WHO experts have reportedly determined that a tolerable daily intake (TDI) of melamine is 0.2 milligrams per kilogram of body weight (mg/kg bw/d). This threshold is lower than the one recently adopted by the U.S. Food and Drug Administration (FDA), which accepts 0.63 mg/kg bw/d as an appropriate TDI for dietary melamine. The WHO standard is also more stringent than the TDIs used in both Europe (0.5 mg/kg mw/d) and Canada (0.35 mg/kg bw/d). Although the organization felt that the U.S. measure provides an acceptable margin of safety, it nevertheless stressed that melamine is not ever considered “safe” for consumption. “Melamine is a contaminant that should not be in food. However, sometimes it is unavoidable,” said WHO in a statement. “TDI represents the tolerable amount of unavoidable contaminant in food that a person can ingest on a daily basis without appreciable health risks.” See Bloomberg.com, December 6, 2008; Law360, December…
Category Archives Issue 285
Reversing a position it took in July 2008, the FDA has issued a notice announcing the withdrawal of a final rule that prohibited the extra-label use of cephalosporin antimicrobial drugs in food-producing animals. As we noted in issue 266 of this Update, the FDA issued its prohibition “based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to human health.” According to the November 26 notice, “The agency received many substantive comments on the order of prohibition. Therefore, to allow more time to fully consider the comments, FDA has decided to revoke the order so that it does not take effect November 30, 2008.” Should the agency again decide to ban use of the drugs, it will provide a public comment period before implementing it. A number of organizations, including agriculture groups and animal-drug…
The National Research Council (NRC) has published a report, titled Review of Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research, that finds “serious weaknesses in the government’s plan for research on the potential health and environmental risks posed by nanomaterials, which are increasingly being used in consumer goods and industry.” NRC describes the research plan developed under the auspices of the National Nanotechnology Initiative (NNI) as “incomplete,” noting that it does not “include research goals to help ensure that nanotechnologies are developed and used as safely as possible.” According to a December 10, 2008, NRC press release, the NNI plan takes only a cursory look at important research areas like “Nanomaterials and Human Health,” which should “include a more comprehensive evaluation of how nanomaterials are absorbed and metabolized by the body and how toxic they are at realistic exposure levels.” NRC also faults the NNI for failing to incorporate vital input from…
The GAO, which serves as the investigative arm of the U.S. Congress, has released a report that analyzes federal oversight of genetically engineered (GE) crops and recommends steps the agencies could take to better address the unauthorized release of these crops into food, animal feed or the environment. Titled Genetically Engineered Crops: Agencies Are Proposing Changes to Improve Oversight but Could Take Additional Steps to Enhance Coordination and Monitoring, the 109-page report discusses the roles that the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) play in regulating GE crops. It also notes how six unauthorized releases of GE crops in recent years may not have adversely affected human or animal health, but did result in lost trade opportunities. The GAO’s assessment was undertaken at the request of Senators Tom Harkin (D-Iowa) and Saxby Chambliss (R-Georgia), the chair and ranking member respectively of the Committee on…
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