Have you ever had a pet that has gotten sick from eating its own food? Or how about a child who has gotten sick from sampling the dog’s food from the bowl? Even if you haven’t known a dog or a child to get sick from eating pet food, this is a very common occurrence and not fun for anyone. It has been estimated by the U.S. Centers for Disease Control and Prevention that about 1,500 humans have been infected by Salmonella through pet food sources.
According to FDA, “The Food Safety Modernization Act, the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
The final Preventive Controls for Animal Food rule, published in September 2015, has also since been established to “build an animal food safety system for the future that makes modern science- and risk-based preventive controls the norm across all sectors of the animal food system.” Although many throughout the industry are anxious and a bit nervous about the implications of this new rule, a majority are glad to see science and risk being brought into the new design of the food safety system for all pets and animals.
If you’re like us (and let’s face it, there’s a good chance you are), your pet’s safety is as important to you as your child’s. For this reason alone, the new guideline released in 2015 has had tremendous support. The American Pet Products Association estimates that approximately 65 percent of households in the U.S. spend over $62 billion each year on family pets.
The Animal Food Rule
The recalls for pet food and the potential human contamination risk led Congress to establish legislation to help FDA create key regulations to help identify hazards around pet food and animal food. This legislation will support pet food companies as they work to improve their food safety systems and thus lower the risk for pet food-related illnesses and the risk for human illness through pet food. However, this final rule also includes the food safety controls for other animal food. Why does regulation reference all animals instead of just pets?
Imagine a chicken farm. Because chickens must eat, what would happen if their feed was contaminated with Salmonella? What are the odds, do you think, that the Salmonella would be transferred to the chicken dinner later served? If a hen lays an egg after she eats feed that is contaminated with Salmonella, would there be a higher risk for Salmonella to the end consumer? Salmonella-contaminated chicken feed can lead to an enormous risk for various end consumers. By controlling the risk of hazards throughout the entire food chain, the overall opportunity for contamination getting into our food supply is significantly reduced.
Thankfully, there are regulations in place designed to protect animals in our food chain, our pets and fellow humans from hazards that might affect the food and feed that are consumed. The big question often heard is: “When do we have to comply?”
In September 2015, the final Preventive Controls for Animal Food rule was established with compliance dates dependent on company size (Table 1).
What Does It Mean?
Now, for the first time in the animal and pet food industry, there is a requirement to comply with the new Current Good Manufacturing Practices (CGMPs) for any location that must comply with the final rule mentioned above. This requirement states:
Any employees who handle, manufacture, process, pack or hold animal foods have rules and practices to follow in order to protect the products and packaging materials from contamination.
For some companies, this may be a completely new process, whereas others will just have to “tweak” their current systems to comply.
Additionally, any animal food company must ensure all its workers (seasonal and temporary) receive training in the principles of animal hygiene and animal food safety if they supervise or perform manufacturing, processing, packing or holding duties in the company. Auditors often ask the production crew making a product on a line, “What is the law or regulation requirements for making this product?” They usually receive deer-in-the-headlights looks from the workers, supervisors and managers. Most of the people could answer only basic GMP requirements like washing hands or clean clothing or not being ill when working with food. Not many individuals could fully explain how they know the products they make meet all of the law requirements or could explain how the company’s designed system ensures they meet the regulatory requirements. Could you answer that question? What about your employees?
The system is supposed to work as follows:
1. The company establishes a system of policies, Standard Operating Procedures and work instructions.
2. The people writing these documents ensure that all the requirements from the many laws (federal, state and local) as well as any other requirements (such as a Global Food Safety Initiative audit, customer requirements and company-specific requirements) are added to the policy, procedure or work instruction.
3. The company designs a training system to train the employees at the right time using an effective method and the right training message.
4. The company establishes an internal audit function to evaluate the effectiveness of the workers for following the company policies, procedures and work instructions (thus showing proof that they are following the current regulations). Usually, a finding on audits is a disconnect between what was done on the production floor and what was written in the instruction documents.
Animal food workers must know the rules for implementing food safety practices into the manufacturing, processing, packing and holding of any animal food. This doesn’t mean just when they are first hired but also periodically throughout their career. FDA expects companies to determine all refresher courses needed to implement up-to-date training schedules. Internal audits will help evaluate this process and answer the question “Is our training program working the way we need it to work?” If a company organizes its internal audit to be the most difficult audit to pass, it will find its noncompliance issues before anyone else and have an opportunity to shine during an external audit (regulatory, customer or third party).
Preventive Controls-Qualified Individuals
If you remember one thing from all your training, it’s that the policies, procedures, work instructions and GMPs should be based on the hazards identified at the facility. The processes a company implements should always be a reflection of the findings of the on-site food safety team. With FSMA, companies must design their food safety plan using an accurate facility- and process-specific Hazard Analysis, which requires a facility to identify a Preventive Controls-Qualified Individual (PCQI) for each facility.
A PCQI is required to be trained and have experience in how to effectively manufacture, process, pack and carry the products being produced. This person also must fully understand the requirements of the final Preventive Controls for Animal Food rule. The most efficient method used to show an FDA inspector that a PCQI meets all federal requirements is to produce a certificate of completion for a PCQI-approved course for animal food. This certificate is not required, but FDA inspectors accept it as evidence of meeting the requirement of the final rule. If you choose not to show the certificate, you would have to show proof of how you were trained, have the experience required to do the job and know the FSMA rule. How long would that take to show an FDA inspector?
There has been a widely used unwritten rule throughout the industry: Get the auditor in, give them what they need and get them out of the facility as quickly as possible. An FDA inspector will expect to talk to the PCQI and the person in charge while visiting the facility. He/she will probably want to see the Hazard Analysis and associated food safety plan that was performed to see what hazards exist within the facility’s processes.
Animal-Specific Hazard Analysis
While performing a Hazard Analysis for pet and animal food, it is important to fully understand the animals consuming the food, their specific nutritional needs and any possible food components that could possibly cause harm. For example, if sheep ingest too much copper with their food, they can develop copper toxicity poisoning, which is when copper builds in the liver and causes the liver cells to die and disperse copper into the bloodstream. Once this happens, sheep become lethargic and anemic, and death usually occurs within 1–2 days.
If a company makes sheep food, the amount of copper in that food becomes a potential hazard that will require an analytical process—the most critical part of the Preventive Controls for Animal Food rule. It is important to have the right people involved in the Hazard Analysis process; a cross-section of workers (production, quality, maintenance, sanitation, warehouse, purchasing, human relations, etc.) is recommended.
When identifying hazards and determining the associated risk of each hazard, don’t forget to determine which controls are already in place and successfully being implemented. During a Hazard Analysis process, be sure to properly examine the following:
1. Formulation of the animal food
2. Condition, function and design of the facility and equipment
3. All raw materials, ingredients and processing aids
4. Normal transportation practices and procedures
5. Manufacturing and processing procedures
6. Packaging and labeling activities
7. Storage and distribution procedures
8. Intended use vs. reasonably foreseeable use
9. Sanitation and employee hygiene
10. Other factors related to the food (such as seasonal issues, weather issues, humidity, etc.)
Every identified hazard must have the amount of risk determined while considering the probability and severity of the hazard. A rubric or matrix is not required, but may be found helpful, when determining this risk.