Industry Perceptions of Proposed FSMA Rule on Preventive Controls
By Food Safety Magazine
On January 4, 2013, the U.S. Food and Drug Administration (FDA) released for public comment two proposed rules:
1) Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, and 2) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. The latter, which is the topic of this article, focuses on preventing problems that can cause foodborne illness. This proposed rule, which is required by the FDA Food Safety Modernization Act (FSMA), would apply to every individual and entity that manufactures, processes, packs, transports, distributes, receives or holds articles of food, requiring them to have written plans that identify hazards, specify the steps that will be implemented to minimize or prevent those hazards, identify monitoring procedures and record monitoring results and specify what actions will be taken to correct problems that arise. FDA would evaluate the plans and inspect facilities to ensure the plans are being implemented properly. The largest question here appears to be the cost of such implementation and inspection; there is current speculation that FDA will for the first time receive the authority to impose registration fees upon food facilities.
The new law requires comprehensive, science-based, preventive controls across the food chain, not only nationally but for globally sourced foods as well. Despite its far-reaching regulations, the law is surprisingly simple, leaving regulators to troubleshoot the most controversial details, which has delayed implementation.
Under the proposed rule, the first compliance date would be 1 year after the final rule is published in the Federal Register. Recognizing that smaller businesses may need more time to comply with the requirements, FDA proposes to allow 2 years for small businesses and 3 years for very small businesses to comply. The proposed rule was published on January 16, 2013, and comments are due by May 16, 2013.
Given the wide-ranging impact of the proposed Preventive Controls rule on the food industry, Food Safety Magazine convened an expert panel, moderated by Larry Keener of our editorial advisory board, to address some of the more critical questions regarding the implementation of this regulation. Participating panelists include David W. K. Acheson, M.D., F.R.C.P., Leavitt Partners (former FDA official); David Calvin, H.J. Heinz Company (multinational processor with a complex product portfolio from thermally processed to refrigerated and frozen foods); Will Daniels, Earthbound Farm (freshcut products); Lisa M. Weddig, M.Sc., National Fisheries Institute (seafood) and Ian Blount, M.Sc., Coalescence LLC (small processor).
Food Safety Magazine (FSM): Previous HACCP guidelines have included pathogen reduction requirements and critical limits, but the proposed rule does not. Should there be some attempt made to include or suggest critical limits in this case? Why has FDA, in your view, moved away from critical limits?
Acheson: FDA is charged by Congress through FSMA to write rules around preventive controls for many FDA-regulated products. The exclusions are those foods that already have preventive control (HACCP) requirements. FDA could have taken the approach to write different rules for different commodities and thus be prescriptive, but they wisely did not do that. Instead, it is one set of rules, but there will be multiple guidance documents that will provide a lot more detail. Many of the foods and processes that FDA needs to regulate under FSMA do not lend themselves to classical HACCP, and thus setting critical limits is not practical. Instead of providing critical limits, FDA is leaving it up to the industry to identify and control risks. Overall, I think that is a much better approach and, if done effectively, will be no less protective of public health than getting bogged down in a myriad of critical limits.
Calvin: The Preventive Controls rule requires food manufacturers to conduct risk assessments and develop science-based preventive controls. These controls will be developed based on scientific data, literature and previous regulatory guidelines that would define specific pathogen-reduction
Daniels: Critical limits are key to a true HACCP program; without them, you are not clearly in control of your hazard. However, in many systems, like fresh-cut produce, there is not a true HACCP plan in place. In other words, we are not totally controlling or eliminating the hazard through a CCP. We operate using HACCP principles and operate our CCPs as such. However, in some instances, they don’t truly eliminate the hazard. Perhaps FDA is recognizing that HACCP is being applied where it can’t truly control the hazards, like in a field. There should be recognition of this, but instead of dumbing down HACCP, perhaps there should be proposed language that suggests risk-based analysis and controls as well as true HACCP programs.
Weddig: “Critical limits” is an HACCP term, so not requiring critical limits per se in the proposed rules doesn’t necessarily suggest that FDA has moved away from critical limits. FDA is proposing that the preventive controls include “parameters” that must be controlled with maximum or minimum values to minimize or prevent a hazard. This is very similar to the language used to define critical limits in FDA’s Seafood HACCP regulation [21 CFR 123], which is “the maximum or minimum value to which a physical, biological or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” The language in FSMA does not mention critical limits, although it does require other elements of HACCP as part of the Preventive Controls rule, such as Hazard Analysis, monitoring, record keeping, verification and corrective actions, which all appear in the proposed rule. It appears that FDA is maintaining this distinction between HACCP and preventive controls by not using the HACCP terminology of “critical limits” in the drafting of the proposed rule. Although “critical limits” aren’t required, the basic concept of establishing maximum or minimum values necessary for control is required.
