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31. General
    • 31.1. What are the restrictions on submitting confidential information under CDR?

      Information submitted under CDR may be claimed as confidential at the time the Form U is submitted. Submitters must provide upfront substantiation of confidentiality claims for processing and use information as well as for confidentiality claims for site or chemical identity. Confidentiality claims for data elements identified as “not known or reasonably ascertainable by” are not allowed (40 CFR 711.30(b)).

    • 31.2. Does the Frank R. Lautenberg Chemical Safety for the 21st Century Act change the requirements for substantiation of CBI claims asserted with submission of CDR forms?

      For the 2016 CDR, there is no revised or new substantiation beyond what the current regulations at 40 CFR 711.30 require. Although the Agency may revise CBI substantiation requirements by subsequent rulemaking, EPA has determined that the retention of current CBI substantiation requirements is the most practicable approach for the 2016 CDR reporting cycle, given that the submission period is already ongoing. EPA will use the answers to the CDR substantiation questions to inform the confidentiality determinations for chemical identity.

    • 31.3. 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 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 that TSCA section 14(c)(2) is referring to.

    • 31.4. What must generally be considered in making a claim of confidentiality under TSCA?

      EPA’s procedures for processing and reviewing confidentiality claims are set forth at 40 CFR Part 2, Subpart B and 40 CFR 711.30. When claiming information confidential, a submitter must ensure that the information meets the regulatory criteria found at 40 CFR 2.208. Under this regulation, business information is entitled to confidential treatment if:

      1. The business has asserted a business confidentiality claim which has not expired by its terms, nor been waived, nor withdrawn;
      2. The business has satisfactorily shown that it has taken reasonable measures to protect the confidentiality of the information and that it intends to continue to take such measures;
      3. The information is not, and has not been, reasonably obtainable without the business’s consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding);
      4. No statute specifically requires disclosure of the information; and,
      5. Either –
         1. The business has satisfactorily shown that disclosure of the information is likely to cause substantial harm to the business’s competitive position, or
         2. The information is voluntarily submitted information and its disclosure would be likely to impair the Government’s ability to obtain necessary information in the future.

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      In addition, the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires that for all claims for protection for any confidential information made with this submission the submitter certify they have:
      
      (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;
      (iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to my competitive position; and
      (iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. 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).

    • 31.5. How does a submitter make CBI claims and provide the required substantiation in e-CDRweb?

      CBI claims are made for CDR reporting by checking a box next to the data element. For those data elements that require upfront substantiation, checking the CBI box automatically triggers the substantiation questions. The answers must be complete and specific to the chemical substance in question.

    • 31.6. Did the Agency install a warning system in the reporting tool to remind submitters to complete required substantiation before submitting Form U?

      Yes. When a user checks a field that requires up front substantiation, a pop-up window will appear containing the substantiation questions a user needs to complete. If a user tries to save the substantiation questions without entering information into each of the required questions, the tool will show a validation warning that will require a user to enter information into the text fields. If a user clicks on the 'X' button to close the pop-up window, or on the 'Cancel' button to close the pop-up window, the check will be removed from the CBI box.

    • 31.7. Can information that is “not known or reasonably ascertainable” be claimed as confidential?

      No. Entries designated as “not known or reasonably ascertainable” (i.e., “NKRA”) may no longer be claimed as confidential (40 CFR 711.30(a)).

    • 31.8. Does the Agency contact submitters after it determines the data is non-CBI and releases it as public information?

      CBI claims made under the CDR rule must comply with certain procedural provisions in order to be recognized, 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 declassified pursuant to specific regulatory provisions. EPA has long established procedures for the protection of properly asserted CBI claims and also the review of these claims. Regarding those instances where a substantiation is required for a CBI claim but EPA concluded that it was insufficient, the Agency has procedures in place in 40 CFR part 2, subpart B that provide for notification to the submitter prior to disclosure.

    • 31.9. 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.

    • 31.10. How do I claim my CBI substantiation answers as CBI themselves?

      In order to claim information in your answers to the required CBI substantiation questions as CBI, you must clearly identify the information that is claimed confidential by marking the specific information in each answer with a label such as “confidential business information,” “proprietary,” or “trade secret.”

32. Part I — Company and Site Information (Blocks 2.B.1-2.B.3)
    • 32.1. Can the identity and contact information for the person listed as the technical contact for a site be claimed as confidential?

      Yes. Check the CBI box adjacent to block 2.B.3. Note that this CBI claim is a chemical-specific claim and must be made for each reported chemical substance for which the technical contact information is being claimed as confidential.

