• FDA has partnered with Purdue University and Indiana produce industry stakeholders to launch an environmental microbiology study to better understand the ecology of human pathogens, focusing on assessing risks related to Salmonella in the environment. The study is intended to develop a better understanding of the source of pathogens, their persistence, and how they transfer through the growing environment to ultimately help inform food safety practices.
  • The study is in response to outbreaks of Salmonella linked to cantaloupe grown in the Southwest Indiana agricultural region where a specific source or route of contamination was not found. The identification of other Salmonella varieties that were genetically similar to other isolates collected in the region over the last decade suggests that Salmonella is a reoccurring issue and that multiple reservoirs for Salmonella spp. may exist. According to FDA, “[t]he outbreak investigations have shown that there are complex environmental survival, proliferation, and dispersal mechanisms of pathogens in this region that need to be better understood.”
  • Researchers will sample air, soil, water, and animal scat, as well as collect weather data, to better understand what environmental conditions may encourage the survival, growth, and spread of pathogens. The study will occur at a farm in central Indiana, four Purdue-operated farms in northwest Indiana, and the Southwest Purdue Ag Center.
  • Indiana ranks sixth in U.S. cantaloupe production, according to USDA data from 2018 when Indiana growers planted 1,800 acres of cantaloupe worth $8.6 million. Growers “want to participate in this study because of their commitment to do everything they can to keep their produce as safe as possible.”
  • Keller and Heckman will continue to report on FDA’s efforts to understand and prevent foodborne illness outbreaks.  
  • On October 10, 2024, FDA hosted a public webinar to discuss the Voluntary Sodium Reduction Goals (Edition 2) and review progress.  Key FDA speakers provided updates on the latest sodium reduction targets and insights into the progress made so far.
  • As previously discussed on this blog, FDA issued Edition 2 of the Draft Guidance for Industry Voluntary Sodium Reduction Goals in August 2024.  These goals aim to encourage the food industry to gradually reduce sodium levels in packaged and prepared foods, addressing diet-related chronic diseases and promoting health equity.  Over 70% of sodium consumed in the US comes from processed and prepared foods.  The goal is to lower average daily sodium intake from 3,400 mg to 2,300 mg.
  • FDA developed baselines for sodium concentrations based on label data and created target mean and upper bound sodium concentration goals.  The target mean is an average for the food category as a whole, while the voluntary upper bound applies to every individual product and for which no individual product should exceed.
  • During the webinar, FDA highlighted the draft targets issued on August 15 and provided a preliminary assessment of progress towards Phase 1 targets.  The new 2024 guidance lowers the average sodium intake goal to 2,750 mg/day, includes restaurant data from 15 categories, and adds 3 new subcategories.
  • Key findings from the preliminary assessment include:
    • There are 16 broad food categories with 163 subcategories.  Of the 16 overarching categories, 11 categories had at least 50% of their subcategories decrease in sodium.
    • From 2010 to 2022, 52% of all food categories decreased in sodium, 34% increased, and 14% saw no change.  Packaged foods showed more significant reductions at 62% compared to restaurant foods at 35%.  Notably, 100% of subcategories in the toddler and baby food category saw a reduction in sodium.
    • Overall, 40% of food categories have already achieved the Phase I sodium targets or were within 10% of meeting those targets.
  • FDA clarified that the targets are voluntary, as this approach has proven effective globally.  The gradual and voluntary approach is designed to afford the industry flexibility, and it was noted that consumer palates adjust to salt reduction over time, and small reductions often go unnoticed.  A recording of the session is available on FDA’s meeting page here.
  • FDA is encouraging feedback on the draft targets and categories and will be accepting comments until November 14, 2024.  Please feel free to contact Keller and Heckman for assistance providing FDA comments.  We will continue to monitor for updates and provide further information as it becomes available.
  • On September 28, 2024, Governor Newsom signed California’s AB 660 into law, which would standardize date labels on food packaging.  The legislation is the first of its kind in the U.S. and intends to reduce both customer confusion and food waste.
