Posted by Jeff Kronenberg | August 28, 2015
The Food Safety Modernization Act (FSMA), H.R. 2751, was signed into law by President Obama on January 4, 2011. This new law is the largest expansion of the FDA authority over the food and animal feed industry since the Food, Drug, and Cosmetic Act became law in 1938. It applies to all food and dairy processors who manufacture products that are not regulated by USDA FSIS (meat and poultry inspection), to importers of food, and to farms. The impact of this law goes well beyond the food industry: it also applies to companies that manufacture pet food and animal feed, and farms that grow fruits and vegetables!
The law requires the development by FDA of at least 12 new regulations and 10 new guidance’s. Many of the FSMA provisions that give FDA more enforcement tools went into effect in 2011. However, the biggest impact regulations lie just around the corner and will be published in August and October of 2015. The calendar for implementation of these rules will span over at least three years, and in some cases, more time is allocated.
The new law is categorized by FDA into four components: prevention, inspection and compliance, response, and imports. Prevention looks at using a proactive approach to controlling incidental and intentional food product contamination by using such tools as hazard analysis and HACCP principles, prerequisite programs, good agricultural practices, good manufacturing practices, and food defense. The new regulations may also address contamination from economic adulteration, such as melamine addition to dairy products and pet food ingredients.
Inspection and compliance is the enforcement component of FSMA, and will be driven by a risk-based approach, putting priority on high risk products and bad actors. Response puts new powers into the hands of FDA to deal with food contamination and outbreaks, including a new mandatory recall authority, expanded administrative detention, suspension of registration, a product tracing system, and further record keeping requirements for high risk products. Since an increasing volume of food products are now imported, the FSMA regulations gives FDA significantly expanded powers to oversee foreign processors and domestic importers.
Regulations now in effect include facility registration, recall authority, administrative detention, expanded records access, increased inspection frequency, a whistleblower provision, user fees for recalls, inspections, and re-inspections; and import certification. Other key rules for human and animal food processors and growers will be out shortly, including Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls (human and animal food), Produce Safety Standards, and Foreign Supplier Verification Program. Beyond 2015, further regulation will be issued, including food defense, sanitary transportation of food, accreditation of testing laboratories, and others.
The new powers bestowed on FDA are significant. The agency can now require a firm to initiate a recall to remove unsafe foods from the marketplace. It can cause food products that FDA has “reasonable belief” to be adulterated to be detained for up to 30 days. Similar enforcement can also be achieved now by the suspension of facility registration by FDA, again based on “reasonable probability” of product causing serious adverse health consequences or death to human or animals. Suspended registration will put a halt to intra or inter-state commerce.
Learn more about how we can help make FSMA simple for you here . Save your place in line for FSMA workshops, assessments and implementation services by completing our FSMA Participation Priority form.
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Jeff Kronenberg, University of Idaho
August 21, 2015