What Have We Learned about FSMA Implementation?
By Food Safety Magazine
The Food Safety Modernization Act (FSMA), the most sweeping reform of U.S. food safety legislation in over 70 years, was enacted in 2011, and its implementation is now underway. Through seven major substantive rules, FSMA introduced a paradigm shift in food safety by focusing on the prevention of food safety risks rather than on a response to crises after they happen. Each of the rules plays a specific role in the mandate of the U.S. Food and Drug Administration (FDA) to comprehensively regulate the food industry. FSMA requires transparency from the entire supply chain and fundamentally changes the way food is regulated in the U.S. and abroad, from farm to fork.
Given the wide-ranging impact of FSMA 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 FSMA implementation. Participating panelists were David W. K. Acheson, M.D., F.R.C.P., the Acheson Group, John M. Ryan, Ph.D., PCQI, Ryan Systems Inc., Dan Brooks, PCQI, food safety consultant, Willette M. Crawford, Ph.D., M.P.H., Katalyst Consulting LLC, Aurora A. Saulo, Ph.D., University of Hawaii at Manoa, and Tatiana Koutchma, Ph.D., Agriculture and Agri-Food Canada.
Food Safety Magazine (FSM): Describe what you feel are the strengths and weaknesses of the FSMA regulations.
David Acheson: The biggest strength of FSMA is that it has taken us into a comprehensive world of risk-based controls with a heavy focus on prevention. The inclusion of supply chain control and environmental control requirements for RTE [ready-to-eat] foods is a necessary focus in today’s food safety environment. The greatest weakness is that there are some key parts waiting for regulations, such as high-risk foods and the move toward greater requirements for product tracking. The recent romaine outbreak is a good example of that need. Obviously, the lack of resources for both education and inspections continues to be a weakness. I personally don’t like the fact that very small entities are not covered by FSMA; I would much rather they be covered but with more time and education to allow them to get it right. Similarly, the fact that juice and seafood are exempt adds more complexity where a one-size-fits-all approach would have been better.
John Ryan: FSMA regulations attempt to define a complex system-wide set of rules designed to move the food supply chain to improve over the next 50 years. Such changes generally take at least a generation to effectively implement. Current deadlines for “full implementation” are unrealistic.
With little or no ability to rapidly and cost-effectively detect primary hazards at the farm level, contaminants are set to travel through the supply chain with no traceability clearly defined or required. This leaves the public exposed and recall efforts lacking. Greater emphasis must be placed on low-cost, easy-to-implement hazard-detection tools (sampling) that can be put in the hands of farmers for early hazard detection. Traceability must be mandated, and food movement, identity, condition, and location information should be visible as real-time information.
When FDA teams get involved in recall investigations, they ignore “food safety” certificates and head straight for areas where they can take samples for laboratory analysis. These samples provide objective evidence. Food safety audits provide subjective information about food safety. If FDA leans solidly on objective sample data, so should the entire food chain. The industry is being misguided by old-timers in food safety and audit companies that do not shift to dependence on sampling in order to establish preventive control validity.
Dan Brooks: After years of Seafood and Juice HACCP [Hazard Analysis and Critical Control Points] regulations, FSMA brings enhanced risk-based HACCP principles to all foods for a preventive, rather than reactive, approach to food safety. FSMA aligns U.S. food safety to global standards with the convenience of familiar certification protocols. On the downside, the FSMA regulation set seems complex, with complex implementation and exemption schedules.
Willette Crawford: Regarding FSMA’s weaknesses, I believe there are some unintended consequences and missed opportunities. Specifically, a more comprehensive, yet flexible, risk-based approach could have been employed for agricultural water in the Produce Safety rule. Additionally, I believe the size exemptions in the FSMA law developed by Congress miss the mark of prevention and shared responsibility across the supply chain. Additionally, the question of sufficient, skilled inspection resources to support implementation and enforcement is a weak point in the system. All things considered, there is always the opportunity to update regulations and adjust as scientific information evolves.
I believe some of FSMA’s strengths are as follows: FSMA articulates food safety objectives that were once vague in the implementing regulations and further clarifies the agency’s expectations through compliance guidance documents and training programs and tools. For example, produce growers are no longer left to their own devices to figure out what hazards are of main concern and what operational considerations need to be made when selecting appropriate control strategies. They now have FDA’s expectations and concerns communicated through guidance and the Produce Safety rule. Similarly, carriers in the transport industry and importers have now had their roles in the food safety equation explained for them.
