DeLauro Wants Answers on Stomach Bug Outbreak Caused By Cyclospora Calls On FDA, CDC to Be Fully Transparent With American Consumers

DeLauro Wants Answers on Stomach Bug Outbreak Caused By Cyclospora Calls On FDA, CDC to Be Fully Transparent With American Consumers WASHINGTON, DC—Congresswoman Rosa DeLauro (D-CT) today demanded answers from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on the recent outbreak of cyclosporiasis that has struck nearly 400 Americans. Consumer and food safety advocates have also raised serious questions about the lack of information from those two agencies. “To date there is minimal information available to the public on the possible cause(s) of this outbreak from federal agencies,” DeLauro wrote. “The first page dedicated to this outbreak investigation on the Food and Drug Administration (FDA) website was posted on July 31, 2013 – a full month after the outbreak investigation first began by the CDC and days after Iowa and Nebraska announced an association with a salad mix. Neither of the states have released information on the brand, producer, or country of origin of the food product associated with cases within their state. Both the FDA and CDC pages on the outbreak also lack information for consumers on the product implicated in Iowa and Nebraska.” DeLauro asked the agencies to report back on a series of question, including: • Details on how the investigation unfolded • Does either the FDA or CDC consider it acceptable to identify the source of an outbreak and withhold the timely, public release of that information? • If so, what is the rationale and legal justification for withholding this information and how is it determined how long such information should be withheld from the public? The full letter is as follows: August 1, 2013 Margaret Hamburg, M.D. Director Thomas Frieden U.S. Food and Drug Administration Centers for Disease Control and Prevention 10903 New Hampshire Avenue 1600 Clifton Road Silver Spring, MD 20993-0002 Atlanta, GA 30333 Commissioner Hamburg and Director Frieden, I write today out of deep concern about the ongoing outbreak of cyclosporiasis as well as the impact of budget reductions including those due to sequestration on staffing resources and the timeliness of the investigation. In addition to sporadic cases and clusters of cases, outbreaks of this disease caused by an intestinal parasite have been confirmed since the mid-1990s and have been associated with specific types of imported fresh produce. Since the Centers for Disease Control and Prevention (CDC) was first notified of cases on June 28, 2013 the number of Americans affected has dramatically increased. Nearly 400 individuals in 16 states, including one in my home state of Connecticut, have become ill. Earlier this week two state health agencies, Iowa and Nebraska, released information on their epidemiological activities and completed trace back. Cases reported in these two states make up more than 50 percent of the reported cases to date, with 143 cases in Iowa and 78 in Nebraska. In both states the trace back activity indicates an association with a prepackaged salad mix that “came through national distribution channels” according to the announcements from both states. Yet, to date there is minimal information available to the public on the possible cause(s) of this outbreak from federal agencies. The first page dedicated to this outbreak investigation on the Food and Drug Administration (FDA) website was posted on July 31, 2013 – a full month after the outbreak investigation first began by the CDC and days after Iowa and Nebraska announced an association with a salad mix. Neither of the states have released information on the brand, producer, or country of origin of the food product associated with cases within their state. Both the FDA and CDC pages on the outbreak also lack information for consumers on the product implicated in Iowa and Nebraska. Understandably, investigations of disease outbreaks, including foodborne disease, must be thorough and thoughtful. At the same time, the public was left in the dark as an outbreak leaped from 2 cases to nearly 400 and questions around data and information sharing abound. Furthermore, recent press coverage indicates that a product may be strongly associated with the outbreak while we await communication from the lead federal agencies investigating the outbreak. Some press coverage indicates this outbreak has been associated with specific food products, but that details of that source are being intentionally withheld from the public. This would be an alarming precedent and incredible disappointment to consumers who expect a transparent federal food safety system that protects the public health. Given this, I look forward to timely and comprehensive responses to the following: • What have been the specific challenges in this outbreak that have slowed the investigation and what lessons can the CDC and FDA apply to future outbreaks? • A timeline of the investigation and related communication to date including a comprehensive list of: date(s) of conference calls involving officials from federal, state, and local public health agencies; date(s) of conference calls with industry and/or producers; date(s) of conference calls with consumer and/or public health advocates; date(s) of communication with the public related to the outbreak. • A timeline of the investigation specific to identifying the food product(s) associated with this outbreak, including: data and specific date(s) that indicated possible associations between the outbreak and particular food products; date(s) that information was shared with state and local health agencies; date(s) that information was shared with industry or producers; and date(s) that information was shared with the public. • Does either the FDA or CDC consider it acceptable to identify the source of an outbreak and withhold the timely, public release of that information? If so, what is the rationale and legal justification for withholding this information and how is it determined how long such information should be withheld from the public? Thank you for your efforts to protect the public health from unsafe foods and improve the federal response when an outbreak does occur. Sincerely, Rosa L. DeLauro Member of Congress