Asserting Confidential Business Information (CBI) Claims and Certification Statements
- 33.1. What are the restrictions on submitting confidential information under CDR?
Most information submitted under CDR may be claimed as confidential at the time the Form U is submitted, although there are exceptions. Specifically:
- Confidentiality claims for data elements identified as “not known or reasonably ascertainable” are not allowed (40 CFR 711.30(a)).
- Many “use” information data elements are not eligible for CBI status. (40 CFR 711.30(a)(2)(ii)).
- Chemical identities listed on the public portion of the TSCA Inventory are ineligible for CBI status, (40 CFR 711.30(a)(2)(i)).
- 33.2. Do the Frank R. Lautenberg Chemical Safety for the 21st Century Act and the 2020 CDR Revisions rule change the requirements for substantiation of CBI claims asserted with submission of CDR forms?
EPA made changes to requirements related to claiming CDR information as confidential to be consistent with new statutory requirements from amendments to TSCA enacted in 2016 under the Lautenberg Act. Changes to confidentiality claims included the addition of upfront substantiation requirements and exemptions consistent with the Lautenberg Act, changes to the substantiation questions, specification of data elements that are not eligible for confidentiality claims, and the development of joint submitter confidentiality considerations. For example, certain chemical specific “use” information data elements are not eligible for CBI status.
Additional information on how the 2020 CDR Revisions rule changed requirements for substantiation of CBI claims and CBI claims in general can be found on the CDR website at www.epa.gov/cdr.
- 33.3. TSCA section 14(c)(2) now provides that certain information will not be 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 substantiation requirements of 40 CFR 711.30?
No. The information for which confidentiality claims are barred or for which upfront substantiation is required under 40 CFR 711.30 (e.g., general use and process information collected under 40 CFR 711.15(b)(4) of CDR) is not the type of specific information within the scope of TSCA section 14(c)(2).
- 33.4. What must generally be considered in making a claim of confidentiality under TSCA?
Procedures for the assertion, substantiation, and review of confidentiality claims are set forth at TSCA section 14, 40 CFR part 2, subpart B and 40 CFR 711.30. When claiming information as confidential, an authorized official for the submitting company must certify that for all information claimed as confidential, the claimant has:
(i) taken reasonable measures to protect the confidentiality of the information;(ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
(ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
(iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the company; and
(iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. See TSCA section 14(c), 15 U.S.C. 2613(c).
Additional requirements apply when chemical identity, site identity, or processing and use information is claimed to be confidential (See 40 CFR 711.30).
- 33.5. How does a submitter make CBI claims and provide the required substantiation in e-CDRweb?
CBI claims are made for CDR submissions by checking a box next to the data element in the e-CDRweb reporting tool. For those data elements that require upfront substantiation, and most data elements require upfront substantiation, checking the CBI box automatically triggers the substantiation questions when reporters review the CBI claims for accuracy in e-CDRweb. The answers must be complete and specific to the chemical substance in question.
- 33.6. What should be included in a substantiation?
The CDR reporting tool includes questions to be answered to substantiate each data element claimed as confidential, consistent with the requirements at 40 CFR 711.30. These questions include, but are not limited to, whether the information claimed confidential includes a trade secret, or whether any of the information claimed to be confidential is required to be publicly disclosed under another law, and address issues related to the substantial harm that might result from the disclosure of the information. See, in general, 40 CFR 711.30(b). CBI claims for specific chemical identity must address additional substantiation questions at 40 CFR 711.30(c) related to reverse engineering. In response to these questions, submitters may provide to EPA any information they believe supports the validity of their CBI claims. Submitters must ensure that the responses to these questions provide a sufficient factual basis for the assertion that the particular data element is CBI.
The substantiation questions will appear when reporters review the CBI claims for accuracy in the e-CDRweb reporting tool.
- 33.7. Can information that is “not known or reasonably ascertainable” be claimed as confidential?
No. Information entries designated as “not known or reasonably ascertainable” (i.e., “NKRA”) may not be claimed as confidential (40 CFR 711.30(a)).
- 33.8. If EPA determines that information claimed as CBI is not entitled to confidential treatment, does the Agency contact the submitter before releasing the information to the public?
Yes, if the information was properly claimed as CBI in the CDR submission.
CBI claims made under the CDR rule must comply with certain procedural provisions in order to be considered properly asserted, and if the procedures for asserting a claim are not followed the information may be disclosed without further notification to the submitter.
Information properly claimed as confidential may only be disclosed to the public pursuant to specific statutory and regulatory provisions. EPA has long established procedures for the protection of properly asserted CBI claims and the review of these claims. Where EPA concludes, upon review, that the information is not entitled to confidential treatment, the Agency follows the procedures in 40 CFR part 2, subpart B, which include notification to the submitter prior to disclosure, consistent with TSCA section 14(g)(2).
