Article Index:

• Redefining FDA in light of FSMA
• A closer look at HARPC
• But, what really is a qualified individual?
• Training under FSMA

The comment period for HARPC ended last November. However, according to Douglas Karas, FDA spokesman, FDA announced in December 2013 that it would propose revised rule language for the Preventive Controls (PC) for Human Food and the Produce Safety Rule. Preventive Controls for Animal Food and Foreign Supplier Verification, which share many elements with the PC-Human rule, are also being revised. These “supplemental” rules have been submitted to the Office of Management and Budget (OMB) for review, and are expected to be published soon, says Karas.

“These proposed revisions are being made in response to extensive outreach by FDA and the thousands of comments submitted during the comment periods for each rule, all of which are now closed,” adds Karas. “There are court-ordered deadlines for the issuance of a final rule for each of the seven rules proposed in 2013 and 2014, beginning on August 30, 2015 and continuing through May 31, 2016. That does not mean they won’t post before then, but that is the deadline.”

According to Roberta Wagner, deputy director for regulatory affairs at FDA’s CFSAN, when FSMA was signed into law in January 2011, FDA initiated a plan for responding to the many mandates within the law. Up until now, FDA has focused primarily on Phase 1 (Standard Setting)—the rulemaking and guidance development process required to establish the new prevention-oriented standards.

So far during Phase 2, implementation workgroups have developed ideas for how FDA can better oversee the food industry, strengthen the global food safety system and enhance public health, according to Wagner. FDA published its Operational Strategy for Implementing the FSMA on May 2, 2014. This document is intended to guide the next phase of FSMA implementation by broadly outlining the drivers of change in FDA’s approach to food safety with respect to preventive controls in food and feed facilities, produce safety standards and import oversight. The document provides a framework to guide FDA teams responsible for developing the specific strategies, building capacity, training and operational plans needed to implement FSMA in these areas. It also provides the basis for dialogue on the implementation of the FSMA rules with FDA’s partner agencies, international organizations, the food industry and growers.

Redefining FDA in light of FSMA

Coupled with FDA’s completing FSMA comes a realignment of FDA to make the entire agency more efficient and vertically structured. In a memorandum announcing a core set of operational changes recommended by FDA’s Program Alignment Group, and issued via email to key FDA group leaders, FDA Commissioner Margaret A. Hamburg charged the members to develop plans to improve the efficiency, effectiveness and timeliness of the agency’s regulatory and compliance activities, which include commodity-based and vertically integrated regulatory programs, specialization/training, agency work planning, compliance policy, enforcement strategy, laboratory optimization and streamlining business practices.

FDA’s program alignment effort, according to Wagner, is designed to organize activities around distinct programs such as food and feeds, pharmaceutical quality, tobacco and three other non-food categories. The realignment effort also includes streamlining business processes, decision-making and structural changes in the organization, such as streamlining interactions between the Office of Regulatory Affairs (ORA) and CFSAN experts (e.g., food and feed). Also, FDA’s inspection and compliance functions will be specialized to adapt to rapid technical advancements. This program alignment, says Wagner, will support FSMA implementation.

The program alignment effort promises a focus on food safety and includes advancing public health by promoting widespread voluntary industry compliance, leveraging and collaboration in the formation of a global food safety network, as well as integrating data and sharing information among and between public and private partners. Also, the program creates strategic and risk-based industry oversight by expanding FDA workforce skills through training and real-time technical support for frontline personnel to promote consistent inspections and decision-making.

It was out of this alignment effort that the Operational Strategy for Implementing the FDA Food Safety Modernization Act was created. This document makes it apparent that FDA’s direction for the future is clearly risk based. According to the document, food safety depends primarily on the food industry working in a continuous improvement environment to:

• Implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum and
• Manage their operations and supply chains in a manner that provides documented assurances appropriate preventive measures are being implemented as a matter of routine practice every day.

