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Beltway Beat

FDA’s Guidance for Industry: Action Levels for Lead in Processed Food Intended for Babies and Young Children

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The Food and Drug Administration (FDA) announced on its website the availability of a final guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.

In accordance with § 109.6 (21 CFR 109.6), this guidance establishes the following action levels for lead in processed food intended for babies and young children less than 2 years old:

  • 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain- and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats
  • 20 ppb for single-ingredient root vegetables; and 20 ppb for dry infant cereals

Consistent with § 109.6(d), these action levels reflect levels of lead at which FDA may regard the food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). FDA said it intends to consider these action levels, in addition to other factors, when considering whether to bring enforcement action in a particular case.

Beltway Beat

First Bird Flu Death in U.S. Reported in Louisiana

By Food Safety Tech Staff
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The news comes on the heels of a report that the patient had carried mutations that might help the virus infect people more easily.

This article is in follow up to the Dec. 30 article, Genetic Sequences of Highly Pathogenic Avian Influenza A(H5N1) Viruses Identified in a Person in Louisiana

The New York Times reported that a Louisiana patient who had been hospitalized with severe bird flu has died, the first such fatality in the United States, state health officials.

The patient was older than 65 and had underlying medical conditions, the officials said. The individual became infected with the bird flu virus, H5N1, after exposure to a backyard flock and wild birds.

The Centers for Disease Control and Prevention said late last month that the mutations were not present in virus samples taken from the backyard flock, suggesting that they developed in the patient as the illness progressed.

One of the mutations was also present in virus sampled from a 13-year-old Canadian girl who was hospitalized and required respiratory support. She has since recovered.

Both patients carried a version of the virus that is circulating in wild birds, distinct from the one causing the outbreak in dairy cattle.

SmartSense Names Industry Leader Stefanie Miller to Advisory Board

Miller’s appointment brings extensive expertise in strategic planning, R&D, marketing and other core business functions built over her tenure at global food and beverage brands, including The Coca-Cola Company and Kellogg Company.

SmartSense by Digi®, part of Digi International announced the appointment of Stefanie Miller, Managing Director of Category Strategy and Growth at Kellanova Europe, to its Food Service Advisory Board, which focuses on consumer packaged goods (CPG) safety. Miller joins a distinguished group of leaders from Giant Eagle, Inc., Schnuck Markets, Inc., NewRoad Capital Partners, Nutrition Core Solutions, and Clipper Advisory Group.

“I’m honored to join the Food Service Advisory Board and help drive dedication to innovation and excellence,” said Miller. “SmartSense has an unwavering commitment to improving food service and reducing CPG risks through innovative technology, a more important mission than ever with foodborne illnesses and recalls spread throughout the supply chain seemingly more prevalent than ever. By working alongside professionals from across the food service sector, I am eager to contribute to elevating food manufacturing and supply chain safety standards and enriching the quality of service for SmartSense customers.”

Miller’s appointment brings extensive expertise in strategic planning, R&D, marketing and other core business functions built over her tenure at global food and beverage brands, including The Coca-Cola Company and Kellogg Company.

“An incredibly valuable addition to our Food Service Advisory Board, Stefanie brings industry experience that will help foster a more strategic path forward for SmartSense food service solutions,” said Guy Yehiav, President of SmartSense by Digi. “Her pioneering approach to tackling industry challenges across diverse sectors and various leadership roles in food manufacturing will continue to inspire innovative solutions, foster collaboration, and set new standards for risk management.”

Miller joined the SmartSense Food Service Advisory Board on Nov 1, 2024, further advancing the company’s mission to empower food service organizations to safeguard consumer outcomes through advanced IoT technology

Beltway Beat

Genetic Sequences of Highly Pathogenic Avian Influenza A(H5N1) Viruses Identified in a Person in Louisiana

CDC has sequenced the influenza viruses in specimens collected from the patient in Louisiana who was infected with, and became severely ill from HPAI A(H5N1) virus. The genomic sequences were compared to other HPAI A(H5N1) sequences from dairy cows, wild birds and poultry, as well as previous human cases and were identified as the D1.1 genotype. The analysis identified low frequency mutations in the hemagglutinin gene of a sample sequenced from the patient, which were not found in virus sequences from poultry samples collected on the patient’s property, suggesting the changes emerged in the patient after infection.

