Understanding Upcoming FDA Food Safety Rules

Forty-eight million. That’s the estimated number of foodborne illnesses each year, according to the Centers for Disease Control. Those numbers, along with an inadequate patchwork of food-related agencies, made it obvious that action was needed. In 2011, President Obama signed the Food Safety Modernization Act (FSMA) into law, giving the Food and Drug Administration (FDA) the tools to strengthen the food safety system. 

With the recent fresh-food trend in convenience stores, the new FSMA requirements will have increased relevancy. While the rules are still being finalized, there is a general outline of what the FDA will be doing and requiring. The biggest change is in focus: from reacting to food safety problems to preventing food safety problems.

Under FSMA, the new mandates and authorities of the FDA include: 

• Requiring preventive controls across the food supply;
• Increased inspections and records access;
• Imported food safety requirements;
• Mandatory recall authority for all food products; and
• Integration and enhanced partnerships.

PREVENTION

Food facilities will be required to create written preventive control plans that cover: hazard analysis; identifying preventive steps to minimize or prevent the hazards; monitoring the effectiveness of these controls; record keeping; and identifying corrective actions to be taken when problems arise.

Another element of FSMA is food defense. Food defense is an effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting or other illegal, intentionally harmful means. FDA will also establish science-based standards for produce production.

There will be many rules issued over the next few years, and it may be confusing and overwhelming for people in the food production and service industries.

The FDA and its new partners will be great resources for information. The Food Safety Preventive Controls Alliance will develop training materials on preventing contamination of food during production to help the industry, particularly small- and medium-size companies, comply with the new rules.

Inspections & Documentation

Inspections will be increasing under FSMA. High-risk domestic food facilities will be inspected at least once every three years. All other domestic food facilities will be inspected at least once every five years.

The FDA’s record-keeping inspection authority has also expanded. FSMA will require that facilities engaged in manufacturing, processing, packing or holding food for consumption in the United States submit additional registration information to the FDA. 

Another part of the new regulations is product tracing. The production and distribution chain of products will be documented so that a common source can be identified in the case of an outbreak or evidence of contaminated food.

RESPONSE

If a company fails to recall a product after being asked, the FDA can now issue a mandatory recall. The registration of a facility can be suspended if the FDA determines that the food poses a reasonable probability of serious, adverse health consequences.

The FDA may require a responsible party to submit to the FDA “consumer-oriented” information regarding certain reportable foods, which the FDA will publish on its website as a one-page summary.  

Stores that are part of a chain of establishments with 15 or more physical locations that sold a reportable food with an FDA summary will have to prominently display the summary within 24 hours of its publication.

New Liabilities for Retailers

New violations under FSMA include failing to comply with food safety, transportation, and FSMA food defense regulations and FDA recall orders. Compliance officers and robust follow-up procedures in response to known food safety problems are possible methods of reducing liability risks.

If the FDA determines a reasonable probability that food manufactured, processed, received or held by a registered food facility caused serious, adverse health consequences to humans or animals, the FDA may suspend the registration of the facility that was responsible for or knew about the contamination and packed, received or held such food.

RULEMAKING PROCESS

For the first time, the FDA has a legislative mandate to require prevention-based controls; it will also have mandatory recall authority for all food products.

Under the new food safety law, the FDA will be issuing a number of rules. The rulemaking process includes:

• Step 1: The FDA proposes and publishes a rule in the Federal Register for review.
• Step 2: The public has 30 to 90 days to submit comments.
• Step 3: The FDA considers comments from the public.
• Step 4: The FDA issues a final rule and publishes it in the Federal Register.
• Step 5: Companies comply with the rule based on the “effective date.”

It’s still early and there aren’t many details yet, but there are a few things you can do to ensure you’re ready to comply with FSMA.

First and foremost, stay informed about the rulemaking developments over the next year. The sooner you know about a requirement, the sooner you can start preparing for it. You can sign up for FSMA email updates at the FDA website.

Also, beef up your foodborne illness prevention. The HACCP (Hazard Analysis & Critical Control Points) methods of preventing foodborne illnesses, such as hazard analysis, identifying critical control points, monitoring procedures and diligent recordkeeping, will make complying with the FSMA requirements much easier.

Editor’s note: The opinions expressed in this column are the author’s and do not necessarily reflect the views of Convenience Store News.