Blount: Yes, there should be some attempt for critical limits to be set. However, critical limits should be established for each application, taking into consideration processing conditions and the complexity of the entire supply chain. For example, if we were to supply a seasoning blend as a topical for a snack application, we would take into consideration where individual spices originated and how they were processed. In addition, we also need to understand how the end-user will apply the seasoning, and if there is a kill step involved. Critical limits should be suited to worst-case scenarios to ensure the safety of the consumer. I also believe they moved away from setting limits because they have received push back from industry, which has struggled in the past with meeting rules that are not applicable to their specific processes.
Keener: It also occurs to me the old message that the government is not responsible for food safety; rather, food safety is the responsibility of those involved in its manufacturing and marketing. It is inconceivable that FDA could anticipate the multitude of casual relationships that exist in food production operations and then prescribe reasonable critical limits for ensuring public health. Some will recall the days when FDA, prior to the adoption of the umbrella GMPs, attempted writing product-specific GMPs. This was a monumental exercise in futility. I agree with Dr. Acheson that the activity of identifying and validating critical limits is outside the purview and mandate of the FDA.
FSM: Prior to FSMA being signed into law, there was discussion about moving food safety forward by forming a single government agency responsible for the oversight of all food safety programs. Can FSMA move forward in the current government bureaucracy, that is, without a single agency in charge? Will the USDA FSIS [U.S. Department of Agriculture Food Safety and Inspection Service] adopt FSMA requirements?
Acheson: Ultimately, the answer to U.S. food safety is a single agency. But the time and the resources are not right currently to move that forward. Most certainly, FSMA can move forward in the current bureaucracy under FDA. The bigger challenge is resources, not government structure.
Calvin: The hazards are unique for meat and poultry, and the program requirements defined by USDA address typical food safety risks. As FSMA builds enhancements in specific programs such as allergen controls and threshold limits, it would be advisable for USDA to consider similar improvements and be aligned.
Daniels: The current structure of food safety governance in the U.S. is complicated, to say the least. Clearly, there would be better coordination, allocation of funds, utilization of resources and focus on that which is truly high risk if there were a single agency in control of food safety.
Weddig: Successful implementation of FSMA rules should quell the call for a single food agency, as this reform of food safety laws will strengthen FDA oversight over foods that are under its jurisdiction.
At the facility level, to address food safety issues, there is really no need to adopt FSMA requirements, because all facilities already operate under an HACCP regulation. Is there a need to modify the FSIS HACCP regulation to require supplier verification for FSIS establishments? The benefits for such a requirement for the entire food system will need to be assessed if and when FDA decides to include these provisions in a final Preventive Controls rule.
On an inspectional level, though, for secondary processors of meat and poultry plants with HACCP already in place, there could be a more uniform approach to risk-based inspections, with the lower-risk facilities being inspected on a less-frequent basis.
Blount: FSMA would be regulated well by a single agency in theory. Conversely, from a practical standpoint, I believe that a large, single agency will create more opportunity for inefficiency, primarily through redundancy. FSMA will have to work under the current government bureaucracy, because it is now law. I also believe USDA FSIS will adopt the new FSMA directives, but it will be a slow and arduous coordination process. Lastly, we need to be cognizant of the training. Food professionals are receiving both an academic perspective as well as on-the-job training to ensure that we have individuals in place who understand all aspects of food safety. In addition, protocols and best practices should be established and shared, so that every organization has a role in keeping our food supply safe against threats of terrorism and adulteration.
Keener: It is safe to say we all agree that food safety oversight is currently a crazy quilt with a great deal of unproductive overlap and expensive redundancy. The situation is much bigger than just USDA and FDA. There are at least 12 federal agencies involved with overseeing food safety. I agree with Dr. Acheson that FSMA can move forward in this bureaucratic bedlam, however slowly.
Another pressing and interesting question has to do with FDA’s current mandate for overseeing the safety of foods, drugs, cosmetics and medical devices. Can the agency realistically, in the current environment, meet these obligations and bring FSMA to full and functional fruition?