This technical summary of an analysis of the genomic sequences of the viruses identified in two upper respiratory tract specimens from the patient who was severely ill from an infection with highly pathogenic avian influenza (HPAI) A(H5N1) virus in Louisiana. The patient was infected with A(H5N1) virus of the D1.1 genotype virus that is closely related to other D1.1 viruses recently detected in wild birds and poultry in the United States and in recent human cases in British Columbia, Canada, and Washington State. This avian influenza A(H5N1) virus genotype is different from the B3.13 genotype spreading widely and causing outbreaks in dairy cows, poultry, and other animals, with sporadic human cases in the United States. Deep sequencing of the genetic sequences from two clinical specimens from the patient in Louisiana was performed to look for changes associated with adaptation to mammals. There were some low frequency changes in the hemagglutinin (HA) gene segment of one of the specimens that are rare in people but have been reported in previous cases of A(H5N1) in other countries and most often during severe infections. One of the changes found was also identified in a specimen collected from the human case with severe illness detected in British Columbia, Canada, suggesting they emerged during the clinical course as the virus replicated in the patient. Analysis of the N1 neuraminidase (NA), matrix (M) and polymerase acid (PA) genes from the specimens showed no changes associated with known or suspected markers of reduced susceptibility to antiviral drugs.

Overall, CDC considers the risk to the general public associated with the ongoing U.S. HPAI A(H5N1) outbreak has not changed and remains low. The detection of a severe human case with genetic changes in a clinical specimen underscores the importance of ongoing genomic surveillance in people and animals, containment of avian influenza A(H5) outbreaks in dairy cattle and poultry, and prevention measures among people with exposure to infected animals or environments.

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Beltway Beat

APHIS Announces Updates to Indemnity Program for Highly Pathogenic Avian Influenza on Poultry Farms

By Food Safety Tech Staff
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As part of its ongoing efforts to stop the further spread of Highly Pathogenic Avian Influenza (HPAI) and give farmers tools to help combat the disease, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) announced an interim final rule that updates the conditions for poultry facilities to receive indemnity and compensation after testing positive for HPAI. Based on evidence that strong biosecurity measures remain the most effective strategy to combat HPAI, APHIS will now require that farmers undergo a biosecurity audit before restocking their poultry after an HPAI detection, and before receiving future indemnity payments.

“During the outbreak of HPAI in 2014 and 2015, U.S. poultry owners made great improvements to biosecurity to protect their flocks, which greatly reduced the presence of HPAI among the country’s poultry flock,” said Dr. Rosemary Sifford, USDA Chief Veterinary Officer. “Biosecurity is proven to be our best weapon in fighting this virus, and this update will ensure that poultry producers who received indemnity for HPAI are taking measures to stop future introductions of the disease and avoiding actions that contribute to its spread.”

Under the interim final rule, if a commercial poultry farm affected by HPAI wants to restock their poultry and be eligible for future indemnity on that restock, the premises will be required to pass a biosecurity audit by APHIS before restocking. APHIS will also require a biosecurity audit for commercial poultry premises within the “buffer zone” (minimal 7 km radius around the infected zone) prior to movement of poultry onto the premises if the owner wishes to be eligible for future indemnity for the poultry moved onto the premises. Additionally, APHIS will not pay indemnity for flocks moved onto premises in active infected zones if the flocks become infected with HPAI within 14 days following the dissolution of the control area around an active infected premises. A producer who does not make corrections recommended in APHIS’s biosecurity audit will not be eligible for indemnity payments if the premises experiences future infections within the same outbreak.

