divided on who should be responsible for updating public copies of submissions to make newly non-CBI information available (the submitting company or EPA). EPA states that based on its experience, it concluded that companies submitting CBI claims should retain primary responsibility for updating public copies. Because the company best understands the intended scope and purpose of its original CBI claim(s), that company is in the best position to determine with precision which of its claims remain and assure these are indicated in the public copy accurately prior to release of the data. EPA notes the final rule does include some minor amendments to clarify how EPA will append public copies to make newly non-CBI information available, in cases where EPA must perform this function.
EPA Review of Confidentiality Claims
EPA states that the final rule maintains the proposed case selection methodology (one in four TSCA submissions with non-exempt CBI claims for information other than chemical identity) but clarifies that this is the method EPA will use in general. According to EPA, it believes that “some flexibility is appropriate here in case it might occasionally be necessary to issue additional confidentiality determinations to ensure that the Agency is meeting the minimum 25% required” by TSCA Section 14(g)(1)(C)(ii). The final rule also maintains the proposed exclusions from the representative subset, including certain pre-submission types of correspondence intended mainly to ascertain subsequent TSCA reporting obligations (e.g., bona fide notices under 40 C.F.R. Section 720.25), occasional submissions that may be excluded from the otherwise nearly universal electronic reporting requirement, and amendments. EPA notes that in general, it believes that excluding these submissions “is appropriate and will not significantly affect the total number of claims reviewed because these submissions may not contain many claims in the first place, the claims they do include are or will be duplicated in other submissions, and/or the submission type is relatively rare.”
According to EPA, TSCA does not specify the criteria that must be used in making a confidentiality determination, so EPA proposed and will retain in the final rule elements drawn from TSCA Section 14(b) limitations of confidentiality protections, TSCA Section 14(c) requirements to assert confidentiality claims, as well as EPA’s “long pre-existing” criteria for evaluation of confidentiality claims as set out in 40 C.F.R. Section 2.208.
EPA states that after considering comment on the proposal, it decided to omit the reconsideration process (for denied CBI claims) from the final rule. According to EPA, while some commenters supported the proposal, others did not, describing it as “biased, open-ended, and lacking in transparency.” EPA notes that it now believes that codifying a reconsideration process is unnecessary. If a person believes that a determination was incorrect or has questions about the determination, they may contact EPA (using the contact information in the final CBI determination letter) about their concerns prior to filing a judicial appeal.
Related or Corresponding Revisions to Other TSCA Rules
Revisions to 40 C.F.R. Parts 702, 704, 707, 716, 717, 723, and 790
The final rule replaces the CBI provisions of several TSCA rules with a cross reference to 40 C.F.R. Part 703 to centralize the CBI rules and make them more consistent among submission types. EPA states that it received some comment advocating for retaining some of the existing CBI provisions, but that it believes this is “unnecessary, redundant, and/or needlessly inconsistent” with the final CBI rules centralized in 40 C.F.R. Part 703.
Clarification of TSCA Section 12(b) Rules
EPA states that it revised the language in 40 C.F.R. Part 707 to cross reference 40 C.F.R. Part 703 for CBI reporting requirements, to require electronic reporting, and to clarify that it is generally not necessary to list confidential specific chemical identities in a TSCA Section 12(b) report.
Revision in 40 C.F.R. Sections 717.17 and 723.250 to Reflect Electronic Reporting
The final rule revises 40 C.F.R. Parts 717 and 723 to reflect that TSCA Section 8(c) incident reports and TSCA Section 5 polymer exemption notices must be submitted electronically.
Revisions to Confidentiality Provisions in the Premanufacture Notice (PMN) and Microbial Commercial Activity Notice (MCAN) Rules
The final rule revises 40 C.F.R. Parts 720 and 725 as proposed. According to EPA, the language in 40 C.F.R. Section 720.85(a) is mostly redundant with TSCA Section 14, other provisions of the final rule, or both. Under the final rule, persons may assert CBI claims for chemical identity in a PMN, but they must also submit a generic name consistent with TSCA Section 14(c). EPA notes that persons who would like to consult EPA concerning an appropriate generic name may continue to do so through the pre-notice consultation process.
