Confidential Business Information Claims under the Toxic Substances Control Act (TSCA); Final Rule (RIN 2070-AK68)
                         Response to Comments Document
                                   May 2023
On May 12, 2022, the Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) published a proposed rule entitled "Confidential Business Information Claims under the Toxic Substances Control Act (TSCA)" (87 FR 29078). The proposed rulemaking would propose 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). Amendments to TSCA in 2016 (aka "the Lautenberg amendments" or "Lautenberg") included many new provisions concerning the assertion, Agency review, and treatment of confidentiality claims. This document proposes 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 preexisting rules that are inconsistent with amended TSCA. The proposed rule also addresses EPA procedures for reviewing and communicating with TSCA submitters about confidentiality claims.
EPA received 18 unique public comments on the proposal. These included comments from industry, non-governmental organizations, trade associations, consultants, and others. The public comments are available in Docket Number: EPA-HQ-OPPT-2021-0419.

The commenters (with docket identifier) included:
 3M Company (Docket ID EPA-HQ-OPPT-2021-0419-0046)
 American Chemistry Council (ACC) (Docket ID EPA-HQ-OPPT-2021-0419-0044)
 American Coatings Association (ACA) (Docket ID EPA-HQ-OPPT-2021-0419-0054)
 American Fuel and Petrochemical Manufactures (Docket ID EPA-HQ-OPPT-2021-0419-0052)
 American Petroleum Institute (API) (Docket ID EPA-HQ-OPPT-2021-0419-0045)
 Anonymous (Docket ID EPA-HQ-OPPT-2021-0419-0037)
 Anonymous (Docket ID EPA-HQ-OPPT-2021-0419-0025)
 Association of State Drinking Water Administrators (ASDWA)(Docket ID EPA -HQ-OPPT-2021-0419-0043)
 Chemical Users Coalition (CUC) (Docket ID EPA-HQ-OPPT-2021-0419-0041)
 Earthjustice et al. (Docket ID EPA-HQ-OPPT-2021-0419-0049)
 Environmental Defense Fund (Docket ID EPA-HQ-OPPT-2021-0419-0026)
 Environmental Defense Fund (Docket ID EPA-HQ-OPPT-2021-0419-0050
 Environmental Protection Network (EPN) (Docket ID EPA-HQ-OPPT-2021-0419-0042)
 Fragrance Creators Association and Society of Chemical Manufacturers and Affiliates (SOCMA) (Docket ID EPA-HQ-OPPT-2021-0419-0051)
 Household & Commercial Products Association (Docket ID EPA-HQ-OPPT-2021-0419-0048)
 National Association of Chemicals Distributors (NACD) (Docket ID EPA-HQ-OPPT-2021-0419-0040)
 Toxic Substances Control Act New Chemicals Coalition (TSCA NCC), n-methylpyrrolidone (NMP) Producers Group and TDCE Consortium (Docket ID EPA-HQ-OPPT-2021-0419-0053)
 U.S. Chamber of Commerce (Docket ID EPA-HQ-OPPT-2021-0419-0047)

EPA considered the public comments during the development of a final rule entitled, "Confidential Business Information Claims under the Toxic Substances Control Act (TSCA)." In several instances, EPA made adjustments to the provisions of the rule based on feedback from public comments. Unit III. of the preamble of the final rule provides a description of how EPA considered public comments and the changes that were made to the final rule. This Response to Comments Document supplements the discussion in Unit III. of the preamble to the final rule. This document does not always cross-reference each response with each commenter(s) who raised a particular issue. However, in many cases where commenters provided particularly detailed comments that were used to frame EPA's overall response on an issue, those individual comments are paraphrased. The responses presented in this document are intended to augment discussion that appears in the preamble to the final rule. Although portions of the preamble to the final rule are paraphrased in this document, to the extent such paraphrasing introduces any confusion or apparent inconsistency, the preamble itself remains the definitive statement of the rationale for the provisions included in the final rule.
For this Response to Comments Document, EPA has only addressed comments directly applicable to the final rulemaking. Comments that were out-of-scope of the rulemaking were noted but not addressed in the document and may be used by EPA in developing science policies, revising the guidelines, or future rulemakings, as appropriate.
This Response to Comments Document is organized into the following topic areas:
Contents
Unit 1: General Comments	4
Unit 2: TSCA Section 14(d) Disclosures and Notice Requirements	5
Unit 3. Obtained under TSCA and resolution of conflicts (40 CFR 703.1)	6
Unit 4: Health and safety study (40 CFR 703.3; definitions)	12
Unit 5: Requirement to assert claims at the time of submission; knowledge of chemical identity (40 CFR 703.5)	15
Unit 6: Providing substantiation and substantiation questions (40 CFR 703.5(b))	20
Unit 7: Substantiation exemptions under TSCA 14(c)(2)	27
Unit 8: Public Copies (40 CFR 703.5(c))	29
Unit 9: Generic Names (40 CFR 703.5(d))	30
Unit 10: Deficient Claims (40 CFR 703.5(e))	33
Unit 11: Electronic Reporting (40 CFR 703.5(f))	37
Unit 12: OECD Templates (40 CFR 703.5(g))	38
Unit 13: Contact Information and Electronic Notices (40 CFR 703.5(h))	38
Unit 14: Amending Public Copies (40 CFR 703.5(j))	40
Unit 15: EPA Review under 14(g) (40 CFR 703.7)	41
Unit 16: Representative Subset of Case Selection (40 CFR 703.7(a))	41
Unit 17: Review Period/Effect of Amendments (40 CFR 703.7(c))	43
Unit 18: Publication of final determinations (40 CFR 703.7(d))	44
Unit 19: Substantive criteria (40 CFR 703.7(f))	44
Unit 20: Reconsideration Requests (40 CFR 703.7(g) as proposed)	45
Unit 21: EPA Review under 14(f) (40 CFR 703.8)	46
Unit 22: Proposed revisions and consolidation of pre-existing TSCA rules on CBI	46
Unit 23: Notice beyond TSCA section 14 requirements	50
Unit 24: CBI claim review and public disclosure obligations generally	51

 Unit 1: General Comments
Comment:  A few commenters wrote in general support of EPA's rulemaking effort and several commenters supported particular provisions, such as EPA's proposed consolidation of TSCA CBI rules, use of the generic name guidance document, and integration of substantiation into reporting forms.
Source: -0044; -0043; -0042; -0051; -0048; -0053; -0047
Response:  EPA appreciates these comments.
Comment: Several commenters urged that new requirements included in the proposal should apply only prospectively.
Source: -0044; -0041; -0051; 0052; -0045
Response:  EPA generally agrees with this comment; the requirements, when finalized, will generally apply prospectively, especially with respect to assertion of CBI claims after the effective date of the rule. Note, however, that some regulatory changes due to revisions in section 14 are already in effect.  The Lautenberg amendments rendered certain aspects of existing regulations out of date, as discussed generally in the preamble, such as requirements for asserting confidentiality claims. EPA has incorporated these changes into several regulations that were promulgated or amended after Lautenberg, and also has published its interim procedures for implementing the new law. See, e.g., https://www.epa.gov/tsca-cbi . Further, EPA may or in some cases must review or take other actions authorized or required by Lautenberg with respect to claims that pre-date either the requirements of this rule or the Lautenberg amendments. These rules, including the substantiation, electronic notice requirements, and review procedures, will apply to such actions initiated after the effective date of this rule.
Comment: One commenter asserted that the Economic Assessment was incomplete, in that it did not account for the increased burden of providing substantiation in general, or for answering a different competitive harm question.  They suggested that a sensitivity analysis was needed.
Source: -0044
Response:  EPA disagrees with this comment. The burden associated with providing substantiation for TSCA submissions has already been incorporated into several existing Information Collection Requests for the various TSCA submissions.  See, e.g., OMB Control Nos. 2070-0033 (section 4), 2070-0038 (section 5), 2070-0202 (section 6); 2070-0162 (CDR); 2070-0224 (section 8(c) and (d)); 2070-0046 (section 8(e)); 2070-0030 (section 12(b)); 2070-0207 (section 8(b)(10)(D)); 2070-0185 (TSCA Title VI).
Comment: One commenter requested a comment period extension.
Source: -0026
Response: EPA declined to grant this comment period extension request.
 Unit 2: TSCA Section 14(d) Disclosures and Notice Requirements
Comment: EPA received two comments concerning section 14(d)(3) disclosures; one of these requested elaboration on how section 14(d)(3) disclosures would be made, especially in connection with risks to workers and potentially exposed or susceptible subpopulations, and the other voiced concern that the EPA Office of General Counsel would "veto" the TSCA program office's risk decisions.
Source: -0050; -0049
Response: Prior to Lautenberg, the Agency was required to make a similar risk determination before disclosure of information pursuant to this provision. See 15 U.S.C. § 2613(a)(3) (1976) (information "shall be disclosed if the Administrator determines it necessary to protect health or the environment against an unreasonable risk of injury to health or the environment.") The process for disclosing such information was established in 1978 in 40 CFR 2.306(k), and required a determination from the program office and notice to the General Counsel's office for a final determination -- OGC's final determination is focused on whether the disclosure is "necessary," not on second-guessing the program office's risk determination.
EPA did not propose, nor is it finalizing, either substantive criteria for making the necessary "risk" determination under section 14(d)(3) or any change in the roles of the Agency offices involved. EPA has retained the same process in the final rule, with updates only to reflect the revised risk determination at section 14(d)(3) and notice requirement in section 14(g)(2)(C)(i). The final rule corrects one inconsistency with the statute in the proposed rule, changing "may be disclosed" to "shall be disclosed."  Further elaboration on how section 14(d)(3) disclosures would be made, including when unreasonable risk to workers or potentially exposed or susceptible subpopulations may be identified, is beyond the scope of this rulemaking.
Comment: A few commenters noted that the proposed rule did not elaborate on all notification periods listed in section 14, or that in some cases, the proposed rule required notifications that are not required by TSCA.
Source: -0050; -0052
Response:  For two notice requirements in section 14, EPA is not repeating the notice requirement in the final regulation (the notice requirements pertaining to sections 14(b)(4) and 14(d)(8)). Where the statutory requirement is evident on its face, there is generally no need to repeat it in the regulations.  As the D.C. Circuit noted in recent litigation also touching on section 14 of TSCA, "there is nothing facially troubling about the failure to copy every relevant statutory obligation into the regulation."  EDF v. EPA, 922 F.3d 446, 457 (D.C. Cir. 2019) (quoting Texas v. EPA, 726 F.3d 180, 195 (D.C. Cir. 2013)).
However, in the final rule EPA has clarified that several of the existing processes for disclosure pursuant to provisions in section 14(d), including the notice requirements, continue to apply.
TSCA section 14(g)(2)(C)(iii) states that "[n]otification shall not be required" for the disclosure of information pursuant to sections 14(d)(1), (2), (7), or (8). The final rule does not require additional process prior to disclosure under section 14(d)(8). However, EPA has retained the existing procedures for disclosure pursuant to 14(d)(1), (2), and (7).  Although TSCA does not require notice in such circumstances, neither does it prohibit providing notice.  Especially in the case of these three 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. Further, providing notice of disclosure in these circumstances does not affect what information is ultimately shared outside the Agency, so the level of transparency is not impacted.
Comment: A commenter pointed out that language in proposed 40 CFR 2.306(d) implied that disclosure under TSCA section 14(d)(4), (5), or (6) was discretionary, noting that disclosure pursuant to these provisions is non-discretionary.
Source: -0050
Response:  The proposed rule was not intended to suggest that once all the conditions for disclosure are met, disclosure is discretionary. 40 CFR 2.306(d) has been revised to clarify that disclosures will be made pursuant to these provisions as long as all requirements for such disclosures are met.

 Unit 3. Obtained under TSCA and resolution of conflicts (40 CFR 703.1)
Comment: EPA received several comments critical of how the proposed rule described information "obtained under TSCA." Some commenters asserted that EPA had revised its interpretation of "under TSCA," impermissibly broadening it to include information originally submitted under another statute, and/or that the disclosure provisions of the statute under which the information was originally submitted should control.

