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From: Food Quality & Safety magazine, December/January 2013

Opening the Regulatory Floodgates Two Years After FSMA Passage

by Ted Agres

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.

Jeff Glasheen, MD, SFHM

“My estimation is that the rules were sufficiently complex, both economic-wise and trade-wise, that they put OMB into a conniption. 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.”

–David Acheson, director of the food and import safety practice at Leavitt Partners

Some Progress Made

Despite delays in issuing regulations and guidance documents, the FDA did make progress in other areas. It created a mechanism for food facilities to re-register with additional information required by FSMA. Even though the agency has had the authority to order mandatory food product recalls since January 2011, it has not done so. But it did use its enhanced ability to administratively detain food products several times since 2011, Acheson noted. And in November 2012, the FDA suspended the food facility registration of Sunland Inc., the Portales, NM-based nut producer that has been linked to an outbreak of Salmonella bredeney that sickened at least 41 people in 20 states. It was the first time that the FDA had exercised this authority under FSMA.

In addition, the FDA and the nonprofit Institute of Food Technologists completed pilot projects exploring methods of food tracking and tracing. One such program sought to demonstrate tracking and tracing of processed foods and key ingredients, while another dealt with selected fresh fruits and/or vegetables. Both pilots identified and evaluated the types of data that would be useful for tracing cases of foodborne illnesses; connected points along the supply chain from farms to restaurants and grocery stores; and determined how quickly data could be made available to the FDA.

The agency accepted the IFT’s report on the pilots in July and is required to submit its own report to Congress before making the results public. Rules concerning record-keeping regulations for tracing high-risk foods are still to come.

“Some product-tracking work has been done and some hasn’t,” Dr. Acheson said. “The administration has moved forward on some of the easiest stuff. We’re waiting to see what’s contained in the other ton of rules that will likely be very impactful,” he said.

Broad Authority

The FSMA gives the FDA responsibility for mitigating food safety problems by using science- and risk-based approaches to oversee about 80% of the nation’s domestic and imported food supplies. In addition to establishing a comprehensive product-tracing system, the FSMA also requires minimum produce safety standards and the implementation of hazard prevention control plans by food growers and facilities. The agency also has authority to conduct a broad range of food facility inspections and hold imported food products to the same safety standards as domestic products.

In this area, qualified third parties will eventually be authorized to certify that foreign food facilities comply with all U.S. food safety standards, a step that will help facilitate entry of their products into the country. The FDA can expedite review and entry of foods from importers that participate in a voluntary qualified importer program and refuse entry if the agency is denied access by a facility or by the country in which the facility is located.

Despite delays in issuing regulations and guidance documents, the FDA did make progress in other areas.

The FDA faces significant challenges in implementing these requirements, especially for foreign inspections, according to a new report from the Government Accountability Office, the investigative arm of Congress. The GAO report, released in November, notes that in fiscal year 2011, the agency inspected only 0.4 percent of the more than 270,000 registered foreign food facilities and performed tests on less than 0.5 percent of all food entry lines. GAO notes that many foreign governments have also expressed concerns about being evaluated by an organization outside the FDA.

The GAO recommends that the FDA revise its approach to foreign inspections under the FSMA by adopting “comparability assessment agreements” for specific food products, rather than looking at a foreign country’s entire domestic and export food safety system, which is unlikely to meet FDA requirements. This “equivalence approach” would be similar to that used by the USDA’s Food Safety Inspection Service for poultry and meat and by the European Union for specific imported food products.

Doing so would allow the FDA to “leverage the resources of countries with comparable systems for just one food product” and reduce the agency’s need for accrediting and using third parties, the GAO says. To do this, the FDA would have to modify its approach for selecting comparable foreign countries, instead using comparability assessments “to identify countries that have similar food safety systems for targeted food products, such as seafood.” The FDA neither agreed nor disagreed with the GAO’s recommendation.

Agres is based in Laurel, Md. Reach him at



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