According to EPA, the final rule retains much of 40 C.F.R. Section 720.85(b), but it has been moved to 40 C.F.R. Section 720.102, while the substantiation provisions are replaced with the substantiation provisions in 40 C.F.R. Part 703. EPA states that the provision in Section 720.85(b)(1), providing that a CBI claim for chemical identity may not be asserted in an NOC unless that CBI claim has been asserted for the underlying PMN, is not necessary. If the chemical identity is not claimed as CBI in the PMN, the chemical identity is published in the public notice required by TSCA Section 5(d)(2). PMNs and NOCs are identified by the same case number, providing a public link between the NOC and the PMN. Upon required TSCA Section 14(g) review of the chemical identity claim in the NOC, EPA would not uphold a confidentiality claim that was not made in the PMN.
The final rule addresses important issues related to TSCA CBI under the Lautenberg Act. As summarized above, the rule, among other things, addresses inconsistencies between the current regulations and Lautenberg’s statutory text, codifies substantiation procedures, codifies a process to review generic names, addresses conflicting information disclosure standards between statutes (e.g., TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)), clarifies what information in a health or safety study may be claimed as confidential, and establishes a formal procedure to manage the sunsetting or withdrawal of CBI claims. EPA issuing regulations that formalize the policies and procedures that it has been using is a necessary step. As we commented originally, EPA’s approach largely codifies its current policies.
EPA’s final rule consolidates all TSCA CBI claim assertion and review procedures, in a new, single section under 40 C.F.R. Part 703, except as modified elsewhere by more specific provisions in 40 C.F.R. Part 2 or other TSCA-specific regulations in Title 40 of the C.F.R. This increased consolidation of the TSCA CBI provisions, policies, and procedures will, in our view, make it more efficient for EPA to maintain the CBI regulations and further stakeholders’ efforts to find, review, and comply with those regulations.
We support most aspects of the final rule, but have some concerns, certain of which were discussed in commentary on the proposed rule in our May 17 and May 18, 2022, memoranda. The following is a discussion of key aspects of the final rule.
Information Submitted under Different Statutes or Voluntarily
The final rule retains proposed provisions concerning the scope of information that is considered “reported to or otherwise obtained by EPA pursuant to TSCA or its implementing regulations,” particularly that data need not have been submitted pursuant to an exercise of TSCA authority in order for it to be considered obtained under TSCA. This includes information that was first obtained by EPA under other authorities, such as FIFRA. 40 C.F.R. Section 703.1(c) states, however, that “where such information is not protected from disclosure under TSCA Section 14, but the statute under which the information was originally provided to EPA limits disclosure for reasons other than business confidentiality (for example, limited disclosure of pesticide data to multinational pesticide producers under 7 U.S.C. § 136h(g)), the disclosure limitation in the statute under which the information was obtained by EPA continues to apply, except where TSCA expressly requires disclosure of that information.” In its response to comments, EPA explains that it does not view a conflict between TSCA and FIFRA CBI provisions in most cases, rather data that are protected under FIFRA retain that protection if EPA uses that information for a TSCA evaluation. Further, EPA states that while Section 14(b)(2) limits what can be protected under TSCA, it does not compel disclosure if, for example, the information is eligible for protection under another statute.
In our view, it remains unclear that EPA will view the protection afforded under the original statute as being a valid reason to not disclose if it is used in a TSCA action. In EPA’s response to comments, EPA focuses on data that are protected for reasons other than business confidentiality retaining protection, suggesting that if data are claimed for business confidentiality under another statute, if used by EPA in a TSCA assessment, such confidentiality could be lost. If that is the case and EPA’s election to reuse business confidential information for a TSCA action and doing so voids the confidentiality protection, one might reasonably view EPA’s repurposing of the data that lead to disclosure of that originally confidential information as an impermissible taking of the value of that information. We believe also that the rule will have the effect of discouraging the voluntary submission of information to EPA that will or may later become information considered “obtained under TSCA” under the rule. A data owner might not wish to risk disclosure if and when EPA decides to use those data for TSCA assessment purposes .