Source: -0044; -0052; -0045; -0046; -0051; -0040

Response: EPA disagrees that the rule impermissibly broadens EPA's interpretation of "under TSCA."  EPA is finalizing, with minor modifications, the provision in the rule that identifies information as being "reported to, or otherwise obtained, under TSCA." This provision is intended to clarify EPA's prior regulation at 40 CFR 2.306(b), which stated:
      This section applies to all information submitted to EPA for the purpose of satisfying some requirement or condition of the Act or of regulations which implement the Act, including information originally submitted to EPA for some other purpose and either relied upon to avoid some requirement or condition of the Act or incorporated into a submission in order to satisfy some requirement or condition of the Act or of regulations which implement the Act. Information will be considered to have been provided under the Act if the information could have been obtained under authority of the Act, whether the Act was cited as authority or not, and whether the information was provided directly to EPA or through some third person.
When 40 CFR 2.306(b) was promulgated, EPA determined that information would only be considered information submitted or obtained "under" TSCA if TSCA provided the statutory authority to compel submission of the information. The provision in 703.1 does not change EPA's previously codified position that information that could be obtained under TSCA may be made subject to TSCA authority. Additionally, it is consistent with the same policy underlying the original provision in 40 CFR 2.306(b), which is to facilitate use of information that could be required under TSCA without requiring companies to resubmit that same information. Rather, the new provision clarifies how use of such information operates, and indicates that disclosure restrictions in the original statute not based on business confidentiality still apply.
Comment:  Commenters also criticized the proposed rule, asserting that it would impermissibly narrow EPA's interpretation in 40 CFR 2.306(b) regarding what it means for information to be "reported to, or otherwise obtained by, [EPA] under [TSCA]," by requiring additional criteria beyond that which they argue was previously contained in 40 CFR 2.306(b), "the information could have been obtained under authority of the Act." One commenter criticized the condition that EPA "makes use of the information in the course of carrying out its responsibilities under TSCA."
Source: -0050; -0049
Response: The comments inaccurately describe the effect of 40 CFR 2.306(b). This provision established related but conceptually distinct standards for determining whether such information is obtained under TSCA: (1) whether the information was submitted for the purpose of satisfying some requirement or condition of TSCA or of regulations implementing TSCA; and (2) whether the information could have been obtained under authority of TSCA.  The first standard focused on the purpose of the submission, while the second standard focused on EPA's authority under TSCA to compel the submission. However, 40 CFR 2.306(b) was not clear as to whether both standards must be met for 40 CFR 2.306 to apply. In order to address this ambiguity, EPA has retained both of these elements in the final rule while clarifying that both must be met in order for the information to be considered TSCA information. There has been no narrowing of EPA's interpretation. EPA is modifying, at 40 CFR 703.1, the proposed approach to information originally submitted under another statute. EPA has somewhat revised the proposed language in response to public comment but retains 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 did not intend for "makes use" of the information to narrow the scope of information that would be deemed submitted under TSCA. In fact, under the most restrictive interpretation of the language in 40 CFR 2.306(b), the information had to be "either relied upon to avoid some requirement or condition of the Act or incorporated into a submission in order to satisfy some requirement or condition of the Act or of regulations which implement the Act." This rule clarifies EPA's interpretation that such events are not required to establish TSCA jurisdiction.
Nonetheless, EPA is not asserting that the mere fact that information that could have been submitted under TSCA becomes subject to the provisions of TSCA Section 14 even where such information has no nexus with TSCA whatsoever. To clarify the intent, EPA has modified the 40 CFR 703.1(c)(2) language to clarify that making use of information includes, e.g., considering the information in actions under TSCA. This language is consistent with the language in section 26(k) of TSCA, which requires EPA to "take into consideration" reasonably available information in carrying out sections 4, 5, and 6 of TSCA. Thus, it would cover, for example, studies considered during systematic review of section 6 risk evaluations, including studies that are not selected as the "main study" for purposes of identifying the most sensitive health outcome or developing the dose-response.
Comment:  EPA received several comments on its proposal for resolving conflicts in CBI treatment between statutes (such as when EPA uses and wants or is requested to disclose data originally obtained under a statute other than TSCA). Some of these commenters argued that data originally submitted under another statute should not be considered as "obtained under TSCA" in the first place (see response to these comments elsewhere in this Unit).  Other commenters argued that TSCA disclosure requirements and rules should control, such that if TSCA does not provide protections against disclosure, the information should be disclosed under TSCA regardless of the requirements under which the information was originally submitted, or that when the disclosure provisions of two or more regulations might apply to the same piece of information, the rule that provides for maximum disclosure should be applied.
Source: -0050; -0049
Response:  EPA first notes that what appears to be a conflict of laws -- where one statute requires one outcome and the other requires the opposite  -  is not the case here.  Instead, the final rule clarifies and reconciles the various protections and disclosure requirements provided under TSCA with those of the other laws by which EPA may receive data that is later used for TSCA purposes.
EPA also notes that the arguably expansive view of what is considered obtained under TSCA in the final rule is balanced by this provision concerning reconciliation of possible differences in disclosure protections between statutes, where EPA uses information under TSCA that was originally provided pursuant to another statute.
Comment: Considering information submitted under another statute but used for TSCA purposes to be subject to the confidentiality provisions of that other statute constitutes a violation of TSCA sections 14(a) and 14(b), which require information that is "under" TSCA to be subject to TSCA's confidentiality provisions.
Source: -0050; -0049
Response: EPA believes that this comment has some merit (see explanation below). The Agency has therefore modified the language in 40 CFR 703.1 to more accurately reflect the law. The provision now makes clear that the confidentiality provisions of section 14 apply to such data. However, in some cases data not eligible for business confidentiality under section 14 may be withheld for other reasons, such as personal privacy or national security. This same principle applies to provisions in the statute under which the information was originally submitted, where such provisions are not based on business confidentiality.  Where certain data is not entitled to business confidentiality protections under TSCA but does enjoy disclosure protections 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 such requirements of the other law.
Data used under TSCA might have originally been submitted under and remain protected or restricted from disclosure under another statute, such as FIFRA 10(g), which limits disclosure of certain pesticide data to persons who can certify they are not acting on behalf of a multinational competitor of the data submitter. Recognizing that while certain data is not entitled to business confidentiality protections under TSCA, it does enjoy disclosure protections under another statute for other reasons (e.g, FIFRA 10(g)) does not put EPA in the position of having to resolve a conflict. It does not violate TSCA to withhold or restrict disclosure of such data pursuant to the requirements of the other law. Note that FIFRA section 10(g) does not prevent the public from getting access to health and safety data originally submitted under FIFRA and later used for TSCA purposes. FIFRA section 10(g) merely keeps such data from being disclosed to multinational pesticide companies (see comment response immediately below), and EPA has long interpreted section 10(g) as permitting release of summaries of data without restriction.
The only true potential for conflict is where TSCA explicitly requires the disclosure of such data such as TSCA section 26(j)(2), which requires disclosure of test data submitted under section 4 where that information is not protected by section 14. In this particular situation, TSCA would control the availability of such data. However, where TSCA does not explicitly mandate disclosure, the fact that section 14 business confidentiality protection is unavailable would not rule out other bases for protecting the information.  Such an approach is consistent with TSCA section 14(b)(2). TSCA section 14(b)(2) states that TSCA section 14(a) "does not prohibit the disclosure of" certain health and safety studies and information obtained from a study, while section 14(a) states that EPA "shall not disclose" certain information. EPA has explained that this means information under section 14(b)(2) "will not be afforded TSCA `Confidential Business Information' (CBI) protection." (68 FR 33129, 33136 (June 3, 2003)). Information can both not be afforded TSCA CBI protection and be provided protection under another statute. Because TSCA section 14(b)(2) is limited to lifting TSCA CBI protection for, but not compelling disclosure of, such information, continuing to protect from disclosure information pursuant to another statute, for reasons other than business confidentiality, avoids conflict with TSCA section 14(b)(2).
EPA has therefore replaced the proposed language concerning resolution of conflicts with language clarifying that information that was originally provided under a statute other than TSCA may be protected from disclosure under the provisions of that 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, except where TSCA expressly requires disclosure of that information.
 Comment:  EPA's approach is less transparent than the existing regulation at 40 CFR 2.202(d):
       If two or more of the sections containing special rules [§§ 2.301 through 2.311] apply to the particular information in question, and the applicable sections prescribe conflicting special rules for the treatment of the information, the rule which provides greater or wider availability to the public of the information shall govern.
Source: -0050; -0049
Response: EPA finalized 40 CFR 2.202(d) in 1976, noting that "The first inquiry, in a situation where two statutes appear to require different results concerning the treatment of the same information, should be an examination to determine whether in fact there is a conflict. If there is a true conflict, however, the Administrator believes that the public policy in favor of disclosure of information should prevail." 41 FR 36902, 36919 (Sept. 1, 1976).  EPA is not aware of any instance where 40 CFR 2.306 was found to conflict with any of the other special rules in 40 CFR §§ 2.301 through 2.311, let alone where it disclosed information pursuant to that provision.  Instead, uncertainty over how to handle the differing CBI provisions of FIFRA and TSCA has likely hindered cross-office sharing of information within EPA.  Given the enhanced requirements in the Lautenberg amendments to consider or use existing data EPA has access to, not limited to data originally submitted under TSCA, EPA expects resolution of these uncertainties is a necessity, especially with respect to use of data originally submitted under FIFRA.
Protection of confidential data under TSCA and FIFRA are in many ways similar. Both statutes reference the FOIA standard as the ultimate basis for determining whether information is entitled to confidential treatment, and both statutes exempt from confidential treatment studies and related information: health and safety studies under section 14(b)(2) of TSCA, and safety and efficacy studies under FIFRA section 10(d)(1). The two statutes do carve out somewhat different exceptions to the lack of confidential treatment, but the chief difference in that regard is that FIFRA does not exempt confidential protection for the identities and percentages of specific inert ingredients in specific pesticides (FIFRA section 10(d)(1)(C)). Such information rarely if ever appears in the specific studies on specific chemical substances that would generally be used for TSCA assessments. Thus, it is unlikely that consideration under TSCA of studies submitted under FIFRA would result in significant information being determined not to be entitled to confidential treatment under TSCA where it would be entitled to confidential treatment under FIFRA.
Where the two statutes differ is in how non-confidential data are made available to the public. FIFRA section 10(g) provides that data submitted by a pesticide registrant or applicant may not be disclosed to "any employee or agent of any business or other entity engaged in the production, sale, or distribution of pesticides in countries other than the United States or in addition to the United States or to any other person who intends to deliver such data to such foreign or multinational business or entity unless the applicant or registrant has consented to such disclosure." EPA requires persons requesting such data to affirm that they are not acting on behalf of such a multinational pesticide company. The Agency considers section 10(g) to be a FOIA Exemption 3 statute rather than providing confidentiality under FOIA Exemption 4. Note that section 10(g) still allows disclosure of significant information about information that is subject to the provision. EPA has interpreted section 10(g) to allow complete public disclosure of information that does not "reveal the full methodology and complete results of the study, test, or experiment, and all explanatory information necessary to understand the methodology or interpret the results." (See, e.g., 40 CFR 158.33(d)(2)). In other words, persons able to affirm non-multinational status are able to view complete studies submitted under FIFRA (though their ability to further disclose complete studies is limited), and anyone can be given access to non-confidential summary information regarding such studies. EPA's Office of Pesticide Programs has decades of experience creating public summaries of studies that do not implicate section 10(g).
Comment: Companies would submit studies under FIFRA to circumvent the TSCA protections.
Source: -0050
Response: EPA considers this possibility extremely unlikely. Section 10(g) applies to information submitted "under this subchapter" (i.e., FIFRA).  Data requirements under FIFRA are generally very specific to registered (or applied for) products. Such data is submitted at very specific points in the product's registration or consideration under FIFRA, and may be time-consuming and expensive to produce. Moreover, as discussed above, the changes made in this final rule to clarify the application of the respective confidentiality provisions will lessen further any incentive to attempt to launder TSCA data by first submitting it under FIFRA.
