Practical Implications of Submitting 8 e Studies

As soon as there is sufficient evidence to conclude that a study shows a substantial risk, product stewardship principles come into play. Depending on the procedures in place at each company and the significance of the observed effect, product stewardship could require warnings on product labels and MSDSs, notification to customers and implementing workplace safety precautions. 

TSCA 8(e) reports are made pubfic, and if the fact that a company is investigating a specific chemical could reveal trade secrets, certain information in the submittal can be marked as confidential. 

A person may claim that some or all of the information submitted to EPA pursuant to TSCA 8(e) is Confidential Business Information (CBI). CBI is 

However, although many companies claim CBI for large portions of 8(e) submittals, TSCA 14(b) provides that health and safety studies on chemicals that have been offered for distribution in commerce are not confidential under TSCA. EPA has said it will not keep confidential the results of these studies, or the chemical identities of the test substances. Although in practice the EPA has abided by claims that submissions contained CBI, on January 21, 2010 it issued a policy stating that as a general practice it will reveal the names of chemicals that are the subject of 8(e) reports if the chemicals are on the publicly available version of the Inventory. When 8(e) reports are submitted with a claim of confidentiaHty for the chemical identity of a substance on the nonconfidential Inventory, the EPA will write to the submitter and state that it has found that the chemical identity is not entitled to CBI treatment. The submitter may appeal that determination. 

Manufacturing processes and the percentages of substances in formulations can be claimed as CBI, and if necessary to protect the confidentiality of such information the EPA will not release the chemical identity under the 

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