WASHINGTON — Plain and simple, pets are beloved members of most families, and safety should be the top priority for pet food and pet treat processors of all sizes. While a majority of US households — nearly two-thirds — have at least one dog or cat, most Americans are likely not aware that federal regulations under the new US food safety law, the Food Safety Modernization Act (FSMA), are now in force.
The members of the Washington, D.C.-based Pet Food Institute (PFI), the national trade association for US dog and cat food processors, are committed to continuous improvement in food safety. PFI promotes this culture of safety by convening members regularly to share their food safety innovations and advancements and by funding independent pet food safety research. Additionally, PFI has worked with its member companies over the recent years to prepare for FSMA readiness, including new compliance requirements and FSMA facility inspections. The time to prepare for the changes is now.
At the most recent 2017 Feed & Pet Food Joint Conference, which PFI held in conjunction with the National Grain & Feed Association (NGFA), a panel of participants in the animal feed sectors reenacted a series of inspection scenarios that pet food processors and ingredient suppliers may now face under FSMA. The audience learned that in the new era of conversation-based inspections with regulators, all pet food processors and ingredient suppliers should be in-the-know and stay ready for US Food & Drug Administration (FDA) visits to their facilities.
Preventive controls for animal food
FSMA impacts pet food processors both large and small by creating a shift toward regulation that focuses on prevention rather than reacting to potential food safety issues. As such, the FSMA preventive controls (PC) rule for animal food includes requirements for adhering to Current Good Manufacturing Practices (CGMPs), which include components such as sanitation and training requirements for employees, facility design criteria and equipment maintenance.
In addition, pet food processors are also required to identify, evaluate and document potential hazards, as well as document the PCs they are implementing to address hazards in a written food safety plan. With the newly established authority provided under FSMA, FDA has begun inspections for CGMP requirements and will commence enforcement for PCs in fall of 2018.
Know where you stand
As companies and facilities prepare for FDA inspections, it is vital for operators to be aware of compliance deadlines for the new food safety regulations and how employees should respond in conversations with regulators. Large pet food processors and small businesses — defined as those with fewer than 500 employees — can now expect inspections for compliance with CGMPs. FDA will commence CGMP inspections for very small businesses, defined as those with less than $2.5 million in annual sales, in the fall of 2018.
The inspections for compliance with PCs, including a written food safety plan, will begin in 2018 for larger pet food processors, but now is the time for small and very small businesses to prepare. This is an opportunity for companies to determine their rights and obligations under FSMA and identify who in the organization will be the Preventive Controls Qualified Individual (PCQI) required to be in place in each facility. This person must be properly trained to identify and address potential hazards and may be the appropriate contact to communicate these hazards with ingredient suppliers, who are also likely subject to FSMA provisions.
What to expect
FDA has communicated that the agency is training its state inspectors for a conversation-based process as part of its strategy to “educate before they regulate” while preparing inspectors for visits to pet food processing facilities. The goal is to create consistent expectations for FSMA compliance between both the regulator and the regulated community.
Regardless, facilities may receive requests for documentation not related to FSMA, such as consumer report logs or financial records. Companies are not required to provide business confidential documentation to the FDA inspector, but it is important for each regulated organization to understand and communicate its policy and procedure for handling these requests. It may be appropriate to ask why information is being requested to ensure understanding or more accurately address an inspector’s questions or concerns. An inspector may request to see records to confirm the number of full-time employees, and small businesses are required to substantiate the size of the business in relation to compliance and enforcement dates under the new regulation.
FDA has also noted that for several years the agency has been asking questions to assess the company’s readiness for PCs under FSMA. While a company may be well underway in preparing and identifying a PCQI and developing a food safety plan, there may not be an obligation to provide the requested information based on the company’s compliance date. With an advanced plan in place on how to handle these requests, companies will be better prepared for FSMA readiness questions.
Readiness starts now
The new inspection process under FSMA offers a unique opportunity to dialogue with regulators as PFI and processors continue working together to provide safe food and treats for dogs and cats. PFI encourages companies to begin preparing now for questions that may be asked by an inspector and understand their rights and obligations in order to help ensure a smooth and predictable inspection process.
Together, we can all promote food safety and long and healthy lives for pets around the world. For more information about PFI, FSMA and pet food safety, visit www.petfoodinstitute.org.
Pat Tovey is the director of technology and regulatory compliance for the Pet Food Institute.
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