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Less rhetoric, more data; market cantaloupe safety at retail so consumers can choose; buyers go on price

As the salmonella-in-cantaloupe outbreak reached 178 sick in 21 states with two dead, California melon growers are really starting to lose it, frustrated after the second straight year of seeing their market potentially damaged because of food-safety issues far from the fields in the Golden State.

The Produce News reports that at this time of year, California is the major supplier of cantaloupes, honeydews and other melons, but this is also the time of year when regional and local deals are in full swing.

Western Growers Association, which represents most of the melon growers in California and Arizona, is calling for greater scrutiny by buyers as they purchase local and regional melons at this time of year.

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Advanced Traceability Solutions is an industry leader in food safety technology, especially traceability technology.

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Implementation of the U.S. Food Safety Modernization Act: Building a Partnership for Prevention


Good morning. First, let me thank the conference organizers for inviting me to speak here, and thanks also to my colleagues in the Chinese government, who have given me and our entire FDA delegation a very warm welcome to China this week.

I’m pleased to be here on my fourth trip to China and third to Beijing, because every time I come to China I learn something new and gain new relationships, all of which I value greatly.

I am also delighted to again be part of this important gathering of the international food safety community. While we may differ in language, culture and economies, we are connected through the global marketplace, which makes it essential that we move forward on food safety together—regardless of where we call home.

Food Safety Modernization Act
My subject today is FDA’s implementation of the Food Safety Modernization Act, which I believe makes it more critical than ever that we move forward together on food safety.
When I spoke at this conference last year, before Congress passed our new law, I outlined the key elements of FDA’s food safety strategy. They included:

The need for food safety systems based on the food industry’s primary responsibility to prevent food safety problems,
The need for risk-based, prevention-oriented standards and stronger accountability for meeting them, and
The need for a global approach to food safety.

Now, the Food Safety Modernization Act makes this strategy the law of the land in the United States. And the new law, with the support of a broad coalition of consumer and industry groups, gives the Food and Drug Administration a strong mandate and new tools to implement the strategy.

This blueprint for change addresses the safety of imported foods in important new ways. In fact, the import safety provisions in our law make a fundamental paradigm shift – from primary reliance on FDA inspectors detecting and correcting problems at the port of entry—to making importers accountable for verifying that their foreign suppliers have adequate preventive controls in place. Importers must manage their supply chains.

FDA welcomes the new paradigm embodied in the Food Safety Modernization Act and the challenge of implementing it, in collaboration with the entire food safety community. We welcome the new law because it will be good for public health.

We also see in the new law a powerful vision of a food safety system that both achieves higher levels of assurance about the safety of food and does it more efficiently by harnessing the efforts of all participants in the food system in a partnership for prevention. This partnership is based on clearly defined responsibilities and strengthened accountability for taking steps we know can improve food safety.

Today, I want to talk about how the law’s major requirements relate to this vision, focusing on the preventive control mandates and the new framework for overseeing imported foods. I also want to talk about how we are proceeding with implementation, and how you can participate in this process. And please rest assured that there is plenty of time to participate in shaping our new food safety system through the rulemaking process we’ll soon start.

As we proceed with implementation, and with defining responsibilities and accountability under the new law, two principles stand out loud and clear. Continue reading

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The ‘Teeth’ of FDA’s Food Safety Law

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.

FDA Commissioner Margaret A. Hamburg says the law directs the agency to oversee food safety in a way that applies “the best available science and good common sense to prevent the problems that can make people sick.”

What lends the new law additional importance is that it provides FDA with new enforcement and inspection authorities.

“These new authorities are critical for the law’s success,” said Michael R. Taylor, FDA’s deputy commissioner for foods. “They give the food companies strong additional incentives for keeping their products safe, and that helps us achieve the new law’s goal, which is to protect consumers from unsafe food.”

Foodborne outbreaks are a significant public health burden that increases the cost of the nation’s health care and, as Taylor has emphasized, many of them can be prevented. And keeping foodborne outbreaks from happening in the first place is what FDA intends to do by implementing the following key provisions:

Preventive Measures
Expanded administrative detention: The law gives FDA more authority to prevent the release into the marketplace of adulterated or misbranded food, including potentially harmful food.

Food adulteration can be caused by many factors, including bacterial or chemical contamination, filth or decomposition, the presence of an unsafe food additive, being prepared, packed or held under insanitary conditions, and leaving valuable materials out of the product or substituting other, inferior materials.

Misbranding food can be caused by ways that include not declaring certain ingredients or major food allergens, and not complying with nutrition information content on labeling.

This tool allows FDA to effectively remove the food from distribution channels while the agency pursues legal or other enforcement actions.
Records inspection: The law expands FDA’s authority to gain access to records about potentially hazardous foods. In addition to examining the records tied to a particular food that could pose a health hazard, the agency can now inspect records related to any other food it believes is likely to be affected in a similar manner.
Authority to deny entry: Under FSMA, if a food producer in another country does not permit FDA to inspect its facility, FDA can refuse to allow food from that facility into the United States.
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Enforcement Measures
The new law also strengthens FDA’s enforcement tools in the event that potentially unsafe food has already entered the marketplace.

