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Confidential Business Information under TSCA

Policies for Deficient TSCA CBI Submissions

NEW POLICY ON NOTICES OF DEFICIENCY: Beginning with TSCA submissions received on August 15, 2019, EPA will stop sending out notices of deficiency to businesses whose submissions do not meet all the statutory requirements for asserting a TSCA CBI claim. Read the Federal Register notice announcing this change.

For submissions received prior to August 15, 2019, EPA will continue the practice of sending notices to companies whose CBI submissions are missing one or more of the following elements:

  • required certification statements;
  • substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2); and
  • if a CBI claim is for the specific chemical identity of a substance, a structurally descriptive generic name.

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New Policy for Deficient CBI Claims

On July 10, 2019, EPA published a Federal Register notice announcing a change in its practices relating to Toxic Substances Control Act (TSCA) submissions in which the submitter claimed information as Confidential Business Information (CBI). Beginning with TSCA submissions received on August 15, 2019, EPA will no longer send notices of deficiency to companies whose submissions do not meet all the statutory requirements for making a CBI claim. Instead, the Agency will provide written notice to affected submitters that those CBI claims are invalid, and the underlying information is treated as not subject to a confidentiality claim, and therefore subject to disclosure without further notice.

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Making Sure All CBI Claims Are Substantiated

TSCA submitters are solely responsible for ensuring that all the requirements for claiming information as CBI are met at the time the information is submitted to EPA.  The procedural requirements for making a CBI claim include:

  • the required certification statements;
  • information claimed as CBI is clearly identified;
  • substantiation of CBI claims for information that is not exempt from substantiation under section 14(c)(2);
  • sanitized copy provided where needed; and
  • if a CBI claim is for specific chemical identity, a structurally descriptive generic name.

One of the most common deficiencies that EPA sees is that submitters substantiate only some of the information claimed as CBI. In particular, submitters will often only substantiate claims for specific chemical identity but not for other information that is claimed as CBI. Submitters should carefully review the entirety of their submission, including all studies, correspondence, and other attachments for information that is being claimed as CBI and make sure there is a substantiation for every information element in all the documents. Learn more about how to substantiate CBI claims. 

If a submitter wishes to assert that certain information is exempt from substantiation, it should be noted in the substantiation response, citing the exemption and the reason it applies. Learn more about what information EPA considers to be exempt from substantiation under TSCA.

EPA electronic reporting systems within the Central Data Exchange (CDX) prompt users for some required elements when CBI claims are made. For paper submissions, it is up to the submitter to comply with all procedural requirements.

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Responding to a Notice of Deficiency

TSCA submissions received by EPA prior to August 15, 2019, that lack complete substantiation or that fail to meet any other procedural requirement for asserting a CBI claim are considered deficient. EPA will send a notice of deficiency to the affected business in these cases. The notice informs the affected business that:

  • it must submit its substantiation or correct other procedural deficiencies within 30 calendar days in order to remedy its deficient CBI claim; and
  • if a timely substantiation or amendment correcting other procedural deficiency has not been received by EPA within 30 days of receipt of the letter, any affected CBI claims will be considered withdrawn, and the information may be made public with no further notice to the affected business.

You also have the option of not responding to the deficiency notice. This again might be an appropriate option if the CBI claim is no longer valid or necessary.

Claims with deficiencies that are not remedied by the end of the 30-day period will be considered withdrawn.

If you have received a deficiency notice from EPA regarding your CBI submission you can respond in one of the following two ways:

Amend the submission, addressing the identified deficiency or deficiencies. Instructions on correcting certification, substantiation and generic name deficiencies can be found below. Amend the submission to withdraw the CBI claim. This might be an appropriate option if the CBI claim is no longer valid or necessary.

You should contact EPA if you believe that you received a notice of deficiency in error.

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Obtaining a Hard Copy of Your CBI Submission

If you are unable to access your CBI submission(s) in CDX to address the noted deficiency(/ies) due to a lost passphrase, you can request a copy of the submission(s) from EPA.

To obtain a hard copy of your submission(s), send a letter requesting a copy of the identified submission(s) on corporate stationery. The letter should included the transaction ID for each submission; indicate the person(s) authorized to receive the submission; and be signed by the authorized official (or technical contact). Requests should be sent to:

TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
U.S. EPA
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
(202) 564-8930

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Certification Deficiencies

Certification deficiencies in CBI submissions include:

  • Missing certification statement. All CBI claims must be accompanied by a CBI certification statement.
  • No signature. Certification provided, but not signed.
  • Wrong certification. Certification provided, but wrong one or it does not meet the requirements of the law.

Certification deficiencies generally only occur in TSCA submissions made on paper because the TSCA CDX electronic reporting applications were modified to require the appropriate certification statement.

For a paper submission, submit a new document which identifies the submission by type and document control number (or case number). This document should include the certification text and the signature of the authorizing official indicating the statements are truthful.

As noted above only paper submissions should be missing certifications, so only instructions for filing paper submissions are provided below.

The affected business must submit the certification to:

TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
U.S. EPA
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
(202) 564-8930

Substantiation Deficiencies

Substantiation deficiencies in CBI submissions include:

  • Missing Substantiation. Substantiation is required for all information elements claimed as CBI except for information that EPA recognizes as exempt from substantiation under TSCA Section 14(c)(2).
  • Partially substantiated. Substantiation is required for all information elements claimed as CBI except for information that is exempt from substantiation under TSCA Section 14(c)(2). Note that certain types of TSCA submissions, including Chemical Data Reporting and Pre-Manufacture Notices provide for substantiations of specific CBI claims within the electronic reporting forms. The substantiations provided for the specific CBI claims in these submissions are only applicable to the specific information noted and are not applicable to other information claimed as CBI in those submissions. Other information that is claimed as CBI in these submissions must also be substantiated. EPA encourages submitters to use the substantiation templates for substantiating these other CBI claims.
  • Claims information is exempt from substantiation. The Agency has identified specific information elements as exempt from substantiation. You do not have to substantiate those exempt elements. However, if you have claimed information that the Agency has not recognized as exempt from substantiation, this is your opportunity to substantiate your claims.  You may include in your substantiation response a detailed explanation of why you believe that this information should be exempt from substantiation and also why, if the Agency does not agree with this position, the information would qualify as CBI under TSCA. Please cite to applicable law and facts specific to the submission to support your assertion.

EPA encourages submitters to utilize the substantiation templates that have been developed to assist them with fully substantiating all CBI claims.

For purposes of accuracy, the most effective means of correcting the deficiency is by logging into your CDX account and amending the submission(s) in question.

If a paper submission is required, the affected business must submit the substantiation to:

TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
U.S. EPA
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
(202) 564-8930

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Generic Name Deficiencies

Generic name deficiencies in CBI submissions include:

  • Missing generic name. The new law requires that any time a submitter claims chemical name as CBI, the submitter must provide a structurally descriptive generic name.
  • Not structurally descriptive name. Provided generic name does not meet generic name criteria.

Submitters should follow EPA’s instructions for developing generic names.

For accuracy purposes, the most effective means of correcting the deficiency is by logging into your CDX account and amending the submission(s) in question.

If a paper submission is required, the affected business must submit the amended document to:

TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: TSCA CBI Substantiations.
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
U.S. EPA
Office of Pollution Prevention and Toxics
Confidential Business Information Center (CBIC)
Attn: TSCA CBI Substantiations
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302
(202) 564-8930

EPA Contacts

For more information on notices of deficiency please contact:

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