FDA Food Safety Modernization Act

The FSMA requires the FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks.

The law was prompted after many reported incidents of foodborne illnesses during the first decade of the 2000s and was largely crafted by members of the Grocery Manufacturers Association.

[8] Under the new law, the FDA will now have new prevention-focused tools and a clear regulatory framework to help make substantial improvements in their approach to food safety.

[4] For example, for the first time, the FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain.

The new law also significantly enhances the FDA's ability to achieve greater oversight of the millions of food products coming into the United States from other countries each year.

[10] The new (FSMA) law broadens that authority, allowing for administrative detention based on ‘reason to believe’ that the food item has been misbranded or adulterated’ and thus violates a legal standard for the product.

[19] Instead, these small-scale producers (like those who sell their goods at farmers' markets or roadside stands) would continue to be regulated by local and state entities.

Documentation may include licenses, inspection reports, or other evidence that the farm is in compliance with State, local, county, or other applicable non-Federal food safety law.

The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them.

These standards will be met by implementing the following components: The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign.

In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals.

The following are examples of enhanced collaboration: The FSMA also includes provisions that protect employees who try to prevent food safety problems.

The agency estimated that it would require at least 1,000 more inspectors and $1.4 billion over the following five years, with uncertainty that Congress would appropriate such funds given the economic climate at the time, and calls for spending cuts.

[33] In March 2012, the FDA's Senior Advisor, Coordinated Outbreak Response and Evaluation Network, Sherri McGarry, on a blog reported the types of foods to be used in the pilot project on tracing products to prevent illnesses.

[34] Tomatoes both sliced and whole were chosen because of the significant number of outbreaks recorded; mirroring a multifaceted food supply chain.

[34] The Frozen Kung Pao-style dishes contain ingredients such as chicken, red pepper spice and peanut products which are foods that are involved in outbreaks, and for this reason were included in the pilot project.

[34] That summer, the pilot projects results were expected to be accomplished with hopes of developing a complete product tracing system with the information received.

[37] Large trade organizations joined public health advocates in supporting the bill, while groups aligned with individuals and small farms generally opposed it.

The primary effects expected are to tie New Zealand to Codex Alimentarius and the World Trade Organization permanently, although those international agreements will be constantly adjusted.

There has been criticism that the FDA's proposed rule[42] would be prohibitively expensive on the practice of alcoholic beverage facilities selling spent grain to farmers for animal food.

[43] Under current law, alcoholic beverages, such as beer, wine, cider and spirits, are exempt from the FDA's normal oversight of food products.

The USA brewing industry is legally obliged to provide a safe for consumption product and to ensure safety throughout the supply and manufacturing chain.

Brewing beer generally creates a much safer product than non-alcoholic beverages and foods, naturally protected from certain mycotoxins and bacteria, however it can still be contaminated by foreign bodies and chemicals at various stages within the manufacturing process.

President Obama signs FSMA into law.
The 2011 fiscal year report on foreign food inspections by the FDA. [ 23 ]