The American Bakers Association and a number of other industry trade associations have submitted a citizen petition to the Food and Drug Administration (FDA) seeking regulations that would exempt those businesses engaged in storing packaged foods from hazard analysis and prevention controls applicable to food producers and processors. The petition notes that under the Food Safety Modernization Act (FSMA) Congress allowed FDA to implement its food safety provisions “in a manner that acknowledges the difference in risk posed by various types of operations.” Claiming that “storage facilities themselves pose a very limited, if any, food safety risk,” the petition notes that any potential hazards in warehouses are already addressed through existing good manufacturing practices governing warehousing and distribution facilities. The petitioners, including the Grocery Manufacturers Association, International Bottled Water Association, and Snack Food Association, seek a rule that would state, “A facility that is engaged solely in the storage, holding,…
Category Archives U.S. Government and Regulatory Agencies
Two U.S. senators have asked the Food and Drug Administration (FDA) to finalize standards for a 2007 proposed rule for gluten-free food labels. In a letter to FDA Commissioner Margaret Hamburg, Senators Ron Wyden (D-Ore.) and Patrick Leahy (D-Vt.) claim the delay is “creating unnecessary confusion for consumers and uncertainty for agricultural producers.” Included as part of the Food Allergen Labeling and Consumer Protection Act of 2004, the proposed gluten-free labeling rule represents the last time “any significant action on this has been taken,” the lawmakers wrote, adding that “regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups.” Wyden also issued a July 21, 2011, press release asserting that “accurate and standard” labeling on gluten-free products is essential for those with Celiac disease—“a painful disorder stemming from the inability to properly digest the gluten found in breads.”
A bipartisan group of lawmakers has called on the U.S. Food and Drug Administration (FDA) to stop the approval process for genetically engineered salmon. Fifteen members of the House of Representatives and eight members of the U.S. Senate signed separate letters to FDA Commissioner Margaret Hamburg expressing economic and environmental concerns over the fast-growing fish. “We are concerned that the FDA’s review of GE salmon uses the same criteria as it would for approving a veterinary drug,” noted the Senate letter, adding that “the lack of transparency in the approval process is extremely disconcerting given that approval of GE fish is likely the first step toward approval of many more GE animals for human consumption.” The House recently approved an amendment prohibiting FDA from using money to approve GE salmon applications in fiscal year 2012 and, according to the letters, similar language has been drafted for consideration by the Senate.…
The U.S. Department of Agriculture’s (USDA’s) recent decision to exempt genetically engineered (GE) Kentucky bluegrass from federal approval has reportedly stirred debate over how the agency regulates biotech crops, with some critics calling the outcome “a blatant end-run around regulatory oversight.” According to a July 1, 2011, press release, USDA’s Animal and Plant Health Inspection Service (APHIS) dismissed a petition from the Center for Food Safety and International Center for Technology Assessment claiming that GE bluegrass developed by Scotts Miracle-Gro for golf courses should be regulated as a “noxious weed” under the Plant Protection Act. After conducting its assessment, APHIS apparently declined to regulate “Kentucky bluegrass, GE or traditional,” as a federal noxious weed because it does not contain plant pest components. As a July 7 New York Times article further explained, GE crops “are regulated under rules pertaining to plant pests” that “are really meant for pathogens and parasites,…
“House Republicans are siding with food companies resisting the Obama administration’s efforts to pressure them to stop advertising junk food for children,” writes Associated Press reporter Mary Clare Jalonick in a July 6, 2011, article examining the efforts of individual legislators to stymie proposed Federal Trade Commission (FTC) food marketing guidelines. According to Jalonick, while food companies have lobbied “aggressively” against the proposal, Republican representatives have sought to include a provision in next year’s FTC budget “that would require the government to study the potential costs and impacts of the guidelines before implementing them.” As Representative Jo Ann Emerson (R-Mo.) explained, the guidelines might otherwise “lead to extraordinary pressure from the federal government” on those who do not conform to the voluntary measure. But consumer advocates like the Center for Science in the Public Interest (CSPI) have disputed this reasoning. “The industry is exaggerating the influence of these voluntary regulations to gin…
