Who is Covered Under the Preventive Controls for Human Food Rule?

In this video, you will learn who is covered under the Preventive Controls for Human Food Rule. Learn if your operation is affected and what you need to do to comply.
Who is Covered Under the Preventive Controls for Human Food Rule? - Videos Available in Spanish

View Transcript

- [Narrator] In general, this rule applies to domestic or foreign food facilities that manufacture, process, pack, or hold human food for consumption in the United States.

The requirements apply to your company if your facility is required to register with FDA under Section 415 of the Federal Food, Drug and Cosmetic Act.

Entities defined in FSMA as farms, retail food establishments, and restaurants are some of the entities that are not subject to the preventive controls requirements, because they are not required to register.

In addition, there are several exemptions or modified requirements that may apply.

Facilities must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act, as well as the Modernized Current Good Manufacturing Practices, GMPs, of this rule, unless an exemption applies.

It is important to note that applicability of the GMPs is not dependent upon whether a facility is required to register.

In general, the requirements for current Good Manufacturing Practices, GMPs, apply to you if you manufacture, process, pack, or hold human food.

As with the preventive controls requirements, there are exemptions and modified requirements, but they are not identical.

Compliance dates are staggered based on the size of the business, with separate dates for the requirements of the supply chain program.

To learn key facts about the preventive controls for human food rule, visit.

Thank you for watching this video.

Please follow us at www.extension.psu.edu/fsma.

This program was developed by Food Safety CTS, LLC, for the USDA's Food Safety and Agricultural Sustainability Training Program and Penn State University.

Reviews

Only registered users can write reviews. Please, log in or register

Frequently Asked Questions

faq

What are the technical requirements for watching videos?
What devices and browsers are supported for watching videos?
Can a video be viewed multiple times?
Can I share a video with multiple people?
Is there closed captioning available for videos?
Are videos accessible for people who require special needs or services?
Who do I contact if I have a question about a specific video?