What Does The New Food Safety Modernization Act Mean To Your Business?
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The FDA Food Safety Modernization Act (“FSMA”) is now law.
The FSMA is the first major amendment in almost 75 years to the food safety regulations of the Federal Food, Drug and Cosmetic Act.
Since FDA regulated manufacturers may feel overwhelmed by the 89 page act, let’s take a deep breath and walk through some of the FSMA’s key provisions -- and when they go into effect.
The FSMA governs food products regulated by the FDA; it does not apply to meat, poultry or egg products regulated by the USDA. The new law grants additional power to, and also places additional requirements on, the FDA:
- Inspections: FDA must inspect high-risk food processing facilities at least once in the next five years, and once every three years after that. Low-risk facilities must be inspected at least once every seven years. [Effective immediately].
- Detentions: FDA has the authority to detain food product if it has “reason to believe” that a product is adulterated or misbranded and may cause harm to humans or animals. This is a lower standard than under the FD&C Act. [Effective June 2011].
- Suspensions: FDA may now suspend facility operations if it believes there is a reasonable probability that food from the facility could cause harm to humans or animals. [Effective June 2011 or upon FDA’s issuance of regulation to implement].
- Recalls: FDA now has the authority to force a food recall. [Effective immediately].
- Performance Standards: FDA must evaluate relevant health data every two years to determine the most significant foodborne contaminants and then issue guidance documents or regulations setting contaminant-specific performance standards. [Effective date undetermined, implementation requires FDA rulemaking].
- Imports: FDA may require importers to provide a safety certification from an accredited third-party auditor as a condition of granting admission. [Effective immediately.]
Under the FSMA, food companies will also now have to develop and implement Hazard Analysis and Critical Control Point (HACCP) plans. Although this may initially be a burdensome task, companies implementing strong HACCP protocols will, most importantly, produce safer food. And further, companies executing good HACCP controls may see strong inspection results and avoid detentions, suspensions and recalls.
The written HACCP plan must include five elements:
- Hazard Analysis: Food companies must identify and evaluate all known or reasonably foreseeable hazards that may be associated with the facility (such as biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives, and hazards that may be intentionally introduced) and prepare a written hazard analysis.
- Preventative Controls: Food companies must identify and implement preventive controls to provide assurances that hazards identified in the hazard analysis will be significantly minimized or prevented and the food processed by the facility will not be adulterated or misbranded.
- Monitoring: Food companies must monitor the effectiveness of the facility’s preventive controls.
- Corrective Actions: Food companies must establish procedures to ensure that, if preventive controls are not properly implemented or are found to be ineffective: (a) appropriate action is taken to reduce the likelihood of a recurrence (b) all affected food is evaluated for safety (c) all affected food is prevented from entering commerce if the company cannot ensure it is not adulterated.
- Verification: Food companies must verify that the facility’s preventive controls are adequate to control the hazards identified in the hazard analysis, that monitoring is being conducted, that appropriate decisions about corrective actions are being made, and that there is periodic reanalysis of the HACCP plan.
In addition, food companies must maintain, for not less than 2 years, records documenting the monitoring of the preventive controls, instances of nonconformance material to food safety, the results of testing and other means of verification, corrective actions, and the efficacy of preventive controls and corrective actions. These records must be made available to FDA upon request.
Food companies, other than small businesses, must have their HACCP protocols in place by June 2012.
Other notable requirements placed on food companies by the FSMA include:
- Registration: Food companies must register with the FDA biennially, between October 1 and December 31 of each even-numbered year. [Effective immediately.]
- Imports: Food importers must perform risk based foreign supplier verification activities to verify that the food imported is not adulterated. [Effective January 2013.]
- Additional Future Performance Standards: Food companies must engage a Federal laboratory or other accredited laboratory to perform analyses of food products and submit the results directly to the FDA. [Effective January 2013.]
While many of the FSMA’s key provisions do not take effect for a year or more, it is critical that food companies begin planning for these changes now. If your company already operates under the HACCP methodology, now is the time to re-evaluate your plan and verify it will comply with the FSMA standards. If your company has not yet implemented a HACCP system, now more than ever is the time to enhance your food safety system with formal recognition and monitoring of potential hazards.
Please contact us with any questions regarding these significant changes in food safety law.
“Foodborne diseases cause approximately 76 million illnesses each year in the United States.”