Note that TSCA section 14(g)(1)(A) provides that EPA must make a CBI determination on 100% of specific chemical identity CBI claims and at least 25% of all other CBI claims. This means that a CBI claim asserted in June, could be subject to a determination in September.
- 33.9. How will the confidentiality of CDR data submitted electronically to EPA be maintained?
EPA maintains data security according to the Federal Information Processing Standards (FIPS) standards. The Central Data Exchange environment maintains ‘In Progress’ and ‘Submitted’ Form U’s in an encrypted state within a firewalled environment. Submissions can only be accessed by passphrase as a secondary security mechanism to prevent unauthorized access to company submissions. The submissions remain encrypted through the transmission process from CDX into EPA’s firewalled Confidential Business Information (CBI) LAN. Only once inside EPA backend systems is the data decrypted for EPA use. In summary, all data is encrypted during preparation, during transmission to EPA, and while it is maintained post submission within CDX. The information only becomes available for use once securely inside EPA systems.
- 33.10. How do I assert a confidentiality claim for information included in a substantiation in the e-CDRweb reporting tool?
In order to claim your response to a required CBI substantiation question as CBI in the e-CDRweb reporting tool, you must check the CBI box associated with the response you are claiming as confidential.
- 34.1. Can the identity and contact information for the person listed as the technical contact for a site be claimed as confidential?
Reporters are able to assert a confidentiality claim for the link between the technical contact identity and the chemical substance, for each chemical substance reported. In the e-CDRweb reporting tool, check the box associated with “technical contact” when asked to “check any claim(s) below to mark the corresponding information as confidential” in Part II of Form U. Note that this CBI claim must be made separately for each reported chemical substance for which the technical contact information is being claimed as confidential.
- 34.2. How does a submitter claim the link between the identity of the company and the information submitted under CDR to be confidential?
Reporters are able to assert a confidentiality claim for the link between company identity for each chemical substance reported. To claim this link as confidential, check the box next to “company information” when asked to “check any claim(s) below to mark the corresponding information as confidential” in Part II of Form U. Note that this CBI claim must be made separately for each reported chemical substance for which the company identity information is being claimed as confidential. Also, if you separately send correspondence to EPA that may link the company name or site to the reported chemical substance, you would need to mark that information as confidential in order to maintain the confidentiality claim.
- 34.3. How does a submitter claim site information as CBI?
Under CDR, a CBI claim for site identity is appropriate if the chemical link between the information reported in the CDR report and the site is confidential. A submitter may assert a confidentiality claim for the site identity for each chemical substance reported. Claiming site information confidential protects the release of the site name, address, city, county, state, zip code, and Dun & Bradstreet number. Confidentiality claims should be limited to circumstances in which they are absolutely necessary and legally justified (see TSCA section 14(c)(1)(B) and 40 CFR 2.208). Note that claiming site identity confidential does not alone protect the link between the specific chemical identity and the company’s identity. It does protect the identity of the site where the chemical substance was manufactured (including imported). To claim the site address as confidential on the e-CDRweb reporting tool, check the box next to “site information” when asked to “check any claim(s) below to mark the corresponding information as confidential” in Part II of Form U. Note that written substantiation is required to claim site information as CBI. Note that this CBI claim must be made separately for each reported chemical substance for which the site identity information is being claimed as confidential.
- 34.4. What is the difference between claiming Company Information as confidential and claiming Site Information as confidential? Should they both be claimed confidential?
Confidentiality claims for both site and company information are to be made in conjunction with a specific chemical substance and cannot be made generically for a whole submission. A claim of confidentiality for the identity of the site may be made if the linkage of the site with a reportable chemical substance and the fact that the substance is manufactured there is confidential and not publicly available. Selecting the CBI box in Part II for site information protects the link between a specific chemical substance and the information reported in Part I of Form U. Claiming site identity as confidential does not protect the link between the chemical identity and the company name. Selecting the CBI box for company information protects the link between a specific chemical substance and the information reported in Part I Form U. Both of these confidentiality claims require upfront substantiation.
Where several chemical substances are being reported, a submitter may claim the company name and/or site identity as confidential for some of the chemical substances being reported, while not making those claims for others. EPA also has observed that submitters sometimes claim only their company identity, but not their site identity, as confidential. EPA will not impute the existence of a CBI claim for site identity from a CBI claim for company identity, even if the company name appears within the site identity information. Neither will EPA impute the existence of a CBI claim for company name or site identity from a CBI claim associated with a different chemical substance.
