Tag Archives: human food

In the Food Lab

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

By Caitlin Karolenko, PhD, Wendelyn Jones, PhD
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Most people don’t think twice about pouring kibble into a pet’s bowl or tearing open a packet of crackers. Dry foods feel safe. They sit on shelves for months without spoiling, don’t require refrigeration, and look and smell unchanged long after initial purchase.

But “dry” does not mean risk-free. Pathogens such as Salmonella and Listeria monocytogenes can survive in low-moisture environments for months or even years, and when contamination happens, the effects can be widespread. Whether the end consumer is a child snacking on peanut butter crackers or a dog chewing jerky treats, the hazards—and many of the prevention strategies—overlap far more than most realize. Understanding these connections can strengthen food safety across sectors, protecting both people and pets.

The connection between pets and humans is well documented, with many pets now viewed as part of the family. As a result, pet food is no longer an afterthought but is considered just as important as the food of human members of the household. With know-how on working with brick and mortar retailers, on-line shopping platforms and opportunities for increased positive brand positioning, it is not surprising the number of acquisitions of pet food companies by human food companies in recent years. Additional parallels from a processing and manufacturing perspective also reinforce the business case for the expansion of human food companies into pet food. Of note (and certainly not an exhaustive list), General Mills purchased Blue Buffalo in 2018, and Post Holdings entered the pet food market by acquiring several brands from J.M. Smucker in 2023. Additionally, Mars and Nestlé have sold both human food and pet food for decades.

Shared Risk: Low-Moisture Foods

Pet diets often include dry kibble, jerky treats, and freeze-dried or dehydrated proteins which are considered low-moisture foods (LMFs). LMFs are defined as those with a water activity below 0.85. While this level of available water prevents microbial growth, it does not eliminate pathogens once present. Instead, microorganisms can persist in a dormant state, becoming more resistant to heat and other stressors.

The most concerning hazards in LMFs are Salmonella, Cronobacter and Escherichia coli. (while less common Listeria monocytogenes is still a risk.) These hazards emphasize the risks associated with seemingly benign dry foods. Numerous outbreaks have been tied to LMFs in humans including Salmonella contamination in peanut butter, E. coli and Salmonella contamination in flour and Salmonella and Cronobacter concerns in dried spices and powdered milk respectively.

Despite their dry appearance, pet food products can provide a long-term refuge for pathogens. With both human and animal foods, contamination can occur at multiple stages: at the raw ingredient procurement steps, within processing environments, and after packaging during storage, distribution, or even in the household through improper handling. The microbial risks are not confined to one step but are woven into the very nature of LMFs themselves.

Regardless of whether discussing human food or pet food, pathogen contamination events can result from a variety of circumstances, such as the introduction of a pathogen:

  • Through a contaminated ingredient (e.g., at the beginning of the line or at an intermediate step when an ingredient is added)
  • Along the processing line where the product or its ingredients are exposed to the environment
  • Introduction of an environmental pathogen by personnel in the plant
  • Onto dry processing equipment through introduction of water (e.g., through condensation or a leaking roof).

The above list is a modification of FDA draft guidance for “Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods…”– but it clearly applies to pet food (Link to source https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-establishing-sanitation-programs-low-moisture-ready-eat-human-foods-and).

In pet food, these contamination risks are not hypothetical.. In 2012, Salmonella contamination in dry dog food was linked to human illnesses in multiple states. More recently in 2021, several brands of pet food were recalled after more than 130 pet deaths and 220 illnesses were reported. And in August 2025, there was another recall of dog and cat food due to Salmonella and L. monocytogenes contamination. (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viva-raw-issues-voluntary-recall-two-lots-dog-cat-foods-due-salmonella-and-listeria-monocytogenes)

The risks extend beyond the pet’s health. A dog fed contaminated kibble may appear healthy yet shed Salmonella in its feces. Humans can then be exposed by touching pet food, handling bowls, or cleaning up after the pet. Children, the elderly, and immunocompromised individuals are particularly at risk. Pet food contamination is not just a veterinary issue. It is a household food safety issue.

Overlap in Preventative Strategies

While human food and pet food are marketed and regulated differently, the science of prevention is strikingly similar. The Food Safety Modernization Act (FSMA) requires risk-based preventive controls for both human and animal foods. This alignment reflects an important reality: hazards in dry foods are not consumer-specific—they are science-specific. Whether the end user is a toddler eating cereal or a dog chewing on kibble, the microbial risks and the tools to mitigate them are shared.

Preventative strategies originally developed for human LMFs often have direct application in pet food. These include environmental monitoring programs to detect pathogens, dry sanitation practices to reduce the introduction of water which can inadvertently create microbial harborage sites, and kill-step validation to ensure that processes achieve the necessary lethality against resistant pathogens in low-moisture conditions.

Lessons learned in one sector often migrate to the other. Extrusion validation in pet food manufacturing now closely mirrors approaches in human snack and cereal production where thermal processing under low-moisture conditions must be validated for microbial control. Zone-based environmental monitoring is a long used best practice in human food facilities, and is increasingly standard in pet food plants to reduce cross-contamination between raw and finished product zones. Air handling strategies pioneered in dry dairy product facilities are also being adopted by pet treat producers, particularly those making freeze-dried or dehydrated products.

