From: Food Quality & Safety magazine, December/January 2012

Bumpy Path to Food Safety

Enforcement of FSMA faces hurdles as FDA funding and staffing are threatened

by Ted Agres

2012 promises to be a pivotal year for improving the security and safety of the U.S. food supply. By June, the FDA plans to have issued and finalized the regulations by which it will exercise the broad new enforcement powers granted by the Food Safety Modernization Act (PL 111-353), the first major change in food safety legislation in more than seven decades.

Under FSMA, enacted in January 2011, the FDA is responsible 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. The plan includes establishing minimum produce safety standards, exercising the authority to order mandatory recalls of suspected food products, conducting a broad range of food facility inspections, establishing a comprehensive product tracing system, holding imported food products to the same safety standards as domestic products, and requiring food growers and facilities to develop and implement hazard prevention control plans.

However, the path to implementing these responsibilities is likely to be bumpy because the FDA lacks the scientific expertise and faces ongoing budgetary challenges. The agency needs $1.4 billion from 2011-2015 to fulfill FSMA requirements. For fiscal year 2012, which began Oct. 1, Congress increased the FDA’s budget by $50 million, $39 million of which is to begin implementing FSMA in January. This is a “small but significant increase that will enable us to work in some critical areas both in food safety and on drug and medical product issues,” said FDA Commissioner Margaret Hamburg at a forum in November.

But budget challenges are far from over. The failure of the congressional Joint Select Committee on Deficit Reduction, known as the Super Committee, to identify at least $1.2 trillion in discretionary spending cuts over 10 years means that automatic across-the-board spending reductions, split between defense and discretionary domestic spending, will kick in starting in 2013. Unless Congess and President Obama agree on an alternative savings approach, the FDA is facing an automatic cut of $150 million to $250 million.

“FDA would be unable to implement recent legislation to improve the food safety system,” wrote Rep. Norm Dicks, D-Wash., ranking Democratric member of the House Appropriations Committee, in a letter to the Super Committee in October.

Even with full funding, the FDA would be hard-pressed to accomplish all its responsibilities. For instance, FSMA requires the FDA to inspect at least 600 foreign food facilities within the next year and double that number each year for the next five. “While the goal may be attainable in the first year, it would be impossible for FDA to complete 19,200 foreign food inspections in year six without a substantial increase in resources or a complete overhaul in the way it operates,” the FDA acknowledged in a June report, “Pathway to Global Product Safety and Quality.”

Further complicating matters, the FDA faces longstanding deficiencies in conducting science-based assessments. According to a November 2007 report by the FDA’s Science Board, the nation’s food supply is at risk because of chronic deficiencies in the FDA’s scientific organizational structure, workforce, and IT capabilities. Sustained additional resources are needed to correct these shortcomings, the board concluded—an unlikely scenario given present fiscal pressures.

But it’s not only the FDA’s budget that’s problematic. The FDA relies on more than 400 state agencies nationwide to conduct field inspections and detect food security and safety problems. Due to state budget cutbacks, there are 44,000 fewer state and local health department employees today than there were a few years ago.

Hazard Prevention, Control

Under FSMA, food manufacturing facilities and importers must take steps to guarantee the security and safety of their products. For producers, these requirements include submitting written food safety plans modeled after the HACCP system methodology, used by the FDA in the past to address the safety of seafood, juices, and shell eggs (see “HACCP Principles: Benchmark for Food Safety,” Food Quality, February/March 2010).

“Globalization has presented its own food safety challenges, which must be addressed....It is clear that FDA can’t be everywhere all the time, especially when it comes to the oversight of imported foods.”

—Michael R. Taylor, FDA deputy commissioner for foods

The FDA was expected to issue draft regulations covering these plans by the end of 2011. The agency is focused on two areas: conducting hazard analyses for biological and chemical threats, and implementing process controls to prevent, eliminate, or reduce such hazards. Critical areas include sanitation, raw materials and supplier practices, allergen control, environmental monitoring for Salmonella and Listeria monocytogenes, and microbiological and other testing.

The FDA also planned to publish, by the end of 2011, a rule governing production, harvesting, and packing of fresh produce. This is expected to include control of animals, use of manure, water quality, and worker hygiene, among other factors. It is not clear whether assays or other tests will be required to detect foodborne pathogens, although that likelihood has increased following the recent outbreak of listeriosis that was linked to cantaloupes grown at Jensen Farms in Colorado and has been responsible for at least 139 illnesses and 29 deaths in 28 states. But growers must develop plans to minimize the risk of such contamination, and FDA inspectors have the authority to verify implementation of the plans. (There are exemptions for very small farms and producers, as well as certain other food facilities.) Other produce-related outbreaks this year include Salmonella-tainted sprouts and strawberries contaminated with E. coli.

Keep tabs on FSMA

Get the latest updates on implementation of FSMA from the FDA’s official website.

“Although we need testing to validate HACCP and other prevention programs, you cannot test your way to safer foods,” said J. Stan Bailey, PhD, director of scientific affairs for bioMérieux Industry, a manufacturer of assays and other tools for the food industry. “Safe foods will come from implementing appropriate technologies at all phases of production and processing and monitoring the effectiveness of these technologies on a regular basis,” Dr. Bailey told Food Quality.

