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.

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Beltway Beat

USDA Announces New Federal Order, Begins National Milk Testing Strategy to Address H5N1 in Dairy Herds

By Food Safety Tech Staff
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Today, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is announcing the start of its National Milk Testing Strategy (NMTS), which builds on measures taken by USDA and federal and state partners since the outbreak of highly pathogenic avian influenza (HPAI) H5N1 in dairy cattle was first detected in March 2024. Today, USDA is issuing a new Federal Order, as well as accompanying guidance, requiring that raw (unpasteurized) milk samples nationwide be collected and shared with USDA for testing. This new guidance from USDA, which was developed with significant input from state, veterinary and public health stakeholders, will facilitate comprehensive H5N1 surveillance of the nation’s milk supply and dairy herds.

According to the USDA’s announcement on their website, this NMTS is designed to increase USDA’s and public health partners’ understanding of the virus’ spread in the United States through a structured, uniform, and mandatory testing system that will help swiftly identify which states, and specific herds within them, are affected with H5N1; support the rapid implementation of enhanced biosecurity measures to decrease the risk of transmission to other livestock; and importantly, inform critical efforts to protect farmworkers to help lower their risk of exposure. USDA believes this additional step is needed to proactively support effective biosecurity measures, which is key for states and farmers to contain and eliminate H5N1 infections from their livestock and to eliminate HPAI in livestock across the U.S. dairy population.

The Federal Order released today makes three new requirements.

  1. it requires the sharing of raw milk samples, upon request, from any entity responsible for a dairy farm, bulk milk transporter, bulk milk transfer station, or dairy processing facility that sends or holds milk intended for pasteurization.
  2. the Federal Order requires herd owners with positive cattle to provide epidemiological information that enables activities such as contact tracing and disease surveillance.
  3. finally, like USDA’s April 24 Federal Order, it requires that private laboratories and state veterinarians report positive results to USDA that come from tests done on raw milk samples drawn as part of the NMTS.

The first round of silo testing under the Federal Order and the NMTS is scheduled to begin the week of Dec. 16, 2024, although some states are already conducting testing compatible with the NMTS.

This new Federal Order does not override or supersede USDA’s April 24 Federal Order, which still requires the mandatory testing of lactating dairy cows prior to interstate shipment and requires that all privately owned laboratories and state veterinarians report positive test results connected with those tests. The new Federal Order announced today is intended to complement and enhance this existing order.

National Milk Testing Strategy

As part of the National Milk Testing Strategy, APHIS will work with each state in the contiguous United States to execute testing in a way that works for the state and that aligns with the NMTS standards. Once a state begins testing under the NMTS, APHIS will place that state into one of five stages based on the HPAI H5N1 virus prevalence in that state. As states move to another stage, we will have a stronger picture of our progress towards eliminating HPAI H5N1 at state, regional and national levels. These stages include:

Stage 1: Standing Up Mandatory USDA National Plant Silo Monitoring

USDA will immediately begin nationwide testing of milk silos at dairy processing facilities. This national sample will allow USDA to identify where the disease is present, monitor trends, and help states identify potentially affected herds.

Stage 2: Determining a State’s H5N1 Dairy Cattle Status

Building on the results of silo monitoring, in collaboration with states, USDA will also stand up bulk tank sampling programs that will enable us to identify herds in the state that are affected with H5N1.

Stage 3: Detecting and Responding to the Virus in Affected States

For states with H5N1 detections, APHIS will work quickly to identify specific cases and implement rapid response measures, including enhanced biosecurity using USDA’s existing incentives programs, movement controls and contact tracing.

Stage 4: Demonstrating Ongoing Absence of H5 in Dairy Cattle in Unaffected States

Once all dairy herds in a given state are considered to be unaffected, APHIS will continue regular sampling of farms’ bulk tanks to ensure the disease does not re-emerge. Bulk tank sampling frequency will progressively decline as the state demonstrates continual silo negativity (e.g., weekly, monthly, quarterly if continually negative). If a state becomes affected, USDA will re-engage detection and response activities, and the state will return to Stage 3.

Stage 5: Demonstrating Freedom from H5 in U.S. Dairy Cattle

After all states move through Stage Four, APHIS will work with the states to begin periodic sampling and testing to illustrate long-term absence from the national herd.

