Media

TSCA Confidential Business Information Guidance

Confidential Business Information (CBI) under TSCA

Under the Toxic Substances Control Act (TSCA), the Environmental Protection Agency (EPA) has the authority to evaluate claims of proprietary chemical information considered confidential by a submitter. Under TSCA section 14, those making claims generally are required to substantiate assertions of Confidential Business Information (CBI) at the time they it to the agency. When such claims have been approved by EPA, the chemical substance will receive protection from disclosure for a ten-year period, which can be renewed if CBI requirements continue to be met. Submitters can also assert and maintain a CBI claim for a specific chemical identity even if they were not the original claimant.

What Information Is Exempt from Substantiation?

Under Section 14(c)(2) of TSCA, certain information is classified as being automatically exempt from CBI substantiation requirements. A submitter is exempt from having to substantiate claims of CBI regarding its chemical manufacturing processes, identification of material suppliers or customers, specific production volumes, formulations, marketing and sales information and information related to the chemical substance’s uses. With appropriate justification, a submitter can also claim as CBI the specific chemical identity of a substance, including its chemical name, molecular makeup, CAS Registry Number or any other information that would cause the specific identity of the substance to be revealed. (In such cases, the claimant must instead provide a structurally descriptive generic name.)  These exemptions are applicable to both Chemical Data Reporting (CDR) Form U submissions and Premanufacture Notices (PMNs), among other things. 

What Information May Not be Protected as CBI?

TSCA also identifies information that may not be protected under a CBI claim. TSCA both mandates and utilizes information from health and safety studies to determine whether both existing and new chemical substances pose an unreasonable risk of injury to human health or the environment. Information from such health and safety studies is not protected as CBI, except where it could disclose information regarding manufacturing processes or mixture formulations. Chemical identity may be protected where its disclosure would have that effect. Processes that are described in macro terms in the context of the chemical industry or product sectors may also not be protected as CBI. Additionally, any general information that provides an aggregate or ranged value of a manufacturing volume may also not be subject to CBI protection. 

EPA is required by law to inform CBI claimants when an organization has requested information regarding their CBI claim(s) through a Freedom of Information Act (FOIA) request. In the event a FOIA request is granted on information claimed as CBI, a submitter may choose to bring a reverse FOIA action, whereby a court will review the CBI claim de novo and determine if disclosing such information would bring substantial harm to the submitter of the CBI claim. 

What Substantiation Information Does EPA Need?

EPA has developed a number of sample templates available online that can provide submitters with assistance in preparing their electronic or paper CDR and PMN submissions. The general substantiation questions for asserting CBI are as follows: 

1. The portions of the information which are alleged to be entitled to confidential treatment;
2. Whether disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects;
3. Measures taken by the business to guard against undesired disclosure of the information to others, such as non-disclosure agreements, limiting access to persons with a need to know, and securing the information physically or electronically;
4. Whether the information appears in any public documents, such as safety data sheets, advertising or promotional materials, professional or trade publications, or other media generally available to the public;
5. Whether any of the information contains trade secrets; and
6. Pertinent confidentiality determinations, if any, by EPA or other Federal agencies, and a copy of any such determination, or reference to it, if available.

For claims involving specific chemical identity, the submitter should also explain whether:

1. The substance is on the confidential portion of the TSCA Inventory;
2. The substance has been offered for commercial distribution;
3. The substance is known to be in U.S. commerce;
4. Disclosure of the specific chemical name would release confidential process information; and
5. In the case of a mixture, disclosure of the chemical name would disclose the portion of the mixture comprised by any of the substances in the mixture.

In the event a FOIA request is received for the information, EPA will decide on the validity of a CBI claim by reviewing responses to the questions listed in 40 CFR § 2.204(e).
 
Return Home