FDA clarifies the shared responsibility throughout the supply chain through the seven finalized regulations that expand FDA’s jurisdiction to segments of the industry previously out of its reach. Such is the case for retailers that may now fall under FDA’s purview for the Foreign Supplier Verification Program (FSVP) regulation. This shared accountability will help fill some of the gaps in our disjointed supply chain that were previously out of reach.
The flexible, goal-oriented approach of the FSMA regulations allows industry to implement creative, cost-effective controls appropriate to their scale and circumstances rather than follow one-size-fits-all requirements that may be inappropriate or out of reach.
Aurora Saulo: FSMA regulations are being implemented at an opportune time when the public is more aware of fitness and health issues, and of the causes of foodborne illness. The law becomes meaningful to the consumer during these times because they have heard, read, seen, experienced, or responded to issues related to the food they eat. They also generally agree with the rationale for the law, and certain groups are monitoring how it is enforced. That is a strength of FSMA.
To some, however, the introduction of FSMA implies that the U.S. had a widespread problem with the safety of the foods that are sold and consumed in the nation. And some expected the law to completely eliminate unsafe foods. Thus, when an outbreak occurred, the farmer, processor, wholesaler and retailer, and restaurant were often implicated as the most probable source of the illness. The consumer may be minimally mentioned. This unintended result may be construed as a weakness of FSMA, but no law is absolute or perfect. As trainers, we must communicate that food safety is a responsibility that everyone must bear, from the grower and harvester to the consumer. There are no exceptions.
Tatiana Koutchma: The weakness is that industry struggles with the interpretation of FSMA rules that can be quite broad and not sufficiently detailed. The strength is that industry is looking for new solutions or reconsidering and revising existing practices to comply with the rules. Often, industry is looking for long-term solutions and is willing to invest time and resources. Another strength is that during the lengthy rule-making process, FDA took the time to gather thousands of written comments and meet with stakeholders in person.
FDA has acknowledged that FSMA is imposing costs on the food industry, but it also makes the point that the goal is to eliminate foodborne illness outbreaks that are just as costly or more for the food industry.
FSM: What are we currently seeing with regard to FSMA enforcement? Do you think the FDA is capable of adequately enforcing the rules and providing validation guidelines for new technologies?
DA: There is not very much enforcement so far, but there are 483s being written around the lack of FSMA compliance. Of course, FDA is not capable of full enforcement for two reasons: lack of resources and lack of training of inspectors.
JR: Although the food side of FDA has recently received a limited increase in funding, FDA must rely on other agencies for enforcement assistance. It is doubtful that FDA can adequately enforce the complex system of FSMA statutes.
FDA seems to struggle with the concept of validation and apparently has presented no solidly established preventive control foundation. The emphasis is still on old-style HACCP concepts and a verification (inspection and audit)-based approach that wallows in subjectivity. Newer environmental sampling tools capable of helping supply chain members validate processes and procedures are required. The time lag between taking the sample and obtaining the results must be drastically shortened if supply chain members are expected to gain any semblance of preventive control.
DB: While FDA inspection activities abroad seem to have increased under FSMA, we have seen no evidence where any recent FDA inspections emphasized food safety plans or were triggered by foreign supplier verification information. This could mean that a) FDA is not yet strongly auditing against FSMA requirements, b) FDA-audited plants are compliant with FSMA requirements, or c) inspected plants were covered under other regulations such as Seafood HACCP or LACF [low acid canned food regulations].
WC: At this stage, some inspections are being conducted by FDA and its state partners. As communicated by FDA, inspections during the early phase of implementation are more educational in nature, providing a learning ground for industry to continue to improve while also providing training opportunities for the agency’s inspection force. This approach fosters a spirit of cooperation and partnership that marks a new posture from the agency that will certainly serve both groups moving forward.
AS: In the region that I serve, we are seeing some enforcement of FSMA rules. Enforcement activities from the state department of health, according to inspected food industry personnel, asked for HACCP plans instead of FSMA food safety plans. As of May 2018, this confusion has been corrected and the state department of health is accepting any food safety plan, regardless of how it is labeled or what it is called.
With proper training on the FSMA rules, FDA would be capable of adequate enforcement. Validation guidelines for new technologies may be more reasonably addressed by units within and external to FDA other than those involved in enforcement, and in partnership with academia, private industry, and others in the public sector.
