By David Fairfield, Senior Vice President of Feed Services
The Food Safety Modernization Act (FSMA) workshop hosted by the Association of American Feed Control Officials (AAFCO) on Aug. 4 in conjunction with its annual meeting attracted over 110 attendees to Louisville, Ky., to receive updates and perspectives on the implementation of FSMA-related regulations.
Information provided during the workshop by U.S. Food and Drug Administration (FDA) and state regulators primarily focused on the FSMA-related rule for Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk-Based Preventive Controls (PC) for Food for Animals that applies to firms involved in manufacturing and distributing animal feed, feed ingredients and pet food products. Among other things, topics addressed by the regulatory officials included:
- Animal Food CGMP Inspections: Under FDA’s direction, approximately 400 CGMP inspections were conducted from Oct. 1, 2017 through Sept. 30, 2018. Approximately 60 percent of the inspections were performed by FDA investigators, and 40 percent by state agencies. Approximately 6 percent of inspections resulted in observations on FDA Form 483, which is used to document alleged objectional findings. However, only one FDA warning letter was issued for CGMP violations. The most frequent findings documented on Form 483 related to pest management and plant operations not being conducted in way to protect against contamination of animal food or handling raw materials in a way that prevents contamination.
Since the CGMP compliance dates for all business sizes are in effect, inspections now are occurring at all sizes of businesses. However, the overall number of CGMP inspections scheduled to occur during fiscal year 2020, which runs from Oct. 1, 2019 through Sept. 30, 2020, likely will be less than the prior fiscal year as FDA directs more resources to conduct PC inspections.
- Animal Food Preventive Controls Inspections: FDA began conducting routine PC inspections in October 2018 at businesses defined as being “large,” with 100 inspections occurring through mid-July. Although FDA said there is not yet enough data to draw definitive trends on PC compliance issues, 28 percent of the inspections resulted in a Form 483 being issued. Common citations that have been issued based on PC inspections conducted to date include: 1) failure to identify or implement a preventive control; 2) inadequate hazard analysis; 3) no written food safety plan; 4) food safety plan not developed or overseen by a preventive controls qualified individual; 5) failure to establish/implement corrective action procedures; 6) failure to validate a preventive control; and 7) failure to conduct a reanalysis.
FDA will begin to conduct routine PC inspections at “small” businesses in October 2019. Currently, FDA has 330 routine and “for-cause” PC inspections scheduled to occur during fiscal year 2020. Businesses that meet FDA’s “very small business” definition are to submit attestations to FDA to demonstrate compliance with modified PC requirements during the last quarter of 2019 through an electronic portal that FDA will make available.
- FDA’s Comprehensive Inspection Approach: FDA has shifted to a comprehensive inspection approach in which investigators evaluate compliance for all FDA regulations applicable to the facility during one inspection. For example, if a facility is subject to FDA’s regulations for medicated feed, bovine spongiform encephalopathy (BSE)-prevention, sanitary transportation and FSMA’s animal food rule, FDA intends to evaluate the facility’s compliance for all of these regulations during one inspection. As such, FDA’s comprehensive inspections at facilities may last four to five days, or longer.
- Emerging Potential Hazards: FDA currently is interacting extensively with the U.S.Department of Agriculture to address the potential introduction of foreign animal diseases, including African swine fever (ASF) virus, into the United States. Although studies have indicated that feed may be inoculated with ASF and transmit the disease to animals under controlled conditions, significant data gaps exist about what role feed may have in transmitting the disease, including:
- How the virus would contaminate feed under natural conditions and then subsequently survive and cause viral infection, which currently is unknown.
- Current testing methodology can identify the presence of viral DNA in feed, but a positive test result does not provide conclusive evidence the virus is viable and capable of causing an infection.
- Appropriate mechanisms for control of ASF in animal food are not well established.
In addition to information shared by regulatory officials, David Fairfield, NGFA senior vice president for feed services, and Matt Frederking, vice president for Mid American Pet Food and chair of NGFA’s Feed Manufacturing and Technology Committee, provided industry perspectives on FSMA implementation issues. Remarks offered during their 1.5-hour session focused on various aspects of preventive controls inspections, how to prepare for and react to FDA inspections, and educational and training materials available from the Food Safety Preventive Controls Alliance; Fairfield chairs the Alliance’s Animal Food Task Force that developed the training materials.
AAFCO Meeting Outcomes: More than 470 industry representatives and regulatory officials attended the AAFCO meeting on Aug 5-7 to discuss a variety of animal food regulatory topics.
FDA Center for Veterinary Medicine Director Dr. Steven Solomon provided the keynote address and discussed the agency’s current priorities and initiatives.
During his remarks, Solomon emphasized FDA’s continued collaboration with state regulatory agencies to conduct inspections and ensure the safety of animal food products. Solomon said that 22 states currently are involved in the Animal Feed Regulatory Program Standards – a program designed jointly by FDA and AAFCO to establish a uniform foundation for the design and application of states’ programs responsible for the regulation of animal feed. To facilitate enhanced involvement in the program, Solomon said FDA has targeted an additional $5.6 million in its fiscal year 2020 budget to increase the number of states involved in the program and build capacity within states to conduct FSMA-related inspections.
In addition, Solomon said FDA is working to enhance its animal food ingredient approval process so that innovative products can reach the market sooner. To do that, FDA has requested an additional $5 million in its fiscal year 2020 budget so that additional resources can be directed toward ingredient approvals.
Solomon also highlighted FDA’s “Smarter Food Safety” initiative to better utilize modern approaches and processes to facilitate food safety. The initiative consists of four key components: utilizing technology to enhance traceability and transparency; using smarter tools, such as predictive analytics, to help prevent contamination of food; modernizing compliance activities directed at retail businesses; and promoting a positive food safety culture within the industry. Solomon said FDA will conduct a public meeting this fall to get external stakeholder input on the initiative.
AAFCO is the professional organization of federal and state feed regulatory officials, with which the NGFA interacts extensively. Among other things, NGFA feed industry members and NGFA staff serve as non-voting advisers to key AAFCO committees and participate actively in committee discussions.
Click here for information on actions taken during the AAFCO meeting on feed ingredient approvals and updates on activities of other AAFCO committees.