Poulty Farmer

Iowa HHS Reports First Human Case of Highly Pathogenic Avian Influenza (HPAI) in Iowa

By Food Safety Tech Staff
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The Iowa Department of Health and Human Services (Iowa HHS) reported the first human case of avian influenza A(H5) in the state. The individual was exposed to infected poultry while working with a commercial flock in northwest Iowa. The individual reported mild symptoms, has received appropriate treatment and is recovering. The case was identified through testing at the State Hygienic Laboratory and confirmed by the Centers for Disease Control and Prevention (CDC).

“Iowa has monitored the spread of avian influenza closely since it was first detected in poultry in the state in 2022, and our state is prepared with the established knowledge, strong partnerships, and effective tools to mitigate its impact on our community,” said Iowa HHS State Medical Director Dr. Robert Kruse.

As of December 20, 2024, the CDC has reported 64 confirmed human cases of H5 HPAI across nine states. The majority of the exposures are linked to infected poultry or dairy cows.

Voluntary Recall of Northwest Naturals’ Pet Food Due to Highly Pathogenic Avian Influenza (HPAI) Contamination

By Food Safety Tech Staff
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Northwest Naturals of Portland, Oregon announced that it is voluntarily recalling one batch of Northwest Naturals brand 2lb Feline Turkey Recipe raw frozen pet food after it was tested positive for Highly Pathogenic Avian Influenza (H5N1) virus.

According to the Oregon Department of Agriculture’s website, testing conducted by the U.S. Department of Agriculture’s (USDA) National Veterinary Services Laboratories (NVSL) and the Oregon Veterinary Diagnostic Laboratory (ODVL) at Oregon State University confirmed a house cat in Washington County, Oregon contracted H5N1 and died after consuming the raw frozen pet food. Tests confirmed a genetic match between the virus in the raw and frozen pet food and the infected cat.

“We are confident that this cat contracted H5N1 by eating the Northwest Naturals raw and frozen pet food,” said ODA State Veterinarian Dr. Ryan Scholz. “This cat was strictly an indoor cat; it was not exposed to the virus in its environment, and results from the genome sequencing confirmed that the virus recovered from the raw pet food and infected cat were exact matches to each other.”

The Oregon Health Authority (OHA) and local public health officials are monitoring household members who had contact with the cat for flu symptoms. To date, no human cases of Highly Pathogenic Avian Influenza (HPAI) have been linked to this incident. Although Oregon has reported one confirmed human case of HPAI, there are no confirmed cases of the virus in dairy cows or cow milk. As a precautionary measure, ODA announced on December 11 that it will test milk from every commercial dairy across the state. Neighboring states such as Idaho, Nevada, and California have reported HPAI cases in dairy cattle herds, contributing to over 700 confirmed cases in 16 states nationwide.

I.M. Healthy SoyNut Butter, recall
Beltway Beat

FDA updates nutritional requirements a food must meet to use the claim “healthy” on the package

By Food Safety Tech Staff
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I.M. Healthy SoyNut Butter, recall

The U.S. Food and Drug Administration (FDA) announced today it has updated the nutritional requirements a food must meet to use the claim “healthy” on the package, which includes criteria a food must meet to use the “healthy” claim on the package. The FDA also is exploring the development of a symbol to represent the claim “healthy” to make it easier to spot foods that can be the foundation of healthy eating patterns.

Updating the “Healthy” Definition on Food Packaging

The last time “healthy” was defined on packaging was in the 1990s. Based on the nutrition science and federal dietary guidelines at that time, the definition was solely focused on individual nutrients; for example, it included limits for saturated fat, total fat, cholesterol, and sodium and required a certain amount of beneficial nutrients like certain vitamins, minerals, fiber, and protein.

With a greater understanding of dietary patterns and their effects on health, and FDA recognizes that foods are made up of a variety of nutrients that work together as part of a healthy dietary pattern.

To be consistent with the latest nutrition science and federal dietary guidelines the updated definition of “healthy” requires that:

  • A food must contain a certain amount of a food group like fruits, vegetables, grains, protein foods, or dairy.
  • A food can’t contain too much saturated fat, sodium, or added sugars.

How the “Healthy” Claim Works

Placing a “healthy” claim on a food package is voluntary. If manufacturers choose to do it, their products must have the nutrient content required by the “healthy” definition. Manufacturers who choose to use the “healthy” claim can use the new criteria starting on February 25, 2025.

