FSMA is coming: Are you ready?
In 2011, Congress passed the Food Safety Modernization Act (FSMA), which mandates a shift in approach to food safety from reaction to prevention. Now, four years later, the major rules are set to be released and the food industry is preparing for 2016, when the focus will be on implementation.
To understand more about FSMA and both the benefits and concerns in the industry associated with the new laws, we spoke with food safety experts Robert Rogers of precision instrument and services provider Mettler Toledo and William McPhail, the Chairman of the FPSA Dairy Council Board and a Professional Engineer at MAX Engineering and Consulting.
In this article:
- The current state of FSMA
- How FMSA affects food processors -- Provisions, benefits, and concerns
- What food processors can do now to prepare
The Current State of FSMA
In March, FDA Deputy Commissioner for Foods Michael R. Taylor wrote in Food Safety News:
“After a decade of illness outbreaks, import safety problems, and market disruptions that shook consumer confidence and imposed billions of dollars in costs on the food system, Congress mandated a paradigm shift to prevention -- to establishing a modern system of food safety production based not on reacting to problems but on preventing them from happening in the first place….FSMA is about far more than new rules. It’s about how the FDA changes fundamentally its approach to implementing food safety rules.”
This “paradigm shift” is huge, requiring not only a new mindset, but new practices, processes, and technologies that enable food producers and processors to catch and solve problems before they happen. While FSMA has been four years in the making, this summer will see the first release of the final rules, with all seven foundational rules coming out over the next 12 months. Bill McPhail stresses that FSMA is a living document -- one that will continue to be revised and updated -- even after the rules are released.
Full implementation and funding of FSMA will be provided for in the 2016 budget. (Taylor’s article was written in support of the President’s Budget, which requests $1.5 billion to support food safety, representing an increase of $109.5M over this year’s funding.) Following that, compliance requirements are expected to kick in starting mid-2016 and take effect on a rolling basis through 2019.
Here is when the final rules are expected to be issued:
August 30, 2015
- Preventative Controls for Human Food
- Preventative Controls for Animal Food
October 31, 2015
- Produce Safety
- Foreign Supplier Verification Programs
- Accreditation of Third Party Auditors
March 31, 2016
- Sanitary Transportation of Food
May 31, 2016
- Intentional Adulteration
The OFW Law Blog has more information about the FSMA timeline and expected compliance dates.
Meanwhile, the FDA has continued to issue guidance documents and other resources to help the food industry prepare for the coming changes. Just this month, they released a draft guidance of the controversial new rule about mandatory food recalls.
How FSMA Affects Food Processors
The goal of FSMA is preventing food safety problems before they happen. Given the diversity of the food industry, this is no small task, and, to achieve it, the FDA’s role is expanding considerably. This expansion of the FDA’s powers is both the cornerstone of the law and, as we’ll explore later, the cause of many concerns in the industry.
Provisions of the Law
Here are some of the main provisions of the law:
- Food safety plans. Food processors will be required to have written food safety plans that identify possible problems with their products and how they will solve those problems. As part of this provision, facilities will be required to conduct a hazard analysis and implement preventative controls.
- Inspections. Food facilities will be subject to more frequent inspections and those inspections will be based on the perceived degree of risk (i.e., higher perceived risk = more inspections). The FDA will have increased access to records and will also have the authority to suspend a facility’s registration if they suspect a problem.
- Product tracking. All registered facilities will be subject to new recordkeeping requirements.
- Mandatory recalls. While manufacturers and distributors will still be able to recall products voluntarily, the FDA will have the power to impose mandatory recalls as well.
- Imports. Food facilities in other countries that provide food to the United States will be held accountable to the same standards as those in this country.
When asked about the main impact of FSMA, Robert Rogers said: “The biggest shift in the industry is now just simply more of a focus on areas related to food safety in all aspects, whether it’s food sanitation, material control, supplier verification programs, and so on.” Now, rather than waiting for a crisis (such as a contamination followed by a recall) to happen, food producers and processors must be proactive.
What it all comes down to, according to McPhail, is food traceability. McPhail calls food traceability the “real premise” and the “backbone” of FSMA. Under the law, food producers and processors will be required to monitor and trace the chain of custody from raw goods that come into their plants to the products that reach consumers. While tracking has always been important to good food safety plans, and many companies already have traceability plans in place, McPhail notes that now these plans are “absolutely mandatory.”
Benefits of FSMA
Before getting into concerns that the industry is voicing about over FSMA, it’s worth pointing out that both Rogers and McPhail emphasize the benefits of the new rules. There will certainly be a period of adjustment, particularly for smaller facilities and those that haven’t yet started implementing new technologies and procedures, but overall the benefits will vastly outweigh these growing pains.
These benefits range from better safety programs on a global level to increased efficiencies that can boost the bottom line, to more positive perceptions in the minds of customers (which also leads to increased revenue).
To start, the food supply will be safer. Food safety is today considered a matter of national security, and earlier this year bills to consolidate the regulation of food safety under a single agency, the Food Safety Administration, were introduced into both houses of Congress.
In addition, McPhail cites the benefits of the new rules related to imports and their capacity to “identify and potentially alleviate risks associated with the global food supply,” which he notes “has been a challenge” historically. He also suggests that a partnership is starting to emerge between domestic and foreign companies, which aim at putting food safety programs in place. And he predicts that “we will see similar programs initiated and implemented in other countries, such as in Asia and the Pacific Rim,” which will further increase food safety domestically.
Rogers identifies several “unforeseen benefits of going through the process,” which include “a shift to preventative controls, improving efficiencies, and reducing waste.” These practices will position companies to grow into the future based on increased efficiency rather than just on the development of new products.
