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One of the first steps for assessing a facility’s compliance status under the rules implementing the Food Safety Modernization Act is to consider whether the facility is required to comply or if it may qualify for an exemption, however narrow it may be.

As a simple rule of thumb, if a food establishment is required to register with the agency, it is required to comply with FMSA rules. But some registered facilities may qualify for exemptions from some requirements. The FDA released draft guidance last month on exemptions for “solely engaged” facilities from the current good manufacturing practice (CGMP) and preventive controls requirements in 21 CFR Part 117 or Part 507.

For example, an establishment that exclusively holds raw agricultural commodities (RACs) — other than fruits and vegetables — for human and animal food use, hulls or shells nuts, and does not engage in any other activities covered by the CGMP requirements in Parts 117 and 507 is exempt from the CGMP requirements.

Similarly, if all activities performed by a facility are exempt under one or more preventive controls exemptions, the facility is not subject to the Part 117 and/or Part 507 preventive controls requirements. But if any part of a facility is engaged in an activity subject to the CGMP or preventive controls requirements, the entire facility is then subject to CGMPs, the preventive control requirements, or both, the agency said.

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. However, a facility that stores unexposed packaged human food that does not require time/temperature control but also cuts vegetables – that is, manufactures/processes food – is not “solely engaged” in activities exempt from the preventive controls requirements, so it must comply with the preventive controls requirements in Part 117.

The agency also issued final guidance in October on Current Good Manufacturing Practice Requirements for Food for Animals. The guidance emphasizes the “flexible” nature of the CGMP requirements, and says there may be significant differences in how CGMPs are implemented in facilities where undesirable microorganisms are a food safety concern for the type of animal food produced compared to facilities producing an animal food for animals that are not as likely to be affected by undesirable microorganisms.

This means animal food companies must implement appropriate CGMPs for their unique facility, the type of animal food, and the animal(s) for which they are producing.

There are a number of FSMA initiatives coming out of FDA, the requirements of which can be confusing, particularly in the case of those companies which are authorized an exemption. Greater details on exemptions can be found on FDA’s website. Those companies wishing to discuss their particular circumstances may wish to contact a consulting firm such as EAS to learn more about which rules of FSMA apply.

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