FDA: An Independent Review of FDA’s Foodborne Outbreak Response Processes

This review is part of FDA’s “New Era of Smarter Food Safety: FDA’s Foodborne Outbreak Response Improvement Plan” that also requires a hard look and the support by those concerned about improving the safety of our food and driving the numbers of ill consumers down.

Thanks to the deep dive by Craig Hedberg.  Here is the Full Report: NewEra-OutbreakResponseIndependentReview-102621

Here are some of my takeaways from the review and my thoughts:

1. Surveillance – we need to use the power of Whole Genome Sequencing (WGS) of food products and environmental testing to help prevent and identify outbreaks.With WGS the ability of scientifically linking pathogens and people will allow government, the food industry, and consumers more certainly to know what the most likely cause of a foodborne illness was. I am certain that genetically linking illnesses to products – and possibly the environment – will allow for a common understanding of the likely cause of an outbreak.
2. There is an ongoing need for coordination of outbreak response within the FDA and with other federal and state agencies that touch on food safety.There is clearly an ongoing need to more effectively coordinated the multiple acronyms that make up governmental food safety responses at the federal, state, and local levels.  This one is well “above my pay grade” to figure out.
3. Traceback – The technology does exist to track food products from “farm to fork.” The real question is when it will be implemented so a pathogen tainted product can be traced quickly and accurately to the likely source.  Electronic records and Block Chain are coming.  We just need to speed it up.
4. Transparency – FDA and other acronyms need to rethink what should and should not be made public.Other that patient identities, in my experience reading years of governmental redacted reports, there is frankly little that should not be made public.  Being transparent build trust between all the people that grow, manufacture, ship, sell and consume food.
5. Root Cause Analysis – “Root cause analysis (RCA) is a method of problem-solving used to isolate the central “how” and “why” a given event occurred. While root cause analysis is used in various industries already, it has strong implications for helping researchers and investigators understand the central causes of events like food contamination and foodborne illness outbreaks. RCA is also useful for clarifying steps needed to correct the cause of a problem to prevent recurrence.”FDA need to be able to fully assess the “root cause” of an outbreak without limitations.  A concern noted in Dr. Hedberg’s review:

“Efforts are made to identify farm sources, or production sources depending on the commodity, so that farm or facility visits, and environmental assessments can be made to identify the source of the contamination event.”

“Farm visits and sample collections have become an increasing part of outbreak investigations involving REP strains and recurrent settings. Getting to farms while produce is still being grown and harvested has been a challenge.”

“Given the challenges inherent in identifying farms and fields during the course of outbreak investigations, it is not reasonable to expect to be able to link every case to a specific source, or to isolate the outbreak-associated strains from product or environmental samples collected from the farms. The biology of the organisms and ecology of the fields challenges the limits of our laboratory methods. This is compounded by the lack of access to animal and environmental samples from adjacent fields managed by different owners.”

Question – does anyone know why FDA can’t go on adjoining land – especially during an outbreak investigation?  Does another acronym have access – EPA?  Has there ever been any proposed legislation to allow access?  Not being allowed to search for the root cause dooms the process from ever finding the root cause.

Here is the Executive Summary:

As the federal food regulatory agency with oversight for the large majority of commercially distributed foods, FDA plays a key role in conducting multistate outbreak investigations and in translating investigation results into prevention activities. The importance of this role is highlighted in the development of FDA’s blueprint for the future, the “New Era of Smarter Food Safety.”

The development of whole genome sequencing (WGS) has improved foodborne illness surveillance and led to the recognition that some pathogenic strains are causing reoccurring, emerging, and persisting (REP) food safety problems. Outbreaks of shigatoxin-producing E. coli associated with leafy green vegetables have been a particular concern in recent years.

FDA established the Coordinated Outbreak Response and Evaluation (CORE) Network to coordinate its outbreak response efforts with subject matter experts from the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Regulatory Affairs (ORA) and Centers for Disease Prevention and Control (CDC). CORE Teams take food exposure information from CDC, make assignments for record and sample collection by ORA field staff, and identify outbreak sources through the convergence of product distributions across multiple legs of a traceback, supported by epidemiology and laboratory data. Tracebacks are time and labor intensive and frequently limited by inadequate records and comingling of product in distribution. Efforts are made to identify farm sources, or production sources depending on the commodity, so that farm or facility visits, and environmental assessments can be made to identify the source of the contamination event. In some outbreak response efforts, root cause investigations are conducted to collect information that can be used “to develop and recommend risk mitigation strategies for industry to reduce the risk of repeated food contamination events.” (FDA, Office of Regulatory Affairs, Procedure Manual for Fresh Produce Root Cause Investigation).

A review of FDA’s outbreak response activities was conducted to explore the dynamics of FDA’s relationships with federal, state and industry partners during and after these investigations. The review included documents related to outbreak investigation procedures, policies, and outcomes with interviews of key stakeholders identified by FDA.

