Category Archives Legislation, Regulations and Standards

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has announced a final rule intended to bring its import regulations for bovine spongiform encephalopathy (BSE) in line with “internationally-accepted scientific literature and standards set by the World Organization for Animal Health (OIE).” According to a November 1, 2013, press release, the new rule will require APHIS to use OIE criteria and categories to determine BSE risk classification when setting import policy for a particular country. It will also allow APHIS “to conduct its own assessment when deemed necessary, such as when a country is not yet classified by the OIE for BSE risk and requests that APHIS conduct a risk evaluation using criteria equivalent to that used by OIE.” “This action will bring our BSE import regulations in line with international standards, which call for countries to base their trade policies on the actual risk of animals…

The U.S. Food and Drug Administration (FDA) has issued a request for comments regarding a proposed information collection about food labeling regulations. According to FDA, current approval periods for information collection requests regarding (i) third-party disclosure burdens about the amount of trans fatty acids present in a food, and (ii) voluntary declarations of the quantitative amount and the percent of Daily Value of a dietary ingredient on a “per day” basis in addition to the required “per serving” basis, have expired. To remedy the oversight, to most appropriately streamline these information collections, and to eliminate redundancy in its information collection requests, FDA seeks to revise the collection to “include these third party disclosure elements and have included them in the burden estimates and discussion.” Comments will be accepted until December 31, 2013. See Federal Register, November 1, 2013.    

The U.S. Food and Drug Administration (FDA) has issued a request for comments concerning a proposed information collection for a Food Safety Survey. Specifically, the agency seeks comment on the following questions: (i) is the information collection necessary and will it provide practical utility; (ii) is the estimate of the burden of the information collection, including the validity of the methodology and assumptions used, accurate; (iii) can the quality, utility and clarity of the information be enhanced; and (iv) how can the burden of the information collection on respondents be minimized. The Food Safety Survey, which the agency notes will contain many of the same questions and topics as previous Food Safety Surveys, will also be updated to explore emerging consumer food safety topics and expand understanding of previously asked topics. New topics to be explored include the increase in listeriosis rates in people older than age 60; consumer understanding of…

The U.S. Food and Drug Administration (FDA) “has tentatively determined that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives.” If the agency finalizes this determination, “food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.” It would not, however, affect the trans fat that occurs naturally in small amounts in meat and dairy products. Announcing the initiative, FDA Commissioner Margaret Hamburg said, “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the…

Mexican lawmakers have reportedly approved a 1 peso-per-liter tax (US 23 cents) on sugar-sweetened beverages (SSBs) and an 8 percent tax on junk food. The controversial legislation, which aims to curb rising obesity levels, was approved in a 73-50 vote and is expected to take effect January 1, 2014. According to news sources, Mexico, whose obesity and diabetes rates surpass those of the United States, will be the first major market to tax SSBs, following a handful of other Latin American and European countries. Mexicans reportedly consume more than 700 8-ounce servings of SSBs annually. More details about the legislation appear in Issue 501 of this Update.  

The U.S. Food and Drug Administration (FDA) has issued a statement cautioning people older than age 40 about eating too much black licorice—2 ounces per day for two weeks. FDA experts explain that black licorice contains glycyrrhizin, a sweetening compound that can cause the body’s potassium levels to plummet, leading to an irregular heart rhythm, high blood pressure, edema, lethargy, and possibly heart failure, said FDA. The agency also warned that black licorice can interact negatively with some medications and supplements. According to FDA Director of Cosmetics and Colors Linda Katz, potassium levels are usually restored with no permanent health problems when black licorice consumption stops.  

The U.S. Food and Drug Administration (FDA) has released a draft of its spice risk report, which calls attention to the most common microbial hazards and filth in imported spices, along with possible sources of contamination. The report, “Pathogens and Filth in Spices,” also evaluates current mitigation techniques, recommends options and identifies research needs and data gaps. According to FDA, a notice about the report will be published in the November 4, 2013, Federal Register. Calling the findings a “wake-up call” to spice producers, FDA revealed that of the products tested between 2007 and 2010, (i) spices are twice as likely to be contaminated as other types of imported food; (ii) 12 percent of spices imported into the United States were contaminated with insect parts, excrement, rodent hair and other materials; (iii) 7 percent of the shipments contained Salmonella; and (iv) spices imported from Mexico and India apparently have the highest rate of contamination.…

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would establish current good manufacturing practice (CGMP), hazard analysis and risk-based preventative controls for animal food. According to an October 29, 2013, Federal Register notice, FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.” Billed as “part of the Food Safety Modernization Act’s larger effort to modernize the food safety system for the 21st century,” the proposed rule would require domestic and foreign animal-food manufacturing facilities registered under the Federal Food, Drug, and Cosmetic Act to develop a formal plan to prevent foodborne illness as well as respond to “any…

Three days after the U.S. Food and Drug Administration (FDA) filed a motion for emergency stay pending appeal before the Ninth Circuit, the federal district court that had established November 30, 2013, as the deadline for the agency to publish notices of proposed rulemaking (NPRM) for specific food safety rules under the Food Safety Modernization Act denied the motion for stay pending appeal that FDA filed before it in September. Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered October 21, 2013). Details about the emergency stay request based on delays attributable to the federal government shutdown appear in Issue 501 of this Update. According to the district court, FDA failed to show that it would be irreparably injured absent a stay. The court recognized that the agency was unprepared to issue a final rule on the intentional adulteration of food by the November 2013 deadline, “But…

Los Angeles city council members Paul Koretz and Mitch O’Farrell have reportedly introduced a motion that would call on the city attorney to “prepare and present an ordinance which would prohibit the growth of genetically modified (GM) crops within city limits. Specifically, the ordinance should prohibit each [of] the following practices related to the growing of GM crops within city limits: the planting of GM seeds; the sale of GM seeds by vendors; the sale of any seeds that could potentially be contaminated by other genetically modified organisms (GMOs); the sale of GM fruit trees and plants.” The motion notes that 52 percent of “LA County residents voted in favor of Proposition 37, which would have required labeling on raw or processed genetically modified food products offered for sale to consumers.” It also raises questions about the safety of consuming GM foods and risks to the environment, including honey bee…

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