TK: The current validation guidelines are very broad by nature and hard to find in the form of publications. From my experience, FDA is committed to work with industry and other partners on white papers and via task forces that will guide industry on the validation of new technologies. However, in many cases, FDA has to learn as it moves to higher levels of enforcement.
FSM: Are there any differences in rules/approaches between goods: fresh produce from the field versus prepacked products from the manufacturer?
DA: No fundamental differences: They are all risk based and prevention oriented.
JR: Surely. To some extent, farmers have been let off the hook. The problem is, the farm is the furthest upstream supply spot and the beginning of most evil. Ramming preventive controls downstream shows the inability of FDA to understand what needs to be done to prevent problems. Once the trash is dumped in the stream, it is impossible to clean out or control.
WC: FDA’s recognition of the need for different approaches based on product type and production conditions is reflected in several of the FSMA regulations. Operations that produce whole, intact raw agricultural commodities have a different set of considerations than processed, prepackaged products; hence, each is addressed in a different rule, while meeting the same food safety objective of minimizing reasonably foreseeable hazards.
Producers of prepackaged produce must adhere to the Preventive Controls for Human Food (PCHF) regulation, whose controls are more appropriately focused on control of the manufacturing environment and handling practices.
AS: There are no differences in the basic principles. Produce Safety (21 C.F.R. 112), however, is heavily focused only on biological hazards, whereas PCHF (21 C.F.R. 117) focuses on biological, chemical (including radiological), and physical hazards. As trainers, we teach these regulations as they are written but also alert those in the food industry to remain vigilant in recognizing and addressing current and reasonably foreseeable hazards in their food and facilities.
TK: First of all, FDA had to provide clear differentiation between certain on-farm procedures (e.g., crating, boxing, washing, and sorting) and food processing activities. Without clear differentiation, many farms would be required to register with FDA as food processors and, therefore, comply with PCHF. Standards for produce safety would apply to all foreign and domestic farming operations that intend to sell produce into U.S. markets.
FSM: What impact is implementation having on industry thus far? Which parts of FSMA implementation is the food industry struggling with the most?
DA: Struggles include how to employ an environmental management plan and manage zone 1 testing (which is not required). Supply chain control is also proving a struggle as is what to tell customers and what to demand of customers if the customer is controlling the risks.
JR: Food carriers, to some extent, have been left out of food safety drives, while farms, packers, processors, etc. have had several years to upgrade their food safety systems. This lag in experience with food safety requirements has left some carriers completely confused to the point that they are doing what receivers define and require to the exclusion of FSMA rules.
DB: The primary impact on local industry to date seems to be time spent in awareness and Preventive Controls-Qualified Individual (PCQI) training.
WC: FSMA has spurred a frenzy of activity within the regulated industry to get into compliance. I find many firms are still in the process of trying to update their existing programs to meet the FSMA requirements. I’ve observed many struggling with validation of their preventive controls, conversion of their existing HACCP plans to risk-based preventive controls plans and their current procurement practices into a compliant FSVP, or just determining whether they are subject to FSVP.
FSMA has had a positive impact also. There has been a tremendous infusion of attention and resources allocated to training to meet the PCQI requirements that state an individual must have the education, experience, or combination thereof necessary to perform the tasks assigned for product safety. This is driven also by the updated Current GMPs [Good Manufacturing Practices] that communicate FDA’s training expectations. I have also observed increased attention to areas that previously lacked adequate support or oversight, such as sanitary transport and sanitation.
AS: Some of the FSMA elements that the food industry is struggling with include laboratory analyses due to a limited number of available labs, identifying and organizing their programs (and the voluminous amount of data) in preparation for the development of FSMA food safety plans, and getting overwhelmed by the large number of “things to do” in order to pass future audits and inspections. As a result, many small food industry establishments look to consultants to develop their FSMA food safety plans so that they can remain available to manage the business. There remains a lack of understanding and acceptance that the safety of the food they produce precedes managing a food business. If the food they prepare is not safe, it is not a food. If there is no safe food, there is no food to sell.
TK: I hear the industry struggles with FSMA transportation rules and their interpretation and implementation.
FSM: What is FDA’s stance on compliance via GFSI (Global Food Safety Initiative) schemes at this stage of implementation? Is there sufficient training available for companies exporting to the U.S. to meet FSMA requirements?
