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Increasing Transparency in TSCA
CBI Declassification
March 2, 2012 -- EPA is encouraging industry participants to focus their confidential business information (CBI) declassification efforts in FY 2012 on TSCA section 8(e) submissions filed with the Agency between FY1991-94 and after 2001. Read instructions on how to declassify these materials. For further information contact Scott Sherlock, (202) 564-8257.
In September 2009, EPA Administrator Lisa P. Jackson committed to strengthen EPA's current chemical management program. Part of that commitment was to increase access to and transparency in TSCA-related chemical information held by EPA and companies.
Read about the series of actions EPA has been taking to fulfill that commitment:
- Increasing the Public's Access to Chemical Information
- Chemical Data Access Tool Available to Find Health, Safety Data Submitted to EPA
- New IUR/CDR Rule Improves Reporting of Exposure Information
- Chemicals, Facilities Added to Envirofacts Database
- TSCA Inventory Free on Web for First Time
- Tightening Confidential Business Information (CBI) Policy:
Increasing Access to Chemical Information
November 28, 2011 -- EPA reported progress reviewing and declassifying CBI. The results reflect the Agency's two-year effort to increase the public's access to critical chemical information that had been classified by companies as CBI. The declassified and newly available health and safety studies can be found under a new "declassified tab" using the Chemical Data Access Tool. Read on to learn about the tool and results of the effort to declassify CBI.
Chemical Data Access Tool Available to Find Health, Safety Data Submitted to EPA
On December 22, 2010, EPA made available the new Chemical Data Access Tool to find health and safety data that has been submitted to the Agency, under authorities in sections 4, 5, and 8 of the Toxic Substances Control Act (TSCA). The tool is also available on Data.gov
The new chemical access tool enables you to search the following databases:
eDoc - The eDoc database includes a broad range of health and safety information reported by industry under TSCA Sections 4,5, 8(d), and 8(e).
TSCATS - The TSCA Test Submissions (TSCATS) database is an online index to unpublished, nonconfidential studies covering chemical testing results and adverse effects of chemicals on health and ecological systems.
HPVIS - The High Production Volume Information System (HPVIS) is a database that provides access to health and environmental effects information obtained through the High Production Volume (HPV) Challenge.
Declassified CBI - This database includes health and safety studies and other information submitted to EPA in which chemical identities have been declassified, as part of EPA's effort to increase transparency in TSCA.
In some instances the search tool makes this information accessible for the first time. It provides results based on data that currently is in a searchable format. The amount of searchable data will increase over time as additional information either is reported to the Agency electronically or is scanned from historically submitted documents. If you do not receive results for a particular chemical, it does not mean EPA does not have information on that chemical; the results may not be in the repository yet.
New IUR/CDR Rule Improves Reporting of Exposure Information
In August 2011, EPA issued the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The purpose of this program is to collect quality screening-level, exposure-related information on chemical substances and to make that information available for use by EPA and, to the extent possible, to the public. The new CDR rule enhanced the information to be reported and increased the frequency of reporting from every 5 years to every 4 years. The CDR data constitute the most comprehensive source of basic screening-level, exposure-related information on chemicals available to EPA. The next submission period for reporting for the 2012 CDR is February 1, 2012, to June 30, 2012.
Processing and use information reported in 2012 will help EPA, other agencies, and the general public to readily screen and prioritize chemicals for the purpose of identifying potential human health and environmental effects. This information will also provide the American people with greater access to a wide range of information on those chemicals to which their children and families are exposed every day. The requirement for improved data will enhance the Agency's ability to more effectively identify and address potential chemical risks.
Chemicals, Facilities Added to Envirofacts Database
On May 17, 2010, EPA added more than 6,300 chemicals and 3,800 chemical facilities regulated under TSCA to EPA's public Envirofacts database. The Envirofacts database is EPA's single point of access on the Internet for information about environmental activities that may affect air, water and land, and provides tools for analyzing the data. It includes facility name and address information, aerial image of the facility and surrounding area, and the map location of the facility. It links to other EPA information on the facility, such as EPA's inspection and compliance reports that are available through the Enforcement Compliance History Online (ECHO) database. EPA is also adding historic facility information for another 2,500 facilities.
