The Canadian Food Inspection Agency (CFIA) has issued a draft food inspection model as part of its Inspection Modernization: Optimizing Confidence in Food Safety plan. According to CFIA, the modernized approach to food inspection will apply to both imported and domestic commodities and, in addition to the inspection model, rely on modern science, improved data collection and better training and tools for CFIA inspectors. The new draft model apparently favors a risk-based approach to regulatory oversight and covers the following components: (i) licensing and registration, (ii) CFIA oversight, (iii) inspection, (iv) compliance and enforcement, and (v) system performance. In particular, food and beverage manufacturers would need to develop “preventative control plans scalable to the size and complexity of their operation” that “mitigate all sources of food safety risk and demonstrate that the measures effectively meet regulatory requirements.” CFIA would in turn determine the level of required oversight—enhanced, normal or reduced—based…
Category Archives Legislation, Regulations and Standards
A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update. The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance…
The European Food Safety Authority’s (EFSA’s) Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has issued two guidance documents establishing “the scientific requirements for the substantiation of health claims related to functions of the nervous system, including psychological functions, and those related to physical performance.” In particular, the new guidance documents address “which claimed effects are considered to be beneficial physiological effects, and which studies/outcome measures are appropriate for the substantiation of function claims and disease risk reduction claims.” They are the final installments in a series of documents covering health claims related to gut and immune function; antioxidants and cardiovascular health; weight management; and bone, joint and oral health. According to EFSA, the NDA Panel has also finished its further assessment of general function health claims, approving two additional claims that member states substantiated with supplemental data: (i) prunes and normal bowel function, and (ii) alpha-cyclodextrin and a…
The U.S. Patent and Trademark Office (USPTO) has issued a final rule that incorporates certain changes that took effect in January 2012 under the Nice Agreement Concerning the Classification of Goods and Services for the Purpose of the Registration of Marks, to which the United States is a signatory. Among other matters, (i) Class 5 is changed from “dietetic substances adapted for medical use” to “dietary food and substances adapted for medical use”; and (ii) Class 32 is change from “non-alcoholic drinks; fruit drinks” to “non-alcoholic beverages; fruit beverages.” USPTO’s classification of goods and services under the Trademark Act is codified at 37 CFR part 6. See Federal Register, August 9, 2012.
The U.S. Department of Agriculture (USDA) has announced an August 27-28, 2012, meeting of its Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) in Washington, D.C. USDA Secretary Tom Vilsack has specifically asked the committee to report on the types of compensation mechanisms that could be used “to address economic losses by farmers in which the value of their crop is reduced by the presence of GE [genetically engineered] material(s).” The committee will also discuss eligibility standards for triggering these mechanisms as well as other actions that may be appropriate “to bolster or facilitate coexistence among different agricultural systems in the United States.” According to USDA, “AC21 consists of members representing the biotechnology industry, the organic food industry, farming communities, the seed industry, consumer and community development groups, as well as academic researchers and a medical doctor.” Members of the public who wish to the attend the meeting must register…
U.S. Senators Kay Hagan (D-N.C.) and Saxby Chambliss (R-Ga.) recently wrote a letter to U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson, asking the agency to use its waiver authority “to adjust the corn grain-ethanol mandate of the Renewable Fuel Standards (RFS)” in light of ongoing drought conditions. Signed by 26 senators, the bipartisan letter notes that the U.S. Department of Agriculture has already rated 50 percent of the nation’s corn crop as poor or very poor while “stressful weather conditions continue to push corn yields lower and prices upward.” The signatories have thus urged EPA to employ some of the “safety valves” built into the Energy Independence and Security Act of 2007 “that enable the agency to adjust the RFS in the event of inadequate supplies or to prevent economic harm to the country, a region, or a state.” “With record droughts across the United States causing corn supplies…
Turtle Island Restoration Network and the Center for Biological Diversity have filed a complaint for declaratory and injunctive relief in a federal court in California against the Food and Drug Administration (FDA) to force the agency to act on their June 2011 petition seeking to reduce the allowable level of mercury in seafood. Turtle Island Restoration Network v. Hamburg, No. 12-03884 (N.D. Cal., filed July 25, 2012). The organizations claim that while FDA had 180 days, or until December 17, 2011, to respond to the petition, “[t]o date, FDA has neither granted nor denied the petition and has taken no action to reduce human exposure to mercury from commercial fish.” They request a court order declaring that FDA has violated the Administrative Procedure Act and requiring the agency to issue a decision on their petition within 30 days. The plaintiffs contend that FDA’s current action level for mercury in seafood…
Chilean Senator Guido Girardi has reportedly filed a formal complaint with the country’s Ministry of Health, alleging that fast-food companies have violated a new ban on using toys and other giveaways to market children’s meals. According to media sources, the complaint claims that several fast-food restaurants have flouted the law, along with other food manufacturers that purportedly use crayons, stickers and similar incentives to market products which appeal to children. Girardi has asked the Ministry of Health to enforce sanctions if the companies named in the complaint do not begin complying with the toy ban. “These businesses know that this food damages the health of children and they know that the law is in effect. They’re using fraudulent and abusive means,” said Girardi, who apparently drafted the law. “These corporations threatened that if the law was approved there would be no more money for children’s foundations, the sick, or athletes, but…
As part of an ongoing food additive assessment, the European Food Safety Authority (EFSA) has requested additional scientific data on aspartame “related to 5-benzyl-3,6-dioxo-2-piperazine acetic acid (DKP) and other primary or secondary degradation products from aspartame.” Asked by the European Commission in 2011 to reevaluate the safety of aspartame as a food additive, EFSA’s Scientific Panel on Food Additives and Nutrient Sources Added to Food initially called for aspartame data by September 30, 2011, but has since determined that there is further need for “data on products which can be formed from aspartame in different types of foodstuffs, in particular on [DKP], depending [for example] on pH, temperature and storage time.” As a result, EFSA has delayed its findings and instead requested data on “the presence and levels of DKP found in aspartame-containing foodstuffs (including beverages) found on the market” as well as “the formation of DKP and other primary…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) and U.S. Environmental Protection Agency (EPA) have announced the availability of a guideline “for conducting microbial risk assessment (MRA).” Intended for government risk assessors and other public stakeholders, the guidance seeks to promote transparency and consistency between the two agencies as they conduct risks assessments of food- and water-borne disease. According to a July 31, 2012, EPA press release, the MRA guideline for the first time “lays out an overarching approach to conducting meaningful assessments of the risks to Americans posed by pathogens in food and water.” The agency has also touted the measure as a way to improve the quality of data “collected by public health scientists charged with protecting Americans from pathogen-related risks in food and water.” “This guidance contributes significantly to improving the quality and consistency of microbial risk assessments, and provides greater transparency to stakeholders…