DA: FDA seems to accept that meeting GFSI requirements puts a plant in a good place regarding FSMA Preventive Controls compliance. But having a GFSI certification does not yet reduce the likelihood of an FDA inspection. In my view, the GFSI standards are very similar to FSMA; where GFSI struggles is auditor competency, and thus FDA does not have as much confidence as they could on a GFSI audit. There is very little training available for foreign firms, and that is not likely to change due to resources.
JR: FDA seems to be somewhat incapable of competing with other compliance approaches. They do not seem to be getting the business-level and industry-wide buy-in that groups such as GFSI are achieving.
DB: National regulatory agencies and local trade associations have made efforts to ensure FSMA awareness on a local basis. Most major exporters in Asia have certifications under a GFSI program; therefore, they are mostly compliant with food safety plan requirements.
WC: FDA has contemplated use of third-party audits, such as those benchmarked by GFSI, as part of its overall compliance strategy, particularly to foster compliance with the Produce Safety rule; however, they have clearly communicated that compliance to such standards does not ensure full FSMA compliance. The agency has stated in many forums its intention to work with the produce industry and other partners to improve the rigor and reliability of private audits. To this end, FDA has held several public meetings and a 2-day public hearing on the role of strategic partnerships for improving the safety of imported food where questions about the role of private certification schemes and third-party audits for supporting FSMA compliance were discussed. The 2017 public hearing differed in tone than previously expressed at public meetings, with the agency communicating greater interest in working with GFSI and private third-party schemes.
FDA also has been in dialogue with GFSI to determine whether audits and certain schemes can serve as an appropriate verification activity under FSVP for produce. As such, the agency is working to understand auditor competency requirements and oversight of the program for alignment with FSMA. Additionally, FDA is gathering information through a pilot program with third-party auditors under the FSMA Accredited Third-Party Certification Program.
On the matter of whether there is sufficient training for exporters, there has been a proliferation of consultants and technical trainers, as well as programs offered through universities and trade associations. Though readily available in a variety of platforms and formats, many are not sufficient, as I observe many individuals attempting to deliver these services without being a PCQI themselves and lacking the education, and/or practical experience to truly connect the concepts for participants in a meaningful way.
AS: In the region I serve, GFSI requirements currently accept only HACCP plans from audited establishments. Food industry personnel who received training on PCHF and are developing or have developed their FSMA food safety plans are now asking to attend in-classroom HACCP courses so that they may also demonstrate compliance with an HACCP course certificate. HACCP plans are not required by U.S. law, but FSMA food safety plans are. There needs to be harmonization in the implementation of these requirements.
Those who are importing food and food materials are generally aware that there are FSVP requirements. Since FSVP training is not required by FSMA, food processors do not seem interested in taking the FSVP course. This might change when auditors and inspectors look for FSVP compliance.
TK: To my knowledge, FDA offers a comprehensive and evolving training strategy through public and private alliances. Exporting companies can find the specific programs that meet their needs; the training opportunities are very broad and easy to find. The Institute of Food Technologists offers a number of resources and updated courses for FSMA training.
Food companies are sending personnel from a variety of areas such as transportation, trade, and the executive suite to FSMA training.
FSM: Exceptions to the FSMA rules are helpful to small businesses, but are we sending the right message about food safety?
DA: Absolutely not. This decision was political and not based on public health.
JR: No. Food safety is a universal issue regardless of company size. While the lobbyists may have won this one in 2011, the concept of small-business exclusion is inconsistent at best.
DB: I would agree that we might be sending the wrong message given the growth of small “boutique” processors, such as organic, raw milk, etc., given their risk potential.
WC: While I believe regulations should be somewhat flexible to allow an operation to determine the most appropriate methods to meet regulatory requirements and produce safe food, I think this flexibility should not just be a factor of size but rather the diversity of practices and conditions that exist in the industry.
Food safety hazards can occur in any-size operation, and all consumers should be afforded safe food. On the basis of risk, small-scale and local operations should employ the same practices and types of controls as larger players to ensure a safe supply chain. Though there may be differences and some constraints for smaller players to navigate, the same care should be taken to protect public health and their brand.
Further, FDA provides tools to support smaller operations’ food safety management systems through development of guidance documents and other resources.
