FROM: U.S. ENVIRONMENTAL PROTECTION AGENCY
Declassifying Confidentiality Claims to Increase Access to Chemical Information
Background
Under the Toxic Substances Control Act (TSCA), EPA collects a range of data, including health and safety studies on chemicals, some of which may be claimed asConfidential Business Information (CBI) by the submitter.
The Agency uses this information to carry out a range of activities including prioritizing chemicals for review, conducting risk assessments and taking risk management action if needed. This information is equally important to entities outside the Agency including product formulators, manufacturers, state governments, communities and others.
Access to chemical safety information allows a greater understanding of the possible implications of certain chemicals and enables users to make informed chemicals-related decisions. Through these efforts, EPA is attempting to make this information available in as timely a manner as possible.
In the past, public access to many of these studies on human health and the environment had been restricted by confidential business information claims. In 2010, the Agency initiated a program to review and where appropriate challenge confidentiality claims for chemical identity. The criteria for review were that the filing needed to contain health and safety data that had been submitted to the Agency under TSCA and relate to chemicals in commerce. The FY 2011-2015 EPA Strategic Plan included a measure to review, and challenge where appropriate, more than 22,000 existing TSCA cases with CBI claims for chemical identity, potentially containing health and safety studies.
EPA continues to encourage TSCA submitters to declassify unnecessary CBI claims made in submissions under TSCA section 8(e) through the TSCA CBI Voluntary Challenge. Additionally, EPA is reviewing certain older submissions made under TSCA sections 4 and 8(d) to verify that these cases contain CBI claims for chemical identity and health and safety studies. Finally, EPA is reviewing the non-CBI data recently collected under the Chemical Data Reporting Rule to determine if there are related cases with health and safety data and the chemical identity claimed as CBI that can be declassified.
The effort supports both legitimate CBI claims and protecting the public’s right to know about potential risks posed by widely-used chemicals. In addition to reviewing existing cases, all new cases containing health and safety data submitted under TSCA that claim the chemical identify as CBI and are chemicals in commerce are being reviewed upon receipt to determine if the claim is appropriate.
