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From: Food Quality & Safety magazine, February/March 2011

The Obama Administration and Food Safety

A Midterm Report Card

by Ted Agres

The Obama Administration and Food Safety

Two years into its term, the Obama administration gets a solid grade of B for overall food safety from a range of interest groups that includes consumer advocates, growers, processors, and manufacturers. But consensus is lacking on specific efforts, including conducting inspections, because different groups are impacted very differently by these activities. For instance, while consumers applaud more frequent testing of fresh produce, growers complain that the process takes too long and can hold up and even spoil shipments.

Some believe that the grades should be given in context, relative to how they believe the Bush administration performed. “You have to grade the Obama administration on the curve,” said David W. Plunkett, senior staff attorney for the food safety program at the Center for Science in the Public Interest (CSPI). “You have to look at what the previous administration did that worsened the situation for food safety and balance what the Obama administration had to do to dig their way out of it,” Plunkett told Food Quality magazine.

Plunkett and other experts gave their assessments on a range of food safety issues, including inspections, funding for food science research, drafting and issuing of regulations, passage of federal legislation, and outreach to industry. Not everyone had opinions on every issue, and some were willing to grant the administration the benefit of the doubt when results were inconclusive. Here, then, is how the Obama administration scored on food safety at the two-year mark.

Legislation: A-

Despite their differences, nearly every group gives the administration high marks for enactment of the FDA Food Safety Modernization Act (PL 111-353). The measure, signed in January, is the first major overhaul of the nation’s food safety laws in more than seven decades. “Getting that bill done was a huge accomplishment,” said Sandra Eskin, project director of the Food Safety Campaign at the Pew Charitable Trusts. “It takes a village to pass a piece of legislation like that,” she told Food Quality.

The new law, which had been several years in the making, gives the U.S. Food and Drug Administration (FDA) broad new powers to mitigate food safety problems by using science- and risk-based approaches to monitoring the nation’s food supply (see “Highlights of the FDA Food Safety Modernization Act,” p. 16). Whether the FDA will receive the funds needed to implement the legislation is questionable, however; some republicans in the House of Representatives have threatened to withhold some or all of the $1.4 billion in appropriations that will be necessary over the next five years.

“This landmark legislation provides FDA with the resources and authorities the agency needs to help strengthen our nation’s food safety system by making prevention the focus of our food safety strategies,” said Pamela G. Bailey, president and chief executive officer of the Grocery Manufacturers Association, in a statement that followed the president’s signature.

But not everyone was as pleased. The American Farm Bureau “strongly opposes efforts to eliminate years of food safety expertise by creating a new, single food safety regulator. Rather than streamlining authorities, the result would be less organization, more energy expended in transition than inspections, and the cumulative loss of valuable technical knowledge,” the bureau warned on its website.

Also troubled was the United Fresh Produce Association, which withdrew its long-standing support for the food safety bill last November after Sen. Jon Tester (D-Mont.) added an amendment providing full or partial exemptions to smaller farms and processing facilities deemed to be low risk. Small businesses and producers had sought the exemptions, and the compromise helped to ensure the bill’s passage in Congress. Calling the amendment a “profound error,” Robert Guenther, United Fresh’s senior vice president of public policy, said “the administration had a responsibility to step in and advocate for the things they liked and disliked. Instead, they sat on the sidelines.”

Despite this dissatisfaction, Guenther gives the administration a B- when it comes to legislation. “Overall, the bill will do good,” Guenther told Food Quality. “Implementation of preventive controls for production and processing of specific fruits and vegetables, when shown necessary by a risk-based, scientific analysis by FDA, will be integrated into the food safety framework,” he said. Overall, the Obama administration gets an A- for food safety legislation.

Inspections: B-

FDA inspectors have purview over 80% of the nation’s food supply, including all domestic and imported food except poultry, egg products, and meat, which come under the jurisdiction of the U.S. Department of Agriculture (USDA). The FDA had been criticized for not adequately monitoring and inspecting food suppliers and distributors and for not taking a proactive approach to food safety, especially following multiple, well-publicized outbreaks and recalls involving Salmonella in eggs, peanuts, and jalapeño peppers and E. coli in leafy greens and other produce.

