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  • As our readers may recall, in July of 2019, the USDA’s Food Safety and Inspection Service (FSIS) issued a notice of availability and a request for comment on a new guideline for establishments producing multi-component kit products that contain meat or poultry products. On September 21, FSIS announced updates to the guideline and responded to comments received in 2019. FSIS intends for the guideline to help establishments and other food handling facilities determine whether the kit product needs to be prepared under FSIS inspection and how to label a kit product that contains fully labeled meat or poultry components.
  • FSIS received 15 comments on the guideline, mainly from firms that prepare kits and trade associations that represent the meat and retail industries. Comments, and FSIS responses, covered a range of topics, including:
    • One comment requested that FSIS provide a clearer definition of a kit and clarify whether Agency policy distinguishes between a kit and a meal kit. FSIS reiterated that a kit product consists of individually packaged meat or poultry components and other food components sold together as a single unit. FSIS policy does not distinguish between the terms “kit” or “meal kit.”
    • One comment sought clarification on whether FSIS inspection and label approval requirements apply to firms that receive and further process bulk product as part of final kit assembly. FSIS updated the guideline to clarify that Agency guidance on the preparation of kit products without FSIS inspection does not apply when the meat or poultry component is processed, including portioned or packaged, by the firm assembling the kit.
    • One FSIS employee commented to ask for clarification whether a kit may be assembled under voluntary inspection and bear a USDA inspection legend. FSIS confirmed that the assembly of a kit product is eligible for voluntary inspection as a food inspection service under 9 CFR 350.3(c).
  • FSIS noted that the guideline represents the Agency’s current thinking on multi-component kit products and will be updated as necessary.
  • FDA issued a corporate-wide warning letter to Midwestern Pet Foods, Inc. (Midwestern) on August 9, 2021. The letter states that inspections of the company’s pet food manufacturing plants revealed violations across multiple plants that were connected to illness or death of hundreds of animals that ate Midwestern’s dry dog food. The warning letter states that Midwestern’s manufacturing facilities presented serious violations of FDA’s Hazard Analysis and Risk-Based Preventative Controls (HARPC) requirements and that the company has not taken sufficient action to respond to FDA’s concerns about preventative measures for the presence of mycotoxins and Salmonella.
  • In January 2021, Midwestern recalled over one thousand lots of its SPORTMiX-brand cat and dog food products manufactured in the company’s Oklahoma plant because of the presence of aflatoxin. This was followed by a March recall of other Midwestern brands manufactured at the company’s Illinois plant where samples tested positive for Salmonella.
  • Some Midwestern product samples were found to contain levels of aflatoxin as high as 558 ppb; FDA considers pet food to be adulterated if it contains more than 20 ppb of aflatoxin. The adulterated products were linked to 130 pet deaths and more than 220 pet illnesses. Groups of consumers with pets that died or became ill after consuming the recalled products filed two proposed class action lawsuits in January and February 2021. We will continue to monitor and report on developments regarding these cases and FDA enforcement in pet food manufacturing.
  • The European Commission has again taken aim to reduce the presence of heavy metals in food by setting new limits for lead and cadmium in certain food products. Lead and cadmium, along with other heavy metals like arsenic and mercury, are naturally occurring and can be present in foods, cosmetics, and dietary supplements. Studies have suggested they may pose a health risk, particularly to neurological development in children.
  • In revising its standards for lead, the Commission considered the European Food Safety Authority’s (EFSA) 2010 opinion on lead in food and recent data from the Codex Alimentarius Commission to determine that limits for infant food, salt, and wild fungi merited revision. For cadmium, the Commission considered a 2009 EFSA opinion about health risks of cadmium in food and other new data showing that cadmium levels can be further reduced. The new limits cover a variety of products, including garlic, berries, nuts, fish, and salt. The new measures for lead will take effect on August 30, 2021, and the limits for cadmium will take effect the following day.  Foodstuffs that were lawfully placed on the market before the new limits go into effect may remain on the market until February 28, 2022.
