FSMA Update: FDA Releases Guidance Documents on CGMP Requirements of Animal Food Rule and Exemptions from FSMA Requirements of Human and Animal Food Rules

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):

• #235 – Current Good Manufacturing Practice Requirements for Food for Animals; Final Guidance for Industry;
• Application of the “Solely Engaged” Exemptions in Parts 117 and 507: Guidance for Industry; Draft Guidance.

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             In August 2016, FDA published a draft guidance document to assist industry in complying with the Current Good Manufacturing Practice (CGMP) requirements contained in the FSMA rule, Current Good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:

• A Self-Assessment Tool to assist facilities in reviewing their implementation of CGMPs (Appendix B, page 38);
• FDA removed a portion of the draft guidance regarding human food by-products for use as food for animals. This information is now contained in a draft guidance document entitled, #239 – Human Food By-Products for Use as Animal Food.

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FDA also released new draft guidance to assist human food and animal food manufacturers in interpreting the “solely engaged” exceptions contained in the human food (part 117) and animal food (part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:

• Establishments solely engaged in the holding and/or transportation of one or more raw agricultural commodities (RACs) (21 CFR 117.5(k)(1)(iii)); and
• Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts (without additional manufacturing/processing, such as roasting nuts) (21 CFR 117.5(k)(1)(v)).

Exemption from human food preventive controls requirements

Part 117, subparts C and G do not apply to:

• Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (21 CFR 117.5(j)); and
• Facilities solely engaged in the storage of unexposed packaged food (21 CFR 117.7(a)).

Exemption from animal food CGMP requirements

Part 507, subpart B does not apply to the following:

• Establishments solely engaged in the holding and/or transportation of one or more RACs (21 CFR 507.5(h)(1));
• Establishments solely engaged in hulling, shelling, drying, packing, and/or holding nuts and hulls (without manufacturing/processing, such as grinding shells or roasting nuts) (21 CFR 507.5(h)(2)); and
• Establishments solely engaged in ginning of cotton (without manufacturing/processing, such as extracting oil from cottonseed) (21 CFR 507.5(h)(3)).

Exemption from animal food preventive controls requirements

Part 507, subparts C and E do not apply to:

• Facilities that are solely engaged in the storage of RACs (other than fruits and vegetables) intended for further distribution or processing (21 CFR 507.5(g)); and
• Facilities solely engaged in the storage of unexposed packaged animal food that does not require time/temperature control to significantly minimize or prevent the growth of, or toxin production by, pathogens (21 CFR 507.10(a)).

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:

1. An establishment that holds and transports RACs for human and animal food use, hulls and shells nuts, and does not engage in any additional activities covered by the CGMP requirements is exempt from the CGMP requirements in parts 117 and 507.

The CGMP exemption applies because the activities described above are all exempt from CGMP requirements.

2. An establishment that holds and transports RACs, hulls and shells nuts, and grinds the shells, all for animal food use, is not “solely engaged” in activities exempt from the CGMP requirements. Therefore, the establishment must comply with the CGMP requirements in part 507.

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

1. A facility that stores unexposed packaged human and animal food that does not require time/temperature control, stores grain RACs intended for further processing and distribution, and does not engage in any additional activities covered by the preventive controls requirements is exempt from the preventive controls requirements in parts 117 and 507.

Facilities can be engaged in multiple forms of exempt activities and maintain their exemption from preventive control requirements.

2. A facility that stores unexposed packaged human food that does not require time/temperature control but also cuts vegetables (i.e., manufactures/processes food) is not “solely engaged” in activities exempt from the preventive controls requirements. Therefore, the facility must comply with the preventive controls requirements in part 117.

If the facility engages in any activity that is not exempt, such as processing vegetables, then the facility is not eligible for an exemption.

3. A facility that stores unexposed packaged human food, including unexposed packaged food that requires time/temperature control, but also stores fruits and vegetables for human consumption that are exposed to the environment (e.g., stored in vented containers) is not “solely engaged” in activities exempt from the preventive controls requirements. Therefore, the facility must comply with the preventive controls requirements in part 117.

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:

1. A facility consisting of a grain elevator that holds grain RACs for human and animal food use and does not engage in any other activities covered by the CGMP or preventive controls requirements is exempt from the CGMP and preventive controls requirements in parts 117 and 507.

Here, this facility engages solely in activities that are exempt from both requirements.

2. A facility consisting of both a grain elevator that holds grain RACs for animal food use and a feed mill that manufactures animal food is not “solely engaged” in activities exempt from either the CGMP or preventive controls requirements. Therefore, the facility is subject to the CGMP and preventive controls requirements in part 507.

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.