(This article by Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine for the U.S. Food and Drug Administration, was originally posted here on May 20, 2015.)

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries. Above all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims — the 10 people who were hospitalized and the three who died. Blue Bell ice creamOur mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse. But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year. Ultimately, the only way we will achieve the goals that we are focused on — the goals that consumers expect us to achieve, and that industry wants us to reach — is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally. There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history, and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year. For example, the preventive controls for human food rule, if finalized as proposed, would require that companies, such as Blue Bell, have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working. We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls — authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law, we want to promote strong food safety cultures and create real accountability throughout the industry. We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted. No law can guarantee zero risk from contaminated ice cream or any other food that has come in contact with dangerous bacteria or another harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it can possibly be.
  • Roy E Costa

    I appreciate Michael Taylor’s comments and also believe that FSMA is a step in the right direction. The fact, however, is that companies around the globe have already adopted food safety systems. This article makes it sound like this is something new and such programs will be brought about by new federal law, when we already have preventative controls in place. There are firms that have not adopted such in their operations, and FSMA may help to address this, but by and large, the major outbreaks we have seen are not the result on a lack of a prevention program, but the failure of the program to prevent the hazard from occurring. Laws, however, come with a high cost for non-compliance, that hammer is needed by some, but for most this is not the answer to the microbial contamination problem. Our goal in industry should be to be in compliance, but at the same time we need effective food safety management systems, and we do not always have them, as illustrated by the tragic Blue Bell outbreak and a long list of others.

    As a former regulator, consultant and auditor for almost 40 years, I am painfully aware of the difficulties in implementation and sustaining preventative measures in a company; simply more or different “preventative controls” is not likely to improve anything.

    We look to FDA to help us, and I am still wondering if we will get what we need. We need consistent application and enforcement of the rules, and FDA has to get agents into the field, but most importantly, firms must organize around food safety. Companies must also effectively train and educate everyone in the organization, and most importantly, apply the available science and technology. A lack of commitment within companies is a root cause of much of the failures of the existing programs, along with a lack of resources. We waste tons of money on audits, manuals, record keeping etc, etc, when we should be investing in educating our employees, our infrastructures and applying technology.

    I totally support what FDA is doing with FSMA, but we should recognize that a new system of preventative controls is only a solution if our food safety management systems are working.

    • Gary

      From what I interpret in the FSMA the biggest advantage over previously law is that it is risk based. So, food manufacturers that consistently have issues will undoubtedly receive more attention from the FDA which makes complete sense. Also, the financial penalty of repeat visits by the FDA will definitely perk up the ears of food manufacturers and incentivize them to correct the issues versus covering them or sweeping them under the rug.

      Historically, recalls are not pointed to one source or issue. It is a breakdown on multiple levels within an organization. The FSMA will certainly help to combat and prevent this breakdown over multiple levels. It isn’t foolproof, but it is significantly better than current regulation.

      • roy costa

        Gary, I agree on some level, but this is a political solution to a microbial contamination problem. What the industry really needs is not more rules, however well designed or well intentioned. The food industry needs to invest in the education and training of employees, and right now, those educational efforts nationally are not well established, second, industry needs to apply the available technology that includes, on site laboratory capability, remote monitoring of temperatuire and other critical parameters, and a serious investment in better desinged buildings and equipment.

        • moshelevzvei

          I don’t disagree with the part about investing in education and training of employees, but I’ll suggest that our Colleges and Universities have largely
          inadequate programs in basic and advanced bacteriology, food or industrial microbiology, and food safety. These programs have been edged aside
          by the ascent of “high tech” and a collective amnesia of the good old
          Durham tube, IMViC etc., and knowledge of the behavior of organisms in the real world.

        • Gary

          Roy, sure all of that would be great, but it isn’t going to happen. There are far too many small food producers and farms who cannot afford to do those things. The FSMA isn’t necessarily about more laws, but better laws in focusing on “problem producers”.

  • Calvin

    The majority of violations noted by the FDA, at Blue Bell factories in April, however are observations that should have been made on previous visits by inspectors, either FDA or the local health agency acting as an extension of the FDA.

    For example:

    OBSERVATION 4 Failure to provide running water at a suitable temperature for cleaning of equipment, utensils and food-packaging materials.

    OBSERVATION 5 The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials.

    OBSERVATION 7 Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.

    OBSERVATION 9 The design ofequipment does not allow proper cleaning and maintenance.

    OBSERVATION 11 Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation offood particles and organic matter and the opportunity for growth of microorganisms.

    While FSMA “is the most sweeping regulatory overhaul in the agency’s history”, and is a major proactive shift in policy rather than a reactive approach, it is important to acknowledge that systems and oversight are currently in place that should have noted violations prior to this outbreak.


    • Malarky71

      The majority of violations noted by the FDA, at Blue Bell factories
      in April, however are observations that should have been made on
      previous reviews by the manufacturer who was There. Every Day.

      • Calvin

        I wholeheartedly agree with that statement. Blue Bell failed many ways internally. I am in no way excusing the apparent lack of internals systems/checks. Be it HACCP et al. Example: Hot water for proper wash and sanitize temps should have been logged internally several times a day. Perhaps every 2 hours equipment in use and kept on file, probably 12 months. I should have cut that post by 50% and given *equal* coverage to BB failings. Thx for the comment.

  • moshelevzvei

    Many years ago I attended a food safety “seminar” held near Fl State, hosted by a small testing company which was using the latest PCR techniques to test submitted samples. I apologize that my recall of the specifics is gone.

    One of the speakers was an attorney who addressed the legal, economic, and PR fallout from discovery of Listeria in a product. He discussed the damage done to the small community where the plant was located too.

    Neither the Listeria problem nor the potential for it to ruin a company, destroy individual lives, cause mass unemployment, and damage a local economy, are new previously unknown issues in the food industry.

    100%- zero tolerance is a tough standard, but anyone in charge of a food production facility certainly knows what is required and should know the consequences of not taking that requirement seriously.

    This stuff is mostly just common sense and it shouldn’t take the hammer of the new law which allows for criminalization to get the message across.

    Unfortunately, as with everything else in life, sometimes a 2X4 is the only way to get companies to move from penny wise and pound foolish management styles.

  • Linda Dodd

    Inspections by the FDA can differ greatly between being there for routine inspection and being there for cause. My guess is most food facilities will have some findings if FDA inspectors are on a bug hunt. By far and large, I believe companies are trying to do a good job on food safety – but there are a lot of costs involved for staffing, environmental monitoring, etc. that are very tough to handle for small to medium companies. In many cases, quality/food safety simply are not viewed as value-added. They are a cost that affects the bottom line and often some of the first cuts when things are tough.

    • Oginikwe

      So, a recall and the loss of trust by consumers is cost-effective?

    • Malarky71

      Big companies cut Quality, too.