FSMA: From Complacency to Compliance

For more than three years, the Food Safety Modernization Act (FSMA) has been at the forefront of the food industry. So much so, in fact, that after the years of FSMA focus with little new except the extremely slow roll out of the seven proposed rules, and an often overwhelming complexity within these rules, it can be all too easy to become complacent; to figure that you’ll wait until FDA finalizes its rules and you have some concrete direction, dates—and full understanding, before you get too concerned.

This complacency can be exacerbated by the continuous extending of deadlines to take “proposed” to “final,” the necessarily ambiguous predictive nature of much of that which is published about FSMA because of this, the politics that sidetrack the FSMA rollout, the knowledge that FDA will have limited resources for enforcement, and your own day-to-day food safety and quality needs and activities that take precedence over some elusive, future, difficult-to-interpret, unfinalized rule. It’s not hard to understand how one can decide to simply take it a day at a time and worry about FSMA when it becomes final.

It’s not hard to understand, but it’s not really the best tactic to take. As advised by both Dr. David Acheson (Legislative Update, page 5) and Bruce Ferree (From the Plant Floor, page 66): “Don’t wait.”

Compliance isn’t going to be easy. FSMA is often cited as “the most sweeping reform of our food safety laws in more than 70 years.” The original Act, enacted “to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply,” is 89 pages long—and this doesn’t even begin to cover the seven specific rules that are being developed, the Guidance for Industry on each, or the number of questions you are likely to have in relation to the specifics of compliance with the requirements of each rule (and overlapping rules) in your facility. Because of this, you can expect that the FSMA focus will be increasing even more as the rules finally are finalized and the compliance periods begin. But this time, there will be less projection and prediction, more specificity of application, and, hopefully, extensive guidance for understanding.

And, there isn’t really a lot of time. By the time the rules are finalized, it will have taken FDA more than five years to write them. You will have a great deal less time than that to comply with them.

A number of articles in this issue focus on FSMA or reference the Act within the article, including:

• Legislative Update: Where Have We Come From and Where Are We Going? (page 5)
• Orlando Baking Company: Kneading Tradition with Innovation (page 8)
• Global Partnering: FSMA and GFSI (page 52)
• Practical Solutions: Quality Systems: Simple or Complex (page 61)
• From the Plant Floor: New GMPs Are Coming Our Way (page 66)
• AIB’s FSMA and Food Imports and Preparing for Domestic FSMA Inspections (pages 5 and 9, AIB publication)
• Even Products (page 62) mentions FSMA.
   

The author is Editor of QA magazine. She can be reached at llupo@gie.net.