Final Rule: Requirements for Confidential Business Information Claims under TSCA

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Implementation of New Organization for Economic Co-Operation Development OECD Harmonized Template Requirement

The final CBI procedures rule includes a requirement to report health and safety studies using an appropriate Organisation for Economic Co-operation and Development harmonized template OHT. Because EPA has not yet developed detailed, TSCA-specific instructions for choosing, populating, and submitting OHTs, EPA intends to be flexible in the initial implementation of this new requirement. Under the new rule, if an appropriate template exists for a health and safety data submission, submitting templated data is required, regardless of the reporting requirement that triggered the submission or the age or format of the data. If a submitter has already created an OHT file for their data (e.g., for submission in another jurisdiction), the same file may be submitted to EPA at this time. If a submitter is uncertain that the data type they are submitting has an appropriate template, the submitter may omit the templated data from the submission initially.

Until EPA elaborates on requirements and instructions for including the harmonized templates as appropriate in individual reporting rules or orders (e.g., under section 4) and/or in reporting tool instruction documents (e.g., ePMN), the Agency will be flexible regarding submissions that do not include templated data, and does not intend to delay EPA review of those submissions. 

View Webinar on the Final TSCA Confidential Business Information Procedures Rule

On July 18 and 20, 2023, EPA conducted two webinars covering the final Toxic Substances Control Act (TSCA) Confidential Business Information (CBI) Procedures rule. The webinar included an overview of the rule and focused on new requirements for TSCA submitters. The webinar also included a demonstration of how and where to locate and open time-sensitive notifications from EPA relating to CBI claims, how to update company contact information, and how CBI claim requirements have been further integrated in to TSCA reporting applications.

Read the questions and answers from the webinar. 

View a recording of the webinar below.

Final Rule: Requirements for Confidential Business Information Claims under TSCA 

On June 1, 2023, EPA issued a final rule to update confidential business information (CBI) requirements under TSCA that increases transparency, modernizes the reporting and review procedures for CBI, and aligns with the 2016 amendments to TSCA. The requirements will become effective 60 days after the rule is published in the Federal Register.

In addition to clarifying changes to ensure the regulations specify precisely where EPA has a statutory obligation to require substantiation and deny claims, which will result in more information being made available, the final rule also includes the following. 

  • Changes to better assure that the scope of a CBI claim is clear and limited to information the submitter views as confidential. The final rule also narrows the types of information in health and safety studies that can be claimed as CBI.
  • A provision to address overly broad CBI claims in public copies of TSCA submissions, especially health and safety related information, that specifies a process for the submitter to promptly correct those issues early in the CBI review. These changes are expected to remove ambiguity about the scope or validity of the claims.
  • Expanded requirements for electronic reporting and uniform requirements to provide publicly releasable copies of certain documents like scientific studies, which would make more data available to the public more quickly.
  • Requirements for electronic communication and maintaining accurate contact information to ensure that required notices of CBI claims are delivered more quickly to the submitters.
  • Clarifying language on how EPA will handle information used in the TSCA program but obtained under other statutes that also has valid CBI claims under those statutes. This will ensure consistency with the Agency’s duty to make information publicly available when it’s legally able to do so.
  • Clear, uniform guidance on requirements for asserting and maintaining CBI claims, including a standard set of substantiation questions used to support a CBI claim.
  • Requirements for electronic reporting of nearly all CBI claims, with enhancements to reporting tools that will prevent or mitigate common procedural errors.
  • A new section of the TSCA regulation to centralize and standardize how TSCA CBI claims must be asserted and substantiated.
  • Requirement that submitters use an appropriate Organisation for Economic Co-operation and Development harmonized template, when available, when submitting health and safety information.

Read the final rule.

On May 12, 2022, EPA published the proposed rule to update CBI requirements under TSCA and opened a public comment period for 60 days.

Read the proposed rule.

Read the proposed rule announcement.

Questions and Answers from the TSCA CBI Rule Webinar

  1. General Questions
  2. CDX Questions
  3. OECD Harmonized Template Questions
  4. Maintenance of CBI contact/ownership questions
  5. Electronic Reporting Requirements
  6. 10-year Reassertion/Resubstantiation Requirement

General Questions

1. What is CBI?

CBI stands for “Confidential Business Information.”  CBI is information claimed as confidential by the person who submitted it and which has not been determined by EPA as ineligible for confidential treatment.

