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Confidential Business Information under TSCA

CBI Claims and Reviews Under TSCA

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CBI is broadly defined as proprietary information, considered confidential to the submitter, the release of which would cause substantial business injury to the owner.

Companies generally request CBI for confidential proprietary information believed to give other companies an advantage in the marketplace, such as details of their manufacturing processes and formulas.

Amendments to the Toxic Substances Control Act (TSCA) enacted in 2016 require the Agency to review and make determinations regarding the validity of claims based on the criteria in the statute and regulations.

The 2016 amendments to TSCA also imposed new requirements that submitters must meet when claiming information as CBI.  Some of these requirements include:
  • assertions that the submitter must make;
  • substantiation of all CBI claims, except for those on information exempt from substantiation under section 14(c)(2); and
  • if a CBI claim is for specific chemical identity, a structurally descriptive generic name.

The Agency may also review and make determinations on CBI claims in other circumstances, including when information that is claimed as CBI is responsive to a request under the Freedom of Information Act (FOIA).

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Health and safety information

Under TSCA, EPA collects a range of information, including health and safety studies on chemicals, and in some cases the law allows some of it to be claimed as CBI.

Health and safety studies, information from health and safety studies, and certain other information may not be protected as CBI under TSCA. However, section 14(b) of the law prevents EPA from releasing “information that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture.”

EPA uses the chemical information it has received under TSCA to carry out activities such as prioritizing chemicals for review, conducting risk assessments and taking risk management action as needed.  Information collected under TSCA is also used by a variety of entities both inside and outside the government for public health and environmental protection purposes.

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