U.S. Food Safety Overhaul is Underway: FDA Gets Broad Oversight Powers
FDA Food Safety Modernization Act brings sweeping changes to food processing industry
Davis, Wright, Tremaine LLP
By William L. Weigand
On Jan. 4, President Obama will sign into law a major overhaul of food safety regulation in the United States. The FDA Food Safety Modernization Act gives the U.S. Food and Drug Administration broad new powers to force recalls of tainted foods, gain access to internal records of food processors, regulate imported foods and ingredients, and conduct more frequent inspections of food production facilities.
The law gives the government far-reaching authority to set and enforce safety standards for food processors. It affects all whole and processed foods, except meat, poultry, and some egg products, which are regulated by the U.S. Department of Agriculture.
This advisory provides a brief list of the key regulatory changes food processors must address as the FDA ramps up its implementation of the new law.
Key provisions of the law
* Registration: The law requires food facilities to renew registration with the FDA every two years—with agreement to potential FDA inspections as a condition of registration. The FDA may suspend registration of a food facility if the facility “has a reasonable probability of causing serious adverse health consequences or death to humans or animals.” A suspended facility may not introduce food products into interstate or intrastate commerce.
* Company-prepared plans: The law requires each owner, operator, or agent in charge of a food facility to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by the facility. Food companies will be required to submit detailed reports that identify risks within their facilities and systems (including acts of terrorism), and to create a plan for preventing contamination and a plan for handling problems if they occur. The FDA will have 18 months to conduct a study and develop a report that will include the types and sizes of food facilities and risks associated with each size and type.
* Mandatory recalls: The new law gives the FDA the authority to recall food products if they are adulterated or misbranded and “the use of or exposure to such article will cause serious adverse health consequences or death.” Currently, the FDA must rely on food companies to voluntarily pull products off the shelves. The FDA also now has the authority to order the administrative detention of food products when it has “reason to believe” they are adulterated or misbranded.
* More frequent inspections: The FDA will be required to inspect “high-risk” facilities at least once in the first five years after the law goes into effect, and once every three years after that. “Low-risk” facilities must be inspected at least once every seven years. Inspections of foreign facilities must double every year for five years.
* Food supply monitoring: Food companies will be required to submit records of sales and shipments so that products can be tracked through the food supply chain. A new product tracing system will be implemented to track and trace food in the United States or food offered for import into the U.S. The new law establishes a process to set standards for the safe production and harvesting of raw agricultural commodities (e.g., fruits and vegetables).
* Imported food certification: Importers must certify that their food products meet the same safety standards required for production in the United States. The FDA is to issue guidance to importers for developing the certification system. The new law requires food to be refused admission into the U.S. if permission to inspect the food facility is denied by the facility owner, operator, or agent, or by the foreign country.
* Whistle blower protections: The law establishes protections for employees who report food safety violations. These protections only cover workers who report FDA violations, not USDA violations.
* Exemptions for small producers: The law exempts from recordkeeping and hazard analysis requirements certain establishments where direct sales exceed sales to distributors and annual sales total less than $500,000. The FDA may revoke the exemption in the event of a food problem directly linked to the exempt establishment or to protect public health.
Implementing the law
Implementation of the FDA Food Safety Modernization Act will undoubtedly take time. For smaller food producers, the law has a lengthy phase-in period designed to minimize financial effect. It will take time and money for the FDA to draft implementing regulations and increase staffing for expanded responsibility. Early estimates place the cost at $1.4 billion over the next four years, including the expense of hiring 2,000 new FDA inspectors.
Cautions and comments
The registration obligations under this new law appear to broaden the obligations associated with the Bioterrorism Act of 2002, and provide more teeth to related food safety rules, since a facility’s registration may be suspended by the FDA even under theories that have not actually created an adverse health matter. Even small businesses with sales exceeding only $500,000 will now be subject to more costly tracing, sales, and shipment record-keeping obligations.
Also, the FDA’s increased role over raw agricultural commodities may be of particular concern for processors who receive products directly from farm operators, since FDA staff is typically less-accustomed than USDA staff to certain of the inherent hazards associated with crop and livestock production in natural environments (as opposed to more controlled environments within a laboratory or confined processing facilities receiving only previously processed ingredients). Politically, this represents something of a further shift in food safety, even at the farm level, away from the USDA.
Stay tuned for future guidance as the new food safety regulations are prepared and implemented. Please contact us for more information.
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