When the in-plant trial requires a waiver of any provision of FSIS’ regulations, an establishment official or a representative of the company that intends to conduct the trial needs to submit to the Risk & Innovations Management Division (RIMD) a written request for a waiver with data that demonstrate that the in-plant trial is scientifically sound; that the new procedure, equipment or processing technique will facilitate definite improvements; or that there is a public health emergency; and that issuing the waiver will not conflict with the provisions of the relevant Act, relays the American Meat Institute.
Data that would justify a waiver would include validated laboratory results; peer-reviewed journal articles; prototype production results.
When the RIMD completes its review, if it determines the submitted data support the waiver, and that issuing the waiver will not conflict with the provisions of the Acts, the Administrator may issue a letter waiving provisions of the regulations for a limited period of time for the in-plant trial. The in-plant trial may not begin until the submitter has received the letter. If the waiver is granted, FSIS will review the data that is developed in the trial to determine whether they indicate that the purpose of the waiver is being met.
To read this guidance document, visit: http://www.fsis.usda.gov/OPPDE/op/technology/New_Technology_Waiver.pdf