DeLauro Wants Answers on Stomach Bug Outbreak Caused By Cyclospora
Calls On FDA, CDC to Be Fully Transparent WithAmerican Consumers
WASHINGTON, DC—Congresswoman Rosa DeLauro (D-CT) todaydemanded answers from the Food and Drug Administration (FDA) and Centers forDisease Control and Prevention (CDC) on the recent outbreak of cyclosporiasisthat has struck nearly 400 Americans. Consumer and food safety advocates havealso raised serious questions about the lack of information from those twoagencies.
"To date there is minimal information available to thepublic on the possible cause(s) of this outbreak from federal agencies,"DeLauro wrote. "The first page dedicated to this outbreak investigation onthe Food and Drug Administration (FDA) website was posted on July 31, 2013 – afull month after the outbreak investigation first began by the CDC and daysafter Iowa and Nebraska announced an association with a salad mix. Neither of the states have released information on the brand, producer, orcountry of origin of the food product associated with cases within theirstate. Both the FDA and CDC pages on the outbreak also lack informationfor consumers on the product implicated in Iowa and Nebraska."
DeLauro asked the agencies to report back on a series ofquestion, including:
· Details on how the investigation unfolded
· Does either the FDA or CDC consider itacceptable to identify the source of an outbreak and withhold the timely,public release of that information?
· If so, what is the rationale and legaljustification for withholding this information and how is it determined howlong 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 DrugAdministration Centers for Disease Control and Prevention
10903 New Hampshire Avenue 1600 Clifton Road
Silver Spring, MD 20993-0002 Atlanta, GA 30333
Commissioner Hamburg andDirector Frieden,
I write todayout of deep concern about the ongoing outbreak of cyclosporiasis as well as theimpact of budget reductions including those due to sequestration on staffingresources and the timeliness of the investigation.
In additionto sporadic cases and clusters of cases, outbreaks of this disease caused by anintestinal parasite have been confirmed since the mid-1990s and have beenassociated with specific types of imported fresh produce. Since theCenters for Disease Control and Prevention (CDC) was first notified of cases onJune 28, 2013 the number of Americans affected has dramaticallyincreased. Nearly 400 individuals in 16 states, including one in my homestate of Connecticut, have become ill.
Earlier this week two statehealth agencies, Iowa and Nebraska, released information on theirepidemiological activities and completed trace back. Cases reported inthese 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 backactivity indicates an association with a prepackaged salad mix that "camethrough national distribution channels" according to the announcements fromboth states.
Yet, to date there is minimal informationavailable to the public on the possible cause(s) of this outbreak from federalagencies. The first page dedicated to this outbreak investigation on theFood and Drug Administration (FDA) website was posted on July 31, 2013 – a fullmonth after the outbreak investigation first began by the CDC and days afterIowa and Nebraska announced an association with a salad mix. Neither ofthe states have released information on the brand, producer, or country oforigin of the food product associated with cases within their state. Boththe FDA and CDC pages on the outbreak also lack information for consumers onthe product implicated in Iowa and Nebraska.
Understandably, investigations ofdisease outbreaks, including foodborne disease, must be thorough andthoughtful. At the same time, the public was left in the dark as anoutbreak leaped from 2 cases to nearly 400 and questions around data andinformation sharing abound.
Furthermore, recent presscoverage indicates that a product may be strongly associated with the outbreakwhile we await communication from the lead federal agencies investigating theoutbreak. Some press coverage indicates this outbreak has been associatedwith specific food products, but that details of that source are being intentionallywithheld from the public. This would be an alarming precedent andincredible disappointment to consumers who expect a transparent federal foodsafety system that protects the public health.
Given this, I look forward totimely and comprehensive responses to the following:
· What have been the specific challenges in thisoutbreak that have slowed the investigation and what lessons can the CDC andFDA apply to future outbreaks?
· A timeline of the investigation and relatedcommunication to date including a comprehensive list of: date(s) of conferencecalls involving officials from federal, state, and local public healthagencies; date(s) of conference calls with industry and/or producers; date(s)of conference calls with consumer and/or public health advocates; date(s) ofcommunication with the public related to the outbreak.
· A timeline of the investigation specific toidentifying the food product(s) associated with this outbreak, including: dataand specific date(s) that indicated possible associations between the outbreakand particular food products; date(s) that information was shared with stateand local health agencies; date(s) that information was shared with industry orproducers; and date(s) that information was shared with the public.
· Does either the FDA or CDC consider itacceptable to identify the source of an outbreak and withhold the timely,public release of that information? If so, what is the rationale andlegal justification for withholding this information and how is it determined howlong such information should be withheld from the public?
Thank you for your efforts to protect the public health fromunsafe foods and improve the federal response when an outbreak does occur.
Sincerely,
Rosa L. DeLauro
Member of Congress