Confidentiality Claims for Submissions Using Accession Numbers to Identify a Chemical
EPA proposed that if a TSCA submission identifies a chemical substance listed on the confidential portion of the TSCA Inventory (e.g., by its accession number) but does not assert a confidentiality claim for the chemical identity, then the identity would no longer be eligible for confidentiality treatment under TSCA (except where the submission does not pertain to manufacture or processing for a commercial purpose, e.g., research and development (R&D)). Under the proposal and as noted by certain commenters, any entity that knows the accession number for the chemical (accession numbers are by their nature public information) could invalidate another company’s valid CBI claim for chemical identity by reporting, for example, under the TSCA Section 8(a) Chemical Data Reporting Rule (CDR), identifying the substance by accession number and not claiming the chemical identity as CBI. In EPA’s view (as codified in this rule), this would be true regardless of whether the submitter actually knows the specific identity of the substance. EPA incorrectly assumed that entities that know the accession number also know the underlying chemical identity. As a result, any instance of any submitter providing an accession number without maintaining a CBI claim would lead EPA to move the identity from the confidential portion to the public portion of the Inventory. EPA’s response to comments is that it expects parties to address these situations in private agreements — a position that ignores the fact that accession numbers may have already been shared without non-disclosure agreements (NDA), meaning that a manufacturer could not prevent a customer from disclosing (intentionally or not) the identity of a substance the manufacturer has a significant interest in maintaining as confidential. In the final rule, EPA acknowledges the proposed approach can have the problematic result where an entity lacking knowledge of a specific chemical identity nonetheless waive confidentiality for that chemical but does not address the issue in the final new or amended CBI regulations. Instead, EPA states that because the final rule “addressees a wide variety of situations where the knowledge issue is not presented,” it believes the best way to address the concerns expressed by commenters is to include measures (e.g., where reporting is made by accession number and there is no CBI claim for the chemical identity, EPA would require the reporting entity to identify the specific chemical identity) in specific TSCA reporting rules where the issue may arise, and cites to the proposed TSCA Section 8(a)(7) reporting rule for PFAS as a situation where EPA is considering the issue in a specific context. While EPA’s approach may alleviate the problem presented by reporting under specific future rulemakings, it is not clear how the approach addresses the fundamental issue as presented in situations where reporting is currently required where there is no rulemaking associated with the required reporting (e.g., TSCA Section 8(e)) or existing TSCA rules with ongoing reporting requirements (e.g., CDR). We are disappointed that EPA effectively punted on this critical issue. It is illogical that an entity that knows the accession number, but not the specific identity, can “disclose” the specific identity by simply failing to check a CBI box on a submission.
Electronic Submission Requirements
As was proposed, the final rule requires electronic reporting via CDX except for where reporting is requested or required under TSCA Section 11. Concerns were raised by commenters that electronic reporting should not be a requirement, but an option given past problems that have plagued EPA regarding CDX. EPA states, however, that it expects that if problems do arise in the future, it will promptly resolve the issues and make appropriate accommodations (e.g., extend comment deadlines). We applaud EPA’s interest in moving to electronic reporting to facilitate the efficient handling of information and information transparency; CDX has many advantages over other transmission types. Unfortunately, doing so puts additional burden on CDX and will likely lead to additional CDX glitches. How effectively EPA implements the broadened electronic reporting requirements remains to be seen. We hope that EPA commits the resources necessary to improve CDX’s reliability and capacity as EPA moves to increase the data flows that must be submitted by CDX.