Suspension of registration: The law authorizes FDA to suspend the registration of a facility under certain circumstances if the food it manufactured, processed, packed, received or held presents a serious health hazard. A facility with a suspended registration will not be able to legally offer food for sale in the United States until FDA lifts the suspension.
Mandatory recall: Before FSMA, FDA had to rely on a firm’s voluntary decision to remove food from the marketplace that could be hazardous to humans or animals. Under the new law, the agency can order a recall if the company does not cease distribution itself and recall its product. If there is reason to believe that the food is adulterated or misbranded and that use of the product could result in serious illness or death, FDA can order that distribution be halted and all implicated products recalled. Additionally, FDA has launched a new search engine6 where consumers can quickly and easily check on new and recent recalls.
FDA is also directed by the law to upgrade its ability to track both domestic and imported foods. To do this, FDA will establish pilot projects to test how to rapidly identify recipients of food—this is critical information FDA needs to rapidly find the source of a foodborne outbreak and to understand its scope.

“Product tracing doesn’t prevent an outbreak, as it’s more about response,” says Bill Correll at FDA’s Center for Food Safety and Applied Nutrition. “However, it can prevent further illnesses during an outbreak when FDA can determine the source, contain further exposure and get the product recalled and out of distribution and consumer households.”

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Positive Feedback
The new FDA authorities have been widely acclaimed by consumer advocates as well as industry.

Caroline Smith DeWaal, the veteran food safety director of the Center for Science in the Public Interest, has hailed FSMA as a far-reaching improvement over previous food safety laws. “The bill contains important provisions for prevention, standard setting and enhanced enforcement. It will significantly reinforce the FDA’s food safety program,” she predicts, “and help the agency advance in its public health mission.”

Kathy Means, vice president of the Produce Marketing Association, said that members of her organization “regard FSMA as a law that takes a good, comprehensive look at food safety. It sets the expectations for food safety measures by the industry, and it sets the priorities for the FDA—all of which is important for keeping our food safe.”

This article appears on FDA’s Consumer Updates page7, which features the latest on all FDA-regulated products.

August 10, 2011

Advanced Traceability Solutions is a provider of traceability systems including software and hardware options for a range of food traceability requirements.

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Safer Fruits and Vegetables: FDA Aims to Set Production Standards

As headlines from Europe implicate tainted vegetable sprouts in more than 4,000 illnesses and dozens of deaths, American consumers may wonder, “Could that happen here?”

The U.S. has had its own headline-grabbing outbreaks from contaminated vegetables—such as lettuce in 2010, peppers in 2008, and spinach in 2006—but a new law has set in motion sweeping improvements to the safety of our food supply.

President Obama signed the FDA Food Safety Modernization Act into law on Jan. 4, 2011, but the year before, the Food and Drug Administration was already gearing up for important work that was mandated by the act: the Produce Safety Regulation.

This regulation will establish mandatory, science-based, minimum standards for the safe growing, harvesting, sorting, packing, and storage of fresh fruits and vegetables. “This will be a monumental shift in food safety,” says James R. Gorny, Ph.D., FDA’s senior advisor for produce safety.

Since 1998, produce growers have had available the “Good Agricultural Practices” issued by FDA and the U.S. Department of Agriculture (USDA). But this guidance is not an enforceable regulation like the Produce Safety Regulation will be, says Gorny.

Advanced Traceability Solutions uses GPS food tracking technology to track agricultural products from harvest to your plate.

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Will the Food Safety Modernization Act Help Prevent Outbreaks of Foodborne Illness?

Michael R. Taylor, J.D.
N Engl J Med 2011; 365:e1

Large-scale outbreaks of foodborne illness have recently focused attention on the ability of the U.S. food-safety system to protect the public health. The nationwide outbreak of Salmonella enterica serotype Typhimurium infection associated with peanut products that is described by Cavallero et al. is one example.1 This contamination, which was ultimately traced to the Peanut Corporation of America (PCA), took a high toll — 714 people were affected, about 200 were hospitalized, and 9 died. Investigators found multiple potential routes of contamination at PCA facilities, such as rain leakage and cross-contamination between raw and roasted peanuts. Although the outbreak was eventually contained, key parts of the food-safety system clearly failed.

There is a public health imperative to do better. The burden of foodborne illness is substantial: about 1 in 6 people in the United States get sick each year, 128,000 are hospitalized, and about 3000 die. We know that foodborne illness is not just a mild annoyance — it can lead to lifelong chronic diseases, such as arthritis and renal failure, and can cause death. Moreover, outbreaks can reduce consumers’ confidence in the food supply and cause major economic disruptions for the food system.

Ensuring food safety is a difficult job. A global marketplace provides a diverse array of food products. Many processed foods are manufactured through complex technology. New strains of Escherichia coli are emerging — such as the O104:H4 strain in the recent German outbreak2 — and we’re seeing unexpected pathogens in some food items, such as salmonella in nuts. Given our complex food-distribution channels, it’s not easy to trace contaminated products to their source rapidly.