CDX Questions

1. Are electronic notices sent via email or CDX?

Will the email notice give us specific details of what needs to be checked in CDX/ where the notice is located in CDX?  Sometimes it is very hard to find in CDX where the new notice is located, especially when the company has many submissions.

Electronic notices are sent via CDX, with an email sent to alert the recipient that a CDX communication is available. Instructions for using the information provided in the email to access the communication are posted here.

2. When does the timing of the 10-days to correct a deficiency (e.g. a deficient generic name) start? Is it when EPA sends the notification in CDX or is it when the submitting company opens the notification?

The 10-day period starts when the notice is delivered to the CDX account. The fact and date of delivery of such notice is verified automatically by CDX.

3. How is EPA ensuring that communication errors, validation errors, and submission errors will not result in the inappropriate revocation of CBI protections?  E.g., Under 40 CFR 703.8(f), EPA review of confidentiality claims under TSCA Section 14(f), states the 30-day timeline [giving notice of the review and opportunity to substantiate or resubstantiate] begins the next business day following the date the notice is made available to the submitter in their CDX account.

It remains important for companies to identify what appear to be technical issues or errors to EPA promptly.  EPA is not aware of the problems commenters appeared to be referring to; EPA is aware of situations in which the company contact (specifically, the Authorized Official) had changed, EPA was not informed, and this caused a delay in the company receiving notifications from EPA about a CBI claim. The emailed notices pertaining to CBI determinations sent via CDX are sent only to Authorized Officials, not to Technical Contacts (unless they are the same person), so for the purpose of maintaining CBI claims, it is most important to keep Authorized Official contact information current.  For submissions made prior to the effective date of the rule, EPA will continue its practice of individual outreach to companies for which email notifications failed, or EPA does not have an electronic record of the company having opened the submission, but this individual outreach may take several weeks or months after the CBI determination is issued.  For submissions made after the effective date of the rule, if a notice to the original Authorized Official is undeliverable, EPA will review the file for updated contact information and provide the notice to the newest Authorized Official.  Under the new rule, CBI submitters are responsible for monitoring their CDX accounts for communications from EPA regarding CBI, and for keeping company contact information current to facilitate timely delivery of CBI-related notices.

EPA is attempting to reduce the likelihood of missed or delayed notices and other communication issues with the requirement to keep company contact information current.  Built-in validation is also intended to reduce the likelihood of inadvertent omissions of required information and other such submitter errors.  TSCA submitters are reminded that the reporting applications provide a sanitized PDF of a submission that is available to the user at any time during the creation of the submission, and during the submission process. It is highly recommended that users review the sanitized versions of their submissions prior to completing the submission process.  A careful review of the sanitized copy of the submission should reduce submitter error that validation cannot catch.  It also helps to demonstrate the care and diligence the company has taken to maintain the confidentiality of the information.  On many occasions, companies have made a CBI claim one place in their submission, but failed to claim or redact the same information elsewhere in their submission.  For example, claiming company name as CBI in the main reporting form, but including the company name in a sanitized attachment or attachment filename.

4. Does the date of delivery correspond with when the recipient has actually opened the document?   What if we don't know it is there due to missing emails?

The date of delivery is when the notice is delivered to the CDX account and not the date on which the recipient has actually opened the communication. As noted in the response to comments to the rule, 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. 

5. Can we save the document before all the CBI questions are answered, or will it give us an error?

Users may save their entries before all CBI questions are answered for every claim, but the questions must all be answered for any given claim before saving.  For example, the user may save their complete substantiation response for a company identity claim without providing substantiation for a chemical identity claim; however, it is not possible to save the document if only one or two substantiation questions are answered for the company identity claim.

6. Will you be able to copy and paste from a Word document into these new CDX in-line forms? If not, that should be made very clear on all CDX CBI screens.

Users may copy and paste substantiation responses from another document into their TSCA submission.  However, text copied from Word directly sometimes includes hidden codes that can create unpredictable submission issues.  To avoid these errors, substantiation responses may be copied from Notepad (either created in Notepad or copied from Word into Notepad and then into the reporting application). It remains important to make sure that the substantiation response being provided corresponds to the claim or claims being substantiated (e.g., you should not re-use a chemical identity substantiation response to support a CBI claim for technical contact identity).

7. The updated reporting tools and substantiation look very similar to the CDR reporting. A challenge with substantiating claims in CDR submissions has been the need to copy the same information many times which did not always function as expected. Has that been addressed?

