Qualifying FSMA’s “Qualified Individual”

Features - Training and Education

What We Know ... and Don’t Know

June 12, 2013

We know that FDA’s proposed Preventive Controls rule (Section 103) of the Food Safety Modernization Act (FSMA) includes a requirement that each plant have a qualified individual who will be responsible for the development and application of a food safety system, one requirement of which is to be a written Food Safety Plan. And we know that the training or job experience of that individual is to be “at least equivalent to that received under a standardized curriculum recognized as adequate by FDA.” (See detail in sidebar at right.)

However, we don’t yet know what that approved “standardized curriculum” is, therefore, what “minimum standards” will be required.

“There are just so many uncertainties,” said Jeff Kronenberg, University of Idaho Extension food processing specialist. Thus, while the lack of definition in the proposed regulations make it difficult for the industry to prepare for some sections of FSMA, Donna Schaffner, associate director of food safety, quality assurance, and training for Rutgers Food Innovation Center, expects that being HACCP trained will be a minimum.

Schaffner is a member of the Food Safety Preventive Controls Alliance (PC Alliance), a public-private alliance of key industry, academic, and government stakeholders whose mission is to develop a nationwide core curriculum, along with training and outreach programs to help industry comply with FSMA’s preventive controls regulations. As such, Schaffner said, “We have a framework in place for a curriculum for preventive controls. The model is seafood HACCP.”

This is referenced in the proposed rule, with relation to seafood HACCP, as: “FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA.” It goes on to explain that the title of the rule, Hazard Analysis and Risk-Based Preventive Controls, “identifies two critical elements of HACCP—hazard analysis and preventive controls.... Further, establishment of a system of preventive controls for these hazards is the central purpose of HACCP” and “FDA issued the juice and seafood HACCP regulations because a system of preventive controls is the most effective and efficient way to ensure that these products are safe.”

This doesn’t mean that lettuce, candy, and bread producers should sign up for seafood HACCP courses, but participating in a general HACCP program with breakout sessions in which participants apply principles to their own processes can be very beneficial, Schaffner said. “If you’ve gone through a HACCP curriculum that covers the general principles, that’s a start.”

What is a Qualified Individual?

What we know about FSMA’s “Qualified Individual” as written by FDA in the proposed Preventive Controls Rule (XII. H. Proposed Sec. 117.155, page 3761-3762):

  • Qualified individual means a person who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system.
  • The proposed rule would establish minimum requirements for the “qualified individual.”
  • The qualified individual need not have the experience and expertise to conduct validation studies, but must have sufficient expertise in risk-based preventive controls to understand the studies and how they support the validity of the preventive controls with respect to the hazard of concern.
  • Proposed § 117.155(b) would establish the qualification requirements applicable to a qualified individual.
  • The qualified individual may be, but is not required to be, an employee of the facility.
  • The proposed requirement is consistent with HACCP regulations for seafood and juice, which have virtually identical requirements.
  • Training or job experience is essential to the effective development and implementation of a hazard analysis and risk-based preventive controls.
  • FDA is seeking comment on all of the above.

Reference: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls For Human Food Proposed Rule issued by FDA. (http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001)

Kronenberg agrees, stating that accredited HACCP programs are accepted by many of the audit schemes, “and that is what FSMA is saying too.” He sees seafood HACCP as particularly applicable because it has a standardized curriculum that provides a broad background and the principles to put together a food safety plan that includes oversight, verification, and validation. “FDA is just really leveraging off the model of seafood and juice HACCP.”

Kronenberg expects that the Association of Food and Drug Officials (AFDO), which issues seafood HACCP certificates of course completion, also will be accredited to issue qualified individual certification for FSMA. “AFDO certification has become the gold standard, but it’s not the only one,” he said. “FDA does allow for an equivalent curriculum, so if you’re not running your training through AFDO, there are others that offer equivalent certification.”

He also expects there to be a similar training program requirement, with the first segment being individual online study and the second segment being classroom training of at least one full day, including a hands-on workshop in which a team works together to develop a food safety plan.

One of the benefits of the seafood HACCP training curriculum is that the manual developed by the Seafood HACCP Alliance and the FDA Hazards and Controls guide, both of which are used for the approved training, are available for free download from the Internet, Kronenberg said, adding, “It’s unbiased; it’s free; it’s really advancing food safety, so I’m sure if FDA follows the same model, everything will be available for free.” He would further expect that FDA will issue a great deal of guidance on any required FSMA certification to help the industry understand how to comply with the regulations.

