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Confidential Business Information under TSCA

Frequent Questions about TSCA CBI

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General questions

Q1. The Frank R. Lautenberg Chemical Safety for the 21st Century Act revised TSCA section 14 concerning confidential business information (CBI) claims for information submitted to EPA.  What are the major changes for CBI claim submitters?

There are new requirements relating to the submission of CBI, its management, and periodic reviews of CBI claims, including expiration of CBI claims.

All CBI claims must be substantiated at the time the information claimed as CBI is submitted to EPA, except for those types of information exempt under TSCA section 14(c)(2). The law requires that the submitter provide a statement concerning the need for the CBI claim and a certification that the statement of need is true and correct. EPA has collapsed the two requirements into a single certification statement.  There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided.

EPA must, with limited exceptions, review all CBI claims for chemical identity, as well as a representative sample of at least 25% of other claims. These reviews must occur within 90 days of receipt. Other CBI claims can also be reviewed by the Agency based on specific events.  For example, EPA may conduct a CBI review pursuant to a Freedom of Information Act (FOIA) request, when a substance is designated as a high priority or active substance under the statute, or when the Agency believes that disclosure would be important in implementation of TSCA section 6. Most CBI claims expire after 10 years unless the information submitter reasserts and re-substantiates the CBI claim.  When EPA approves a CBI claim for chemical identity, the Agency must develop a unique identifier for the chemical.  Learn more about unique identifiers.

TSCA CBI may also be shared with non-federal authorities including states, subdivisions of states, tribes, emergency responders, and health care professionals if, certain requirements are met. For example, CBI may be shared with states if, among other things, the state has adequate authority to maintain the confidentiality of the information.

Q2. Can any information be protected as CBI?

TSCA section 14 broadly defines information that may not be disclosed by EPA (i.e., CBI) in the context of FOIA exemption 4.  5 U.S.C. 552.  FOIA exemption 4 allows for “trade secrets and commercial or financial information obtained from a person and privileged or confidential” submitted to EPA to be withheld from public disclosure. However, TSCA section 14(b) identifies several categories of information that may not be protected as CBI. Find examples of information that may not be protected as CBI.

Q3. TSCA section 14(c)(1)(B) requires that the assertion of a CBI claim be accompanied by a specific supporting statement. What is the impact of this requirement on filings submitted after June 22, 2016?

As of June 22, 2016, the effective date of the new law, all persons asserting CBI claims are required to include the supporting statement described in TSCA section 14(c)(1)(B) and the certification required in section 14(c)(5).  EPA has revised TSCA electronic reporting systems to require persons making CBI claims to make the required statement and certification as a single certification that is part of the submission. Paper submitters must include this certification in their filings.  Learn more about making CBI claims in TSCA submissions and read the certification statement.

Q4. TSCA section 14(e) provides for potential limitations on the duration of CBI claims.  How does EPA expect to implement this provision?

Information submitters should be aware that TSCA section 14(e) limits the duration of many confidentiality claims to 10 years, unless those claims are timely reasserted and substantiated. TSCA section 14(e) requires EPA to notify the submitter of a CBI claim at least 60 days prior to the expiration of a claim.  Additionally, if the submitter fails to reassert and substantiate their claims by the expiration date or EPA denies the claim, TSCA section 14(g)(2) requires that EPA notify the submitter at least 30 days prior to the intended disclosure of the information. EPA expects to develop policies, rules, or guidance to implement this provision. 

Q5.  TSCA section 14(c)(1)(C) requires that when a CBI claim is made for specific chemical identity, the claim shall include a structurally descriptive generic name, developed consistent with EPA guidance.  Will EPA’s reporting processes be modified to enable submitters to comply with this requirement?

There are existing generic name reporting requirements for submissions under certain sections of TSCA, and EPA anticipates no change in these requirements for information submitters in the near term.  Electronic reporting systems have been modified to allow for providing structurally descriptive generic names in submission types where not previously required.  Read EPA's guidance for developing structurally descriptive generic names.

Substantiation requirements

Q6. Will substantiation of CBI claims be required with submission of information to EPA under TSCA?

Yes.  TSCA requires substantiation of all CBI claims, except for those regarding information specifically exempted by section 14(c)(2), at the time of submission. Learn more about substantiating CBI claims under TSCA at the time of initial submission.

Q7. TSCA section 14(c)(2) provides that certain information is not subject to substantiation requirements, including “[s]pecific information describing the processes used in the manufacturing or processing of a chemical substance, mixture, or article,” and “[s]pecific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture or article.”  Do these provisions conflict with the existing substantiation requirements under the Chemical Data Reporting (CDR) Rule?