Here are some examples of what qualifies to use the “healthy” claim under the updated definition:

  • Nuts and seeds, olive oils, higher-fat fish, like salmon, and eggs would qualify as healthy because of their nutrient profile. They didn’t qualify under the previous definition.
  • Water. While water isn’t part of a food group, it is considered an optimal beverage by the Dietary Guidelines.

Here are some examples of what no longer qualifies to use the “healthy” claim under the updated definition:

  • Fortified white bread, highly sweetened yogurt, highly sweetened cereal.

For more details, see Use of the Term Healthy on Food Labeling.

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California Declares an Emergency Over Bird Flu (H5N1) in Dairy Cows

By Food Safety Tech Staff
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On Wednesday, December 18, Governor Gavin Newsom proclaimed a State of Emergency to streamline and expedite the state’s response to Avian influenza A (H5N1), commonly known as “Bird Flu.” This action comes as cases were detected in dairy cows on farms in Southern California, signaling the need to further expand monitoring and build on the coordinated statewide approach to contain and mitigate the spread of the virus. The virus has spread in 16 states among dairy cattle, following its first confirmed detection in Texas and Kansas in March 2024.

To date, no person-to-person spread of Bird Flu has been detected in California and nearly all infected individuals had exposure to infected cattle. California has already established the largest testing and monitoring system in the nation to respond to the outbreak.

This emergency proclamation that was on the State’s website will provide state and local agencies with additional flexibility around staffing, contracting, and other rules to support California’s evolving response.

According to the website, California has mobilized a comprehensive cross-agency response to Bird Flu in dairy cattle and poultry farms to minimize farm worker exposures, reduce raw dairy product contamination, and mitigate the spread of the virus. The state has enlisted local, state, and federal government technical and operational expertise to support all facets of the response; worked to educate the public, health professionals, employers, and workers on prevention and control measures to reduce the risk of exposure to Bird Flu; provided comprehensive information for employers and workers on personal protective equipment (PPE) requirements; and distributed millions of pieces of PPE to high-risk workers at dairy farms.

Through coordinated public awareness efforts between the California Department of Public Health (CDPH), the California Department of Food and Agriculture (CDFA), California Office of Emergency Services (CalOES), and other agencies, the state is leading a cross-agency response that includes timely public updates, multilingual outreach to dairy and poultry workers, targeted social media efforts to promote preventive practices, online and printed resources for the public, and media interviews to keep Californians informed. Additionally, the state is ensuring that agriculture workers have access to additional doses of seasonal flu vaccine from the Centers for Disease Control and Prevention (CDC) to reduce concurrent flu risks.

Officials have also been working in close collaboration with the Centers for Disease Control, the U.S. Food and Drug Administration, the U.S.  Department of Agriculture, and local health and agricultural officials, as part of a whole-of-government effort to coordinate, implement, and ensure timely surveillance and investigation of potential cases of Bird Flu.

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Beltway Beat

FSIS Announces Stronger Measures to Protect the Public from Listeria monocytogenes

By Food Safety Tech Staff
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The changes FSIS is announcing fall into three categories: enhancing its science-based approach to mitigate foodborne pathogens, with a key focus on Listeria monocytogenes; improving training and tools for its inspection workforce; and evolving its oversight of regulated facilities, with an emphasis on data review and state inspection agreements. FSIS will initiate the following changes in the next 30 days:

Enhancing FSIS’ Regulatory and Sampling Approach to Listeria 

  • Effective January 2025, FSIS will add broader Listeria species testing to all samples of ready-to-eat product, environmental and food contact surfaces. FSIS laboratories currently test these samples for Listeria monocytogenes, which is the specific type of Listeria species that causes illness. However, adding additional species testing to the agency’s regulatory framework will help provide more information about the effectiveness of a facility’s sanitation program and can signal to FSIS if follow up is needed (for example, a Food Safety Assessment, intensified sampling, or enforcement actions).
  • FSIS will leverage the expertise of its National Advisory Committee on Microbiological Criteria for Foods (NACMCF). NACMCF is a federal advisory committee that provides scientific advice and recommendations to USDA and other government agencies on microbiological and public health issues. In December, FSIS will begin recruitment for new committee members, who will be given the specific charge of reviewing the agency’s regulatory approach to Listeria monocytogenes. Expertise in Listeria will be sought for membership. The committee’s input will be used to guide more long-term policy changes.