- 35.1. When is written substantiation required for claiming confidentiality under Part II of Form U?
Checking the CBI box for any data element requiring upfront substantiation will automatically trigger the appropriate substantiation questions in the “CBI Substantiation” section of the e-CDRweb reporting tool. In addition to signing the Certification on page one of CDR Form U, an Authorized Official must also electronically sign and date the responses to the substantiation questions. CBI claims will not be accepted if they are not asserted as required at the time information is submitted to EPA. If these instructions for making CBI claims are not followed, EPA may release the information to the public without further notice to the submitter. Written substantiation at the time of submission is not required for confidentiality claims for the five production volume data elements. See the Instructions for Reporting.
- 35.2. A company plans to report a chemical substance on a CDR submission using the TSCA Accession Number and associated generic name listed on the public portion of the Inventory, which represent the chemical substance as listed on the confidential portion of the TSCA Inventory. To maintain the listing of the specific chemical identity for this substance on the confidential portion of the Inventory, does the chemical identity information need to be claimed CBI on the CDR form and must written responses be provided to the substantiation questions up front with the CDR report?
Yes, to both questions. In order to maintain the specific chemical identity for the chemical substance on the confidential portion of the Inventory, the company must claim chemical substance identity as confidential and provide written answers to the provided substantiation questions when submitting the CDR report.
- 35.3. If a company has previously reported production volume, plant site, or other information for the original TSCA Inventory (1977 data) or for subsequent IUR or CDR reporting periods, and did not claim the information as confidential at the time, can the company now make confidentiality claims for any of that information?
Yes, with a new information collection, a company may assert new CBI claims under certain circumstances, even ones which are different than previous data collection submissions. However, any assertion of a confidentiality claim must include a statement certifying, among other things, that the company has taken reasonable measures to protect the confidentiality of the information, that disclosure of the information is likely to cause substantial harm to the competitive position of the company, and that the information is not readily discoverable through reverse engineering. In addition, no person may assert a new confidentiality claim for a specific chemical identity that already appears on the public portion of the Inventory. The fact that a particular data element was not claimed as CBI previously may call into question the validity of the now-asserted CBI claim and trigger a CBI review and claim denial consistent with the regulations. CBI claims for information in a CDR submission must be made at the time the information is submitted. 40 CFR 711.30(a). Also please note that EPA will not consider reclassifying non-CBI data elements from previous CDR collections as confidential based on CBI claims asserted in this year’s CDR submissions.
- 35.4. Do submitters need to provide written upfront substantiation when production volumes are claimed confidential?
No. Confidentiality claims for production volumes have the option to be marked as confidential without further justification or upfront substantiation at the time of CDR Form U submission. 40 CFR 711.30(a)(3). The reporting tool will not ask for substantiation of the five production volume data elements: for 2020 reporting, these are the total volume for 2016, 2017, and 2018 and, for 2019, the domestically manufactured volume and the import volume.
However, any confidentiality claim for production volume that is exempt from upfront substantiation under this rule may later be subject to review as authorized under TSCA section 14(f). If the claim is subject to review, the company will be required to substantiate the claim(s) at that time.
- 35.5. A company makes a chemical substance which is listed on the public version of the TSCA Inventory. How can the company keep the manner in which it uses the chemical substances confidential?
The company keep the manner in which it uses the chemical substances confidential by claiming as confidential the connections between the chemical substance (including its uses) and the company name, site, and/or technical contact by checking the appropriate CBI boxes in Part II of Form U.
- 35.6. If I am reporting a chemical on the confidential portion of the TSCA Inventory and claim the chemical identity as CBI, is the CBI claim subject to review?
Yes. Under TSCA section 14(g)(1)(C)(i), all CBI claims for chemical identities reported under CDR are subject to CBI review.
For the 2020 CDR submission period: CDR submitters should be aware that a subset of the chemicals on the TSCA Inventory, as reflected on the SRS List, identified as confidential have been found to be ineligible for confidential treatment. The list of chemical substance identities listed as of June 1, 2020, on the confidential portion of the Inventory that the Agency believes are ineligible for confidential treatment is found here.
The reasons for the ineligibility include, but are not limited to, that the CBI claim for the chemical identity has been previously reviewed and denied, or that during the process of updating the TSCA Inventory the chemical substance was identified as an active substance and the CBI status was not reasserted by any person under 40 CFR 710.37(a), as required to maintain the chemical substance on the confidential portion of the Inventory per TSCA section 8(b)(4)(B).
Because of complications stemming from safety measures taken due to the Coronavirus (COVID-19) pandemic, the Agency was not able to update the non-confidential portion of the Inventory before the 2020 CDR submission period began. Persons who must report these substances should carefully consider whether they wish to make CBI claims for these substances, as the Agency expects these claims will be denied upon review.