  • Officials in the U.S. have also increased scrutiny on heavy metals in food, particularly in baby foods. In particular, FDA’s Toxic Elements Working Group seeks to identify vulnerable populations, prioritize toxicity concerns, and improve testing for heavy metals in foods. We will continue to monitor and report on updates in this area.

FSIS Announces Revised Guidelines for Minimizing the Risk of Shiga Toxin-Producing Escherichia coli (STEC) in Beef Slaughter and Processing Operations

  • On July 19, 2021, the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) published notice that it has updated two of its guidelines for minimizing the risk of Shiga toxin-producing Escherichia coli (STEC) in beef slaughter (including veal) and processing operations.  The beef slaughter and beef processing guidelines, which were initially published for comment on March 3, 2017 as “compliance” guidelines, provide advice on the best practices to prevent, eliminate, or reduce levels of fecal and associated microbiological contamination and address contamination with STEC in raw non-intact beef products and beef products intended for non-intact use.  Although these guidelines were developed to help small and very small establishments meet best practice recommendations, all FSIS regulated beef slaughter and processing establishments may be able to apply the recommendations in the guidelines.
  • Updates to the guidelines for minimizing the risk of STEC in beef slaughter and processing operations include:
    • Removal of the word “compliance” from the titles of both documents and other changes to clarify that the guidelines are recommendations and do not create any new regulatory requirements, a change that was made in response to concerns from industry groups that FSIS inspectors could incorrectly interpret the beef slaughter and beef processing guidelines as regulatory requirements;
    • Removal of information regarding Salmonella from both documents, as a result of FSIS choosing to address that foodborne hazard in other documents;
    • Additional information on technical procedures (e.g., cattle washing and pre-harvest interventions in beef slaughter and a brief question and answer section on antimicrobial interventions and retained water in beef processing);
    • Removal of best practices recommendations that would not be practical (e.g., the use of chlorophyll to detect contamination on carcasses); and
    • Additional information in relation to product recalls to clarify FSIS policy regarding adulterant STEC strains, which include E. coli O157:H7 as well as strains that have certain O groups (O26, O45, O103, O111, O121, and O145) and contain two specific virulence genes (stx and eae).
  • The revised beef slaughter and beef processing guidelines are expected to be posted today on the FSIS guidance web page at: https://www.fsis.usda.gov/policy/fsis-guidelines.  Although comments on these guidelines will no longer be accepted through www.regulations.gov, FSIS will continue to update these documents, as necessary.
  • FDA published a report on June 11 that expresses concerns with farm animal operations located nearby fields growing produce. The report focuses on a 2020 Salmonella enteritidis outbreak in peaches that affected 101 people across 17 states and explains FDA’s testing and traceback processes from the outbreak.
  • The report explains that FDA connected pathogen samples from peaches and peach tree leaves to a strain of Salmonella on an adjacent chicken operation using whole-genome sequencing on chicken isolates from the same period as the outbreak. The results prompted additional testing around the company’s orchards where other strains of Salmonella were connected to genetically identical pathogens found in beef and cattle isolates from an adjacent cattle feedlot. The findings helped FDA quickly identify and prioritize investigations at certain peach packing and holding operations and other peach orchards.
  • The report states these findings underscore FDA’s concern about the potential impact adjacent land uses have on produce safety, including the potential impact of dust exposure. Past outbreaks have been linked at least in part to animal feeding operations, including a 2018 E. coli outbreak in romaine lettuce. FDA encourages collaboration between neighboring farms to identify areas of concern and tailor their land management to the specific practices and conditions on individual farms.
  • On June 1, the FDA published a press release announcing that Real Water Inc., a Nevada-based bottled water manufacturer, agreed to cease operations until they can comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
  • As our readers may recall, the FDA has been investigating an outbreak of acute non-viral hepatitis of unknown cause in Nevada. The consumption of Real Water brand alkaline water was the only known common link between five cases of acute liver failure in children that occurred in November and December 2020. An additional 11 cases of acute non-viral hepatitis in adults, including one death, have since been identified as possibly linked to the consumption of Real Water brand alkaline water.
