@Risk

The Food Safety Modernization Act, which was signed into law in January, requires the U.S. Food and Drug Administration (FDA) to establish at least two pilot projects: one involving produce and one involving processed foods.

Last week, the FDA announced that two pilot projects are underway.  These pilots, designed to enable both the agency and the food industry to better trace products responsible for foodborne illness outbreaks, will evaluate methods and technologies for rapid and effective tracing of foods, including:

• types of data that are useful for tracing,

• ways to connect the various points in the supply chain and

• how quickly the data is made available to the FDA.

Key stakeholder groups from industry, government and consumers will have input into the pilots, and the FDA also will make efforts to include those representing the food supply chain – from farms to restaurants and grocery stores.

After completing the pilots and gathering additional data, the agency will begin rulemaking on recordkeeping requirements for high-risk foods to facilitate tracing. Step one will be to define high-risk foods, considering such factors as: (more…)

Global production of food and other goods regulated by the US Food and Drug Administration has skyrocketed over the past decade –so much so that the distinction between domestic and imported products is now obsolete, according to Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

“There has been a perfect storm – more products, more manufacturers, more countries and more access.  A dramatic change in strategy must be implemented,” she said last week, as the FDA unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain.

The strategy, outlined in a report called the Pathway to Global Product Safety and Quality, calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of the nation’s consumers. For example, the FDA says it will:

• partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. These coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

• build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

• leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

• augment changes already set in motion. For instance, between 2007 and 2009, the FDA increased the number of foreign drug manufacturing inspections by 27 percent and has opened a series of international offices in key locations.  FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to  integrate certain aspects of drug regulation via the International Conference on Harmonization and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization of the drug manufacturing inspectorates from 39 countries.  The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.

• broaden its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible.  There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.

These new initiatives will enable the FDA to better address fundamental global shifts that are on the horizon. In particular, the agency says it is preparing for these worldwide trends: (more…)

The US Department of Agriculture has proposed a new requirement for the meat and poultry industry, and the agency says this new rule will significantly reduce serious recalls for meat and poultry products.

Currently, when USDA’s Food Safety and Inspection Service (FSIS) collects a sample for testing, the sampled products are requested –but not required –to be held until test results are known. With the proposed requirement, FSIS would be able to hold products from commerce until its test results for harmful substances are received.

FSIS inspects billions of pounds of meat, poultry and processed egg products each year, and it estimates that 44 of the most serious recalls between 2007 and 2009 could have been prevented if this additional safeguard had been in place.

“There is no more fundamental function of government than keeping its people safe from harm, and today we are taking another proactive approach to further prevent consumers from falling victim to foodborne illness,” Under Secretary for Food Safety Dr. Elisabeth Hagen, said. “We believe this will result in fewer products with dangerous pathogens reaching store shelves and dinner tables. In addition, by testing and holding at US points-of-entry, FSIS will also strengthen safety efforts focused on imported food – offering an additional safeguard to American consumers.”

President Obama’s Food Safety Working Group (FSWG) developed three core principles to help guide food safety in the United States: (more…)

Late last month, a coalition of global food and health organizations government agencies, academic institutions, and nonprofit communication experts launched a collaborative initiative to help ensure a collective international resource of food-specific risk communication.

The International Center of Excellence in Food Risk Communication aims to:

• Increase the effectiveness of food risk communication, thereby enabling informed decisions about food safety, nutrition, and health;

• Convene credible and influential governmental, communications, and health authorities to maximize their individual and collective reach and effectiveness for the public good; and

• Contribute to the international body of knowledge on food risk communication.

The Center’s website provides resources to help government officials, health professionals, academicians, food producers, journalists, the public, and others communicate concepts, practices, research, and data about food safety, nutrition, and health. The website also includes content from other leading global institutions involved in risk communication. (more…)

The US food supply is among the safest in the world. But, even so:

• Each year, 70 million Americans are sickened, 300,000 are hospitalized and 5,000 die after consuming contaminated foods and beverages.
• More than 56 percent of domestic food manufacturers have gone five or more years without a federal inspection, and regulators can inspect only a small fraction of the foreign firms that ship food to the U.S.
• In a report on food traceability, researchers found that only 5 of 40 selected products could be traced through each stage of the food supply chain.

(See this earlier post for even more statistics.)

It’s time to update our national food safety laws, and that’s why I applaud Congress for passing the Food Safety Modernization Act (S. 510) earlier this month. This legislation represents the first major changes to food safety laws in 70 years, and as such, it will have an impact on virtually all aspects of the food supply chain. The bill allows for the US Food and Drug Administration (FDA) to order mandatory food recalls and requires food facilities to put sorely-needed food safety plans in place.

But, the legislation is far from a fete de complete. The Los Angeles Times reports that this historic effort “may run into trouble next year over an old problem –money.” (more…)