Investigators are getting closer to the source of the E. coli O157:H7 outbreak and recently lifted the ban on produce from from counties other that the three in California. Washington Post reporter Annys Shin says all bagged spinach that has tested positive was conventionally grown, processed by Natural Selection Foods, and sold under the Dole brand. We cannot find confirmation from the FDA spinach website.
The tainted spinach has been traced to 12 fields on nine farms in California’s Salinas Valley that supplied spinach to Natural Selection. The company washes and packs spinach for 30 brands, including Safeway’s O Organics, Dole and Ready Pac.
So far, E. coli has been isolated in nine bags of spinach supplied by victims. All have been Dole-brand conventional spinach, according to Kevin Reilly, deputy director of prevention services for the California Department of Health Services.
The outbreak has been traced to spinach grown in three California counties, but they produce a very large fraction of spinach solid in the US.
So far all attention has been devoted to Natural Selection Foods” processing plant, and only recently have investigators begun to check out the fields where spinach is grown:
Natural Selection executives said yesterday that they had begun testing raw spinach for E. coli and salmonella before it enters a processing plant, an uncommon practice in the fresh-produce industry.
Meanwhile, FDA has extended to spinach its Lettuce Safety Initiative, established on August 26, 2006, and set to begin this fall. The objectives of the Lettuce Safety Initiative are unassailable (“reduce public health risks by focusing on the product, agents, and areas of greatest concern”), but it’s not clear what effect the actions it includes will have any material effect.
To begin the Initiative, FDA, in cooperation with California’s Department of Health Services and Department of Food and Agriculture, will issue an assignment to visit farms and cooling and packing facilities, and inspect processors, focusing on Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs). FDA will evaluate practices and processes for potential sources of contamination. Other components of the Initiative include continuing outreach with the industry at all points in the supply chain, facilitating and promoting research on lettuce safety, and working with federal, state and local public health officials in disease detection and outbreak response.
FDA says the Lettuce Safety Initiative “supports the goals of the 2004 FDA Produce Safety Action Plan, which is intended to minimize the incidence of foodborne illness associated with consumption of fresh produce.” The objectives of the Action Plan are equally unassailable:
- Objective 1: Prevent Contamination of Fresh Produce with Pathogens
- Objective 2: Minimize the Public Health Impact When Contamination of Fresh Produce Occurs
- Objective 3: Improve Communication with Producers, Packers, Processors, Transporters, Distributors, Preparers, Consumers, and Other Government Entities about Fresh Produce
- Objective 4: Facilitate and Support Research Relevant to the Contamination of Fresh Produce
The Action Plan includes a number of metrics for measuring success, but in almost all cases these metrics are limited to bureaucratic outputs such as the issuance and implementation of more guidance documents, fact sheets, model forms, standard operating procedures. Nothing in the Plan description indicates that FDA intends to evaluate alternative actions based on effectiveness (e.g., the number of foodborne illness cases prevented), gross benefits (e.g., the value foodborne illness cases prevented), or net benefits (i.e., the value of foodborne illness cases net of costs).
A logical place to focus resources is on the use of manure, especially in organic agriculture. In our first post on spinach we noted that a Department of Agriculture program intended and designed to promote organic agriculture strongly encourages the use of manure by, among other things, largely prohibiting the use of synthetic fertilizer. As for whether manure was safe, USDA admitted it had no clue and rejected the notion that it had any responsibility to even find out:
Although public health officials and others have identified the use of raw manure as a potential food safety concern, at the present time, there is no science-based, agreed-upon standard for regulating the use of raw manure in crop production. The standard in this rule is not a public health standard. The determination of food safety demands a complex risk assessment methodology, involving extensive research, peer review, and field testing for validation of results… The NOP does not have a comparable capacity with which to undertake a comprehensive risk assessment of the safety of applying raw manure to human food crops.
When the Produce Safety Action Plan was out for public comment, in 2004, the activist group Center for Science in the Public Interest criticized FDA’s proposed Produce Safety Action Plan for several reasons, including what CSPI says is a need for federal guidance on manure use:
It is also critical that FDA specifically address manure and compost issues for growers. For instance, for cornposting, the guidance only states that the high temperature will kill most pathogens in a number of days. It does not identify either a minimum temperature or minimum time for composting the manure prior to field application. FDA should require that producers follow the manure compost standards set forth in the National Organic Program as a way to reduce animal pathogens in fresh produce. (p. 8)
CSPI says that its database reveals that more cases of foodborne illness are attributable to produce than any other type of food. produce Its database is located here and its summary report on those data is here. CSPI does not advocate using risk assessment or benefit-cost analysis to rank alternative regulatory measures or to evaluate the performance of regulatory measures FDA adopts.
Within its research component (Objective 4), FDA’s Action Plan calls for “[c]larifying specific areas of concern for fresh produce (such as agricultural water quality, human and animal vectors, and use of manure in production) and mechanisms of contamination under commercial conditions.” We do not know what this means.
The Produce Marketing Association offers more specific recommendations to reduce contamination resulting from manure. PMA says that pathogens such as E. coli can live in sol for “up to three months,” but does not disclose the scientific basis for this figure. Others say pathogens are more long-lived. According to activist Laurie Girand of Safe Table Our Priority (STOP):
Science has demonstrated that E. coli can survive for months in soil, and up to a year in sheep manure, so the intentional application of manure results in long term contamination of the growing environment.
Girand does not reference the scientific evidence used to make this statement. She has a long list of regulatory recommendation, some of which are related to manure:
ban the application of untreated manure
require manure to be “aged for a minimum of one year or composted to eliminate pathogens prior to application”
prohibit commerce in untreated manure
require manure to be applied prior to planting
“set soil quality standards by level of biological contamination”
mandate soil testing of lands adjacent to or downhill from an animal farm or wildlife refuge
Some of these items have a potential risk-based quality to them, but STOP appears to seek a regulatory regime that expects zero risk. It is affiliated, through its board of directors, with the law firm of Marler Clark, which specializes in representing plaintiffs in foodborne illness litigation. Of course, this legal practice would vanish if FDA actually achieved that goal.
FDA’s Produce Safety Action Plan now has been in place for two years. Neutral Source cannot find on the web any evaluation of the program. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a list of program priorities for FY 2005. It includes implementation, but no evaluation, of the Action Plan. Its report card on the FY 2005 priority list says the agency held a public meeting on the safety of sprouts. We cannot find a list of CFSAN program priorities for FY 2006.