The U.S. Food and Drug Administration (FDA) denied a citizen petition to ban the use of perchlorates in dry food packaging while revoking regulations permitting the use of potassium perchlorate in food-container seals, saying industry makers no longer use the chemical. FDA said it will amend food additive regulations allowing the use of potassium perchlorate as a component in sealing gaskets for food containers. Trade groups petitioned for the change, arguing that plastics manufacturers have stopped using the compound. The following day, FDA rejected a petition from public interest groups seeking to ban use of potassium perchlorate and sodium perchlorate monohydrate in dry food packaging and requesting that the agency issue new regulations prohibiting use of perchlorates in packaging. Neither request was “the proper subject of a food additive petition,” the agency stated, but the groups could petition to revoke or reevaluate the Threshold of Regulation exemption. Issue 633
Tag Archives perchlorate
In a lawsuit brought by the Natural Resources Defense Council (NRDC) alleging failure to meet a deadline to set limits on perchlorate levels in drinking water, a New York federal court has issued an order adopting the U.S. Environmental Protection Agency’s (EPA’s) preferred language to admit the failure. Nat. Res. Def. Council v. EPA, No. 16-1251 (S.D.N.Y., order entered September 19, 2016). An EPA attorney reportedly admitted in court that the agency had missed the deadline of February 11, 2013, to set limits on perchlorate in drinking water after announcing its intention to propose regulations two years prior. NRDC and EPA then submitted proposed orders admitting the failure, and the court adopted EPA’s language without further discussion. See Law360, September 20, 2016. The court’s order finds that (i) EPA triggered a non-discretionary duty to propose a maximum contaminant level goal by February 11, 2013; (ii) EPA failed to propose that goal…
The U.S. Food and Drug Administration (FDA) has filed an opposition to a petition for a writ of mandamus seeking a response to several consumer groups’ petition to prohibit perchlorate, an additive currently approved for limited use in food packaging. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed July 8, 2016). The groups’ petition urged the Ninth Circuit Court of Appeals to compel FDA to respond to their December 2014 food additive petition, arguing the agency was required to respond by June 2015. Details about the petition for a writ of mandamus filed by the groups—which include the Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Working Group and the Natural Resources Defense Council—appear in Issue 599 of this Update. FDA’s response first challenges the group’s standing to sue. “Even if petitioners could demonstrate that perchlorate poses some risk…
Several consumer organizations, including the Center for Food Safety, Environmental Working Group and Natural Resources Defense Council, have filed a petition for a writ of mandamus in the U.S. Court of Appeals for the Ninth Circuit seeking a writ compelling the U.S. Food and Drug Administration (FDA) to address the groups’ administrative petition filed in December 2014. Breast Cancer Fund v. FDA, No. 16-70878 (9th Cir., petition filed March 31, 2016). FDA missed a June 2015 deadline to respond to the groups’ petition, which implored FDA to rescind foodcontact approval for perchlorate, “an endocrine-disrupting chemical that interferes with the thyroid gland” used in food packaging. “Perchlorate is primarily used in rocket fuel. There is no reason FDA should allow a chemical like this in or on food products,” Andrew Kimbrell, executive director of Center for Food Safety, said in a March 31, 2016, press release. “It is irresponsible, illegal, and…
The European Food Safety Authority’s (EFSA’s) Panel on Contaminants in the Food Chain (CONTAM Panel) has issued a scientific opinion assessing the health risks of acute and chronic dietary exposure to chlorate, “a byproduct when using chlorine, chlorine dioxide or hypochlorite for the disinfection of drinking water, water for food production and surfaces coming into contact with food.” At the request of the European Commission, the opinion considers the presence of chlorate in both drinking water and food, setting “a tolerable daily intake (TDI) of 3 micrograms per kg (µg/kg) of body weight per day for long-term exposure to chlorate in food,” with “a recommended safe intake level for a daily intake (called the ‘acute reference dose’) of chlorate of 36 µg/kg of body weight per day.” After reviewing data collected by the EFSA Evidence Management Unit, the CONTAM Panel identified drinking water as “the main average contributor to chronic dietary exposure,”…
The Environmental Protection Agency’s (EPA’s) Science Advisory Board (SAB) has announced a July 18-19, 2012, public meeting of the SAB Perchlorate Advisory Panel and September 25 public teleconference to address a maximum contaminant level goal (MCLG) for the rocket fuel constituent perchlorate. Perchlorate contamination has been detected in samples of milk, drinking water and lettuce, and exposure at high levels has been linked to thyroid dysfunction and neurological problems in children. See Federal Register, May 30, 2012.
The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has issued a notice addressing its amendment to “the calculation used to convert estimates of animal cancer potencyto estimates of human cancer potency, which is used to calculate no significant risk levels for carcinogens listed under Proposition 65.” According to the notice, the amendment took effect November 11, 2011, and will change “the existing regulatory provision to a ratio of human to animal bodyweight to the one-fourth power for interspecies conversion and delete[] the provision giving specific scaling factors for mice and rat data.” OEHHA has also announced that its Carcinogen Identification Committee has been asked to consider whether Dibenzanthracenes should be added to the Proposition 65 list. These substances are ubiquitous polyaromatic hydrocarbons that are the product of incomplete combustion, and human exposure may occur from contaminated food or water. Public comments are requested by January 10, 2012.…
The Environmental Protection Agency (EPA) has announced the addition of 134 chemicals to its second Tier 1 screening list under the Endocrine Disruptor Screening Program (EDSP). Among those chemicals listed are DBCP, 1,4-dioxane, acetaldehyde, acrolein, acrylamide, benzene, benzo(a)pyrene, chlordane, HCFC-22, perchlorate, PFOS, PFOA, and polychlorinated biphenyls. Comments are requested by December 17, 2010. According to EPA, “[t]he list includes chemicals that have been identified as priorities under the Safe Drinking Water Act (SDWA) and may be found in sources of drinking water where a substantial number of people may be exposed. The list also includes pesticide active ingredients that are being evaluated under EPA’s registration review program to ensure they meet current scientific and regulatory standards.” Following public comment and review, “EPA will issue test orders to pesticide registrants and the manufacturers of these chemicals to compel them to generate data to determine whether their chemicals may disrupt the estrogen,…
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…
A U.S. Government Accountability Office (GAO) report to Congress has concluded that perchlorate, which interferes with iodine uptake and poses potential effects on fetal and infant brain development and growth, is ubiquitous in the nation’s water and food supply. The chemical is a product of both man-made processes, occurring in rocket fuel, explosives and fireworks, and atmospheric processes. It can be found in drinking water, ground water, surface water, soil and sediment and has been detected in 74 percent of foods tested, with the highest levels in tomatoes and spinach. GAO was apparently asked to learn what is known about the extent of perchlorate in water and food supplies, its likely sources, actions federal agencies have taken to respond to or reduce perchlorate releases, and state regulatory actions. The report, titled “Perchlorate: Occurrence is Widespread but at Varying Levels; Federal Agencies Have Taken Some Actions to Respond to and Lessen…
12
