FDA Releases New FSMA Guidance Documents Related to Preventive Controls and cGMPs
Today, the U.S. Food and Drug Administration released two new guidance documents, both aimed at food facility that must adhere to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule.
The guidance documents are as follows:
Current Good Manufacturing Practice (cGMP) Requirements for Food for Animals
This guidance is meant to help animal food manufacturers determine whether or not they must comply with cGMP requirements outlined in the Preventive Controls for Animal Food rule, part of the U.S. Food and Drug Administration’s Food Safety Modernization Act. It will also help those manufacturers figure out if they need to provide an explanation, along with recommendations for meeting said cGMP requirements. Finally, in Appendix B of the guidance document, industry will find a helpful Self Assessment Tool to evaluate their compliance with the cGMP requirements related to animal food.
Application of the “Solely Engaged Exemptions in Parts 117 and 507: Guidance for Industry
This guidance--open to public comments for 180 days--sheds light on circumstances that will allow for exemption from cGMP or preventive control rules for facilities that are “solely engaged” in certain specific activities. These exemptions may apply in relation to the holding, transport or storage of specific raw agricultural commodities, storing unexposed packaged food items, and methods that involve preparing nuts and cotton ginning.
More details can be found directly via FDA.gov.