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
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
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
The Food Protection Plan’s three core elements
— prevention, intervention and response — incorporate four
cross-cutting principles for comprehensive food protection along the entire
• 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.
It’s a money problem
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
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.
More funds needed
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.”
The Food Safety & Security Summit ramps up for
its 10th gathering
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
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
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
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
"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.
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