No. The information for which substantiation at the time of submission is required under CDR (e.g., chemical identity in health and safety studies as described in 40 CFR § 711.30 or general use and process information collected under 40 CFR § 711.15(b)(4) of CDR), is not the type of specific information referenced in TSCA § 14(c)(2).

Q8. If my claim is not subject to a substantiation requirement in a currently-existing regulation, what information do I need to provide to substantiate a CBI claim?

EPA has posted guidance questions that may be used as a model for substantiating CBI claims at the time of initial submissions.  If a substantiation has already been provided to EPA with the submission or in response to a substantiation request, no additional substantiation need be filed for the same information. Learn more about substantiating CBI claims under TSCA at the time of initial submission.

Q9. Does EPA have a list of types of information that is exempt from the substantiation requirement, according the provisions at 14(c)(2)?

EPA has developed a list of data elements in CDR and Pre-Manufacture Notice (PMN) submissions that are or might be exempt from the substantiation requirement.  EPA will be developing additional guidance regarding what information might be exempt from routine substantiations according to the provisions at 14(c)(2).

Q10. I have CBI claims for many different information elements in my submission.  Is there some way to streamline the substantiation process?

In cases where the rationale for protecting information is the same, it may be appropriate to group the information into a class of information rather than responding to each item claimed as CBI.  For example, information that identifies a company, including the company name, address, official and technical contact names and telephone numbers, and other company identifying data could be grouped into one class and a single set of substantiation responses provided in support for all the CBI-claimed information types included in the specific class.  The Agency expects to develop additional guidance on how to approach substantiations of the more complex filings so submitters will be able to better understand the type of information which should be provided when substantiating claims while also limiting unnecessary burden.

Q11. The 40 CFR part 2 questions seem inapplicable to many of my CBI claims.  What questions need to be answered? 

The questions that are provided in 40 CFR part 2 are intended to elicit facts that will enable the Agency to understand the basis for the submitter’s belief that a particular data element claimed as CBI is in fact entitled to this status.  It is possible that some of these example questions will not be applicable to certain CBI claims.  You should answer only those questions that would enable the Agency to understand the basis for the particular claim.  For information on substantive criteria for evaluating CBI claims, see 40 CFR 2.208.

Q12. How can a submitter drop CBI claims in a prior submission?

You may amend a prior submission made electronically by accessing the submission in CDX and removing any unnecessary or inappropriate CBI claims.  If the document is subject to current CBI review, in your substantiation response please advise the Agency of the change of CBI status for any amended data elements.  

Q13. How do I seek an extension for substantiating a CBI claim if I have received a notice requesting substantiation? 

Extension requests should be directed to Ms. Quoc Nguyen of EPA’s Office of General Counsel by email at Nguyen.quoc@epa.gov. Please include in the subject line “Request for Extension.”

Q14. What specifically is EPA looking for when it asks a submitter to substantiate a CBI claim?

The Agency is looking for specific facts to support particular CBI claims.  Please review the substantive criteria for use in confidentiality determinations at 40 CFR 2.208.  Bare assertions of loss of competitive advantage or financial loss to the company without explanation are not sufficient to support a claim. Learn more about what information to include in CBI substantiations.

Q15. In many instances the response to a substantiation will be the same as in prior claims or prior submissions, meaning the facts underlying the basis for a claim are the same.  Do I have to substantiate all CBI claims in a submission if many of the substantiations are very similar?

The Agency recognizes that the expressed basis for confidentiality claims may seem similar.  Persons substantiating CBI claims should be mindful of the need to provide case-specific facts to support the claims and avoid mere conclusory assertions.  When substantiating CBI claims for similar information types, it is permissible to substantiate them as a group or class of information, while being careful to clearly identify to which claim types the substantiation applies. 

Q16. My submission made between June 22, 2016 and March 21, 2017 contains many CBI claims.  Do I need to separately substantiate each of the CBI claims made in the document? 

Most CBI claims in a submission must be substantiated, as required by TSCA section14(c)(3).   Certain claims are exempt from substantiation under TSCA section 14(c)(2). For claims not exempt from substantiation, one approach would be to substantiate each data element claimed as CBI individually.  In cases where the rationale for protecting information is the same, it may be appropriate to group the information into a class of information rather than responding to each item claimed as CBI.  For example, information that identifies a company, including the company name, address, official and technical contact names and telephone numbers, and other company identifying data could be grouped into one class and a single set of substantiation responses provided in support for all the CBI-claimed information types included in the specific class.

