Category Archives Legislation, Regulations and Standards

The Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services (HHS) have announced the addition of an emerging Bacillus cereus strain that causes anthrax-like disease to the HHS list of Select Agents and Toxins. “Bacillus cereus Biovar anthracis is a recently recognized, emerging pathogen[] that has all the virulence characteristics and threat potential of Bacillus anthracis, a Tier 1 select agent,” states the interim final rule, which takes effect October 14, 2016. “This organism is not currently on the HHS List of Select Agents and Toxins; we are proposing regulating this organism as a Tier 1 select agent because of its potential for misuse and its threat to public health and safety.” HHS defines a biovar as “a group of microorganisms that are genetically similar but differ from other members of the species by biochemical or genetic characteristics.” Isolated from gorillas and chimpanzees with anthrax-like illness,…

Several consumer-protection groups, including the Natural Resources Defense Council (NRDC) and the Center for Science in the Public Interest (CSPI), have filed a citizen petition with the U.S. Food and Drug Administration (FDA) urging the agency to withdraw approval of seven antibiotics for disease prevention and growth-promotion use in livestock and poultry. “The use of medically important antibiotics in livestock production for growth-promotion or disease-prevention purposes is not shown to be safe,” the September 13, 2016, petition asserts. “FDA’s voluntary program will not end these drug uses. FDA must immediately begin proceedings to withdraw approval for these uses.” The day before the groups filed the petition, FDA announced a comment period about therapeutic uses of medically important antimicrobials. The agency seeks information about (i) “[t]he underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases”; (ii) “[m]ore targeted antimicrobial…

The U.S. Food and Drug Administration (FDA) has extended the public comment periods for draft guidance “that provides practical, voluntary sodium reduction targets for the food industry.” Titled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods,” the guidance sets short- and long-term sodium targets for the following food categories: (i) cheese; (ii) fats, oils and dressings; (iii) fruits, vegetables and legumes; (iv) nuts and seeds; (v) soups; (vi) sauces, gravies, dips, condiments and seasonings; (vii) cereals; (viii) bakery products; (ix) meat and poultry; (x) fish and other seafood; (xi) snacks; (xii) sandwiches; (xiii) mixed ingredient dishes; (xiv) salads; (xv) other combination foods; and (xvi) baby/toddler foods. The agency will now accept comments pertaining to the food categories and two-year salt reduction goals until October 17, 2016. The comment period for the 10-year targets as well as feedback on technical…

The World Trade Organization (WTO) has ruled in favor of the European Union in a dispute over Russia’s 2014 ban on the import of live pigs, fresh pork and other pig products following cases of African Swine Fever in some EU regions. The ban violated WTO rules on restricting trade based on sanitary and phytosanitary measures, the organization concluded. In an August 19, 2016, press release, the European Commission admitted that many of the products covered by the prohibition continue to be “restricted by a politically motivated ban imposed on EU agri-food products by Russia,” but noted that “the panel’s findings are of systemic importance, since they remind Russia about its international obligations and the fact that these cannot be arbitrarily ignored.” See EU Press Release, August 19, 2016.   Issue 615

Her Majesty’s Treasury (HM Treasury) has released the details of a proposed soft-drink levy announced during March 2016 budget talks as part of the U.K. government’s childhood obesity action plan. Slated to take effect in April 2018, the Soft Drinks Industry Levy (SDIL) would affect the manufacturers of added-sugar soft drinks “with total sugar content of 5 grams or more per 100 millilitres, with a higher rate for drinks with 8 grams or more per 100 millilitres.” The levy exempts beverages with no added sugar—including 100-percent fruit juice—as well as alcohol beverages with alcohol content above 0.5-percent alcohol by volume. The SDIL would also apply to imported soft drinks. HM Treasury has requested comments on the SDIL by October 13, 2016. Among other things, the government seeks evidence and views from respondents about (i) “the types of added-sugar low alcohol products that may be captured by the levy, and the appropriate approach…

