Jan 13, 2016

FDA Finalizes First FSMA Rules

What you need to know to get your company compliant

Back in September the federal Food and Drug Administration finalized the first rules of the Food Safety Modernization Act, and the clock has started ticking for feed operations to comply with the law.

FSMA, as the FDA says, is focused on shifting efforts from responding to food contamination to preventing that contamination. The upshot for feed and grain processing operations is that they will need to provide training for all workers, detail good management practices, evaluate food safety hazards, and implement controls, either in their facility or supply chain, for hazards that pose a serious risk to product safety.

“We’re going to enter into this new era where FDA’s inspection focus is going to be more on practices and procedures and whether facilities are meeting these benchmarks rather than FDA coming in and observing the facility and testing products,” says Dave Fairfield, vice president of feed services for the National Grain and Feed Association. “The processes and practices have to give assurance that the product is going to be safe.”

Richard Sellers, senior vice president of legislative and regulatory affairs for the American Feed Industry Association, says there is already a lot of information available for businesses, and more will be coming over the next few months.

“AFIA is currently inundated with questions from members, and we understand; this is a thick rule with many new requirements on our industry,” Sellers says. “As we try to wade through the nuances of rule, we are traveling across the country discussing the rule with members and communicating answers to commonly asked questions in various ways.”


Under the final rules, workers must be qualified to do their jobs in a feed operation. They must be trained to “manufacture, process, pack or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene” before they can begin working.

Fairfield says the training requirement applies to “individuals,” which means it could be interpreted to apply to anyone working in the facility, including contractors or temporary employees.

A facility will now be required to have or hire a “preventive controls qualified individual,” or PCQI. This person will be tasked with developing a written Animal Food Safety Plan, which includes a hazard analysis for the plant.

The rules say that the PCQI may be qualified by successfully completing a training program recognized as adequate by FDA, or otherwise qualified through job experience.

FDA’s rule does not require documentation of job experience for an individual to qualify as a PCQI. Instead, FDA during inspections will focus on the adequacy of the animal food safety plan. FDA says it will consider whether any deficiencies identified in the plan suggest that the PCQI may not have adequate experience to carry out the assigned functions.

Charles Hurburgh, professor of agricultural engineering at Iowa State University, will be a lead instructor for those trainings and is helping the organization responsible for developing the training — the Food Safety Preventive Controls Alliance — finalize the program. He says companies should be careful about choosing the option of deeming an employee qualified without the training program.

“If there’s ever a problem found, you can imagine the consequences would be more severe without a PCQI,” Hurburgh says. “It’s going to be a legal liability thing.”

Hurburgh says that though the rules do not require it, companies should consider having a trained PCQI for each facility it operates rather than simply having one person for the entire company.

“It will be important for there to be a person at every facility — each feed mill, ethanol plant, etc., — that has had the training for legal protection and to communicate with the FDA if and when there is a preventive issue,” he says.

At the moment, Hurburgh says the training is expected to take two days, and the first sessions are targeted for early May. There will be a fee, but it hasn’t been established yet.

Sellers also recommends that companies participate in the AFIA’s Safe Feed/Safe Food Certification Program, which establishes standards for feed mills and feed- and ingredient-related facilities that go beyond existing regulations.

“FDA has stated it is likely to conduct shorter and less frequent audits in facilities that are Safe Feed/Safe Food certified, as the certification program is undergoing updates to parallel FSMA requirements,” Sellers says.

Hurburgh says elevators are exempt from the rule, but they should also familiarize themselves with the procedures as they could be a part of an audit if a feed operation finds itself dealing with a preventive control issue. As part of the supply chain, the elevator might be required to show that grain it delivered met certain requirements or that it was free from contamination.

“An FDA audit is likely to go back to the elevator,” Hurburgh says. “It would be incumbent upon the elevator to have some type of verification program in place to prove that they’re meeting that requirement.”

Hurburgh adds that Iowa State will be developing a mini training program sometime in the next year that elevators could use to familiarize themselves with the new rules.

Management practices

Businesses will need to develop “Current Good Manufacturing Practices,” foundational standards meant to keep animal feed safe.

Requirements include keeping facilities sanitary, clean and in proper working order, and grounds around facilities in a condition to help prevent food contamination. Raw materials should be inspected and tested as necessary, and animal food should be stored in a manner that minimizes deterioration.