  • The new law at Section 82001 of the California Food and Agricultural Code, requires food manufacturers, processors, and/or retailers  to use standardized language for date labels across their products.  Beginning July 1, 2026, “Best if Used By” will be used to communicate peak quality, and “Use By” will be used to communicate product safety.  To further reduce confusion on food date labeling, AB 660 prohibits the use of consumer facing “sell by” dates, reducing the likelihood of confusing “sell by” dates with quality and/or safety dates.
  • At the federal level, companion bills were introduced in the House and Senate in May 2023 (HR 3159 and S 1484) to standardize food date labels across the U.S.  With the exception of infant formula, there are no uniform federal standards for date labels.  The legislation would establish a dual label system reducing the available labeling language to two phrases: one quality date indicator and one discard date indicator.  If a manufacturer chooses to use a date to indicate when a food should be discarded for safety reasons, it must use the standard language “Use By” or “UB” if the package has limited space.
  • Keller and Heckman will continue to monitor and relay legislative developments.
  • On September 30, 2024, the U.S. District Court for the District of Oregon dismissed a complaint filed by Pratum Farm, LLC which challenged the Strengthening Organic Enforcement (SOE) provisions regarding certification of “grower groups” allowing for inspection of a sample of growers from the grower group, as opposed to inspection of every grower.
  • Grower groups are certified at a group level, and under the SOE rule, inspection by a USDA-accredited certifier is required for “at least 1.4 times the square root or 2% of the total number of producer group members, whichever is higher.” This equates to at least 10 members in a 50-member group (20% inspection rate), 14 members in a 100-member group (14% inspection rate), or 31 members in a 500-member group (6.2% inspection rate). The larger the group, the lower the minimum inspection rate. Other farms within the group that are not inspected by a USDA-inspected certifier are required to be inspected for compliance by a designated employee of the grower group.
  • Plaintiff alleged that the grower group certification regulation (7 CFR 205.403(a)(2)) is contrary to the Organic Foods Product Act’s provision for “annual on-site inspection” of organic farms. (7 USC 6506(a)(5)). Plaintiff further alleged that it had suffered harm because (1) the USDA organic seal acted as a kind of license that had been degraded through lack of enforcement, and (2) it was placed in a competitive disadvantage, as the rule had allowed other growers to sell fraudulent organic product on the U.S. market. Plaintiff is a small farm growing hazelnuts and had prompted a Federal Trade Commission (FTC) investigation of Turkish hazelnut growers.
  • However, the Court dismissed the complaint for lack of injury (i.e., standing) because the argument that Plaintiff was injured as a licensee (of the organic seal) was speculative and because Plaintiff had not shown that it had been injured by the regulation. On the contrary, the Court held that the injury it alleged could be attributed to the “unlawful action of third parties.”
  • The Food Safety and Inspection Service (FSIS) has extended the comment period for its proposed rule prohibiting the sale of chicken and turkey contaminated with certain types of Salmonella. Comments will now be accepted until Jan. 17, 2025, adding 72 days to the comment period.
  • As previously discussed on this blog, the National Chicken Council had requested a 90-day extension beyond the initial 60-day comment period and 30-day extension. Two representatives, as well as the Poultry Safety Coalition and several consumer advocacy groups had asked for an additional 180 days to comment, citing concerns that “the proposed rule is not sufficiently comprehensive and may by itself foreclose important reforms” that USDA should consider including in the final rule.
  • According to FSIS, stakeholders requested additional time to comment following the initial extension “to allow sufficient time to consider the proposal and supporting documentation to formulate comments on these documents.”
  • As a reminder, the proposed rule (published on August 7, 2024) is intended to establish standards to prevent raw poultry products that contain high levels of Salmonella from entering commerce and to require poultry establishments to develop a microbial monitoring program to prevent pathogen contamination through the slaughter system.  
  • Keller and Heckman will continue to monitor and report on this proposed rule.
