Declassifying Confidentiality Claims to Increase Access to Chemical Information
- Progress on Review of Health and Safety Studies
- Progress on Review of CBI in the TSCA Inventory
- More Information on the Agency's Transparency Initiatives
- Charts Showing CBI Review Progress
- EPA has increased the number of publicly available health and safety studies. EPA is releasing health and safety submissions in which the chemical identity had formerly been confidential but has recently been declassified. Find the declassified documents for these cases by searching the Chemical Data Access Tool (CDAT).
EPA has completed reviews of over 16,200 cases. These reviews include both existing and new cases. Completed reviews include cases in which the chemical identity has been declassified, cases in which the CBI claims were allowed, and cases where there was no health and safety study. The most significant contributing factors to date for declassifications and reviews were: TSCA CBI Voluntary Challenge; internal review of data generated from older IT systems and the release of CBI claims for chemical identity by submitters at time of a TSCA section 5 Notice of Commencement of Manufacture.
- The universe of existing TSCA cases to be reviewed is now down to 7,246 from 22,483. To address the remaining cases left to be reviewed, EPA is placing a major emphasis on the TSCA CBI Voluntary Challenge, extending the focus on cases under TSCA section 8(e). In addition, greater attention will be placed on comparing other types of TSCA cases, for example, filings under Chemical Data Reporting, for relevance to CBI claims for chemical identity in cases containing health and safety studies.
Progress on Review of Health and Safety Studies
EPA reports progress in reviewing more than 22,000 submissions for health and safety studies that could include CBI claims for the chemical identity on a periodic basis.
Progress on Review of CBI in the TSCA Inventory
From the TSCA Chemical Substances Inventory, EPA's comprehensive list of chemicals authorized to be in commerce, a total of 635 chemical identities have been moved from the confidential to the public side of this list since 2009.
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 as Confidential 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.
More Information on the Agency's Transparency Initiatives
- Increasing Transparency in TSCA
- Chemical Data Access Tool
- TSCA CBI Voluntary Challenge
- Glossary below
- Health and Safety Studies – Review Outcomes of CBI in Case Files
- Health and Safety Studies – Review Outcomes of CBI in Case Files Divided by New and Existing Cases
- Health and Safety Studies – Progress of CBI Review in Existing Cases
TSCA Inventory - Increase in Chemical Identities Made Available
|The above horizontal bar chart shows the Agency's progress in reviewing case files for health and safety studies and declassifying chemical identities where appropriate. The results are from reviews of both existing submissions from the files as well as new submissions to the Agency.
Under the FY 2011-2015 EPA Strategic Plan measure CBI claims are allowed under the following circumstances:
Table 2: Health and Safety Studies – Review Outcomes of CBI in Case Files Divided by New and Existing Cases
|The two charts above provide a breakout of the new and existing cases partly represented in the horizontal chart earlier on this page. The existing chart goes further to provide information on the universe of existing cases the Agency has been reviewing and those that remain to be reviewed by September 30, 2014. New cases includes submissions under TSCA section 8(e) received since January 21, 2010 and submissions under TSCA sections 4, 5 and 8(d) received since August 25, 2010.|
|Chart 1 TSCA Inventory
Chart 2 Inventory Declassifications 2009 to February 2013
|This TSCA Inventory chart shows the numbers of chemicals on the TSCA Inventory, indicating the portions which are currently public, confidential, and declassified.||A list of some of the declassified chemicals can be displayed by clicking on the "IUR Declassifications" segment of the Declassified Chemical Identities chart on the right.|
 Glossary of Terms Used in TSCA Transparency Progress Charts:
- CBI: Reference to Confidential Business Information.
- CBI Claim Validated: Refers to a decision that as of the time of review, based on the Agency's internal criteria, the CBI claim appeared to be valid. This does not constitute a legal finding that the CBI claim is in fact legally valid.
- Chemicals: Short for chemical substances. Those chemical substances listed on the TSCA Chemical Substance Inventory. Chemical substances in this context are defined by TSCA section 3(2)(B). Source: 40 CFR 710.3.