In the process of reviewing and substantiating claims, you may decide a claim is not necessary.  You may then waive, or give up, the claim.  You should document this waiver in your response, by identifying the claim and then providing the word “waived” after it.

Q17. Are TSCA section 8(e)s where the filing relates to a research and development (R&D) pesticide formulation subject to CBI review?  What is the status of the individual chemicals in the formulation?  Must CBI claims for the individual ingredients be substantiated?

Excluded from substantiation and review are claims for specific chemical identity on those 8(e)s on chemicals or mixtures that have not been offered for commercial distribution, such as chemicals not on the TSCA Inventory and R&D or experimental mixtures.  Other data elements claimed as CBI are subject to substantiation at time of filing and review.

Q18.  Is there a PDF version of the example substantiation questions? 

Yes. View a PDF version of the example substantiation questions.

Q19. Upon consideration I have decided that my company’s substantiations in the recent CDR submissions are not robust enough—meaning they do not sufficiently describe my company’s need for the CBI protection.  Can I amend the CDR submissions now?

If a CBI determination has not already been issued, you may amend CBI substantiations in an existing CDR filing. As with all CDR amendments, they need to be done in accordance with the provided CDR instructions.

Instructions for amendments are found in the user guides:

2016 eCDRweb User Guide-Primary Authorized Official, starting on pg 60

2016 eCDRweb User Guide-Secondary Authorized Official, starting on pg 41

EPA review of CBI claims

Q20. Will EPA initiate a review of CBI claims made in TSCA submissions?

EPA will review and make determinations within 90 days on new CBI claims for chemical identity in submissions to the Agency filed after June 22, 2016, as required by TSCA section 14(g)(1)(C)(i). A representative subset of CBI claims for other kinds of information filed after June 22, 2016, will be reviewed in accordance with TSCA section 14(g)(1)(C)(ii). The Agency’s procedures for CBI determinations are reflected in Agency confidentiality regulations at 40 CFR part 2 and in regulations for certain specific TSCA reporting obligations.  EPA will use the substantiation provided by the submitter as part of the information considered when making a CBI determination.

Learn more about EPA’s review and determination of CBI claims under TSCA.

Q21. EPA must review a representative sample of at least 25% of other, non-chemical identity CBI claims under section 14(g).  How will the Agency be selecting its representative sample?

To satisfy the obligation to review a representative subset of 25% of non-chemical identity CBI claims, EPA is reviewing every fourth submission with at least one CBI claim for information other than specific chemical identity.  EPA is reviewing CBI claims in 25% of those TSCA submissions that include such claims. EPA may modify its selection and review procedures in the future, as it gains experience with the new law.  Pursuant to 40 CFR section 2.204(e), submitters of filings selected for this 25% review who have not previously been required to substantiate their CBI claims will be notified and provided an opportunity to comment (substantiate) on the claims.  If the CBI claims are not waived and comments were received in a timely manner, EPA will proceed in making its final determination.

Submissions in which the only CBI claim is for chemical identity will not be reviewed as part of the 25% because chemical identity CBI claims are already to be under TSCA section14(g)(1)(C)(i).  Also not included in the reviews will be CBI claims for the data elements identified in section 14(c)(2).

Please note that, as explained in the recent Federal Register Notice, all CBI claims included in a TSCA submission, except for those identified in TSCA section 14(c), are subject to substantiation at time of filing.

Q22. How does EPA expect to make public non-CBI data collected under the authority of TSCA?

EPA makes some information from TSCA submissions available on its ChemView site. Most non-CBI submissions are available on request at EPA’s Chemical Libraries located at EPA headquarters at Room 3340, EPA West Building, 1301 Constitution Avenue NW, Washington, DC 20004.

Q23. What is EPA’s definition of a health and safety study?

Under TSCA section 3(8) (15 U.S.C. 2602(8)):

The term “health and safety study” means any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying information and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological studies of a chemical substance or mixture, and any test performed pursuant to this chapter. Note that chemical identity is considered part of a health and safety study according to 40 CFR 716.3 and 40 CFR 720.3(k).

Health and safety studies may be submitted under various sections of TSCA, including:

  • TSCA section 8(d) rules explicitly requiring submission of health and safety studies;
  • notices of substantial risk under TSCA section 8(e);
  • TSCA section 4 rules or orders requiring persons to perform testing (15 U.S.C. 2603, 2607(d), and 2607(e)); and
  • Pre-Manufacture notices submitted under TSCA section 5 (15 U.S.C. 2604(d)(1)(C)).

Q24. Does EPA intend to continue its practice of making non-CBI and sanitized submissions available via Chem View?

Yes. EPA will continue to publish non-CBI information in ChemView and in other locations.

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