As of this announcement, the following six states will be included in the first round of states brought into the program for testing: California, Colorado, Michigan, Mississippi, Oregon, and Pennsylvania.

As states begin testing under the NMTS and as they move through the five stages, their progress will be shared at USDA HPAI in Livestock Testing. While the majority of states will enter the NMTS at Stage 1, we anticipate states with ongoing testing may meet the testing requirements described above in Stages 2-4. USDA will work closely with states to determine each state’s status. While the majority of states will enter the NMTS at Stage 1, we anticipate states with ongoing testing may meet the testing requirements described above in Stages 2-4. USDA will work closely with states to determine each state’s status.

Hygiena Acquires Nexcor Food Safety Technologies Inc.

The acquisition exemplifies the shared commitment and aligned values of Hygiena and Nexcor, aiming to enhance the safety and operational efficiency of food and beverage facilities through innovative technologies and comprehensive solutions.

Hygiena, announced that is has completed the acquisition of Nexcor Food Safety Technologies, Inc., the creator of KLEANZ and CAMS-PM, two software solutions for managing sanitation and equipment maintenance in food and beverage manufacturing facilities.

“Effective cleaning and monitoring of facilities with food safety diagnostic testing are essential for quality control and risk mitigation across all food processing environments. With our acquisition of Nexcor software solutions, we plan to integrate our SureTrend® analytics platform with KLEANZ’s sanitation software, delivering powerful tools to drive quality improvement, prevent food safety issues and enhance operational efficiencies,” said Steven Nason, CEO of Hygiena. “Hygiena’s extensive global customer base and commercial channels will introduce KLEANZ and CAMS-PM software solutions, along with our integrated SaaS food safety offerings, to a wider audience. This expanded portfolio provides our customers with a streamlined, prevention-focused approach to sanitation and food safety management. With a centralized platform offering comprehensive, real-time solutions, we are empowering businesses to enhance their food safety programs and operational effectiveness worldwide.”

Robert Burgh, President of Nexcor Food Safety Technologies, Inc., commented, “This collaboration with Hygiena allows Nexcor to create greater customer value by streamlining two critical, interconnected functions within food companies worldwide. Together, we accelerate market growth while staying true to our values of innovation, integrity and customer satisfaction. We are excited to merge our expertise, creating enhanced SaaS platforms and comprehensive solutions for sanitation, safety and compliance management. United, we are poised to lead the future of food safety with a shared vision and strong commitment.”

David Grant, General Manager of Software and Instrument Firmware at Hygiena, added, “We are excited to integrate Nexcor’s solutions into our existing suite of software offerings and extend the capabilities of SureTrend. SureTrend currently enables our customers to efficiently plan, schedule, test, capture, store, protect, analyze, audit and report on their critical testing data. Integrating Nexcor’s data will allow us to leverage sophisticated machine learning AI for predictive insights, enhancing risk mitigation and advancing food safety.”

The acquisition exemplifies the shared commitment and aligned values of Hygiena and Nexcor, aiming to enhance the safety and operational efficiency of food and beverage facilities through innovative technologies and comprehensive solutions. Nexcor’s dedicated customer base and strong market presence in the food, beverage and packaging sectors will significantly contribute to the partnership’s success, fostering global expansion, enhanced product offerings, operational efficiencies and cross-selling opportunities.

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Beltway Beat

USDA Food Safety and Inspection Service Announces Leadership Changes

By Food Safety Tech Staff
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On November 21, 2024, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced changes to the agency’s leadership team.

Dr. Denise Eblen, currently FSIS’ Assistant Administrator for the Office of Public Health Science, has been named agency Administrator. As Assistant Administrator for the Office of Public Health Science since 2018, Dr. Eblen has led the agency’s scientific analysis, including oversight of FSIS laboratories and testing of regulatory samples, risk assessment, and outbreak investigation and response. Drawing from her twenty five years of experience at USDA, she will continue to steer FSIS in its efforts to use science-based decision making to modernize the agency’s inspection strategies, policies, and approaches to improve public health. In addition to her work with FSIS, Dr. Eblen has held roles with USDA’s National Institute of Food and Agriculture and the Agricultural Research Service.

Denise Eblen, Ph.D., FSIS, Administrator, Office of Public Health Service portrait in Washington, DC on May 30, 2018. USDA photo by Ken Hammond.