  • The U.S. District Court for the Eastern District of California has entered a consent decree of permanent injunction against Rizo Lopez Foods and the company’s co-owners.  Among other requirements, the consent decree prohibits Rizo Lopez Foods from manufacturing and selling certain food products until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other federal regulations.  The consent decree requires the defendants to make corrective actions and receive FDA approval from the U.S. Food and Drug Administration (FDA) before they may resume operations.
  • As we previously reported, FDA and the Centers for Disease Control and Prevention (CDC) investigated a multi-year, multistate outbreak of Listeria monocytogenes (Listeria) infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods.  In February 2024, Rizo Lopez Foods voluntarily recalled its entire inventory of dairy products, regardless of the sell-by date of the product.
  • In total, the CDC outbreak investigation identified 26 illnesses, which occurred across 11 states and included 23 hospitalizations.  Two of the individuals subsequently died.  Four individuals were pregnant, including one who suffered a pregnancy loss.
  • Similar to California’s Proposition 12, Massachusetts’ Prevention of Farm Animal Cruelty Act (also known as “Question 3”) imposes animal welfare standards for hens, sows, and veal calves raised in Massachusetts and makes it unlawful for businesses to sell eggs, veal, or pork that they know to be in violation of these standards (even if the animals were raised out of state).
  • A July 22nd order from the U.S. District Court of Massachusetts dismissed a challenge to the law brought by various pork producers, holding that the law was not preempted by the Federal Meat Inspection Act (FMIA) because it does not regulate how slaughterhouses operate. This decision has been appealed to the First Circuit Court of Appeals.
  • Last month the pork producers’ appeal was joined by Iowa (the top pork-producing state) as well as 21 other states. The states’ brief argues that the law will increase costs for pork producers (and prices for consumers) and that such state laws, if upheld, could create a regulatory maze of differing state requirements. We note that such arguments were not foreclosed by the Supreme Court’s 2023 Proposition 12 decision (National Pork Producers Council v. Ross) which held that such laws violate the dormant commerce clause if the “burden imposed on interstate commerce” is “clearly excessive in relation to the putative local benefits.” Nevertheless, it’s not clear how such a fact-based argument can be evaluated on appeal. The states’ brief also latches onto Justice Kavanaugh’s concurring opinion in National Pork Producers Council v. Ross and states that Question 3 “may also implicate other constitutional provisions like the Import-Export Clause and the Full Faith and Credit Clause.”
  • We will continue to monitor and report on this case.  
  • Representative Rosa DeLauro has introduced the Toxic Free Food Act to require FDA to “close the ‘Generally Recognized as Safe’ (GRAS) loophole and make chemical food additives subject to FDA approval and oversight.” 
  • According to DeLauro, the GRAS loophole permits companies to determine whether food additives are safe without oversight from FDA through the voluntary GRAS notification system. This allows “potentially dangerous chemicals” to be present in the food supply.
  • The Toxic Free Food Act would require FDA to amend its regulations to prohibit manufacturers from marketing a substance as GRAS without providing notice to FDA, making the GRAS notification system mandatory. Public comment would be required for all GRAS notifications. In addition, newly synthesized or novel chemical substances and carcinogenic substances would not be permitted to be GRAS.
  • Other provisions of the Act would require revisions to FDA’s regulations to:
    • Prohibit reliance on the determination of experts with conflicts of interest when determining whether a substance is GRAS;
    • Incorporate recommendations into the November 2017 draft guidance “Best Practices for Convening a GRAS Panel;”
    • Create a process to systematically reassess any substance that was previously determined to be GRAS if the determination did not meet the revised standards.
  • Finally, FDA would be required to reestablish the Food Advisory Committee to work on the reassessment standards, process, and methods necessary to complete the reassessment of previous GRAS substances.