In all reporting applications, the user may copy substantiation from one claim to another similar claim.  Where this is not allowed, users may cut and paste from another “master” document (but see answer #7 above, regarding copying directly from Word documents).

8. Is it possible to have a generic/group mailbox for a company which also receives the communication in the event of vacation or illness?

Companies may choose to use a generic/group email address when registering with CDX.

9. Does creating a group mailbox conflict with the CDX certifications required when establishing a CDX account? Can it be made available to Agents/Consultants?

No, a group or generic mailbox does not conflict with CDX certifications.  Yes, the mailbox may include agents or consultants in the recipient list.

10. The current NOC substantiation template does not include a means to claim chemical identity as confidential and substantiate it.  Can EPA update the NOC template to add this important area of substantiation please?

Chemical identity substantiation has long been built into the NOC reporting form inline so there is no need to provide separate substantiation for that claim in a substantiation attachment.  Moreover, all substantiation will be provided in the reporting form in the updated NOC reporting tool—there will be no need to provide a separate substantiation attachment for any claims in the NOC form.

11. Is the sanitized pdf [of the substantiation attachment] still necessary?

Generally speaking, no.  The reporting tools have been updated to incorporate substantiation into the reporting tool itself, including features that permit CBI claims within the substantiation response.  These reporting tools already or could be enabled by EPA to automatically generate a sanitized copy of the submission, including substantiation responses (see, e.g., the PMN form).  There is no need to prepare a separate sanitized substantiation document when all CBI substantiation responses are included in the reporting form.  

12. Can a CDX user update the contact information both directly in the PMN and TSCA General Communications?

Only the technical contact information can be manually updated in the PMN.  Submitter information is pulled directly from CDX to ensure the user submitting the information and claiming to be the legally responsible representative is, in fact, the person captured in the submission.

13. Can the general communications form in CDX be updated so that users other than the Authorized Official will be able to use this functionality?

EPA is planning to update the functionality to allow Secondary Authorized Officials to submit communications, but since these communications can be used to request copies of record, EPA will need to ensure the submitter is an Authorized Official of the organization.

14. Can the new reporting tools be used now?

Yes, the new and updated reporting tools are available for use now. 

15. How is EPA anticipating the CDX technical issues and how does it plan to protect against the inappropriate disclosure of CBI?

EPA will be continuing to work to enhance CDX reporting tools to add functionality and make them more user friendly. While EPA acknowledges that the CDX tools can be improved, EPA is not aware of any CDX issue that has resulted in inappropriate disclosure of CBI.  Note that the applications provide users with the ability to view full and sanitized PDF versions of the submissions at any time during the creation of the data package, and before the submission process is completed.  It is the responsibility of the submitter to review and verify none of their confidential information is exposed.

OECD Harmonized Template Questions

1. Does the requirement to provide health and safety study in OECD template form (where available) for all TSCA submission types and does it apply to a study performed prior to the rule effective date?

Use of the OECD Harmonized Templates (OHTs) is required for all TSCA submissions that include health and safety studies or information from health and safety studies covered by the CBI procedures rule, if an appropriate template exists for that data type.  This requirement applies regardless of the reporting requirement that triggered the submission (e.g. whether section 4, 5, 6, or 8), or the age or format of the data.  EPA anticipates that specific reporting rules or orders going forward will provide more specificity on appropriate templates for that particular rule or order, and for submissions that are ongoing (e.g., section 5 submissions), EPA suggests discussing template expectations with either the pre-notice coordinator or program manager before or early in the section 5 submission process, at least until such time as general instructions become available.  If a submitter is uncertain that the data type they are submitting has an appropriate template, the submitter may also omit the templated data from the submission initially. Until EPA elaborates on requirements and instructions for including OHTs as appropriate in individual reporting rules or orders (e.g., under section 4) and/or in reporting tool instruction documents (e.g., ePMN), the Agency will be flexible regarding submissions that do not include templated data, and does not intend to delay EPA review of those submissions.

2. What training and guidance will be provided by EPA relating to the requirements to submit health and safety studies in OECD template form and/or using the IUCLID software?

