Q. Could you help me understand or point me to material that can give me an overview of the process from identifying a foodborne outbreak to a supplier fulfilling a recall? Who are the stakeholders in this process?

FDA works with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA) in responding to outbreaks of foodborne illness. This CDC infographic describes the steps in an outbreak investigation.

Q. How will this plan impact imported produce? Specifically, how much will FDA 's tech-enabled approach focus on the foreign supplier as opposed to the U.S. importer, which bears responsibility to import safe foods under the FDA Food Safety Modernization Act (FSMA)?

FDA will go where the outbreak leads in investigating the contamination of a food product, whether the supplier is a U.S. company or one in another country that exports to the U.S. FSMA does hold importers covered by the Foreign Supplier Verification Programs rule responsible for ensuring that their foreign suppliers meet applicable U.S. safety standards, but that is not the only safeguard against contaminated imports. The New Era of Smarter Food Safety blueprint specifically calls for facilitating the exchange of information with other countries on reported foodborne illnesses and pathogens isolated from food samples.

Q. In what ways will this plan impact dietary supplement manufacturers?

The plan focuses on the improvement of foodborne outbreak response, which can include dietary supplements.

Q. Can you explain what, if any, impact the plan will have on the response to bivalve molluscan shellfish-associated outbreaks? Such outbreaks are handled under an established cooperative program (the National Shellfish Sanitation Program) in which state control authorities primarily handle response activities, with FDA providing assistance and oversight.

Shellfish subject to NSSP requirements (raw bivalve molluscan shellfish: oysters, clams, mussels, and scallops) are indeed handled differently under the cooperative program, which has an established process for responding to outbreaks of foodborne illness associated with this food, with FDA providing assistance and oversight. NSSP is the federal/state cooperative program recognized by FDA and the Interstate Shellfish Sanitation Conference for the sanitary control of bivalve molluscan shellfish produced and sold for human consumption.

Q. What are some potential challenges in emerging industries, like vertical farming, that would cause a delay in response to an outbreak?

The investigation of outbreaks involving novel vehicles or production practices may be more challenging, but they offer an opportunity to learn and improve. It’s hard to answer this hypothetically. It will depend on the situation.

Q. What sort of help is there for a single, local environmental health specialist to utilize in the case of an outbreak of foodborne illness outbreak in a remote county?

One source of information would be the CIFOR Guidelines for Foodborne Disease Outbreak Response, which has information on foodborne disease investigation and control for local, state and federal health agencies. The Council to Improve Foodborne Outbreak Response is a collaboration of national associations and federal agencies working together to improve methods to detect, investigate, control, and prevent foodborne disease outbreaks.

Q. Does the FDA have videos or other resources that could be used to improve the public’s understanding of an outbreak and help improve their cooperation? If not, has FDA looked at this area?

FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network has resources available on fda.gov that explain how the agency detects, responds to, and prevents outbreaks of foodborne illness.  We also are considering developing other resources, which we will post on our website.

Q. Is there a way to encourage physicians to identify a pathogen when their patients seek medical care, rather than telling them that they likely have a stomach bug or food poisoning? This would help start the investigation sooner when sources may still be present.

FDA’s Foodborne Illness Continuing Medical Education Program has information for physicians on suspecting, identifying, treating, and reporting foodborne illness. The web page also has information for patients about food safety.

Q. Will there be a more streamlined communication approach regarding outbreaks to keep states better informed?

One of the FORIP goals is to enhance transparency of outbreak investigations to increase public confidence in results and help facilitate improved collaboration on investigation activities. The activities associated with this goal includes establishing a standard set of data elements that can be released publicly for all outbreak investigations, updating the CORE Investigation Table, and making outbreak investigation findings public as soon as possible after an outbreak’s conclusion. FDA will continue efforts to be more transparent and will look for opportunities to share what we’re working on.

Q. Can FDA discuss how government and industry can coordinate to overcome challenges industry faces in adopting technologies?

An important part of the New Era of Smarter Food Safety is the partnership with industry in working to bringing about changes in the food safety system. One example is the Low- or No-Cost Tech-enabled Traceability Challenge that FDA launched in June 2021 to encourage the development of traceability solutions that would be affordable for small and mid-size businesses. There were 90 submissions from around the world – and FDA chose 12 winning teams from  the   U.S., Canada, and New Zealand. Their solutions were presented in a webinar in September. We are now actively working to communicate these ideas – from the winners and other teams that entered the Challenge - to the stakeholders who need them most.

Q. What is the FDA doing to follow up on recommendations for change once investigations are complete and pinpoint a company or the practice of a company?

When an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, Form 483 is issued to notify management of those conditions. Companies are encouraged to respond with a corrective plan. The form, along with other evidence and documentation is considered when FDA determines what further action may be needed to protect public health.