Comment: EPA should finalize a process for notifying entities that their information was being considered TSCA information and provide an opportunity to substantiate any claims in accordance with TSCA.
Source: -0052; -0044
Response:  EPA agrees with these commenters that such a process is necessary prior to disclosure of information claimed as CBI (except in the limited circumstances where TSCA section 14(d) or 14(g) specify that no notice is required), and notes that such a process already exists in the form of the CBI review process under section 14(f) of TSCA.  As elaborated in the final rule at 40 CFR 703.8, there are several bases for EPA to initiate a CBI review under section 14(f), some of which are mandatory, some discretionary.  In the case of most CBI reviews under section 14(f) (and in all cases in which information was not previously submitted under TSCA or was not previously substantiated), the submitter of the information would be notified of the TSCA 14(f) CBI review and provided an opportunity to substantiate their CBI claims.  They would also be provided notice and an opportunity to appeal the denial of any of their claims prior to disclosure, consistent with section 14(g).
 Unit 4: Health and safety study (40 CFR 703.3; definitions)
Comment:  Several commenters were in favor of the proposed exclusions from the definition of "health and safety study" at 40 CFR 703.3, in several cases suggesting more exclusions that would permit, among other things, greater protection of the value of the intellectual property in the studies.  Some commenters opposed any such exclusions, arguing that the information categories proposed to be excluded are inconsistent with TSCA, and are in fact information underlying and relevant to the studies. See specific comments following this general response.
Source: -0051; -0050; -0049; -0044; -0043; -0053
Response:  EPA disagrees with commenters that the exclusions are inconsistent with TSCA (see discussion of specific exclusions below and elsewhere in this Unit). As explained in the preamble to the proposed rule, EPA believes these exclusions are consistent with the definition of health and safety study under TSCA section 3(b) and section 14(b)(2).
Most of the proposed exclusions have long been part of the existing TSCA rules in one form or other, such as in 40 CFR parts 720 and 716, so the final rule will in most respects maintain the status quo. These existing carveouts have permitted companies to redact information that is arguably valuable to them while also not impacting the ability of the public to access and interpret the study document. Notably, the current exclusions will vary from some existing TSCA rules by relying on an exclusive list rather than an open-ended exclusion like in 40 CFR 720.90(a)(3) ("Information which is not in any way related to the effects of a substance on human health or the environment").
EPA also considered section 14(b)(1) of TSCA in developing the final list, considering that the excluded types of information may be protected from disclosure under section 14 although included in a document that also contains information that is not protected from disclosure. Prior to the TSCA amendments, which included the addition of section 14(b)(1), information entitled to confidential treatment contained within the same document as information not entitled to confidential treatment was already protected from disclosure, so that section 14(b)(1) would appear to be a provision without effect. One way to give the provision meaning and effect would be to interpret it, in the case of health and safety studies, to indicate that the definition of health and safety study in section 3(8) does not necessarily include all information contained within a study report, such that other information, like the names of lab personnel, do not constitute information from a health and safety study, but rather (potentially) confidential information that is mixed with the information that is not confidential under section 14(b)(2). In other words, section 14(b)(1) clarifies that protection is still warranted for information in health and safety studies that is not explicitly identified as protected from disclosure in section 14(b)(2).  EPA also notes that study reports can be and often are provided in a number of formats, with variable detail, and with varying levels and types of information that might be considered ancillary to the study report.
EPA is declining to add additional exclusions, as many of the suggestions made were either redundant with the proposed list (e.g., laboratory address is redundant with the name of the laboratory), or do not constitute information that EPA can categorically determine as unnecessary to interpret the study (e.g., raw data, specific chemical identity), and therefore cannot be categorically excluded from the definition of a health and safety study under TSCA section 3(8).
Instead, the final rule is modified from the proposal somewhat to combine similar exclusions and clarify the intended scope of the exclusion.  The exclusion for name of the submitting company (long included in 40 CFR parts 716 and 720) is combined with the exclusion for name of laboratory -- this exclusion is intended to permit confidentiality claims for submitting company identity and other information that would disclose company identity, such as addresses and laboratory name in the case that the laboratory that conducted the study was part of or closely related to the submitting company: (1) The name, address, or other identifying information for the submitting company, including identification of the laboratory that conducted the study in cases where the laboratory is part of or closely affiliated with the submitting company.  The exclusion for "internal product codes" is clarified: (2) Internal product codes (code names for the test substance used internally by the company or to identify the test substance to the test laboratory).  The exclusions for names of laboratory personnel and for names and other private information of study subjects are also combined in the final rule: (3) Names and contact details for testing laboratory personnel and names and other private information for health and safety study participants or persons involved in chemical incidents such as would typically be withheld under 5 USC 552(b)(6) or under other privacy laws.  Finally, the proposed exceptions for costs and other financial data and for product development, advertising, and marketing plans are combined.  These types of information do not often appear in study reports themselves, but may be included with a larger submission that includes a study report or other health and safety data, or included in materials relating to cost sharing for chemical testing (e.g., in relation to a test order): (4) Information pertaining to test substance product development, advertising, or marketing plans, or to cost and other financial data.
Notably, if there is a FOIA request for a study, some of this information that is not considered underlying information pursuant to section 3(2) could be considered as personal privacy information under 5 USC 552(b)(6) in certain situations (e.g., the names and contact details for laboratory personnel). TSCA only specifies that the business confidentiality protections of FOIA Exemption 4 cannot be the basis for protecting this information from disclosure. 15 USC 2613(b)(5).
Comment:  The identity of the submitting company can be directly relevant to understanding the potential exposures to the chemical that is the subject of a study.
Source: -0050
Response: This comment confuses interpretation of a study with the analysis that is done on aspects of risk that are not part of the study. The definition of health and safety study in TSCA section 3(8) is clear on this point, including, e.g., a "study of any effect of a chemical substance or mixture on health or the environment" and "studies of occupational exposure to a chemical substance or mixture." That the submitter of a particular study manufactures a chemical substance or mixture that is the subject of the study does not make the study one "of occupational exposure to a chemical substance or mixture." EPA's assessment of exposure is based on specific information submitted under applicable authorities, such as TSCA section 8(a).
Comment:  Understanding whether a company with a vested financial interest in the subject chemical is the submitter of a study is of direct relevance to assessing the reliability of the study. The name of the laboratory conducting a study may well be relevant to gauging the reliability of the study.
Source: -0050
Response: Assessing the reliability of a study is an integral part of the Agency's consideration of the study, regardless of its source. EPA evaluates reliability by examining factors including the quality of reporting, the appropriate use of positive and negative controls, the sensitivity of the exposure methods, and other factors that affect both study sensitivity (the ability to detect a toxic effect when one occurs) and risk of bias (the tendency to over- or under-estimate effects).
Comment:  The definition of health and safety study in TSCA section 3(8) makes no mention of parts or pieces of information within the studies, and the concept of ancillary information does not appear in TSCA. Section 14(b)(2) requires disclosure of information obtained from a study.
Source: -0049
Response:  Section 3(8) explicitly includes "underlying information." If the intent of Congress were to include all text in a study document, there would be no need for including underlying information. To give meaning to the phrase, EPA must interpret section 3(8) as not including information that does not underlie the study. This rule sets out information that does not underlie a study.
Comment:  EPA should permit certain markings, such as watermarks or copyright statements, on health and safety study documents and/or withhold or replace (with, for example, robust summaries) select information from health and safety studies for the purpose of protecting proprietary rights to those studies.
Source: -0046; -0044
Response:  While the rule does not specify the use of watermarks or statements concerning authorized use of health and safety studies, EPA has permitted the use of such markings, as well as copyright and similar statements, and the final rule would not prohibit this practice from continuing.  On the other hand, EPA's view is that withholding a health and safety study document in its entirety, releasing only a robust summary as the "public copy" is inconsistent with TSCA section 14(b) and would go well beyond the list of exclusions from the definition of health and safety study.  Similarly, withholding other significant portions of the study report (such as raw data, tables, or charts) not covered by the exclusions in the rule may be impermissible under TSCA section 14(b) so would be inappropriate in a public copy and cause the submission to be considered incomplete (e.g. under 40 CFR 720.65).
Comment:  A few commenters suggested that EPA should permit entities to claim as confidential the specific chemical identity of a substance in a health and safety study and provide instead the generic name or accession number in place of the specific chemical identity in the health and safety study.
Source: -0046; -0044; -0053
Response:  This comment is beyond the scope of the rulemaking. First, this rule does not limit when chemical identity in a health and safety study may be claimed as CBI (although it does address the review of such claims). Second, the rulemaking concerns how information claimed as CBI is asserted and treated, not what information is required to be submitted in a health and safety study.
 Unit 5: Requirement to assert claims at the time of submission; knowledge of chemical identity (40 CFR 703.5)
Comment:  Several commenters raised concerns with a provision of proposed 40 CFR 703.5, that "If no such [CBI] claim accompanies the submission, EPA will not recognize a confidentiality claim, and the information in or referred to in that submission may be made available to the public (e.g., by publication of specific chemical name and CASRN on the public portion of the TSCA Inventory) without further notice." Some commenters raised concerns that multiple stakeholders may have an interest in maintaining the confidentiality of a specific chemical identity, even though one stakeholder may believe that confidential treatment is no longer needed, or not be aware that the substance has been the subject of a CBI claim. Some of these commenters state that in such circumstances EPA must not determine that confidential treatment of an identity will be lifted on the basis of one entity's submission when other entities have a stake in the matter. A few advocated that late and third-party claims should be permitted in certain cases where a submitter fails to make a claim at all, fails to make an adequate claim, or at any point prior to actual disclosure of the information.
Additionally, three commenters were specifically concerned that persons might report a substance using the accession number while being ignorant of the underlying specific chemical identity, and then not assert and support a CBI claim for that substance in their submission.
One commenter was also concerned that disclosure without notice would be a violation of the TSCA notice requirements at TSCA section 14(g)(2)(A).
Source: -0044; -0051; -0041; -0045; -0052; -0047; -0053; -0054
Response:  This final CBI procedures rule will continue to require, consistent with TSCA section 14(c)(3), that CBI claims be asserted and substantiated in accordance with the applicable reporting rule, including claims for specific chemical identity, and that any information reported without such a claim would be subject to public release without further notice.
EPA disagrees with the general idea that one company's decision not to maintain or assert a CBI claim for specific chemical identity should not result in disclosure of the information on the public Inventory if any other company has asserted a claim for the same substance. A substance's eligibility to remain on the confidential Inventory depends on each manufacturer and processor of the substance keeping confidential the fact that anyone manufactures or processes the chemical substance in the United States for a non-exempt commercial purpose.  If any manufacturer or processor of the substance reports to EPA or otherwise publicly discloses their activity without asserting a CBI claim, the substance is then no longer eligible for confidential Inventory treatment, regardless of what other manufacturers or processors of the substance assert on their own behalf.  This has been the EPA position since EPA established the confidential portion of the Inventory.  See., e.g. 42 FR 64572, 64591 (comment 93; "If any person reports a particular identity and does not claim it as confidential EPA will place the identity on the [public] inventory.") (December 23, 1977).
Chemical identities are unlike other information, such as yearly production volumes, specific manufacturing processes, marketing and sales information, etc., that are generally unique to individual companies. For example, EPA's approval of one company's CBI claim for its company identity or specific production volume would not apply to other companies' identities or specific production volumes. By contrast, if two companies claim the same specific chemical identity as CBI, and one company does not adequately protect the identity from public disclosure, then the specific chemical identity CBI claims for both companies as to the existence of the chemical in U.S. commerce would not be supportable.
