FDA and FSMA Insight – How are Animals affected?
By: Juliana Canale
Food Industry Safety, Compliance & Regulatory Solutions Specialist at NJMEP- Food Vertical Team Cornell Food Science Alumna & CNJIFT Secretary
Professional Certifications: HACCP, Seafood HACCP, LI PCQI, LI FSVP, SQF, & ServSafe Certified
Do you own a dog, cat or another pet or know someone who is a pet owner? Chances are you answered “yes” and therefore you should be aware of the Food Safety Modernization Act (FSMA) updates that were released to the public in September of 2015 to help ensure animal food is being closely regulated regarding food safety.
The second major compliance dates for the FDA FSMA Preventive Controls for Animal Food rule arrived in September of 2017. The final rule was published in September of 2015 and larger animal food facilities were required to comply with the Current Good Manufacturing Practice (CGMP) requirements by September of 2016. Now larger animal food facilities have been required to comply with the preventive controls requirements since September 18, 2017, and small businesses were required to implement the CGMPs by that date. Due to the compliance dates being staggered, depending on the size of the business, the next major compliance dates came in September of 2018, when small businesses had to meet preventive controls requirements and very small businesses must implement the CGMPs. This rule requires animal food facilities to have a food safety plan in place that includes an analysis of hazards to determine which ones need control and risk-based preventive controls to minimize or prevent those hazards1.
Key requirements are summarized below for the FDA FSMA Preventive Controls for Animal Food rule:
- Covered facilities must follow Current Good Manufacturing Practices (CGMPs) for animal food production.
- The FDA has finalized CGMPs for producing safe animal food that takes into consideration the unique aspects of the animal food industry and provides flexibility for the wide diversity in types of animal food facilities.
- Processors already implementing human food safety requirements and who are just holding by-product for use as animal food, do not need to implement additional preventive controls or CGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except to prevent contamination. Examples of contamination include placing trash or cleaning chemicals into the container holding the by-products. This regulation applies to human food facilities that donate or sell a by-product for use as animal food.
- If the human food facility processes its by-product for use as animal food (e.g., drying, pelleting, heat-treatment), the facility must process the by-product in compliance with CGMPs to help ensure the animal food’s safety. The facility can choose to follow either human food or animal food CGMPs when further processing the by-product. In addition, unless it is a qualified facility or otherwise exempt from 21 CFR part 507, subpart C (hazard analysis and preventive controls), the facility needs to determine whether there are any hazards that require a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control would document such a determination in its hazard analysis but would not need to establish preventive controls.
For more information, see the draft Guidance for Industry #239: Human Food By-Products for Use as Animal Food.
2. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and, if necessary, risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:
- Hazard analysis
- Preventive controls
- Oversight and management of preventive controls
- Corrective actions
- Recall plan
3. Some animal food facilities will need a supply-chain program to address hazards in raw materials and other ingredients.
4. The definition of a ‘farm’ describes two types of farm operations. Operations meeting the definition of ‘farm’ are not subject to the Preventive Controls for Animal Food rule.
5. Feed mills that are part of farms (vertically integrated operations) are not covered by the Preventive Controls for Animal Food rule. 2
For a current example of how the FDA FSMA Preventive Controls for Animal Food rule is being leveraged, there is an ongoing FDA investigation of reports of canine dilated cardiomyopathy (DCM) in dogs eating certain pet foods. DCM is a disease of a dog’s heart muscle and results in an enlarged heart. As the heart and its chambers become dilated, it becomes harder for the heart to pump, and heart valves may leak, which can lead to a buildup of fluids in the chest and abdomen (congestive heart failure). If caught early, heart function may improve in cases that are not linked to genetics with appropriate veterinary treatment and dietary modification.