- 35.7. Do I have to re-substantiate CBI claims for chemical identity that I asserted in the 2016 CDR collection or other more recent TSCA collections?
A report submitted for one CDR reporting cycle is a separate submission from a report for a different CDR reporting cycle. Because it is a separate submission, it requires its own substantiation for any confidentiality claims requiring up-front substantiations. Note the CDR regulations at 40 CFR 711.30(b)(6) provide that a submitter should address in their substantiation whether EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance. This is your opportunity to identify that the claim was previously made and substantiated.
- 36.1. Can processing and use data reported in Part II – Section D of Form U be claimed as confidential?
Some of the processing and use data elements cannot be claimed as confidential. In total, there are six industrial processing and use data elements, three of which cannot be claimed as confidential, and seven consumer and commercial data elements, four of which cannot be claimed as confidential.
The following data elements, which provide general processing and use information within the meaning of TSCA section 14(b)(3)(B), cannot be claimed as confidential:
- Certain Industrial processing and use data elements:
- type of process or use (40 CFR 711.15(b)(4)(i)(A));
- industrial sector (40 CFR 711.15(b)(4)(i)(B)); and
- function code (40 CFR 711.15(b)(4)(i)(C)).
- Certain Consumer and Commercial use data elements:
- product category (40 CFR 711.15(b)(4)(ii)(A));
- function of the chemical in the consumer or commercial product (40 CFR 711.15(b)(4)(ii)(B));
- whether the chemical is used in commercial or consumer products (40 CFR 711.15(b)(4)(ii)(C)); and
- whether the chemical predictably is used in children’s products (40 CFR 711.15(b)(4)(ii)(D)).
A claim of confidentiality may be asserted for other data associated with the processing and use information, if a submitter has reason to believe that release of the information would reveal trade secrets or confidential commercial or financial information, as provided by section 14 of TSCA and 40 CFR part 2. The electronic reporting tool will enable a submitter to check a CBI box next to each data element and complete the required upfront substantiation for such claims. Checking a CBI box for a specific data element automatically triggers the required substantiation questions in the “CBI Substantiation” section of the e-CDRweb reporting tool. The written answers must be complete and specific as to the chemical substance and each data element in question. If any information is not known or reasonably ascertainable, “NKRA” for “not known or reasonably ascertainable” may be selected for the box corresponding to that data element. However, submitters cannot claim an “NKRA” designation as confidential. See the Instructions for Reporting for more information.
- Certain Industrial processing and use data elements:
- 37.1. Are confidentiality claims for chemical identity treated differently for submissions made directly by suppliers in a joint submission?
A joint submission is necessary when a manufacturer (including importer) cannot provide the specific chemical identity of a chemical substance it manufactures, either because it is unknown to the importer and claimed as confidential by the supplier of the chemical substance or mixture, or because the chemical substance is manufactured using a reactant having a specific chemical identity that is unknown to the manufacturer and claimed as confidential by the reactant supplier.
In a joint submission, the primary submitter should identify whether the supplier information, including the supplier identity and the chemical substance or mixture trade name (or other designation), is confidential. Substantiation of the confidentiality claims for this information will not be required at the time of submission. The secondary submitter of the joint submission will provide its company name and location, a technical contact, trade name, chemical identity(ies), function, percentage, and function of each chemical substance in the composition of the substance or mixture represented by the trade name.
The secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims not exempt under 40 CFR 711.30(a)(3)(iii). Chemical substance identity can be claimed as confidential by the secondary submitter following the provisions in 40 CFR 711.30. Except for the percentage composition information, which is generally exempt from substantiation pursuant to TSCA section 14(c)(2)(D), all other reported data elements are subject to substantiation at the time the information is submitted.
- 37.2. What assumptions about CBI claims does EPA make with respect to information submitted in a Secondary Form U and the participants in joint submissions?
For 2020 and future CDR submissions, EPA has enabled the joint submitters to identify if data related to their submissions is confidential. See the Instructions for Reporting for additional information.
In 2016 and earlier CDR submissions, EPA presumed that the information reported in Section 4.D. (Trade Product Identification Information) of Form U and the connection between the chemical identity and the primary company associated with the joint submission was subject to a confidentiality claim when it was reported by a secondary submitter. In addition, EPA presumed that the information reported in Section 4.D. of Form U and the connection between the chemical identity and the secondary company associated with the joint submission was subject to a confidentiality claim when it was reported by a tertiary submitter.
- 36.1. Can processing and use data reported in Part II – Section D of Form U be claimed as confidential?