Dr. Eblen holds a Bachelor of Science Degree in Human Nutrition from the University of Ulster at Coleraine in Northern Ireland, a Master of Science Degree in Food Science from Queen’s University, Belfast, in Northern Ireland, and a Ph.D. in Food Safety Microbiology from the University of Ulster at Jordanstown, Northern Ireland.

Paul Kiecker will take on the role of Assistant Administrator in the Office of Investigation, Enforcement and Audit, where he will apply his deep experience with the agency and his leadership capabilities to head FSIS’s investigation, enforcement, and audit functions. Mr. Kiecker has served FSIS for more than thirty years, beginning as a food inspector in 1988 and most recently serving as Administrator. His previous roles include experience across the Office of Field Operations and as a Compliance Investigator and Supervisory Compliance Investigator with the Office of Investigation, Enforcement and Audit.  Mr. Kiecker has advanced the agency’s workforce recruitment effort and engagement with FSIS’ large team of field employees, among other key priorities.

“Each of these leaders brings a wealth of experience with FSIS, expertise in different aspects of the agency’s mission, and a personal commitment to protecting public health by ensuring a safe food supply,” said Dr. Emilio Esteban, USDA Under Secretary for Food Safety. “I am honored to work alongside them, and I look forward to seeing the path they will chart forward to advance food safety in the days and years to come.”

According to USDA’s website, these leadership changes will take effect Dec. 9, 2024.

Beltway Beat

Trump Picks RFK Jr. as Health Secretary. What can the food industry expect?

By Food Safety Tech Staff, Rick Biros
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According to the Wall Street Journal, President-elect Donald Trump is planning to nominate environmental lawyer Robert F. Kennedy Jr. to serve as Health and Human Services secretary. Kennedy’s nomination was not a surprise. Last month, Kennedy said Trump had promised him control of the department and its many subagencies, which include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Medicare and Medicaid (CMS), and others. Trump himself pledged during the campaign to let Kennedy “go wild on health.”

To put things into context, the mission of the U.S. Department of Health and Human Services (HHS) according to it’s website is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. FDA is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices including the newly reorganized Human Foods Program headed up by Jim Jones.

Kennedy’s website, Make America Healthy Again states that Kennedy has spent nearly 40 years fighting corrupt corporations and government agencies. During his tenure at RiverKeeper, he successfully sued dozens of municipalities to force compliance with the Clean Water Act. He won cases against corporate giants, including a suit against General Electric for toxic runoff from its corporate jet hangar and a court order against ExxonMobil mandating they clean up tens of millions of gallons of spilled oil in Brooklyn, NY. As of Dec 2022, the Monsanto lawsuits to which Kennedy has devoted much of the past decade have yielded $11 Billion for farmers, migrant workers, day laborers, and families exposed to the pesticide RoundUp.

If approved, what can the food industry expect from Kennedy?

According to Make America Healthy Again, Kennedy sees Big Pharma and Big Agriculture having an undue influence on what Americans eat and how they manage their health over time.

Kennedy says the public health establishment is too focused on infectious diseases and wants to redirect resources toward issues he characterizes as the chronic disease epidemic, including obesity, diabetes, autism and mental illnesses. He blames them on corporations including food producers using harmful pesticides and additives. He traces America’s high levels of chronic disease to the widespread availability of highly processed, non-nutritious food, which he blames in part on a broken agriculture policy.

Some of his food and agriculture ideas plans share the same pseudoscience as Kennedy’s views on vaccines. Kennedy recently posted on social media that the FDA had “waged a war on public health” by “aggressive suppression” of Americans’ access to raw milk, despite raw milk’s risk of causing life-threatening diarrheal diseases and now, bird flu,

Kennedy has labeled Trump’s fast food diet as “poison” and wants to reduce the amount of ultra-processed food in the American food supply. In recent interviews, Kennedy has suggested clearing out “entire departments” at FDA, including the Center for Food Safety and Applied Nutrition.

However, if Kennedy wants to restrict the use of already-approved food additives, he needs more resources — not fewer: The process involves rigorous reviews of data, issuing public warnings, and actively monitoring the food supply. If Kennedy succeeded in closing the food safety office, that would reduce the number of people who could be dedicated to the job.