In addition to similarities to HACCP, FSMA has a great deal in common with the standards of Global Food Safety Initiative (GFSI) audit schemes. “Companies that are doing the GFSI program will be very, very close to FSMA,” Kronenberg.

Schaffner agreed, noting that some GFSI-benchmarked standards, such as those of SQF, require HACCP certification. “If a company is GFSI certified, you won’t have any trouble complying with FSMA,” she said.

Such certification has, in fact, put much of industry ahead of FSMA. “Regulation is not keeping up with industry self-policing,” Schaffner said. “I think the intent (of FSMA) was GFSI, but I don’t think that what we get out of it will be as strict.” This is, at least in part, because of the burden it would place on smaller companies.

Rather, Schaffner again stated that taking a HACCP course and a pre-requisite course, and ensuring that GMPs are fully implemented could bring even smaller companies close to expected FSMA requirements. “As a long-time HACCP instructor, I don’t find anything new in the proposed FSMA rules that I haven’t been telling people they should be doing for years,” she said. “The new things that FSMA is going to mandate were, for the most part, already there. They’re just defining them more explicitly.”

As part of the PC Alliance committee, Schaffner has the inside track on the curriculum that was recommended to FDA. One area, however, on which no decision has been made is that of ownership of the program. Seafood HACCP is “owned” by AFDO, while The HACCP Alliance “owns” and approves general HACCP courses. Although it does not issue certificates, courses that meet its accredited curricula are issued seals which denote approval and can be affixed to certificates issued by the approved program, e.g., Schaffner’s Rutgers certificates. “This proves that it is meeting certain guidelines and standards,” she said.

Although participating in such courses is of benefit to a plant’s food safety program and may fulfill a GFSI standard, one should not go into a HACCP course—or any other course—with the expectation that it will make him or her fully compliant with FSMA’s qualified individual certification requirements.

As Kronenberg noted, the rule is still only in proposed status and an FDA-approved curriculum for training of the qualified individual has not yet been published. Thus, he said, industry should “beware” of any software, workshops, or other products that claim to provide qualified individual certification. “Since the preventive controls regulation has not been finalized, it would be impossible to train participants on the specifics of the final rule.”

And while finalizing the rule, FDA is still seeking comment, he said. Should training and/or certification be mandatory? Is experience enough? If so, what experience should be required? “These are two things that are now ‘should’ but FDA wants to go to ‘must.’ Personally, I think both of those are very important and should be requirements,” he said.

Additionally, Kronenberg feels that training be required for employees as well. “If you look at all the voluntary standards, most of them are requiring quite extensive training for employees; and I do think it’s quite important,” he said. “A lot of companies get in trouble because they don’t have it.”

In the Plant. Once the rule is issued and information and guidance on requirements are available, the industry will be able to move forward with training as well as implementation of preventive controls. However, in many ways, that will signify just the beginning. As Schaffner stated, “Overseeing it; making sure it is happening in the plant—that’s the real challenge.”

“That’s why large companies with great HACCP programs in place still have recalls,” she said. Schaffner visits food plants to assist in their food safety programs and audit compliance. “But the next part is when I go away. How do you get the employees to do the right thing?”

The most important answer to that, she said, is, “Make sure they know what the right things are, then enforce them.”

Thus, while continuing to await the finalization and specifications of the preventive controls rules of FSMA, many companies are participating in approved HACCP courses and getting individuals certified. “Everything [in the course] is a good idea even if they don’t mandate it directly,” Schaffner said.

One example she gave was the rule’s proposal to mandate validation of environmental monitoring, which in the past has been voluntary. Whether or not the final rule mandates it, it’s a good idea, she said. “How do you know if pathogens are there if you don’t have an environmental monitoring program?”

In fact, Schaffner added, many companies are already implementing this and other expected provisions of the preventive controls rule for business reasons, and those that aren’t—those that are doing only the bare minimum, are already on shaky ground.

“Being compliant with GFSI is the best thing you can do,” Schaffner said. “Then it’s drilling down to make sure it happens on the plant floor.”


The author is Editor of QA magazine. She can be reached at llupo@gie.net.