The FDA Food Safety Modernization Act (FSMA), signed into law in 2011, represents the most sweeping reform of food safety laws in the United States in more than 70 years. The FSMA imposes significant new responsibilities on food companies to proactively prevent food safety problems, while also increasing the FDA’s enforcement authority. The FSMA’s broad scope affects nearly all food producers, importers, distributors, manufacturers, and transporters. The FSMA also requires foreign food suppliers to comply with the FSMA’s requirements and increases the FDA’s authority overseas.
While large food companies have been required to comply with the FSMA since 2016, many small food companies (generally those with fewer than 500 employees) are just now being required to comply as of September 2017, while very small food companies (generally those with less than $1 million in annual sales over the past three years) have until September 2018 to begin complying. A food company may face severe penalties for failing to comply with the FSMA.
This short summary broadly addresses two aspects of the FSMA: the requirement for a written food safety plan and the FDA’s expanded enforcement powers.
Written Food Safety Plan Requirement
The FSMA requires food facilities to implement a written food safety plan that identifies possible hazards in the food manufacturing process and establishes preventive controls to prevent such hazards from occurring. Additionally, food facilities must verify that the preventive controls are being followed and are effective. Food facilities must also design and implement corrective actions to address any problems with the preventive controls that might occur. The written safety plan must also contain a written recall plan that describes the company’s procedures for recalling a defective food product.
The food safety plan must be written by a Preventive Controls Qualified Individual (PCQI). A person can become a PCQI by completing the training courses offered by the Food Safety Preventive Controls Alliance, or through work experience. The written food safety plan must be maintained at the appropriate food facilities. Upon a FDA inspection, the food facility must produce to the FDA the required written safety plan documents within 24 hours. These records may go back two years from the FDA’s request.
Under the FSMA, the FDA has been granted expanded powers to keep contaminated, defective, and misbranded food products from reaching the public. Depending on the type of violation, the FDA may consider different regulatory actions, including issuing a mandatory recall when a company fails to voluntarily recall unsafe food products after the FDA requests that the company to do so; administrative detention of food products that may be defective; suspension of a company’s FDA registration where the FDA determines that the food manufactured in the facility poses a high risk of serious adverse health consequences or death. Additionally, under the FSMA, the FDA can keep products from entering the US when a food producer fails to allow the FDA to inspect any facility that is used to manufacture, process, pack, or hold food products.
Michael Korniczky and Nicole Altman are attorneys who can answer your questions about FSMA compliance. Michael Korniczky has been working with food and beverage companies for over 20 years and is a Preventive Controls Qualified Individual and can prepare preventative food safety plans. Michael is also an Advisory Board member of the Maui Food Innovation Center. Nicole Altman has been representing manufacturers for 10 years, and has worked with companies to favorably resolve FDA enforcement matters. Nicole also serves on the Board of Directors of Aloha Harvest, a non-profit organization that rescues quality, donated food and delivers it free of charge to social service agencies feeding the hungry in Hawai‘i.
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