The final rules eliminated requirement that a person with any illness be kept out of a facility and changed language that originally said CGMPs needed to “prevent contamination” to a requirement that they “protect against contamination.”

Hazard analysis

The most significant portion of the FSMA rules, in terms of time and money, comes under the requirements for a written food safety plan, developed by the PCQI.

Part of that plan is a hazard analysis that details each known or foreseeable biological, chemical and physical hazard that could be present in a facility. These may be naturally occurring, unintentionally introduced or intentionally introduced for economic gain.

Sellers says the AFIA is working with the University of Minnesota Center for Animal Health and Food Safety to develop a generic hazard analysis that covers the basics for most businesses.

“When we deliver the generic hazard analysis for the plant, we will give them instructions for making it their own,” Sellers says. “Each facility will have to consider what and how much of the hazard analysis is appropriate to its plant and develop its facility’s animal food safety plan accordingly.”

Sellers says the generic plan could save businesses significant money.

“This will save the industry millions of dollars as the cost of the hazard analysis is $169,000, and AFIA believes firms would likely have similar costs,” he says.

If a business deems a hazard significant and likely to occur frequently, a preventive control plan would be need to be drafted. That could include process, and sanitation controls, as well as supply-chain controls and a recall plan. It would require multiple levels of monitoring procedures, validations and verifications.

“If you have a hazard that is frequent and is very serious, you will need a preventive control. If it is a rare occurrence or has a low severity, you don’t have to have that preventive control,” Sellers says. “You have to kind of build a matrix around these and decide.”

Sellers and Fairfield hope, however, that most — if not all — operations would be able to find their hazards fall short of that need.

“We don’t think most facilities involved with livestock and poultry feed will determine they have a hazard requiring a preventive control,” Fairfield says. “If a hazard requiring a preventive control is identified, then the facility will be obligated to perform a variety of management activities to assure the preventive control is effective. These management activities would take considerable time and energy, and increase compliance costs.

Sellers says businesses will have to make that determination on their own, however.

One possible wrinkle could be mycotoxins, toxic substances that can contaminate crops and are tied to weather patterns. Mycotoxins are particularly dangerous for animals and can cause severe illness or death.

That means they may meet one of the requirements for a preventive control — the potential to cause severe illness or death. But it’s the likelihood of a mycotoxin contamination each year that’s uncertain. It could be that mycotoxins aren’t a problem for many years, but in other years conditions may be present that increase mycotoxin levels and increase the likelihood of the hazard.

Finally, facilities that identify a hazard requiring a preventive control in an inbound ingredient or raw material and choose to rely on their supplier to control the hazard will need to conduct supplier approval and verification activities.

Those facilities would need to use approved suppliers and determine, conduct and document supplier verifications, which may include on-site audits, sampling and testing of ingredients and review of suppliers’ food safety records.

Wiggle room

One of the key changes from the proposed rules is in flexibility added to the language — words such as “adequate,” “when necessary,” and “where appropriate.”

That flexibility will still need some interpretation, but it should ease up on what some saw as onerous requirements.

“Flexibility in the rules is helpful and something we absolutely demanded,” Sellers says.

One of the big wins for the industry is in electronic signatures. As drafted, the rules would have required that feed operations back up electronic records with printed, signed and dated paper records, which would have added significant expense. But the final rule exempts those requirements.

“Applying the rule to the industry would have required firms to ‘validate’ every computer system that keeps records required by any and all FDA rules,” Sellers says. “This is potentially the largest cost saver for the industry in AFIA’s eyes.”

FDA also approved staggered compliance dates, with larger companies needing to meet requirements sooner than smaller ones. Businesses will need to meet the CGMP requirements one year before preventive control requirements.

For large companies with more than 500 employees, the CGMP portion of compliance must be met within one year of the rules being adopted, which was Sept. 17, 2015. They must meet the preventive control rules within two years.

Companies with fewer than 500 employees must meet CGMP within two years, and preventive control in three.

And companies averaging less than $2.5 million have three years for CGMP and four years for preventive controls.

Sellers says the important thing for all businesses to remember is that FDA and industry associations are working to help.

“It is a lot of training, but we’re trying to get it down to a manageable [amount]. There will be resources put together to help you,” Sellers says.

FGLiveInterested in FSMA? Check out the #fglive Feed Track. icon-feed-bag-200px

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