Further, one company's decision not to make a CBI claim in their submission would not generally cause automatic release of another person's submission that had previously been maintained as confidential, even if the specific chemical identity were moved to the public Inventory.  Instead, in the case of chemical identity, one submitter's decision not to assert a claim or the denial of one submitter's claim would most immediately affect that submitter's claim and related eligibility of that substance for continued confidential Inventory treatment.   Later (or concurrently), when EPA reviews other persons' CBI claims for the same chemical identity, it is most likely that those claims will be denied as well (because it would no longer be secret that the substance is in U.S. commerce). It is then that the other affected parties would receive notice that the chemical identity is no longer "confidential" because the CBI claim was previously waived or denied confidential treatment.  The affected business(es) would then have an opportunity to appeal this determination prior to any possible public release of their submission. Also, any later submissions would still be eligible to make claims for information that is not the specific chemical identity, like company name, that could provide ample protection of a business's proprietary interests in a particular chemical.
In the case of chemical identity claims, that public release would most likely be disclosure on the public Inventory, as well as the possibility of disclosure of the information in the submission document.  This is because once the chemical substance identity is no longer being protected from disclosure (the claim has been waived or withdrawn, denied, or expired), there is no longer a basis for confidential Inventory protection.  As EPA noted in the preamble to the proposed CBI procedures rule, "A substance may be afforded confidential Inventory treatment (e.g., listing by generic name and accession number) so long as the fact that anyone manufactures or processes that substance for commercial purposes in the United States has not been disclosed to the public. By making a non-confidential report of having manufactured or processed a particular substance, the reporter in effect discloses their activities concerning the substance to the public and renders the substance ineligible for continued confidential Inventory treatment."  87 FR 29078, 29082 (May 12, 2022).
TSCA reporting on existing chemicals (i.e., on the TSCA Inventory) often relies on use of accession numbers as a means to avoid misidentification and other reporting errors and ease reporting burden while protecting confidential chemical identities. See 76 FR 50816, 50825 (Aug. 16, 2011). CDR reporting, for example, uses a "pick list" of accession numbers included in the Agency's Substance Registry Services (SRS) database, which lists all chemical substances on the TSCA Inventory, to provide a public list of reportable confidential chemical identities.  Reporters that do not know the accession number for the substance they are reporting (primarily importers) may use a joint reporting mechanism by which their supplier is contacted to provide specific chemical identification.  Manufacturers (including importers) that do know the accession number are required to assert and substantiate any claims they may wish to maintain, either on their own behalf or on the behalf of a supplier.  The substantiation question at 40 CFR 711.30(b)(1) accommodates consideration of harm to the submitter's competitive position, which could include consideration of the competitive positions of business partners or others with whom the supplier has contractual or similar relations.  In other words, it is up to the reporting party to work with his business partners to assure that CBI claims are maintained for chemical identities in which they have a mutual interest.
EPA appreciates some commenters' concern that companies without knowledge of specific chemical identity (such as processors or importers) could waive a CBI claim previously asserted by another company. 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.  Addressing the issue in the context of specific reporting rules will allow EPA to take into consideration the unique reporting context for the rule, such as the attributes of specific reporters. For example, if a reporting rule includes certain reporters who lack knowledge of specific chemical identities, EPA may consider solutions such as relieving some obligations to maintain CBI claims, shifting that obligation to a joint reporter (such as the initial manufacturer), and clarifying how the Agency will proceed when EPA has information demonstrating that a reporter lacks knowledge of the specific chemical identity.  See, related discussion in TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Notice of Data Availability and Request for Comment, 87 FR 72439, 72441 (November 25, 2022).
Some commenters suggested that in cases where accession number only is used to report confidential Inventory substances (e.g., CDR), EPA should treat the submission as not including a CBI claim for chemical identity, since no confidential identifier actually appears on the reporting form.  EPA disagrees with these comments in part, particularly as applied to established reporting rules such as CDR.  Confidential Inventory protection was a tool devised by EPA early in the initial implementation of TSCA and intended to balance two competing interests ingrained in TSCA -- maximizing availability of public information concerning chemicals while protecting valid trade secrets and intellectual property rights.  See 42 FR 64572, beginning at 64573 and at 64590 (comment 93) (December 23, 1977).  From the outset, any TSCA chemical reported without a CBI claim and any required supporting information has been subject to removal from the confidential to public portion of the Inventory.  Id, at 64591.  Diligent maintenance of such claims has always been important to maintaining confidential protections and upholding the balance between transparency and protection of trade secrets.
The shift over the past decades to e-reporting was not meant to upset that balance -- indeed, Congress's amendments to section 14 of TSCA evidence an intention that CBI claims should be robustly supported and regularly maintained. The amendments include an extensive CBI review requirement for EPA to evaluate the appropriateness of many claims, including all chemical identity claims concerning substances that have been introduced into commerce, as well as provisions that most CBI claims expire after ten years unless reasserted and substantiated.  It would not be consistent with these amendments to wholesale exclude hundreds or thousands of confidential reports in any given year from any scrutiny of reported chemical identities, especially not without considering such a significant change in the context of more specific reporting rules.  Neither would it be desirable to return, for the purposes of assuring that the reporter knows the specific chemical identity, to reporting confidential chemicals by specific Inventory name and CASRN.  Doing so would create a substantial burden for both reporters (looking up or requesting the full Inventory name from EPA and reporting it accurately) and EPA (correcting the inevitable and numerous chemical identification reporting errors).  Such a requirement would also disadvantage domestic manufacturers, who would have to diligently maintain and defend their confidentiality claims and work with their customers to do the same, while foreign manufacturers and their (perhaps willfully) ignorant customer/importers would be insulated from virtually any meaningful requirement to maintain their CBI claim (since EPA would not be able to effectuate a denial of the claim or a withdrawal of the claim without a demonstration of chemical identity knowledge on the part of the submitting company).  Instead, this final rule will maintain the status quo with respect to CDR and other rules that were not proposed to be amended in substance as part of this rule.
EPA does note that the TSCA section 12(b) rules (Part 707) usually do not require that a confidential specific chemical identity be reported -- relying on identification of the substance as it was identified in the underlying rule or order that triggered the 12(b) reporting requirement -- in most instances, this means that the rule only requires that a public identifier be reported and the rule does not and will not require that CBI claims be asserted to protect any specific identity underlying those public identifiers.  The reasons for this difference in treatment in 12(b) reporting versus CDR reporting are elaborated in Unit 22.
Comment: Disclosing chemical identity claimed as CBI by one company, because another company failed to assert a CBI claim for that chemical identity, is inconsistent with the notice requirements of TSCA section 14(g)(2).
Response:  This rule serves as the notice required by the statute.  EPA has long interpreted rules providing for disclosure of information claimed as CBI, where the rule makes those situations clear, as satisfying TSCA section 14 notification requirements, both under pre-Lautenberg TSCA and under the Lautenberg amendments to TSCA. This rule, and any specific TSCA reporting rules providing such disclosure, such as 40 CFR 711.30, satisfy the notice requirement of TSCA section 14(g)(2) for waived claims.
 Unit 6: Providing substantiation and substantiation questions (40 CFR 703.5(b))
Comment: A few commenters were concerned that the allowance made for asserting claims and substantiating materials collected during a TSCA inspection was inadequate, suggesting a longer period, such as 30 to 45 days to assert and substantiate claims.  Commenters also noted that clarification was needed on when an inspection is considered to have ended.
Source: -0044; -0046; -0054; -0053
Response:  For purposes of this provision, the inspection ends when the inspector physically exits the regulated facility's property on the last day of the inspection. The day after the last day of the inspection is the first of ten days the company has to assert and substantiate claims. The Agency has discretion to provide additional time on a case-by-case basis (e.g. if claims are numerous or the documents involved are voluminous) but considers 10 days to be an acceptable and achievable timeframe in the majority of cases.  The final rule clarifies these points.
Comment: One commenter suggested that EPA exempt "personal identifying information" from substantiation requirements.
Source: -0044
Response:  Information that qualifies for protection from disclosure under other laws (e.g., FOIA exemption 6 personal privacy information) is still eligible for protection under those laws even if TSCA CBI protection is not available, unless TSCA expressly requires disclosure of that information (see, e.g., TSCA section 26(j)). That said, TSCA Section 14(c)(1) requires that CBI claims be substantiated at the time of submission, and TSCA Section 14(c)(2) establishes what information can be exempt from substantiation. Personal privacy information is not a category of information listed in Section 14(c)(2). Therefore, the Agency cannot consider such information exempt from substantiation under TSCA as the commenter suggests.
However, a submitter may assert and substantiate a business confidentiality claim for this category of information. Persons including personal information in TSCA submissions should consider whether a CBI claim is appropriate for the information and support any such claim with substantiation under the CBI criteria established in 40 CFR 703.7.  As long as the information remains eligible for business confidentiality under section 14, EPA would not publicly disclose it (with potentially limited exceptions under section 14(d)).
While the Agency does not consider all personally identifiable information included in TSCA submissions provided in relation to an individual's work to be eligible for personal privacy protection under FOIA exemption 6, the Agency will consider this exemption, along with all other applicable FOIA exemptions, in the event the information is subject to a FOIA request.
Comment: One commenter suggested that EPA limit the number of times per year the same claim would need to be substantiated by allowing cross-references to the prior substantiation and any approval determination.
Source: -0044
Response:  While cautioning that EPA generally considers CBI claims to be submission-specific, and that the substantiation for CBI claims must be appropriate for each claim to which it is applied, it is generally acceptable to reuse substantiation responses for what is essentially the same claim.  This is explicitly permitted in certain rules, such as in the Review Plan Rule (40 CFR 710.43).  The submitter wishing to reuse previously provided CBI substantiation must take care to identify the previously provided substantiation (including submission number, submission date, etc.) and the specific claims to which they would like to apply the previously provided substantiation. Typically, previously provided substantiations should only be reused when the new submission consists of a new iteration of the same information that was claimed and substantiated in the previously provided submission. Before a previously provided substantiation is applied to a new submission of similar information, the submitter should consider whether it is aware of any changes in circumstances surrounding its treatment of the information since the initial submission, any external releases of the information during that time, and that all substantiation responses previously provided still apply the same way to the information claimed in the new submission. Other requirements for asserting CBI claims must also be fulfilled for the new claims, such as completing certification statements required by section 14(c) of TSCA.
Comment: One comment noted that EPA should require detailed answers to substantiation questions and not rely solely on what the claimant asserts in their substantiation in reviewing CBI claims, but should also consider other information available to EPA.
Source: -0050
Response:  EPA agrees with these comments.  In most cases, yes or no responses to substantiation questions must be elaborated, and in the case of some claims, such as chemical identity claims, EPA is enhancing its capability to review prior claim history and publicly available information bearing on the confidentiality of the information.
Comment: One comment asserted that CBI claims should not be allowed for information that is already public, and that any positive response to the prior public disclosure substantiation question should end the CBI review with a denial.
Source: -0050
Response:  EPA agrees that in most cases, prior public disclosure of CBI information will result in denial of the claim.  However, prior disclosure of specific information in a submission might not disclose the same information in the same context.  For example, EPA often receives studies under TSCA section 8(e) regarding a chemical substance undergoing research and development. If that chemical substance identity is not claimed as confidential in the 8(e) submission, a chemical identity CBI claim in a subsequent section 5 PMN submitted by the same company (or other company) for the same chemical substance might nonetheless be appropriate where the 8(e) submission does not reveal a person's intent to manufacture the chemical substance for commercial purposes in the U.S.
Comment: One commenter suggested a clarification to proposed 703.5(b)(3)(ii) with a firmer statement that information reported as non-CBI previously can't be treated as CBI thereafter: "Was the same or similar information previously reported to EPA as non-confidential (such as in an earlier version of this submission)," instead of "If the same or similar information was previously reported to EPA as non-confidential (such as in an earlier version of this submission), please explain the circumstances of that prior submission and reasons for believing the information is nonetheless still confidential."
Source: -0050
Response: EPA agrees generally with the premise of this comment, but does not view it as absolute, so the final rule will include the version of the question that permits the submitter to explain the prior non-CBI disclosure.  While prior non-CBI reports to EPA usually foreclose CBI treatment of the information afterwards, EPA is aware of occasional errors, including human and technical errors, where information intended to have been claimed as CBI and supported with substantiation, etc., was nonetheless temporarily available in a public source, such as the EPA Reading Room or ChemView.  If an explanation of these circumstances is ascertained by EPA for use in determining the extent to which the information was actually disclosed, the Agency may assess the potential competitive harm in light of the scope of that previous disclosure.