Several consumer protection organizations have filed a citizen petition with the Food and Drug Administration (FDA), seeking a rulemaking “for labeling and point of sale advisories concerning mercury in seafood to minimize methylmercury exposure to women of childbearing age and children.” According to the petition, some 200,000 children in the United States, between ages two and five, have blood mercury levels nearly 50 percent higher than base levels recommended by the Environmental Protection Agency. Noting that the percentages of women and children exceeding recommended mercury levels are higher in coastal regions and among African-Americans, Asians, the affluent, and those in the fishing industry, the petition claims that consumers “do not know the risks inherent in exposing themselves and their families to this potent neurotoxin.” Jane Hightower, a physician who authored Diagnosis: Mercury—Money, Politics & Poison, signed the petition, which was also brought on behalf of Earthjustice, the Zero Mercury Working…
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced an expansion of the Salmonella Initiative Program (SIP) to help industry reduce foodborne pathogens in raw meat and poultry products. The agency has extended the comment period to September 12, 2011. According to FSIS, the voluntary, incentive-based program allows “participating establishments to operate under certain regulatory waivers to try new procedures, equipment or processing techniques to better control Salmonella.” As a condition for participation, establishments selected for SIP must regularly collect product samples to test for Salmonella, campylobacter and generic E. coli, and then share the data with the agency. FSIS has set new deadlines for establishments currently operating with regulatory waivers to apply for SIP and has allowed a “limited number of establishments to operate with modified line speed” which will be evaluated by a National Institute for Occupational Safety and Health study. See USDA…
The United States and Mexico have signed a memorandum of understanding (MOU) that resolves a long-haul, cross-border trucking dispute involving “retaliatory tariffs” on more than $2 billion in U.S. exports, including food and agricultural products. According to the U.S. Department of Transportation (DOT), the July 6, 2011, agreement will “lift tariffs and put safety first.” Under the agreement, Mexico will immediately suspend half of the retaliatory tariffs imposed in March 2009, with the remaining 50 percent to be removed within five days of the first Mexican trucking company receiving U.S. operating authority. In return, Mexican long-haul truck drivers will be allowed to ship goods into the United States after complying with, among other things, the Federal Motor Vehicle Safety Standards and electronic vehicle monitoring designed to track “hours-of-service compliance” to ensure that drivers make cross-border shipments and not “domestic cargo between points within the United States.” According to U.S. Agriculture…
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (IG) has issued a June 21, 2011, report criticizing the Food and Drug Administration’s (FDA’s) imported food recall guidance as “not adequate to ensure the safety of the nation’s food supply because it was not enforceable.” According to the audit, which covered the period from July 1, 2007, through June 30, 2008, “FDA oversaw 40 Class I recalls of imported food products contaminated with pathogens and other harmful substances that can cause serious illnesses.” After reviewing 17 of those recalls, the IG concluded that firms (i) “did not promptly initiate recalls,” (ii) did not submit viable recall strategies, (iii) “did not issue accurate and complete recall communications to their consignees,”, and (iv) “did not submit timely and complete recall status reports.” The report also faults FDA for the inconsistent application of its own monitoring procedures, including the…
A federal court in California has denied Safeway, Inc.’s motion to dismiss or stay proceedings alleging that it has an obligation to use information in its loyalty card customer database to provide email notice about produce recalls ordered by the Food and Drug Administration (FDA) or U.S. Department of Agriculture. Hensley-Maclean v. Safeway, Inc., No. 11-1230 (N.D. Cal., order entered June 13, 2011). Additional details about the case, which was first filed in state court, appear in Issue 380 of this Update. The grocery company argued that the “primary jurisdiction doctrine” or “equitable abstention” required the court to dismiss or stay the litigation “until and unless regulatory agencies have had the opportunity to consider and adopt appropriate rules governing the obligations a grocery store has with respect to providing its customers notice of such recalls.” According to Safeway, the Food Safety Modernization Act requires FDA to develop notice guidelines by…