The Alabama Alcoholic Beverage Control Board (ABC) will reportedly vote on a proposed rule requiring brewers to collect personal information from purchasers of beer for off-premises consumption. The proposed rule, which requires gathering a customer’s name, address, age and phone number, follows a rule enacted June 1 allowing craft breweries to sell six-packs, large bottles and other containers of beer. The rule’s purpose may relate to enforcement of Alabama’s 288-ounce limit on single purchases, but the ABC has reportedly not publicly commented on the reasoning underlying the proposal. The board will vote on September 28, 2016. See Associated Press, August 5, 2016.   Issue 614

The U.S. Food and Drug Administration (FDA) has extended until July 26, 2018, the deadline for posting the calorie counts of “certain gums, mints, and roll candy products” sold in glass-front vending machines, as well as for complying with type-size front-of-pack (FOP) labeling requirements. Published December 1, 2014, and effective December 1, 2016, the final rule requires businesses operating 20 or more vending machines to clearly disclose calorie counts “in a direct and accessible manner” if calories are not easily visible to prospective purchasers via FOP labeling. According to FDA, “several trade associations requested the extension for glass-front vending machines because of concerns regarding the requirements for the size of front-of-pack (FOP) calorie disclosures.” The trade associations apparently noted that “current voluntary FOP labeling programs require calorie information to be presented in a type size that ranges from 100 to 150 percent of the size of the net weight contents…

Following an investigation into potential criminal violations of federal immigration laws, Mary’s Gone Crackers Inc. will pay $1.5 million and establish a corporate compliance program but will not be prosecuted, the U.S. Department of Justice has announced. The investigation determined that 48 of the company’s employees were ineligible to work in the United States; Mary’s informed Immigration and Customs Enforcement that the employees had left the company, but further investigation found that Mary’s hired at least 13 of those employees back under different names. In addition to the $1.5-million payment, Mary’s must establish an anonymous tip line for employees to report noncompliance issues, provide I-9 training to employees and report compliance measures to the U.S. Attorney’s Office for two years.   Issue 613

The Southern Poverty Law Center (SPLC) has urged the U.S. Occupational Safety and Health Administration to investigate Farm Fresh Foods, LLC, arguing the company forced sanitation workers to race against one another to carry and unpack 80-pound crates of chicken. The company allegedly required workers to unload raw chicken after cleaning the processing plant without washing their hands or changing clothes; SPLC asserts that workers’ concerns about contaminating the chicken were ignored. Farm Fresh also allegedly denied workers bathroom breaks, disciplined them for walking around empty-handed and jeered at them while they worked. “It’s clear from the treatment of these workers that Farm Fresh Foods has little regard for its employees,” Naomi Tsu, SPLC deputy legal director, said in a July 26, 2016, press release. “Farm Fresh needs to listen to workers rather than retaliating against them. We’ve seen this happen again and again in the poultry industry—these companies must…

The U.S. Department of Agriculture’s National Organic Standards Board (NOSB) has removed five non-organic nonagricultural substances—egg white lysozyme, cyclohexylamine, diethylaminoethanol, octadecylamine, and tetrasodium pyrophosphate—from the National List of Allowed and Prohibited Substances governing the use of synthetic and non-synthetic substances in organic food production and handling. After determining that these substances “are no longer necessary or essential for organic handling” based on public comments and supporting documents, NOSB decided to let their use exemptions expire on September 12, 2016. According to NOSB, suitable alternatives or new processing and handling practices have eliminated the need for (i) egg white lysozyme as a “processing aid/preservative for controlling bacteria that survived the pasteurization process of milk that is used for cheese manufacture”; (ii) cyclohexylamine, diethylaminoethanol and octadecylamine “for use only as a boiler water additive for packaging sterilization”; and (iii) tetrasodium pyrophosphate “for use only in meat analog products.” See Federal Register, August…

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