FDA has enforcement authorities under FSMA, such as mandatory recall when a facility fails to voluntarily remove unsafe food from the market and suspension of registration to prevent a facility from distributing unsafe food. There is also a process that the agency follows when conditions are observed during an inspection that are potentially hazardous to public health.

Q. Has FDA talked to Nielsen or IRI (data analytics and market research companies) to better understand how UPC (Universal Product Code) numbers can be used to determine where a suspect product was distributed?

This question assumes that FDA knows the UPC number of the suspect product. The goal of an outbreak investigation is to determine the suspect product(s) and the lot or date code(s) based on information collected by local health officials and the CDC from ill consumers. This often does not include UPC information, which is more about product features. Aggregate retail sales data can provide insight into the number of units sold for a given time period and location for a given UPC but does not provide the lot or date code information essential to tracking the product.

Q. Most of the modernization in blockchain-driven traceability platforms is owned by private partnerships. How can the FDA and other federal agencies enable state ownership of traceability platforms?

FDA does not have a role in state ownership of traceability platforms. As the agency works with the food industry to support voluntary, widespread adoption of traceability solutions, it will share lessons learned with state partners.

Q. Does FDA plan to approve or require certain platforms or software to be utilized to meet tech-enabled traceback? 

FDA is supporting the voluntary adoption of traceability tools but will remain technology agnostic. The agency’s focus is on ensuring that traceability platforms be harmonized and interoperable to support the goal of end-to-end traceability.

Q. What are the incentives for stakeholders to have tech-enabled traceability?

Everyone benefits from the ability to rapidly trace food to its source. During an outbreak of foodborne illness, the inability to rapidly track and trace food can cost lives, millions of dollars in avoidable product loss, and damage to consumer trust. It also stands in the way of the transparency needed to better understand the supply chain in the event of public health crises, such as the COVID-19 pandemic.

Q. How accessible is whole genome sequencing currently, especially for LPHDs (local public health departments)?

FDA funds state laboratories to conduct sequencing, including through programs such as the Laboratory Flexible Funding Model, Vet-LIRN (Laboratory Investigation and Response Network), the National Antimicrobial Resistance Monitoring System (NARMS) and GenomeTrakr programs. To learn more, visit FDA’s Whole Genome Sequencing page. It’s important to note that everyone has access to the National Center for Biotechnology Information (NCBI) database  of sequences.

Q. Will root cause investigations and dissemination of data also extend to situations that are not related to microbial contamination (such as peanuts in cumin)?

The FORIP covers all outbreaks that CORE responds to, which does not include those caused by allergens. That said, other teams in FDA respond to allergen contamination. FDA enforces regulations requiring companies to list ingredients on packaged foods and beverages. The FDA also conducts inspections and sampling to check that major food allergens are properly declared on products and to determine whether food facilities implement controls to prevent the introduction of a major food allergen into a product) and labeling controls to prevent undeclared allergens during manufacturing and packaging. When problems are found, the FDA works with firms to recall products and provide public notification to immediately alert consumers. In addition, the FDA has the authority to seize and remove violative products from the marketplace or refuse entry of imported products.

Q. What data is missing from currently available datasets to continuously monitoring regulated food products and proactively identify/triage signals of potential food-borne outbreaks?

Whole genome sequencing from industry testing is a potentially valuable source of information. But that’s just one piece of information. One of the priority areas in the outbreak improvement plan is the use and dissemination of data to fuel more open communications with government partners, industry, and the public. The New Era of Smarter Food Safety blueprint also establishes goals for facilitating the exchange of valuable data between companies and between government and industry. Information-sharing agreements and public-private data trusts that can be accessed for analytical work are just two of the options being pursued.

Q. How can the industry provide more sources of analysis data?

We are eager to work with industry to enable them to provide more data sources.  To facilitate this, one  of the goals in the New Era of Smarter Food Safety blueprint is to work with industry to find the balance between the need for transparency and concerns about the confidentiality of business data in advancing predictive analytics. One proposal is the  development of protocols to establish that requests for data are targeted for a specific purpose.

Q. What are the roles of CORE and ORA in outbreak investigations? Have there been discussions about getting CORE investigators in the field with ORA investigators if this isn’t currently happening? 

CORE’s homepage on fda.gov explains how the CORE teams work with FDA’s field staff in outbreak investigations. CORE was established in 2011 for just this purpose – to bring together experts in medicine, public health, and science for the purpose of finding, stopping, and preventing foodborne illness.

Q. Will FDA arrange any certified distance learning programs, seminars, and training in implementing the outbreak plan?

When implementing the FORIP, FDA will work to identify training and educational opportunities. The agency is committed to educate consumers, industry, or federal and state food safety staff.