Eagle Protect Files Citizen Petition Urging FDA to Ban Vinyl Gloves in U.S. Food Handling

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Eagle Protect PBC, specialist global supplier of responsibly sourced disposable gloves, has formally submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) calling for a nationwide ban on polyvinyl chloride (PVC or “vinyl”) disposable gloves in all food handling applications.

The petition, filed under 21 CFR § 10.30, cites extensive scientific evidence showing that vinyl gloves can contaminate food with toxic phthalates and fail to provide adequate microbial barriers for wearers, creating unnecessary risks to both consumers and food service workers.

Steve Ardagh“Vinyl gloves are among the weakest links in America’s food safety system,” said Steve Ardagh, CEO & Founder of Eagle Protect. “They can potentially leach harmful chemicals, tear easily, and can mislead buyers with claims of being ‘food safe’ or ‘phthalate free.’ It’s time to replace this outdated material with safer, higher performing alternatives.”

Key Findings from the Petition

  • Chemical Migration: Peer-reviewed studies show vinyl gloves can transfer phthalates into foods at levels exceeding European safety limits.
  • High Failure Rates: Research reports glove failure rates between 12–61% under normal use, compared with 1–4% for nitrile, dependent on nitrile quality.
  • Endocrine Risk: Studies in Japan and the EU link phthalate exposure from vinyl gloves to endocrine and reproductive harm.
  • Regulatory Gap: The FDA’s current oversight relies on limited material tests and does not verify imported glove composition or defect rates.
  • Environmental Burden: PVC glove production and disposal can release hazardous pollutants—including dioxins, vinyl chloride and PFAS.

Proposed FDA Action

  1. Ban PVC gloves for all food handling in the United States.
  2. Mandate lot testing for phthalates and toxic additives, with public reporting.
  3. Adopt a 24-month transition period to safer materials such as nitrile and high quality polyethylene.

A Public Health and Economic Imperative

The petition references research estimating that endocrine-disrupting chemical exposure costs the U.S. over $340 billion annually in healthcare impacts. Vinyl gloves, while appearing cheaper, increase contamination risk, recall liability and waste.

“Protecting consumers and food workers requires the use of science backed glove materials and purchasing accountability,” Ardagh added. “Our industry must evolve from cheap disposables to verified safe glove protection.”

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SQF Edition 10 Delayed

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In Q3 of this year, the Safe Quality Food Institute (SQFi) announced it would be releasing Edition 10 of its Safe Quality Food (SQF) Code to align with the latest Global Food Safety Initiative (GFSI) benchmarking criteria, updated regulatory requirements, and scientific changes. The publication date was targeted for September 2025, with audits beginning in April 2026. However, SQFi recently announced that the release of SQF Edition 10 has been delayed due to an extension in the GFSI benchmarking application timeline, which now runs through March 2026.

Key changes in SQF Edition 10:
  • Food Safety Culture:  Edition 10 places a stronger emphasis on a positive food safety culture through comprehensive plans, employee training, effective communication, and continuous feedback mechanisms. 
  • Change Management:  There is an increased focus on robust change management processes to ensure that any changes in the food production environment do not compromise food safety. 
  • Environmental Monitoring:  The new edition requires more comprehensive environmental monitoring programs as a proactive measure to control potential food safety risks. 
  • Documentation: Documentation requirements have been consolidated into a single, clear section to simplify compliance and auditing. 
  • Quality Code: There is a greater focus on the Quality Code, which moves beyond food safety to address consistency, quality control, and product defects. 
Because of this delay, SQF Edition 9 will remain the recognized version of the SQF Code. This means that audits will continue under the requirements of Edition 9 until Edition 10 is released. At that point, sites will have a six-month transition period before audits begin under Edition 10.
Beltway Beat

Update: Outbreak Investigation of Infant Botulism: Infant Formula

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Current Update

November 19, 2025  

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states. Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized. No deaths have been reported to date. For 23 infants with age and 24 with sex information available, they range in age from 16 to 200 days and 11 (46%) are female.

