FSIS Issues Guidance on Requesting Waiver for Use of New TechnologyFriday, October 22, 2010
(American Meat Institute)
The Food Safety and Inspection Service (FSIS) has issued a Guidance on Requesting a Waiver of Food Safety and Inspection Service (FSIS) Regulatory Requirements informing meat and poultry establishments, egg product plants, companies that manufacture and sell technology to official establishments and other interested persons of the procedure for obtaining a regulatory waiver for a limited period of time to test their new technology.
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. Data that would justify a waiver would include: 1) validated laboratory results; 2) peer-reviewed journal articles; or 3) prototype production results.
When the RIMD completes its review, if it determines that 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 view this guidance document in its entirety, click here: http://www.fsis.usda.gov/OPPDE/op/technology/New_Technology_Waiver.pdfshare on facebook share on twitter