Information from Health and Safety Studies
EPA’s proposed definition of “health and safety study” specifies types of information that are not within the scope of the TSCA Section 3(8) definition of “health and safety study,” including: the name of the submitting company; the name of the laboratory in cases where the laboratory is part of or closely affiliated with the submitting company; internal product codes; the names of laboratory personnel; names and other private information included in study data or reports; cost or other financial data; and product development, advertising, or marketing plans. We agree. Such information is not germane to the interpretation of the study. The information excluded from the definition allows full visibility into the study results while rendering the public version of the study unacceptable to another regulatory entity in case a competitor wishes to use the public version to support a substance registration in another jurisdiction. EPA was unpersuaded by other commenters’ views that the identity of the study sponsor is critical to evaluate the quality of the study. We note that the one of the primary purposes of developing the Good Laboratory Practices (GLP) was to allow data to be developed without undue influence by the study sponsor. If studies sponsored by industry cannot be trusted because of conflicts of interest, then industry should not be sponsoring (or be required to sponsor) studies to support regulatory filings at all.
Maintenance of Company Contact Information and Communications Concerning Claims
EPA is issuing in final its proposed requirements that submitters maintain contacts for individual submissions in CDX indefinitely to maintain CBI claims and that communications regarding claims will be made via CDX. EPA will use CDX instead of formal letters with delivery verification to satisfy EPA’s requirement to provide notice of its CBI review decision or CBI sunsetting dates, among others. As discussed in our memoranda on the proposed rule of May 17, 2022, we believe that this may be problematic. If a submitter fails to receive notice through CDX due to a technical issue, because the submitting official is not available to log in to receive the notice, or the passphrase for the submission has been lost, the response window (ten or 30 days, depending on the notice type) may expire before anybody at the company is even aware of the notice in CDX. There are both technical issues (e.g., is CDX sufficiently reliable to serve this function?) and logistical issues (e.g., is the submitting official still at the company?) that could make EPA’s scheme unreliable. EPA is requiring submitters to keep current the contacts on submissions — that is, EPA is requiring that a company ensure that the technical contact is current on all submissions so that EPA has a point of contact for each submission. In its response to comments, EPA states that “it should not be necessary for the company to access the original submission in CDX in order to reassert claims,” but fails to recognize that the passphrase for the original submission is a predicate to viewing any response in CDX. Without the passphrase for the original submission, a company cannot even view EPA’s notice of expiration. In our view, requiring submitters to update each and every submission with CBI claims will present a significant burden on companies that have many submissions, especially as EPA is moving even more data flows to CDX. EPA does not state why it could not update CDX to send notifications to all users registered under the submitting organization that an expiration notice is posted for a case. It could be burdensome to reprogram CDX, but it would be a one-time change to EPA’s system. Instead, EPA is requiring that submitting companies repeatedly expend effort every time a key contact leaves a company, which is likely to be predictably often. EPA dismisses these concerns and suggests that CDX users employ shared mailboxes as their contact information — a suggestion that we find problematic since EPA’s policy (as explicitly stated as part of the registration process) is that CDX logins may not be shared. Using a shared e-mail is not equivalent of shared logins, but security of passwords is based on access to the registrant’s e-mail, so EPA’s suggestion that CDX users employ shared e-mail addresses strikes us as a significant departure from EPA’s security policy.
Harmonized Templates for the Reporting of Health and Safety Studies
EPA is including in the final rule a requirement that submitters of health and safety studies, or information from such studies, provide such data in templated format (along with the full studies) using an appropriate OECD template, if such template is available for the data type. Although use of the templates is already required for submitting data to authorities in certain other countries (e.g., submissions made to the European Chemicals Agency (ECHA)) and thus completed templates may already be available to certain submitters, we believe there will be many cases where the submitters must complete the templates for the first time under this broad, new requirement. Additionally, we believe that EPA continues to underestimate the frequency that such new templating efforts will be needed and the time needed to complete and submit the templates. We further question the propriety of EPA including this requirement in the TSCA CBI regulations given the obligation to submit data in template format exists even in cases where there is no CBI claim in the submission at all.
