New Hazard Analysis Resource Eases FSMA Burden
IFEEDER funds Univerisity of Minnesota research that identifies common feed facility hazards.
The Institute for Feed Education & Research (IFEEDER) is dedicated to furthering research and education outreach on efficient procedures to produce safe feed and food. More recently, these efforts have turned toward funding research that assists feed manufacturers in complying with complicated regulations.
On Jan. 4, 2011, President Obama signed the Food Safety Modernization Act (FSMA). The 2011 FSMA reform stood to be the largest shake-up American food safety had seen in the past 70 years. The main goal of the reform was to shift manufacturers from responding to contamination to preventing it. In a nutshell, pet food and animal feed manufacturers would be required to follow regulations similar to those in the human food industry.
The new legislation upgraded food safety defense mechanisms but left many manufacturers dismayed and confused on how to comply. Complicated verbiage and rules confirmed the disconnection between government and manufacturers. The result was a minacious forecast for the feed industry, with manufacturers of every size concerned with how they would be able to afford making the changes necessary.
The American Feed Industry Association (AFIA) estimated that abiding by the final rule page by page would cost the feed industry around $1 billion and decided to take action, not only to assist manufacturers in the feed industry but to provide insight to the FDA on improving the rule as a whole. Through the process, AFIA has been able to clear regulatory confusion and buy manufacturers time to conform to the drastic changes within their operations.
While the FSMA final rule on animal food was approved in September 2015, the FDA has yet to release a final guidance document to industry. Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, manufacturers are required to oblige by four key requirements, the last two of which essentially clarify the first three:
- Current Good Manufacturing Practices must be established for animal food production.
- Covered facilities must establish and implement a written food safety plan that includes an analysis of hazards and any required risk-based preventive controls.
- Animal food manufacturing and processing facilities must have a risk-based supply chain program for those raw materials and other ingredients that have been identified as a hazard requiring supply chain.The two following definitions of a “farm,” as defined in the ruling, are not subject to the preventive controls rule: primary production farm (i.e., growing or harvesting crops, the raising of animals or a combination) or secondary activities farm (i.e., harvesting, packing or holding).
- Feed mills associated with fully vertically integrated farming operations (i.e., farms where the feed mill, animals, land and establishment are all owned by the same entity) generally meet the definition of a “farm” and are therefore not subject to the Preventive Controls for Animal Food final rule.
Feed manufacturers found the second requirement to be one of the least clear. It mandated registered facilities to perform a hazard analysis and create preventive controls based on the analysis’s findings. The facility’s hazard analysis is required to determine the severity of any illness or injury in the event that it should occur and the likelihood, or probability, that the hazard will occur in the absence of preventive controls. The AFIA recognized that this reform could impose complications for their members and feed manufacturers alike.
Richard Sellers, senior vice president of public policy and education at AFIA, felt manufacturers would need a helping hand in conducting the scientific analysis of their operations. Thus, AFIA set out to create a user-friendly guide to assist manufacturers in response to their member’s anticipated request for help. Funding from IFEEDER and the National Grain and Feed Foundation supported this effort.
Previous regulations mainly focused on the prevention of unadulterated products. According to Sellers, feed regulations went from being considered manageable, to “overwhelming requirements.” Most people would find it difficult to access the science literature, let alone digest it, conduct an analysis and put preventive measures in place, Sellers contended.
AFIA also found that its members were overwhelmed by the potential cost of working with consultants to understand the regulations, prior to taking the necessary steps to even comply with the requirements.
“There has to be some sort of middle ground,” Sellers said, “A food based [ruling] does not have much reality in the feed industry.”
Manufacturer friendly project
With looming compliance dates and with the FDA only releasing a draft of a 180-page help guide intended for the human food industry, AFIA sought to translate the ruling into a more understandable document with
practical applications for feed manufacturers. AFIA partnered with the IFEEDER foundation and the National Feed and Grain Foundation to fund a $170,000 scientific literature review project of the feed ruling, which would be conducted by the University of Minnesota’s Center for Animal Health and Food Safety. Both organizations hoped that in fully analyzing the hazard analysis portion of the rule and creating a useful tool, common ground and potential improvements would be found for feed manufacturers across the nation.
Dr. Tim Goldsmith, DVM, MPH, associate professor at the University Minnesota and co-director of the university’s Veterinary Public Health and Preventive Medicine Residency Program, agreed to head the project along with several other staff members. Dr. Goldsmith stated the best form of action would be “an evaluation and hazard identification of animal feed to help create a tool” for manufacturers in the industry.
In doing so, the University of Minnesota would thoroughly review literature, conduct a hazard evaluation on the occurrence of potential hazards in ingredients, animal feed, and pet food, review recalls within the feed
industry, and examine the severity of the identified hazards.
Through this project Dr. Goldsmith hoped the university could help close the “gap challenge area for facilities to meet upcoming requirements.”
Goldsmith explained that Andre Nault, associate librarian at the University of Minnesotra, was a key contributor to the project due to the magnitude of scientific literature reviewed and amount of research needed.After thoroughly searching the literature and surveying FDA recalls, the group did not identify any previous unknown feed hazards.
The university created an interactive spreadsheet that can provide a summary of hazards that have been reported in various animal food matrices based on the published literature and recalls. Feed manufacturers would be able to enter their operation’s typical processes, ingredients and previously recorded hazards in order to augment the university’s analysis. This ultimately will result in a more accurate medium for feed manufactures to abide by the FSMA Feed ruling and efficiently produce safe feed.
Along with the University of Minnesota project, AFIA has worked to provide a plethora of resources for its members regarding FSMA. These include: free tutorial videos, an example Animal Food Safety Plan for feed mills and adapted for pet food facilities, qualified individual training tools, and in-person seminars. Members are also welcome to attend AFIA’s in-person trainings, which includes the Preventive Controls Qualified Individual training, offered during the International Production and Processing Expo, Jan. 31 - Feb. 2, 2018, in Atlanta.
Discussions requesting the FDA explain how the rule will impact feed facilities, have been successful in gathering information. Recently, the FDA effectively delayed inspections for animal food facilities to be in compliance with some parts of the animal food rule within FSMA until fall 2018. The extension applies to large businesses of over 500 employees; however, all feed facilities should continue working toward compliance with CGMP rules.
Educating the feed industry on how to comply with FSMA is one of IFEEDER’s utmost priorities. Through its contributions to the University of Minnesota’s project, manufacturers nationwide will have a handy tool to make it easier than ever to comply with FSMA’s hazard analysis rules. ❚