The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) has determined that genetically engineered (GE) sugar beets are “no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms.” According to the agency, the crop, which is engineered to tolerate the herbicide glyphosate and is known as “Roundup Ready®, is “unlikely to pose a plant pest risk and, in fact, is not a plant pest.” Thus, the crop is no longer subject to federal GE regulation. The determination ends a lengthy dispute that began when organic farmers claimed that APHIS failed, when deregulating the crop in 2005, to properly consider the crop’s propensity to cross-pollinate nearby fields of conventional sugar beets and the likelihood that herbicide resistant weeds would also result from planting the GE crop. A federal court agreed and ordered the preparation of an environmental impact statement (EIS).…
Category Archives U.S. Government and Regulatory Agencies
FDA has issued a request for comments on a proposed information collection that will add the manufacturers of certain beers as respondents to its labeling regulations and seeks Office of Management and Budget approval of allergen labeling for these beers. The agency explains that after the Alcohol and Tobacco Tax and Trade Bureau determined that certain beers, which are made from substitutes for malted barley, such as sorghum, rice or wheat, do not meet the definition of “malt beverage” and are thus not subject to its regulations, the Food and Drug Administration (FDA) prepared draft guidance to assist these manufacturers in complying with its labeling regulations. On the basis of the labeling regulations discussed in the guidance, the agency provides estimates of the average burden per disclosure for each regulation— that is, “12 respondents will each label 2 products annually, for a total of 24 labels” and “the manufacturers will…
The Government Accountability Office (GAO) has issued a July 26, 2012, report criticizing the Food and Drug Administration’s (FDA’s) efforts to implement a comprehensive food advisory and recall process. As directed by the FDA Food Safety Modernization Act, GAO reportedly assessed the agency’s ability to order recalls and effectively inform consumers and retailers about food safety issues, concluding that although FDA has established internal procedures “describing the steps it will take to order a food recall ... these procedures are not yet public and the agency has not issued regulations or industry guidance to clarify its ordered food recall process.” In particular, the report faults FDA for failing to fashion “a comprehensive food recall communication policy and related implementation plans.” Noting that recent foodborne illness outbreaks have drawn national attention to food supply safety issues, GAO argues that FDA has not yet drafted measures to better manage its communication challenges or…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has posted on its website a report from the 35th Session of the Codex Alimentarius Commission that convened in Rome earlier in July 2012. In addition to adopting a number of standards on food additives, food hygiene guidelines, maximum levels of melamine for liquid infant formula, and maximum pesticide residue levels, the Commission agreed to update a scientific review of the use of recombinant bovine somatotropin (rBST) to stimulate milk production in dairy cows. Maximum residue levels have been stalled at Step 8 since 1995, and debate over the issue apparently continues. Those opposed to the use of rBST cited animal health, welfare and possible anti-microbial resistance, while the United States and others contend that these issues exceed the Codex’s scope, the science is sufficient and no food safety issues remain.
The U.S. Department of Agriculture (USDA) has reportedly agreed to fund produce safety inspections through the end of 2012 despite the government’s failure to include the agency’s Microbiological Data Program (MDP) in next year’s budgets. According to media sources, neither the Obama administration nor Congress allocated resources for the 11-year-old program, which coordinates with local officials to screen alfalfa sprouts, cantaloupe, cilantro, hot peppers, lettuce, spinach, and tomatoes for pathogens such as E. coli (STEC), E. coli 0157:H7, Listeria monocytogenes, and Salmonella. Responsible for 30 recalls since 2009, the MDP has garnered praise from consumer groups that have since decried its imminent demise while lambasting public officials for dispensing with the $5 million needed to keep the program running. “It’s a small sum of money in the government sense,” David Plunkett, senior staff attorney for the Center for Science in the Public Interest, told reporters. “For the government, it’s not…
The Food and Drug Administration (FDA) has issued a final rule amending the food additive regulations at 21 CFR part 177 “to no longer provide for the use of polycarbonate (PC) resins,” including bisphenol A (BPA), in infant feeding bottles or spill-proof sippy cups. Effective July 17, 2012, the final rule apparently responds to a petition filed by the American Chemistry Council (ACC), which claimed that “that baby bottles and sippy cups manufactured from PC resins are no longer being introduced into the U.S. market and that manufacturers of baby bottles and sippy cups have abandoned the use of PC resins in making these products.” After reviewing the submitted data and seven public comments addressing the petition, FDA concluded that the use of PC resins in these products has been “completely and permanently abandoned,” and agreed to amend the regulations accordingly. The agency has requested objections to the final rule…
A federal court in Wisconsin has reportedly approved a consent decree between the U.S. government a Wisconsin livestock operation that allegedly violated federal drug laws by failing to maintain adequate animal treatment records, using new animal drugs illegally and failing to adequately distinguish between medicated and non-medicated animals for sale for use as human food. The Food and Drug Administration (FDA) initially warned the owner of Nolan Livestock in 2004 that a U.S. Department of Agriculture inspection revealed the presence of an illegal antibiotic in the edible tissues of its dairy cows. Under the consent decree, the owner must cease operations and then resume only when it has documented to FDA’s satisfaction that it has corrected the problems observed and has instituted appropriate procedures to prevent a recurrence. See U.S. Department of Justice News Release, June 26, 2012; FDA News Release, July 10, 2012.
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a July 6, 2012, notice announcing its decision to restructure its National Residue Program to permit more extensive compound testing of meat, poultry and egg products. According to FSIS, the revamped program aims to reduce the number of samples analyzed while allowing the agency to assess more compounds per sample using improved multi-residue methods. In particular, these methods will enable FSIS to screen for pesticides and environmental contaminants as well as legal and illegal veterinary drugs such as antibiotics, anti-inflammatories and growth promoters. “Under the new system, one sample may be tested for as many as 55 pesticide chemicals, 9 kinds of antibiotics, various metals, and eventually more than 50 other chemicals,” explained the agency in a July 2 press release, which noted that the previous program required FSIS to collect one sample per animal and…
The Food and Drug Administration (FDA) will take part in a collaborative effort to create a public database that will contain 100,000 foodborne pathogen genomes to help facilitate the identification of those responsible for outbreaks involving bacteria such as Salmonella, Listeria and E. coli. Called “The 100K Genome Project,” the undertaking will apparently be a five-year genetic sequencing program openly accessible to researchers and others helping to develop tests that would identify the type of bacteria present in a sample within days or hours. According to one project participant, “Each year in the United States there are more than 48 million cases of foodborne illness. A problem of this magnitude demands an equally large countermeasure.” See FDA News Release, July 12, 2012.
The Natural Resources Defense Council (NRDC) has filed a lawsuit against the Food and Drug Administration (FDA) and the Center for Veterinary Medicine (CVM) alleging that they have failed, in response to a Freedom of Information Act (FOIA) request, to produce documents pertaining to risk assessments for antibiotics used in livestock production. NRDC v. FDA, No. 12-4757 (S.D.N.Y., filed June 18, 2012). Seeking a declaration that the defendants violated FOIA and an order that they disclose “all responsive, non-exempt records to plaintiff within fifteen days,” NRDC refers to industry guidance that FDA issued in 2003 on “assessing the safety of antimicrobial new animal drugs with regard to the microbiological effects on bacteria of human health concern” and actions the defendants have taken since then relying on the guidance. After FDA acknowledged in a December 2011 Federal Register notice that it had begun “to look at the safety of some .…
