Even with new food safety plans, FDA budgeting issues put consumers at risk

The Food and Drug Administration (FDA) is up against the more than 250 different foodborne illnesses that pose food safety threats. In the past year, contaminated peanut butter led to illnesses in more than 300 people and at least 50 hospitalizations. Contaminated spinach resulted in 206 illnesses, three deaths and more than 100 people hospitalized.

Based on the Centers for Disease Control and Prevention estimates, 76 million Americans become sick, more than 300,000 are hospitalized and 5,000 die each year from foodborne illnesses. The recent outbreaks highlight the need for increased resources to strengthen food safety and enhance FDA’s ability to reduce and respond to foodborne outbreaks.

To combat the danger, in November, the FDA released The Food Protection Plan, designed to strengthen efforts to protect the nation’s food supply. The plan calls for effective action before an outbreak occurs. The Food Protection Plan, which focuses on both domestic and imported products, complements the Import Safety Action Plan released on the same day. Import Safety Action Plan provides short- and long-term recommendations to enhance product safety at every step of the import life cycle.

The Food Protection Plan is premised on “preventing” harm before it can occur, “intervening” at key points in the food production system, and “responding” immediately when problems are identified. Within these three overarching areas of protection, the plan contains a number of action steps as well as a set of legislative proposals.

To strengthen its efforts to “prevent” contamination, the FDA plans to reinforce support of food industry efforts to build safety into products manufactured either domestically or imported. The agency will work with industry, state, local and foreign governments to identify vulnerabilities, and will look to industry to mitigate those vulnerabilities, using effective methods such as preventive controls.

The plan’s “intervention” element emphasizes inspections and sampling based on risk at the manufacturer and processor level, for both domestic and imported products, that will help verify the preventive controls. This approach is complemented by targeted, risk-based inspections at the points where foreign food products enter the United States, including ports.

The plan also calls for enhancing FDA’s information systems related to both domestic and imported foods to better “respond” to food safety threats and communicate during an emergency.

The Food Protection Plan’s three core elements — prevention, intervention and response — incorporate four cross-cutting principles for comprehensive food protection along the entire production chain:

• Focus on risks over a product’s life cycle from production to consumption;

• Target resources to achieve greatest risk reduction;

• Use interventions that address both food safety (unintentional contamination) and food defense (deliberate contamination); and

• Use science and employ modern technology, including enhanced information technology systems.

Possibly threatening those efforts is funding. Money changes everything, as the axiom goes. That tune is being echoed regarding beverage and food safety by an advisory panel for the FDA, congressmen and national associations.

In December, an FDA advisory panel stated in the report, “FDA Science and Mission At Risk,” that the administration is so under-funded and understaffed that it is putting U.S. consumers at risk in terms of food and drug safety. The group of independent advisors from academia, the food industry and other government agencies said in the report: “The demands on the FDA have soared due to the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for pre-market review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates.”

In turn, the FDA’s resources have not increased in proportion to its demands. The panel said, “The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.”

This “weakness” places the nation’s food supply at risk, the report says. Crisis management in FDA’s two food safety organizations, Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine, has moved attention and resources to food safety. But the shift has not given the FDA the infrastructure to support “innovation in the food industry, provide effective routine surveillance and conduct emergency outbreak investigation activities to protect the food supply,” the report says.

Additionally, the panel says the FDA cannot fulfill its mission because it does not have a large, highly trained scientific workforce, and its information technology infrastructure is inadequate. The 60-page report states that two decades of insufficient funding have placed the FDA in this situation.

The FDA protects U.S. food supply through regulatory activities designed to cover 80 percent of the food and beverages consumed in the country in addition to regulating drugs, human vaccines and medical devices. The organization’s role is critical in protecting the country from potential effects of terrorist attacks on the food supply, as well as naturally occurring threats.

But with all the demands placed on the FDA and pleas for more funding, the government’s 2008 budget is not allowing for the desired amount of additional funding. At the end of December, President Bush signed a $516 billion omnibus spending bill that included $513 million for FDA food safety programs. The 2008 budget is for the fiscal year that began Oct. 1, 2007. The FDA’s $513 million is up $56 million for the 2007 fiscal year, and the sum is 12 percent more than the agency received for food safety last year, but not the 15 percent increase called for by the Coalition for a Stronger FDA, made up of patient groups, nonprofit organizations, consumer advocates, public health organizations and three former secretaries of Health and Human Services. It is estimated that half of the increased budget will be spent on operation increases, and not satisfying the increasing demands placed upon the FDA.

Also last December, the Grocery Manufacturers Association (GMA), the Food Marketing Institute, the American Frozen Food Institute, the Coalition for a Stronger FDA and FDA Alliance, the Center for Science in the Public Interest, the Consumer Federation of America and Sens. Dick Durbin, D-Ill., and Edward M. Kennedy, D-Mass., called on the White House to increase FDA’s food safety resources. Additionally, in a letter to President Bush that included cosigners from both political parties, Durbin proposed a significant funding increase for the FDA’s Foods Program in the 2009 fiscal year budget.

