Issue Date: April 19, 2010
A recent laboratory experiment found that fetal rats developed malformations when their pregnant mothers were fed a particular commercial chemical. The results of the study were submitted to the Environmental Protection Agency, just as thousands of other reports on other toxicity tests have been over the past three decades. EPA makes this information available to the public.
But the publicly available version of this recent developmental toxicity study in rats, like many other submissions before it, omits key pieces of information, notably the name of the chemical that was used in the test. In the public version of that report, dated October 2009, the substance is described generically as a substituted nitrogen-containing heterocycle, a moniker that fits thousands of chemicals.
Such omissions in public reports are fairly common. And they have led environmental activists and others to complain for years that the lack of this essential data renders a substantial chunk of the publicly available health and safety data on commercial compounds nearly worthless. EPA is now ready to limit the amount of information that can be withheld from the public’s view.
Companies regularly send these reports to EPA—the agency receives dozens each month—as required by the federal law that governs the manufacture of chemicals, the Toxic Substances Control Act (TSCA). That law doesn’t directly require chemical producers to test their products. But whenever these businesses obtain information indicating that a substance they produce may pose a substantial risk to health or the environment, TSCA mandates that they send the data to EPA. Submission of such a report alone may not trigger regulatory action, but it may lead to further scrutiny of the compound.
The public version of the October 2009 report is stamped “company sanitized.” This redacted version omits not only the identity of the chemical, but also the name of the business.
The company that submitted the report claims its identity and that of its chemical are confidential business information (CBI), which could hurt its competitiveness if released. EPA has this information but keeps it locked up in a secure file. Under threat of criminal prosecution, agency employees must not disclose this information to anyone outside of the U.S. government, including regulators from states and other countries.
Some companies choose to include their product’s identity in the public version of these submissions, but plenty opt for secrecy. A significant number claim their business’s name is confidential, too.
This situation is about to change.
At the chemical industry’s annual conference on regulation in late March, EPA’s top chemical regulator announced that the agency will challenge firms’ confidentiality claims in many health and safety studies. The agency wants to ensure that company and chemical names appear in the public version of as many of these reports as possible.
“It’s important for the American people to know the identity of these chemicals and to have access to this information,” said Steve Owens, EPA assistant administrator for the Office of Prevention, Pesticides & Toxic Substances.
The agency wants Americans to have access to information about commercial substances to help inform their decisions about the products they buy and use, Owens said at the Global Chemical Regulations Conference (GlobalChem). Held in Baltimore, GlobalChem was hosted by two trade associations, the American Chemistry Council (ACC) and the Society of Chemical Manufacturers & Affiliates (SOCMA).
For decades, EPA has rarely challenged businesses’ confidentiality assertions under TSCA. Now, these claims are getting greater scrutiny as part of EPA Administrator Lisa P. Jackson’s policy reforms to make information on commercial chemicals more readily available to the public, Owens said.
There are “very legitimate reasons” for many of the confidentiality assertions by chemical makers, Owens said. “It’s also very clear that confidentiality claims have been made far too long by far too many companies for far too many reasons,” he added.
Owens asked GlobalChem participants to scan their companies’ future submissions to “ensure that critical health and safety information that you’re providing to EPA is not claimed as CBI.”
Separately, an agency attorney explained to the conference that confidentiality protections under TSCA are limited to information “the release of which will substantially injure the competitive position of your company.” For health and safety reports, trade secret claims “are profoundly limited,” said Scott M. Sherlock, attorney adviser in EPA’s Office of Pollution, Prevention & Toxics.
Some information in a health and safety report can merit a confidentiality claim, Sherlock said. For instance, data about the percentage of a compound in a mixture or information that would reveal a proprietary chemical processing method would qualify for protections, he said.
But the identity of a chemical and a company’s name and address do not usually qualify for trade secret protections in a health and safety report, he said.
The agency doesn’t just want fewer future CBI claims, however, as Owens made clear. He also challenged chemical companies to help weed out unneeded secrecy claims in the thousands of health and safety studies submitted to EPA since TSCA was enacted more than three decades ago.
It is questionable that confidentiality assertions in these older reports are still valid today, Owens stated. Generally, the need for trade secret protections is expected to decline the longer a chemical is on the market.
“I’m asking you to review your old filings with EPA and send us notice of any and all CBI claims that are no longer necessary because they’re either outdated or inappropriate,” Owens said.
Doing so is in businesses’ own interest, he argued. “The chemical industry should be doing all that it can to restore public confidence in its products by reducing confidentiality claims,” Owens said.
This cooperation will help EPA understand which types of trade secrecy assertions maintain their value over the years and which “go stale over time,” Owens said.
Even though the agency is asking industry to help reduce CBI claims, EPA isn’t relying solely on their voluntary efforts, Owens warned. The agency will begin searching through health and safety reports it has on file and scrutinizing them for superfluous confidentiality assertions.
SOCMA and ACC indicate they are willing to back changes regarding confidentiality claims.
“We support removal of outdated or unnecessary claims and would recommend our members update their health and safety data,” SOCMA President Lawrence D. Sloan said in a statement to C&EN. “EPA has the authority to penalize companies that overclaim, and it should make examples of companies that do.”
However, some confidentiality protections need to be maintained, Sloan added. Releasing product formulation, molecular chemistry, and other product-specific information would compromise a company’s intellectual property, he said.
Likewise, ACC said in a statement to C&EN that it “can support enhancements to TSCA to address some of the concerns that have been raised about confidential business information. But a balanced approach to protect the trade secrets that foster innovation and create jobs is also needed.”
ACC also noted that “health and safety information on chemicals should never be considered confidential and cannot be claimed confidential under current laws.”
Richard Denison, senior scientist at the Environmental Defense Fund, an environmental group, tells C&EN that the proposed CBI reforms are “a very welcome development.” Denison hopes the agency will track the removal of confidentiality claims in health and safety studies and report the results of its effort publicly.
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