The U.S. Government Accountability Office (GAO) has issued a September 2011 report claiming that the Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) have failed to obtain credible data on the use of antibiotics in food animals, as well as the presence of resistant bacteria in animals and retail meat. After examining the extent to which U.S. agencies have addressed this area of concern, GAO apparently found major gaps in the information needed to understand how livestock antibiotics can contribute “to the emergence of resistant bacteria that may affect humans.” In particular, the report faulted the Food and Drug Administration (FDA) for failing to adequately monitor a 2010 voluntary strategy designed to limit “approved uses of antibiotics” and increase “veterinary supervision of use.” According to GAO, “FDA does not collect the antibiotic use data, including the purpose of use, needed to measure the strategy’s effectiveness.”…
Category Archives Legislation, Regulations and Standards
The U.S. Government Accountability Office (GAO) recently delivered its evaluation of how well federal agencies have implemented the nation’s food and agricultural defense policy known as Homeland Security Presidential Directive (HSPD)-9. Established to protect the food supply “against terrorist attacks, major disasters, and other emergencies,” HSPD-9 divides emergency response activities among several agencies, including the Departments of Agriculture (USDA), Health and Human Services, and Homeland Security, the latter of which has designated a system of emergency support functions (ESFs) within a National Response Framework. According to the August 2011 GAO report, however, “There is no centralized coordination to oversee the federal government’s overall progress implementing… HSPD-9.” In testimony before a subcommittee of the U.S. Senate Committee on Homeland Security and Governmental Affairs, GAO Natural Resources and Environmental Director Lisa Shames explained that because this general oversight is lacking, the agencies responsible for HSPD-9 cannot guarantee their “cross-cutting” efforts are “well-designed and…
According to a news source, Del Monte Fresh Produce NA Inc. has indicated, as part of its campaign to counter allegations that its cantaloupes, imported from Guatemala, were tainted with Salmonella, that it intends to sue the Oregon Health Authority and a public health official for making “misleading allegations” about its products. Company Vice President Dennis Christou reportedly said, “These statements were made despite the lack of a substantive factual basis for the allegations and the failure to adequately investigate the true source of the contamination.” Information about litigation Del Monte filed against the Food and Drug Administration (FDA), seeking to lift an import alert related to its Guatemalan cantaloupes appears in Issue 407 of this Update. The Center for Science in the Public Interest (CSPI) has criticized the company for taking action against government agencies, stating in a press release, “FDA and Oregon used state-of-the-art techniques to identify the food…
The Food Safety and Inspection Service (FSIS) has announced the availability of final compliance guidelines for video monitoring at federally inspected establishments, such as meat and poultry plants. The guidelines, which have received Office of Management and Budget approval, stem from a 2008 USDA Office of Inspector General (OIG) recommendation that called for FSIS to determine whether such monitoring would be beneficial for “slaughterhouse establishments.” Additional information about the guidelines appears in Issue 369 of this Update. Although not mandatory, in-plant video monitoring can be used to strengthen food safety and humane animal-handling practices, and to monitor product inventory and building security, according to FSIS. The agency has provided the guide to help those plants choosing this method to create records for maintaining “compliance with [f]ederal regulations, including humane treatment of livestock and the use of good commercial practices in poultry.” It also “provides information on issues establishments should consider…
The Natural Resources Defense Council, Inc. (NRDC), a non-profit advocacy organization, has filed a complaint for declaratory and injunctive relief against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), seeking an order compelling FDA to issue a final response to NRDC’s October 2008 petition calling on the agency to prohibit the use of bisphenol A (BPA) in food packaging and other food-contact materials. NRDC, Inc. v. HHS, No. 11-5801 (S.D.N.Y., filed August 19, 2011). In June 2011, the D.C. Circuit Court of Appeals apparently dismissed a similar complaint, agreeing with FDA that it had been filed in the wrong court. Additional information about that complaint appears in Issue 356 of this Update. According to the new complaint, the Food, Drug, and Cosmetic Act requires FDA to respond to petitions like the one NRDC filed “within 90 days.” Yet, “ [m]ore than one thousand…