For smaller and medium-sized processors, there is some good news: In its new and expanded role, FDA is expected to provide technical expertise in setting and fostering compliance with food safety standards, in addition to responding to and learning from problems when they occur. Training courses will be available, although the delivery mechanisms and options haven’t yet been completely worked out. FDA has created the Food Safety Preventive Controls Alliance, a public-private partnership, to assist processors with their compliance to preventive controls regulations. (See Training under FSMA on page 100.)

But, FDA still has work to do. According to Joann Givens, co-chair of FDA’s FSMA Operations Team Steering Committee and acting regional food and drug director, three workgroups have been created to focus on:

• Preventive controls, considering issues such as the need to develop a trained workforce that can complete consistent, high-quality inspections
• Produce safety and the development of performance measures
• Import controls and the need for goals and timelines for each phase of the two proposed rules designed to strengthen FDA oversight of foods imported into the US.

A closer look at HARPC

At first glance, HACCP and HARPC may look similar, but the two are markedly different, says Stephanie Lopez, vice president, food safety innovation, AIB International. HACCP has become a global standard and is part of Codex Alimentarius.  But HARPC is a US standard that affects a limited number of FDA-regulated products. Also, while both HACCP and HARPC define hazards as biological, chemical and physical, HARPC adds radiological and intentionally introduced hazards to the list. With HACCP, hazard analysis is largely done for an industry using documents such as the Seafood Hazards and Controls Guide and the Juice HACCP Hazards and Controls Guide, says Lopez. With HARPC, research must be performed and documented by each facility. Plus, HACCP uses the identification of critical control points, whereas HARPC uses the identification of preventive controls; HARPC doesn’t distinguish CCPs from other controls, adds Lopez.

The preventive controls in HARPC refer to the reasonably appropriate procedures, practices and processes that a person knowledgeable about the safety of food would employ to significantly minimize or prevent hazards, says Lopez. While HACCP makes use of SSOPs (sanitation standard operating procedures), HARPC’s proposed preventive controls rule has within it process, sanitation and food allergen controls plus a recall plan; pending additions include hygiene training, environmental monitoring, some cGMPs and supplier verification.

Under HARPC, FDA requires a qualified individual to prepare the plan, validate the controls, review records and conduct re-analyses. The definition for qualified individual will likely remain a little sketchy until the final rule is published, although FDA does say the individual can be qualified either by experience or training.

Under the proposed rule, a qualified individual “must have 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 the FDA” or “be otherwise qualified through job experience to develop and apply a food safety system.” FDA does not stipulate whether that person has to be an employee of the processor, but in most cases, he or she probably will be.

But, what really is a qualified individual?

What about the guy with 20 years of on-the-job experience? “That’s a good question,” says Benjamin England, founder and CEO of fdaimports.com. “I think in a sense, it’s a bit of a red herring.” While FDA may not have an immediate answer on the experience question, England is optimistic the answer will work itself out—not in enforcement actions, but in FDA’s developing experience with the program.

At a hypothetical FDA HARPC inspection, England asks you to imagine the following. At the inspection, the FDA inspector finds the plant person has 20 years on the job and knows more about this product than anyone else in the building, including the FDA inspector. The FDA auditor says, yes, he recognizes the experience, but then comments, “You know you don’t actually have any formal food safety training, do you?” While he doesn’t, the plant person knows everything about where the food safety risks are and how to control them, as opposed to a young adult who recently graduated from college and who has passed an exam or written a HACCP program. It’s going to be hard for the FDA inspector to discount the plant person with all of his experience as a qualification, says England.

“My understanding is there will be about a three-and-a-half-day course combining presentation/textbook learning with hands-on activities,” says Jennifer McEntire, vice president and chief science officer, The Acheson Group. In a discussion on “FSMA Fridays” sponsored by SafetyChain Software, McEntire added that people who take these courses and get certificates will be recognized as qualified individuals. At this time, the curriculum and course information are not available. “The other option the FDA gives is that if you can demonstrate you have the experience, education and training equivalent to what FDA has in its standardized curriculum, you can make the assumption you’re a qualified individual. FDA is not requiring that an outside body grant you some certificate that says you’re qualified.”

