Opening the Regulatory Floodgates Two Years After FSMA Passage

Now that President Barack Obama has been reelected, industry experts predict that the White House will let loose a torrent of proposed regulations and guidelines that have been kept under wraps, including key food safety regulations required under the Food Safety Modernization Act.

Hundreds of pages of proposed rules have spent most of 2012 languishing in the White House Office of Management and Budget. It was widely speculated that the Obama administration had kept the rules bottled up for fear of being accused during an election year of promulgating regulations that imposed heavy financial and/or regulatory burdens on food growers and processors.

Among them are four key food safety regulations: preventive control standards for human and animal food facilities, produce safety standards, and foreign supplier verification requirements for importers. “It has been frustrating,” FDA Commissioner Margaret Hamburg, MD, acknowledged when asked about the delay during a conference in October. “It has been harder and slower than any one of us would have wanted.”

“My estimation is that the rules were sufficiently complex, both economic-wise and trade-wise, that they put OMB into a conniption,” said David Acheson, MD, director of the food and import safety practice at Leavitt Partners and former FDA associate commissioner of foods. “My speculation is they put them on hold pending the election. If I’m right, we’ll see the rules come out in the December to January timeframe,” he told Food Quality.

Craig W. Henry, PhD, director of enterprise risk services-business risk at Deloitte LLP, agreed. “Many people feel that the regulations could create some significant challenges and require major changes to the way food products are produced and brought to the marketplace,” Dr. Henry said. “It will be interesting to see how quickly Mr. Obama’s administration makes the proposed regulations final rules, considering the potential impact on industry [and] food safety, and the desire by consumer advocates to see the final rules and enforcement begin.”

Two-Year Anniversary

Signed into law on Jan. 4, 2011, the FSMA was approaching its two-year anniversary not only with the Obama administration having missed statutory deadlines but also with the FDA woefully short of the funds needed to implement the law. “FDA lacks the tools and resources to keep up with the flood of food imports, which have roughly doubled over the last decade,” said Michael R. Taylor, deputy FDA commissioner for foods, in an address to science writers at a symposium held in September.

The FDA needs $1.4 billion through 2015 to fulfill FSMA requirements, according to the Congressional Budget Office. But the agency’s budget for FSMA received only modest increases since the FSMA’s enactment. Like other discretionary federal programs, the FDA’s budget was at risk of being cut in the automatic budget deficit sequestration process, as the so-called fiscal cliff approached at year’s end. An automatic budget cut “would be a huge blow to our progress on food safety. One way or another, we’ve got to find a way to fund [the FSMA], or we will simply not be able to fulfill the vision that underlies the law,” Taylor said at the meeting.

In November, House Speaker John Boehner (R-Ohio) predicted that the “lame duck” Congress that convenes after the election would likely pass a temporary measure to postpone the automatic budget cuts, set to take effect on Jan. 1, 2013. But protracted fiscal problems remain to be dealt with next year.

Even if the FDA were given additional funding for FSMA, the agency needs time to create the necessary process and management infrastructure. “A new management structure, supporting processes, and permanent staff positions must be created to launch a systems approach to risk-based decision-making,” the agency stated in a five-year strategic plan released in April 2012.