Confidential Business Information and Protection from Disclosure

Confidential Information TSCA’s section on disclosure of data has been completely revamped in the new rule, and renamed “Confidential Information”. The Agency must not disclose of any information that is protected under the new rule. Disclosed information does not include any information from health and safety studies, information describing the manufacturing volumes, or information describing the process used in the manufacture or processing of a chemical substance or mixture. In the case that a chemical substance is prohibited or will be phased out, protection from disclosure will no longer apply. This only applies to the conditions of use of the chemical for which the ban or phase-out is promulgated. Upon receiving notification, a manufacturer or processor of a banned or phased-out chemical substance may submit a request to keep certain information disclosed. In requesting disclosure, the submitter of the request must assert that:

• They have taken measures to protect the confidentiality of the information.
• They have determined that such information is not required to be disclosed by law.
• They have a reasonable basis to conclude that disclosure of information is likely to cause substantial harm to their position.
• They have a reasonable basis to believe that such information could not be discovered through reverse engineering.

The agency may submit or deny such a request. The agency is not authorized to alter or add to these standard resubstantiation requirements. Certain information is not subject to these substantiation requirements, such as marketing information, identifying information, specific information regarding the use of a chemical, and specific information about the process used to manufacture a chemical. Information will not be protected from disclosure in the case that disclosure is needed to protect health or the environment against an unreasonable risk of injury. Costs and other nonrisk factors will not be considered in these cases. This information may also be disclosed to public health officials or emergency responders in the case of an emergency, and to health or environmental professionals who provide a written statement of need and sign a written confidentiality agreement with the Agency. Any information that is disclosed will be protected until the person who asserted the claim withdraws it, the EPA determines that the information does not qualify for protection from disclosure, or ten years have passed since the initial claim. 60 days before the protection expires, the Agency must notify the submitter of the claim. Upon expiration of protection from disclosure, the EPA may grant a ten-year extension. Any person that has claimed protection from disclosure before or after the enactment of the new TSCA rule may be required to resubstantiate their claims. The EPA must review all claims before and after the new rule, and make a determination on disclosure. If the Agency requires resubstantiation of the claim, the submitter must either reassert their claim or withdraw the claim. In the case that a request for disclosure is granted, a ten-year expiration period applies as well. Administrator Duties No later than 90 days after the receipt of a claim for protection from disclosure, the agency must review, approve in part or in whole, or deny the claim or request. If the agency denies the claim in part or in whole, they must provide a statement of reasons for the denial and must notify the submitter of which information will be disclosed. Information cannot be disclosed until 30 days after the submitter receives this notification. If the EPA determines that disclosure is necessary to protect human health or the environment, they may disclose after 15 days, and in the case of imminent or substantial harm, no notification will be required. Notification to any manufacturer or processor is also not required if a claim is not made by any person. In the case that the agency fails to make a determination within 90 days, the claim is not automatically considered denied or accepted. To maintain discretion, the agency must assign a unique identifier to each chemical substance that is approved for protection from disclosure. This identifier cannot include the specific chemical identity or a structurally descriptive generic term. Each year, the EPA must publish a list of chemical substances which have been approved for protection from disclosure, referring to each chemical by its unique identifier. If a person receives notification that information will be disclosed, they may contest that by bringing an action to restrain disclosure of the information in the United States District Court. While under appeal, the Agency may not disclose any information about a chemical substance that is subject to the action. Furthermore, someone who knowingly discloses protected information may be subject to fines and imprisonment. Such acts can result in fines of up to $1,000,000 or imprisonment of up to one year. This does not apply to medical professionals who may need to disclose protected information in order to make medical or health care decisions.