California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has added bisphenol A (BPA) to the “list of chemicals known to the State to cause reproductive toxicity for purposes of Proposition 65” (Prop. 65). The listing, which will require warnings to consumers, took effect April 11, 2013. Failure to provide the warnings can result in significant financial penalties, and alleged violations can be enforced by private citizens. OEHHA based its determination on a National Toxicology Program report which concluded that the chemical “causes reproductive toxicity (developmental endpoint) at high doses.” BPA is commonly found in cash register receipts, CDs and DVDs, and food packaging material, including plastic containers and bottles, and metal cans and lids. When OEHHA proposed listing the chemical, it also proposed adopting a maximum allowable dose level (MADL) of 290 micrograms per day. Additional information about the MADL proposal appears in Issue 468 of this Update. When…
Category Archives Issue 479
The U.K. Food Standards Agency (FSA) has launched public consultations on two sets of proposed legislation, “The Contaminants in Food (England) Regulations 2013” and “The Food Additives, Flavourings, Enzymes, and Extraction Solvents (England) Regulations 2013.” The first set of regulations related to food contaminants will revoke the 2010 version and take into account new European Commission regulations regarding (i) “maximum levels for nitrate in foodstuffs”; (ii) “maximum levels for the presence of coccidiostats and histomonostats in food resulting from the unavoidable carry-over of these substances in non-targeted feed”; and (iii) under-enforcement of EU provisions providing for “the labeling of groundnuts, other oilseeds, derived products thereof and cereals.” The Contaminants in Food Regulations will also revoke “national legislation on mineral hydrocarbons in food and revoke and remake[] the provisions of the Erucic Acid in Food Regulations 1977.” The second set of regulations will consolidate “all legislation within [FSA’s] remit covering food…
The World Health Organization (WHO) has issued a global alert and response update on a new strain of novel avian influenza A (H7N9) virus identified by Chinese health officials, who have apparently confirmed 38 cases resulting in 10 fatalities. According to WHO, which has not yet recommended any trade or travel restrictions, there is no evidence to date of “of ongoing human-to-human transmission,” although the agency is working with Chinese authorities to monitor those with close contacts to infected patients and to determine potential disease reservoirs in domestic and wild poultry. Meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) has reportedly activated its Emergency Operations Center in Atlanta, Georgia, in response to the outbreak, in addition to publishing interim guidance for U.S. clinicians, public health departments and health care workers outlining virus testing and control methods. “Ongoing (sustained) person-to-person spread is necessary for a pandemic to occur,” states…
The National Toxicology Program (NTP) and the Office of Dietary Supplements are seeking information and comments on an approach document titled “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid.” According to NTP, the information gathered through the request will be used to prioritize topics for a workshop the agency is planning “to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid.” Although “[t]he benefit of supplemental folic acid for pregnant women to prevent neural tube defects in their children is well established,” NTP stated, “at the same time, there is interest in understanding potential adverse health impacts from high intakes of folic acid.” The agency is specifically seeking information on the following topics: (i) “health effects of most concern for high folate intake”; (ii) “assessments of folic acid intake and folate levels…
The National Toxicology Program (NTP) will host an April 23, 2013, Webinar to discuss case studies on the alleged health effects of bisphenol A (BPA) and the chemicals perfluorooctanoic acid and perfluorooctane sulfonate. The studies are intended to illustrate how the NTP Office of Health Assessment and Translation will implement its draft systematic literature-based review methodology in carrying out potential human health hazard assessments. Comments on the draft approach and case studies are requested by June 11. The BPA case study provides a draft protocol to evaluate the evidence for an association between obesity and exposure to the chemical, used in food contact materials, including plastic and metal cans; cash register receipts; sports equipment; and CDs and DVDs. It does not reach any final risk conclusions, but shows how relevant literature will be identified and rated in developing hazard identification conclusions.
The U.S. Food and Drug Administration (USDA) has proposed two new fees—a food import user fee and a food facility and inspection fee that the agency says will “enhance the safety protections for imported food and feed” as well as support “new and improved activities required by the Food Safety Modernization Act (FSMA) to modernize FDA’s inspection system.” According to FDA, programs to support FSMA are scheduled to cost $295 million next year and will apparently be 94 percent funded by user fees. “These investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply,” the agency asserts in its budget proposal. FDA has also proposed new user fees to support its cosmetic and food contact substance notification programs. In a statement releasing the budget, FDA Commissioner Margaret Hamburg said, “These are tight budget times, and the FDA…
The U.S. Occupational Safety and Health Administration (OSHA) has reportedly cited Natural Flavors Inc. for 12 alleged workplace safety and health violations at its Newark, New Jersey, facility and proposed penalties in excess of $60,000. According to OSHA, an inspection confirmed that company employees were “overexposed to diacetyl,” a butter flavoring purportedly associated with bronchiolitis obliterans, a debilitating lung disease. An agency regional administrator said, “As early as 2004, the flavoring manufacturing industry has been aware that its workers who are overexposed to diacetyl on the job have developed severe, life-threatening lung disease. It is outrageous that Natural Flavors would expose workers to this debilitating chemical without taking the necessary steps to properly assess exposure and protect its employees.” OSHA included a willful violation in the citation for the company’s alleged failure “to adequately identify and evaluate respiratory hazards.” See OSHA Regional News Release, April 8, 2013.
The U.S. Department of Justice (DOJ) has reportedly indicted a London, Kentucky-based cattle company and its treasurer for falsifying records related to a federal investigation and creating false documents. The charges apparently arise out of a Food and Drug Administration (FDA) investigation to determine whether the company was violating a 2006 court-ordered injunction requiring it to notify buyers if the company sells them animals with medical drugs in their systems. The order also requires the company to “identify the potential cause for the medical drugs in the animals and to refrain from purchasing animals from sellers who supply cattle that contain medical drugs.” Williams Cattle Co. treasurer Pamela Collette allegedly “falsified weekly reports that were supposed to be sent to buyers verifying that the animals sold were drug free, in an attempt to influence the outcome of the investigation. She is also alleged to have created false documents that appeared…
U.S. Rep. Edward Markey (D-Mass.) and Sens. Richard Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have issued a joint report presenting the results of their investigation into the energy drink industry. Titled “What’s all the Buzz About?,” the report is based on survey responses from 14 energy drink companies asked to outline their current marketing, labeling and manufacturing practices. According to the lawmakers, the responses highlight various inconsistencies in how these companies market and label their products under current regulations, “leading to consumer confusion and a lack of transparency.” In particular, the report alleges that (i) “four out of the 14 companies surveyed classify and market one or more of its products as dietary supplements, as opposed to conventional beverages”; (ii) “concentrations of caffeine are not uniformly represented on the label of the brands evaluated,” with some concentrations exceeding safety levels set by the Food and Drug Administration (FDA) for soda;…
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