AS: Many small food businesses feel targeted by FSMA. They feel that it is their size that will drive them out of the marketplace. They seek exemptions as a legal way not to spend their already limited funds to meet FSMA requirements, at least for a certain time period. As trainers, we emphasize that although there are exemptions, having a food safety plan is good business and will be received favorably by consumers.
TK: According to FSMA, covered facilities have a number of years to comply with the regulations, based upon business size. The regulations also establish compliance dates for the CGMP requirements a year prior to the deadline for implementing the Preventive Controls requirements, meaning that small businesses have more time to comply. Giving small companies less time wouldn’t improve the situation.
FSM: How do the other countries react to the U.S. FSMA regulations? Canada, Australia, and New Zealand try to meet them, but how about others?
DA: Others are accepting them if they want to do business with the U.S. Some struggle quite a bit, and I think many don’t even understand what has to be done or how to do it. There is not much help unless they pay for it.
JR: Many are attempting to duplicate or adapt to the FSMA schemes. Others are further ahead (e.g., EU). Rapidly evolving countries like China are struggling with antiquated systems that leave them playing catch-up. One might expect that China will leapfrog FSMA since they have a more authoritarian approach to enforcement.
DB: This includes awareness workshops in the local languages. In Thailand, the National Bureau of Agricultural Commodities and Food Standards is working to become a FSMA-accreditation body.
WC: Some countries have achieved comparability recognition from FDA, while a few others attempt the process. Other countries like Mexico acknowledge the importance of FSMA compliance and pursue dual paths of educating their industry on FSMA while pursuing the development of national standards that comply with every other country in the world.
Ultimately, I think FDA’s commitment to partnering with regulatory authorities in other countries is generally welcomed and is seen as an encouraging means to collaboration, mutual understanding, and building reciprocal regulatory cooperation tools that foster cooperation and better protect the supply chain.
AS: Some countries (e.g., Philippines, Indonesia, and Thailand) with food manufacturers exporting their products to the United States are generally aware of FSMA and are taking FSMA courses to learn how to comply. There is confusion on the different terminologies used and associated with FSMA. For example, some ask for HARPC [Hazard Analysis and Risk-Based Preventive Controls] training or a PCQI course. As trainers, we need to explain that what is important is to ensure that the training session uses a curriculum that meets the FSMA training requirements.
TK: I am well aware about the focus on food security and FSMA in South America, especially in Brazil. Brazil is also looking at Codex Alimentarius as the main international regulation for trade.
FSM: Has the Foreign Supplier Verification Program demonstrated the capacity to reduce the public health burden associated with imported food and food ingredients?
DA: Not yet, but it will in time.
JR: I haven’t seen any data on this one, but we love to point fingers, and it is easier to point fingers at foreign suppliers than it is to clean up our own house.
DB: I think it’s too early to say. But experience (from Seafood HACCP) is that FSMA regulatory action can be driven largely by assessing the supplier verification programs kept on record in the offices of U.S. domestic importers.
WC: I think FSMA overall, and particularly FSVP, has positively impacted the public health burden associated with imported foods and ingredients; however, it is a bit early to determine its true impact as we are still relatively early in the implementation phase.
The outreach efforts to prepare industry for compliance raise the bar by ensuring a common understanding of FDA’s expectations and the risk-based hazard approach required for imported foods and ingredients. That alone is noteworthy and encouraging.
AS: The FSVP has good intentions to contribute to the protection of public health from imported food and food ingredients. Certain foreign suppliers, however, consider FSVP requirements so tedious that they are choosing not to supply U.S. processors, leaving some American processors vulnerable to higher pricing or having no suppliers at all. Some foreign suppliers also consider their HACCP plan or third-party audit results as proprietary information and would not share them with their U.S. buyers, who then resort to an audit of the supplier as the only viable option to demonstrate food safety. Operating costs increase and FSVP increasingly becomes a hardship to U.S. businesses.
TK: According to Food Safety News, the total costs being imposed on importers are $434.7 million on an annual basis. FDA could not quantify how much it might save.
It’s certain that the FSVP rule is complicated in its final version. Should records be accepted only in English, or should importers be permitted to present records first in their native language and only later provide the English versions? The final rule went with giving importers more time to provide documents in English.
FSM: With more food being delivered by UPS, mail, or FedEx, do you perceive any threats to food safety?
