The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) has issued a 66-page proposed rule that would update import rules for bovine spongiform encephalopathy (BSE). The topic was discussed in Issue 427 of this Update. Current U.S. trade rules prohibit beef imports from countries that have outbreaks or high risks of BSE, commonly known as mad cow disease. Under the proposal, APHIS would adopt criteria used by the World Organization for Animal Health (OIE) that identify a country’s BSE risks as negligible, controlled or undetermined. Basing its import policy for a particular country on that country’s risk classification, APHIS would also conduct its own assessment, such as when a country is not yet classified by the OIE for BSE risk and requests APHIS to conduct a risk evaluation using OIE criteria. Countries would be considered an undetermined BSE risk unless officially recognized as negligible or controlled. Calling…
Category Archives U.S. Government and Regulatory Agencies
The National Consumers League has written to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, asking the agency to take enforcement action against several companies that label their products as “100%” lemon juice, while they actually contain 35 percent or less lemon juice. According to the March 21, 2012, letter, “The products tested omit requisite amounts of real lemon juice and substitute water, citric acid, and in some cases sugar. The cheating is concealed by labeling the products as ‘100%’ lemon juice or simply ‘Lemon Juice from concentrate,’ and the producers make it appear that the products are of greater value than they really are.” Included with the letter are labels from four different products and lab reports from the company that apparently tested them. The National Consumers League characterizes the juice as “heavily diluted with water beyond what is necessary and appropriate to reconstitute the product.” Its letter also…
The Food and Drug Administration (FDA) has issued a warning letter to Staples, Inc. concerning inspections conducted at its California facility where food products are stored. FDA apparently discovered “serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.” Among other matters, rodent excreta pellets were found on or near “at least 11 different food products, including various brands of candies, crackers, creamers, pistachios, ramen noodles, and bottled water.” The inspectors also apparently found dead rodents in traps throughout the facility and rodent gnawed holes on individual food packages. FDA acknowledged that the company voluntarily destroyed food products under the agency’s supervision in October 2011 and that the company repaired six roll-up doors at the facility. Still, because the company did not document its corrections with photographs or include a site map indicating the placement of rodent traps or pest control records with its response, it had not…
The U.S. Government Accountability Office (GAO) has issued a March 2012 report urging the U.S. Department of Agriculture (USDA) to adopt several measures to reduce Shiga toxin-producing Escherichia coli (STEC) in cattle before they are slaughtered. According to GAO, USDA currently recognizes bacteriophages, probiotics, vaccines, and sodium chlorate as preslaughter interventions able to control STEC, but has received few applications for commercial products that use these methods. The report notes that even in the case of STEC vaccines, USDA’s requirements for approval are “unclear” and do not address “some of the unique challenges faced by manufacturers of animal health products.” GAO found that, unlike the Canadian Centre for Veterinary Biologics, USDA fails to specify when it requires laboratory or field demonstrations of vaccine efficacy, resulting in delayed application approval. There is also apparently a lack of available products designed to test for six STEC strains—other than STEC O157:H7—that are now considered…
Fifty-five members of Congress have sent a letter to the Food and Drug Administration (FDA) in support of a legal petition demanding the labeling of genetically engineered (GE) foods. Signed by 10 senators and 45 representatives, the March 12, 2012, letter urges FDA “to protect a consumer’s right to know, the freedom to choose what we feed our families, and the integrity of our free and open markets.” Filed in October 2011 by the nonprofit Center for Food Safety, the petition reportedly has the support of more than 400 health and consumer agencies and has received nearly a million comments in favor of GE labeling, the lawmakers said. They assert that FDA’s 1992 policy statement allowing GE foods to be marketed without labeling is inadequate and outdated because it merely covers foods changed “materially” by taste, smell or other senses. “The use of novel food technologies like genetic engineering on…
Based on documents obtained from the U.S. Department of Agriculture (USDA) under the Freedom of Information Act, Food & Water Watch has urged the agency not to expand its pilot HACCP-based inspection project, contending that inspections conducted by poultry processing plant employees miss many defects. While USDA hopes to expand the program, claiming it will save the federal government $90 million and eliminate more than 800 inspector positions over three years, Food & Water Watch asserts that consumer health would be compromised by any such expansion. According to the consumer watchdog, USDA’s pilot project, launched in 1998 and involving two dozen slaughter facilities, relies on untrained plant employees to inspect carcasses for food safety and other consumer protection issues. Many of the pilot plants have apparently been granted line speed waivers and have sped up their lines to 200 birds per minute. In plants where USDA inspectors still conduct conventional…
Part II of the American Bar Association’s (ABA’s) Nanotechnology Project, this recently released book comprehensively considers, by product category, how the Food and Drug Administration (FDA) reviews nanotechnology-based products. Shook, Hardy & Bacon Agribusiness & Food Safety Attorney James Andreasen was among those practitioners contributing to the work. Among the chapters are “Color Additives,” “Food Additives and Related Substances,” “Dietary Supplements,” “Food and Animal Feed Products,” and “Biological Products.” They address “how FDA can, and to some extent, has, regulated nanomaterials in products falling under its multiple areas of responsibility,” and (i) identify “products that already feature nanomaterials”; (ii) review “FDA’s regulatory program for the specific product category (such as particular pre-market and post-market controls)”; and (iii) discuss “how that program might apply to nanomaterials.”
A federal court in South Carolina has dismissed three of four claims in a lawsuit filed by a family farming operation that claims the Food and Drug Administration’s (FDA’s) 2008 tomato recall, which later proved unnecessary as the agency conceded that tomatoes were not the source of the Salmonella contamination, caused the farm substantial economic harm. Seaside Farm, Inc. v. United States, No. 11-1199 (D.S.C., decided March 6, 2012). Further details about the litigation appear in Issue 395 of this Update. The court dismissed the plaintiff’s Takings Clause claim, the claim that FDA violated the South Carolina Unfair Trade Practices Act and the defamation claim. The plaintiff’s negligence claim will, however, proceed. While the court suggested that this may actually be a claim for defamation and thus may also be subject to dismissal under the Federal Tort Claims Act, because the defendant did not seek to dismiss on this ground, the court declined…
The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.” Noting that a variety of products are manufactured from fermentation processes, such as “competitive exclusion products” that consist of one or more microorganisms intended to prevent harmful bacteria like Salmonella from colonizing, FDA has requested comments on the guidance at any time. See Federal Register, March 8, 2012.
The Food and Drug Administration (FDA) has released industry guidance addressing the testing procedures for Salmonella species “in human foods and direct-human-contact animal foods.” Applicable to firms that manufacture, process, pack, or hold these products for distribution to consumers, institutions or food processors, the guidance also discusses the interpretation of test results when the presence of Salmonella “in the food may render the food injurious to human health.” The guidance excludes egg producers and others covered under different FDA food safety rules. The agency will accept comments at any time. See Federal Register, March 8, 2012.