TSCA Inventory Free on Web for First Time
On March 15, 2010, EPA announced that for the first time it was providing free access to the TSCA Chemical Substance Inventory. This inventory contains a consolidated EPA list of thousands of industrial chemicals, and is part of a series of ongoing steps the Agency is taking to empower the public with important information.
Tightening Confidential Business Information (CBI) Policy
Ensuring CBI Claims Are Necessary, Consistent with the Requirements of TSCA
As part of EPA's ongoing effort to increase the public's access to chemical information, the Agency has been reviewing past claims to treat the identity of chemicals as CBI in health and safety studies submitted to EPA.
The Agency reported on November 28, 2011, that since 2009, 577 formerly confidential chemical identities had been made public and more than 1,000 health and safety studies had been made accessible to the public that were previously unavailable or only available in limited circumstances.
Previously on June 8, 2011, EPA declassified the identities of more than 150 chemicals contained in 104 health and safety studies that were claimed confidential. See these health and safety studies in which EPA determined that chemical identities are no longer confidential.
EPA also challenged the chemical industry to voluntarily declassify unwarranted CBI claims. As of November 2011, more than 35 companies have agreed to review previously submitted TSCA filings containing health and safety studies and determine if any CBI claims may no longer be necessary.
Included in the materials made available to the public were filings on EPA priority chemicals used in the manufacture of industrial and consumer products such as non-stick and stain resistant materials, fire resistant materials, air fresheners and dispersants. The chemicals include nonylphenol compounds, perfluorinated compounds, lead, and substances used in dispersant formulations.
The declassified health and safety studies include some declassified by the Agency and others voluntarily declassified by in response to EPA's challenge.
EPA is committed to posting new declassified materials under TSCA on the Agency web site on a regular basis.
Background
In 2010, EPA challenged industry to voluntarily declassify unwarranted Confidential Business Information (CBI) claims and issued new guidance outlining the Agency's plans to deny confidentiality claims for chemical identity in health and safety studies under the Toxic Substances Control Act (TSCA).
Based on this guidance, EPA notified five companies in February 2011 that the Agency had determined that their CBI claim was not eligible for confidential treatment under TSCA and that EPA intended to make the information public. See the letter sent to the companies. (2 pp. 276 kb, About PDF) On March 24, 2011, EPA made 42 health and safety studies that had been claimed and treated as confidential available to the public.
Where EPA determines that the information is not eligible for confidential treatment, the Agency is taking various actions in order to make that information available to the public. For example, EPA may notify companies that information is not eligible for CBI, and in those instances where the company will not voluntarily relinquish the claims, EPA may initiate administrative action under Section 14 of TSCA. In some instances, the information submitters proactively released the confidential claims in the associated studies. In other instances, the claims were released as a result of EPA action.
Under TSCA, companies may claim that information they submit to EPA should be treated as “confidential business information” (CBI) and not be disclosed to the public. Under Section 8(e) of TSCA, companies that manufacture, process, or distribute chemicals are required to immediately provide notice to EPA if they learn that a chemical presents a substantial risk of injury to health or the environment. Section 8(e) reports are made available on EPA’s website, but when a chemical has been claimed confidential by a company, the chemical name is removed on the public report.
As mentioned, part of this effort has involved the tightening of EPA's CBI policies, first on January 21, 2010, when EPA said 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. In a follow-up policy change issued May 27, 2010, EPA said it planned to generally deny confidentiality claims for and the identity of chemicals in health and safety studies filed under the TSCA, except in specified circumstances.
EPA's Voluntary CBI ChallengeSteve Owens, Assistant Administrator of EPA's Office of Chemical Safety and Pollution Prevention, June 4, 2010, sent letters (PDF) (2 pp. 1.2 mb, About PDF) asking companies to voluntarily declassify some of their confidential business information (CBI) and reduce their CBI claims.
Read Instructions to Declassify CBI.
