The Food and Drug Administration (FDA) has reopened the comment period for a proposed rule published August 4, 1993, that would amend the quality standard for bottled water. FDA is seeking further comment on finalizing the allowable level for the chemical di(2 ethylhexyl)phthalate (DEHP) in the bottled water quality standard. In a final rule published March 26, 1996, FDA deferred final action on DEHP’s proposed allowable level of 0.006 milligrams/liter (mg/L) in response to a comment which “maintained that finalizing the proposed allowable level for DEHP would result in a limit on the level of this chemical in bottled water that conflicts with this chemical’s permitted use under the existing food additive regulation for closures with sealing gaskets, and that taking such action would effectively ban the use of this plasticizer.” The comment further stated that “gaskets containing DEHP are permitted for use in packaging food and bottled water under…
Category Archives Food and Drug Administration
The Environmental Protection Agency (EPA) recently published an action plan to address concerns over bisphenol A (BPA), which has purportedly “caused reproductive and developmental effects in animal studies and may also affect the endocrine system.” Intended to strengthen the agency’s chemical management program, the plan focuses on the plasticizer’s environmental impact and proposes (i) adding BPA to the chemical concern list; (ii) gathering information on BPA concentrations in surface, ground and drinking water; (iii) requiring manufacturers to provide EPA with test data related to long-term effects on growth, reproduction and development in aquatic organisms and wildlife; (iv) using EPA’s Design for the Environment program to reduce unnecessary exposures and find acceptable substitutes; and (v) continuing to evaluate “the potential disproportionate impact on children and other sub-populations through exposure from non-food packaging uses.” In addition, EPA has pledged to work with the Food and Drug Administration (FDA) and other federal entities to…
The U.S. Government Accountability Office (GAO) recently issued a report criticizing the Food and Drug Administration (FDA) for its handling of irradiated food products. In response to congressional inquiries, GAO examined current and proposed FDA labeling requirements for irradiated foods, as well as “the extent to which FDA has effectively managed the petition review process for irradiated food.” Despite efforts to bolster public acceptance of irradiated products, FDA “has not effectively managed its petition review process, which is the vehicle to potentially allow more food products to be irradiated,” according to GAO. The report describes ionizing radiation as a safe and effective process capable of eliminating “99.999 percent of E. coli 0157, Listeria and Campylobacter,” but notes that the current labeling scheme may suggest “these foods are less safe.” It also censures FDA’s failure to meet “key statutory and regulatory timeframes” for six currently active and pending food irradiation petitions.…
The Food and Drug Administration (FDA) has issued two requests for public comments regarding proposed collections of information under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. One notice involves the registration of domestic and foreign food facilities. FDA is calling on owners, operators or agents “in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States,” to provide comments on (i) whether FDA’s proposed information collection is necessary for the agency’s performance and the information has practical utility, (ii) the accuracy of the agency’s information collection burden estimates, (iii) ways of improving the “quality, utility, and clarity of the information to be collected,” and (iv) ways to minimize collection burdens. The second notice concerns the collection of information pertaining to prior notice of imported food. Under the Act, FDA must “receive prior notice for…
The Food and Drug Administration (FDA) has requested public comments on how the agency can increase transparency in its interactions with regulated industry. According to a March 12, 2010, FDA press release, the agency regulates products responsible for approximately 25 percent of the U.S. gross national product, as well as overseeing the industries that manufacture these items, which include foods, veterinary medicines, human drugs, and medical devices. FDA’s Internal Transparency Task Force, which already held public meetings in 2009, is developing “recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while protecting confidential information.” Representing FDA’s third and final phase of its transparency initiative, the latest request particularly seeks ideas on how the agency can (i) improve training and education for regulated industry about its regulatory process in general and about specific new requirements, (ii) strengthen the guidance development process, (iii) maintain open channels of…
The Food and Drug Administration (FDA) has reportedly met with spice industry representatives to consider ways to make spices safer amid a nationwide Salmonella outbreak linked to black and red pepper. According to a news source, FDA wants companies to prevent contamination by using one of three methods to rid spices of bacteria: irradiation, steam heating or fumigation with the pesticide ethylene oxide. The American Spice Trade Association is expected to address the issue at its annual meeting to be held April 25-28, 2010, in Naples, Florida. Although FDA does not possess authority to order manufacturers to treat their products, the agency recently reaffirmed its intention to take a closer look at spice handling “from farm to table” and to create a spice risk profile focusing on “microbiological contaminants and filth issues related to spices.” As FDA stated in a March 17, 2010, press release, this risk profile will help determine…
U.S. Senator Kirsten Gillibrand (D-N.Y.) has introduced legislation (S.B. 3114) that would require food distributors, retailers and health agencies to notify consumers and local officials in the event of a Class I food recall. Under the Consumer Recall Notification Act, the Food and Drug Administration (FDA) could ask grocery stores and other retailers to provide “on-site notification” where recalled foods are sold. In addition, purveyors that track data through customer card systems would need to alert, by phone and mail, the purchasers of recalled items or risk civil penalties of $100 per customer. Suppliers would also need to notify “applicable retail establishments and restaurants” within 24 hours of a Class I recall to avoid a $1,000 penalty per day, per notification of each level of distribution. “In America, in 2010, it is unconscionable that we don’t have an effective way to communicate food-borne illness outbreaks to consumers and health departments,”…
The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge. According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault…
Food and Drug Administration (FDA) inspectors issued a report March 4, 2010, stating that Basic Food Flavors, Inc., the Las Vegas-based company at the center of a massive and growing food recall, “continued to distribute HVP [hydrolyzed vegetable protein] paste and powder products” for nearly a month after receiving the first lab results “indicating the presence of Salmonella in your facility.” While no illness has apparently yet been attributed to the HVP, it is used in dozens of products. As of March 11, FDA had identified some 150 products containing HVP, including bouillon, dressing and dressing mixes, frozen foods, ready-to-eat meals, sauces and marinades, snacks and snack mixes, soups, soup mixes and dip mix products, and stuffings. According to some quality management specialists, this outbreak could be particularly challenging because HVP is considered a generic commodity; it can be purchased from many different suppliers, stored without an effective tracking system for…
The Pew Charitable Trusts’ Produce Safety Project (PSP) recently published a cost analysis claiming that health-related expenditures for foodborne illness far exceed the U.S. Department of Agriculture’s estimate of $6.9 billion annually. Authored by former Food and Drug Administration (FDA) economist Robert Scharff, the report concludes that the United States spends $152 billion per year on foodborne illnesses from all sources. The study also notes that these numbers cover health-related costs only and thus represent “a lower bound estimate of the total societal costs,” including costs to industry and government. “Even when pain and suffering losses from acute illnesses are not included, the cost to society is $103 billion,” maintains the report, which used FDA methods to determine the costs of physician services, pharmaceuticals, and hospital visits related to foodborne illnesses, as well as quality of life losses such as lost life expectancy, pain and suffering, and functional disability. Intended…