It’s also interesting to contemplate whether FDA’s historic pattern of leadership provides for the requisite experience, knowledge and vision required for driving the public health improvements demanded by FSMA. Certainly, if a major corporation were contemplating the large-scale changes that are anticipated from implementing FSMA, there would be a critical assessment of its leadership team. I’ve often heard it said, “You can’t keep doing things the same way and expect to get a different outcome.”
FSM: The proposed rule discusses allergen control at length. What impact will these preventive controls regarding allergens have on food safety? On the food industry overall? Will they require new facilities to be built?
Acheson: Allergen control has become a major public health focus in FDA and is specifically called out in the preventive control requirements. Facilities will have to identify, manage and document the management of allergen risk. For some in the food industry, this will be a heavy lift because they have not paid enough attention to allergens. We also struggle with the lack of thresholds and what “clean enough to protect public health” really means. What this will do is require facilities to control the risk, not to build new facilities. However, when purchasing new equipment or designing new facilities, it will be critical to pay attention to allergen control during the procurement and design phases.
Calvin: A consistent approach to allergen management is helpful to the industry. Standardized approaches to validate cleaning and sanitizing regimens will reduce ambiguity and improve food safety. Developing science-based limits for some allergens will allow food manufacturers to provide safe products and reduce nuisance recalls that erode consumer confidence in specific brands.
Daniels: Preventative controls are the cornerstone of food safety. Allergens continue to be a major cause of illness in the U.S., and food companies need to take them seriously. I believe that by instilling greater discipline, the proposed regulations will strengthen food safety, specifically with respect to allergen control and overall as a result.
Weddig: While there are a lot of recalls due to undeclared allergens, it will be important to see if the level of recalls decreases with new rules in place. Requiring that preventive controls be in place to address proper labeling should help address the issue of using the wrong or incomplete label.
Blount: Preventative controls will significantly improve the food safety system. The requirements of regulation and documentation will only force industries to be more conscious of their practices and ensure they are being properly carried out. Based on our interaction with large-scale, global food companies, there already seems to be a lot of emphasis placed on allergen control, which is having a trickle-down effect on small-to-midsize suppliers/processors. Speaking from personal experience, for many years we have worked hand in hand with our clients to establish preventative controls in our processes from how we receive, store and stage raw materials used in blends. New facilities should not have to be built to control allergens if everyone along the supply chain is focused continuously on improvement by addressing gaps as they occur.
Keener: Asset utilization is a key driver in the economics of food processing. Limiting the availability of a manufacturing asset will have an economic implication. The food industry has struggled mightily for the past 15 to 20 years to solve this equation when allergens are involved. When an asset is common in its use for both allergen- and nonallergen-containing foods, there are very serious downtime considerations and costs associated. Even with the best program of allergen clearing, there will always remain a question about the cross-contamination potential. FDA is justified in ratcheting up its oversight in this area due to the serious nature of the associated risk. Solving this problem will require new thinking and new strategies by all involved parties. Improved design of equipment to facilitate removal of allergens is certainly within the realm of possible solutions, so too is the building and construction of dedicated production facilities. For the near term, FSMA notwithstanding, industry and government will continue to grapple with this very serious issue.
FSM: How will FDA enforce implementation of FSMA preventive control measures for foreign processors selling foods in the U.S.?
Acheson: FDA will use three basic approaches. First, they have increased foreign inspections from about 100 per year to close to 1,500 per year. This is still tiny compared with the number of facilities but is a move in the right direction. This number will not increase much in the coming years despite a congressional mandate due to a lack of resources. Part of this strategy is also to open offices in foreign countries such as China, India and South America. Second, FDA will assess and accredit certain foreign governments to gain assurance that the foreign food safety system is operating at an adequate level and leverage that to the extent possible. This, however, will likely be a limited activity. Third, the burden of safety is placed on importers, and the combination of the Foreign Supplier Verification Program, the requirement for certificates for high-risk foods, the Voluntary Qualified Importer Program and the establishment of accreditation for third-party auditors will all allow FDA to apply filters that will facilitate a risk-based focus of the available FDA resources on imported foods that present the greatest threat.
Calvin: FDA will utilize their inspectors to conduct periodic audits and rely on third-party certification audits; hopefully, GFSI audits and the reliance on foreign governments to enforce and regulate food safety controls will meet our expectations for import. It will be very resource-intensive for FDA to accomplish what FSMA requires.
