California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) is seeking public comments on draft changes to those Proposition 65 (Prop. 65) regulatory provisions addressing no observable effect levels for listed chemicals. According to OEHHA, “[t]hese regulations set out the procedures and criteria for determining an exposure level where there would be no observable effect,” and the proposed changes would “clarify these procedures and criteria.” Comments are requested by October 31, 2010. Prop. 65 requires companies to provide warnings before exposing people to chemicals known to the state to cause cancer or reproductive toxicity. OEHHA is the lead agency implementing the law and maintains the Prop. 65 regulations. The agency has announced the availability of updated hazard identification materials for two chemicals widely used in industry and also formed in certain foods during processing. According to the updated materials, 1,3-Dichloro-2- propanol (1,3-DCP) and 3 Monochloropropane-1,2-diol (3-MCPD), were added to the Prop.…
Category Archives Legislation, Regulations and Standards
European Food Safety Authority (EFSA) Chair Diana Banati has reportedly dismissed conflict-of-interest allegations arising from her involvement with the International Life Sciences Institute (ILSI), a public health nonprofit whose membership includes academic, government and industry scientists. According to Greens MEP José Bové, Banati failed to disclose her industry ties as an ILSI board member when installed at EFSA. “The commission should never have approved her appointment given her clear links to the food industry, which is completely at odds with the need for independence at the EFSA,” Bové was quoted saying. “There can be no alternative but to replace Banati as chair of the EFSA.” Bové has purportedly raised the issue to cast doubt on EFSA’s credibility as the European Commission looks to reform both the food safety body and the approval process for genetically modified organisms. A Banati spokesperson, however, has publicly denied the claims, noting that the chair’s…
The European Food Safety Authority’s (EFSA’s) panel on food contact materials, enzymes, flavorings, and processing aids has released its latest risk assessment for bisphenol A, concluding that there was not any “new evidence which would lead them to revise the current Tolerable Daily Intake [TDI] for BPA of 0.05 mg/kg body weight set . . . in its 2006 opinion and re-confirmed in its 2008 opinion.” The CEF panel undertook the reassessment at the request of the European Commission, which directed scientists to (i) decide on the basis of recent literature whether to update the TDI; (ii) “assess a new study on possible neurodevelopmental effects”; and (iii) advise on a risk assessment made by the National Food Institute at the Technical University of Denmark. Although one minority opinion evidently raised questions about “adverse health effects below the level used to determine the current TDI,” panel members agreed on shortcomings in…
The U.S. Environmental Protection Agency (EPA) has reportedly decided that it will regulate perchlorate, a manmade and naturally occurring chemical used in rocket fuel, explosives and fireworks. While it has not yet established an exposure limit, EPA’s Office of Water sent the Office of Management & Budget a draft notice for its review, outlining EPA’s decision to regulate the chemical by setting a maximum contaminant level under the Safe Drinking Water Act, said a news source. The Food and Drug Administration has found perchlorate in a number of foods, most notably spinach, lettuce and tomatoes, and the Government Accountability Office (GAO) recently reported that it is widespread. GAO notes that the chemical “can disrupt the uptake of iodide in the thyroid, potentially interfering with thyroid function and negatively affecting fetal and infant brain development and growth.” According to a press report, EPA’s decision could pose a challenge to chemical and…
The Food and Drug Administration (FDA) has announced a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, which reviews and evaluates available scientific data concerning the safety of products that might transmit spongiform encephalopathies such as Creutzfeldt-Jakob disease and the bovine variant commonly known as mad cow disease. Agenda items for the October 28-29, 2010, meeting in Gaithersburg, Maryland, include (i) “FDA’s risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII” and (ii) “labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.” The committee will also discuss ways to reduce transmission risks and hear updates on the “development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.” FDA requests written comments by October 21, 2010. See Federal Register, September…
The Food and Drug Administration (FDA) has released a draft strategic priorities document for fiscal years 2011-2015 that outlines four key cost-cutting strategic priorities and four strategic program goals designed to help FDA achieve its public health mission. According to an October 1, 2010, Federal Register notice, the four cost-cutting priorities seek to (i) “advance regulatory science and innovation,” (ii) strengthen the safety and integrity of the global supply chain,” (iii) “strengthen compliance and enforcement activities,” and (iv) “expand efforts to meet the needs of special populations.” Among the program goals, FDA has highlighted intentions to establish effective tobacco regulation as well as advance food safety and nutrition by ensuring the safety of the food supply from farm to table and promoting healthy dietary practices and nutrition. FDA will accept comments until November 1, 2010.
Pinnacle Foods Group LLC has reportedly agreed to reformulate its Log Cabin Syrup® after Vermont Representative Peter Welsh (D) called on the Food and Drug Administration (FDA) to investigate the company for selling a product in apparent violation of agency regulations. Welsh’s September 8, 2010, letter noted that the company’s “All Natural Syrup” contains caramel color, among other ingredients. Welsh suggested that consumers outside the state “who have come to expect quality from natural Vermont products may be fooled by this misleading labeling.” The product is apparently being sold in a beige plastic jug similar to real maple syrup packaging, raising the ire of maple syrup producers. While FDA has not defined the term “natural,” the agency allows it to be used if the claim is truthful and “the product does not contain added color, artificial flavors or synthetic substances,” according to an agency spokesperson. Claiming that its product “provides consumers…
Led by U.S. Senator Mark Begich (D-Alaska), a group of legislators has asked the Food and Drug Administration (FDA) to halt its ongoing review of genetically engineered (GE) salmon, citing “serious concerns with the current approval process and many potential health and environmental risks that are associated with producing GE fish.” FDA recently held public hearings to decide the fate of a new animal drug application (NADA) for AquAvantage® salmon, an Atlantic variety that uses genes from ocean pout and Chinook to increase the speed of maturation. Additional details about these hearings appear in Issue 365 of this Update. In their September 28, 2010, letter to FDA Commissioner Margaret Hamburg, the Senators argue that the NADA process lacks transparency and does not adequately address the “creation of a new animal, especially one intended for human consumption.” The signatories specifically point to reports that GE salmon “‘have slightly higher levels of…
Boston city officials are reportedly considering a move to prohibit or restrict sugar-sweetened beverages sold on city-owned property as a way of combating obesity. The city, which has already prohibited smoking in restaurants and bars and trans fat in fast food restaurants and bakeries, recently convened health, education and housing leaders to develop a policy to reduce sugary beverage consumption. While such a policy has yet to be officially drafted, Barbara Ferrer, executive director of the Boston Public Health Commission, told a news source that such a move seemed inevitable based on the city’s earlier promise to fight obesity by decreasing sweetened soda consumption through “counter-advertising and policy change.” Ferrer was quoted as saying that she expects public resistance to the potential ban because people view soft drinks differently from tobacco. “I think we’re going to run into a big issue of people saying, ‘Why would you take away our…
The European Food Safety Authority (EFSA) has published a scientific statement reaffirming its 2009 conclusion that “in relation to food safety, there is no indication that differences exist for meat and milk of clones and their progeny compared with those from conventionally bred animals.” The food safety watchdog’s assessment, however, pertains only to pigs and cattle because “there is still limited information available on cloning” of other species. The European Commission in May 2010 asked EFSA for an update on scientific developments regarding the safety of cloning farmed animals for food production. In response, EFSA’s Scientific Committee reviewed approximately 100 recent studies and other data from European research centers to determine that no new scientific information has surfaced to change its conclusions about cloned pigs and cattle. According to the statement, EFSA also reconfirmed its previous conclusion that “mortality rates and the number of animals born with developmental abnormalities are…