DA: Yes, most certainly. Some companies operating in this space do not have a good handle on time/temperature control. There seems to be wide variation in how such firms manage the risk during transport.
JR: Time will tell on this one. With so many companies jumping into “last mile” food delivery systems, many unanticipated changes and challenges are impacting food distribution sectors. One of the primary reasons cited by the FDA for FSMA is the dynamic food distribution shift. Now this change has hit the preconsumer acceptance level. Anything can and probably will happen.
WC: There has been a proliferation of food and meal delivery services to meet the growing consumer demand for convenience and fresher foods. Though these options are readily available and use common shipping carriers such as UPS, FedEx, and U.S. mail, they do not assume responsibility for the handling of perishable products; thus, there is a lack of care and attention to basic food safety principles, such as time/temperature controls, accurate and complete labeling and product information, cross-contamination, and appropriate packaging. A recent Rutgers and Tennessee State University study examining such operations found serious deficiencies within these operations.
AS: The more handling our food receives, the higher the risk of exposure to different hazards impacting its safety for human and animal consumption, including the risk of tampering. Incidents of economic fraud, even if they do not impact food safety, may likewise increase.
TK: There is a possibility that delivery by mail will create more food safety risks in high-risk food categories. The focus of Amazon is freshness. “AmazonFresh guarantees every product will be delivered to your home well within the manufacturer’s recommended use by, sell by, best by, or expiration date.”
FSM: What can we expect going forward with regard to collaboration with states and the U.S. Department of Agriculture (USDA) on FSMA enforcement?
DA: More collaboration between states and FDA for sure. Not sure about USDA-FSIS [Food Safety and Inspection Service], but I suspect that AMS [Agricultural Marketing Service] will get more into the act as they did with the LGMA [Leafy Green Marketing Agreement].
DB: I think it will largely depend on budget and training constraints.
WC: We can expect to see FDA continue to collaborate with USDA and state agencies to implement and enforce FSMA regulations. FDA has emphasized collaboration as a main pillar of its FSMA strategy and has worked to strengthen ties with state agencies and allocate resources to support their FSMA efforts to enhance the agency’s involvement with the regulated industry.
FDA and USDA announced a formal agreement in January of this year to bolster coordination and collaboration on produce safety and biotechnology. The aim of the agreement is to streamline regulatory responsibilities and use resources more efficiently to protect public health by reducing the number of establishments subject to regulatory requirements of both USDA and FDA.
FDA is coordinating with state and/or territorial government agencies, which will conduct most farm inspections under the Produce Safety rule. Additionally, FDA along with the USDA has funded a network of public and private partners in state, federal, tribal and international governments, industry, and academia for the development and delivery of training to support FSMA compliance by making FSMA training accessible and comprehensive.
AS: Just as in previous rules on FDA-regulated foods (e.g., LACF, acidified foods, Juice and Seafood HACCP), it is conceivable that USDA will adopt or use as a model with minimal modifications, if any, FSMA rules for enforcement on the foods they regulate. This action will also highlight the intent of FSMA that the new law is a partnership, not only among regulatory agencies but also with the private sector, academia, individual businesses, and the consumer. But we all just have to wait and see.
TK: FSMA forces FDA and USDA to enhance their collaboration and cooperation on produce safety activities. The formal agreement was signed in 2018 and tasks both agencies with identifying ways to streamline regulation and reduce inspection inefficiencies. This can reduce costs on industry and free government resources to better target efforts to areas of risk.
We would like to thank all the panelists for their insightful comments and engaging discussion.
David W. K. Acheson, M.D., F.R.C.P., is the president and CEO of the Acheson Group.
John M. Ryan, Ph.D., PCQI, is the founder and president of Ryan Systems Inc.
Dan Brooks, PCQI, is regional food safety consultant, John Bean Technologies (International) Ltd., Bangkok, Thailand.
Willette M. Crawford, Ph.D., M.P.H., is the founder and principal consultant of Katalyst Consulting LLC.
Aurora A. Saulo, Ph.D., is a professor and Extension Specialist in Food Technology of the College of Tropical Agriculture and Human Resources, University of Hawaii at Manoa.
Tatiana Koutchma, Ph.D., is a research scientist at Agriculture and Agri-Food Canada.
Larry Keener is the president and CEO of International Product Safety Consultants and a member of the Food Safety Magazine Editorial Advisory Board.
Categories: Regulatory: FDA, FSMA