Food Safety Magazine

Food Safety Insights | June/July 2017

What Industry and FDA Are Thinking about FSMA Implementation

By Bob Ferguson

What Industry and FDA Are Thinking about FSMA Implementation

There is no question that implementation of Food Safety Modernization Act (FSMA) regulations will have a significant impact on food processors. This is part one of a two-part report on a survey conducted by Strategic Consulting Inc. and Food Safety Magazine of more than 100 food processors throughout the U.S. We asked about FSMA compliance, relationships with the U.S. Food and Drug Administration (FDA), environmental monitoring and sanitation practices and how they may be changing.

Our Survey Results—FDA Responds

We discussed our findings with Jenny Scott, senior adviser, FDA Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Safety, and asked for the agency’s response.

Our survey showed processors are anxious about FSMA compliance and inspections. Should they be?
People are often anxious about change, and the food industry has been particularly anxious about inspector interpretations of regulatory requirements, so this is nothing new. But FDA has taken a number of steps and done a great deal of preparation to help industry—and our regulators—understand the regulations. We funded and worked with the Food Safety Preventive Controls Alliance to develop training on our cGMP and Preventive Controls rules. The alliance has trained more than 1,200 lead instructors and has issued more than 38,000 certificates (as of May 2017) for human food preventive controls. The same training has been issued to regulators plus specific training we have given them on preventive controls inspections. We have been working on this since long before the FSMA rules were finalized and have been preparing our team by working with industry experts to get information on industry best practices. We have also done an unprecedented amount of outreach, including public meetings and webinars at all stages of the development of the regulations. We have published a large number of materials on our website. We have also done something that I have not seen a federal agency do before and that is to establish the Technical Assistance Network [TAN], which is a central source of information related to the FSMA rules, programs and implementation strategies, and in April, we posted common FSMA TAN questions and answers.

What will be your general approach to enforcement?
You have heard that we plan to “educate before and while we regulate,” and this is a new approach for FDA. It will not be our approach to arrive at a facility with the regulations in hand in an attempt to “catch” someone doing something out of compliance. Our goal is to get compliance with the regulations and as long as a company is not doing something egregious that is a risk to public health, we will give them the opportunity to make corrections to the noncompliances on the spot.

We asked processors if they agreed that the FDA “educates before they regulate” and 60% disagreed. How do you respond?
First, it’s early and we have completed very few preventive controls inspections, so very few companies have had an opportunity to experience this new approach. We are a public health agency, and our mission is to protect public health. If necessary, we will act swiftly, but our message to food processors is that our primary goal will be to work with you to help create a culture of food safety and compliance to promote those practices that enhance food safety and that we know will minimize the risks of illness.
Is there any specific area that you would recommend that processors focus on prior to an inspection?

It all starts with the Hazard Analysis and the right preventive controls, and particularly understanding the science behind those preventive controls. A processor may have a cook step, for example, but they also need to understand the times and temperatures of that cook step and how these achieve a safe food product. We will be looking to see that processors understand the “why” of what they are doing. This will allow processors to make the right choices and better explain to inspectors why they are doing what they are doing, why something is a hazard or, just as important, why is it not a hazard.

Processors said they wished inspectors better understood food processing operations. Any comments on how inspectors can be better prepared?
We have been providing inspectors with more resources so they can better understand food plant operations, developing specific fact sheets about specific industry types in general but also helping inspectors understand process flow, the equipment used, the terminology used and hazard identification in different types of facilities. We have also provided our inspectors with access to subject-matter experts available through a single call to the CFSAN office to ask questions while they are still at the food plant to help better understand the specifics of what they are seeing and get advice on whether their interpretations are correct. We also recommend that it would be best for processors to have their own knowledgeable personnel available during the inspection to help answer questions about the operation of the plant, their Hazard Analysis and the efficacy of their control measures and why they have selected the preventive control measures that they have.

What do you wish processors understood better?
We know that industry and FDA have the same goal—a safe food supply. We understand that industry understands how to make good products. We wish that they better understood the hazards behind making those products and the science behind the selection of the preventive controls, especially with a goal of being able to demonstrate the efficacy of those preventive controls. We also wish that processors better understood how to create a culture of food safety in their own company. “Food safety culture” is certainly a buzzword in the industry, but when we ask some processors what specific steps they are taking to promote that culture, the answers get vague. We understand that this is a learning curve for both FDA and industry, but ultimately our experience has shown that it is those companies that have a better food safety culture who will be doing a better job.

