U.S. feed industry leaders say, for the most part, feed manufacturers are ready to comply with the first phase of the sweeping Food Safety Modernization Act (FSMA) that takes affect for large-sized businesses this September.
“As a whole, animal food companies are in a pretty good place in terms of overall compliance,” said Cassandra Jones, assistant professor of feed technology at Kansas State University (KSU). “Those that do need to comply may find it less cumbersome than they thought it was going to be. There is a shift in the way we approach hazards and controlling hazards. Five years from now, what we’re going through right now is going to become the norm.”
To ensure the safety of the U.S. food supply, the FSMA shifts focus from responding to contamination to preventing it.
“This is the most sweeping reform to food safety laws in 70 years,” Jones said. “The FDA (U.S. Food and Drug Administration) intends the FSMA to be a bigger shift in thinking than any of its previous regulations since the Federal Food, Drug, and Cosmetic Act was enacted in the 1930s.”
After FSMA was signed into law in January 2011, the FDA went to work on writing regulations for enforcement and came up with seven major rules. The final regulations were published on Sept. 17, 2015, and included requirements for Current Good Manufacturing Practices (CGMPs), hazard analysis and risk-based preventive controls as well as supply-chain programs.
Compliance begins Sept. 19 with the CGMP requirement for businesses with more than 500 full-time equivalent employees, and will continue on a staggered basis for the next several years.
The FSMA applies to domestic and foreign facilities that manufacture, process, pack or hold animal feed and/or pet food, and ingredients used in such products. In general, this means the FSMA covers facilities that are required to register with the FDA under the agency’s existing facility registration regulations implemented as part of the Bioterrorism Act.
Key issues for the feed industry center on implementing CGMPs and creating a written food safety plan, which must include, among other requirements, hazard analysis and preventive controls, if necessary.
“We haven’t seen anything close to this size. We estimate the cost to the industry will be $1 billion,” said Richard Sellers, senior vice-president of public policy and education at the American Feed Industry Association (AFIA). “There’s a way to cut $800 or $900 million if we don’t have to provide preventive controls. We can mitigate the risks from hazard analysis with CGMPs or other prerequisite programs. Preventive controls are a huge cost and require a bunch of resources.”
Preparing for this type of sweeping, all-encompassing act has required working groups, special committees, thousands of meetings and just as many educational opportunities.
Industry organizations, universities and private companies have responded with a flurry of online information, webinars, seminars, special training courses and more. Training and education will continue in the foreseeable future as more portions of the rule are implemented.
“We are committed to getting this rolled out. We are quite aware of the struggles and challenges there will be,” Sellers said. “We are answering questions as quickly as we can. Ones we can’t answer, we are submitting to the FDA portal.”
AFIA is offering a series of four 2.5-hour webinars starting at the end of August, presented by experts from AFIA and the FDA. There will be time for questions and answers. Three of the events will focus on feed and the fourth will specifically cover pet food. See the box on page 69 for a list of upcoming FSMA-related training and education.
“We have a working group of 85 people from 65 companies that worked on comments to the rule and are working with the FDA. We have two working groups and eight sub-working groups that are still active,” said Sellers, noting that AFIA has also hired additional staff to work on FSMA issues. “This is a monumental effort.
“At some point in time, probably in the next year, we will look at where we are in compliance, and we may ask for more time from FDA.”
If a company fails to comply with FSMA, the FDA can take them to court, Sellers said. If they knowingly violate the law, criminal felony charges are possible. The FDA can also determine that products are adulterated if they are not manufactured under the required rules, and can detain or require a recall of all products.
Failing to follow a recall recommendation can lead to seizure of products and loss of FDA bioterrorism registration, meaning the company would have to cease operations, Sellers said.
Good manufacturing practices
The first round of compliance is with CGMPs, a concept that is not new to the feed industry, particularly facilities that have manufactured and handled medicated feed, Jones said.
“While it is new to some segments of the industry, others will find it quite similar in concept,” she said. “For the most part, CGMPs develop a baseline standard for what would be acceptable in terms of sanitation, plant operations, water use and more.”
The FDA says CGMPs ensure that all food, including animal feed, is “manufactured under conditions and practices that protect against contamination with undesirable biological, chemical, physical and radiological agents.” Specifically, the rule establishes requirements in: personnel; plant and grounds; sanitation; water supply and plumbing; equipment and utensils; plant operations; and holding and distribution.
