Category Archives U.S. Government and Regulatory Agencies

The U.S. Department of Agriculture’s (USDA’s) Office of Inspector General (IG) has issued an audit report criticizing USDA agencies for lacking coordinated oversight of regulations behind research and development of genetically engineered (GE) animals and insects. The agencies conduct and fund research into how GE animals can enhance the productivity of food animals and how GE insects can reduce problems posed by agricultural pests, according to the report. Among its criticisms, the report faults the Animal and Plant Health Inspection Service (APHIS) for not developing regulations for GE animals and insects that pertain specifically to their introduction for “import, interstate movement, or field release.” Noting that “APHIS program units focusing on biotechnology and animal health, respectively, had not coordinated with one another to prioritize the development of a regulatory framework for GE animals and insects,” the report states that consequently “the requirements that apply to these organisms were not clear…

Another tomato grower has filed a claim for damages against the Food and Drug Administration (FDA), alleging that the agency announced a nationwide recall of all tomatoes in the United States in 2008 without having identified tomatoes as the source of a Salmonella outbreak. Williams Farms Produce Sales, Inc. v. United States, No. 11-01399 (D.S.C., filed June 8, 2011). Details about similar claims also filed in a South Carolina federal court appear in Issue 395 of this Update. According to the complaint, FDA ultimately conceded that tomatoes were not the source of the Salmonella contamination, but not before the price for tomatoes plunged. Alleging negligence, defamation, slander of title, product/ commercial disparagement, unconstitutional taking, and violation of unfair trade practices law, the plaintiff seeks actual damages in excess of $11 million, special damages, compensatory damages, treble damages, attorney’s fees, and costs.

German authorities have finally narrowed the field of suspects in an E. coli outbreak affecting Europe, where a reported 31 people have died from a rare strain of the disease. Speaking at a June 10, 2011, press conference, Robert Koch Institute President Reinhard Burger confirmed that an organic bean sprout farm is the likely epicenter, putting to rest widespread public confusion as officials worked frantically—and sometimes erroneously—to pinpoint the source. Although it lacked a set of definitive test results, the institute apparently based its conclusion on evidence showing that people who consumed the bean sprouts at one restaurant were nine times more likely to contract the illness, which has been linked to renal and neurological complications in approximately 700 out of 3,000 total cases. Authorities have since quarantined the Lower Saxony farm, but tomato, cucumber and lettuce farmers implicated at the outset are already seeking compensation for plummeting prices and…

The U.S. Department of Agriculture (USDA) has reportedly found at least 34 unapproved pesticides on cilantro samples during routine testing. According to the agency’s recently issued 2009 Pesticide Data Program report, 94 percent of the 184 samples tested in a rotating selection of produce came up positive for at least one pesticide. With no definite answers as to why the cilantro samples contained pesticide residues, government researchers have suggested that growers may have confused guidelines for cilantro with those for flat-leaf parsley, which is approved for more pesticides. Asserting that they will take follow-up action, some industry leaders are equally puzzled. “It’s something we need to look into,” Kathy Means of the Produce Marketing Association was quoted as saying. “We need to determine: Why this year, why this crop? What’s going on?” See Chicago Tribune, May 31, 2011.

The U.S. Department of Agriculture (USDA) has launched a new food icon aimed at helping consumers make healthier food choices. By replacing the pyramid guide to healthy eating with a plate divided into fruit, vegetable, grains, protein, and dairy food groups, USDA reportedly hopes the MyPlate icon will “prompt consumers to think about building a healthy plate at meal times.” New York University Professor Marion Nestle was among those who praised the icon as an easy-to-understand nutrition guide. “The new plate icon makes it clear that healthy eating means lots of vegetables, fruits, and whole grains, and for that alone it is a big step forward,” she said. “You don’t need a computer to use it. It lets you fill your plate with whatever foods you like without worrying about portion numbers. Best of all are the messages that come with it. Enjoy your food!” See USDA Press Release, June…

A coalition of non-profit advocacy organizations has filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA), alleging that the agency has unreasonably delayed action on several of its petitions relating to the use of antibiotics in animal feed. Natural Res. Def. Council v. FDA, No. 11-3562 (S.D.N.Y., filed May 25, 2011). The plaintiffs seek orders compelling the agency to “withdraw approval for subtherapeutic uses of penicillin and tetracyclines, unless FDA’s findings are reversed in new administrative proceedings.” According to the complaint, while FDA determined in 1977 that these drugs” have not been shown to be safe,” it never withdrew its approvals for the drugs’ subtherapeutic uses. Contending that “misuse and overuse of antibiotics has given rise to a growing and dangerous trend of antibiotic resistance,” the coalition alleges that some of its organizations filed citizen petitions in 1999 and 2005 requesting that FDA “withdraw approvals…

An administrative law judge has apparently begun hearing a Federal Trade Commission (FTC) complaint alleging that POM Wonderful LLC makes false and unsubstantiated claims that its pomegranate juice products will prevent or treat “heart disease, prostate cancer, and erectile dysfunction.” According to a news source, the government opened its case by asserting that the studies on which the company relied do not support the marketing claims and that its executives “repeatedly ignored warning signs that the marketing didn’t match the science.” Food and beverage companies and advertisers are reportedly watching the dispute closely; if the agency prevails, the companies will have to support their advertising with more scientific evidence. POM contends that its product claims are supported by $35 million in research and that the company has “sponsored or participated in more than 90 scientific investigations with over 65 studies on POM products, including 17 clinical trials.” POM will also…

The Food and Drug Administration (FDA) is seeking public comment on a study examining labeling claims on whole-grain products. Titled “Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages,” the study is part of the agency’s “continuing effort to enable consumers to make informed dietary choices and construct healthful diets,” according to FDA. The study will examine (i) “consumer judgments about a food product including its nutritional attributes, overall healthiness, and health benefits”; (ii) “consumer judgments about a label in terms of its credibility in conveying the product’s nutritional attributes and its helpfulness in making product purchasing decisions”; (iii) “consumer perceptions about differences between different statements, such as ‘Made with Whole Grain,’ ‘Contains Whole Grain,’ and ‘Whole Grain”; (iv) “consumer extrapolation of whole grain statements beyond the scope of the statements themselves (i.e. halo effects)”; and (v) “how whole grain statements influence consumer use of the…

The Food and Drug Administration (FDA) has announced a public meeting to discuss inspections and compliance provisions of the recently enacted Food Safety Modernization Act (FSMA). Set for June 6, 2011, in Silver Spring, Maryland, the meeting will allow stakeholders to comment on FSMA’s implementation strategies regarding (i) “enforcement authorities”; (ii) “frequency and targeting of facility inspections”; (iii) “manner of inspection in a preventive controls environment”; and (iv) “improving the reportable food registry (RFR).” The meeting will also be available through live webcast, and FDA encourages early registration. Details of FSMA were covered in Issue 376 of this Update. See Federal Register, May 26, 2011.

The Center for Science in the Public Interest (CSPI) has filed a citizen petition “requesting that the administrator of the Food Safety and Inspection Service (FSIS) . . . issue an interpretive rule declaring certain delineated strains of antibiotic-resistant [ABR] Salmonella, when found in ground meat and ground poultry, to be adulterants” under federal law. In re: CSPI Petition, No. __ (USDA FSIS, filed May 25, 2011). Noting that FSIS declared E. coli an adulterant in 1994, the petition contends, “Scientific and medical research demonstrates that contamination of meat and poultry by ABR strains of Salmonella poses grave public health dangers that are comparable to those posed by E. coli 0157:H7 in 1994.” According to the petition, several ABR strains in ground meat and poultry products have resulted in recalls, outbreaks and deaths. Seeking expedited review, CSPI claims that 36 documented outbreaks, causing thousands of illnesses and some deaths, were…

Close