Comment: One commenter suggested that proposed 40 CFR 703.5(b)(3)(v) should be amended so that "the claimant should be asked not only "whether the information was found [by EPA, another agency, or a court] to be entitled to confidential treatment," but also whether the information was found not to be entitled to confidential treatment."
Source: -0050
Response:  EPA has edited the question to read as follows: "Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether or not the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination."
Comment: Two commenters indicated confusion over the certification statement in proposed 40 CFR 703.5(b)(4)(i).  One suggested a specific replacement statement: "I certify that on the date referenced I searched the internet for the chemical substance identity (i.e., by both specific chemical name and CASRN). I did not find a reference to this specific chemical substance identity being manufactured for a commercial purpose and have no knowledge of public information identifying the specific chemical identity as being manufactured or imported by anyone for a commercial purpose in the United States. For purposes of this certification, use of a substance for research and development only (consistent with the definition at 40 CFR 720.3(cc)) is not considered to be use for a "commercial purpose." [provide date]."  The other commenter appears to be concerned that if a person included the certification but otherwise failed to substantiate, the chemical identity might be disclosed on the public portion of the Inventory without notice to the "'owner'" of that chemical."
Source: -0048: -0044
Response:  The final rule will use the proposed certification statement, which has already been used in the CDR (40 CFR Part 711) substantiation questions.  Note that the first part of the question establishes whether the substance is known to be in US commerce for any use.  If it is, the submitter will need to explain why the chemical identity should still be treated as confidential -- for example, it might only be known as an R&D chemical available in small quantities for that use, and not a chemical that has any other commercial use.  If the submitter is asserting that the substance isn't known to be in commerce for any commercial purpose, they must certify that they made an effort to support this belief.  EPA is concerned that the suggested addition that use for R&D only is not considered a commercial purpose for purposes of the certification would introduce unnecessary confusion -- manufacture for R&D use can be and often is commercial in purpose.
EPA notes that failing to fully substantiate, regardless of the response to the certification question in 703.5(b)(4)(i), may cause a CBI claim to be denied (unless the deficiency is corrected in accordance with 40 CFR 703.5(e)).  See Unit 5 for a more detailed discussion of the effect of a withdrawn or denied chemical identity CBI claim on confidential Inventory protection for that substance and subsequent review of other CBI claims for the same chemical identity.
Comment:  One commenter noted that the proposed rule did not require the substantiation of CBI claims included within substantiation, asserting that EPA must review these CBI claims as well.
Source:  -0050
Response:  As the commenter themselves noted, collecting substantiation on CBI claims made within substantiation documents and reviewing such claims would often lead to a recursive loop, where EPA would be reviewing CBI claims on CBI claims, potentially ad infinitum.  It seems unlikely that Congress intended that EPA extend the CBI review program it outlined in section 14(g) to reviewing the CBI claims in substantiations for CBI claims in more substantive TSCA submissions.  While CBI substantiation responses often include CBI claims, EPA has observed that the claims are typically for the same information that was included and claimed in the underlying submission -- e.g., company name, chemical identity, etc.  In other words, the CBI claims in the substantiation document are included in the review of the TSCA submission itself.  To the extent there is a CBI claim in the substantiation document or responses that is unique to the substantiation document, such as an explanation of competitive harm that the company views as confidential information, such responses might also be considered as not truly "part of" the underlying TSCA submission.  Substantiation responses or documents are provided for the purposes of supporting the CBI claim in the TSCA submission.  They are not themselves required by TSCA (except to support a CBI claim).   EPA does not believe that Congress intended the Agency to expend significant resources conducting CBI reviews of claims increasingly remote from a substantive TSCA submission and thereby unlikely to affect public availability of information on chemicals. That, combined with the typical duplication of claims between substantiation responses and the TSCA submission, leads EPA to decline in the final rule to require substantiation of CBI claims in substantiation responses or documents.
Comment:  EPA received several comments on the proposed and alternative versions of the substantiation question regarding competitive harm.  Several commenters supported the proposed version of the question, while others preferred the version of the question currently used for CDR.  One commenter criticized the use of "probable" as an example or synonym for "likely," and argued that EPA should not attempt to define "likely to cause substantial harm to the competitive position of the person."
Source: -0050; -0049; -0044; -0045; -0048; -0041; -0046
Response:  EPA agrees with comments supporting the proposed version of the question and has retained it in the final rule.  The version was developed in part to improve the quality of responses EPA has received using the version of the question recently used in 2020 CDR.  EPA anticipates that this question, if answered fully, will generally result in CBI claims being better supported than with other versions.  EPA expects that this question will help submitters address the necessary review criteria for each type of information in a submission (e.g. chemical information, exposure information, company information) that EPA has found to be lacking in specificity at times in submissions it has reviewed over the past several years.   EPA's elaboration on what is necessary in a response to this question is less an attempt to define substantial competitive harm than it is an explanation of EPA's expectations for the necessary level of detail in a claim substantiation. This specificity would help support an EPA determination that the submitter of the claim has adequately demonstrated it has a reasonable basis for its conclusions about the likelihood of substantial competitive harm.
Comment: Several commenters supported omission of a patent-specific question, either because of a view that disclosure of information in a patent context is so remote from public disclosure in other contexts that it essentially shouldn't ever be considered public disclosure of CBI, or because of a view that information disclosed in a patent should always be considered a disclosure and that EPA should not invite argumentation to the contrary.
Source: -0050; -0044; -0046; -0045; -0052
Response:  EPA finds the arguments of many commenters persuasive -- that disclosure of information claimed as CBI such as chemical identity in a patent may not be a disclosure at all, given that a patent may lack key details or steps about the creation of the substance, or that the commercialized substance might appear in the patent as a one component of a series created by a complex process that does not allow a reader to discern what component is commercially valuable. In addition, inclusion of a chemical substance in a patent application (in the case of chemical identity claims) does not mean that the chemical subject to the TSCA submission has been commercialized.  Therefore, EPA has omitted the proposed patent-specific substantiation question from the final rule.  However, to the extent that the any of the information claimed confidential is included in a patent, submitters must still address it in the more general question about public disclosure included in the final rule at 40 CFR 703.5(b)(3)(iii).  The question has been expanded in the final rule to address disclosure in patents specifically.
Comment: Three commenters made comments concerning the proposal to omit a trade secrets-specific question from 40 CFR 703.5(b).  One commenter noted that FOIA Exemption 4 distinguishes between confidential and trade secret information and on that basis supported retaining a trade secrets-specific question.  Two other commenters agreed that it was difficult to imagine a circumstance where information would constitute a trade secret but not CBI.
Source: -0051; -0053; -0044
Response:  EPA agrees that FOIA Exemption 4 distinguishes between confidential and trade secret information, but in the context of the review of TSCA CBI claims, it is a distinction that does not make a difference to the outcome of the TSCA CBI review.  See Confidential Business Information Claims under the Toxic Substances Control Act (TSCA); Proposed Rule.  87 FR. 29078, 29083 (May 12, 2022).  EPA has concluded therefore that a trade secrets-specific question is redundant and has omitted one from the final rule.
Comment: One commenter expressed confusion at the intent of the question at 40 CFR 703.5(b)(4)(i), concerning the claimant's understanding of whether the chemical substance is known publicly to be in commerce.
Source: -0050
Response:  40 CFR 703.5(b)(4)(i) applies to chemical identity claims and asks: "Is this chemical substance publicly known (including by your competitors) to be in U.S. commerce?"  The intent of the question is to help ascertain whether it is known to the public (be they competitors or the public at large) that this particular substance is available in U.S. commerce.  If it is known either to competitors or the public at large that a given substance is in U.S. commerce, the substance is likely no longer entitled to confidential Inventory protection and the particular claim will very likely be denied.  The question does not have any relationship to determining whether the substantiation exemption at TSCA section 14(c)(2)(G) applies -- if a claimant is answering this question at all, it is because they themselves do not believe the section 14(c)(2)(G) exemption applicable in their case.
Comment: One commenter asserted that known presence in overseas markets (e.g., the European Union) renders CBI claims for the same substance identity in the U.S. invalid.
Source: -0050
Response:  EPA does not agree that known presence in overseas markets disqualifies that chemical identity from confidential treatment in the U.S.    Section 3(3) of TSCA defines "commerce" as "trade, traffic, transportation, or other commerce (A) between a place in a State and any place outside of such State, or (B) which affects trade, traffic, transportation, or commerce described in clause (A)."  "State" in turn, means any of the 50 states, the District of Columbia and U.S. territories and possessions.  Thus, where TSCA refers to "offered for commercial distribution" (e.g., TSCA section 14(c)(2)(G)), it is referring to distribution in U.S. commerce.  While the fact that a chemical is distributed in overseas commerce may increase the likelihood that the substance is also distributed in U.S. commerce, it does not guarantee such a result.  If a submitter claiming a chemical identity as CBI is aware that its distribution in commerce outside the U.S. is publicly known, their substantiation should explain why distribution in U.S. commerce remains unknown. The Agency's inquiry into public knowledge of distribution of a chemical substance in U.S. commerce specifically is also closely tied to the TSCA Inventory and confidential Inventory protections.  The Inventory is a partial compilation of substances in U.S. commerce -- it's not a list of all substances known to exist anywhere.  If properly substantiated, substances on this Inventory of substances in U.S. commerce may be afforded confidential Inventory treatment if it is a secret that they are distributed in U.S. commerce and EPA has not identified any reason to believe otherwise.
Comment: One commenter expressed confusion at proposed 703.5(b)(4), which allows for substantiation questions to vary according to the type of TSCA submission they accompany: "Unless otherwise specified in the relevant electronic reporting form, answers to the following questions must be provided for each chemical identity-related confidentiality claim in a TSCA submission." The commenter asserted that "EPA has not explained why these questions would not need to be answered in all cases, including when a claim is asserted in a submission filed using an electronic reporting form. Indeed, claimants should be required to answer these questions in all cases involving such claims."
Source: -0050
Response:  EPA agrees that all submissions involving non-exempt (under TSCA section 14(c)(2)) chemical identity CBI claims must be substantiated.  Part 703.5(b)(4) simply permits the substantiation questions for individual reporting rules and as presented on their corresponding reporting forms to vary according to the information intended to be collected.  EPA anticipates that chemical-identity claims are not necessary or not permitted in certain cases (such as those concerning TSCA sections 4, 6, or 8 reporting on existing chemicals that are on the public Inventory).  Chemical identity claims may not require substantiation in other cases (e.g., section 5 PMNs in which chemical identity CBI claims are exempt from the substantiation requirement under TSCA section 14(c)(2)(G)).  In such cases, these questions may be omitted from the reporting form entirely, or the form may permit them to be skipped.  Additionally, individual reporting rules might specify somewhat different substantiation questions tailored to the particular reporting exercise, so 40 CFR 703.5(b)(4) allows that the substantiation questions themselves might be somewhat different from the standard or default questions included in 40 CFR 703.5(b).
 Unit 7: Substantiation exemptions under TSCA 14(c)(2)
Comment: One commenter asserted that the substantiation exemption at TSCA section 14(c)(2)(G) (for specific chemical identity asserted prior to introduction of that chemical substance into commerce) is temporary, such that once the chemical substance is introduced into commerce the CBI claim asserted prior to commercialization must then be substantiated.  The commenter asserted that EPA must review such claims under TSCA section 14(g) when a Notice of Commencement (NOC) is filed.
Source: -0050
Response:  EPA disagrees with the commenter's assertion that exempt chemical identity claims under TSCA section 14(c)(2)(G) asserted before commercialization lose their exemption once the particular chemical substance is introduced into commerce. The exemption continues to apply to the pre-commercialization claim, but any chemical identity claim asserted post-commercialization does not qualify for the exemption. As an example, when EPA receives a PMN for Chemical X claiming the specific chemical identity as confidential, that CBI claim is exempt under section 14(c)(2)(G) and review under 14(g)(1)(C)(i). However, if EPA subsequently receives an NOC for Chemical X claiming the chemical identity as CBI, the claim in the NOC is not exempt because the substance is now commercialized.