“For years, Congress has pointed out that the FDA is understaffed and under-funded,” Durbin said in a statement. “Now, the FDA's own science advisors admit the agency is failing at its mission. The only good news is that these reports may give us the momentum we need to change. I am calling on the Administration to commit to doubling FDA funding over the next five years. We simply cannot leave American families vulnerable when it comes to food safety.”

“The nature of our food supply is evolving more rapidly than ever before, and the food industry is adapting in order to provide consumers with abundant, safe and affordable food,” said GMA President and Chief Executive Officer Cal Dooley in a statement. “In order to adequately protect the food supply and restore consumer confidence in our nation’s food safety net, Congress and the Bush Administration must provide FDA with the resources it needs to modernize the agency and allow it to properly fulfill its food safety mission.”

For its 10th anniversary, the Food Safety & Security Summit has pulled out all the stops.

Held in Washington, D.C., from March 17-19, 2008, the FSS Summit will have 30 seminars in five areas, covering testing and technology, sanitation and operations, process control and quality assurance, foodservice and retail, and food security and the supply chain.

The summit will feature a top slate of professionals. Members of the FSS Summit Executive Educational Advisory Council, who contribute to planning the event, include Michael C. Robach, corporate vice president of food safety and regulatory affairs at Cargill; Susan Forsell of McDonald’s USA; and Dr. Gary Smith of Colorado State University. Seminar presenters include Joe Scimeca of Cargill Inc., Dave Franz of the National Agricultural Biosecurity Center and Syed Hussain of ConAgra Inc.

The event begins March 17, with half-day workshops at the Washington, D.C., Convention Center. The workshops cover topics on the implementation of a HACCP plan, international standards in food safety and the importance of handwashing.

Seminars begin March 18, with sessions for each of the five tracks. Tuesday also features keynote speeches from Rick Frazier, senior vice president of technical stewardship at The Coca-Cola Co., and Richard Rivera, chairman of the board of the National Restaurant Association.

Wednesday will feature the final keynote speech from Dr. David Acheson of the Food and Drug Administration and the Center for Food Safety and Applied Nutrition, Dr. Steve Solomon of the Office of Regulatory Affairs, and Dr. Jeff Farrar of the California Department of Health Services. The Summit Luncheon and National Science Foundation Food Safety Leadership Awards Presentation will be held that afternoon.

Seminars will cover a variety of topics including “Increasing Control of Results When Outsourcing Your Lab,” “Surviving and Succeeding as a Food Safety Professional,” “Trends & Interventions for Food Safety and Quality,” “Crisis Management & Recall Strategies” and “Issues & Trends in Supply Chain Management.”

On both Tuesday and Wednesday, the summit exhibit hall opens at 10:30 a.m. More than 200 suppliers will be exhibiting during the show. The exhibit hall also has some new additions. The Vendor Track Theatre will provide video from exhibitors on the show floor, and a New Products Showcase will showcase products that have debuted since the 2007 summit.

For more information and details about the Food Safety & Security Summit, visit www.foodsafetysummit.com

In January, after years of study and analysis, the Food and Drug Administration, concluded that meat and milk from clones of cattle, swine and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. Insufficient information was available for the agency to reach a conclusion on the safety of food from clones of other animal species, such as sheep.

An animal clone is a genetic copy of a donor animal, similar to an identical twin, but born at a different time. Cloning is not the same as genetic engineering, which involves altering, adding or deleting DNA; cloning does not change the gene sequence. Due to their cost and rarity, clones currently are used as elite breeding animals to introduce traits into herds more rapidly than would be possible using conventional breeding.

Even though the FDA approved cloning, major dairy and meat producers, such as Dean Foods and Smithfield Foods, at this time are not planning to use cloned animals. The response foreshadows the long road ahead if the industry decides to use clones and wants to win consumer acceptance of cloned animals.

Jerry Kozak, president and chief executive officer of the National Milk Producers Federation, issued this response to the FDA's announcement: "While we are reassured that the FDA's review finds no health or safety issues with food from cloned animals, we strongly support the request made to continue the moratorium on the marketing of cloned animals and their products during a transition period allowing for the examination of the potential economic implications of a change in the marketing environment.

"Thus, we endorse the U.S. Department of Agriculture's request that cloning technology providers, and the owners of existing cloned livestock, continue to observe the moratorium on the commercial marketing of cloned animal products. This period of purposeful review is important given that opinion research that has indicated a degree of consumer apprehension of this technology.

"We also need to make certain that the U.S. regulatory status of cloned animals parallels the regulatory process used in our major export markets. We are ready to work with USDA and other government agencies to facilitate the regulatory review of animal cloning in other countries."

The FDA is not requiring labeling or any other additional measures for food from cattle, swine and goat clones, or their offspring because food derived from these sources is no different from food derived from conventionally bred animals, the agency says. Should a producer express a desire for voluntary labeling (e.g., "this product is clone-free"), it will be considered on a case-by-case basis to ensure compliance with statutory requirements.

Because clones would be used for breeding, they would not be expected to enter the food supply in any significant number. Instead, their sexually reproduced offspring would be used for producing meat and milk for the marketplace.