Why FSMA Needs Full Funding For 2016
By John Kalkowski, editor in chief, Food Online
From time to time, the U.S. Congress passes sweeping laws that certainly appear to have a major impact on American society. Unfortunately then, the legislators fail to fully fund the implementation of the new regulations, leaving the impact in question. This may be the scenario for the Food Safety and Modernization Act.
FSMA, which was passed and signed into law by President Obama in 2011, but still is awaiting full implementation, mandates a major modification of U.S. food safety laws. The law requires the FDA to improve its programs designed to forestall safety problems for both domestic and imported foods using science- and risk-based prevention. It has taken several years of comment and compromise for the FDA to construct regulatory details of how it will carry out this task.
FSMA gives the FDA broad powers to prevent outbreaks of foodborne illnesses, authority to require food recalls, institute greater surveillance of food imports, and preventive controls for use in animal feed. Establishing how these powers will be enforced requires considerable planning and design of inspection and enforcement to ensure the letter of the law is followed.
Funding for FSMA is winding its way through Congress. In mid-June, the House Appropriations Committee approved a $41.5 million increase in funding for fiscal year 2016 that is to be dedicated to the launch of the new regulations. That sounds like a considerable sum. However, that is less than half of the $109.5 million recommended by the president’s administration and far less than the $580 million that the Congressional Budget Office estimates will be required to implement the regulations over the next five years.
Funding Is Needed To Maintain Momentum
As Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine, says, “President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum and implementation will be badly disrupted.”
FSMA was passed to help prevent outbreaks of foodborne illnesses that kill thousands each year. While food safety in this country continues to improve, we still are faced with continuous outbreaks and numerous recalls that threaten consumers. The fact of the matter is that if the government does not provide adequate resources to execute implementation, all the work done to this point may once again be delayed or not adequately enforced.
As Taylor says, “We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls … Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.”
Industry Changes Are Already Underway
Formulating the regulations has required an enormous effort by the FDA, food companies, consultants, associations and, yes, even consumers. Many of these operations have already begun instituting changes — such as training, audits, procedural changes, and software installation — in anticipation of the rules being implemented.
Failure to pass the president’s recommended budget for implementation will not slow or stop the publication of the final rules or impact the dates at which companies will have to be compliant, says food safety expert David Acheson of The Acheson Group. However, it likely would limit the FDA’s ability to train the inspectors at federal, state, and local levels on the intricacies of the regulations and would also limit the number of inspections that can be carried out.
Ultimately, the only way the FDA can achieve its goals is to put in place measures provided for in FSMA that are effective in preventing contamination, both domestically and globally. Many times, such a race can only be won if there is a good jump out of the starting blocks. That is why adequate funding for the upcoming fiscal year is so important.
Congress controls the purse strings of the federal government. Each year, it must use its collective wisdom to parse the value of each federal program and then allocate the appropriate money. In the coming weeks, let’s hope our representatives see how important a good start on implementation is to the nation’s welfare. It also might be appropriate for those with an interest in the success of FSMA implementation to contact individual senators and representatives to let them know of their concern.