American Coatings Association

The White House Office of Management and Budget (OMB) has begun its review of a yet-to-be released U.S. Environmental Protection Agency (EPA) proposed rule that is expected to narrow the situations in which manufacturers could claim as confidential business information the identity of a chemical they intend to make under the Toxic Substances Control Act (TSCA).

The EPA proposal would apply to chemical information manufacturers submit to the agency. According to EPA, the rule would “increase transparency related to chemicals and microorganisms undergoing review prior to the commencement of manufacture, and is also likely to increase the availability to the general public of health and safety data on chemicals in commerce.”

According to a description on OMB's website, the proposed rule would make the situations for allowing confidentiality claims for a chemical or microorganism in health and safety studies submitted in manufacturers' pre-manufacture notices consistent with situations authorized by TSCA.

Section 14(b)(1) of TSCA provides that health and safety studies and data from health and safety studies are not entitled to confidential treatment, with an exception for information that “discloses processes used in the manufacturing or processing of a chemical substance or mixture,” or, in the case of a mixture, where release of the data discloses the portion of a mixture comprised by a particular substance.

EPA considers chemical identity to be part of a health and safety study.

As such, the identity of a chemical could not be kept confidential unless it disclosed processing information or information about the portion of a mixture it comprised, according to EPA's description of its proposal.

Pre-manufacture notices must include information such as specific chemical identity, anticipated use, anticipated production volume, and exposure and release information. Pre-manufacture notices are not required to have health and safety data, but any existing data must be submitted.

The EPA proposal was transmitted to OMB on Dec. 27. OMB typically reviews proposed rules for up to 90 days, but it may take longer.

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