The U.S. Food and Drug Administration (FDA) is finally getting around to finalizing proposed rules implementing the Food Safety Modernization Act (FSMA), which was signed into law in 2011. Rules regarding preventive controls for human and animal food were recently finalized, and rules affecting produce safety and food imports are just around the corner. Compliance with the rules must be achieved as early as one year from now, depending on the particular rule and the size of your business.
A common refrain these days is that most companies, especially larger companies, are already doing what is required under the new and upcoming FSMA rules. I’ve been guilty of saying that myself. But any business—no matter how large or small—should be asking itself whether that is true. The new rules are lengthy and nuanced, and unlike with horseshoes and hand grenades, close enough does not count.
For example, are the records you are creating and maintaining sufficient? Are your policies and procedures robust enough to pass muster under the regulations? Are you properly ensuring compliance with, and re-analysis of, those policies and procedures? Do you have the right training programs? Have you truly scrutinized and mitigated the risks in your process? If you answered yes to these questions (and dozens of others that are raised by the new rules), how about one more: Are you prepared to demonstrate compliance to the FDA when an inspector knocks on your door?
Even if you are not one of the types of facilities covered by FSMA (one that manufactures, processes, packs, or holds food), you may not be entirely in the clear. You still need to understand FSMA’s impact on your operations given the requirements imposed on covered facilities to understand their supply and customer chains. This includes technology and service providers as well as raw material suppliers. The impacts on you may be indirect, but they can be met and addressed with some careful preparation.
To make a long story short: Ask the tough questions and engage the right advisors now, while you’ve got the luxury of time to address issues outside of the context of an inspection, agency enforcement, or emergency.
Brandon W. Neuschafer
Partner, Bryan Cave LLP