Existing Chemicals

This chart shows the Agency's progress in reviewing case files for health and safety studies and declassifying health and safety chemical identities, where appropriate. The declassifications were either voluntarily made by the submitter or determined by EPA to not meet the criteria for CBI as defined in TSCA section 14.

Also included in the declassified case files are filings submitted under Section 5 of TSCA in which the chemical identity was claimed as confidential at the time the Premanufacture Notice (PMN) was submitted, but the confidentiality claim for chemical identity was withdrawn at the time the associated Notice of Commencement of Manufacture (NOC) was submitted. Based on its review of these cases, EPA is placing a notation in the original PMN files which provides the chemical identity that was declassified. The information provided in this notation was not available to the public prior to this effort.

The sources of the information for these charts include reviews of new incoming TSCA filings claiming a chemical identity as CBI, as well as reviews of a portion of the existing universe of TSCA filings that were previously received by EPA containing confidential chemical identities.

To view the declassified health and safety studies, visit the Chemical Data Access Tool. Please note that a small number of the documents associated with the 565 case files in which confidential chemical identities were declassified are not available in the Chemical Data Access Tool. Pending resolution of technical issues, EPA will endeavor to make as many of these documents available, as soon as possible.

This chart reflects the numbers of CBI claims for chemical identities made in new incoming TSCA case files for health and safety studies that potentially contained confidential chemical identities. Additional information can be displayed by clicking on active portions of the bar chart, which show more detail relating to the Agency's review of these incoming case files. The chart on the left shows the CBI status of these case files as received. The chart on the right, which is displayed after clicking on the left hand chart, shows the status of these case files after review. Please note that the case files in this chart are a subset of the case files shown in the charts above which show the outcomes of reviews. Included in the numbers in the NOC'd section 5 column are 31 submissions containing health and safety studies where chemical name has been claimed as confidential. EPA's review of these filings are pending legal and policy reviews and actions. These charts will be updated as additional information becomes available.

In addition to reducing the number of CBI claims for chemical identities in health and safety studies, these transparency activities are also facilitating the Agency's digitization and organization of tens of thousands of documents received under TSCA since the late 1970s. Consistent with TSCA section 10(b), the Agency has built various data systems to manage the large volume of information collected under TSCA. Accordingly, multiple data systems and tracking mechanisms have been built, updated and replaced in the 35 years since TSCA was enacted. Not surprisingly, as policies and technology have evolved, maintaining the reliability of the information in these systems has become extremely challenging.

A number of case files that were characterized in various data systems as having chemical identity claimed as CBI were found to not have these CBI claims when the actual files were reviewed. In these cases, the inaccuracies are being noted and data systems updated. Additionally, cases in which paper or microfiche documents are retrieved and reviewed are being digitally scanned and are being made available on the web. While not directly resulting from declassifying data that was formerly maintained as CBI, these transparency activities are making information collected under TSCA more accessible to the public.

For more information on the Agency's transparency initiatives visit:

• Increasing Transparency in TSCA
• Chemical Data Access Tool

1. CBI:  Reference to Confidential Business Information.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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).
8. 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.
9. 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.
10. 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.
11. 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.
12. Public:  Refers in the context of these charts to chemical substances on the TSCA Inventory whose specific identity has been made public.
13. 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.
14. 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.
15. 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.
16. 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).
17. 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.
18. 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.
19. 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.