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Agriculture Secretary Tom Vilsack has announced the appointment of Jerold R. Mande, M.P.H., as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA). In this position, Mande will have responsibility for the Food Safety and Inspection Service (FSIS), the USDA agency which protects public health through food safety and defense by ensuring that the nation's supply of meat, poultry and processed egg products are safe and wholesome.

According to Vilsack, "Jerold Mande brings years of experience in health, nutrition and epidemiology, food safety, and public policy in both government and academia that will greatly serve USDA and the public as we continue to work to protect public health."

Most recently, as Associate Director for Public Policy at the Yale Cancer Center, Yale University School of Medicine, Mande developed a national model to increase support for cancer prevention and control, including diet, exercise, and obesity. He also initiated and helped manage the cancer center disparities program, to improve cancer control and care in underserved populations. He was also a lecturer in public health, and helped train select groups of physicians for careers in public policy.

Prior to this, Mande served on the White House staff as a health policy adviser where he helped lead key food safety, tobacco control and cancer initiatives, including expansion of FoodNet and PulseNet. He was Deputy Assistant Secretary for Occupational Health at the U.S, Department of Labor. He also served as Senior Advisor and Executive Assistant to the Commissioner of the Food and Drug and Administration, where he led design of the Nutrition Facts food label, for which he received the Presidential Award for Design Excellence. Mande began his distinguished career in the U.S. Congress where he was first hired to work on food safety legislation.

Mande holds a Masters Degree in Public Health (M.P.H. Nutrition and Epidemiology) from the University of North Carolina at Chapel Hill and a Bachelor of Science Degree, magna cum laude (B.S. with Distinction in Nutritional Sciences) from the University of Connecticut at Storrs. He also attended the John F. Kennedy School of Government, Harvard University, completing a Program for Senior Managers in Government.

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The President's “Food Safety Working Group,” chaired by the Secretaries of the Department of Health and Human Services (Kathleen Sebelius) and the Department of Agriculture (Tom Vilsack), was conceived in March 2009 to help modernize our food safety system. In turn, Vice President Biden, Sebelius and Vilsack, have now announced key findings of the Group.

Following numerous meetings, and imput from key stakeholders, the Working Group has recommended a new approach to food safety based on three core principles: (1) prioritizing prevention; (2) strengthening surveillance and enforcement; and (3) improving response and recovery.

"There are few responsibilities more basic or more important for the government than making sure the food our families eat is safe," said Vice President Biden. "Our food safety system must be updated – 1 in 4 people get sick every year due to food-borne illness, and children and the elderly are more at risk. I applaud the Secretaries of HHS and the USDA for tackling this problem head-on, and coming up with key recommendations to ensure the health and safety of our food supply and, with it, the American people."

"Instead of spending their time trying to get kids to eat healthier food, too many parents and families are worrying about whether their food is safe in the first place," said Secretary Sebelius. "In just the past few months since we began work with the Food Safety Working Group, we have seen recalls on everything from spinach to peanut products to now even cookie dough.” According to Sebelius, the Administration believes “that the current system just isn’t working for America’s families, and under the President’s leadership, we are taking action to keep our food supply safe and prevent outbreaks that can impact millions of Americans."

"There isn’t a single American that isn’t impacted by our efforts to protect the food supply," said Secretary Vilsack. "We owe it to the American people to deliver on President Obama’s bold promise to greatly enhance our food safety system, moving our approach into the 21st century, employing the best surveillance techniques available, and ensuring that we are doing all we can to prevent illness before it occurs."

In its announcement, the Working Group outlined specific steps designed to advance its three core principles:

• HHS and USDA are targeting Salmonella contamination by developing tougher standards to protect the safety of eggs, poultry, and turkey.

• To fight the threat of E. coli, USDA is stepping up enforcement in beef facilities and the Food and Drug Administration (FDA) is developing new industry guidance improving protections for leafy greens, melons, and tomatoes.

• The Obama Administration is building a new national traceback and response system including clearer industry guidance, a new unified incident command system, and improved use of technology to deliver individual food safety alerts to consumers.

• Finally, the Administration announced a plan to strengthen the organization of federal food safety functions, including the creation of new positions at key food safety agencies and a continuing oversight role for the Food Safety Working Group.

The Food Safety Working Group is chaired by Secretaries Sebelius and Vilsack, and participating agencies include the FDA, the FSIS, the CDC, the Department of Homeland Security, the Department of Commerce, the Department of State, the Environmental Protection Agency, and several offices of the White House.

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Tom Vilsack, Secretary of the United States Department of Agriculture, announced that the final rule (74 FR 2658) for mandatory country-of-origin labeling (“COOL”) will become effective on March 16, 2009. Under the new rule, retailers will be required to notify customers of the country of origin of certain food products. Food products (or, “covered commodities”) included within the COOL program include whole muscle cuts, ground beef, lamb, chicken, goat and pork; wild and farm-raised fish and shellfish; perishable agricultural commodities (specifically fresh and frozen fruits and vegetables); and macadamia nuts, pecans, peanuts and ginseng. Additionally, for food such as fish and shellfish, the method of production, wild or farm-raised, must be specified.