There is no requirement in TSCA that EPA require substantiation or review of past claims once a chemical is introduced into commerce. Further, such a mandate cannot be squared with the requirement in section 14(g)(1)(A) that 14(g)(1) CBI claim review take place "not later than 90 days after the receipt of a claim." The substantiation exemption provision specifically states that the exemptions are "[s]ubject to subsection (f)" of section 14, and there is no mandatory trigger in TSCA section 14(f)(2) relating to distribution in commerce. Such earlier claims may be reviewed or re-reviewed, but not automatically -- instead, they could be reviewed under either the mandatory or discretionary provisions of section 14(f).  Additionally, if a company submits an NOC, any claim for chemical identity would have to be substantiated at that time. Any such chemical identity claims would also be subject to mandatory CBI review under TSCA section 14(g). NOCs are explicitly linked to their corresponding PMNs by the PMN number -- if the CBI claim in the NOC is withdrawn or denied, the specific chemical identity in the NOC may be readily linked to the PMN chemical.
Comment: One commenter criticized 40 CFR 703.5(b)(5)(ii) for paraphrasing and not directly quoting the statutory language in TSCA section 14(c)(2)(G), especially for omitting "if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 5."
Source: -0050
Response:  EPA's intent in including and discussing the application of the TSCA section 14(c)(2) exemptions in the rule is to clarify EPA's interpretation of how and when these exemptions may be asserted and applied.  As indicated in 40 CFR 703.5(b)(5)(ii), EPA interprets the section 14(c)(2)(G) exemption as generally applying to any chemical identity claim made prior to the date on which the chemical is first offered for commercial distribution.  EPA further interprets the section 5 limitation mentioned in section 14(c)(2)(G) as only applying to CBI claims for chemicals that have actually been the subject of a section 5 notice.  In other words, in order for a PMN, PMN amendment, or section 8(e) submission chemical identity CBI claim to be exempt from the substantiation requirement, the claim would need to have been asserted in any prior section 5 submission concerning that substance (which might be an LVE or PMN, for example).  This limitation is likely to do with consistency and assuring that the CBI claim is valid in the first place; TSCA requirements and routine EPA practice make non-confidential copies of section 5 submissions and/or information from such submissions available to the public such that information, including specific chemical identity, that was not claimed as confidential in a section 5 submission would not actually be confidential.  As such, subsequent CBI claims for the chemical identity would likely be invalid and substantiation exemptions would be inapplicable.  EPA does not believe it necessary to elaborate in 40 CFR 703.5(b)(5) on the basic requirement that information must actually be confidential in order for it to be claimed as CBI, let alone restate the obvious that substantiation exemptions only apply to valid CBI claims.  The TSCA section 14(c) statement and certification requirements (implemented in 40 CFR 703.5(a)) are required for all CBI claims and already adequately assure that the person asserting the claim believes the information is actually confidential and their claim is valid.
Comment: One commenter asserted that EPA's knowledge of commerce status should control whether the TSCA section 14(c)(2)(G) exemption applies.  Specifically, the commenter criticized the certification portion of the substantiation question at 40 C.F.R. § 703.5(b)(4)(i) "appears to rely on the claimant's lack of knowledge of public information indicating a chemical is in commerce as sufficient to warrant an exemption under TSCA section 14(c)(2)(G)."
Source: -0050
Response:  The commenter misunderstands the certification included in the substantiation question at 40 CFR 703.5(b)(4)(i).  The certification is meant to confirm the submitter has researched whether the chemical identity is actually secret and better assure the substantiation addresses public references to the chemical identity, if any.  It has nothing to do with verifying whether or not the substantiation exemption at TSCA section 14(c)(2)(G) applies -- indeed, if a submitter is answering this substantiation question, it is very likely because they are not asserting that section 14(c)(2)(G) applies.
 Unit 8: Public Copies (40 CFR 703.5(c))
Comment: One commenter noted that the proposed rule did not elaborate on how public copies of individual submissions will be generated or made available, particularly where existing regulations do not require that the submitter prepare public copies themselves.  They cited TSCA section 5 Notices of Commencement as one example of where this is the case.
Source: -0050
Response:  EPA is finalizing the exemption at 40 CFR 703.5(c)(1) because where the electronic reporting tool includes a system for designating with specificity the CBI claim, the electronic reporting tool can automatically generate a public version [or "automatically designates data that is made available to the public."]. EPA does not believe that any further clarification is necessary in the regulatory text.
To further elaborate, EPA acknowledges that some of its TSCA reporting applications do not presently generate a public copy that renders the data entered into the reporting tools into a .pdf format or form resembling paper forms used in the past.  The PMN reporting application does this for PMNs, but the CDR application does not, for example.
Although not addressed in the final rule, EPA has and intends to continue to increase the automatic publication of public versions of TSCA submissions in ChemView shortly after submission. Where public copies are required to be generated and submitted by the submitter, EPA aims to make them publicly available as soon as practicable to increase transparency but has not elaborated on this in the final rule.  See related discussion in Unit 24 of this document.
In the case of some submissions, however, EPA does not intend at this time to make available public copies of individual submissions rendered as a single form.  There are two reasons for this.  In the case of CDR, EPA has for several years used individual CDR reports to generate nationwide statistics on chemical production, including aggregated production volumes for each substance.  Confidential individual site production volumes are protected from disclosure by EPA's practice of masking these individual volumes by using aggregates and ranges.  If complete individual site reports were published, the non-confidential volumes in one site report could in some cases be used to calculate the confidential volumes in another site report, for example.  EPA could consider changing its practice of producing aggregated statistics in the national report and database in favor of publishing individual site reports (with CBI data redacted), but this consideration would be best undertaken in the course of rulemaking to update the CDR rule, which occurs periodically.
The other primary reason that EPA has not routinely made computer-generated public or sanitized copies available for all submission types is that much of the data is typically made available in another source or format, such as with section 5 Notices of Commencement -- much of the public data in those submissions are made available in section 5(d)(2) notices and on EPA's website.
EPA intends to continue focusing on making health and safety data and information available in accordance first with statutory requirements and as demand and resources permit.  For example, new chemical (section 5) submissions are now available to the public within days of submission and section 8(e) submissions are now routinely posted in ChemView.
Comment: A couple of comments expressed support for the proposed requirements for public copies, one agreeing in particular that SDSs include health and safety information so should include limited CBI claims, though both expressed skepticism that EPA could make public copies of TSCA submissions available more quickly than 15 or even 45 days.
Source: -0053; -0040
Response:  EPA appreciates this comment but notes that EPA is already making sanitized copies of many submissions available within a few days of receipt, most notably section 5 submissions.  Public copies are becoming or are expected to become rapidly available in ChemView for several other submission types in the near future (e.g., section 8(e) and 8(d) submissions, NOC data, etc.)
 Unit 9: Generic Names (40 CFR 703.5(d))
Comment: Some commenters questioned the differences between the generic name provisions in 40 CFR  703 (applicable to any TSCA submission) and the provisions in amendments to part 720 (applicable to section 5 Notices of Commencement only).
Source: -0050; -0051
Response: EPA acknowledges that there are some differences between the handling of generic names in general and for Notices of Commencement (NOCs) in particular.  This difference is due in large part to the historic purpose of including a generic name with an NOC.  The generic name submitted with an NOC is, if determined acceptable by EPA, one of a handful of public identifiers used for chemical substances that are on the confidential portion of the Inventory.  Before any chemical is placed on the TSCA Inventory, EPA must ascertain that it is specifically identified as required by TSCA section 8(b) and its implementing regulations.  Since early in the assembly and implementation of the original Inventory rules, substances protected from disclosure on the public Inventory have been identified instead by a specific accession number and generic name.  Part of the approval process for placing a substance on the Inventory is assuring that it is identified as specifically as possible, and that any generic name used in lieu of a specific name is only so generic as is necessary to protect the claimed confidential features of the molecule.  While generic names are carefully reviewed in PMNs, alongside the specific name (and PMNs may be and are rejected for poor generic names), this review takes place early in premanufacture review, before EPA has thoroughly analyzed the PMN or made conclusions such as which parts of the molecule are most toxicologically relevant or which parts would be likely to cause competitive harm if disclosed.  Prior to submission of an NOC and initiation of chemical identity CBI review under section 14(g), TSCA does not specify at what point EPA must determine compliance with the section 14(c) requirements to assert a CBI claim for chemical identity. Since information pertinent to determining whether the generic name is adequate may not be fully available until NOC, EPA typically defers making any final CBI determination based on an inadequate generic name until a full CBI review occurs under 14(g), when the NOC is received.  The CBI procedures rule would preserve existing procedures and considerations for processing NOCs, including a streamlined version of the current process for negotiating disputed generic names.  Chemical names -- specific and generic -- are meant to be relatively permanent once agreed, and since any feature that is not claimed as CBI will be revealed on the Inventory, EPA believes that some room should be left for reasonable technical debate over which features are necessary and appropriate to either conceal or disclose.
Once a generic name that is acceptable for purposes of Inventory listing is in use, there should be less need to further negotiate that name (though the rule does leave room for modification of Inventory generic names over time, such as to update older generic names that do not meet the newer 14(c) requirements).  And for submissions concerning substances that are not or not yet on the Inventory (e.g., R&D substances, PMN substances, substances included in section 5 exemption applications), it is less vital that the generic name meet Inventory requirements (a listing of relevance to any person involved or prospectively involved with the substance) and it need only meet section 14(c) requirements as applied to that submission (relevant only to the individual submitter).
Comment: EPA received a few comments concerning application of the generic name policy, especially the "presumption" that only one structural element should be masked.  One commenter advocated that every generic name submitted should have to demonstrate the competitive harm suffered by masking more than one structural element, while another was opposed to including this presumption (from the generic name guidance) in the rule.
Source: -0050; -0046
Response:  EPA notes that reviewing all generic names for compliance with the requirements of section 14(c) goes considerably further than what TSCA section 14 requires for review under section 14(g).  Section 14(c)(2)(G) exempts pre-market chemical identity claims from substantiation, and section 14(g) exempts the same claims from CBI review under that section.  Considering the volume of section 5 and section 8(e) submissions concerning pre-market chemicals, this would represent a sizable increase in technical CBI review burden for EPA, examining and negotiating over generic names for chemicals that are not and may never be commercialized.  In addition, undertaking a review of whether inclusion of a structural element would cause competitive harm is essentially a substantive review of the CBI claim -- requiring substantiation when section 14(c)(2)(G) exempts it and review when section 14(g) excludes it.  On the other hand, where such substantiation is required and review is required, pursuant to section 14(g), EPA believes that incorporating some elements of the guidance into the rule is useful and appropriate, and will aid compliance with guidance that, while intended as guidance with all the flexibility that usually implies, is nonetheless incorporated into the statute as a procedural requirement.
Comment: One comment suggested that EPA should review generic names at the time of initial submission of a section 5 submission and that if EPA and the submitter cannot agree on an acceptable generic name, the submitter should be permitted to withdraw the submission with a refund of any appliable fees.
Source: -0053
Response:  Current fee rules permit EPA to issue a partial refund on TSCA section 5 submission fees if the submission is withdrawn within 10 business days of the start of the applicable section 5 review period.  40 CFR 700.45(i)(1).  EPA's practice of "prescreening" section 5 submissions can be expected to reject generic names that are clearly not acceptable under EPA's generic name guidance, or otherwise not compliant with section 14(c)(1)(C), and the final rule includes procedures for negotiating acceptable generic names.  However, EPA has historically deferred extended debate over more contentious generic names until it receives notice that the PMN has been commenced and the chemical is to be placed on the TSCA Inventory, saving considerable resources by avoiding controversy over chemicals that may never be commenced.  Even if this negotiation took place immediately after the PMN is submitted, it is unlikely it would conclude with an impasse in time for the submitter to withdraw the section 5 submission and request a partial refund.