Del Monte Fresh Produce N.A., Inc. has filed a complaint for declaratory and injunctive relief against the Food and Drug Administration (FDA) in a federal court in Maryland alleging that the agency lacked an adequate factual basis after a Salmonella outbreak in early 2011 to conclude that the company’s Guatemalan cantaloupe supplier was the source of the contamination. Del Monte Fresh Produce N.A., Inc. v. United States, No. __ (D. Md., filed August 23, 2011). On the basis of that conclusion, FDA allegedly demanded that the company issue a recall or “suffer the consequences of an FDA consumer advisory questioning the wholesomeness of Del Monte cantaloupes.” The agency also imposed an import alert under which Del Monte is prohibited from importing cantaloupes from its Guatemalan source without proving the fruit is “negative” for Salmonella and other pathogens. According to Del Monte, “this prohibition will continue indefinitely into the future unless…
According to a press report, the U.S. Department of Justice (DOJ) plans to oppose the request for $90.8 million in attorney’s fees filed by counsel for African-American farmers who sued the U.S. Department of Agriculture for discrimination in the administration of farm loan programs. Additional information about the fee petition appears in Issue 405 of this Update. While DOJ lawyers have not yet filed a formal opposition to the fee petition, in other court papers they have apparently indicated that “the government does not agree with every point made by plaintiffs in support of final approval of this settlement agreement.” The fee request represents 7.4 percent of the proposed $1.25 billion settlement. Ten individuals reportedly filed an objection to the settlement earlier in August, contending that settling the matter before discovery would be detrimental to plaintiffs who would lose their bargaining leverage with the federal government. See The BLT: The…
The Food and Drug Administration (FDA) has issued its “Strategic Plan for Regulatory Science,” a document deemed to be the agency’s “blueprint for overhauling the science it uses to develop and evaluate food, medicines, and medical devices.” In a section underscoring the agency’s emphasis on food safety, the document focuses on prevention and risk-based priorities required by the Food Safety Modernization Act. “To effectively implement this new food safety mandate, it is imperative that FDA ensures a strong science infrastructure, clearly identifies its research needs, and collaborates with other public health and research agencies in the [f]ederal government, state government agencies, academia, and private industry,” states the document, which details FDA’s Regulatory Science Initiative outlined in October 2010. Regarding food science, FDA plans to (i) “[e]stablish and implement centralized planning and performance measurement processes,” (ii) “[i]mprove information sharing internally and externally,” (iii) “[m]aintain mission critical science capabilities,” and (iv) “[c]ultivate…
The U.S. Department of Agriculture (USDA) has rejected New York City Mayor Michael Bloomberg’s (I) plan to prohibit residents from using food stamps to buy sugar-sweetened beverages and soda. In October 2010, Bloomberg and state officials had proposed a two-year experiment that would exclude the drinks from USDA’s Supplemental Nutrition Assistance Program (SNAP) in an effort to reduce obesity. In an August 19, 2011, letter to a state official, SNAP’s associate administrator Jessica Shahin wrote that the waiver was denied because of concerns that the “scale and scope” of the plan were “too large and complex” to implement and evaluate. Asserting that it would be too difficult to assess the ban’s effectiveness, Shahin instead suggested that USDA collaborate with the city on “anti-obesity intervention targeting consumption and associated behaviors while encouraging healthy choices.” Expressing disappointment with the decision, Bloomberg said, “We think our innovative pilot would have done more to…
The U.K. Food Standards Agency (FSA) has issued an August 16, 2011, notice soliciting information about “the sale and consumption of whole insects and other animals, such as worms,” which may eventually require novel food assessment under the European Union’s (EU’s) food safety laws. Directed at insect suppliers, the Natural History Museum, and various consumer, manufacturer and retailer associations, the request seeks feedback about U.K. insect consumption, including the extent and duration of sales, with the aim of generating “as comprehensive a list as possible of insects and other animals” likely to come under the auspices of EU Novel Food Regulation (EC) 258/97 when it is revisited in 2012. The current food safety regulation apparently omits insects and other whole animals, “largely due to an apparent oversight in the wording of the existing text.” According to FSA, the responses will contribute to “a broader EU-wide investigation into the marketing of edible…
