FSMA Updates From the 10th Annual Feed and Pet Food Joint Conference
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The 10th Annual Feed and Pet Food Joint Conference, hosted by the National Grain and Feed Association-Pet Food Institute, met last week in Kansas City, MO. More than 250 attendees gathered for presentations and a trade show.
A major focus of this year’s conference was Food Safety Modernization Act (FSMA) compliance in the livestock, poultry and pet food industries.
Center for Veterinary Medicine (CVM) FSMA updates
Dr. Steven Solomon, Director of the Center for Veterinary Medicine (CVM) at the U.S. Food and Drug Administration (FDA) spoke about the importance of FSMA compliance throughout the industry.
According to Solomon, the agency’s approach to FSMA implementation is different from other regulations in that regulators are expected to “educate before and while [they] regulate.” This doesn’t mean the agency isn’t ready to enforce the rules and this mindset will not last forever. If inspectors find issues that will lead to or cause significant public health concerns, the agency will consider advisory or enforcement action.
The FDA relies on many state agencies to conduct FSMA inspections and has close relationships with the Association of American Feed Control Officials (AAFCO) and the National Association of State Departments of Agriculture (NASDA). In FY2020, the agency plans to focus on advancing FSMA and increasing the number of FSMA inspections.
Dr. Solomon also addressed new challenges in the area of animal food safety:
- African Swine Fever – ASF is a continual concern in the United States because there is no vaccine and it can be transmitted through feed. The FDA announced they are willing to expedite the review of potential mitigants to control this hazard and encouraged the animal food industry to work closely with the pork industry on this issue, as the introduction of ASF to the United States could be devastating to the pork industry.
- Pig Ear Pet Treats – So far, there have been 143 cases of human infection tied to exposure to pig ear pet treats contaminated with Salmonella. The FDA encourages the industry to be aware of their suppliers and food safety related to imports.
- Dilated Cardiomyopathy (DCM) – DCM has been a concern due to a potential link between the increase in DCM cases and diets predominantly labeled grain-free. The CVM has provided three updates with information, but are looking for additional research on this issue.
- Cannabis products for animals – hemp-derived ingredients have not been approved for use in animal food by FDA and the addition of THC or CBD in animal food is not permitted. More data are needed to support the safety and effectiveness of these products in animal food.
Dr. Marla Keller from the CVM Office of Surveillance and Compliance at FDA also spoke about FSMA implementation for the animal food industries. She spoke about the training inspectors receive under FDA. They take courses on CGMP regulations, as well as preventive controls.
According to Keller, so far CGMP inspections have taken place at all business sizes and routine preventive control inspections have taken place for large businesses and additional inspections have taken place “for cause.” “For cause” indicates that a facility has had previous food safety issues or manufactures high-risk products.
The most common inspection citations were for:
- Failure to identify or implement a preventive control
- The hazard analysis
- No written food safety plan
- Food safety plan not completed or overseen by a PCQI
- Failure to establish/implement corrective action procedures
- Failure to validate a preventive control
- Failure to conduct a reanalysis
Dr. Keller emphasized the importance of having your employees be familiar with the food safety plans and how plans are being implemented at the facilities.
Preventive control inspections will start this month for large and small businesses and there will be CGMP inspections for all business sizes.
Preventive control inspections for very small businesses will begin in October 2020.
Facilities that are going to submit a qualified facility attestation should do so between October 1, 2019, and December 31, 2019.
Industry FSMA updates
The conference also featured a panel discussion with industry representatives Jan Campbell, Regulatory Affairs Manager from Purina Nutrition LLC, Matt Frederking, Vice President of Regulatory Affairs and Quality Assurance from Mid-America Pet Food, and Matt Surdick, Safety Manager for CHS-Country Operations.
The panel discussed recent preventive controls inspections at their facilities. Some of the main points discussed were:
- Preventive controls inspections are lasting between one and four days.
- Be sure to do what you say you are doing in your food safety plan.
- Prepare employees for the inspection process. They should have an understanding of the company’s policies on inspections, which documents should be kept and which documents can be given to inspectors. Panelists suggested that facilities prepare a list of documents that can and cannot be shared.
- Inspectors are asking about qualified individual training. This can consist of outside videos or training in addition to facility-specific information or training. Facilities may consider training people outside of their facility that have been deemed necessary because they are involved in the process of manufacturing, processing, packing, or holding animal food.
- Having more than one Preventive Controls Qualified Individual (PCQI) at a given facility may be helpful, but is not required.
- Some useful resources to help determine whether a hazard is known or reasonably foreseeable are:
- Corporate decisions
- Scientific literature
- Veterinarians & nutritionists
- FDA guidance or other FDA documents
- Corporate or facility information
- FDA Warning Letters
- Food Safety Team to make some decisions based on experience