Comment: One comment asserted that the generic name review and negotiation process for NOCs is too complex, that there is no deadline for processing NOCs, and that there is no real consequence for a company submitting an inadequate generic name.
Source: -0050
Response:  EPA disagrees with this comment.  The generic name negotiation process for NOCs is actually a simplification of pre-existing procedures, intended to more efficiently elicit a structurally descriptive generic name in line with the EPA generic name guidance and in compliance with the section 14(c) requirements for generic names.  It is a simplification of the process previously set out in 40 CFR 720, but still allows room for good faith technical debate and initial disagreement over acceptable names for more difficult molecules.  While neither the final rule nor other regulations specify a time for EPA to complete the processing of NOCs, failing to provide a compliant generic name is not consequence-free for the submitter -- if EPA ultimately determines the generic name does not meet the requirements of section 14(c), the CBI claim will be denied and the specific substance identity will be listed on the public portion of the Inventory.
 Unit 10: Deficient Claims (40 CFR 703.5(e))
Comment:  One commenter requested clarification of a statement in proposed 40 CFR 703.5(c) that "Generally, a public copy that removes all or substantially all of the information would not meet the requirements of this paragraph (c) of this section and the submission may be temporarily put on hold as deficient" to reflect that sometimes whole pages or diagrams need to be redacted to protect CBI and that EPA should not require substantiation for every component of the redaction (such as axes and captions on charts).
Source: -0044
Response:  EPA continues to believe that generally, a public copy that is blank or nearly blank is not consistent with the requirement at 40 CFR 703.5(c) to only redact information that is claimed as confidential, because such cases generally reflect the fact that the submitter has not reviewed the appropriateness of confidentiality claims as required by section 14(c)(1)(B).   However, there may be individual cases where all of the information in an entire document has been claimed as confidential and a blank public copy may therefore be appropriate. For example, if a submission consists of one chart that shows information that has all been claimed as confidential, redacting the chart and producing a blank public copy of that short document could be acceptable.  But TSCA submissions rarely consist of only a single chart, so the generalization made in the proposed rule is still appropriate and had been retained in the final rule.  EPA further notes that with respect to providing substantiation for graphical elements, a single substantiation response will generally suffice for the whole graphic, and that while it is necessary to explain each redaction, it is not necessary to provide repetitive substantiation responses for each redacted element of a single chart.  (I.e. "The disclosure of elements A, B, and C would cause competitive harm because..." is acceptable.)
Comment:  EPA received several comments concerning the proposed deficiency provisions (40 CFR 703.5(e)), arguing both that the provisions were too lenient and too strict.  One commenter asserted that TSCA does not give EPA discretion to approve a deficient CBI claim.
Source: -0050
Response: TSCA does not require that EPA allow submitters to correct deficiencies with the assertion of CBI claims, procedural or otherwise. However, section 14(c)(1)(A) does provide broad authority for EPA to promulgate "rules regarding a claim for protection from disclosure".
EPA is exercising its statutory authority in a manner that balances the interests at stake. While permitting any period for correction might complicate EPA's task in meeting the statutory time limit for conducting CBI reviews, the Agency believes that allowing a limited time to correct deficiencies adequately protects companies who make innocent errors without adversely impacting public access to information that is not entitled to CBI treatment.
Drawing on its experiences to date with implementing the 2016 Lautenberg amendments and recognizing that some perceived deficiencies may be subject to reasonable (often technical) debate or simply more efficiently dealt with by permitting correction, rather than proceeding with a more punitive denial, EPA developed the proposed deficiency provisions as a means to balance the competing concerns evident in the comments.
Comment:  Concerning CBI claim deficiencies generally, a few commenters favored either not recognizing deficient claims as CBI claims and immediately releasing such information, or that EPA should reject the entire submission as invalid.  One argued that EPA should "more aggressively" enforce procedural requirements for asserting claims (up to and including reviewing every claim to some degree).  One commenter urged EPA to "reject" any submission for which the public copy redacts information that is not protected from disclosure under section 14(b), and was concerned that EPA would not make this conclusion until section 14(g) CBI review was complete.  This commenter opined that the holding period specified in the deficiency provisions (40 CFR 703.5(e)) would "reward" the submitter for their mistake and that placing submissions on hold to address deficient claims denies public access to the information.
Source: -0050; -0049
Response:  EPA disagrees with these comments.  EPA requires submission of information required under TSCA and its regulations to perform the functions delegated by Congress to the Agency. Rejecting a submission because of inadequacies related to requirements for asserting a CBI claim might deprive the Agency of necessary information. The appropriate remedy for a deficient CBI claim lies with addressing the confidentiality deficiency, not with rejecting the underlying submission.
While safeguards built into CDX such as validation and automatic incorporation of certification statements are expected to significantly reduce instances where one of the TSCA section 14(c) requirements to assert a claim are missing entirely, EPA has observed that innocent mistakes and technical errors do happen from time to time, and that immediately releasing information for which a CBI claim had evidently been attempted would be unduly punitive.  Further, some of the deficiencies that EPA identifies are not necessarily clear cut--whether a study report is appropriately or inappropriately redacted as it concerns a particular piece of information or diagram for instance, or whether a substantiation exemption applies to a particular piece of data.  Some reasonable technical debate may be appropriate in the case of some generic names as well.  The deficiency provisions allow for clarification of CBI claims and prompt resolution of any initial confusion or disputes over whether redacted information is in fact health and safety study data of the type restricted by section 14(b), and if so, whether that data reveals portion of mixture or process information.  Rather than resolve these matters by litigation, or sink costs into reviewing, rejecting, and re-reviewing the same submission, the proposed rule included the deficiency provisions to allow a quick correction of what are likely to be otherwise valid or largely valid CBI claims.
The brief holding period described in 40 CFR 703.5(e) does not serve to reward the submitter for having made an error.  The correction period is necessarily short, owing to time constraints built into TSCA, like the 90-day period to review CBI claims and the 90-day period to review PMNs.  Moreover, the hold described in the deficiency provisions applies to other time-limited reviews, such as section 5 review, meaning section 5 review periods would also be paused while the submitter is afforded a brief opportunity to correct the CBI deficiency. Assuming the deficiency is corrected and it is not necessary to deny the CBI claims, the public would have access to the information that was the subject of the deficiency at the same time the section 5 review period resumes.  (If the claim must be denied, the information would become available only after EPA provides notification of the denial to the submitter and waits for a 30-day appeal period to run out.)  EPA expects that providing this opportunity to correct deficiencies, albeit a short one, will allow the correction or resolution of most deficiencies, while not overly delaying CBI review, new chemical review, or public access to information that is not entitled to CBI treatment.
It is anticipated that deficiencies with the public copy would usually be identified early in the section 14(g) process (certainly in the first 60 days), and not after 14(g) review is complete.

Comment:  One commenter argued that deficiency review should have a strict deadline and be incorporated into "pre-screen" and that section 5 review shouldn't start until prescreen is complete.
Source: -0050
Response:  EPA disagrees with this comment, in part.  While some deficiencies are readily apparent at the time of submission or very early in the submission process, more technical or obscure deficiencies may not be noted until a few weeks later.  A generic name or the assertion of an exemption from the substantiation requirement may not come under close scrutiny until several weeks after submission.  If EPA had to identify all deficiencies at "prescreen," which is typically only a few days and mainly for TSCA section 5 submissions, the coverage and utility of the deficiency provisions would be significantly diminished while not assuring that any data would be available any sooner.
Comment: Commenters also argued that the proposed 10-day correction period was insufficient and that 30-45 days would be more reasonable.
Source: -0044; -0051; -0041; -0054; -0048; -0053
Response:  TSCA does not require that EPA allow submitters to correct deficiencies with the assertion of CBI claims, procedural or otherwise. However, TSCA section 14(c)(1)(A) does provide broad authority for EPA to promulgate "rules regarding a claim for protection from disclosure".
EPA is exercising its statutory authority in a manner that balances the interests at stake. While permitting any period for correction might complicate EPA's task in meeting the statutory time limit for conducting CBI reviews, the Agency believes that allowing a limited time to correct deficiencies adequately protects companies who make innocent errors without adversely impacting public access to information that is not entitled to CBI treatment.
Comment: Commenters suggested that EPA should send multiple notices of the deficiency, by mail, email, and other repetitive notifications, in addition to the proposed notice via CDX.
Source: -0044; -0051; -0041; -0052; -0053
Response:  EPA disagrees with these comments, to the extent they argue for additional notice by mail, in addition to CDX notification and email.  See Unit 13 for a more detailed discussion of the final rule's provisions on electronic notices.
Comment: A commenter suggested that EPA should permit substantiation as much as 45 days after submission.
Source: -0054
Response:  Except in the case of information that is exempt from upfront substantiation requirements under section 14(c)(2), TSCA requires substantiation to accompany each submission with a CBI claim.  This view was elaborated in a previous FRN (Statutory Requirements for Substantiation of Confidential Business Information (CBI) claims Under the Toxic Substances Control Act (TSCA) 82 FR 6522 (January 19, 2017)) and remains EPA's interpretation of the section 14(c) requirements, particularly given that section 14(g) provides a time limit for conducting CBI reviews that EPA can generally meet only by commencing CBI review soon after submission.  Given the unique circumstances surrounding in-person TSCA inspections (e.g., EPA inspectors may arrive unannounced or with relatively short notice, collect documentation unknown in scope or volume in advance, and/or take photographs and conduct employee interviews the scope and content of which would be unknown in advance), EPA did propose some flexibility from the usual requirement to provide substantiation concurrent with submission in these cases and EPA still believes this flexibility is appropriate.
Comment: One commenter advocated reviewing all generic names provided with PMNs and rejecting the PMN if the generic name is found to be inadequate.
Source: -0050
Response: EPA agrees with this comment.  Indeed, all generic names are reviewed at prescreen for compliance with the PMN regulations and it is not uncommon for a PMN to be rejected shortly after submission due to problems with the chemical identity, including an inadequate generic name.  Further, the generic names of chemicals that go on to be commercialized are reviewed for compliance with both EPA's generic name guidance and with TSCA section 14(c) at the point a NOC is filed and triggers section 14(g) CBI review requirements.  EPA does not, however, conduct a CBI review under section 14(g) for chemical identity claims made in PMNs, as prior to commercialization, chemical identity claims are exempt from the substantiation requirement under section 14(c) and thus excluded from routine CBI review under section 14(g).  Such claims ARE reviewable at either EPA's discretion or as required under certain provisions of TSCA section 14(f).
Comment:  One commenter argued that EPA should reject submissions that included overly generic use descriptions and/or consider such submissions deficient.
Source: -0050
Response: This comment is outside the scope of the proposed rule.  Generic use description requirements are described in individual reporting rules and can take several forms (whether a free-text description or based on use codes set out in individual reporting rules).  EPA did not propose nor is it finalizing with this rule any changes to those pre-existing reporting requirements.
 Unit 11: Electronic Reporting (40 CFR 703.5(f))
Comment: A few commenters raised the issue of CDX reliability as a barrier to e-reporting, suggesting that e-reporting should be only encouraged and not required.  One commenter also questioned whether an exception might be made for certain sensitive national defense-related submissions.
Source: -0044; -0053; -0040; -0041
Response:  EPA first notes that electronic reporting has been required for most TSCA submissions for many years, and that the proposed rule would mainly close the few remaining gaps for section 8(e) submissions, polymer exemption reports, and section 12(b) reports.  In most cases, these reports are short letters, or a cover letter with a single attachment, so the possibility of CDX being overwhelmed with a very large submission are relatively small.  CDX also has a dedicated Helpdesk available to address technical issues.  EPA is aware of particular issues with past instances of electronic reporting, such as a few incidents in 2020 CDR reporting, and worked quickly to correct these issues, and extended the reporting period to accommodate necessary repairs and improvements.  As EPA explained in the proposed rule, moving toward near-universal electronic reporting has many benefits, including better prevention of CBI claim-related errors, and is a practical necessity for modern recordkeeping and efficient and timely CBI review.  EPA also notes several recent positive comments the Agency has received on the optional electronic section 12(b) reporting tool, and the growing proportion of electronic section 12(b) and 8(e) submissions.