IUCLID6 is free software that may be used to prepare OHT submissions.  The rule does not require the use of any particular software, but this is the currently recommended application.  EPA anticipates developing EPA- and TSCA-specific guidance materials and/or instructions in the future, but at this time, submitters of these templates may rely on instructions and materials available on the IUCLID6 website or provide templated data they have previously prepared for submission in other jurisdictions.  Training materials, including webinar links, video tutorials, and written instructions for using the latest version of IUCLID are available on the IUCLID6 website.

OHTs are available from the OECD website: https://search.oecd.org/ehs/templates/harmonised-templates.htm

IUCLID, free software that may be used to create templated files is available here: https://iuclid6.echa.europa.eu/  

User support for IUCLID6 may be found here: https://iuclid6.echa.europa.eu/support

3. Are there specific instructions for redacting data in studies in OECD template format?

An option exists to mark data as confidential.  In the case that templated data is claimed as confidential, the data submitter will also need to prepare a sanitized copy of this attachment.

4. Did EPA include the burden of providing information in OECD template format in its cost estimates?

The burden for requiring OECD templates was included in the Economic Assessment and Information Collection Request analyses; these documents are available in the docket for this rule at regulations.gov.  While some public comments included a general assertion that the burden estimate was low, none of these comments included enough detail to provide a basis for EPA to adjust its estimates.

5. Please provide details on phase in for OECD templates?

All new data submissions subject to the CBI procedures rule and that include data for which an appropriate template exists should include a templated version of the data.  However, because EPA has not yet developed detailed, TSCA-specific instructions for choosing, populating, and submitting OHTs, EPA intends to be flexible in the initial implementation of this new requirement. Under the new rule, if an appropriate template exists for a health and safety data submission, submitting templated data is required, regardless of the reporting requirement that triggered the submission, or the age or format of the data. If a submitter has already created an OHT file for their data (e.g., for submission in another jurisdiction), the same file may be submitted to EPA at this time. If a submitter is uncertain that the data type they are submitting has an appropriate template, the submitter may omit the templated data from the submission initially. Until EPA elaborates on requirements and instructions for including OHTs as appropriate in individual reporting rules or orders (e.g., under section 4) and/or in reporting tool instruction documents (e.g., ePMN), the Agency will be flexible regarding submissions that do not include templated data, and does not intend to delay EPA review of those submissions.

6. What is EPA’s CBI rationale behind the use and submission of the OECD templates IN ADDITION TO submission of complete studies [40 CFR 703.5(g)] under relevant TSCA Sections, such as Section 4, or Section 8(e) or with submitted PMNs?  

As noted in the preamble to the final rule, templated data will make CBI review of the submission more efficient (by aiding in identification of CBI claims) and aid in data sharing and dissemination within EPA and in public databases.  Full study reports, where already required, remain necessary for the same reasons as when the rules requiring full study reports were promulgated.

Maintenance of CBI contact/ownership questions

1. What happens if there is a change in personnel (someone leaving) without filing a notice to update the contact information?  Is there any attempt by EPA to review other contacts in CDX?

EPA has no way to know if there is a change in personnel at a company without some type of notification from the company.  If a company contact’s CDX or company email account is no longer active, EPA may receive notification that the notice could not be delivered to that email account, in which case EPA will follow up as needed with other company contact(s) and provide the notice to that person. 

2. Can a list of documents be included in the contact update, or is it one document per submission?

Are these transfer notifications individual submissions in general communications? Or can a list of submissions a single new contact be submitted?

Does Notice of Transfer form need to be competed for every document (PMN, CDR etc)?

EPA’s Updating Contact Information form in the CDX is a blank dialogue box or attachment upload. Can EPA explain how this information will get populated and how long it anticipates that process will take? How does this timeline affect and/or impact the short timeline for responding to deficiencies and other EPA communications?

Is there or will there be a way to update all CDX accounts at one time? Ex. Can you say that John Smith left ACME and was replaced by Beth Green. At that point, the CDX system will automatically update Beth Green for every account that John Smith was identified at the contact at ACME. Alternatively, can an Excel spreadsheet be attached to the TSCA communication with a list of PMNs and updated contact information for each PMN and a worksheet for each legal entity set up in CDX that is part of the current company? (This could also apply to a change of company name and CBI ownership.)

