Court Tells FDA That FSMA Deadlines Are Required
May 16th, 2013 // 9:25 pm @ jmpickett
Latest FDA and cGMP Compliance News
The Food Safety Modernization Act, or FSMA, has made major changes in how FDA and the government is monitoring food safety. FSMA has science based standards and controls on food companies, and it directs companies to do hazard analysis and to create strong, preventive control plans. FDA also has more powers for inspections and enforcement, and importers and the US government must really scrutinize imported foods and also foreign suppliers.
Because FSMA is so important to public health, Congress ordered FDA to issue by July 2012 7 new regs that cover critical topics:
- Hazard analysis and preventive controls based upon risk
- Come up with new safety regulations
- The manufacture, processing, packing and holding of various foods on the farm
- Protection against intentional adulteration
- Sanitary transportation
- Verification of foreign suppliers
- How to select third party suppliers and ensure they are neutral
As many in the industry know, FDA has not met the deadlines for the above. Many food manufacturing companies are upset that the rules have not been made final. They want to have clear clarify on what the rules are that will be governing their companies. And, consumer advocates are upset that the delay on these rules can put Americans at higher risk of illnesses from the foods we eat.
To that end, last fall, the Center for Food Safety and the Center for Environmental Health issued a complaint against FDA in federal court. The two organizations stated that FDA had delayed the issuance of new rules against the law.
Note that FDA has missed seven deadlines to this point and still has not implemented the major food safety regs of FSMA. FDA has provided several of the delayed regs to OMB, but they have not yet been approved.
To help deal with the delay, the two nonprofits above asked the federal court to declare that FDA violated FSMA because it did not issue regulations by deadline. FDA has responded that it is working on the FSMA regulations. They have noted that the regulations are complex and take many months to get them right. Also, FDA states that OMB is reviewing several rules right now.
FDA also pointed out that it issued in January 2013 these two proposed rules: Current Good Manufacturing Practice and Hazard Analysis and Preventative Controls for Human Food†and “Standards for Growing, Harvesting, Packing and Holding of Food for Human Consumptionâ€.
The bottom line – FDA said it didn’t break any laws.
However, the federal court has sided with the two nonprofits in this case. The court stated that FDA did not comply with the rulemaking schedule for FSMA. The court ordered both parties to meet and to talk about a proposed new deadline for the new rules.
It seems that the implementation of FSMA will move forward more quickly. Food companies need to track the rulemaking and to make sure they analyze and comment on any proposed new FSMA regs that will be governing the food industry. Stakeholders may turn in comments on the proposed rules until May 16, 2013 here: http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
