EPA to Reject Confidentiality Claims for Chemical Identity Starting Aug. 25th

[tweetmeme]Starting August 25th, Environmental Protection Agency (EPA) will likely reject all confidentiality claims for chemical identity in health and safety studies. 

As it stands now, submitters may claim confidentiality for proprietary information within a Toxic Substances Control Act (TSCA) submission — but should submit a detailed written explanation to substantiate all confidential business information (CBI) claims.  Also, submitters must submit a sanitized or “cleaned-up” copy of the submission for placement in the TSCA Public Docket.

Back on January 21, 2010, EPA announced this new policy in order to increase the public’s access to information on chemicals. EPA stated its intention to reject a certain type of confidentiality claim, known as Confidential Business Information (CBI), on the identity of chemicals.

For the first time in a long time, EPA will systematically review all confidentiality claims pertaining to chemical identity in any industry submissions of health and safety studies and associated data.  Such claims are routinely asserted in submissions of health and safety data under TSCA section 4 (for test rules), section 5 (for new chemicals and new uses of existing chemicals), section 8(d) (for call-ins of health and safety studies), and section 8(e) (for mandatory reporting of substantial risk information). 

Arguably the most contentious assertions come in with section 8(e) submissions.  EPA statistics indicate that, over the last 3 years, more than 40% of such 8(e) notices claim the chemical identity to be confidential. 

EPA states that it intends to respond to certain confidentiality claims regarding chemical identities in health and safety studies and in data from health and safety studies with a determination letter; “that such information is clearly not entitled to confidential treatment.” At this time, EPA says it expects to issue determination letters when the chemical identity claimed as confidential:

  1. Was submitted as part of a health and safety study, or of data from a health and safety study, submitted under TSCA that is subject to TSCA Section 14(b)(1).
  2. Does not explicitly contain process information.
  3. Does not reveal data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.

According to the EPA they are taking these steps to improve the transparency of chemical information.  Earlier EPA determined that some information previously held confidential would no longer be, and they also put the public portion of the TSCA Inventory on the internet for free availability for all (previously you had to purchase access through private vendors).


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