The rule generally requires that updated contact information be supplied by amending the original submission with the new contact info.  CBI deficiencies are expected to generally be identified shortly after submission, if the submission is selected for review—in which case, EPA expects most submissions should still be accessible to the original submitter and available to amend directly.  The contact update form should only be necessary in cases where the submissions are a little older and were originally on paper or in cases where the submission is no longer accessible in CDX (passcodes have been lost or forgotten).  The contact update form in the communications tool may be used to report a personnel change for several submissions at once, if desired.  The communications should be as specific as possible about identifying each submission (including any EPA-assigned case or submission numbers, like a PMN number) and who the new contact is for each.

Contact information updates will be associated with the submission(s) in EPA’s databases.  In the near term, in the event delivery of the pertinent notice fails (e.g., the email notification “bounces”), EPA will check the file for updated contact information and follow up with the company to provide the notice, if necessary (e.g., in the case of notice required under 14(g)—especially CBI claim denials).   

3. Other than sharing passphrases, passwords, and email addresses, which could all lead to the potential disclosure of CBI, has EPA considered other less burdensome ways for industry to keep their CDX contact information up to date? Such as the alternative mentioned above.

EPA considered all means of updating company contact information that it was aware of or was suggested by public commenters and concluded that the rule requirement was the only currently feasible means to do so.  To the extent that companies no longer have access to a given submission due to losing the passphrase, the change of company contact form may be used to update the company info for more than one submission.  To limit the potential for unauthorized access to CBI materials by, for example, former company employees or unauthorized employees, companies are reminded that new CDX users need new accounts, and those who no longer need their CDX account are required by the CDX user agreement to terminate and deactivate their CDX account when they are no longer authorized to view or submit TSCA information on behalf of a given company.

4. How does a new owner of a CBI claim need to update this information?  Can it be asserted and substantiated during any reporting activity, such as CDR?  i.e., by substantiating the transfer, which includes the parties, the type of transfer, and all other required information?

CBI claims are asserted on a submission-by-submission basis.  If one company acquires another company or unit of another company, the new owner of the company or business unit may assert CBI claims on its own behalf going forward.  If a new person becomes the company contact for a given submission, they should create a new CDX account for themselves, and then they may assert or maintain and support new or existing CBI claims on behalf of the company.  CBI claims are usually treated as specific to the individual submission.  One exception to this general rule is that confidential chemical identities, once actually disclosed or otherwise shown to be no longer treated as CBI, will no longer be eligible for confidential Inventory treatment and cannot generally be claimed as CBI anymore.  However, other information pertaining to the chemical, like production volume or site identity, may be claimed as CBI in the future.  Confidential chemical identities may also be claimed as confidential by more than one company, but if any manufacturer or processor of that substance withdraws the claim, has the claim denied, or otherwise discloses the fact that the substance is manufactured or processed for non-exempt commercial purposes in the US, the substance identity is no longer eligible for confidential treatment.  The transfer of ownership of a company or part of a company need not be substantiated, except that CBI claims in a notice of transfer form must be substantiated.

5. Can a change in CBI ownership be updated through the submission of a Notice of Commencement?

Updating company contact information in the NOC will only apply to the NOC submission—if an acquiring company wishes to update the contact information in the corresponding PMN (to permit CBI claim maintenance), the PMN submission must be amended separately. 

6. If the EPA has been notified previously of a transfer of ownership, i.e., through a CDR submission or NOC, must that change be renotified under this new process?

If contact information for an individual submission is updated, there would be no need to submit a separate notice of change of ownership, except when such notice is required under other rules or orders, like 5(e) test orders.  Documentation of change of ownership is also required when a company requests a copy of record for a submission made by another company they acquired.

7. Is the 2026 10-Year Re-Assertion of CBI Substantiation process the appropriate time to complete this transfer information? If this CBI ownership hasn’t been formally transferred previously?

CBI review may occur at any time, particularly those triggered by section 14(f).  For this reason, it is best to update company contact information promptly after it changes.  At a minimum, company contact information should be updated well in advance of claim expiration, to facilitate individual company notice of expiration.  Otherwise, companies will need to track their claim expiration on their own and rely on public lists of submissions with expiring claims as a means to obtain the 60-day notice required by section 14(e).

8. If the submission of an additional form is required, rather than separate substantiation of the facts of the ownership transfer, did EPA consider this burden when calculating the ICR burden estimates?

Ownership transfer need not be substantiated except to the extent that it is claimed as CBI in a notice of transfer or other submission.  The burden associated with updating contact information is either accounted for in the ICR for this rule or covered by existing ICRs.  Burdens associated with reasserting CBI claims starting in 2026 will be covered in a forthcoming ICR.