Lack of resources has been a major factor, concluded a June 2010 report by the National Academy of Sciences (NAS), echoing similar concerns from a November 2007 assessment by the FDA’s own Science Board. In fiscal year 2010, to help close the gap, the Obama administration boosted the FDA’s food safety budget to $1.05 billion, a 33% increase of nearly $260 million over the Bush administration’s fiscal 2009 budget. The following year (fiscal 2011), Obama increased the FDA’s food safety budget by another $318 million, or 30%, to $1.37 billion.

Not all the money went for inspections, however. The increase allowed the FDA to hire 700 full-time employees for multiple areas, expand laboratory capacity, strengthen its import safety program, improve data collection and risk analysis, “and begin to establish an integrated national food safety system with stronger inspection and response capacity,” the agency said.

Overall, the bill will do good. Implementation of preventive controls for production and processing of specific fruits and vegetables, when shown necessary by a risk-based, scientific analysis by FDA, will be integrated into the food safety framework.

—Robert Guenther, United Fresh Produce Association

“We would have liked FDA to have moved more quickly into the field and perform more inspections,” said the CSPI’s Plunkett. “But we understood they also needed time to hire and train additional inspectors.” He gives the FDA a grade of B for inspections, “with the potential to improve that grade in the next few years.”

The USDA’s Food Safety Inspection Service (FSIS), which is responsible for all meat and poultry products in the country, did not fare nearly as well as the FDA during Obama’s first two years. In fiscal 2010, FSIS received a 4.5% funding boost to $1.02 billion but was allowed to add only 25 new full-time employees, not all of them inspectors. FSIS’s budget request for fiscal 2011 was increased by only $18 million, less than 2%, to $1.05 billion. “The inspectors FSIS does employ are spread too thinly, and oversight of slaughterhouses and other facilities is insufficient,” said a recent report by OMB Watch, a nonprofit research and advocacy organization. The Obama administration scores a B- for food safety inspections.

Food Science and Research: C+

As the new law shifts the FDA’s focus from response to prevention, the agency’s scientists must develop safety standards for farmers to prevent microbial and environmental contamination, rank the greatest risks to food safety every two years, and offer suggestions on prevention. The food safety law will likely put a strain on the FDA’s 170 or so scientists, concluded a recent article in Science magazine. “This is going to be a very steep learning curve,” commented Robert L. Buchanan, PhD, director of the Center for Food Safety and Security Systems at the University of Maryland, College Park.

During the previous two years, food science and research at the FDA failed to keep pace with advances in industry, or even match the progress the agency had made in overseeing drugs. The June 2010 NAS report, for instance, called the FDA’s food research “unfocused and fragmented.” Food-related research at the FDA and USDA during the past two years has been too theoretical and not focused on improving the nation’s food safety practices, said United Fresh’s Guenther. “It’s more bench research and not applied research,” he said. “You have to have a coordinated strategy on research to help the food industry meet the expectations of this new law,” Guenther said, awarding the administration a C-.

Others, such as CSPI’s Plunkett, offer the caveat that the administration’s performance has to be viewed through the lens of capacity building. “It’s not just how much the agency needs; it’s how much it can absorb,” Plunkett said. Budget increases for FDA food science have “matched pretty closely with what was recommended by the Science Board and what was needed by FDA to do its job,” he added. The Obama administration gets a C+ for food science and research.

Regulations: B+

The Obama administration gets credit for moving quickly on food safety issues, particularly by establishing the Food Safety Working Group in March 2009 to advise on and coordinate government-wide food safety efforts focused on prevention. This move helped lay the groundwork for the new food safety bill. In July 2009, the administration finalized a regulation on preventing Salmonella contamination in eggs that had been readied in 2004 but never issued. “That particular rule-making had been really languishing under the previous administration,” said the Pew Charitable Trusts’ Eskin.

