Off the Books II: More Secret Chemicals

Seven years later, federal toxics law is still protecting the chemical industry’s dirty secrets

May 9, 2016

Off the Books II: More Secret Chemicals : Introduction

Off the Books: EWG’s 2009 report

In 2009, EWG highlighted the remarkable extent to which the chemical industry can hide information about its products. Often omitted are the names of the chemicals and production data such as the identity of the manufacturer and the quantities produced, along with the names of chemicals in health and safety studies submitted to the EPA. EWG found that nearly two-thirds of all 17,000 chemicals added to the TSCA inventory since 1979 had been claimed confidential, including substances linked to cancer and hormone disruption. The EWG report also found that hundreds of chemicals produced in significant volume were claimed confidential, including 10 intended for use in children's products.[i]

EPA actions on Confidential Business Information since EWG’s report

Three weeks after EWG’s Off the Books report was published, EPA announced it would make major policy changes to ensure that CBI be claimed only in appropriate circumstances. The agency said that it “planned to reject CBI claims for chemicals submitted to EPA with studies that show a substantial risk to people's health and the environment and that have been previously disclosed on the TSCA Chemical Inventory.”[ii]

In 2010, EPA announced a number of changes to its handling of CBI claims, including:

  • A voluntary challenge to the major industry trade associations asking them to declassify outdated CBI filings and to greatly limit future CBI claims.[iii]
  • A proposed rule that would begin to review CBI claims on “chemical identity” in health and safety studies submitted to EPA. In its notice, the agency cited TSCA’s Section 14(b) – which prevents companies from claiming confidentiality in cases when a chemical formula is not directly disclosed publicly.
  • A policy announcement that chemical identity would be considered an integral part of health and safety studies and could not be hidden under CBI claims. Specifically, EPA announced that:

Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture. Where a chemical identity does not explicitly contain process information or reveal portions of a mixture, EPA expects to find that the information would clearly not be entitled to confidential treatment.[iv]

This last provision met with significant opposition from the chemical industry. The American Chemistry Council submitted a white paper to the Administration arguing that EPA’s interpretation of the TSCA statute was incorrect: “Congress intended for EPA to protect chemical identities in submitted health and safety studies while also providing the public with the health and environmental information it needs to evaluate those studies. In other words, EPA must balance the competing interests, as it has done for nearly 30 years.”[v] The official stance of the Board of Governors of the Society of Chemical Manufacturers was: “chemical identity is not an essential element of health and safety studies and must continue to be protected against public access.[vi] To date EPA’s general announcement has not resulted in a general policy of publishing the name of chemicals claimed confidential in health and safety studies.

Testifying in 2013 before the House Subcommittee on Environment and the Economy of Committee on Energy and Commerce, the Government Accountability Office (GAO) reasserted its recommendation that EPA routinely challenge CBI claims in order to “expand public access to this (chemical) information – such as sharing it with state environmental agencies and foreign governments, which potentially limits the effectiveness of these organizations’ environmental risk programs.”[vii]

In a 2014 update to its CBI declassification initiative, the EPA reported that since 2009 it had:

1) declassified 643 previously confidential chemical identities and moved them to the public TSCA Inventory;

2) increased the number of publicly available health and safety studies on chemicals listed in the TSCA Inventory;

3) completed reviews of more than 24,000 declassification cases; and  

4) reduced the number of TSCA CBI cases that needed to be reviewed for relevancy from 22,483 to 565.[viii]

EPA uses its ability to review certain CBI chemicals and if applicable, disallow these claims if they don’t meet EPA’s “substantive criteria in the (TSCA) statute.”[ix]   

In light of these EPA actions and the imminent prospect of legislative changes, EWG has taken a fresh look at the issue of confidentiality and TSCA.


Has anything changed?

The Good

  • Confidentiality claims masking chemical identity in 7,690 industry production volume reports dropped from 1,105 in 2006 to 230 in 2012.
  • In 2006, companies used CBI claims to shield the identities of at least 58 of 215 chemicals intended for use in children’s products. As of 2012, only one of 355 children’s use chemicals submitted to EPA claimed CBI.
  • The chemical inventory is now freely available on the EPA website.
  • EPA published guidance documents for substantiating CBI claims submitted in companies’ production information reports.

The Bad

  • The public has no access to the name (technically, the specific chemical identity) of approximately 17,500 of the more than 85,000 chemicals on the master TSCA inventory compiled by EPA.
  • Industry has placed CBI claims on the identity of 13,975 new chemicals introduced since 1979 – nearly two-thirds of the 22,450 chemicals added to the TSCA list in the past 40 years.
  • In the last six months (since October 2015), chemical identities were claimed secret in over 50 percent of industry’s more than 250 Section 8(e) submissions. Under TSCA’s section 8(e), companies are required to hand over all documentation showing that a chemical presents “a substantial risk of injury to health or the environment.” By definition, Section 8(e) filings raise the greatest health concerns.
  • In 2014, EPA published an update to its 2012 Chemical Data Reporting (CDR)– which showcases chemicals submitted to the TSCA Inventory that are produced in amounts greater than 25,000 pounds a year in a single facility. Of the 33,000 submissions to the CDR, more than 14,000 (44 percent) had at least one CBI claim.
    • 3,379 (10 percent) had CBI claims on the company’s name.
    • 3,591 (11 percent) had CBI claims on the production site.
    • 9,915 (30 percent) had CBI claims on the amount of a particular chemical manufactured at a particular site.

[i] Andrews D. et al. Off the Books: Industry Secret Chemicals. Dec 2009. Available at

[ii] EPA. Policy Changes to Ensure CBI is Claimed Only for Appropriate Information. Sep 21, 2015. Available at

[iii] EPA. Voluntary Challenge to Declassify Confidential Business Information. Sep 15, 2015. Available at

[iv] GPO. Federal Register: Claims of Confidentiality of Certain Chemical Identities Contained in Health and Safety Studies and Data from Health and Safety Studies Submitted Under the Toxic Substances Control Act. May 27, 2010. Available at

[v] ACC. White Paper: TSCA Protects Confidential Chemical Identities in Health and Safety Studies from Disclosure. Jan 19, 2012. Available at

[vi] SOCMA. U.S. Chemical Control Regulation Policy Position. Apr 9, 2013. Available at

[vii] GAO. CHEMICAL REGULATION Observations on the Toxic Substances Control Act and EPA Implementation. June 13. 2013. Available at

[viii] EPA. Progress Declassifying Information Classified as Confidential Business Information (CBI). Sept 15, 2015. Available at

[ix] EPA. About Confidential Business Information (CBI) Claims and their Reviews under TSCA. Sept 15, 2015. Available at