Exempted from COOL, however, are various products (e.g., ingredients) used to manufacture “processed” food items. Processed foods are generally defined as: (1) any retail item derived from a covered commodity that has undergone specific processing resulting in a change in the character of the covered commodity; or (2) any retail item that has been combined with at least one other covered commodity or substantive food component. “Specific processing” that results in a change in the character of food includes cooking (e.g., frying, broiling, grilling, boiling, steaming, baking, roasting), curing (e.g., salt curing, sugar curing, drying), smoking (cold or hot), and restructuring (e.g., emulsifying and extruding). For this reason, Vilsack also expressed concerns, in an open letter to industry, that the definition of processed foods contained within the final rule "may be too broadly" drafted. Because Vilsack was also concerned about the labeling of products of mixed origins, and time allowances for labeling of certain ground meat products, he asked industry to voluntarily adhere to the following additional labeling practices:

• With respect to processed foods, Vilsack suggested that processors voluntarily use country-of-origin labeling for those products that "are subject to curing, smoking, broiling, grilling, or steaming."

• With respect to products derived from animals with multiple countries of origin, Vilsack asked processors to include labeling information identifying what production step -- born, raised and/or slaughtered -- occurred in each country.

• Finally, because final rule allows a label for a ground meat products to bear the name of a country when meat from that country was present in the processor's inventory within the last 60 days, Vilsack suggested that time allowance be reduced to 10 days.

American Meat Institute President J. Patrick Boyle stated that, despite Vilsack’s concerns, the organization was "gratified" that USDA is allowing the final rule to go into effect. Namely, this is because the new rule, in its current form, took nearly six-years (with assistance from industry) to develop. Boyle also noted that, once the rule is effective, nearly 95 percent of beef and pork products would likely be eligible to bear a "Product of the USA" label.

Nevertheless, Boyle also stated that it would ultimately be up to individual companies to decide whether to voluntarily comply with Vilsack’s recommendations. According to Boyle, "to the extent that companies are able and elect to go beyond [the] federal labeling requirements, as requested by Agriculture Secretary Vilsack, [that] is an individual company decision, which will have to be made in collaboration with a company's retail grocery customers . . .."

In any event, Vilsack confirmed that the USDA “will closely review industry compliance with the regulation and its performance in relation to these suggestions for voluntary action.” Depending upon such performance, the USDA “will [then] carefully consider whether modifications to the rule will be necessary to achieve the intent of Congress." The rule had also been under review on the orders of the new presidential administration. Ultimately, Vilsack stated that, allowing the rule to go into effect on March 16, 2009, and then monitoring implementation and compliance by industry, would likely be the most efficient way to evaluate the success of COOL, and also to determine whether additional rulemaking would be necessary.

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Agriculture Secretary Tom Vilsack recently announced that, despite previous opposition, he now favors combining the food safety functions of the United States Department of Agriculture (“USDA”) and Food and Drug Administration (“FDA”) into a single food safety agency. Currently, the USDA through it’s Food Safety and Inspection Service (“FSIS”) is responsible for regulating the safety of meat, poultry and egg products. In turn, the FDA has responsibility for most other foods. In his recent comments, Vilsack also stated that he has not yet decided whether a single agency would be best located within the FSIS, the FDA or an independent agency.

As debate continues about merging the food safety responsibilities of the USDA and FDA, Janie Gabbett (from Meatingplace.com) reported that the majority of industry participants in an online survey favored combining the food safety regulatory functions of the USDA and FDA, but only one in five believed that such a merger would result in improved food safety.

Of 289 readers who responded to the survey, 58 percent agreed the two agency functions should be combined, while 42 opposed a merger. When respondents were asked if they thought that a merger of the two agencies would improve food safety, 50 percent believed that food safety would remain unchanged, while 30 percent believed that the quality of food regulation could actually decline.

According to the survey, participants were more concerned with deficiencies in FDA regulation than in FSIS protocols. Namely, this is because, unlike the FDA, FSIS inspectors currently maintain a continuous, on-site presence in meat packing facilities, and also regularly test meat and poultry products for harmful pathogens. As a result, several respondents also concluded that if the agencies were to merge, the FDA would need to become more like FSIS, and not the other way around.

Other suggestions from survey participants included:

• Providing better technology and tools for inspectors;

• Increased laboratory testing;

• Imposing fines on plants with repeated serious violations;

• Requiring all food establishments to adopt and implement Hazard Analysis and Critical Control Point (“HACCP”) plans;

• Requiring all food establishments to adopt and implement sanitation standard operating procedures (“SSOPs”);

• Continuing to improve risk-based analysis of food safety systems in plants;

• Targeting high-risk foods (under FDA jurisdiction) and moving toward to the USDA model of inspection;

• Providing better training for inspectors; and

• Funding additional research to improve food safety.

According to Gabbett, many respondents also believed that, even with a single food safety agency, increasing the funding and number of federal inspectors would likely be needed to improve the effectiveness of regulations. According to one respondent, "simply merging two departments and changing their names . . . won't affect food safety." Rather, "there would need to be fundamental changes at the plant inspection level to actually make a difference."

Currently, the United States is the only industrial nation to have two separate federal food safety regulatory systems. Moving forward, we'll continue to post on emerging developments.

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