9. Do the requirements to maintain company contact information and the 10-year period of CBI protection applied only to TSCA submissions submitted on and after the TSCA amendment of June 22, 2016?

The requirement to maintain contact information applies to submissions made after the effective date of the CBI procedures rule.  However, to facilitate future CBI review and receipt of notices related to such review (whether individual reviews under section 14(f) or notices associated with expiring claims under section 14(e)), submitting companies are encouraged to update contact information for any submission for which they wish to maintain ongoing CBI claims, especially those claims that are subject to expiration.  Most CBI claims made on or after June 22, 2016, expire according to the provisions of TSCA section 14(e).

10. If PMN/LVE (including Letter of Support) is withdrawn during the review period, is the withdrawn PMN/LVE (and Letter of Support) exempt from “this requirement and the re-substantiation after 10 years”?

As a general matter, EPA considers withdrawn submissions to be entirely withdrawn (CBI claims included), so would not generally consider the CBI claims in the withdrawn submission as subject to either routine review or expiration under TSCA section 14(e).  In the event the withdrawn submission becomes the subject of a FOIA request or another circumstance triggers a review under section 14(f), EPA would provide notice of CBI review and opportunity to substantiate any CBI claims.

11. If the final status of a LVE is DENIAL, would the denied LVE be exempt from the requirement to maintain company contact information and re-substantiate CBI claims after 10 years?

Denied LVEs are considered TSCA submissions and are subject to CBI review and expiration.  Note, however, that many of the CBI claims made in an LVE may have been exempt from substantiation requirements under section 14(c)(2), and therefore not expire, per section 14(e)(1)(A).  In addition, after 10 years, EPA would expect that many of the expiring CBI claims made in a denied LVE would have diminished in their potential for competitive harm related to disclosure, or may no longer be secret.

12. Certain pre-submission types of correspondence intended mainly to ascertain subsequent TSCA reporting obligations (e.g., bona fide notices under 40 CFR 720.25) are excluded from the selection of the representative subset for EPA review of confidentiality claims.  However, substantiation is required for CBI claims in bona fide notices.  Are bona fide notices subject to the maintenance requirement and the re-substantiation after 10 years?

Yes.

13. Is substantiation required for CBI information included in Prenotice Consultations (PNCs)?  Are PNCs subject to the maintenance requirement and the re-substantiation after 10 years?

No.  Documents related to prenotice consultation are not considered TSCA submissions.

14. According to section 14(e) of the Act, TSCA submissions containing only CBI under (A)-(F) of section 14(c)(2) of the Act are not subject to the re-substantiation after 10 years.  Would such TSCA submissions be exempt from the contact information maintenance requirement? 

Certain information in TSCA submissions is exempt from substantiation requirements under section 14(c)(2), and such exempt claims do not expire, per section 14(e)(1)(A).  To the extent that a submission includes only exempt claims, maintaining company contact information is not necessary for purposes of section 14(e) claim expiration.  However, section 14(c)(2) claims are NOT exempt from all CBI review.  Any of the circumstances outlined in section 14(f) could prompt a discretionary or a mandatory CBI review, and the 14(c)(2) exemptions do not apply to those reviews.  In case of these reviews, EPA will need current contact information to notify the company of the review as needed and to collect any necessary substantiation or resubstantiation.  Companies that are concerned with the burden of maintaining CBI claims over time are encouraged to regularly consider whether it is necessary to maintain such claims beyond 10 years.  Contact information need not be maintained for submissions that are no longer considered CBI by the company.

15. “EPA strongly suggests that companies develop internal practices to assure that a current company contact is maintained for each of their submissions including CBI. This might include, for example, use of email addresses that more than one person can access to receive CBI notices...” If a TSCA submitter uses an email address that more than one person can access, will “a change of the authorized officials without change of the email address” be exempt from submission of the update of company contact information?

As long as the submission email address is kept current, it is not as necessary that the names of individual contacts also be updated.  In this case, it will be very important for the company to assure that new or additional personnel have CDX access to the submission (e.g., they each have their own CDX accounts and the passcode for that particular submission), beyond the individual who was the original company contact.

16. Current contact information for all of the individuals associated with a particular TSCA submission must be maintained.  Is contact information for technical contacts who are consultants subject to this requirement?