Occasionally, EPA has encountered special situations where a submission could not, for technical or legal reasons, such as national defense concerns, be made via CDX.  As has been the case in the past, EPA would expect to continue handling these cases according to their special needs and would encourage submitters with these issues to contact EPA for guidance well in advance of making their submission.
 Unit 12: OECD Templates (40 CFR 703.5(g))
Comment:  Several persons commented on the proposal to require the use of OECD harmonized templates for reporting health and safety study data, when such a template is available for the study type.  Some commenters were concerned that the proposal was to replace full study reports with templated data or robust summaries.  Other commenters were concerned with the additional burden of providing templated data, arguing that the templates should be optional, and/or that the requirement was not sufficiently related to CBI review to be included in this rule.
Source: -0050; -0049; -0044; -0048; -0045; -0052; -0053
Response:  EPA does not propose to replace full study reports with either robust summaries or with OECD harmonized templated data.  As noted in the proposed rule, the templated data would be in addition to existing requirements to provide full study reports.  EPA believes that data provided in templated form would aid efficient CBI review by virtue of the format (fielded data, rather than relying solely on a free-text report), wherein the identification and scope of CBI claims is clearer.  Templated data is also expected to be easier to search to identify pertinent studies in the early stages of risk assessment.  Finally, templated data are easier to import/export among EPA's internal databases including a CBI instance of IUCLID, and are compatible with data from a variety of international regulatory authorities.  While some commenters expressed concern about the burden of filling in a template, it is EPA's understanding that in many cases, submitters would be compelled to provide templated data to other regulators, so were or will be required to templatize the data anyway.  Commenters did not provide any but a general critique of the burden estimate for creating templated data, so EPA does not have a basis to adjust the burden estimate.
 Unit 13: Contact Information and Electronic Notices (40 CFR 703.5(h))
Comment:  EPA received several comments concerning the proposed provisions on electronic notices and requirements to maintain company contact information to facilitate making required notices.  Commenters asserted that electronic notice does not satisfy the requirement under TSCA Section 14(g)(2)(A) that EPA verify the fact and the date of receipt of the notice. Several commenters recommended redundant notices (via mail, email, etc.) in addition to electronic notice via CDX.  Some commenters also suggested providing longer notice periods or providing additional notices beyond those required by TSCA.  Additional comments expressed concern about the burden of maintaining contact information or being "forced" to rely on a single contact for any given TSCA submission.
Source: -0053; -0040; -0052; -0047; -0051; -0045
Response:  EPA's proposal to rely on electronic notices, rather than more traditional certified mail, is born out of experience.  In the initial years of implementing of the Lautenberg amendments, EPA did indeed rely on traditional certified mail to provide TSCA-required notices, or to otherwise communicate with submitters of CBI claims.  Unfortunately, because of company and personnel changes, most likely, a large number of these notices could not be delivered in the first round of mailing, initiating a time- and resource-intensive process to identify, contact, and confirm receipt in writing with someone else at the company or its successor.  Further, as the COVID-19 pandemic set in in 2020, EPA learned that at some companies, internal mail was often not timely delivered (in other words, the mail room or clerical staff might have signed for certified mail, but there was no guarantee that the mail was timely provided to or opened by its intended individual recipient).  EPA began to rely more and more on electronic notices instead.  In sending such notices, EPA can be assured that the notice is available to the person with access to that account in much the same way that signed-for certified mail has been delivered to a person at the address on the envelope.  What EPA cannot assure in either case is that the individual addressee has opened the e-notice or letter.  Section 14(g) requires only that notice be provided by "means that allows verification of the fact and date of receipt," with certified mail and personal delivery being but two examples of such means.  EPA views notice by CDX as another such example that allows EPA to furnish notice in a manner that EPA can verify the fact and date of receipt (by sending notices via CDX, EPA can assure that the notice is both in the recipient's CDX mailbox, available to be opened and viewed, and has an electronic record of when it was put there), and given recent changes in where many in the workforce work (i.e, the COVID-19-accellerated trend toward remote work) is very likely the best way to assure that required notices timely reach the appropriate company contact.
EPA also notes that for each notice it sends via CDX, a separate notice is sent to the email account of the submitter, according to their CDX account.  This emailed notification does not include CBI information, but notifies the recipient that they have a notice in their CDX account (this notice mechanism is somewhat analogous to the banking notices that a person might receive from their bank).  EPA is aware that some companies use an email address for their CDX accounts that is accessible to more than one person at their company, such that if one company contact is suddenly or temporarily unavailable, other company contacts will be able to access the notice.  Wider adoption of this or similar practices may ameliorate the concerns of some commenters about the burden of maintaining contact information on a specific-submission basis, and concerns about the company not receiving notice if the contact has left the company.  Submitting companies are also strongly encouraged to develop their own means of recording and maintaining submission passphrases so that company employees other than the individual who acted as the original Authorized Official can access the submission as needed to respond to future notices concerning those claims and/or in relation to reasserting expiring CBI claims every ten years.
Comment:  A few commenters expressed concern with maintaining company contact information for older submissions for which the passphrase has been lost, and that current company employees could not access the original submission to reassert CBI claims, especially around the time that such claims begin to expire without reassertion.
Source: -0053; -0051
Response: While EPA has long emphasized (and continues to emphasize) the need for companies to keep records of their passphrases, EPA does recognize that passphrases are nonetheless sometimes lost or not appropriately recorded.  In response, EPA is developing a means for companies to reset their passphrases in newer TSCA submissions.  As it concerns older submissions in particular, EPA notes that companies may always request a copy of record of their previous submissions, and that there is an electronic form for doing so (EPA can provide instructions for using this form upon request).  For expiring claims in particular, EPA is anticipating developing a new reporting form in which companies may reassert expiring claims.  While having a copy of the submission is likely to be very helpful to identifying and reasserting claims, it should not be necessary for the company to access the original submission in CDX in order to reassert claims.
Comment: One commenter asserted that submitters must have individual notification of expiring claims under TSCA section 14(e), and suggested that all primary Authorized Officials for a given company should be notified, as well as all the agents or consultants for that company.  Other commenters suggested that submitters of expiring claims get 180 days notice of expiration, versus the 60 days called for in TSCA.
Source: -0044; -0048; -0053
Response:  EPA disagrees with these comments.  Section 14(e) does not specify that EPA must provide individual notice of claim expiration, and it requires only 60 days notice of claim expiration.  EPA does nonetheless intend to provide notice of expiration as proposed, and at least 60 days ahead of time.
 Unit 14: Amending Public Copies (40 CFR 703.5(j))
Comment:  EPA received a few comments concerning the provisions on amending public copies following CBI claim denial or expiration.  Some commenters believed that EPA should be responsible for this function, while others did not believe it was necessary at all unless there was an immediate need to make the disclosure, such as a pending FOIA request.  Others agreed that companies should be primarily responsible for this function.  One commenter requested confirmation that EPA would indeed perform this function if companies did not do it, and clarification that any addendum prepared to for the newly disclosed data would faithfully capture the newly non-CBI information and not be a summary.
Source: -0050; -0049; -0044; -0041
Response:  EPA agrees with some of these comments, especially that companies should primarily be responsible for this function.  EPA confirms that in the event a company is unable or unwilling to update the public copy, EPA will undertake this activity as needed to make the information available.  The addendum described in the rule would not summarize or otherwise obscure the non-CBI data.  Rather, this is envisioned as a means to disclose the now-non-CBI information without altering the original document.  The final rule clarifies this.  Concerning one comment that suggested that EPA should prepare new public versions where the data was fielded, and therefore a CBI checkbox could, in theory, simply be unchecked by EPA, EPA is considering whether this is technically feasible and may be able to include it as an option in the future.
 Unit 15: EPA Review under 14(g) (40 CFR 703.7)
Comment:  Two commenters noted EPA's use of permissive language or stated a probable outcome rather than stating a definite outcome.  E.g., EPA "may deny" versus "will deny."
Source: -0049; -0050
Response:  EPA notes that the language employed was intentional, to allow the possibility that a CBI claim deficiency might be overcome or that the claim might no longer need a determination (such as if it were withdrawn, or the submitter made a persuasive argument that it was exempt from substantiation requirements).  Elsewhere, "may be" is used when discussing public disclosure.  Here it is not intended to suggest that disclosure is in doubt when the information is requested, but rather to provide EPA with discretion and flexibility on the timing for proactively or unilaterally disclosing data, particularly when there is little or no evident demand for the information.
 Unit 16: Representative Subset of Case Selection (40 CFR 703.7(a))
Comment:  One commenter noted that proposed 40 C.F.R. § 703.7(a)(2) uses permissive language ("may" review all non-exempt claims in 25% cases).
Source: -0050
Response:  EPA notes that this provision describes generally how EPA selects its representative subset of 25%.  EPA has observed that occasional deviations from a strict "one in four" selection are necessary to assure that at least 25% of cases with CBI claims are selected.  This may be necessary where, for example, all CBI claims were withdrawn shortly after being asserted.  EPA has revised the text from "may" to "will generally" to somewhat clarify that the permissive or general language pertains to the selection of the subset, not the size of the subset.
Comment:  EPA received several comments concerning how the Agency proposes to select claims to review as part of the "representative subset" of non-chemical identity claims described in TSCA section 14(g).  Some commenters assert that because TSCA section 14(g)(1)(C)(ii) requires EPA to review a representative subset of "all other claims or requests," EPA does not have the authority to exempt any particular types of CBI claims from the universe of its review (other than what is specifically excluded in section 14(g)(1)(C)(i). Specifically, some commenters disagreed with excluding certain types of TSCA-related correspondence from the selection universe, while others agreed with EPA's proposal.  Some commenters were concerned about exclusions from the representative subset in general, or that excluding these submissions would result in less than 25% of TSCA claims being reviewed.  One commenter was concerned that publishing EPA's case selection method would permit TSCA submitters to game the system to avoid CBI review for their submission.
Source: -0050; -0049; -0044; -0053
Response:  EPA disagrees in part with the two commenters that criticized the proposed exclusions from the 25%.  First, EPA notes that the final rule does not exclude any claims or requests from the universe in section 14(g)(1)(C)(ii) that consists of "all other claims or requests." Rather, the final rule excludes certain claims from selection in the representative subset. The result of these "exclusions" is the increased likelihood that a claim under another submission type would be reviewed. The process for "making up for" the exclusions is one consideration EPA had in proposing the somewhat flexible language on selection of the 25%, that EPA may or will generally review all claims in every fourth submission.  Among other things, such language permits varying from the "one in four" selection method to assure that the 25% requirement is met.  EPA is considering how it may best develop capabilities that would permit it to periodically compile statistics comparing the total number of CBI-containing submissions and claims within those submissions to the number of submissions and claims actually reviewed.  EPA expects that a periodic audit of this nature will assure that at least 25% of non-chemical identity claims are reviewed.  For the time being, EPA notes that most of the document or submission types that are excluded from the representative subset in the final rule are not numerous (e.g., EPA received 143 bonafide notices in FY22 that were flagged as including at least one CBI claim, including for chemical identity, but only 14 were ultimately determined to include non-exempt claims and reviewed as part of the 25%) and typically contain far fewer claims than other TSCA submissions that are included in the subset, such as PMNs and CDR submissions, or include claims that are duplicated in another submission (e.g., claims in a bona fide notice could be repeated in a later PMN).
Second, EPA does have discretion to determine which claims are reviewed as part of the "representative subset" and is finalizing the exclusions from the proposal. EPA notes that in the case of pre-notice correspondence and bona fide inquiries, EPA has observed that these submissions do not include much, if any, substantive information on the chemical, beyond its identity and the identity of the company inquiring into prospective manufacture of the substance, and that if a TSCA section 5 submission is required, this same information and considerably more detail would be included in the section 5 submission.  CBI review of these claims would be redundant.  A similar rationale applies to excluding amendments as submissions subject to selection.