Import Quandary

About 15% of the U.S. food supply is imported. Nearly two-thirds of the fruits and vegetables and 80% of shrimp and seafood come from outside the U.S., much of the latter from countries with questionable food safety records. “Globalization has presented its own food safety challenges, which must be addressed,” Michael R. Taylor, FDA deputy commissioner for foods, told an audience in Shanghai earlier this year. “It is clear that FDA can’t be everywhere all the time, especially when it comes to the oversight of imported foods.”

FSMA requires imported foods to be held to the same standards as domestic foods, and importers and foreign suppliers must have controls in place to ensure product safety. Over the next several years, assuming adequate funding, the FDA will spend nearly $1.4 billion to hire hundreds of new staff and private contractors to inspect foreign food suppliers, especially for high-risk foods. These will include third-party certifiers such as Bureau Veritas, which plans to hire more inspectors to meet the pending U.S. demand.

The FDA can also expedite review and entry of foods from importers that participate in a voluntary qualified importer program, refuse entry of food if any other country has previously done so, and assess fees to reinspect imports that have been detained for safety reasons. (The fees were to have gone into effect on Oct. 1 but the FDA has delayed them pending further agency review.) The law also requires the FDA to develop plans to train foreign governments and food producers on U.S. food safety requirements.

A permanent training facility opened in September at the University of Maryland’s Joint Institute for Food Safety and Applied Nutrition in College Park. The International Food Safety Training Laboratory will bring in academic experts from the university and regulators from the FDA, the USDA, and the EPA to train foreign technicians and scientists using equipment provided by the Waters Corporation. The first group, technicians and lab supervisors from China and Indonesia, focused on detecting pesticide contamination. “We’re giving students unparalleled insight into the way federal regulators operate and how best to apply their techniques to conditions back home,” said Janie Dubois, IFSTL director.

Also working to improve food security and safety is the United States Pharmacopeia, an independent, nonprofit standards-setting organization. Through the Food Chemicals Codex, the USP establishes specifications and test methods for food ingredients, chemicals, and additives.

“Quality is not independent from food safety,” said Markus Lipp, PhD, USP’s director for food standards. “As quality goes down, at some point it intersects with safety, and then the food product becomes unsafe. We’re trying to develop monographs that basically sit at that intersection and define where quality becomes safety,” he told Food Quality.

Sound Off FMSA

When fully implemented, the Food Safety Modernization Act will strengthen food safety in the U.S.:

  • Vastly: 36%
  • Moderately: 35%
  • Barely: 28%

Gaps in the Network

The enhanced authority granted to the FDA under FSMA does not extend to the USDA, which oversees about 20% of the U.S. food supply—namely, most meat and poultry and some egg products. For instance, the USDA’s FSIS lacks the legal authority to test for Salmonella at farms or to require farmers to have a food safety plan. Court decisions have also prevented the USDA from shutting down meat-packing plants found to have had repeated Salmonella problems. But in July, the USDA tightened its standards for Salmonella in poultry slaughterhouses, reducing the percentage of raw chickens that can test positive from 20% to no more than 7.5%. Its weapon: online posting of the names of plants that don’t meet the new standards.

There are many other gaps in the food safety network. For instance, U.S. regulators are not required to test for new, virulent strains of E. coli, such as E. coli O104, which was responsible for more than 4,000 illnesses and 40 deaths during the summer. Rather, safety efforts in the U.S. have mainly focused on E. coli 0157:H7, the strain responsible for outbreaks caused by hamburger in 1993. The USDA received permission from the Office of Management and Budget to expand the E. coli ban for raw beef to include six other strains, but O104 was not among them.

On the plus side, there is growing evidence that testing for foodborne pathogens is effective. Several growers, including True Leaf Farms in San Juan Bautista, Calif., voluntarily submitted romaine lettuce and spinach samples to the FDA earlier in 2011 as part of a research program into early detection of contamination. Listeria contamination was found in at least three batches, including one that led to a 30,000-pound recall in September. Between 1996 and 2008, 82 foodborne illnesses were linked to fresh produce, one-third of them being E. coli in leafy greens, according to the FDA. Under FSMA, the agency is required to expand this and other testing programs.

“It may appear to the consumer that the food supply is less safe than it used to be because of the number of outbreaks that we see,” said Dr. Bailey. “But I maintain it’s just the opposite. The food supply is safer because we now have the ability to recognize outbreaks and stop them.”

Nevertheless, significant challenges remain. The nation is ill equipped to thwart or even effectively deal with potential domestic food sabotage, terrorism, or natural disaster, according to an assessment by the Government Accountability Office, the investigative arm of Congress. In September, Lisa Shames, director of GAO’s Natural Resources and Environment group, told Congress that there is no centralized coordination to oversee federal agencies’ implementation of the nation’s food and agriculture defense policy. She also testified that the USDA lacked a strategy to implement its Homeland Security responsibilities for dealing with terrorist attacks, major disasters, and other emergencies, and pointed out that the agency faced challenges in coordinating federal food and agriculture responses for natural disasters, for which it is responsible. Shames offered nine recommendations, saying that the USDA “generally concurred” with them.

Agres is based in Laurel, Md. Reach him at



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