TSG News Banner World Map

EPA Announces Substantiation Requirement for CBI Claims Under TSCA (February 2017)

The Frank R. Lautenberg Chemical Safety for the 21st Century Act was passed in June 2016 to amend the Toxic Substances Control Act (TSCA). The Environmental Protection Agency (EPA) announced its interpretation for the revised section 14 of TSCA regarding confidential business information (CBI) claims for chemical information submitted to EPA.

CBI Claims

Companies can request to withhold information from the public by submitting CBI claims to EPA. EPA will generally allow these claims, as long as they yield to the requirements outlined in TSCA. However, the Agency may also deny claims that do not comply with these provisions.

Health and Safety Information and CBI Claims

EPA collects a range of data under TSCA to administer regulatory action and for use by other agencies to forward public health and environmental protection efforts. TSCA requires public access be made available regarding health and safety information for chemicals, but considers information disclosing manufacturing and processing data to be exempt from being publicized. EPA is responsible for identifying the cases where data can be protected when appropriately claimed as CBI and the cases where data not claimed as CBI should be made publicly available.

Inappropriate CBI Claims

CBI claims are inappropriate when the material claimed as CBI is publicly known, or if it is related to non-exempt health and safety data. For example, EPA rejects claims for chemicals submitted when studies show considerable risk to human health and the environment, as they undermine EPA’s efforts toward transparency and erode public confidence in the Agency.

Substantiation Requirements

In an effort to minimize the number of inappropriate claims made in the future, EPA is requiring that companies provide substantiation for all information submitted. To implement this action, EPA is providing substantiation questions in the existing confidentiality rules that companies should look to for guidance as to how EPA makes its confidentiality determinations.

This action will take effect on March 21, 2017. To ensure sufficient adjustment time, EPA is installing different policies for those submitting information before and after the action goes into effect. There is a retroactive substantiation requirement for submissions made between June 22, 2016 and March 21, 2017. These retroactive substantiations must be made by September 18, 2017.

share button Share to LinkedIn Share to Twitter Share to Facebook Share to Google+ Share to Email

Follow Us on LinkedIn
 TSG Logo
 Homepage Link     Print this Page










Subscribe to email advisories View all TSG advisories