  • DeLauro has also submitted written comments to FDA urging the agency to close the GRAS loophole, stating that “this loophole and FDA inaction have failed to keep us safe from chemicals added to our food . . . To rebuild consumer confidence, the FDA must take bold action to ban or restrict food chemicals of concern and to reassert its regulatory role and close the loopholes that allow the chemical companies to decide which chemicals are safe for consumers voluntarily.”
  • Given the current political climate, the prospects for this bill are not clear.  As most readers likely know, the option to develop a GRAS position for a food ingredient was added to the Federal Food, Drug, and Cosmetic Act in 1958.  Although the GRAS system has been criticized by various consumer groups in recent years, responsible companies have used it successfully to bring new, safe food ingredients to the market.
  • Nebraska Governor Jim Pillen signed an executive order at the end of August restricting sales of cultivated meat and said he will press state lawmakers to make Nebraska the third state to ban sale of the food products.  Gorvernor Pillen stated at a press conference that the order is the start of a “full blown attack on lab-grown meat and fake meat.”
  • The order bars Nebraska state agencies from buying cultivated meat and requires businesses to contract with the state to attest that they will not discriminate against “natural-meat producers” in favor of cultivated meat producers.  Additionally, Governor Pillen directed the Nebraska Department of Agriculture to develop regulations to make sure any “lab-grown meat products” sold in stores are properly labeled and are not marketed next to natural meat on the same shelves.  A draft hearing on those regulations has been scheduled for October 8, 2024.
  • As we have previously reported, Florida and Alabama have also enacted laws to completely ban the sale of cultivated meat products, adopting frameworks that lay out stiff financial penalties and possible jail time for anyone found in violation.  Iowa approved a law that mandates specific labeling requirements for cultivated meat and bars the sale of such products in public schools and food assistance programs.  Texas has also adopted an aggressive labeling law for cultivated meat products and lawmakers in several other states, including Arizona and Tennessee, have proposed complete bans.
  • Keller and Heckman will continue to monitor and relay the legislative developments addressing cultivated meat.
  • As we previously blogged about, UPSIDE, a manufacturer of cultivated chicken, has sued Florida regarding its ban (SB 1084) on the sale and manufacturing of cultivated meat. The complaint included a request for an injunction (i.e., to block enforcement of the law pending resolution of the case) which the parties finished briefing last month.
  • One of the issues which was briefed was whether SB 1084 is preempted by the federal Poultry Products Inspection Act (PPIA). The PPIA’s preemption provision (21 USC 467e) states in part that “[r]equirements within the scope of this chapter with respect to premises, facilities and operations of any official establishment which are in addition to, or different than those made under this chapter may not be imposed . . . Marking, labeling, packaging, or ingredient requirements (or storage or handling requirements found by the Secretary to unduly interfere with the free flow of poultry products in commerce) in addition to, or different than, those made under this chapter may not be imposed . . .”
  • As a threshold matter, Florida has argued that the PPIA, including its preemption provision, does not apply because cultivated meat cannot be considered a “poultry product” as that term is defined in the PPIA (“any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting …[ingredients with small proportions of meat exempted by USDA]. 21 USC 453(f). In contrast, UPSIDE argues that it’s product “easily falls within the PPIA’s broad definition of ‘poultry product,’ since it is composed almost entirely of chicken cells.”
  • Florida also argues that the PPIA “contemplates state laws that complement and supplement its regulatory scope” and that it does not violate the preemption provision because that provision does “not set requirements for the particular ingredient in UPSIDE’s quasi-chicken products” nor “require UPSIDE to change its plants, laboratories, production methods, or other operations.” Stated differently, Florida argues that “SB 1084 does not ban anything that PPIA mandates.” In contrast, UPSIDE counters that SB 1084 is preempted “because it imposes ingredient and operational requirements that are not identical to those imposed under federal law.” USDA permits the ingredient that UPSIDE sells while Florida does not.  
  • We will continue to monitor and report on the outcome of this litigation. The case number is 4:24-cv-00316 and was filed in the United States District Court for the Northern District of Florida.