  • According to a complaint filed by the Department of Justice (DOJ) on behalf of the FDA, defendants violated the FD&C Act by operating facilities that failed to meet preventive controls requirements to control food hazards, and also failed to follow current good manufacturing practice (cGMP) requirements for bottled water. The Real Water Inc. products were also deemed adulterated within the meaning of the FD&C Act because they were prepared, packed, or held under insanity conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.
  • U.S. District Judge Jennifer A. Dorsey entered a consent decree of permanent injunction between the US and AffinityLifestyles.com Inc. (a majority shareholder of Real Water Inc.), Real Water Inc., Brent A. Jones (president of Real Water Inc.), and Blain K. Jones (vice president of Real Water Inc.). The consent decree requires defendants to cease operations until they complete corrective actions, including hiring a qualified independent expert to inspect their facilities. Further, defendants may not resume operations until procedures are implemented to ensure continuing compliance with food safety requirements.
  •  The largest Salmonella outbreak in over a decade occurred last year when illness from Salmonella Newport associated with consumption of red onions from the Southern San Joaquin Valley and Imperial Valley in California was reported in 1,127 people in the U.S. and 515 people in Canada between June 19, 2020 and September 11, 2020.  Red onions had never previously been associated with a foodborne illness outbreak.  Red onions, as well as yellow, white and sweet onions distributed by Thomson International Inc. were recalled because of the possible Salmonella risk.  The outbreak included 167 hospitalizations and no deaths.
  • On May 13, 2021, FDA released its Investigation Report: Factors Potentially Contributing to the Contamination of Red Onions Implicated in the Summer 2020 Outbreak of Salmonella Newport.  FDA did not make a firm conclusion as to the root cause of contamination of the onions but identified contaminated irrigation water used in a growing field in Holtville, California as the leading hypothetical cause.  Other highlights of FDA’s report include:
    • Out of nearly 2,000 subsamples tested, a total of 11 subsamples (10 water and 1 sediment) were positive for Salmonella Newport representing three different genotypes, but not the same genotype as the outbreak strain linked to consumption of red onions.
    • Aside from irrigation water, FDA identified sheep grazing on adjacent land, as well as signs of animal intrusion, such as scat and large flocks of birds, as plausible opportunities for contamination of the red onions.
    • Further, visual observations and records review of packing house practices confirmed numerous opportunities for spread of foodborne pathogens such as Salmonella, including signs of animal and pest intrusion as well as food contact surfaces which had not been inspected, maintained, cleaned, or sanitized as frequently as necessary to protect against the contamination of produce.
    • FDA found two sediment subsamples and two water subsamples of Salmonella isolates having the same genotype as clinical isolates previously associated with illness from Salmonella Muenchen and Salmonella Montevideo from earlier foodborne illness outbreaks linked to consumption of sprouts in 2016 and 2018, respectively, which FDA said could indicate human pathogen persistence and distribution in the associated growing region, posing a risk of contamination for any produce commodity and, thus, FDA has assigned a follow up investigation at the associated firms.
  • While FDA is considering how best to achieve public health protections in the covered produce agricultural water arena, non-sprout farms are not required to comply with the current agricultural water requirements of the Produce Safety Rule.  Specifically, a March 18, 2019 Final Rule extended the compliance dates for the agricultural water provisions (subpart E) in the Standards for the ‘‘Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ rule (November 27, 2015, 80 FR 74354), for covered produce other than sprouts, to January 26, 2024, for very small businesses, January 26, 2023, for small businesses, and January 26, 2022, for all other businesses.
  • On May 4, the FDA published two Warning Letters for undeclared allergens and the “introduction or delivery for introduction into interstate commerce of any food that is misbranded” which is prohibited by section 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 331(a)).
  • In a March 26 letter sent to Hanover Foods Corporation, the FDA stated that its recalled Baked Rice Pudding and Cheddar Flavored Popcorn were misbranded within the meaning of section 403(w) of the FD&C Act because the labels failed to declare the major food allergens of milk and egg (Rice Pudding) and milk (Cheddar Flavored Popcorn). Specifically, the Rice Pudding was manufactured with milk and egg, but the label incorrectly declared an ingredient list for another product that did not contain milk or egg. Similarly, the Cheddar Flavored Popcorn incorrectly declared another product’s ingredient list, which did not contain milk.