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Thirty-one infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

FDA has received reports that recalled formula is still being found on store shelves in multiple states. FDA is working with state partners and retailers to ensure an effective recall. All ByHeart infant formula products have been recalled, and these products should not be available for sale in stores or online. This includes all formula cans and single-serve “anywhere pack” sticks.

Additionally, recalled product was sold through online marketplaces and was shipped to customers outside of the United States. Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, the California Department of Public Health (CDPH) preliminarily detected the presence of botulinum neurotoxin type A in a culture of ByHeart powdered infant formula from an opened can (lot 206VABP/251131P2) that was fed to an infant with laboratory confirmed infant botulism. Additional work by CDPH confirmed the identification of the bacterium, Clostridium botulinum type A from the culture.

As part of its onsite inspections, FDA collected and is analyzing samples of unopened product. Analysis is ongoing and results will be provided as they become available.

Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

Beltway Beat

FDA and CDC Leading Multistate Outbreak Investigation of Infant Botulism from Infant Formula

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The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP) and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states. Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female.

The company posted a letter on the company’s website. https://byheart.com/ that stated It’s important that you know that neither we, nor the FDA or CDC, have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. The decision to broaden our recall to all ByHeart products comes after a call with the FDA late last night, informing us that they found two more cases of infant botulism in babies that had also consumed ByHeart at some point. The FDA’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions. Your baby’s safety is, and always will be, our biggest priority. Upon learning about this outbreak on Friday evening, we immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation, which has been done regularly at our owned facilities. 

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick.

According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had consumed ByHeart Whole Nutrition infant formula.

This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing, but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism.  Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product.

FDA contacted the firm and requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks.

FDA’s Commissioner, Dr. Marty Makary, interviewed on CBS News on Nov.12, stated that the FDA did find one positive case of the bacteria that produce botulinum toxin in a can of ByHeart infant formula.

Update: The New York Times reported that a Pennsylvania plant run by the company, ByHeart, was shut down this year after inspectors found mold, a leaking roof and more than 2,500 dead insects in a food production area.

According to the Times article, FDA inspection reports detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, the findings raise concerns about the company’s safety record.

For example, in July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant. When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.

Months later, FDA inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The FDA classified the inspection at its highest tier of concern.

CDC, FDA, USDA logos
Beltway Beat

FDA Updates its Outbreak Investigation of Listeria monocytogenes: Prepared Pasta Meals

By Food Safety Tech Staff
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CDC, FDA, USDA logos

According to the FDA’s website, on September 30, 2025, the supplier of the affected pasta, Nate’s Fine Foods, Inc., expanded their recall of certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes.

On October 30, FDA updated the outbreak investigation stating the FDA, U.S. Department of Agriculture Food Safety and Inspection Service (USDA FSIS), and Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to prepared meals.

Since the last CDC case count update on September 25, 2025, a total of 7 new illnesses from 3 states have been reported, with 2 additional deaths reported.  A total of 27 people infected with the outbreak strain of Listeria have been reported from 18 states. Of the 26 people with information available, 25 have been hospitalized and 6 deaths have been reported. One pregnancy-associated illness resulted in a fetal loss.

CDC and states are working to get information on whether sick people ate recalled food or if additional foods may be contaminated with Listeria monocytogenes.

FDA will continue to collaborate with federal and local partners and implicated firms and will provide updates as they become available.

Cooked shrimp
Beltway Beat

FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137

By Food Safety Tech Staff
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Cooked shrimp

The FDA announced today that, effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This represents the first use of this Congressional authorized tool to address ongoing food safety problems while keeping trade flowing for products which meet the certification requirements. In addition to issuing Import Alert #99-52 which outlines FDA’s risk-based determination and notice of the implementation of the new requirements, the FDA published a new webpage explaining its import certification authorities.

Congress gave the FDA import certification authority under section 801(q) of the Federal Food, Drug, and Cosmetic Act through the Food Safety Modernization Act. This tool allows the FDA to require certification or other assurance that imported food meets U.S. requirements before the food can leave the port of export for shipment to the U.S. The FDA may use this authority to address ongoing and repeated food safety problems through additional oversight before shipment. This approach works alongside current tools to cover larger volumes of trade while maintaining safety oversight. Import certification supports foreign firms’ abilities to bring compliant products to U.S. markets while keeping potentially contaminated products out of the U.S.

