FDA Warning Letters to Sprout Growers Highlight Complicated Legal Issues Associated with Warning Letters and Guidance Documents
Since 1996, there have been at least 30 reported outbreaks of foodborne illness associated with different types of raw and lightly cooked sprouts caused mostly by Salmonella and E. coli. In 1999, in response to numerous outbreaks and the potential for microbial contaminations, the U.S. Food and Drug Administration (“FDA“) issued two guidance documents, “Reducing Microbial Food Safety Hazards for Sprouted Seeds” and “Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production,” to assist all parties involved in the production of sprouts to reduce the risk of sprouts spreading foodborne illnesses.
For several years following the issuance of the guidance documents, the FDA reported that foodborne illnesses associated with sprouts appeared to diminish. However, in light of continuing outbreaks, the FDA strongly encouraged firms in the industry to review their operations to reduce microbial food safety hazards for sprouted seeds in accordance with the guidance documents.
Since 1999, the FDA has issued over 80 Warning Letters to firms involved in the production of sprouts. The majority of the Warning Letters state that the sprouts are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Please see our previous reports here and here, discussing whether, and if so how, the recipients of these Warning Letters may respond or challenge the Warning Letters in court in light of the United States Supreme Courts recent ruling in Sackett v. EPA.
In addition to the alleged violations, the Warning Letters state that the “proper handling and controls for sprout manufacturing can be found in [the 1999 guidance documents].” Therefore, the guidance documents are closely examined by industry because they provide important insight as to how FDA will act in terms of enforcement. However, FDA guidance documents describe the Agencys current thinking on a regulatory issue, and do not have the force or effect of law.
Because the FDA continues to heavily rely on the voluntary guidelines for enforcement action, the International Sprout Growers Association (“ISGA“), on behalf of the sprout industry, has urged the FDA to update the outdated guidance documents. The ISGA stated that there are numerous new methods for sprout sanitation that are not outlined in the guidance documents. For example, in the E. coli strain found in sprouts at Jimmy Johns restaurants earlier this year would not have been identified by microbiological tests currently recommended under the guidance. Please see our previous report discussing E. coli testing for more information.
Pursuant to Section 105 of the Food Safety and Modernization Act to provide standards for produce safety, on February 28, 2012, the FDA announced the creation of the Sprouts Safety Alliance (“SSA“) in cooperation with the Illinois Institute of Technologys Institute for Food Safety and Health. The SSA is supposed to help sprout producers in identifying and implementing best practices in the safe production of sprouts. The FDA was expected to issue a proposed rule during early 2012 that would establish science-based standards for the production and harvesting of sprouts and other certain produce. However, the FDA has yet to announce the proposed rule as required under Section 105.
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