Representing the Makers of the World’s Favorite Food, Beverage and Consumer Products

Preparing Food Companies for New Food Safety Regulations

September 22, 2015

By: Shannon Cooksey, Vice President, Science Policy and Program Management, Jennifer McEntire, PhD, Vice President, Science Operations

While GMA wasn’t surprised that a group like Food Safety News decided to publish a 5-part series on Food Safety Modernization Act (FSMA) right after the Preventive Controls Rules were finalized, we were certainly honored to be invited to author a piece for the series.

Our article, “New Era for Food Safety: What Companies Must Do”, highlights the key concerns that we’ve heard expressed by GMA members and the food safety community over the past few years.

Will the finalization, and ultimate implementation, of the Preventive Controls rules substantially change food manufacturing practices? For the most part, no. Although it may help level the playing field by ensuring that some less mature operations meet a minimum standard. By and large most of the industry has already adopted a preventive system for food safety. However, transitioning that system from a voluntary one to one which will now be inspected by Food and Drug Administration (FDA) certainly raises the bar.

One of the main changes we’ve heard industry report is around recordkeeping. Even if food companies do the right thing today and follow good practices, they don’t necessarily have the paperwork to prove it. Moving forward, they will have to. The records documenting who did what, on what day, at what time, will now be required to be kept if the records relate to important food safety programs. They must also be able to find the records when requested during an inspection.

Determining which food safety programs meet that threshold of importance is also changing. There are many steps involved in food production, from sourcing ingredients and vetting suppliers, to making the food properly, to cleaning and sanitizing. Are they all equally important? The answer is “it depends”. It’s up to each facility to take a hard look at their operations and the nature of the food they are producing to determine which of the many food safety-related programs need to be most tightly controlled and documented.

FDA appropriately gave companies the flexibility to make these determinations for themselves, but with flexibility comes responsibility. Companies need to have the expertise to evaluate their food safety risks and develop appropriate programs. When an FDA inspector arrives, however, he or she may disagree with the decisions that have been made. For this reason, it’s critical that food companies have robust justification to demonstrate the rationale behind their decisions and resulting programs.

As the food industry critically evaluates why they are doing what they are doing, and fills in any gaps as they prepare for regulatory compliance, GMA is supporting our members with enhanced education, training, and other resources. Because the needs of our members are as diverse as the products they produce, GMA will be rolling out a multi-component FSMA toolkit to help members continue manufacturing safe food


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