Frequent Questions about TSCA CBI

On this page:

General questions
Substantiation requirements
EPA review of CBI claims

General questions

Q1. 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.

Q2. 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. Learn more about making CBI claims in TSCA submissions and read the certification statement.

Q3. 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 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 has elaborated on the notice, reporting, and EPA review requirements in the CBI procedural rule at 40 CFR 703 and expects to develop an electronic reporting tool to further implement this provision.

Q4. 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

Q5. Is substantiation of CBI claims 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.

Q6. Does EPA have a list of types of information that is exempt from the substantiation requirement, according to 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. Data elements that are exempt from substantiation requirements are indicated in the applicable regulations and/or reporting tools.

Q7. I have CBI claims for many different information elements in my submission. Is there some way to streamline the substantiation process?

Submitters of CBI claims may reuse substantiation that applies to more than one CBI claim. Some reporting tools permit the user to either copy substantiation between CBI claims or use one substantiation response to cover several claims for similar or related information.

Q8. The 40 CFR part 2 questions seem inapplicable to many of my CBI claims. What questions need to be answered?

The 40 CFR part 2 questions should not be used to substantiate TSCA CBI claims. Please use the questions in 40 CFR 703.5(b) or in the applicable specific TSCA reporting rule (e.g., CDR at 40 CFR 711).

Q9. 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, removing any unnecessary or inappropriate CBI claims, and resubmitting the document. If the submission was not made electronically or has become inaccessible to the submitting company (e.g., lost passphrase), CBI claims may be withdrawn using the general communications reporting tool in CDX.

Q10. How do I seek an extension for substantiating a CBI claim if I have received a notice requesting substantiation (such as for a submission affected by a FOIA request and that was originally submitted to EPA prior to June 22, 2016)?

Extension requests should be directed to Casey Pickell of EPA’s Office of General Counsel by email at [email protected]. Please include in the subject line “Request for Extension.”

Q11. 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, which are generally included in complete answers to the substantiation questions required by 40 CFR 703.5(b). You may also wish to review the substantive criteria for use in confidentiality determinations at 40 CFR 703.7. 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.

Q12. 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. However, submitters of CBI claims may reuse substantiation that applies to more than one CBI claim. Some reporting tools permit the user to either copy substantiation between CBI claims or use one substantiation response to cover several claims for similar or related information.

Q13. 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 chemical substances that have not been offered for commercial distribution, such as chemicals not on the TSCA Inventory and R&D and details on full composition and respective percentages of chemicals in mixtures. Other information elements claimed as CBI are subject to substantiation at time of filing and review.

EPA review of CBI claims

Q14. Which CBI claims made in TSCA submissions does EPA review?

EPA reviews and makes 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, is reviewed in accordance with TSCA section 14(g)(1)(C)(ii). The Agency’s procedures for TSCA CBI determinations are reflected in 40 CFR 703 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.

Q15. EPA must review a representative sample of at least 25% of other, non-chemical identity CBI claims under section 14(g). How does the Agency select its representative sample?

To satisfy the obligation to review a representative subset of 25% of non-chemical identity CBI claims, EPA reviews every fourth submission with at least one CBI claim for information other than specific chemical identity. See 40 CFR 703.7.

Q16. How does EPA make public non-CBI data collected under the authority of TSCA

EPA makes many non-CBI and sanitized TSCA submissions available on ChemView. 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.

Q17. 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 TSCA.

The term is also defined for the purposes of TSCA CBI procedures at 40 CFR 703.3. 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 and section 8 requirements to submit health and safety data (e.g., 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)).

Frequent Questions about TSCA CBI

General questions

Substantiation requirements

EPA review of CBI claims

Confidential Business Information under TSCA