CGMPs are mainly observational and address routine operations, AFIA said, and there are no specific record-keeping requirements in the CGMP section of the rule.
However, facilities must also provide training on feed safety and hygiene to all plant personnel, Sellers said. AFIA is also in the process of creating a 20-minute video, which will be available in August, which can be shown to employees to meet that requirement.
Food safety plan
Feed facilities will be required to have a written food safety plan that includes several components: hazard analysis; standard operating procedures to mitigate risk; preventive controls, if necessary; supply-chain program; recall plan; procedures for monitoring; corrective action procedures; and verification and validation procedures.
AFIA has created a sample food safety plan that companies can use as a reference to write their own plan. Sellers said it’s important they don’t just copy the AFIA, because companies are legally bound to create their own.
Hazard analysis is a major part of the written food safety plan, and in the first step is determining if there are known or reasonably foreseeable biological, chemical and physical hazards.
Next, it must determine the severity to animals or humans if the hazard were to occur, and thirdly, the probability that the hazard will occur in the absence of preventive controls. Prerequisite programs and CGMPs can be considered during this determination as they likely reduce the probability in some cases.
In the fourth step, determine if the known or reasonably foreseeable hazard is a hazard requiring a preventive control based on steps 2 and 3. From there, determine the appropriate control for the hazard (process control, sanitation control, supply-chain-applied control, or other control). The step is justifying the determination, particularly if it is not a hazard requiring a preventive control.
Preventive controls are very in-depth, costly and complicated, Jones said, which is why compliance with that portion of the law has an additional year, going into effect on Sept. 18, 2017, for large companies. AFIA believes that for the most part feed mills will be able to control hazards with CGMPs, thereby avoiding the costly preventive controls, Sellers said.
“If you can mitigate the risk from your hazard by a prerequisite program or CGMP, then you don’t have to have a preventive control,” Sellers said. “Unless you have a microbial problem, and that applies to those in pet food. FDA said that’s the way they can enforce it.”
FDA didn’t provide much guidance on hazard analysis, Sellers said, so the AFIA partnered with the National Grain and Feed Association (NGFA) to finance a hazard analysis of typical ingredients and processes associated with the manufacturing and distribution of animal feed and pet food.
Researchers at the University of Minnesota College of Veterinary Medicine’s Center for Animal Health and Food Safety (CAHFS) is completing the analysis, expected to be complete in October, at an estimated cost of $170,000.
CAHFS will develop a generic hazard analysis, which will be shared with AFIA- and NGFA-member facilities. While facilities can’t adopt the analysis wholesale, Sellers said, it can be adapted to a companies’ specific operations, saving them millions of dollars if they had to complete the analysis from scratch.
The hazard analysis must be reviewed every three years, or earlier, if there are changes to equipment, manufacturing process or other operations that make a review warranted. A preventive control qualified individual (PCQI) will have to review the analysis and sign off on it, Sellers said.
Facilities will need a PCQI, which is someone knowledgeable about feed safety and hygiene by job experience or has completed training under standardized curriculum. The FDA and Food Safety Preventive Control Alliance created a framework for training, and several groups are now offering it.
Iowa State University offered PCQI training in June and AFIA hosted two training sessions in July and August in Nashville, Tennessee, U.S., and Auburn, Alabama, U.S. NGFA and KSU are offering training Sept. 20-22 at the IGP Conference Center in Manhattan, Kansas, U.S. Individuals who complete the training will receive a PCQI certificate along with a HACCP certificate.
Upcoming FSMA-training and education
Aug. 30: Topics to be covered include: overview of FMSA; a history of the rule; who is covered; key definitions; dates of implementation; and in-depth review of current good manufacturing practices: building the basics and how to develop a recall plan.
Sept. 6: Topics to be covered include: how to complete an animal food safety plan including the development of a hazard analysis, implementation of preventive controls and the role CGMPs; and how to develop an effective supply-chain program.
Sept. 20: Topics to be covered include: what types of records are required for FSMA compliance and specifically for CGMPs, the animal food safety plan and a company’s supply-chain plan; Foreign Supplier Verification Program; Third-Party Certification; and Sanitary Safe Food Transportation Rule.
Sept. 27: This webinar specifically looks at FSMA from the perspective of pet food and pet food ingredient manufacturing and focuses on hazards requiring preventive controls.