According to the Centers for Disease Control and Prevention, about 48 million Americans get sick each year from foodborne illnesses. Another 128,000 are hospitalized and 3,000 are killed. These alarming statistics helped lead to the signing of the FDA Food Safety Modernization Act (FSMA) in 2011. The legislation, which recently went into effect, enforces proactive measures to prevent food contamination.
What the Law Entails
The FSMA focuses on several elements to minimize both consumer and business risk, including:
- Preventive controls: The legislation encourages a proactive versus reactionary response to incident prevention.
- Inspection and compliance: Expect surprise inspections. The Food and Drug Administration (FDA) will take innovative and effective approaches to see who is and is not compliant.
- Imported food safety: New tools are ensuring that imported food meets U.S. safety standards.
- Response: The FDA can now issue mandatory recalls on all food products while owning other authorities over the food industry.
- Enhanced partnerships: The legislation promotes collaboration between all food safety agencies to meet public health goals.
Who It Impacts
The FDA recently started enforcing their rules for the FSMA. The first year of compliance will affect larger businesses of generally 500 employees or more. Sept. 16, 2016, marked the first compliance date for preventive control rules for human and animal food. This means human food facilities must meet preventive controls and Current Good Manufacturing Practices (CGMPs). Animal food facilities must also meet CGMPs.
There are five other foundational rules in addition to preventive controls:
- Produce Safety
- Foreign Supplier Verification Program
- Third-Party Certification
- Sanitary Transportation
- Intentional Adulteration
You can find a summary of each rule, as well as a complete list of specific rules, on the FDA’s website. These rules apply to all registered food facilities in the U.S. Restaurants and food retailers that aren’t registered with the FDA are exempt from some but not all mandates.
The Costs of Non-Compliance
Individuals who aren’t in compliance with the FSMA can face severe penalties and possible incarceration. Misdemeanor convictions are punishable by up to one year of imprisonment and up to a $100,000 fine per person. A violation that results in death has a maximum fine of $250,000. Organizations face doubled fines.
To meet these regulations, be sure to educate your employees on a frequent basis and seek outside expertise when necessary. You’ll also want to thoroughly evaluate your facilities and operations for possible violations. Documenting policies and procedures will also benefit you in the event of a surprise inspection.