Not necessarily.  TSCA CBI-related notices are directed to the Authorized Official.  This person’s contact information is that which must be maintained.

17. It seems that the TSCA Communications application in the CDX is used to update company contact information.  However, TSCA Communications does not seem to have the role sponsorship function.  Will the role sponsorship function be added to TSCA Communications soon?  Without role sponsorship, it will be difficult for Letter of Support submitters outside the US to submit an update for their contact information, because this requires substantiation of CBI claims and foreign companies are often unfamiliar with how to substantiate CBI claims, often requiring assistance from third parties such as consultants or lawyers.

Correct.  If the company is unable to update contact information by amending the original submission (lost passcode, for example), they should use the TSCA communications module instead.  The agent/consultant role will not be added to the communications module due to the nature and sensitivity of what can be requested, i.e. a copy of record, and the Agency’s ability to verify the request is valid.  An agent/consultant should be registered in CDX under their own company name, not the company they are representing.  If an agent registered under ‘Company X’ requests copies of record for ‘Company Y’ the agency may not be able to verify the request is valid.  Opening up the communications to the agent/consultant role could also result in the Agency inadvertently releasing sensitive information to an inappropriate contact, not truly representing the company that original submitting company, if the agent or their company are no longer representing the authorized company.  Note that updating contact information does not require that the company reassert or substantiate prior CBI claims; only new CBI claims made in the updated contact information need to be asserted and supported in accordance with TSCA section 14(c).

Foreign companies may submit their own updates as well, using Authorized Officials they might have based in the United States and consulting with agents or consultants in the US on the submission process as they wish.  EPA also anticipates adding a secondary Authorized Official role to the TSCA Communications module/coms tool in the near future, so that foreign entities may directly submit their own updates, with or without US-based assistance.

Electronic Reporting Requirements

1. Is electronic reporting for 12(b) submissions required for ALL 12(b) submissions, or only ones that have CBI claims?

It is required for all 12(b) submissions.  The 12(b) rule was amended at 40 CFR 707.65 to require that all 12(b)s be submitted using the appropriate tool in CISS.  This is in addition to the requirement in part 703 that all TSCA submissions including CBI claims be submitted electronically.

10-year Reassertion/Resubstantiation Requirement

1. While there is no limit on the number of CBI claim period extensions a person may request under TSCA section 14(e), is EPA more likely to deny 2nd or 3rd CBI claim extension requests?

EPA expects that for every 10-year re-substantiation cycle, CBI claim submitters will be less likely to continue to reassert and substantiate CBI claims that are more than 10, 20, or 30 years old.  In addition, successor companies may not have as strong an interest in maintaining CBI claims made by a predecessor company.  Also, as CBI claims age, the rationale and justification for maintaining CBI status often weakens—the information may no longer be secret due to prior disclosure in one form or other, or the case for competitive harm may be more difficult to make.  However, the age of a claim, by itself, is not conclusive cause for EPA to deny a claim.

2. According to § 720.102(f)(2), generic names will be reviewed by EPA at the time of submission of NOC.  Does this mean that generic names are not reviewed by EPA at the time of submission of PMN?

Generic names are reviewed at the time a PMN is submitted, but they are re-reviewed at the time of NOC, when EPA has more knowledge of the pertinent chemistry and toxicological concerns related to structure, and when generic name policies directly related to listing on the Inventory become more relevant.  EPA also reviews any sustained chemical identity CBI claims at the time of NOC, but such claims are exempt from routine CBI review at the time of PMN submission—review of generic name sufficiency is integral to the chemical identity review at that later NOC time.

3. New § 723.50(l) (Confidentiality) references 40 CFR part 703.  Is it not the case that currently, generic names are reviewed by EPA at the time of submission of the Low Volume Exemption (LVE)?

Generic names are reviewed at the time an LVE is submitted.  However, such claims are exempt from CBI review under section 14(c)(2) and LVE substances are not placed on the Inventory, so do not require an NOC or equivalent notice that manufacture has commenced.  Consequently, generic names for LVEs are generally not evaluated as part of a CBI review under section 14(g) and they are not evaluated for consistency with Inventory policy.  EPA does review LVE chemical identity claims if the LVE is later proposed to be modified after the company has started to make the substance.  Review of the sufficiency of the generic name (and assignment of a UID, if the chem ID confidentiality claim is approved) is part of that CBI review.

Confidential Business Information under TSCA

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Last updated on July 22, 2024