Any additional comments?
These changes are providing us with a path forward for the paradigm shift toward prevention that FSMA envisioned. We realize that this is a marathon and not a sprint, but FDA and industry have the same goal—better protection of the consumer. We are committed to educating before and while we regulate to align understanding and expectations. We know that this is a change and we hope industry will give us a chance. I look forward to seeing the results of your survey again in the future, where we’ll see the results of this change.

Our survey included companies from 32 states and 4 territories, and consisted of an online questionnaire followed by a series of telephone interviews. Of the individuals who responded, 74% identified their position as quality assurance/control, food safety or sanitation specialists, with 8% identifying as a laboratory manager. The remainder were in general management, regulatory or related positions.

We asked what their biggest concerns were with the implementation of FSMA. The most common answer was implementation: what it will cost and how to get the resources required to get it done right and by the deadline (Figure 1). This was followed by uncertainty about inspections and enforcement, and regulatory interpretation.

We explored this topic in telephone interviews, and it became clear that these top three concerns were really one major concern stated in different ways.

Concerns about Getting It Right
Processors were generally satisfied with the food safety program they had in place prior to FSMA. Because of this, most reported that the main part of their work to comply with FSMA was about writing the plans rather than instituting fundamental changes. All had confidence in their knowledge of food safety and how to produce safe products but were concerned about getting FSMA plans in place and on time with limited resources and no reduction in their daily demand (“...changing the tires on the car while still going 60,” according to one comment). But many also said that they will not know if they got it right until they have an inspection.

We asked, “What do you wish that regulators understood better?” The most common answer was practical regulatory interpretation (Figure 2). Many responded that regulators want companies to follow the letter of the law, but there are the practical considerations in a food processing facility. One respondent mentioned, “It is impossible to do only desk work and review policy and still have something that can be implemented in a food processing facility.” The second- and fourth-most common answers were similar in that they wished that regulators understood the food processing business in general and their specific type of processing, respectively. Many commented that regulators should have a better understanding of food processes so they can have more flexibility in inspections. Others thought there was not enough focus on risk. Several mentioned the lack of attention to the consumer’s responsibility to follow final preparation instructions, while others cited too much attention to highly unlikely risks, with one adding, “…just because regulators can imagine an unlikely-to-occur problem shouldn’t mean we have to have a program to prevent it.”

Questions about Inspections
Processors indicated they are also unsure about how FDA will conduct its inspections. FDA has said that it plans to “educate before and while it regulates,” yet when we asked processors, most disagreed (Figure 3). Several respondents offered that FDA auditors were in the same FSMA training classes as they were and probably didn’t have any better information and thus doubted their ability to “educate.” Several mentioned that FDA inspectors who audit their facilities do not have enough specific experience in food production to offer any valuable assistance for their operations. One respondent commented that new inspectors must be frequently trained on what to look for and “once we train them, we get rewarded with a 483.” [An FDA form 483 is issued at the conclusion of an inspection when an investigator has observed conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act and related acts.] Other respondents expressed that since inspectors are “in a learning process,” this may lead to inconsistent inspections and enforcement.

“This is not surprising,” according to David Acheson, former FDA associate commissioner for food and current CEO of The Acheson Group, one of the consulting companies that respondents are relying on for advice and assistance in their compliance issues. “FDA has not traditionally had a budget for education. Their effectiveness has typically been viewed by Congress based on the numbers of inspections they complete and the citations that they issue, not by more difficult-to-measure performance metrics like ‘education.’ FDA is working hard to change, but culture change is usually an uphill battle. This will be a slow ramp-up.”

The comments were not all negative, however, and several respondents said that inspectors with whom they work are good, understand the regulations, work to understand what the processor is doing and try to offer tips for better food safety during the audits.

Many wanted to know what FDA will focus on during early FSMA inspections. Processors understand that all requirements of FSMA must be met, and none expect FDA to let them “off the hook,” but they want to know if FDA will have specific areas of concern. One former FDA official said it is the agency’s goal to ensure compliance, and that FDA will be looking to see that processors have properly identified their hazards, have the correct preventive controls and scientific validation of the efficacy of those controls and proper documentation. But this official added that FDA clearly has a risk mindset, and the first inspections will be focused on processors with higher risks. Those with previous 483s, recalls and other risks should expect to be near the front of the line when inspections are scheduled.

In the next issue, we will present more data from the survey and report on changes being made to environmental monitoring programs, the use of whole-genome sequencing and changes to sanitation programs in anticipation of FSMA compliance.   

Bob Ferguson is the managing director of Strategic Consulting Inc.

Categories: Regulatory: FDA, FSMA