The 2016 amendments to the Toxic Substances Control Act (TSCA) expanded access to chemical confidential business information (CBI) that businesses are required by law to provide to the EPA. TSCA Section 14, which deals in general with the CBI, now includes three categories of people who are entitled to receive the CBI. The EPA recently issued three draft guidance documents describing the conditions the three categories of people must meet to obtain the requested CBI.
General conditions
TSCA CBI is information for which a business has made a claim of business confidentiality. In EPA’s hands, this information is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.
New Section 14(d) specifically authorizes the EPA to release the CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders. The conditions for access vary for each of the three categories but generally include the following:
- The requester must show that he or she has a need for the information related to their employment, professional, or legal duties.
- The recipient of the CBI is prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it.
- The EPA generally must notify the entity that made the CBI claim at least 15 days before disclosing the CBI. There is an exception for disclosures in emergency situations, which requires that the EPA make the notification as soon as practicable.
Following are additional conditions specific to each category:
State, local, and tribal governments
- Requesting governments have the option, in advance of making a specific request for CBI access, to submit a written request to the EPA detailing the requesting government’s relevant legal authorities and measures for protecting TSCA CBI, which the requesting government regards as comparable to EPA’s.
- If the EPA finds that the requesting government has comparable legal authorities and measures, the EPA and the requesting government will enter into an agreement establishing the parameters of information sharing. A model agreement is provided in the draft guidance.
- If the EPA has an agreement with the requesting government in place, the requesting government can then make a short written request to the EPA for the CBI, explaining that the information is needed for the purpose of administering or enforcing a law.
- In lieu of preapproval, a requesting government may submit a specific written request demonstrating that it meets the appropriate measures and has adequate authority. The EPA will then review the request and make an agreement with the requestor, if appropriate.
- Affected businesses may file a legal challenge to the release of its CBI in federal court.
Medical and environmental professionals in nonemergencies
- Medical professionals are a federal, state, or tribal government employee assigned to an agency or other government subdivision principally concerned with human health matters; a nurse practitioner or registered nurse; or a physician.
- An environmental professional is a federal, state, or tribal government employee assigned to an agency or other government subdivision principally concerned with protection of the environment, natural resources, wildlife, and/or human health.
- Persons covered under this provision must assert in a statement of need that they have a reasonable basis to suspect that the information is necessary for, or will assist in, either diagnosing or treating one or more individuals or responding to an environmental release or exposure; that one or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned; or an environmental release of or exposure to the chemical substance or mixture concerned has occurred.
Emergency situations
- Requests under this category may be made by a treating or responding physician, nurse, agent of a poison control center, or public health or environmental official or a trained first responder, including a police officer, firefighter, or emergency medical technician.
- The requester must have a reasonable basis to suspect that a medical, public health, or environmental emergency exists; that the information is necessary for or will assist in emergency or first-aid diagnosis or treatment; or that one or more individuals being diagnosed or treated have likely been exposed to the chemical substance or mixture concerned or a serious environmental release of or exposure to the chemical substance or mixture concerned has occurred.
- If the request for disclosure is granted, the EPA will provide instructions for accessing the data. In some circumstances, it might be most efficient for the EPA to simply provide the information over the phone. In other circumstances, the information may be provided in writing and/or via electronic access.
Penalties
The EPA states that persons who willfully disclose the CBI to unauthorized persons are liable for a possible fine and/or imprisonment for up to 1 year. Medical professionals may disclose the information to their patient or to persons authorized to make medical decisions on behalf of the patient.
The draft guidance documents are available at here.