The FDA is taking this action to require import certification after U.S. Customs and Border Protection detected high levels of Cesium-137 in multiple shipments of shrimp and in a sample of cloves from certain regions of Indonesia and the FDA’s laboratory confirmed contamination in food samples, in addition to other evidence and information reviewed by the FDA.

IAFNS’ Resources Support National Food Safety Education Month

By Food Safety Tech Staff
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IAFNS supports National Food Safety Education Month which is observed every September to raise awareness about preventing foodborne illnesses and to promote safe food handling practices year-round.

The month of September serves as a reminder for individuals and food safety professionals to commit to reducing the risk of sickness from contaminated food, which affects millions of North Americans annually.

IAFNS participated in a Collective Day of Action on September 18, 2025, started by the Partnership for Food Safety Education. The day supports collective effort to bring awareness to safe food practices that help to reduce the risk of food poisoning.

Below are some IAFNS links to resources available to expand food safety awareness and practice.

Multiple recordings of food safety webinars and presentations are available on IAFNS’ YouTube channel. These include scientific webinars on Nano- and Microplastics in Food Containers, Federal and State Efforts on PFAS chemicals, and many others.

The IAFNS Food Microbiology Committee focuses on improving the understanding and control of microbial food safety hazards to enable scientifically informed decision making. To support this mission the Committee’s “Reference Strain Collection” houses over 100 strains comprised of Listeria monocytogenes, Cronobacter sakazakii, Salmonella and bacterial isolates from floodwater samples that are available for research purposes here.

And lastly, IAFNS provides thought leadership and awareness building through Op-Eds on important food safety topics that encompass both food chemical safety and food microbiology:

Op-Eds

Shared Science for Safety: Strategies for Pet and Human Food Safety

Heavy Metals in Rice and Leafy Greens: Paths to Reductions

 

AOAC International

Analytical Science Leaders Honored at AOAC Internationals 2025 Annual Meeting

By Food Safety Tech Staff
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AOAC International

AOAC INTERNATIONAL honored analytical science leaders in an awards ceremony at the AOAC INTERNATIONAL 2025 Annual Meeting & Exposition in San Diego, California, on Monday, August 25. Awards recognized scientific excellence across the spectrum of AOAC collaboration, including method development, expert review panels, editorial contributions to the Journal of AOAC INTERNATIONAL, and technical service.

The Harvey W. Wiley Award, presented each year for outstanding contribution to analytical method development in an area of interest to AOAC INTERNATIONAL, went to French chemist Eric Verdon. Verdon is the head of the European Union Reference Laboratory (EU-RL) for Antibiotic Veterinary and Dye Residues in Food from Animal Origin. He also heads up the French national reference laboratory at ANSES, the French Agency for Food, Environmental, and Occupational Health Safety. Verdon’s engagement in analytical chemistry has notably influenced the field of Veterinary Drug Residue Control in Foods.

To view the full list of leaders profiled in these awards, visit the 139th AOAC Annual Meeting and Exposition Awards page.

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Beltway Beat

FDA Human Foods Program: Outbreak Investigations & Safety Advisories

By Food Safety Tech Staff
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CORE Outbreak Investigation Table

The CORE Outbreak Investigation Table is a list of outbreak and adverse event investigations primarily being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages, meaning that some outbreaks have limited information, and others may be near completion. The table will be updated weekly.

This week’s updates are:

  • Due to the absence of either a fiscal year 2026 appropriation or a Continuing Resolution, only certain government activities will continue. While FDA will continue to conduct foodborne outbreak surveillance and response activities, the CORE Investigation Table will not be updated weekly during this time. FDA will continue to issue public warnings if there is actionable information to protect consumers from foodborne illness.
  • For the outbreak of Salmonella Lomalinda (ref #1339), the case count has increased from 35 to 37 cases.
  • For the outbreak of Listeria monocytogenes (ref #1309), the case count has increased from 25 to 26 cases.
  • For the outbreak of Salmonella Enteritidis (ref #1329), the case count has increased from 40 to 45 cases.
  • For the outbreak of Salmonella Anatum (ref #1312), the outbreak has ended and FDA updated the outbreak advisory on September 25, 2025.
  • For the outbreak of Listeria monocytogenes (ref #1290), FDA updated the advisory to include additional product recall information related to this outbreak. See the advisory for additional information.

