The Pew Environment Group has released documents obtained through a Freedom of Information Act request showing that the U.S. Food and Drug Administration (FDA) faulted three Chilean salmon farming companies, “including the two largest producers of farmed salmon,” for using a number of drugs not approved by the U.S. government. FDA inspections apparently uncovered use of the antibiotics flumequine and oxolinic acid and the pesticide emamectin benzoate, as well as trace residues in products intended for the U.S. consumers. The agency then informed the Chilean companies that, “if the drug is not listed in the approved drug list . . . they are not allowed to use the drug to treat salmon destined for distribution in the U.S., not even if they meet withdrawal periods and no tissue residue can be detected.” The Pew Environment Group applauded the FDA stance, but urged the agency to enforce its standards abroad. “Standards and…
Category Archives U.S. Government and Regulatory Agencies
A subcommittee of the House Energy and Commerce Committee conducted a hearing February 11, 2009, to hear from victims, regulators and the individuals who own and operate the Georgia peanut processing facility responsible for the latest Salmonella outbreak. Titled, “The Salmonella Outbreak: The Continued Failure to Protect the Food Supply,” the hearing gave congressmen the opportunity to question Stewart Parnell who owns the Peanut Corp. of America (PCA) about the company’s practice of shipping contaminated product to food processors even after it had tested positive for Salmonella. Parnell and the man who managed the plant invoked their Fifth Amendment privilege and refused to answer questions, including whether they would eat the recalled products, which now number in excess of 1,800 items. The outbreak has reportedly sickened more than 600 in the United States and Canada, led to a suspected nine deaths and launched at least four personal injury lawsuits to date.…
The D.C. Circuit Court of Appeals has reportedly denied a Whole Foods Market, Inc. petition that sought to stop the Federal Trade Commission’s (FTC) antitrust proceedings against the company’s merger with Wild Oats Markets, Inc. The FTC’s administrative trial is scheduled to begin April 6, 2009, and Whole Foods contends that the commission has pre-judged the outcome. According to a Whole Foods spokesperson, “There is no question our due process and equal protection rights have been violated and we intend to pursue this case until we can get a hearing in a federal court about those violations.” According to a news source, Whole Foods is considering reframing and refiling its lawsuit. See Dow Jones Newswires, January 23, 2009.
FDA is seeking nominations for several public advisory committees, including the Transmissible Spongiform Encephalopathies Advisory Committee. This committee evaluates “available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health,” according to FDA. Nominees should have experience in clinical and administrative medicine, hematology, virology, neurovirology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, or other related professions. FDA will accept nominations until it fills all current and upcoming vacancies on the committee. See Federal Register, January 29, 2009.
The Agricultural Marketing Service (AMS) has issued a voluntary standard that livestock producers can use to verify “naturally raised” marketing claims with USDA. The standard apparently took into account more than 44,000 public comments from consumers, veterinarians, trade and professional organizations, national organic associations, consumer, agriculture and animal advocates, and retail and meat companies. AMS concurred with the majority of comments requesting “that the three core criteria proposed (animals raised without growth promotants and antibiotics and have never been fed mammalian or avian byproducts) should be a part of a naturally raised marketing claim standard,” but declined to further narrow the scope of the standard because the agency felt additional restriction would limit its usefulness. “A number of livestock producers make claims associated with production practices in order to distinguish their products in the marketplace,” according to AMS. “This voluntary standard will allow livestock producers to utilize AMS’ voluntary, third…
Whole Foods Market, Inc. has reportedly withdrawn from U.S. district court its due process challenge to the Federal Trade Commission’s (FTC) antitrust proceedings against the company’s merger with Wild Oats Markets, Inc. The case was then refiled before the D.C. Circuit Court of Appeals. According to a Whole Foods executive, “Whole Foods Market is interested in getting to the merits of this case as quickly as possible rather than spending everyone’s valuable time and resources arguing about jurisdiction. Filing with the Court of Appeals, which the FTC concedes has jurisdiction over the case, saves time and we want to move this case forward in the most expeditious manner for all concerned.” Additional details about Whole Foods’ petition appear in issue 285 of this Update. The FTC’s administrative hearings are scheduled to begin April 6, 2009, and Whole Foods claims that the commission has already prejudged the case. See PR Newswire, January…
FDA has published a notice requesting comments, scientific data and information “that would assist the agency in its plans to conduct a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods, sliced, prepared, and/or packaged in retail facilities.” According to the notice, “[l]ittle is known about how Listeria contamination occurs in retail facilities . . . There is thus a need to identify potential sources and practices that may increase L. monocytogenes contamination in retail settings and practices or interventions that could reduce or eliminate L. monocytogenes contamination of food products (sold to consumers at the retail level) and resulting human illness.” Comments and materials relevant to FDA’s risk assessment must be submitted by April 21, 2009. The agency specifically requests data and information about (i) ready-to-eat food markets in the United States; (ii) deli department characteristics; (iii) product contamination data; (iv) factors influencing the growth of the…
The FDA has issued its final guidance on regulating genetically engineered (GE) animals under the new animal drug provisions of the Food, Drug and Cosmetic Act. The guidance clarifies FDA’s regulatory authority “and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.” It is intended to apply to GE animals with heritable rDNA constructs. According to the guidance, GE animals are being developed for a number of purposes, including the enhancement of production or food quality traits, improvements to animal health, the production of products for human therapeutic uses, and enhancement of animals’ interactions with humans (e.g., hypoallergenic pets). The FDA explains when GE animal producers must comply with labeling and record-keeping requirements or submit information for agency approval.
The Federal Trade Commission (FTC), continuing to challenge the merger of Whole Foods Market, Inc. with Wild Oats Markets, Inc, has reportedly indicated in court filings that it will seek a court order requiring Whole Foods to rename the Wild Oats stores that were changed into Whole Foods stores and rebrand them as Wild Oats. The FTC also apparently said that a trustee should be appointed to separately manage Wild Oats assets to preserve the status quo in the organic foods market until all legal proceedings have concluded. The $565 million merger has been completed, but the FTC convinced an appeals court in 2008 to allow the administrative antitrust proceedings to resume. Responding to the latest filing, Whole Foods reportedly stated, “Not only have they found us guilty before the final evidence is in, now they want to impose a burdensome remedy even before the first word of final evidence…
USDA this week issued a final rule for its mandatory country-of-origin labeling (COOL) program, which applies to beef, pork, lamb, chicken, goat meat, wild and farm-raised fish and shellfish, perishable agricultural commodities, peanuts, pecans, ginseng, and macadamia nuts. USDA had previously published an interim final rule in advance of a September 30, 2008, implementation deadline to incorporate changes required by the 2008 Farm Bill, including the addition of several agricultural commodities. Effective March 16, 2009, the final rule takes into account public comments on the interim version. In particular, the rule clarifies USDA’s position on multiple countries of origin labeling and eliminates allowances for commodities of U.S. origin to retain this designation if processed or handled in foreign countries. The final rule also upholds a provision criticized by the Ranchers-Cattlemen Legal Fund (RCALF) that excludes processed food ingredients from COOL regulations. “Publication of the final rule may alleviate some of…
