Darryl Michel Sullivan - Comment

Covance would like to ensure that FDA makes sound decisions based on testing data from qualified laboratories. Both FDA and private laboratories must be accredited and must follow good laboratory practices in their testing programs. It is critical that testing be conducted in all situations where detention of food is being considered. The testing must be conducted using validated testing methods that have been accredited and approved. We hope that FDA will issue guidance rules on the approval process for all testing laboratories, so that the laboratory test data can be used for critical situations. We expect that FDA will follow some International standard like ISO 17025 in their rule on lab accreditation. It is important that the rule contain details about the lab qualification. We would like to understand how the Fee Provisions will affect the contract testing laboratories and if there will be any fees associated with becoming certified as a third party testing lab under FDA FSMA.