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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA’s Food Protection Plan Recently Unveiled; Safety Enhancements for All Imports Also Announced

by Walt D. Osborne, M.S., J.D., Assistant Editor
FDA Veterinarian Newsletter 2007 Volume XXII, No V

After 6 months of intensive work to develop a food safety strategy, the Food and Drug Administration released its comprehensive Food Protection Plan on November 6, 2007.

The concerted effort began in May 2007 with the appointment of Dr. David Acheson as Assistant Commissioner for Food Protection. In announcing the plan, Commissioner of Food and Drugs, Dr. Andrew C. von Eschenbach, called it a “forward-oriented concept that uses science and modern information technology to identify potential hazards ahead of time as a means to keeping the American food supply safe.” The plan identifies internal administrative actions designed to achieve a more proactive and strategic food safety and defense system, and it also recommends legislative changes to strengthen FDA’s ability to continue protecting Americans and their pets from foodborne illness.

A safe food supply includes both human and animal food and feed. To that end, Dr. Stephen Sundlof, Director of FDA’s Center for Veterinary Medicine, has been a key player in the development of the Agency’s new initiative. The Food Protection Plan is the end-product of months of study, analysis of consumer demographics and buying trends, an awareness of the vast growth of foreign imports, close consultation with many Federal agencies, and an in-depth review of the Agency’s existing food safety mechanisms.

The year 2007 was marked by nationwide recalls of contaminated peanut butter that resulted in 300 illnesses and 50 hospitalizations. Contaminated spinach was implicated in more than 200 illnesses, 3 deaths, and more than 100 hospitalizations. And reports of kidney failure and deaths in cats and dogs led to a recall of nearly 200 brands of pet food.

Over the past few years, FDA has worked diligently to address microbial and other food safety hazards associated with both domestic and imported food products. As Dr. Sundlof has pointed out, the Agency’s continuing challenge has been the dramatic increase in the volume of imported human and animal food. Specifically, the volume of FDA-regulated products has doubled in the past 5 years, and 60 percent of these product shipments are food products, valued at $49 billion; roughly 15 percent of our food supply now comes from outside the United States.

Three elements of protection

The plan addresses both food safety and food defense for domestic and imported products, and it is integrated with the Administration’s Import Safety Action Plan that was announced the same day. That plan is discussed in further detail below. The Food Protection Plan consists of a three-pronged approach: prevention, intervention, and response. All three of these have both internal aspects that the Agency can carry out on its own, as well as legislative authority aspects that would necessitate statutory changes by Congress.

Internally, FDA’s plan will involve preventing foodborne contamination by promoting increased corporate responsibility for the prevention of foodborne illnesses at the onset. This aspect of the plan also includes identifying food vulnerabilities and assessing risks, as well as expanding the understanding and use of effective mitigation measures.

The plan will also need intervention at critical points in the food supply chain, with a focus on inspections and product sampling based on risk, as well as enhanced risk-based surveillance. FDA also plans to improve the detection of food system signals that indicate contamination.

Lastly, the Agency acknowledges that in order to minimize harm to humans and animals from a foodborne illness, a rapid response is crucial. Even though FDA has made improvements in this area, the Agency realizes more can be done to further improve its immediate response mechanisms. Going hand-in-hand with this element of the plan is the need for improved risk communication to the public, industry, and other stakeholders.

Cross-cutting principles

FDA envisions four important cross-cutting principles that will allow a comprehensive food protection approach along the entire production chain:

  1. Focus on risks from production to contamination over a product’s life cycle. This focus includes consideration of the areas that might fall victim to both intentional and unintentional contamination, such as the point at which the food is grown or produced, and the points of processing, distribution, and storage as well. It also includes handling and storage of the food once it is in consumers’ homes.
  2. Target resources to achieve maximum risk reduction. Many variables define a risk, and all of these must be considered, including whether consumption of a food will result in illness from contamination, how that contamination occurred, and the severity of the illness if it does occur.
  3. Address both unintentional and deliberate contamination. FDA has devoted significant efforts over the past 6 years to address defense of the food supply against deliberate attack—something that food safety efforts have not traditionally included.
  4. Use science and modern technology systems. To fully support the implementation of the plan, FDA plans to enhance its information technology capabilities and further integrate its information systems. FDA’s plan emphasizes the need to know the underlying science that is pivotal to understanding how and where a particular food becomes contaminated and what risks are associated. From there, the priority becomes the need to minimize the likelihood of any harm.

Possible enhanced authority

Legislative changes in the three basic areas of FDA’s Food Protection Plan would involve partnering with Congress to seek FDA authority to do such things as: prevent intentional adulteration by terrorists or criminals; accredit highly qualified third parties for voluntary food inspections; require electronic import certificates for food shipments of designated high-risk products; have enhanced access to food records during emergencies; and issue a mandatory recall of food products when voluntary recalls are not effective. This latter enforcement tool has been explored and discussed in the past. Although FDA currently has the statutory authority to seize adulterated or misbranded food, this tool is not always practical when contaminated products have already been widely distributed. Most recalls of FDA-regulated products are handled voluntarily by product manufacturers or distributors. However, there are occasional situations where a firm is unwilling to carry out a recall. In these situations, it would be extremely useful for FDA to require a product recall in order to ensure a quick and complete removal of an adulterated and potentially dangerous product from the distribution channels.

Import Safety Action Plan

As mentioned above, FDA’s Food Protection Plan is integrated with the Administration’s Import Safety Action Plan, which was released the same day by the Interagency Working Group. President Bush created the Working Group on Import Safety in July 2007. The Group was charged with carrying out an extensive review of the U.S. import system and identifying opportunities for enhancing import safety. The Action Plan represents the culmination of thoughtful dialogue among 12 Federal departments and agencies, months of hands-on information-gathering, and feedback from the public.

The Import Safety Action Plan is a comprehensive approach that provides 14 specific short- and long-term recommendations and 50 action steps to better protect consumers and enhance the safety of the increasing volume of imports entering the United States. It follows the same three organizing principles as the Food Protection Plan: prevention, intervention, and response. It is described as a strategy that moves from a “snapshot” at the U.S. border to a “video” of the product life cycle that focuses on prevention with verification. At its core is the need to ensure that safety is built into all products before they reach our Nation’s borders. The Action Plan is broad in scope and applies to consumer products, foods and feeds, and medical products, including medications.

In closing

Simply stated, implementation of FDA’s Food Protection Plan and the Administration’s Import Safety Action Plan will lead to less illness and fewer injuries to the public and a reduced likelihood of a successful terrorist attack on our food and consumer product supply. Our public health mandate requires nothing less than that.


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