Category Archives U.S. Government and Regulatory Agencies

The Food and Drug Administration (FDA) has issued draft guidance that urges the “judicious” use of antibiotics in food-producing animals to minimize drug resistance in humans. The guidance recommends limiting “medically important” antimicrobial drugs to uses deemed necessary for animal health on the basis of veterinary oversight or consultation. It supports the theory that “nontheraputic” or “subtherapeutic” antibiotic use for production or growth enhancing purposes “is not in the interest of protecting and promoting the public health.” FDA has requested written comments by August 30, 2010. See FDA News Release, June 28, 2010; Federal Register, June 29, 2010. FDA Principal Deputy Commissioner Joshua Sharfstein has called the matter an urgent public health issue, telling news sources that the agency would issue new regulations if farmers do not voluntarily adhere to them. “We’re not handcuffed to the steering wheel of a particular strategy, but I’m not ruling out anything that we…

Hundreds of farmers reportedly attended one in a continuing series of Department of Justice (DOJ) hearings on antitrust issues in agriculture. The focus of the meeting held at the University of Wisconsin-Madison was on the dairy industry. According to U.S. Agriculture Secretary Tom Vilsack, the number of dairy farms has fallen from 111,000 in 2000 to 65,000 today. Farm consolidation and voluntary retirement are reportedly responsible for some of the losses, but most are purportedly due to farmers forced out of business by high costs and the low prices they receive for dairy products. Some of the dairy farmers who spoke during the June 25, 2010, meeting reportedly complained about how prices are set for dairy products by mercantile exchanges; others pointed to the largest dairy companies as the source of reductions in competition. A spokesperson for a cooperatives trade association was quoted as saying, “There are five people who…

The Food and Drug Administration (FDA) submitted two proposed information collections to the Office of Management and Budget (OMB) for review. The first collection pertains to the adoption of the model FDA Food Code by local, state and tribal governments, “an important step toward the agency’s goal for consistent, scientifically sound, and risk-based food safety standards and practices.” To facilitate the implementation of regulations based on the model Food Code, FDA in 2001 began surveying the rulemaking activities of these governments and has concluded that “an extension of OMB approval of the survey is needed in order to keep the current database accurate and up-to date.” Estimating that 75 respondents will provide four quarterly updates, FDA has requested written comments by July 26, 2010. The agency has also announced an information collection involving the threshold of regulation for substances used in food-contact articles. To determine whether a substance used in…

The Federal Trade Commission (FTC) recently took action on the divestiture of certain Whole Foods Market Inc.’s assets as part of the consent order that concluded antitrust litigation the agency brought to challenge Whole Foods’ 2007 acquisition of Wild Oats Market, Inc. According to an FTC news release, the Whole Foods divestiture trustee sought approval to sell three Wild Oats stores and certain intellectual property. FTC commissioners approved the sale of Wild Oats stores in Kansas City, Missouri; Boulder, Colorado; and Portland, Maine. While allowing the sale of Wild Oats’ and Alfalfa Markets’ intellectual property to proceed as to Luberski, Inc., and A-M Holdings, LLC, the FTC denied a proposal to sell their intellectual property to Topco Associates LLC, apparently finding that this sale would not satisfy the purposes of intellectual property divestiture. See FTC Press Release, June 18, 2010; Naturalproductsmarketplace.com, June 21, 2010.

An organic industry watchdog has released a June 7, 2010, letter that urges the U.S. Department of Agriculture (USDA) to increase the transparency of the National Organic Standards Board (NOSB) appointment process. “The Cornucopia Institute, and other organic advocates, have long been concerned that representatives from corporate agribusiness have obtained a disproportionate influence on rulemaking at the USDA,” states a June 8 press release, which claims that in the past, “many eminently qualified candidates . . . did not have the political clout to be appointed.” According to Cornucopia, USDA has continued “the Bush administration policy of keeping secret the nominees and the related corporations or organizations they work for or represent.” The group alleges that NOSB positions reserved for consumers or organic farmers have previously gone to specialists employed by corporate agribusiness or only the largest organic marketers. It has thus asked USDA to make public “the name of…

The Food and Drug Administration (FDA) has called for comment on “the information collection provisions of FDA’s regulations for submission of petitions, including food and color additive petitions (including labeling) and generally recognized as safe (GRAS) affirmations.” As required by the Office of Management and Budget, the agency has invited comments on the following: (i) “Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility”; (ii) “the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used”; (iii) “ways to enhance the quality, utility, and clarity of the information to be collected”; and (iv) “ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.” FDA has also…

The Food and Drug Administration (FDA) and the National Oceanic and Atmospheric Administration (NOAA) have announced joint efforts to secure the safety of Gulf of Mexico seafood in the wake of the April 20, 2010, oil spill. “It is important to coordinate seafood surveillance efforts on the water, at the docks and at seafood processors to ensure seafood in the market is safe to eat,” FDA Commissioner Margaret Hamburg said in a joint press release. The agencies plan a “multi-pronged approach” that includes precautionary closures of fishing areas, increased seafood testing inspections and a “re-opening protocol” for affected Gulf waters. NOAA has apparently created a “seafood sampling and inspection plan” and is using “ongoing surveillance to evaluate new seafood samples to determine whether contamination is present” outside closed fishing areas. If the samples have elevated levels of oil compounds, NOAA said it will consider expanding the closed areas. FDA, which…

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has announced two public meetings for stakeholders to offer input on a new framework for animal disease traceability. Specific details for a proposed animal disease traceability rule will be discussed on June 24, 2010, in Salt Lake City, Utah, and July 1 in Fort Worth, Texas. Written comments will be accepted until July 30, 2010. Additional meetings will be announced in a future Federal Register notice. See Federal Register, June 14, 2010.

The U.S. Department of Agriculture’s National Organics Program (NOP) has announced a settlement agreement with one of the nation’s leading organic certifiers, which had allegedly allowed inspections of Chinese organic food operations by auditors with a conflict of interest. Under the agreement, Nebraska-based Organic Crop Improvement Association (OCIA) will be prohibited from certifying organic operations in China for one year and can be approved for re-accreditation as a certifying agent in China only if it hires inspectors with no connection to governmental or quasi-governmental entities. According to a press report, OCIA allowed government-affiliated inspectors to inspect farms operated on government-owned land and failed to properly oversee the inspectors’ activities. NOP apparently discovered the conflict during an August 2007 onsite OCIA audit and proposed revoking OCIA’s accreditation in China in July 2008. The agreement does not affect OCIA’s accreditation as an organic certifier in the United States, Canada and Latin America.…

The Dietary Guidelines Advisory Committee has released its recommendations to the secretaries of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), outlining proposed changes to the 2005 Dietary Guidelines for Americans. This report recommends 2010 guideline revisions that will implement “a lifestyle approach including a total diet that is energy balanced and nutrient dense.” Recognizing that Americans, a majority of whom are obese or overweight, eat too few vegetables, fruits, high-fiber whole grains, low-fat milk and milk products, and seafood, while consuming too many added sugars, solid fats, refined grains, and sodium, the advisory committee endorses a shift to healthful patterns of eating, such as the Dietary Approaches to Stop Hypertension and certain Mediterranean-style diets. The committee also recommends a coordinated strategic plan to improve the overall food environment that “includes all sectors of society, including individuals, families, educators, communities, physicians and allied health professionals, public health…

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