Category Archives Food and Drug Administration

The Food and Drug Administration (FDA) has issued a final rule amending its regulations “for thermally-processed low-acid foods packaged in hermetically sealed containers to allow other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing.” The final rule follows from a March 14, 2007, proposal covered in Issue 207 of this Update. Effective March 5, 2012, the new regulation also “establishes recordkeeping requirements” for alternative temperature-indicating devices, “allows for the use of advanced technology for measuring and recording temperatures,” and “includes metric equivalents of avoirdupois (U.S.) measurements where appropriate.” In addition, it permits low-acid canned food processors “to transition from mercury-in-glass thermometers to alternative temperature-indicating devices,” which will “eliminate concerns about potential contamination of the food or the processing environment from broken mercury-in-glass thermometers.” See The Federal Register, March 3, 2011.

The Food and Drug Administration (FDA) has issued a warning letter to CEO John Glessner of Ohio Fresh Eggs, after finding that it had shipped nearly 800 cases of eggs from farms that had tested positive for Salmonella. The Ohio company is reportedly linked to the egg producer involved in a massive egg recall in 2010; Glessner apparently has ties to Hillandale Farms of Iowa whose owner Jack DeCoster apparently provided most of the funds to purchase Ohio Fresh Eggs from a previous owner. The company has reportedly characterized the shipment as a mistake and was quoted as saying, “Our farm cooperated fully with FDA to ensure a swift and complete recall of those eggs from our customer, and we are thankful no illnesses were reported.” See Des Moines Register, March 1, 2011.

The Government Accountability Office (GAO) has issued a March 2011 report identifying 34 areas, including agriculture, “where agencies, offices, or initiatives have similar or overlapping objectives or provide similar services to the same populations; or where government missions are fragmented across multiple agencies.” Commissioned by Congress, this first annual report also summarizes 47 areas where lawmakers or regulators could further reduce the cost of government. These results reflect both new research undertaken by GAO and previously compiled reports, such as the February 16, 2011, edition of the High-Risk Series covered in Issue 382 of this Update. When it comes to the agriculture sector, according to GAO, “[t]he fragmented federal oversight of food safety has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.” The report notes that 15 federal agencies “collectively administer at least 30 food related laws,” with the U.S. Department of Agriculture (USDA) overseeing meat, poultry, processed egg…

The Food and Drug Administration (FDA) recently announced that agency analysts turned to next-generation sequencing to test samples collected during a Salmonella outbreak that purportedly sickened nearly 300 people from 44 states and the District of Columbia. The 2009 2010 outbreak was linked to the spice rub used on certain salamis and was ultimately traced to a single food facility. According to FDA, “The findings supported the information gathered in the field phase of the investigation and suggest an important role for this novel tool in augmenting future outbreak investigations.” See FDA Press Release, February 24, 2011.

The Center for Science in the Public Interest (CSPI) has filed a regulatory petition with the Food and Drug Administration (FDA), asking the agency to prohibit two types of caramel coloring used in cola, beer, soy sauce, and other foods. According to CSPI, “the artificial brown coloring in colas and some other products is made by reacting sugars with ammonia and sulfites under high pressure and temperatures,” resulting in “the formation of 2-methylimidazole [2-MI] and 4-methylimidazole [4-MI], which in government-conducted studies caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats.” The consumer watchdog is thus urging FDA to prohibit Caramel III and Caramel IV food colorings because both are made with ammonia. Experts with ties to the National Toxicology Program (NTP) have also penned a letter in support of this request, citing several NTP animal studies finding “’clear evidence’ for carcinogenicity” of both 2-MI and 4-MI. “[T]he…

The U.S. Department of Agriculture, the Food and Drug Administration and the Office of the Under Secretary for Food Safety have announced a February 9, 2011, public meeting in College Park, Maryland, to provide information and receive public comments on draft U.S. positions to be discussed at the 22nd session of the Codex Committee on Fats and Oils (CCFO) on February 21-25 in Penang, Malaysia. CCFO “is responsible for elaborating worldwide standards for fats and oils of animal, vegetable, and marine origin, including margarine and olive oil.” Agenda items include (i) “Draft Amendment to the Standard for Named Vegetable Oils; Inclusion of Palm Kernel Olein and Palm Kernel Stearin”; (ii) “Code Practice for the Storage and Transport of Edible Fats and Oils in Bulk”; (iii) “Proposed Draft Amendment to the Standard for Olive Oils and Olive Pomace Oils: Linolenic Acid Level”; (iv) “Proposal for New Work on a Standard for…

“Each year, federal inspectors find illegal levels of antibiotics in hundreds of older dairy cows bound for the slaughterhouse,” opens this article about the Food and Drug Administration’s (FDA’s) recent decision to begin testing milk from farms “that had repeatedly sold cows tainted by drug residue.” Concerned that “the same poor management practices which led to the meat residues may also result in drug residues in milk,” FDA evidently singled out approximately 900 dairy farms for testing that would include “two dozen antibiotics beyond the six that are typically tested for.” The new protocol also covered flunixin, “a painkiller and anti-inflammatory drug popular on dairy farms . . . which often shows up in the slaughterhouse testing.” Although the plan reportedly drew support from consumer advocates like the Center for Science in the Public Interest, it prompted a backlash from dairy farmers and state regulators who objected to the week-long…

The Food and Drug Administration (FDA) has issued the first annual report on its Reportable Food Registry (RFR) designed to prevent foodborne illness outbreaks. Summarizing 2,240 online food safety reports from the food industry and public health officials between September 2009 and September 2010, the report “is a measure of our success in receiving early warning problems with food and feed,” states FDA Deputy Commissioner for Foods Michael Taylor in the preface. Report findings apparently show that 37.6 percent of the reported food hazards were caused by Salmonella, 34.9 percent by “undeclared allergens/intolerances” and 14.4 percent by Listeria. The report highlighted “two particularly significant issues in multiple commodity groups that require attention”: (i) Salmonella found in such products as spices and seasonings, produce, animal feed and pet food, nuts and seeds; and (ii) allergens and intolerances in fare including baked goods, fruit and vegetable products, prepared foods, dairy, and candy.…

The Food and Drug Administration (FDA) has released a strategic plan that outlines the 2011-2015 goals and objectives of the National Antimicrobial Resistance Monitoring System (NARMS), which aims to protect “the health of Americans through safer food.” Calling the plan “a dynamic roadmap which outlines the program’s commitment to sustained food safety through monitoring and research,” FDA has requested comments by March 25, 2011. Established in 1996 by FDA, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture in collaboration with state and local health departments, NARMS “monitors the susceptibility of enteric bacteria to antimicrobial agents of medical importance.” Its strategic goals are to (i) “develop, implement and optimize a shared database, with advanced data acquisition, analysis, and reporting tools”; (ii) “make sampling more representative and more applicable to trend analysis”; (iii) “strengthen collaborative research projects”; and “support international activities that promote food safety, especially those…

The Institute of Medicine (IOM) has announced a January 28, 2011, forum to discuss the Food and Drug Administration’s (FDA) role in ensuring safe food. IOM’s Committee on Review of FDA will meet in Washington, D.C., with agency representatives to review the recommendations put forth in its June 2010 report, Enhancing Food Safety, which described FDA as “reactive, lacking a systematic focus on prevention.” The findings specifically asked FDA to adopt a “risk-based model” that involves increased coordination “with state and other federal agencies that share responsibility for protecting the nation’s food supply.” It also called on Congress to amend the Food, Drug, and Cosmetic Act “to explicitly provide the authority FDA needs to fulfill its food safety mission.”

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