We would have liked FDA to have moved more quickly into the field and perform more inspections. But we understood they also needed time to hire and train additional inspectors.

—David W. Plunkett, Center for Science in the Public Interest

During its first year, the Obama administration also issued commodity-specific draft guidance documents on reducing microbial contamination in tomatoes, melons, and leafy greens; began a new testing program and established new guidelines for E. coli in beef bench trim and beef production; announced a final rule banning the slaughter of cattle that become non-ambulatory disabled (“downer”) after passing initial FSIS inspection; and initiated a reportable food registry for the public, industry, and health officials.

Response to food safety-related regulations depends on the sector: OMB Watch and similar groups have complained that the administration has not finalized many additional regulations since 2009, preferring instead to issue non-binding guidance documents. Growers and producers, on the other hand, are traditionally wary of regulations, which they say can be burdensome and intrusive.

United Fresh’s Guenther gives the administration a D for regulations, complaining that the USDA’s Microbiological Data Program, a 10-year-old effort to monitor pathogens in selected fruits and vegetables, has turned into a de facto regulatory program. “If a potential finding is made through testing, FDA automatically orders a recall without further sampling or investigation,” Guenther said, even if the sample had been gathered three or four weeks earlier. Considering all the positives and negatives, the Obama administration gets a B+ for regulations during its first two years.

Outreach to Industry: B

The Obama administration gets relatively high marks for reaching out to and holding “listening sessions” with growers, processors, manufacturers, and other industry groups. USDA and FDA officials have held dozens of such sessions during the first two years. “The FDA has been extremely approachable and open. They have spent a lot of time with the produce industry, walking through their expectations,” said United Fresh’s Guenther. “When you look at their efforts at transparency and openness, it’s been very good,” he said. The Obama administration gets a B for outreach to industry.

But from this point on, much will depend on how the administration implements requirements in the new food safety law, said CSPI’s Plunkett. “That’s when the final grades will come out,” he said.

Agres is a freelance writer based in Laurel, Md. Reach him at

Highlights of the FDA Food Safety Modernization Act

Preventive control plans: Food manufacturing facilities must develop and implement science-based written plans that evaluate hazards that could affect the safety of food. They must identify, implement, monitor, and maintain records of these preventive controls.

Mandatory produce safety standards: The FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables. 

Required inspections: Mandatory inspections of food facilities are based on risk. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the FDA must inspect at least 600 foreign facilities and double those inspections every year for the next five years.

Product tracing: The FDA is required to establish a comprehensive product tracing system to track the movement of food products from farm to point of sale or service. The goal is to identify sources of foodborne illnesses earlier and to contain outbreaks more quickly.

Performance standards: The Department of Health and Human Services must identify and determine the most significant foodborne contaminants and develop science-based guidance to assist food producers. Action levels or performance standards will be established to encourage the food industry to strive toward a safer food supply. 

Third-party certification: Designated imported foods must be certified by a third party with expertise in food safety under the oversight of the FDA.

Certification for high-risk foods: The FDA can require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the U.S. 

Increased inspection authority: The FDA can inspect the records of any entity (excluding farms and restaurants) that manufactures, processes, packs, distributes, holds, receives, or imports food products.

Mandatory recall authority: The FDA can require a recall based on a “reasonable probability” that an article of food is adulterated, misbranded, or will cause “serious adverse health consequences or death” to people or animals. The agency must first offer the affected company a chance to voluntarily recall the food.

Suspension of registration: The FDA can suspend registration of a facility if it determines that the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food.

Exemptions: Excluded from these provisions are places of “direct sales,” such as roadside stands and farmers’ markets; “very small businesses” with average annual sales less than $500,000 (although these must maintain hazard prevention controls); and farms with average annual sales less than $500,000 that are made primarily to consumers, restaurants, and grocery stores within 275 miles.



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