On October 19, 2017, FDA announced the publication of two guidance documents to assist industry stakeholders in compliance with regulations promulgated pursuant to the Food Safety Modernization Act (FSMA):
We have prepared this brief summary of the guidance documents.
Animal Food CGMPs
In August 2016, FDA published a draft guidance document to assist industry in complying with the Current Good Manufacturing Practice (CGMP) requirements contained in the FSMA rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (the Animal Food Rule). After reviewing public comments, the agency has released a final version of its guidance document. Some of the notable changes to the guidance document include:
Although this is a final guidance document, FDA will accept public comments on an ongoing basis through the regulations.gov portal for Docket ID: FDA-2016-D-1229-0002.
“Solely Engaged” Exceptions
FDA also released new draft guidance to assist human food and animal food manufacturers in interpreting the “solely engaged” exceptions contained in the human food (part 117) and animal food (part 507) rules. Under these rules, there are four relevant types of exemptions:
Exemptions from human food CGMP requirements
Part 117, subpart B (human food CMGPs) does not apply to the following:
Exemption from human food preventive controls requirements
Part 117, subparts C and G do not apply to:
Exemption from animal food CGMP requirements
Part 507, subpart B does not apply to the following:
Exemption from animal food preventive controls requirements
Part 507, subparts C and E do not apply to:
Exemptions from CGMP Requirements
The Human Food Rule and Animal Food Rule provide exemptions to CGMP requirements for certain facilities that hold or transport RACs or engage in minimal processing for nuts or ginning cottonseed. To illustrate the exemptions, FDA has provided two examples:
The CGMP exemption applies because the activities described above are all exempt from CGMP requirements.
Here, the above facility grinds nut shells for animal food use. Because it engages in an activity that is not exempt, the entire facility is subject to the CGMP requirements.
Exemptions from Preventive Control Requirements
The Human Food Rule and Animal Food Rule exempt facilities if they are solely engaged in either (1) the storage of RACs (other than fruits and vegetables) that are intended for further distribution or processing (e.g., grain elevators); and/or (2) the storage of unexposed packaged human food, or unexposed packaged animal food, which does not require time/temperature controls. To illustrate the exemptions, FDA has provided three examples
Facilities can be engaged in multiple forms of exempt activities and maintain their exemption from preventive control requirements.
If the facility engages in any activity that is not exempt, such as processing vegetables, then the facility is not eligible for an exemption.
Although fruits and vegetables can be RACs, facilities that hold fruits and vegetables are not exempt from preventive control requirements. If a facility holds both packaged food and fruits and vegetables, the facility will not be exempt from preventive control requirements.
Exemptions from both CGMPs and Preventive Controls
A facility may be exempt from both CGMP requirements and preventive controls so long as it is engaged in a combination of activities that meets both exemptions. To illustrate this exemption, FDA has provided two examples:
Here, this facility engages solely in activities that are exempt from both requirements.
In contrast, this facility operates a feed mill, which is not exempt from either CGMPs or preventive controls. The entire facility will be subject to both provisions of the animal food rule.
FDA is soliciting comments on the draft exemptions guidance document. Interested stakeholders may provide comments on the guidance via regulations.gov under Docket ID: FDA-2017-D-6133-0001. FDA will be accepting comments on this draft guidance until April 18, 2018.