Findings and recommendations presented in the report were related to the following areas:

• Initiation of the outbreak investigation and assignment of investigation tasks.
• Role of CORE in traceback activities.
• Factors used to determine whether or not to conduct a root cause investigation.
• Translation of outbreak investigation findings to prevention activities.
• Evaluation activities and systems improvement.

The report reached the following conclusions:

FDA has made considerable investments in recent years to improve its outbreak investigation processes with the establishment of CORE. Its integration of activities through an incident command system has provided a structure for coordinating traceback activities across FDA. The process of making record collection assignments involves multiple steps that must be coordinated across different parts of the agency, with inherent delays built into the process.

Technological and operational innovations provide opportunities to shorten response times. In particular, the identification of REP strains and reoccurring outbreak settings provide investigators with ready hypotheses to test at first recognition of the outbreak.

Improvements in outbreak detection will continue to advance with application of WGS to surveillance of pathogens by public health agencies. Turn-around times in public health laboratories have limited the speed of outbreak detection, but these have decreased in states with adequate resources to perform WGS in real time. Improving the capacity of state and local public health epidemiologists to conduct detailed exposure interviews may depend on additional support through CDC’s epidemiology and laboratory capacity (ELC) grants. While ELC grants are not within FDA’s jurisdiction, helping to ensure the effective coordination of federal outbreak response resources is.

Because tracebacks require exposure assessments conducted by state and local health departments, the speed and effectiveness of FDA activities will always depend on the capacity of the public health system. Expanding the number and distribution of FDA-supported Rapid Response Teams (RRTs) to enhance coordination of investigation activities between FDA and state partners is warranted.

A complementary method of outbreak identification, through environmental and food product sampling by FDA or a federal or state regulatory partner, is becoming more common. When a reportable foodborne pathogen is identified, a search of PulseNet data for matching human isolates may indicate the occurrence of a foodborne outbreak. Investigation of the human case exposures is needed to confirm the source of such a “retrospective” outbreak. This depends on the same public health resources needed for conventional surveillance activities.

A key implication of the expanding use of WGS for foodborne illness surveillance will be the need to investigate more frequent but smaller clusters of cases. Prioritizing traceback of small clusters can lead to earlier detection of outbreaks before they manifest as large, multistate outbreaks. However, this would likely increase the need for informational tracebacks early in the hypothesis generation process. This could be accomplished either by more formal engagement of CORE Response while clusters are still being followed by the Signals Team, earlier transfer of cluster investigations to CORE Response Teams or more formal reliance on CDC and state partners to conduct these informational tracebacks.

The development of improved traceability with electronic records could significantly reduce the burden of investigation required to collect records to document the movement of products in a traceback. This would both speed up tracebacks and permit a larger range of products to be traced. At the same time, prioritizing traceback analyses based on the probability of product availability would improve the efficiency of source identification and better inform the transition from response to prevention. Establishing performance measures for outbreak response activities and outcomes should be established within the CORE database system.

Resource constraints are a limiting factor in many outbreak investigations. Staffing levels for CORE, the Office of Regulatory Affairs (ORA) investigators, produce safety specialists, laboratory support systems and other program areas are not adequate to respond to the growing number of outbreaks associated with REP strains and recurrent settings. Consideration for how to add capacity to CORE and increase the ability of CORE Response Teams to directly interact with outbreak investigation partners outside of FDA is warranted.

Farm visits and sample collections have become an increasing part of outbreak investigations involving REP strains and recurrent settings. Getting to farms while produce is still being grown and harvested has been a challenge. For most produce associated outbreaks, the majority of cases have already occurred by the time the outbreak is recognized. Environmental assessments conducted during these visits, but after the outbreak has ended still need to document conditions that can be directly related to the specific event, and also put them into context of the larger population of similar outbreaks that have been investigated. Integration of these data should be viewed as a routine investigation method. This could help identify factors, such as the presence of animal production facilities on lands adjacent to produce fields that can be compared across multiple investigations and evaluated during applied research studies and long-term environmental assessments. These post hoc environmental assessments can also help develop plans for seasonal surveillance during subsequent harvests.

Earlier and more open communication with industry, public health and regulatory partners would enhance the collaborative nature of outbreak investigations and likely produce meaningful results faster. Trust between partners is needed to effectively solve problems and identify solutions. While there remain questions about how, when and to whom information can be disclosed, the default setting should be to disclose information whenever it can advance the progress of the investigation. Outside of specific regulatory directives, behavioral change by industry requires the understanding of investigation findings and insights on how to implement changes within existing production systems. Timely release of investigation findings to the public and discussion of the implications of the findings directly with the affected industry is critical for effective communication and widespread acceptance of results. While the New Era of Smarter Food Safety seeks to “bend the curve” of foodborne illness, successful outbreak investigations can lead to better prevention methods that may lead to “canceling the curve” of many potential outbreaks.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.