The European culture regarding food additives is generally the additive needs to be proven safe before allowed into the supply chain. Conversely, FDA’s position for years has been the additive is allowed to be used unless it has been proven harmful. Two opposite ways of regulating. Kennedy’s position on additives might move the U.S. to be more like the E.U.

Other actions could be taken by the Trump administration to reduce the amount of ultra-processed food in the American food supply, but many of them would be taken outside of HHS. The US Department of Agriculture (USDA) sets the guidelines that govern school lunch programs, which means much of what children eat is determined by that agency; Trump has not yet nominated a USDA commissioner. The USDA is also primarily responsible for overseeing farming, another industry Kennedy has heavily criticized throughout his public career and pledged to target if he were to take a role in the federal government. He would likely need to work with the USDA to follow through.

One Agency?

Kennedy is correct that food safety regulation in the US is currently a mess, says David Acheson, President of TAG. Meat, poultry, and egg plants are inspected daily under the auspices of the USDA, while every other kind of food production facility — including the farms whose produce is responsible for most of the food-borne illness in the US and the nation’s countless other industrial food manufacturers — are inspected by FDA inspectors at most once a year.

It would make far more sense to unify these functions under one agency and harmonize the frequency of food production facility inspections so none are falling through the cracks. That is the kind of organizational shake-up that could actually make a difference.

The concept of one agency is not new according to Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the U.S. Food and Drug Administration. Yiannas, in his closing keynote presentation at last month’s Food Safety Consortium Conference said the idea has been proposed by the Obama and the previous Trump administration, however, it requires Congress to approve the combination of the two agencies.

It remains to be seen what impact Kennedy’s proposals will have on the food industry but they bear little resemblance to those of prior Republican administrations, which have typically favored cutting regulations, not increasing them.

 

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FDA Publishes New Guidance Document for Voluntary Qualified Importer Program

By Food Safety Tech Staff
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FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.  Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.  This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP.  “Agency” and the pronouns “we” and “our” are used to refer to FDA.  The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

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Beltway Beat

FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration before December 31

By Food Safety Tech Staff
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Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2024. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems (FIS) account, unless they have received a waiver that allows for paper submission.

Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.

The following resources are available to assist in the registration and renewal process:

FFR Renewal:

FFR Guidance:

FFR User Guides:

FIS User Guides:

Food facilities with questions can contact the Data Management Support Services: by phone 1- 240-247-8804; or by email at FURLS@fda.gov on U.S. Government business days (Monday to Friday, excluding U.S. government holidays) from 9:00 a.m. to 6:00 p.m. Eastern Time (see Federal Holidays (opm.gov) and Current Status (opm.gov).

Frank Yiannas, VP of Food Safety, Walmart

Boar’s Head Appoints Frank Yiannas as Chief Food Safety Advisor and Finalizes Food Safety Advisory Council

Frank Yiannas, VP of Food Safety, Walmart

Boar’s Head Brand announced on October 3 the appointment of Frank Yiannas, MPH, as Chief Food Safety Advisor on an interim basis, effective immediately. In this leadership role, Mr. Yiannas will be responsible for helping to ensure leading standards of food safety and quality across the organization. He will also oversee the nationwide search for a Chief Food Safety Officer to succeed him.

In addition to his responsibilities as Chief Food Safety Advisor, Mr. Yiannas will chair the “Boar’s Head Food Safety Advisory Council,” which is comprised of independent industry-leading food safety experts. The council will provide guidance and support to the company’s adoption and implementation of enhanced quality food safety programs. As previously announced, additional founding council members include Dr. David Acheson, Dr. Mindy Brashears, and Dr. Martin Wiedmann

Frank Yiannas will deliver the Closing Keynote at the Food Safety Consortium Conference October 20-22 in Washington DC.

 

Editors Note: in addition to Mr. Yiannas, Dr. Martin Wiedmann is presenting at the Food Safety Consortium Conference and will address the threat of Listeria monocytogenes, a significant pathogen often associated with food processing environments. He will share his passion and experience, which includes addressing microbial food safety and quality challenges from farm to table and emphasize the importance of disassembly and breakdown in food processing equipment. Martin will also present his research findings on reducing foodborne illnesses, explaining how this dangerous microorganism can persist in food environments, and outline the critical steps required to control and eliminate Listeria contamination.

More Information is at www.FoodSafetyConsortium.org