The challenge is great, but we believe we have a historic opportunity to reduce foodborne illness under the new Food Safety Modernization Act (FSMA). Enacted on January 4, 2011, the FSMA gives the Food and Drug Administration (FDA) a modern mandate and toolkit to improve the safety of the country’s food supply.

Most fundamentally, the law clarifies that people and businesses that provide food to the public, whether they produce, process, transport, or sell food, are responsible for taking the steps necessary to ensure that they’ve identified and controlled hazards that could make food unsafe. Though most companies take proper precautions, it takes only one uncontrolled situation to cause an outbreak. The FDA’s core job under the FSMA is to set modern prevention-oriented standards and ensure high rates of compliance. Consumers have a responsibility to ensure food safety by properly handling, preparing, and storing food, but they should not be responsible for correcting mistakes that were made earlier in the farm-to-table chain.

The FSMA shifts our food-safety focus from reaction and response to prevention, so that prudent preventive measures will be systematically built into all parts of the food system. The law directs the FDA to issue a rule requiring comprehensive preventive controls for most facilities. In the future, each facility will have to produce a written analysis identifying the hazards associated with the foods it handles and the processes used to manufacture them. The required documentation will describe the controls the facility has implemented to prevent the identified hazards, including a plan for monitoring the controls and correcting problems when failures occur.

Preventive controls are not new in the food industry; many companies already employ them, and the FDA already requires them for foods such as juices, seafood, and shell eggs. But Congress has given the FDA an explicit mandate to use the tool more broadly. Details of the new requirements under the FSMA will be developed through the rulemaking process, and the public will have the opportunity to provide input (more information can be found at

The new law has provisions to help ensure that food from abroad is as safe as food produced domestically. Our food supply is global, with 15% coming from other countries, and the percentage is higher for certain commodities: 75% of our seafood, 20% of our vegetables, and 50% of our fruit is imported. The FSMA mandates a new safety system that makes importers accountable for verifying that the required controls are in place in foreign food facilities that export products to the United States. The FDA will continue to conduct electronic risk-based screening of all food shipments before they arrive in the country and conduct further analyses at the port of entry when warranted. But the requirement that importers perform verification activities will boost our assurance that imported food is safe.

The FSMA also provides the FDA with new inspection and enforcement tools to ensure that companies are carrying out their responsibilities and to keep contaminated products from reaching the marketplace. With the help of its state partners and others, the FDA will conduct more frequent and targeted inspections that will include verification that facilities are properly implementing preventive controls. We will have access to facilities’ food-safety plans and the records they will be required to keep to document their implementation. With the FSMA’s broad prevention framework, we will be able to develop new inspection approaches that better target facilities and products on the basis of risk. When a company fails to voluntarily recall unsafe food, the FDA has new authority to issue a mandatory recall. The law also gives the FDA more authority to prevent the release into the marketplace of adulterated or misbranded food, including potentially harmful food. In addition, if a food producer in another country does not permit the FDA to inspect its facility, the agency can refuse to allow food from that facility into the United States.

The FSMA also gives the Centers for Disease Control and Prevention new responsibilities to enhance federal, state, and local surveillance systems for foodborne illness so that we can identify and control outbreaks more quickly while gaining the scientific knowledge to prevent future ones. The FSMA implicitly recognizes the importance of good data to drive evidence-based interventions that could reduce illnesses. State and local health departments are responsible for a large proportion of these activities, and we must provide them with resources to do their job with modern methods.

Finally, we have a mandate from Congress to work more closely with our government partners at the federal, state, local, territorial, and tribal level. Our goal is to establish an integrated, nationwide food-safety system with harmonized inspections, requirements, surveillance methods, and training. The FSMA also includes similar directives to work with and help build the capacity of our counterparts in other countries.

The law calls for a new food-safety system — one that makes better use of public and private resources to prevent food-safety problems. Implementation will take time. Some provisions are already in place, but many others require rulemaking, which will ensure that we get input from all our stakeholders and that the regulations we issue are well thought out and practical for the diverse businesses that will be affected.

Implementation also requires investment in the science that can illuminate hazards and ways of preventing them, retraining of FDA field staff in new inspection methods, capacity building that enables us to leverage state resources, and the construction of a new import-safety system that meets the challenges of our globalized food supply.

The FSMA represents an opportunity to build a system that can prevent many outbreaks of foodborne illness and reduce the public health impact of those that do occur. We expect to better meet high consumer expectations and enhance the food system’s economic viability. We will be working with stakeholders, with Congress, and with the administration to ensure that the FDA has the necessary resources to implement this landmark legislation.

Disclosure forms provided by the author are available with the full text of this article at

This article (10.1056/NEJMp1109388) was published on August 17, 2011, at
Source Information

From the Office of the Deputy Commissioner for Foods, Food and Drug Administration, Silver Spring, MD

Advanced Traceability Solutions is an industry leader in food safety technology, especially traceability technology.

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