Keener: Dave Calvin brings up an interesting and likely controversial aspect of FSMA, that is, the reliance of FDA on third-party, nongovernmental bodies for oversight of food safety. Yes, there are, as David suggests, any number of organizations and institutions, foreign and domestic, ready to lay claim to this likely lucrative space. I suspect, however, that FDA and Congress will need some extended period of time for developing an appropriate vetting mechanism. They may require even more time for its implementation. This is truly a tricky aspect of FSMA. Yet, if done correctly, I believe that there is some role for third-party practitioners in assisting FDA in improving its oversight activities.
Daniels: There will be some FDA enforcement for foreign processors, but for this to really be effective, companies must take more responsibility for their suppliers abroad. FDA is already strapped for resources, which will impact their ability to do the job in the U.S. How can we expect any efficacy outside the U.S.? It is irresponsible for legislators to put this type of responsibility on FDA or any regulatory agency if they are unwilling to also allocate the funding that successful implementation requires.
Weddig: Based on experiences with Seafood HACCP, FDA placed the onus on importers to ensure that the foreign suppliers are in compliance with the Seafood HACCP regulations. This concept is very similar to that of FSMA with a preventive control component and a foreign supplier verification component. With only the preventive control piece of the puzzle currently proposed, it is difficult to say how FDA intends to enforce implementation of preventive controls for foreign suppliers. If one were to compare the importer requirements in Seafood HACCP with the Foreign Supplier Verification Program requirements in FSMA, it would be noted that the requirements are very similar.
On the seafood side, we do see FDA’s oversight of foreign processors in two ways—through inspections of the foreign facilities scheduled based on product risk, and through inspections of the importers to review compliance with the importer requirements of the Seafood HACCP regulation. Since it appears that the intent of the Foreign Supplier Verification Program will be to have importers play a key role in ensuring that foreign suppliers are in compliance with the Preventive Controls regulation, it will be essential for importers to fully understand how to fulfill that role. Early outreach with training to the importing community will be essential for importers to prepare for the requirements of the Foreign Supplier Verification
Blount: I think this will be extremely challenging. As most people who work in agribusiness understand, a significant portion of our raw materials is sourced internationally. To address food safety concerns, I believe FSMA inspectors will continue to be deployed globally. However, I also believe their ability to meet their task of auditing the thousands of facilities will be nearly impossible, especially since they are struggling to keep up with domestic audits. I believe it would be in the best interest of food manufacturers and their suppliers to also increase the number of audits either using internal resources, third-party agencies or companies that specialize in food safety.
Keener: Clearly, there is unanimity among the panelists that enforcing the foreign processor provisions of FSMA represents a daunting challenge. Consider that on an annual basis, the U.S. receives product shipments from more than 825,000 importers. Moreover, according to FDA, that volume of imports could double again in 5 years. FDA is also following USDA in assigning staff to our embassies and consulates in select countries. USDA Agricultural Attachés have been in place for a number of years, both serving in promoting trade and advancing food safety.
Over the years, I have dealt with our Attachés overseas and the interactions were very productive and dealt mainly with the issues of food safety. It would be good to do a benchmarking exercise to assess the impact of the Attachés on food safety as an indication of the potential for FDA’s success with its proposed “boots-on-the-ground” strategy. I’ve heard from abroad that this strategy is referred to as “chauvinistic,” whereas others have labeled it “Techno Imperialism.” Any way you look at it, enforcing the foreign processor provisions is going to be hard work for FDA. Again, I wonder if this is a reasonable proposition in the first instance, given that food safety is the responsibility of those who manufacture and market food products. If the answer is yes, then we must ask as Will has suggested, how much is Congress willing to pay for it?
FSM: Are similar preventive controls needed for the retail and foodservice segments?
Acheson: The short answer is yes—and I believe these will come over time. However, this is complicated by the jurisdiction of state and local authorities and the fact that the food code has been in existence a long time. Perhaps we will see the food code move from a guidance to a requirement, but I can see that creating quite a buzz at the state level.
Calvin: As FDA is taking an “upstream in the supply chain” approach to produce safety by proposing standards for the growing, harvesting, packing and holding of produce for human consumption, the question can be raised: Why were preventive controls not proposed for the retail and foodservice segments? Many food retailers are manufacturing or preparing food in their stores similar to foodservice operations; the risk of food safety concerns still exists.