Rogers also believes that from a consumer standpoint, an increased focus on food safety is a positive development, because “people get nervous about food recalls and what they hear on news reports.”
Finally, he says that the fact that contamination is sometimes discovered doesn’t mean that there are more problems today, but that “the systems we are putting into place are working. I would be more concerned if we didn’t hear about any problems.”
Concerns for Food Processors
Implementing FSMA is not without its challenges, of course, but both Rogers and McPhail suggest that the main concerns stem from the fact that currently there are a lot of gray areas.
Until the FDA releases the final rules, food processors will be unsure of exactly what the law will look like and what they need to do to comply. The companies that face the toughest challenges, according to McPhail, will be smaller companies and local processors -- organizations that don’t have a large staff of people who can research and verify federal programs.
Let’s take a look at a few of the biggest causes of apprehension.
To start with, many companies are voicing concerns over the FDA’s new wide-ranging authority, for example, in the realm of inspections.
Rogers notes that there are concerns about the subjective nature of the auditing process. He cites a hypothetical example of an auditor going into a facility that belongs to a large, established company with a lot of resources and seeing the great programs and procedures they have in place, and then visiting a facility of a newer company that doesn’t have the same level of resources. These smaller companies fear that the comparison alone might “be enough for the auditor to have reasonable doubt that the company is doing what needs to be done in regards to food safety.”
Other concerns Rogers identifies relate to the ability of FDA to mandate product recalls, which takes the decision-making power away from the companies themselves. There are also concerns that the FDA now has control over facilities’ registration. Hypothetically, if one product is in question, the FDA could suspend a facility’s registration so that it would not be able to produce any products at all.
At the moment, however, these concerns are mostly theoretical. Not only, as Rogers points out, are the “rules and regulations not very prescriptive,” but it will take some time before we know how the FDA might exercise its new power.
Fortunately, the FDA is actively trying to address at least some of these concerns.
In a Q&A session leading up to an implementation kick-off meeting that was held in April, Phase 2 FSMA Implementation Team Steering Committee leaders Roberta Wagner and Joann Givens outlined how the agency is helping companies prepare for what the new rules will bring, such as by providing written resources. Wagner notes, “We recognize that the rules are written in a flexible way -- they’re not overly prescriptive -- so there will need to be guidance documents and other materials so that agency expectations are clear.”
Givens also commented on the issue of training for regulatory personnel, which will hopefully remove some of the concerns regarding subjectivity. “Training on the new standards and how to inspect the industry to determine compliance with these standards will no longer include just one classroom training opportunity. There will be continuous training for federal and state regulatory personnel, including periodic technical updates regarding industry best practices.”
As for the rest of the concerns, they will prove to be more or less valid once the FDA starts actually utilizing the new power it is being given.
What Food Processors Can Do Now to Prepare Education and Training
For all members of the food industry, a huge component of preparation will come in the form of education and training, about both the new rules and the systems and technologies available to help companies comply with them.
As Rogers says, “Education is the key to understanding the technologies and their capabilities and also how to implement them into a program,” adding that Mettler Toledo takes “responsibility as an industry leader and we want to do all we can to help support the industry through education.”
In keeping with that philosophy, the company offers a large number of live and on-demand webinars, hosts discussions at trade shows and seminars, works to ensure auditor competency and consistency, and works closely with GFSI-regulated programs to help participants understand the technologies and their capabilities.
The FDA is also committed to providing training to help companies adapt. In the Q&A session, Givens said: “Industry will be trained on the content, requirements, and how to comply with the FSMA rules through public-private partnerships that FDA supports, including the Preventive Controls Alliance, the Produce Safety Alliance, and the Sprouts Safety Alliance.”
Again, this initiative will become clearer once the final rules are issued.
Food Safety Plans
As noted earlier, many food companies already have robust food safety plans and traceability plans in place. For these companies, the transition will likely be pretty smooth. For those companies that haven’t started thinking about a new food safety plan, now’s the time.
“The most important component is traceability,” McPhail notes. “If processors and manufacturers get a handle on traceability, then developing a food safety plan is easy.” While the new laws do not specifically mention Hazard Analysis & Critical Control Points management systems, McPhail says that these is also a key component of a strong food traceability plan.
Additional prerequisites for companies to move toward a model of prevention, according to Rogers, are “good solid equipment, validation, ongoing verification, and documentation.”
Companies need to collect data about their systems and processes and then use that data to identify risks and implement preventative measures. This is another area where Mettler Toledo has a lot of expertise. The company performs gap analyses to help facilities identify discrepancies between FSMA or other food safety management programs and what the facility currently has in place. It also provides root cause analyses to ensure solutions are focused on core problems, not just symptoms, and helps companies develop plans for preventative care.
McPhail is also highly involved in helping the food industry make the transition to the new regulatory environment. His company provides consulting on facility design and development -- both for the initial concept and expansions -- that takes the laws into account and focuses on how to prevent introducing allergens and cross-contamination. The company also helps food producers and processors implement robust food safety plans.
Finally, companies can take advantage of the new technologies that are available (or will be available soon) to help companies track their data and their products.
For example, new software applications move facility data management from individual equipment management to complete line management. And an augmented reality (AR) solution, which will be rolled out in the near future, has the potential to enhance traceability by embedding information about a product directly into the label or packaging. These and other new technologies that are shaping the future of food safety and sanitation will be the focus of a subsequent article.
So, where does the industry stand right now in regards to understanding and preparing for FSMA? Well, it’s been a long journey and for some companies the biggest climbs are still to come. But, as Rogers says when it comes to food safety, “We [the industry] are getting better at it every day.”