The Food and Drug Administration has launched a new transparency policy for the reporting of foodborne illness outbreak investigations.
As part of the initiative the public, industry stakeholders and other entities will have access to two new resources once an outbreak investigation has ended:
Executive Incident Summary (EIS) Abstracts for Closed Foodborne Illness Investigations; and
Foodborne Outbreak Overview of Data (FOOD) Reports
“The EIS abstracts will allow stakeholders to better understand the outcomes of each investigation. FOOD reports constitute a more robust, data-driven, retrospective review of repeated events and will be released when there is enough data to support their development. The continued release of both of these types of information should better equip the FDA, our partners in investigations, and industry to maintain a safe food supply,” according to the FDA’s announcement.
The agency says EIS abstracts reflect an effort to complement the FDA’s existing tools and are intended to share as much information as possible about foodborne illness investigations as soon as possible. However, the FDA did not say what constitutes “as soon as possible.”
EIS abstracts will be written after the end of each outbreak or adverse event investigation linked to an FDA-regulated human food product, when the response phase has ended and there is no longer an ongoing risk to the public.
Such investigations are primarily managed by FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network with additional coordination with FDA field offices, FDA subject matter experts, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture’s Food Safety and Inspection Service, and state and local partners.
EIS abstracts are designed to provide post-response information and will often include a high-level overview of the traceback, laboratory and epidemiological information collected during an investigation, according to the FDA.
The abstracts will be redacted to protect confidential commercial information (CCI), including the Trade Secrets Act, personally identifiable information and other information that is exempt from public disclosure under the Freedom of Information Act. The abstracts can be accessed on the FDA’s CORE Investigations Table, which includes all outbreaks managed by a CORE Response Team, or on the new EIS landing page.
Foodborne Outbreak Overview of Data (FOOD) reports
The FOOD reports will provide information for industry and consumers on pathogen-commodity pairs that have been linked to repeated outbreaks of foodborne illness. The reports will include highlights of historical epidemiologic data, laboratory analyses, traceback and investigational findings, and post-response prevention activities taken by the FDA, industry, academic and other federal, state, local, tribal, and territorial stakeholders.
The FOOD reports were developed to provide information that may be useful in preventing future foodborne illnesses, and that may be used in food safety communication, training and identification of research needs.
There will not be a FOOD report for every outbreak. Rather, FOOD reports will summarize data and findings from select outbreak investigations related to a specific pathogen-commodity pair linked to foodborne illness outbreaks.
The first two FOOD Reports, released on Sept. 24, provide summaries of hepatitis A outbreaks linked to berries and Salmonella outbreaks linked to tahini. The reports cover outbreaks in other countries as well as those in the United States.
(To sign up for a free subscription to Food Safety News, click here)