“I’d just like to add that I see this as a potential quagmire or challenge,” says David Acheson, CEO and president of The Acheson Group. What Acheson is concerned about is whether the person with 25 or 30 years of food safety experience who has written the necessary preventive controls documents will be considered to have the right training by the FDA inspector auditing the plant. Is it possible the inspector might not accept the lack of a formal training course? “I hope that won’t happen,” states Acheson. “But the reality of it is that it could happen. It would be a shame if, by default, everybody gets pushed into doing a course that’s going to require unnecessary expenses all around.”

Conversely, is declaring someone qualified just for passing a test good for the industry? “I would think that for it to have any validity, FDA will have to do more than just put out an online test,” says England. “FDA must have some way to ensure a certain level of experience or vetting. You or I could take a test, and we might do pretty well, but what does that mean [without real-world experience]?”

Until the final rule is passed, it’s unclear what level of experience will be required for someone to be considered qualified, but it could be lower than expected to ensure an adequate number of individuals is available to assist facilities in meeting compliance deadlines, says Marc C. Sanchez, Esq., senior council, FDA attorney, in a blog on foodct.com. “The concise definition of qualified individual suggests the FDA is weary of third-party auditors and will propose an equally rigorous rule for third-party audits.”

Training under FSMA

As previously mentioned, the Food Safety Preventive Controls Alliance (FSPCA) is a broad-based, public/private alliance consisting of key industry, academic and government stakeholders whose mission is to develop a nationwide core curriculum, along with training and outreach programs, to help food processors comply with the FSMA preventive controls regulations, i.e., preparing someone connected with the process/operation to become a qualified individual.

To allay some of the fears about the perceived value of on-the-job experience vs. taking a course and/or passing an exam, FSPCA is grappling with these concerns and making adjustments as necessary, according to  the group members. No one knows a process and how to make it better than a person who’s been working with it for several years. And in some ways, a universal training course and exam, while good, can be problematic because food safety issues that are important for one processor are not for another, e.g., a cold chain’s requirements are much different than those of a peanut butter manufacturer.

In addition to providing training for processors, FSPCA’s curriculum and modules include train-the-trainer courses for food industry personnel and state and federal regulators. A state-of-the-art distance learning portal will host and disseminate FSPCA education and materials.

The FSPCA Preventive Controls course is expected to take two or two-and-a-half  days and will cover the following:

• Course introduction and objectives
• Definitions, terms and key concepts
• Prerequisite programs (cGMPs, sanitation, pest control, etc.)
• Conducting a hazard analysis and identifying hazards
• Determining preventive control measures for identified hazards
• Verifying and validating preventive controls
• Record retention and accessibility
• Managing and implementing a food safety plan, including its reanalysis.

The course will also include appendices with resource materials that may be helpful in preparing food safety plans.

A one-year, $1 million partnership grant funded by the FDA Office of Foods and given to the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) was used to create FSPCA. The FSPCA organizing committee consists of key stakeholders representing food industry trade organizations, state and federal regulatory agencies and extension specialists from academic institutions. The organizing committee, FSPCA coordinator and ad hoc advisors jointly developed the management structure of the alliance and established the executive and steering committees. The ad hoc advisors were selected based on their experience in previous industry-wide alliances, such as the Seafood HACCP Alliance, and/or their expertise in the development and delivery of seafood and juice HACCP training.

The training materials won’t be available until the Final Preventive Controls Rule is published. To learn more about FSPCA, visit its website at www.iit.edu/ifsh/alliance/.

For more information:

Benjamin England, fdaimports.com, 410-220-2800, contact@fdaimports.com
David Acheson, The Acheson Group, 801-910-5795, david@achesongroup.com
Jennifer McEntire, The Acheson Group, 301-551-3601, jennifer@achesongroup.com
Stephanie Lopez, AIB International, 785-706-0114, slopez@aibonline.org