    • 32.2. How does a submitter claim the link between the identity of the company and the information submitted under CDR to be confidential?

      To claim the link between the company and the information being reported on CDR Form U as confidential, check the box next to the CBI for Company Identification field (Block 2.B.1). Also mark as confidential any correspondence that may link the company name or site to the reported.

    • 32.3. How does a submitter claim site information as CBI?

      Under CDR, a submitter may assert a confidentiality claim for the site identity (site information) 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 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, check the site information CBI box (Block 2.B.2) on Form U. Note that written substantiation is required to claim site information as CBI.

    • 32.4. 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 is confidential and not publicly available. Selecting the CBI box for site information protects the link between a specific chemical substance and the information reported in Part I, Section B of Form U and automatically triggers substantiation questions which must be answered and submitted as part 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, Section A of Form U and does not 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.

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33. Part II — Chemical Substance and Manufacturing Information (Block 2.A.1 and Blocks 2.B.4-2.B.20)
    • 33.1. When is written substantiation required for claiming confidentiality under Part II of Form U?

      Checking any CBI box for chemical identity or site identity automatically triggers the appropriate substantiation questions. In addition to signing the Certification on page one of CDR Form U, an Authorized Official must also 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.

    • 33.2. A company plans to report a chemical substance on the CDR using the confidential Inventory Accession Number and the generic name that goes with the Accession Number. To maintain the listing of this substance on the confidential Inventory does the chemical identity information need to be claimed CBI on the CDR form and must written responses be provided to the CBI questions up front with the CDR report?

      Yes to both questions, except in the special case of secondary and tertiary submitters participating in joint submissions. In other cases, in order to maintain the chemical substance on the confidential inventory, the company would need to claim chemical substance identity as confidential and provide written answers to the substantiation questions when submitting the CDR report.

    • 33.3. 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 the company may assert new CBI claims, even ones which are inconsistent with previous data collection submissions. Please note, though, that 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 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 in previous data collections, based on this year’s collection CBI assertions, without an amendment of the earlier filing(s). Any reclassification effort will be done in accordance with 40 CFR 2.203(c) and the Agency cannot assure that a reclassification to CBI will be authorized or that such efforts will be effective.

    • 33.4. 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 Form U submission. However, any claim still needs to qualify for confidential treatment (40 CFR 2.208), and submitters should be prepared to provide such substantiation in the event the CBI claim is challenged.

    • 33.5. 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?

      Because the chemical substance is listed on the public version of the TSCA Inventory, the chemical identity cannot be claimed CBI. However, the company can claim as confidential the connections between the chemical substance and the company name and between the chemical substance and the site by checking the appropriate CBI boxes. The company can also make confidentiality claims for processing and use information that it reports in Part III of Form U.

    • 34. Part III – Processing and Use Information (Sections 3.A. and 3.B.)
    • 34.1. Do all CBI claims made in Sections A and B of Form U Part III need to be accompanied by answers to substantiation questions?

      Upfront substantiation of CBI claims is needed for all data elements except production volume. A claim of confidentiality may be asserted for data associated with the processing and use information reported in Part III of Form U 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.

      A submitter may check the CBI box next to each data element to claim data as confidential. Checking a CBI box for a specific data element automatically triggers the substantiation questions. The written answers must be complete and specific as to the chemical substance and each data element in question. If a chemical substance is not used in products intended for use by children and a submitter answers “No” in Part III.B, the submitter is encouraged not to claim that designation as confidential.

      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.

    • 34.2. If a chemical substance is not used in products intended for use by children, can the manufacturer claim that lack of use as confidential?

      Yes, such claims can be made, but the submitter is encouraged not to claim the information as confidential.

    • 35. Part IV — Joint Submissions (Sections 4.A-4.D.)
    • 35.1. How are confidentiality claims for chemical identity treated differently for submissions made directly by suppliers in a joint submission?

      When a supplier in a joint submission (i.e., a secondary or tertiary submitter) reports a chemical substance listed on the confidential portion of the TSCA Inventory, EPA will presume that the chemical identity associated with the Accession Number is subject to a confidentiality claim. In such instances, the secondary or tertiary submitter does not need to claim the underlying chemical identity CBI or provide upfront substantiation.

    • 35.2. What assumptions about CBI claims does EPA make with respect to information submitted in Part IV of Form U and the participants in joint submissions?

      EPA will presume 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 is subject to a confidentiality claim when it is reported by a secondary submitter.

      Similarly, EPA will presume 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 is subject to a confidentiality claim when it is reported by a tertiary submitter.