Today’s announcement of another salmonella outbreak linked to sprouts will inevitably end in litigation on behalf of outbreak victims, the focus of which will largely be on what Caldwell Fresh Foods did, or did not, do with regard to pathogen reduction (i.e. getting the contaminated animal feces off of the seeds before growing the sprouts). Here is a summary of the FDA’s guidance, issued in 1999, to the sprouts industry to achieve pathogen reduction on sprout seeds, followed by the specific measures that it encouraged sprouters, and other business in the chain of distribution of sprout seeds, to take.
Guidance background and summary
Since 1995, raw sprouts have been increasingly implicated in foodborne outbreaks. Between January 1995 and May 1999, there were 11 reported outbreaks in the United States associated with sprouts from commercial growers, 9 of which were due to various Salmonella serotypes and 2 to Escherichia coli O157. The number of culture-confirmed cases in each of these outbreaks ranged from 8 to more than 500, and more than 1,300 cases have been reported overall. And in total, since 1990, sprouts have been associated with at least 37 outbreaks, causing over 2,000 confirmed cases of foodpoisoning.
Sprouted seeds represent a food safety problem because the conditions under which sprouts are produced (time, temperature, water activity, pH, and nutrients) are ideal for the exponential growth of bacteria. If bacterial pathogens are present on or in the seed, sprouting conditions are likely to encourage their proliferation.
Traceback investigations reveal that most of the firms associated with recent outbreaks were not using approved seed disinfection treatments, or were not using them consistently, and were not testing for microbial contamination during sprout production. Although currently approved treatments can significantly reduce pathogen levels in or on seeds, they have not been shown to completely eliminate pathogens. Consequently, outbreaks continue to occur.
On July 9, 1999, FDA issued a consumer advisory advising all consumers to be aware of the risks associated with eating any variety of raw sprouts, and advising persons at high risk of developing serious illness due to foodborne disease (children, the elderly, and persons with weakened immune systems) not to eat raw sprouts. The advisory was updated from a previous advisory issued August 31, 1998, and was prompted by information from clover and alfalfa sprout-associated salmonellosis outbreaks that occurred from January 1999 through May 1999.
Specific guidance:
1. Seed Production: Seeds for sprout production should be grown under good agricultural practices (GAPs) in order to minimize the likelihood that they will contain pathogenic bacteria.
2. Seed Conditioning, Storage, and Transportation: Seeds that may be used for sprouting should be conditioned, stored, and transported in a manner that minimizes the likelihood that the seeds will be contaminated with pathogens. For example, seed should be stored in closed or covered containers in a clean dry area dedicated to seed storage. Containers should be positioned off the floor and away from walls to reduce the possibility of contamination by rodents or other pests and to facilitate regular monitoring for pest problems.
3. Sprout Production: Sprouters should implement appropriate practices to ensure that sprouts are not produced in violation of the act which prohibits the production of food under insanitary conditions which may render food injurious to health (21 U.S.C. 342(a)(4)). In addition to seed treatment and testing for pathogens, sprouters should maintain facilities and equipment in a condition that will protect against contamination. Facilities with poor sanitation can significantly increase the risk of contaminating product. Sprouters should employ good sanitation practices as a standard operating procedure to maintain control throughout all stages of sprout production. Inadequate water quality and poor health and hygienic practices can all increase the risk of food becoming contaminated with pathogens. Sprouters may wish to review 21 CFR Part 110 which sets forth good manufacturing practices (GMPs) in manufacturing, packaging, or holding human food that cover these aspects of food production.
4. Seed Treatment: Seeds for sprouting should be treated with one or more treatments (such as 20,000 ppm calcium hypochlorite) that have been approved for reduction of pathogens in seeds or
sprouts. Some treatments can be applied at the sprouting facility while others will have to be applied earlier in the seed production process. However, at least one approved antimicrobial treatment should be applied immediately before sprouting. Sprouters should carefully follow all label directions when mixing and using antimicrobial chemicals.