FDA's Food Safety Modernization Act Will Soon Become Law
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After weeks of haggling, Congress has now passed the Food Safety Modernization Act.
A few weeks ago, we all thought the new law (passed in its then-current form) was headed for the President’s desk. We soon learned, however, that the legislation which had passed was, in fact, technically unconstitutional. Because the bill inadvertently contained certain revenue provisions, it should have originated in the House of Representatives, not the Senate. These issues have been resolved, Congress approved the legislation shortly before Christmas, and the bill is now heading to the White House.
Click on the following link to view the text of the bill: Food Safety Modernization Act.
The Food Safety Modernization Act (“FSMA”) will govern food processors and products regulated by the U.S. Food and Drug Administration ("FDA"). The new act increases federal inspections, requires virtually all regulated food companies (with very few exceptions) to adopt Hazard Analysis and Critical Control Point (“HACCP”) plans, and grants the FDA mandatory recall authority. The new legislation also proposes to enhance our nation’s foodborne illness surveillance and tracking capabilities.
The biggest change for food companies, however, will be the new HACCP requirements. Under the new law, food companies will be required to: (1) formally consider and identify all potential food safety hazards associated with their products and operations; (2) develop written plans to respond to each of those hazards; and (3) to closely follow those plans to reduce or eliminate such hazards to the greatest extent possible.
Not only will the HACCP plans developed by these companies need to be legally adequate (something which will likely prove extremely difficult to define and enforce on a consistent basis), the resulting plans themselves will also, for all practical purposes, become an extension of in-plant federal regulation.Thus, as companies develop and implement their own individualized HACCP plans, they should also recognize that they will be expected by FDA to follow them precisely. Click on the following link to see a more in-depth discussion of the new law and possible ramifications: Jolley: Bill Marler & Shawn Stevens Talk About The New Food Safety Modernization Act .
Although not all provisions of the new legislation will go into effect immediately, food companies should begin planning for the changes that are likely to occur.
There have also been some recent notable developments relating to produce. Beyond the FSMA itself, the FDA has also announced the creation of a new organization that will likely impact produce growers and packers in the near future. The Produce Safety Alliance is a public-private organization funded by the FDA and United States Department of Agriculture’s Agricultural Marketing Service.
The three-year, $1.15 million alliance aims to help produce growers and packers access food safety educational and training materials by:
- Developing a program on Good Agriculture Practices (GAPs) and co-management;
- Creating an information bank of up-to-date scientific and technical information related to on-farm and packinghouse produce safety and environmental co-management;
- Establishing a network of educational collaborators;
- Conducting an assessment of existing educational outreach tools to identify knowledge gaps and to provide for continuous updating; and
- Launching a website to make the alliance’s work and information readily accessible.
The alliance was also created to assist growers and packers with a new produce safety regulation that the FDA expects to propose in 2011, which will focus on production, harvesting and packing. FDA Deputy Commissioner for Foods Michael Taylor said “As we traveled around the country listening to growers and packers and soliciting their comments even before we propose a produce safety rule, we have committed ourselves to just this kind of collaborative effort.” As always, share your experiences and views with FDA at every opportunity afforded to you.
Put simply, the Produce Safety Alliance aspires to create a one stop shop for the food safety needs of produce growers and packers. The California Leafy Greens Marketing Agreement (LGMA) endorses the alliance and hopes to participate on the alliance’s steering committee. Jamie Strachan, chairman of the LGMA’s advisory board said “The objectives of this new initiative are in line with those of the LGMA.” The alliance’s steering committee will be comprised of government officials as well as industry leaders, including growers and packers and produce trade organizations.
In any event, one question often asked is whether the FSMA will make our food safer. I think the answer is yes. Regardless of where you stand politically on the issue, I think we could all agree that requiring all food companies to develop and follow HACCP plans will have a net positive effect on food safety. Moreover, under the new laws, it should become easier for food safety lawyers like us to defend food companies faced with a foodborne illness claim or caught in an outbreak scenario.
In response to the new rules and regulations now on the horizon, most food companies will be working to enhance their food safety programs. Understanding that, despite our best efforts, mistakes can and will occur, we would much rather be defending food companies with robust food safety programs than defending those companies with none at all.