Between January 1, 2014, and April 30, 2018, the FDA received 524 case reports of diagnosed dilated cardiomyopathy. Some of these cases involved more than one animal from the same household. In the reported cases, there were 560 individual dogs diagnosed with DCM and 119 of those dogs died. There were 14 cats which were also diagnosed with DCM, 5 of which died. The agency received additional reports of cardiac symptoms in dogs, however, the reports did not include a confirmed DCM diagnosis. There is a range of different brands and formulas included in the reports and some reports named multiple brands and/or formulas. The FDA has compiled a spreadsheet of all DCM case reports submitted through April 30, 2019.
Brands named most frequently in reports submitted to the FDA (as of April 30, 2019) that had at least ten reports, include: Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10), and Rachael Ray Nutrish (10).
These include both grain-free and grain-containing diets in all forms (kibble, canned, raw, home-cooked). The common correlation appears to be with legumes, pulses (seeds of legumes), and/or potatoes as main ingredients in the food. This also includes protein, starch, and fiber derivatives of these ingredients, (e.g., [source] protein, [source] starch, or [source] fiber). Some reports we have received also seem to indicate that the pets were not eating any other foods for several months to years prior to exhibiting signs of DCM.
What is the cause?
At this time, it is not clear what it is about these diets that may be connected to DCM in dogs. There are multiple possible causes of DCM. Taurine deficiency is well-documented as a potential cause of DCM, but it is not the only possible contributing factor. The nutritional makeup of the main ingredients or how dogs process them, main ingredient sourcing, processing, the amount used, or other factors might be involved as well.3
Legumes: Legumes are part of the Fabaceae plant family and are the fruit or seed of these plants. Common legumes include peas, beans, lentils, chickpeas, soybeans, and peanuts. Pulses are dry edible seeds of certain legume plants. Examples include dried beans, dried peas, chickpeas, and lentils. Not all legumes are pulses, but all pulses are legumes. Legumes/pulses are used as an ingredient for both human and animal food and have become a common plant-based source of protein. Many of these ingredients have long been included in pet food. Recently, the proportion of legumes and/or pulses has increased significantly in certain diets, including many labeled as “grain-free” or “zero-grain.”
Main Ingredients: A “main ingredient” is generally considered to be the first 10 ingredients listed in a food’s ingredient list before the first vitamin or mineral ingredient.4
What is recommended for dog owners?
The FDA advises pet owners to bring dogs to the veterinarian if symptoms of DCM or other heart conditions are noticed, and to check with the vet before switching foods. If the dog is suddenly very weak or collapses, an emergency veterinarian should be immediately sought. If DCM is caught early, (and not related to the dog’s genetics) heart function can recover. 5
How do I know if my pet’s food is one of the diets discussed in the FDA’s public notification?
We suggest reviewing the ingredient list on your pet’s food to see whether legumes, pulses and/or potatoes are listed as one of the main ingredients. You may also wish to review the compilation of all the DCM reports submitted to the FDA through April 30, 2019, to see what pet owners and veterinarians have reported to the FDA. FDA encourages pet owners to work with their veterinarians, who may consult with a board-certified veterinary nutritionist, prior to making diet changes.
You may also wish to review the compilation of all the DCM reports submitted to the FDA through April 30, 2019, to see what pet owners and veterinarians have reported to the FDA. FDA encourages pet owners to work with their veterinarians, who may consult with a board-certified veterinary nutritionist, prior to making diet changes.
How long will the FDA’s investigation take?
There is no way to know how long the investigation will take, but CVM is hopeful that as they gather more data from case reports, they will gain a better understanding of this possible connection. CVM will continue to convey their observations publicly as the investigation progresses.6
If you want to improve your current business practices around animal food manufacturing, please contact NJMEP Food Vertical Team using the contact information below. NJMEP is part of the larger MEP National network and has additional contacts in several states that we can leverage for animal food and feed expertise regarding training and consulting services.
Food Vertical Team:
Juliana Canale, mailto:firstname.lastname@example.org Food Industry Safety, Compliance & Regulatory Solutions Specialist
 FSMA-Final Rule on Preventive Controls for Animal Food: https://www.fda.gov/media/93897/download