How will EPA’s more stringent policy for the review and submission of confidential business information impact your company?
Nearly 2 years have passed since EPA Administrator Lisa Jackson announced that the agency would be increasing transparency and giving the general public more access to information about chemicals. This announcement was a part of a set of core principals that the agency set forth in the fall of 2009, in response to a great deal of criticism for its overall lack of protection of human health and the environment under its current regulatory authority, the Toxic Substance Control Act (TSCA). In an effort to fulfill this commitment, EPA announced a more stringent policy for the review and submission of confidential business information (CBI) under TSCA.
In January 2010, EPA announced that it would review submissions claiming CBI under section 8(e) of TSCA for chemical identities that previously had been listed on the public portion of the TSCA inventory. Any substance that was listed would not be considered confidential.
A second notification was filed on May 27, 2010, which stated that EPA planned to generally deny all claims of confidentiality for health and safety studies submitted under TSCA. In addition, EPA started contacting individual companies, and requesting that they voluntarily declassify their CBI claims as well as limit all claims in the future. Specifically, the letter asked companies to:
- Review older files containing CBI claims that had been submitted to the agency under TSCA and identify any materials that should not be considered confidential;
- Notify the agency about declassifications. Instructions on the declassification process can be found at http://www.epa.gov/oppt/tsca8e/pubs/declassification-cbi.html; and
- Strictly limit CBI claims in any future TSCA filings with the agency.
In February 2011, five companies received letters from EPA informing them that their CBI claims were not valid and that their information would be made public on the 31st calendar day after the date of receipt, barring any federal injunction or court action. The following month, EPA made its first announcement that 42 health and safety studies were no longer confidential and had been made public. Most recently, in June, another 102 health and safety studies were declassified. And this is just the beginning, as EPA has stated that it is “committed to posting new declassified materials under TSCA on the agency website on a regular basis.”
The declassification effort over the past few months has been a combination of voluntary declassifications made by companies in response to the challenge and designations of non-confidential status by EPA. For now, the focus primarily has been on health and safety studies submitted for 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. But the agency also plan to review claims for materials relating to inventory status and the Chemical Data Reporting (CDR) rule (formerly known as the Inventory Update Rule (IUR)). Under the new rule, information submitted under the CDR to EPA still may be claimed as confidential. However, each CBI claim must be substantiated for all data elements on the report.
Understanding the Impact
So, how does this new policy affect your company and how do companies protect confidential information relating to chemical identities?
It now is obvious that the agency will reject any confidentiality claim made unless the chemical identity explicitly reveals how the chemical is produced or processed. Companies have tried to argue that disclosing the chemical identity of substances on a health and safety study will allow competitors to ascertain a process for manufacturing the chemical substance. EPA has responded that it does not consider the disclosure of a chemical identity to be equivalent to the disclosure of process information.
Thus, claiming chemical identity as confidential is becoming increasingly difficult, especially in this global market. In the EU, the rules are very stringent and require that all hazardous substances be declared on the Safety Data Sheet (SDS), making it nearly impossible to keep chemical names confidential. In the United States, EPA requires that a detailed, written response to 14 standard questions be submitted along with your claim. One question asks: Does the information claimed as confidential appear or is it referred to in any of the following: Material safety data sheets (MSDS) or other similar materials (such as technical data sheets) for the substance or resulting end product?
The answer to this question can be tricky, as it may not be disclosed on any U.S. MSDS but may very well have been on a European SDS.
Industry is entering a new era. Corporate EHS, product stewardship and legal staff need to decide whether they proactively will declassify substances or try to substantiate confidentiality claims. Rights to confidential business information may be questioned, as EPA attempts to expand the guidelines of its current statutory authority.
In addition to EPA’s actions, Congress has been getting involved in the issue. On June 21, the Senate Environment and Public Works Committee hosted the first of several stakeholder meetings regarding TSCA reform. Although it is unlikely that there will be any action taken on the Safe Chemicals Act of 2011, this could be a sign of bi-partisanship in regards to TSCA reform. Any reform could change how EPA handles CBI in regards to chemical management.