The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced plans to implement “new traceback procedures when FSIS or another agency finds raw ground beef or bench trim presumptive positive for Escherichia coli O157:H7.” Under the new system, which takes effect October 14, 2014, the agency will ask suppliers to recall products that test positive for E. coli O157:H7 later in the supply chain if FSIS or another agency determines that contamination most likely occurred at the supplier’s establishment and if the product in question was sent to other grinding facilities. As explained in an August 13, 2013, press release, these new procedures “will allow the agency to trace contaminated ground beef back to its source more quickly, remove it from commerce, and find the root cause of the incident to prevent it from recurring.” To this end, FSIS will begin traceback investigations as soon as it…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Food and Drug Administration (FDA) has amended food additive regulations pertaining to the safe use of vitamin D3 in response to a petition from Abbott Laboratories. The company requested that FDA approve use of the fat-soluble hormone “as a nutrient supplement at levels not to exceed 500 IUs per 240 mL in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and that are represented for use such that that the total amount of vitamin D3 provided by the product does not exceed 1,000 IU per day, and at levels not to exceed 1.0 IU per kilocalorie in food represented for use as a sole source of nutrition for enteral feeding.” Objections to FDA’s approval of Abbott’s petition or requests for a hearing must be filed by September 11, 2014. See Federal Register, August 12, 2014. Issue 534
The U.S. Food and Drug Administration (FDA) has released an executive report summarizing the data collected by the National Antimicrobial Resistance Monitoring System (NARMS) since 1996. Implemented by FDA, the Centers for Disease Control and Prevention, and the U.S. Department of Agriculture, NARMS tracks antibiotic resistance in foodborne bacteria, focusing on antibiotics “that are considered important to human health as well as multidrug resistance [MDR]” to three or more antibiotic classes. According to an August 11, 2014, news release, FDA identified “positive and negative trends in antimicrobial resistance in bacteria isolated from humans, retail meats and food animals.” For non-typhoidal Salmonella, which showed no resistance in 85 percent of samples isolated from humans, the report found that “MDR among humans, slaughtered chicken and slaughtered swine was the lowest [in 2011] since testing began,” though “MDR Salmonella from retail poultry meats generally increased.” NARMS also concluded that “erythromycin resistance in Campylobacter jejuni…
The D.C. Circuit Court of Appeals has vacated a panel’s March 28, 2014, denial of the motion for preliminary judgment filed by meat producer interests in litigation challenging U.S. Department of Agriculture (USDA) regulations requiring retailers of “muscle cuts” of meat to list the countries of origin and production (country-of-origin labeling, or COOL) as to each step of production—born, raised or slaughtered. Am. Meat Inst. v. USDA, No. 13-5281 (D.C. Cir., order entered April 4, 2014). Additional information about the March 28 decision appears in Issue 518 of this Update. A court majority voted to rehear the case before the full court on May 19 and ordered the parties to brief a supplemental issue: “Whether, under the First Amendment, judicial review of mandatory disclosure of ‘purely factual and uncontroversial’ commercial information, compelled for reasons other than preventing deception, can properly proceed under Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651…
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) has proposed revisions to the U.S. Standards for Grades of Maple Sirup in response to a 2011 petition submitted by the International Maple Syrup Institute (IMSI). Arguing that “consumers currently face a patchwork of grading systems in the United States that are confusing,” IMSI has reportedly asked AMS to implement new standards under which “the grade of a sample unit of maple syrup would be determined using the factors of color, flavor, odor, damage, and turbidity (cloudiness).” In addition to changing the spelling of “sirup” to the more common “syrup,” the agency would recategorize Grade B syrup “containing no damage or off-flavors” as Grade A “to allow the darker syrup to be sold at the retail level.” The revised standards would further divide Grade A into the following flavor and color classes: (i) U.S. Grade A Golden (delicate taste, ≥75.0…
The U.S. Food and Drug Administration (FDA) seeks public comments on the estimated time burdens relating to the extension of an existing information collection pertaining to the recalls of all FDA-regulated products (including food, animal feed, drugs, animal drugs, medical devices, cosmetics, biological products intended for human use, and tobacco). The estimates are based on the total number of recalls from 2011 to 2013 (11,403) averaged to 3,801 per year and involve the time burdens of complying with the voluntary reporting requirements of the agency’s recall regulations. Comments must be submitted by October 3, 2014. See Federal Register, August 4, 2014. Issue 533
The U.S. Food and Drug Administration (FDA) this week reminded consumers that “gluten-free” “now means what it says” after a final rule outlining the voluntary labeling standards took effect on August 5, 2014. According to FDA, the new standards stipulate that foods labeled “gluten-free,” “without gluten” or “no gluten” can contain gluten in amounts less than 20 parts per million (ppm) only, “the lowest level that can be consistently detected in foods using valid scientific methods.” “This level is consistent with those set by other countries and international bodies that set food safety standards,” explained the agency, which gave manufacturers one year to bring products into compliance. Additional details about the final rule appear in Issue 492 of this Update. See FDA Consumer Update, August 5, 2014. Issue 533
A recent perspective article in the New England Journal of Medicine (NEJM) has questioned whether nutrient-content claims—such as “sugar-free,” “high in oat bran,” or “contains 100 calories”—are confusing to consumers. Authored by Allison Sylvetsky and William Dietz, the article claims that sugar- and calorie-related claims “may lead parents to underestimate the products’ energy content and allow their children to consume more than they otherwise would.” According to the authors, the use of nonnutritive sweeteners in sugar- and calorie-modified products “may still foster the development of a ‘sweet tooth’ because nonnutritive sweeteners are a hundred times sweeter than table sugar by weight.” In addition, U.S. consumers have no way to gauge whether their children have exceeded the acceptable daily intake for a particular nonnutritive sweetener because the amount added to any given product is considered proprietary information. “We believe that adopting a more straightforward and easily understandable ingredient-labeling system in the…
A recent Nature editorial warns that the U.S. Food and Drug Administration’s (FDA’s) reluctance to approve genetically-modified (GM) salmon for market could hinder future research into new gene-editing techniques. Titled “Fishy Business,” the article claims that even though a draft assessment found AquaBounty Technologies’ GM salmon “environmentally benign,” FDA conducted many of its deliberations “behind closed doors, fuelling confusion as to the cause of the setbacks, and rumors of political interference.” “As the delays have dragged on, the technology used to make AquaBounty’s salmon has become outdated,” explains the editorial. “In the current excitement over targeted gene editing that allows researchers to modify individual genes without leaving traces of foreign DNA, AquaBounty’s salmon—which contain a gene from another species—seem like a relic.” Meanwhile, FDA has yet to decide “how it will evaluate animals engineered with gene-editing techniques.” Raising questions about how these new products will fare under FDA’s oversight, the…
In a 9-2 en banc decision, the District of Columbia Circuit has affirmed an earlier panel decision that the U.S. Department of Agriculture (USDA) can require meat producers to include country-of-origin labeling (COOL) on their packaging. Am. Meat. Inst. v. USDA, No. 13-5281 (D.C. Cir., order entered July 29, 2014). The First Amendment allows for such required disclosures because the government’s interest is sufficient, the court found. Additional information on the American Meat Institute’s constitutional challenge and the D.C. panel’s decision appears in Issues 518 and 520 of this Update. In its discussion, the court interpreted the U.S. Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) to reach beyond mandated commercial labeling necessary to correct deception to include the “factual and uncontroversial disclosures required to serve other government interests” at issue in the COOL context. The language in Zauderer “sweeps far more broadly than…