These parallels are not accidental. They reflect the simple fact that pathogens do not distinguish between crackers and kibble, peanut butter and pet treats. What matters is the environment in which the food is made and the rigor of the controls applied. The convergence of regulatory expectations, scientific insights, and industry practices highlights an important opportunity: when we strengthen safety systems for one type of dry food, we raise the standard for all.

A Connected Responsibility and Shared Interests

The overlap between microbial food safety in human low-moisture foods and pet food is more than a coincidence—it’s a call for shared learning and investment. To reduce risk, manufacturers of both commodities must:

  • Recognize the shared science that underpins safety
  • Invest in preventative controls and environmental monitoring to keep all products safe for the end user- human or pet
  • Continue innovating in science and technology, like dry sanitation or other mitigation techniques to prevent contamination.

Ultimately, food safety does not stop at the dinner plate. It extends to the pet bowl, treat jar and the surfaces where food for every member of the household is prepared and consumed.

The kitchen and the kibble bag are more connected than we think. By treating them as part of the same food safety continuum, we can better protect the health of both people and our pets.

Photo credit and copyright: Beth Biros

Editors Note: One of the authors, Caitlin Karolenko, PhD will be presenting at the 2025 Food Safety Consortium in the session titled: Dry Doesn’t Mean Safe: Pathogens in Low Moisture Foods. For more information go to FoodSafetyConsortium.org and click on Agenda.

 

FDA

FDA Issues Guidance Document for Qualified Facilities Under FSMA Rules

By Food Safety Tech Staff
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FDA

Last week FDA released a guidance document to help facilities understand whether they are subject to the “qualified facility” definition under the FSMA preventive controls rules for human and animal food. Titled “Determination of Status as a Qualified Facility”, the guidance offers frequently asked questions about the requirements for facilities that manufacture, process, pack or hold human as well as animal food (defined separately—Part 117 for human food and Part 507 for animal food).

“Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.” – FDA

Facilities that fall under the PC Human Food rule must submit the first required attestation forms by December 17, 2018, and those subject to the PC Animal Food role must submit the first required attestation forms by December 16, 2019.

More information about the new guidance for industry is available on FDA’s website.

FSMA

Small Businesses: FDA Releases Preventive Controls Guidance

By Food Safety Tech Staff
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FSMA

In order to help small businesses with implementation of the FSMA Preventive Controls for Human Food and Animal Food rules, FDA has released compliance guidances. In an FDA release, the agency highlighted the following:

  • Small businesses (fewer than 500 full-time employees): Compliance with the human and animal food rules required by September 18, 2017
  • Very small businesses (those averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales): Required to maintain records supporting Qualified Facility status as of January 1, 2016
  • Qualified facilities must comply with the human and animal food rules by September 17, 2018

Both guidances are available on FDA’s website:

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Gary Smith, Eurofins’ Food Safety Systems

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza
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Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, director of food safety, Eurofins Scientific

Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

FSMA, Food Safety Tech, FDA

FSMA Rules for Preventive Controls Finalized

By Maria Fontanazza
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FSMA, Food Safety Tech, FDA

More than a week after being submitted to the Federal Register, the rules for preventive controls for human food and animal feed have been finalized.

The Current Good Manufacturing Practice Hazard Analysis and Risk Based Preventive Controls for Human Food final rule includes the following key requirements:

  • Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, and the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification).
  • The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm. Such farms that conduct produce activities will also have to comply with the Produce Safety Rule (to be finalized at the end of October).
  • A more flexible supply chain program, with separate compliance dates.
  • Update and clarification to CGMPs.

This year’s Food Safety Consortium conference will feature first-hand perspectives from FDA and USDA on FSMA implementation and enforcement. REGISTER NOWCompliance dates range between one and three years depending on the size and type of business. Several guidance documents will be created by FDA in an effort to further help companies with compliance, including on hazard analysis and preventive controls, environmental monitoring, food allergen controls, and the validation of process controls.

The Federal Register will publish the 930-page document on September 17. In the meantime, the pre-publication version can be viewed here.

The Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals final rule includes the below key requirements:

  • CGMPs established for the production of animal food, taking into account the diverse types of animal food facilities.
  • Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification), and a recall plan.
  • A more flexible supply chain program, with separate compliance dates.
  • The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm.
  • Feed mills associated with farms (vertically integrated operations) are not covered.

As with the preventive controls for human food, FDA will be creating guidance documents that address CGMP requirements, hazard analysis and preventive controls, human food by-products for use as animal food, and a small-entity compliance guide.

The Federal Register will also publish this 666-page document on September 17. The pre-publication version can be viewed here.

At this year’s Food Safety Consortium Conference, the industry will have the opportunity to hear directly from FDA and USDA on what companies need to know to be FSMA compliant and how the agency will be enforcing the regulation. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA, will delivery the opening plenary presentation, which will be followed by an “Ask the FDA” Q&A town hall meeting.

First FSMA Deadline Here, Industry Awaits Final Preventive Controls Rule

By Food Safety Tech Staff
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According to an FDA alert, the agency has submitted the final preventive controls rules for human and animal food to the Federal Register. FDA notes it can take several days from the date of submission to final publication.

“The FDA is committed to sharing information about the final rules and how food facilities can comply as soon as we are able to do so.” The agency will be providing more information on the FSMA section of its website.

In the meantime, are you prepared for the Preventive Controls Rules for Human and Animal Food?

And if you’re in the animal feed industry, take these steps to prepare for success.