CORE Outbreak Investigation Table

EAS Consulting Group Announces Reduced Rate Services on Fundamental Food Strategy Solutions Across Human and Animal Food Industries

By Jessica Lloyd
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EAS Consulting Group, a trusted leader in regulatory compliance for FDA- and USDA-regulated industries, is proud to announce new reduced rate service offerings tailored to support human food, pet food, animal food, and feed manufacturers in meeting today’s demanding food safety standards and certification requirements.

As regulatory scrutiny intensifies and certification becomes a market necessity, EAS’s newly priced services are designed to help companies cost-effectively enhance their food safety systems, prepare for audits, and maintain compliance with federal and global regulations.

Affordable Expert Support Now Available

  • Onsite Global Food Safety Initiative (GFSI) Certification Audit Gap Assessments
    Including SQF, BRCGS, FSSC 22000, GlobalG.A.P. — customized for both human and animal food operations.
  • Onsite Third-Party GMP / HACCP Certification Gap Assessments
    Practical evaluations to identify compliance gaps and readiness for certification across production environments.
  • Onsite FDA/FSMA Compliance Assessments
    Comprehensive inspections for compliance with the Food Safety Modernization Act (FSMA) for human food, animal feed, and pet food.
  • Development of FDA-Compliant Food Safety Plans
    Expert design or review of preventive controls-based food safety plans tailored to your product category.
  • Development of Seafood HACCP Plans
    Full support to meet FDA requirements for seafood processing and HACCP plan development.

“These reduced rate services are part of our mission to make expert regulatory guidance accessible to more food industry players — from startups to multinational producers — across the human and animal food sectors,” said Tim Lombardo, Senior Director of Food Consulting Services at EAS Consulting Group. “Whether you make pet treats, livestock feed, or packaged foods for human consumption, we’re here to help you strengthen your food safety systems and stay audit-ready.”

With deep expertise from former FDA and USDA officials, GFSI experts, and industry specialists, EAS supports clients at every stage — from planning and development to audit preparation and ongoing compliance.

Clients Include:

  • Human food manufacturers and processors
  • Pet food and treat companies
  • Animal feed and ingredient suppliers
  • Importers and exporters of food and feed products

Looking to the Future: Building the Next Generation of Food Professionals

In addition to these new service offerings, EAS Consulting Group is committed to a long-term goal of fostering the next generation of food safety professionals. Through a unique collaboration with Dr. Clint Stevenson of NC State University and several esteemed academic institutions — including George Washington University, Ohio State University, University of Delaware, Tuskegee University, and Cal Poly University — EAS is helping develop a comprehensive curriculum to train the next generation of food professionals.

This initiative will focus on:

  • Developing a Turn-Key Program for Auditing and Consulting: Preparing junior-level consultants for certification audit preparation and ‘boiler plate’ consulting services.
  • Creating a Community of Practice for Educators: Facilitating knowledge exchange among academic and industry experts to build a robust learning ecosystem.
  • Launching a Marketing Campaign for Food Science: Raising awareness and attracting new students to the field of food science.
  • Building Strategic Alliances: Connecting academia, industry, certification bodies, regulatory agencies, and consulting firms to create a collaborative and forward-thinking food safety ecosystem.
  • Food Safety ConnectED: A portal designed to connect students with industry professionals, providing career insights, mentorship, and guest speakers to foster professional growth. Visit https://www.ifpti.org/food-safety-connected

“Through this collaboration, we aim to develop the skillset of future leaders in food safety and regulation,” said Tim Lombardo. “By nurturing young talent and connecting them with experts across the food safety landscape, we are building a bridge between education and industry to ensure the future of food safety is in capable hands.”

About EAS Consulting Group

EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers regulatory solutions our customers can feel confident in – on time, every time – so the world can trust in what it consumes. Our network of over 150 independent consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD.