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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency's (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA).
The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency’s (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA). TSCA provides EPA authority to require reporting, recordkeeping, testing, and restrictions for chemical substances and/or mixtures, but generally excludes food, drugs, cosmetics, and pesticides. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and pharmaceutical intermediates.
In a Federal Registernotice in May 2010, EPA said beginning on Aug. 25, 2010, the agency was going to begin a general practice of reviewing confidentiality claims for chemical identities in health and safety studies and in data from health and safety studies submitted under TSCA. EPA said confidential treatment under TSCA provisions does not apply to a chemical identity that does not explicitly contain process information or reveal portions of a mixture.
In a letter to the EPA Office of Pollution Prevention and Toxics on Aug. 19, 2010, signed by William Allmond IV, vice-president of governmental relations, and Dan Newton, manager of government relations, at SOCMA, SOCMA outlined its views on EPA’s position on chemical identifiers. Although the association said it supports EPA’s efforts to increase transparency and access to information on chemicals and acknowledged that overclaiming of CBI is a problem, it raised concerns over EPA’s actions.
“It is shortsighted for EPA to assert that ‘disclosure of a chemical identity does not disclose process information except where the identity explicitly contains process information,’” said SOCMA. The association pointed out that disclosing the identity of certain chemicals may reveal information about the manufacturing process of those chemicals and that in those instances, CBI consideration should apply. To illustrate its point, SOCMA said that EPA was correct in asserting that providing the structure of formaldehyde, a well-known chemical, would not reveal the process used to make that chemical substance. In the case of a proprietary palladium catalyst, however, “where the chemical structure uniquely defines the activity of the compound, knowing the chemical identity would indeed reveal the essence of the invention and thus reveal CBI and allow it to be copied,” said SOCMA.
To address these concerns as well as EPA’s concerns with overclaiming CBI, SOCMA said it would like to work with EPA to develop criteria for acceptable CBI claims regarding chemical identity that would distinguish between “formaldehyde-type identities and more complex or narrowly used identities.” SOCMA also proposed that EPA consider an expiration date for CBI claims on chemical identity, at which time a submitter would have the burden of establishing why any longer period of protection was still necessary. SOCMA suggested that this expiration date be applied retroactively to chemicals currently on the TSCA inventory and that chemicals that were added earlier to that period would become immediately subject to disclosure unless the claimant could make the required showing of continued necessity. To facilitate better understanding of health and safety data, SOCMA suggested that EPA provide links to its website resources on risk to health and safety and better emphasize that companies need to report adverse effects to human health and the environment under existing TSCA provisions.
“The ability of the US industry to claim specific chemical identity as CBI is extremely important,” said Allmond and Newton in the SOCMA letter. “Many companies, including a great number of overseas competitors, regularly mine databases seeking a competitive advantage. We have witnessed China develop many copycat products and chemicals using stolen proprietary information. We see no need to facilitate this process for our competition and believe that doing so will not help the agency increase the public’s understanding of risk…We believe that EPA’s policy goals can be accomplished in a balanced way that will not devastate a strategic American industry that is already fighting recession and foreign competition.”