Chemicals, Regulatory Developments

Ability to Request CBI Expanded Under TSCA

The June 2016 amendments to the Toxic Substances Control Act (TSCA) expanded the categories of persons who may request confidential business information (CBI) about chemicals, which regulated entities submitted to the EPA.

Chemicals

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Specifically, the new section added state, tribal, and local governments; treating physicians or nurses in nonemergency situations; and doctors, nurses, and first responders engaged in an emergency response. In March 2018, the Agency issued drafts of three documents to guide the three categories on the conditions they must meet to obtain access to CBI. The conditions for the three categories have general similarities but vary in the details. Final versions of those documents have now been issued.

Following are provisions that apply both to all three categories and selected provisions that apply individually.

All Requesters

Three requirements apply to each of the three categories:

The requester must show that he or she has a need for the information related to their professional or legal duties.

  • The recipient of TSCA CBI is prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to patients).
  • 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 wherein the EPA makes the notification as soon as practicable.

State, Local, and Tribal Governments

The requesting government must have one or more agreements with the EPA that will ensure that the government entity has adequate authority to maintain confidentiality of the information and will maintain it in accordance with procedures comparable to the safeguarding procedures used by the EPA. The guidance provides two options for reaching an agreement with the EPA:

  • A requesting government may seek preapproval that it meets the appropriate measures and adequate authority requirements. Such approval would be memorialized in an agreement. The requesting government may later submit a written request that references the prior agreement and provide assurance that the confidentiality requirements that the EPA previously approved have not changed. The written request must also explain that the information is for the purpose of administration or enforcement of a law.
  • A requesting government may submit a specific written request demonstrating that it meets the appropriate measures, purposes, and adequate authority requirements all at the same time. The EPA reviews the request and makes an agreement with the requester, if appropriate.

Professionals in Nonemergencies

This category comprises health professionals employed by the federal government, a state agency, or tribal government; an environmental professional employed by a federal or state agency or tribal government; or a treating physician or nurse.

The professional must assert in a statement that he or she has a reasonable basis to suspect that:

  • The information is necessary for, or will assist in, either:
    • The diagnosis or treatment of one or more individuals; or
    • Responding to an environmental release or exposure; and
  • The individual(s) being diagnosed or treated has been exposed to the chemical substance for which the CBI is requested.

The professional must agree to use the information exclusively for the health or environmental needs asserted in the statement of need and sign a written confidentiality agreement.

Emergency Responders

This category comprises treating or responding physicians, nurses, agents of a poison control center, public health or environmental officials of a state, political subdivision of a state, or tribal government, and first responders.

An emergency must meet either or both of the following definitions:

  • Environmental emergency includes the environmental impacts of industrial and/or technological incidents and of natural disasters and complex emergencies that require technical support to respond effectively to minimize negative environmental impacts.
  • Medical emergency is any unforeseen condition that a physician, nurse, or other professional whose employment is principally concerned with human health matters would judge to require urgent and unscheduled medical attention.

When the request is made, the EPA will ask the requester to affirm both that there is a reasonable basis to suspect that a medical, public health, or environmental emergency exists and their understanding that the CBI released may be used only for the emergency purpose for which it is requested and not disclosed to any person not entitled to receive it.

Requesters must also provide a brief description of the information requested. For example, one might request a list of all substances reported to be produced at a particular facility or health and safety data for a particular substance.