- Confidential: Refers in general to confidential or non-public status of information directed to EPA under authority of TSCA. Refers more particularly to certain chemicals on the TSCA inventory or specific chemical status in health and safety studies.
- Declassified chemicals: Chemical identities that upon review and action no longer have confidential status. Also, refers to instances since transparency initiatives were begun in 2009, where substances listed on the confidential portion of the TSCA Inventory have been disclosed as being in commerce and, therefore, have been added to the public portion of the Inventory.
- Existing CBI case file: Refers to a single document or a series of documents related to a particular matter received prior to these transparency initiatives. For example, TSCA 5 premanufacture notice (PMN) cases files may include a number of documents, while a TSCA section 8(d) case files could refer to only a single document. Existing CBI cases files refer to those in EPA's possession at the start of the CBI review program in which there was an indication of a CBI claim in a health and safety study submitted under a TSCA requirement.
- Health and safety studies: In the context of these charts and graphs, health and safety studies refer to health and safety studies directed to the Agency under TSCA section 4 (testing of chemical substances and mixtures), TSCA section 5 (manufacturing and processing notices), TSCA section 8(d) (health and safety studies) and TSCA section 8(e) (Notices to Administrator of Substantial Risks).
- In Commerce: Refers to the sale, delivery into commerce, or holding after introduction into commerce of a chemical substance or mixture or article containing a substance or mixture. TSCA Section 3.
- New CBI cases: Cases, generally filings, which were not in EPA possession as of the date of the CBI review program, and in which there was an indication of a CBI claim in a health and safety study submitted under a TSCA requirement. "New CBI cases" may refer to a single document or a series of documents related to a particular matter.
- New chemical substances: In the context of these charts and graphs, new chemical substances refers to chemical substances that have been subject to TSCA section 5 new chemicals review.
- Notice of Commencement of Manufacture (NOC): Refers to a Notice of Commencement (NOC) of Manufacture or Import Form. In order for a new chemical to be added to the TSCA Inventory, a submitter of a Premanufacture Notice (PMN) under Section 5 of TSCA must provide an NOC to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes. The chemical substance is considered to be on the TSCA Inventory and an existing chemical as soon as a complete NOC is received by EPA.
- Public: Refers in the context of these charts to chemical substances on the TSCA Inventory whose specific identity has been made public.
- Reviews: Refers to the status of EPA reviews of TSCA health and safety studies in which a chemical identity has potentially been claimed as CBI.
- Health and safety studies declassified: Refers to an action which leads to a declassification of health and safety data contained in the health and safety studies. In other words the information was made publicly available. Please note that the term "Safety Studies Declassified" is not to imply that every data element in the studies have been declassified. It is to reflect that health and safety data elements in the identified study have been made publicly available.
- Section 4: Refers to a document type submitted under Section 4 of TSCA. Section 4 of TSCA gives EPA the authority to require chemical manufacturers (including importers) and processors to test chemical substances and mixtures.
- Section 5: Refers to a document type submitted under Section 5 of TSCA that requires a person who plans to manufacture a new chemical substance or who plans to manufacture or process any chemical substance for a use that the Administrator has determined is a significant new use to submit to the Administrator a notice, at least 90 days before such manufacture or processing. Source: 40 CFR § 720.3(k).
- Section 8(d): Refers to a document type submitted under Section 8(d) of TSCA, under which EPA has the authority to promulgate rules to require chemical manufacturers (including importers), processors and distributors to submit lists and/or copies of ongoing and completed, unpublished health and safety studies.
- Section 8(e): Refers to a document type submitted under Section 8(e) of TSCA, under which U.S. chemical manufacturers (including importers), processors and distributors must notify EPA within 30 calendar days of new, unpublished information on their chemicals that may lead to a conclusion of substantial risk to human health or to the environment.
- TSCA Chemical Substance Inventory: Reference to the Master Inventory File. EPA's comprehensive list of chemical substances compiled under TSCA section 8(b) of the Toxic Substances Control Act (TSCA). Source: 40 CFR 710.23.