Confidential Business Information under TSCA

About Confidential Business Information (CBI) Claims and their 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. 

While CBI claims under the Toxic Substances Control Act (TSCA) will be honored by the Agency initially as long as there is compliance with procedural requirements, the Agency retains an ability to review, and potentially disallow the claims if they do not meet the substantive criteria in the statute.

Note that TSCA places some limits on the ability of information submitters to retain CBI claims on health and safety data and health and safety studies. 

Since 2010, the Agency has been focused on reducing inappropriate CBI claims in TSCA filings.  Inappropriate CBI claims are those that, at the time of Agency review, do not meet the statutory requirements for TSCA CBI status.  In general this means the material claimed as CBI is publicly known or is health and safety data not statutorily exempt from public disclosure.

The Agency’s recent CBI focus has been on reviewing for appropriateness in prospective submissions (those filings as they come in to the Agency) and also on older filings (those submissions already in Agency files).

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CBI related to health and safety information

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

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. 

TSCA provides that health and safety information on chemicals be made available to the public; however, section 14(b) of  the law prevents EPA from releasing “data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.”  TSCA regulations and policy statements provide additional insights on this.

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Problems associated with inappropriate CBI claims

  • Thwarts EPA efforts to make information on chemicals in commerce available to public.
  • Undermines public confidence in EPA and other governmental chemical management and industry product stewardship activities.
  • Costs taxpayers -- CBI is expensive to maintain and protect.

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Balancing right-to-know with businesses' need for confidentiality

From an “information” management perspective, EPA has two obligations with regard to the data it collects via TSCA: 

  • Protect data which is claimed as CBI in accordance with TSCA section 14.  Review materials for inappropriate CBI claims in accordance with the regulations.
  • Make available to the public that data not claimed as CBI under TSCA section 14.

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Declassification of CBI under TSCA