Equipping FSIS Inspectors with Updated Training and Tools to Recognize and Respond to Systemic Food Safety Issues

  • FSIS will update its instructions and training for food safety inspectors to better equip the workforce to recognize and highlight systemic problems in a standardized way. Agency inspectors will receive updated instructions and training, and FSIS field supervisors will routinely review these instructions with inspectors to ensure full understanding and appropriate application. Inspectors will also receive supplemental Listeria monocytogenes control training designed to help strengthen inspectors’ understanding of the regulatory requirements in FSIS’ Listeria Rule and how to verify establishments have designed and implemented food safety systems that comply with those requirements.
  • FSIS will conduct Food Safety Assessments (in-depth food safety reviews) at ready-to-eat meat and poultry facilities. In FY 2025, FSIS is prioritizing completion of Food Safety Assessments at ready-to-eat meat and poultry facilities that rely exclusively on sanitation measures to control for Listeria. These reviews will provide information about the plants individually and collectively and could inform future policy or process changes to target this microorganism.
  • FSIS field supervisors will conduct in-person, follow-up visits when systemic issues are identified during a Food Safety Assessment. Follow-up visits by FSIS field supervisors will bolster oversight from more senior inspection staff to ensure a facility fully addresses issues identified during a Food Safety Assessment and could inform enforcement action by FSIS. Field supervisors will work with inspectors to ensure the facility stays in compliance.

Tightening Oversight of Regulated Establishments, Including Those Under State Inspection Models

  • FSIS inspectors will verify specific Listeria monocytogenes-related risk factors at ready-to-eat facilities weekly. These risk factors include changes in physical plant modifications, such as new construction; indicators of sanitation problems, such as condensation, roof leaks, damaged equipment, or cracked floors; and Listeria species or Listeria monocytogenes positive test results from company testing. FSIS district offices, agency field supervisors and inspectors will review, analyze and consider the weekly data from each facility to determine if there are systemic issues that warrant further action, such as a Food Safety Assessment, intensified sampling, or enforcement steps.
  • FSIS will clarify state and Federal requirements for consistent oversight of Talmadge-Aiken (TA) programs through updated cooperative agreements and instructions. Through updated cooperative agreements with each participating state, FSIS will set specific requirements, including clear expectations for oversight, enforcing federal food safety laws, comprehensive federal training for TA inspectors, and enhanced regular coordination with FSIS. FSIS will also designate field and headquarters positions assigned to TA oversight; will clarify training requirements and criteria to start, maintain and terminate state inspection coverage of an establishment.
  • FSIS will revise establishment-review alert triggers. One significant criterion used to guide a district office’s decision to conduct a Public Health Risk Evaluation (PHRE), which typically precedes a Food Safety Assessment, is a monthly list of facilities with higher rates of noncompliance related to public health that is generated using an algorithm. Using additional data from the new weekly verification of Listeria monocytogenes-related risk factors, FSIS intends to update its algorithm and triggers to better identify high-risk facilities.

According to a USDA press release, these actions are intended to strengthen FSIS’ inspection and oversight by enhancing its ability to proactively identify and respond to the types of systemic problems that could lead to outbreaks. Listeria monocytogenes is a pathogen of particular concern because it can be especially harmful to people with compromised immune systems, like the elderly and pregnant women, and it can contaminate foods that are not cooked before consumption.

FSIS is continuing to identify other steps that would improve control of Listeria monocytogenes, dependent on funding availability. As requested in the FY 2025 President’s Budget, additional resources are necessary for the agency to continue to meet its mission to keep meat, poultry, and egg products safe and wholesome.