  • On March 30, a separate letter was sent to George DeLallo Company Inc. for their recalled Holiday Cookie Platter and Provolini Antipasti products. FDA stated that the products were misbranded within the meaning of section 403(w) of the FD&C Act because the products did not declare the presence of pecans (tree nuts) and milk, respectively.
  • In comments to both Warning Letters, FDA noted that the manufacturing facilities are subject to the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP and PC rule). Thus, both Hanover and DeLallo are required to identify and implement preventive controls to provide assurances that any hazard requiring a preventive control (e.g., undeclared allergens) would be significantly minimized or prevented. In other words, the presence of the undeclared allergens may have been a result of the manufacturers’ inadequate prevention or failure to comply with CGMP and PCs.
  • As our readers know, food or ingredients that contain one of the now nine major allergens must be specifically labeled with the names of the allergen source. The nine major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. These Warning Letters, in addition to the one sent to Whole Foods in December, reconfirm FDA’s attention and efforts to reduce the prevalence of undeclared allergens and allergen recalls.
  •  On April 16, 2021, the FDA issued an update on its investigation of an outbreak reported March 13, 2021 in Nevada of acute non-viral hepatitis of unknown cause, and associated with consumption of “Real Water” brand alkaline water.  According to the Centers for Disease Control and Prevention (CDC), which is also investigating the outbreak, acute non-viral hepatitis is inflammation of the liver from a cause other than a virus, such as drugs, alcohol, or toxins.
  • Thus far, five hospitalized pediatric patients from four households have recovered, as have two adults and three children from two of the four households, after experiencing less severe symptoms, including fever, vomiting, nausea, loss of appetite, and fatigue.  As the investigation continues, FDA is working to locate any remaining “Real Water” products, particularly products sold on-line, to ensure they are no longer available to consumers.  FDA recommends that consumers, including pets, avoid the recalled alkaline water products until more information is known about the cause of the illnesses.
  • Since FDA’s previous, March 31 update, which indicated a lack of cooperation from the firm, FDA has completed inspections at “Real Water” Inc.’s facilities and has received some requested records.  FDA is also sampling and analyzing Real Water products and will provide updates as the investigation continues.
  • After an Environmental Assessment of factors potentially contributing to the contamination of romaine lettuce with E. coli O157:H7 that was implicated in a 2018 multi-state foodborne illness outbreak (discussed here), FDA announced plans to test samples of romaine lettuce grown in the Central Coast, Central Valley, and Imperial Valley in California and in Yuma, Arizona, for Shiga toxin-producing Escherichia coli (STEC) and Salmonella spp.  There have been five suspected or confirmed multistate outbreaks of foodborne illness linked to produce harvested in the Yuma growing region since 2012 and it is suspected that other farms in that area, in addition to the one farm implicated during FDA’s investigation, may have contributed to the spring 2018 E. coli outbreak.
  • On February 5, 2021, FDA announced plans to soon begin collecting over the growing season approximately 500 samples of romaine lettuce from commercial coolers and cold storage facilities, which hold lettuce from multiple farms in the Yuma region, for STEC and Salmonella as part of the Agency’s ongoing surveillance efforts.  By contracting with an independent laboratory located near the collection sites, FDA expects to receive test results within 24 hours from receipt of the sample by the laboratory.  While not required, the industry may choose to hold the sampled lots pending notification of test results to help prevent potential recalls of any contaminated lettuce that could have entered commerce.
  • In similar testing conducted last year, no STEC of concern to human health and no Salmonella spp. were detected in 118 samples from the Yuma growing region.  Microbiological testing of Romaine lettuce from the Yuma growing region is among several actions identified in FDA’s Leafy Greens Action Plan that seeks to identify potential sources and routes of contamination, inform what preventive measures are needed, and help prevent outbreaks of foodborne illness.