Information in Patents
EPA solicited comments in the proposed rule on whether publication of information in a patent could invalidate a TSCA CBI claim because the information has been disclosed publicly and whether a stand-alone substantiation question relating to patents is appropriate or whether it should be added to the more general substantiation question relating to publications. The final rule requires that where information claimed as confidential appears in some form in a patent or patent application, persons submitting those claims must address this public disclosure in their answer to the CBI substantiation question on public disclosures more generally. We support this approach. Because the question of whether certain specific TSCA information has been disclosed in a patent is fact-specific, we believe publishing a patent should be one consideration in EPA’s determination of whether the information is eligible for CBI protection.
Requirement of Public (Sanitized) Copies of Submissions That Redact Confidential Information
We support the provision in the final rule that requires TSCA submitters to include a public copy of their submission for data not required to be reported in a reporting form field, such as study reports and other documents that might be submitted as attachments to a reporting form. We believe that it is the submitter’s responsibility to redact information determined to be confidential and review the properly sanitized version of submissions.
Amendment of a Public Copy of Submission Following Claim Denial, Withdrawal, or Expiration Following Claim Denial, Withdrawal, or Expiration
We also support the approach taken in the final rule that it is the submitter’s responsibility to amend a submission to reveal declassified information where EPA denies a CBI claim and the submitter does not appeal, the submitter withdraws voluntarily a CBI claim, or if a claim sunsets without substantiation for continuation of the claim. While this is an additional burden on the submitter, it ensures that the submitter has the final opportunity to check the amended submission so that it continues to protect information where CBI claims continue to be valid and relieves EPA of the burden of preparing an updated public copy.
EPA maintains in the final rule the CBI claim selection methodology that was included in the proposed rule to ensure that EPA is meeting the minimum 25 percent representative subset of the CBI claim review required by TSCA Section 14(g)(1)(c)(ii) — with the EPA clarification that the methodology will be used in general. EPA is also keeping the proposed exclusions from the representative subset, including certain pre-submission types of correspondence intended mainly to ascertain subsequent TSCA reporting obligations (e.g., bona fide intent notices under 40 C.F.R. Section 720.25), occasional submissions that may be excluded from the otherwise nearly universal electronic reporting requirement (e.g., in response to TSCA Section 11 subpoenas), and amendments. We believe the approach taken in the final rule is reasonable.
Correction of Deficient Submissions
We support the inclusion in the final rule of a process concerning correction of CBI claims. We believe, however, that the ten-day period provided for the correction may not always be sufficient to allow the submitter to remedy a deficiency notified by EPA prior to its resumption of the review of the submission and/or denial of the claim by EPA. Nevertheless, we acknowledge that EPA must balance the timeline.
Reconsideration of CBI Claim Denials
We support the approach in the proposed rule that includes a means to request reconsideration by EPA’s Office of General Counsel of determinations denying confidential treatment and suspension of the 30-day notice period provided in TSCA Section 14(g)(2)(B) prior to disclosure of information determined to be not entitled to protection from disclosure. EPA has not included this proposed reconsideration appeals procedure in the final rule, stating it now believes that codifying a reconsideration process is unnecessary. EPA states that if a person believes that a determination was incorrect or has questions about the determination, they may contact EPA about their concerns prior to filing a judicial appeal. While this approach may address adequately concerns regarding CBI claim denials in certain cases, we believe the proposed process would provide an added procedure that would have lessened the possibility that judicial review of the determination and the associated expense to the submitter and EPA would be required.
With some exceptions as noted above, we believe the final rule generally is well-conceived and that its provisions will facilitate submitter compliance with TSCA’s CBI submission and substantiation requirements. The rule will also improve transparency and availability of non-confidential information submitted under TSCA.