EPA Releases Identities of Chemicals Previously Claimed Confidential in Studies

The Environmental Protection Agency released March 24 the identities of chemicals in 42 health and safety studies previously claimed as confidential by the companies that submitted the data on the compounds.

The chemical identities and other information that were declassified resulted from both EPA's and chemical manufacturers' reviews of confidential business information claims, the agency said.

The American Chemistry Council, which represents major U.S. chemical manufacturers, said in a statement to BNA about EPA's announcement: “ACC and its member companies have been working cooperatively with EPA on the declassification effort. We are committed to continuing to work with EPA as both the industry and the agency review CBI claims for chemical identity.”

'Substantial Risk' Notifications.

Most of the documents were health and safety studies chemical manufacturers submitted in accordance with section 8(e) of the Toxic Substances Control Act. According to that section of the statute, chemical manufacturers must promptly report to EPA any previously unknown, substantial health or environmental risk they determine may be associated with the compound they make.

EPA did not say how many chemical identities were being disclosed for the first time.

One of the 42 documents was a health and safety study submitted in accordance with section 8(d) of TSCA, which authorizes EPA to order chemical manufacturers to submit unpublished health and safety studies.

Toxicity results in animal studies reported in the 42 documents included allergic responses, diminished sperm levels, and death by inhalation.

The companies provided chemical identifications that were claimed as confidential at the time the health and safety studies were originally submitted to EPA. Several documents stem from a data-collection effort EPA made in 1992 called the TSCA Compliance Audit Program.

Chemical Names, CAS Numbers.

Chemicals named in the 42 health and safety studies included propanoic acid, 2-(4-chloro-2-methylphenoxy)- (CAS No. 93-65-2), which was made by DuPont; two oil dispersant ingredients--propylene glycol (CAS No. 57-55-6) and ethanol, 2-butoxy- (CAS No. 111-76-2)--made by the Procter & Gamble Co.; and 3, 3, 3-trifluoroprop-1-ene (CAS No. 677-21-4), a refrigerant made by Mexichem Fluor Inc.

In an e-mailed announcement of the action, EPA pointed out that it challenged chemical manufacturers in January 2010 to declassify unwarranted CBI claims (34 CRR 75, 1/25/10).

EPA also issued new guidance on its review and declassification process for confidentiality claims concerning the identity of a chemical in health and safety studies.

EPA Says More to Come.

On March 22, a senior EPA official said the agency will release later this year two proposed rulemakings regarding further efforts it is making on CBI declassification efforts. (See related story in this issue.)

EPA will regularly post additional chemical information as it is declassified, the agency's e-mail said.

“This action is part of EPA's ongoing effort to increase the public's access to chemical information and to increase transparency related to TSCA,” the agency said.

Advocate Praises EPA Action.

Richard Denison, a senior scientist with the Environmental Defense Fund, praised EPA's action.

“This is good,” Denison told BNA. “This is information that should have been public all along.”

The 42 documents are only a small batch of what he speculated would be hundreds of thousands of documents that may be declassified as a result of EPA's and chemical manufacturers' efforts.

The information EPA released may be useful to industrial hygienists, researchers, and other parties interested in the toxicological effects of chemicals because it augments health and safety data available in the public arena, Denison said.

Denison said the information is important because 41 of the health and safety studies were submitted in accordance with section 8(e) of TSCA. These are the “substantial risk” notifications.

Not 'Neutral' Information.

That means, he said, the companies were not submitting “neutral” information but rather data on substances they determined might pose a substantial risk.

According to the documents EPA released, at least some of the chemical manufacturers do not agree with Denison's conclusion that the health and safety studies provide information about substantial risks.

In its letter to EPA, the Procter & Gamble Co. said it was declassifying the identity of a chemical ingredient of a mixture. The company had previously classified the entire mixture as confidential, but it submitted a TSCA 8(e) notice in accordance with an agreement about substantial risk notifications that many chemical manufacturers made with EPA in 1992.

In 1992, Procter & Gamble did not think a study on kidney function found “any significant human or environmental safety risks. We continue to believe that this conclusion is valid and that no 'substantial risk' exists,” wrote Julie Froelicher, a regulatory and technical relations manager at the chemicals company.

By Pat Rizzuto

Links to the documents EPA released with chemical identities and other information are available at http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html.