Daniels: Food safety is a continuum from farm to fork. We must have focused efforts throughout the continuum to ensure the highest levels of safety in our food system.
Weddig: FDA’s Model Food Code is in a sense a preventive control system for the retail and foodservice segment. Critical control parameters for food safety such as temperature control, preventing cross-contamination, proper cooking and proper cleaning/sanitation are well covered in the food code, so there is probably little need for overarching modifications. More important than adopting new regulations would be to have a more uniform adoption and enforcement of the current food code across the states and local jurisdictions.
Blount: Yes, there is a layer of complexity that is introduced whenever additional handling is introduced in food preparation. Food codes vary by state and local jurisdictions. The foodservice industry is also very transient. Maintaining a well-trained staff in restaurants and commissaries is very challenging.
Keener: This is an easy one! Of course, and for all the reasons that the panelists have offered, we need preventative controls across the expanse of the supply chain. There is another aspect to this question that also needs to be addressed and that is the food safety IQ of consumers. If FSMA is to be successful, I believe we must launch an aggressive campaign to raise the food safety IQ of the average citizen. At the least, the cause-and-effect relationships between poor food handling practices and the risk of illness need to be communicated. The CDC [U.S. Centers for Disease Control and Prevention] data consistently points to the home kitchen as a leading source of foodborne illness.
FSM: How will implementation impact the industry economically? Can companies expect a suitable return on investment as a result of implementing preventive controls?
Acheson: On the face of it, the food industry looks at FSMA and sees nothing but more cost. However, I subscribe to the notion that in fact the biggest risk to a company is not compliance with FSMA but brand destruction through making someone sick and being castigated in social and mainstream media. If companies approach FSMA correctly, they can put systems in place that are focused on brand protection but at the same time will ensure compliance with FSMA. We have to use technology a whole lot more than we do now. Capturing and trending data real time to catch problems early is the way to go; if computers are doing it in a way that can control both safety and quality as well as reduce manpower, one has the core of an ROI.
Calvin: The cGMP and Preventive Controls proposed rule is accompanied by an economic analysis that provides a summary of estimated costs and benefits for various-size facilities. The economic impact will be greater than what the Office of Management and Budget has reported. The proposed rule is more than HACCP; therefore, you would expect there to be an economic impact in implementing the requirements. Food companies will be making investments to their current food safety control systems to comply with the proposed rules. If you base the ROI on preventing a food recall, the ROI will be very suitable. Food companies want to do the right thing for their customers, consumers, brand equity and their shareholders.
Daniels: Economic viability is key to any successful business, and food companies are no different. However, no price can be placed on the life of a child, mother, brother, father or grandmother. If a product cannot be produced safely, then we need to take a serious look at whether the product is viable or consider that there might be some consumer price tolerance to accommodate the additional cost of implementing a robust food safety program in its production.
Weddig: The economic impact will depend on two separate factors. Firms that are further along the path to having preventive controls already in place will face less of an economic burden to implement a final rule, although as the seafood industry saw with the implementation of the Seafood HACCP regulation, existing preventive control programs will need to be modified to meet the regulatory requirements of a final rule. Developing a preventive control program to meet regulatory expectations is not the same as developing a preventive control program. A second factor in the economic impact is whether there is existing research, either published or held within individual companies, necessary to validate the preventive controls.
Blount: The impact of a company not complying with FSMA can not only negatively impact the viability of a company if there is a product recall or a consumer death, but the damage to a brand’s reputation could also destroy consumer confidence and put a company out of business.
Keener: Those companies that embrace the preventative control strategies of FSMA will likewise see a positive return on their investment. Dr. Deming and his cohorts made a very convincing and compelling case for statistical process controls more than 50 years ago. Deming showed that avoiding defects put money back into the business. Payback time might not be as short as would be desired, but nonetheless, there is a positive ROI associated with greater control over the manufacturing processes consistent with the preventative controls of FSMA.
FSM: FSMA appears to be silent on the subject of transportation food safety other than provisions for certain distribution centers holding packaged (low-risk) foods. Should there have been a more substantial effort to include elements of the Sanitary Food Transportation (SFT) Act (1990) in the FSMA regulations?
Categories: Process Control: Best Practices; Regulatory: FDA, FSMA, Guidelines