Ten Need-to-Know FSMA Compliance Facts


What’s changing – and what you need to do about it

The Food and Drug Administration (FDA) will soon start enforcing new food safety regulations in a broad-reaching set of regulations that will affect many industries—including retailers and transportation companies as well as food and agribusiness itself.

Here are ten things you need to know now to comply when the new food safety rules go into effect next month:

1. What is FSMA?

The Food Safety Modernization Act (FSMA), originally passed in 2011 and clarified with new rules several times since then, takes effect in stages, through at least 2020. It aims to prevent food-borne illness and contamination that can spread nationally or even internationally in an era of supply chains that are long and often global, potentially affecting huge numbers of people, brands and businesses.

2. What’s changing now?

By September 2016, the FDA will be enforcing stricter requirements that emphasize preventive controls for human and animal food. These requirements place a new premium on transparency into both products and trading partners.

One of the key new requirements is that companies must document and implement Hazard Analysis and Risk-Based Preventive Controls (HARPC). Companies must be able to produce required documents for the FDA within 24 hours, for records going back for up to two years prior to the request (called the 24-and-2 rule).

In addition, many retailers with their own private-label brands will be held responsible for their suppliers’ compliance.

3. Are food companies the only ones affected?

No. Large retailers (especially those selling private label product) and food transporters are also impacted. Also, food processors and their suppliers are realizing that they need to make sure that their affected suppliers comply with the new rules and document their compliance. Ignorance of suppliers’ lack of compliance will do little to deflect their legal liability under FSMA.

4. Could I be fined or go to jail?

It’s possible. Central to the FDA’s tougher approach is a no-excuses attitude toward affected companies’ senior management, who can be held liable for violations.

Think Sarbanes-Oxley for food companies. Executives are being held responsible for ensuring compliance, even when they’ve delegated such duties to others.

In particular, the Park Doctrine, which established that an executive could be held legally liable for violations even if the executive had delegated responsibility for food safety, is expected to be enforced much more aggressively than before. A first offense is a misdemeanor; the second is a felony. And ignorance of the law is no excuse. Already. prosecutors have sent executives to jail for food safety violations.

5. What do we have to do to comply now?

Food facilities are required to implement written preventive controls plans. For companies that already conform to existing HACCP regulations, HARPC (FSMA’s Hazard Analysis Risk-Based Preventive Control requirements) adds additional new preventive controls.  Each facility is required to:

  • Evaluate hazards that could affect food safety.
  • Identify what preventive steps or controls, will be put in place to minimize or prevent the hazard.
  • Describe how these controls will be monitored for effectiveness.
  • Maintain routine records of such monitoring.
  • Specify what actions the facility will take to correct problems that arise.

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