FSMA Failures

What does baby food have in common with pet food? A complete failure of food safety preventive controls.

Human foods and pet foods are both regulated by the Food Safety Modernization Act (FSMA) laws that are enforced by FDA. The FDA brags that FSMA shifted the focus of food safety from reacting after a food is recalled to prevention – preventing a food safety concern. Manufacturers of human food and pet food are required to have a written plan identifying all foreseeable hazards, and a written plan to prevent those hazards from entering the food or pet food.

So, knowing these bragged about laws are in place – what happened in baby food?

The U.S. House of Representatives Subcommittee on Economic and Consumer Policy recently released a damning report finding concerning levels of heavy metals in baby food. Their report stated: “commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury.”

Arsenic, lead, cadmium, and mercury are most definitely a known hazard, thus – according to FSMA laws manufacturers were required to identify them and prevent them. Based on the Congressional Report – clearly baby food manufacturers did not abide by the prevention aspect of law.

The same failures of FSMA applies to pet food. Aflatoxins as example are a well known, scientifically proven hazard of corn ingredients in pet food. Pet food manufacturers that use any corn ingredient should have an established aflatoxin hazard identification plan and aflatoxin prevention plan in place. But…in four months time more than 110 dogs have died from aflatoxin contaminated pet food. Yes, the pet foods were recalled (more than 60 million pounds) – but ONLY after pets died. What happened to the FSMA legally required prevention?

The FDA told pet owners (in response to our Citizen Petition) that FSMA laws protect our pets…

“Congressional focus on food safety issues such as the presence of pathogens in human and animal food and melamine in pet food led to the passage of the FDA Food Safety Modernization Act in 2011 and FDA’s subsequent publication and implementation of a new animal food regulation: “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” at 21 CFR part 507. This comprehensive regulation addresses biological, chemical, and physical hazards in animal food. The part 507 regulation requires many animal food manufacturers, including pet food manufacturers, to have a food safety plan in place before they begin producing animal food. The food safety plan must include an analysis of hazards for each type of animal food the manufacturer produces to identify known or reasonably foreseeable hazards and to determine if those hazards require the manufacturer to implement risk-based preventive controls to significantly minimize or prevent the hazards. A manufacturer also must validate that its preventive controls will be adequate against each hazard.”

The above would sound comforting IF preventive controls were actually enforced.

Did FDA examine the written preventive controls with the manufacturers of the aflatoxin recalled pet foods? Did the FDA bother to validate the manufacturers written preventive controls? Will the FDA share with the public exactly what failures they validated about these manufacturers? Such as did these manufacturer have preventive controls in place for aflatoxins and ignore them? – or did these manufacturers just ignore the hazard completely, not include aflatoxins/mycotoxins as a known hazard?

And then there is the issue of heavy metals in pet food. Lawsuit after lawsuit has been filed against pet food manufacturers for concerning levels of heavy metals. Where are the preventive controls with heavy metals in pet food? Has FDA even looked into the preventive controls established by pet food manufacturers to make certain all hazards are addressed?

Clearly, FSMA regulations as they are currently enforced are not effective. Before more babies are poisoned with heavy metals and before more pets die from aflatoxins and poisoned from heavy metals (and so many other issues) – the FDA needs to rethink their strategy.

For pet owners, ask your manufacturer what preventive controls they have in place. Feel free to ask them what hazards they have identified in their written Good Manufacturing plan, and what prevention steps they have in place. Ask what routine testing is performed on ingredients and the finished pet food. The more information you know about your pet food manufacturer…the better.

Wishing you and your pet(s) the best,

Susan Thixton
Pet Food Safety Advocate
Author Buyer Beware, Co-Author Dinner PAWsible
TruthaboutPetFood.com
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