Category Archives Legislation, Regulations and Standards

The Environmental Protection Agency (EPA) has signed a final rule that will prohibit carbofuran residue in fruits and vegetables. The agency is also canceling all existing carbofuran registrations. Effective January 1, 2010, the rule will apply to both domestic and imported produce, including alfalfa, barley, beets, corn, cranberries, cucumbers, grapes, peppers, rice, soybeans, and wheat. According to the agency, “carbofuran products pose an unreasonable risk to man and the environment which outweighs the benefits of continued use, and therefore all uses must be canceled.” EPA has been investigating the insecticide, sold under the brand name Furadan®, for several years. Its granular form was banned in the mid-1990s because it was blamed for killing millions of migratory birds. EPA claims that the pesticide “can overstimulate the nervous system, causing nausea, dizziness, confusion and, at very high exposures, respiratory paralysis and death.” The rule has been forwarded to the Federal Register for publication.…

The Food and Drug Administration has issued a warning letter to General Mills, Inc., alleging that labeling for the company’s Cheerios® Toasted Whole Grain Oat cereal contains “serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).” FDA has specifically alleged that this Cheerios product “is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation and treatment of disease.” The warning letter singles out claims suggesting that Cheerios can “lower your cholesterol 4 percent in 6 weeks” and “reduce bad cholesterol by an average of 4 percent,” as well as a claim that “Cheerios is.. clinically proven to lower cholesterol. A clinical study showed that eating 1½ cups servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet…

The U.S. Department of Justice (DOJ) has intervened in a qui tam, or whistleblower, lawsuit filed in California by the Humane Society of the United States against two former suppliers to the National School Lunch Program. The suit alleges that Hallmark Meat Packing Co. and Westland Meat Co., Inc. knowingly and falsely represented that cattle at their slaughtering facility were treated humanely and that beef supplied to the schools did not include meat from disabled, non-ambulatory animals. Videotape of employees abusing non-ambulatory animals at the slaughterhouse resulted in the recall of 143 million pounds of beef in February 2008. Under the False Claims Act, private parties, or “relators,” may file claims on behalf of the U.S. government and may recover a portion of any recovery. The government, which will file an amended complaint now that it is a party to the action, is entitled to treble damages and civil penalties of…

The Kansas Senate will apparently not try to override former Kansas Governor Kathleen Sebelius’s veto of a bill that would have required a disclaimer on dairy products made without artificial growth hormones. Sebelius, recently confirmed as U.S. Secretary of Health and Human Services, vetoed the bill in late April 2009 reportedly because it would have made it more difficult for consumers to get clear information. “Supporters of the bill claim it’s necessary to protect consumers from false or misleading information,” she was quoted as saying. “Yet there has been overwhelming opposition by consumer groups, small dairy producers and retailers to this proposed legislation.” Under the bill, manufacturers that have stated their product is not from cows supplemented with the genetically engineered bovine growth hormone (rbGH or rbST) would have had to document the claim and put a disclaimer on the product label. State Senator Marci Francisco, (D-Lawrence) a vocal opponent…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has published hazard identification materials for bisphenol A in advance of a July 15, 2009, meeting at which the agency will consider whether to list the substance under Proposition 65 (Prop. 65) as a chemical known to the state to cause reproductive harm. Written comments are requested by June 30, 2009. If bisphenol A is listed, manufacturers of products sold in the state containing the chemical will have to provide consumers appropriate warnings. The May 2009 draft of “Evidence on the Developmental and Reproductive Toxicity of Bisphenol A” observes that the substance “is produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins . . . used in certain food and drink packaging.” According to the draft, detectable levels of the chemical “have been found in the general population.” While human studies are apparently “of…

The Food and Drug Administration (FDA) apparently failed to meet its 2007-08 goals for auditing food-safety inspections that states did on its behalf, according to a news source. State agencies apparently do half of FDA’s food inspections, and FDA aims to audit 7 percent to make sure states reach a satisfactory standard. But FDA fell short of its goal in 17 of 39 states, according to FDA data. In five states, including Kansas, FDA did no audits. But data show that FDA’s performance has apparently improved. For example, data for the 2006-07 contract year show its audit goal was unmet in 21 of 37 states, with no audits performed in eight states. In 1998, the FDA reportedly did no audits in 21 of 38 states. “We don’t meet our target ever year, but . . . we’re looking at continuous improvement,” Richard Barnes, FDA director of federal-state relations, was quoted…

The Food and Drug Administration (FDA) held a public meeting May 1, 2009, designed to find ways to prevent, detect and address the adulteration of food, pet food, dietary supplements, medical devices, and cosmetics for economic reasons that pose the greatest public health risk. FDA invited testimony on Economically Motivated Adulteration (EMA) from industry representatives, organizations and stakeholders. The agency requests comments on EMA by August 1, 2009. See Federal Register, April 6, 2009.

An independent special litigation committee (SLC) recently filed a comprehensive report detailing the actions of Chiquita Brands International executives, directors and counsel that led to the $25 million settlement of a Justice Department investigation into the company’s illegal payments to Colombian terrorist groups. The SLC recommends that shareholder litigation stemming from the payments, settlement and purported “fire sale” of the company’s Colombian banana business be dismissed because the SLC found no evidence that any defendant acted in bad faith. The SLC also found that the litigation will inflict “substantial further damage on the Company,” the costs outweigh any potential recovery, “an event of this nature is unlikely to recur,” and the shareholder litigation “would serve to further divert management from its core mission.” The report explains that payments were made to both right-wing and left-wing groups in Colombia to protect the company’s workers and property. Until the recipients were declared…

The U.S. Department of Agriculture (USDA) has announced the first wide-scale survey of organic farming to ascertain how the growth of such practices is changing the face of American agriculture. The Organic Production Survey will examine organic farming that took place during the 2008 calendar year, including production and marketing practices, income and expenses. “This is an opportunity for organic producers to share their voices and help ensure the continued growth and sustainability of organic farming in the United States,” USDA Secretary Tom Vilsack said. Survey results will apparently help shape future farm policy, funding allocations, availability of goods and services, community development, and other key issues. USDA’s National Agricultural Statistics Service (NASS) will mail the survey in early May 2009 to all known U.S. organic producers, who are asked to respond by June 17, 2009. Participants can also complete the survey online. NASS will publish results in winter 2009.…

The Occupational Safety and Health Administration (OSHA) will convene a rulemaking panel May 5, 2009, to study the effects that a proposed rule on occupational exposure to diacetyl would have on small businesses. The Small Business Regulatory Enforcement Fairness Act (SBREFA) panel allows small businesses that may be affected by the proposal to provide comments before an agency publishes the rule in the Federal Register. The panel must submit its final report within 60 days after convening. Diacetyl is a chemical used in butter flavoring for popcorn and confectionery products that has allegedly been linked to bronchiolitis obliterans, a lung disease diagnosed in a number of workers at U.S. popcorn-manufacturing plants. The topic was covered in issue 296 of this Update. See OSHA News Release, April 29, 2009.

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