FDA's Produce Safety Initiative - Industry Questions

Prior to the recent flurry of news about the FDA's Food Protection Plan and the Import Safety Action Plan was an update from the FDA on the Produce Safety Initiative. On Oct.4, the FDA conducted a teleconference that included industry members about the FDA's outreach on the Produce Safety Initiative. Here is the FDA Web page link that provides some background on the initiative.

In 2004, the Food and Drug Administration (FDA) launched the 2004 FDA Produce Safety Action Plan, which is intended to minimize the incidence of foodborne illness associated with consumption of fresh produce. In 2006, FDA, in collaboration with the State of California's Departments of Public Health and Food and Agriculture, began a multi-year Initiative as part of a risk-based strategy intended to reduce public health risks by heightening the focus on preventive food safety efforts (e.g., in advance of an outbreak) on specific products, practices, agents, and growing areas of greatest concern. The first year of the Initiative focused on lettuce (Lettuce Safety Initiative) as a response to recurring outbreaks of E. coli O157:H7 associated with fresh and fresh-cut lettuce.
FDA and the California Department of Public Health are continuing these efforts in 2007 with a focus on a broader range of leafy greens, including spinach, building upon lessons learned in the first year, subsequent outbreak investigations, and our 2007 Tomato Safety Initiative which is underway in Virginia and Florida.
Beginning in October 2007, FDA investigators, in coordination with their respective state counterparts, and with the cooperation of the industry, will visit farms in California to assess the prevalence of factors in and near the field environment which may contribute to potential contamination of leafy greens with E. coli O157:H7 and the extent to which Good Agricultural Practices (GAPs) and other preventive controls are being implemented. To further focus this risk-based approach, collaborators have been reviewing data to identify areas where co-existing environmental risk factors are present. Data analyses and GIS mapping will be followed by preliminary assessments to confirm the data analyses and to finalize site selection for the field assessment.
Other components of the initiative include:
Continuing outreach with the industry at all points in the supply chain,
Communicating early and often in the event of an outbreak or recall, and
Continuing to build and strengthen collaborative relationships with federal, state and local public health officials in disease prevention, detection, and outbreak response.
By identifying practices and conditions that can lead to product contamination, FDA and our safety partners can improve guidance and policies intended to minimize chances of future disease outbreaks, as well as ascertain future produce-safety research, education and outreach needs. The high degree of collaboration and cooperation in both the Leafy Greens and Tomato Safety Initiatives will play a significant role in allowing these initiatives to achieve their goals. The findings of the 2007 Leafy Greens Safety Initiative will be shared publicly upon completion of the effort, to allow state officials and members of the industry to maximize their food safety efforts.


Here is the draft agenda from the Oct. 4 teleconference:

Teleconference – October 4, 2007 9-11 a.m. Pacific (12-2 p.m. Eastern)
Draft Agenda

Welcome from Hosts:
Western Institute for Food Safety and Security, UC Davis (WIFSS)
Center for Produce Safety, UC Davis (CPS)
California Department of Public Health (CDPH)
Food and Drug Administration (FDA), Center for Food Safety and Nutrition (CFSAN)

Produce Safety Initiatives:
Overview: Michelle Smith, FDA CFSAN
Y2 LGSI - What’s “Special” this Year: John Sanders, FDA CFSAN
Assessment Assignment: Amy Green, FDA CFSAN
Logistics: Sherri McGarry, FDA CFSAN

Questions/Discussion:

Background:
In 2006, the Food and Drug Administration (FDA) in collaboration with the State of California’s Departments of Public Health and Food and Agriculture, began a multi-year Lettuce Safety Initiative as a response to recurring outbreaks of E. coli O157:H7 associated with fresh and fresh-cut lettuce and leafy greens. FDA and the California Department of Public Health are continuing this initiative in 2007.

The 2007 Leafy Greens Safety Initiative expands on last year’s Lettuce Safety Initiative to cover a broader range of leafy greens, including spinach. To further focus this risk based approach; collaborators have been compiling and reviewing available data to identify areas where selected environmental factors appear to be present. Data analyses and mapping will be followed by preliminary assessments to confirm the data analyses and to finalize site selection for the field assessment.

Beginning in October this year, FDA investigators, in coordination with their respective state counterparts, and with the cooperation of the industry, will visit farms in California to assess the prevalence of factors in and near the field environment which may contribute to potential contamination of leafy greens with E. coli O157:H7 and the extent to which preventive controls are being implemented. Additional components of the initiative include:
o Continuing outreach with the industry at all points in the supply chain;
o Communicating early and often in the event of an outbreak; and
o Continuing to build and strengthen collaborative relationships with federal, state and local public health officials in disease prevention, detection, and outbreak response.

By identifying practices and conditions that can lead to product contamination, FDA can improve its guidance and policies intended to minimize chances of future disease outbreaks, as well as ascertain future produce-safety research, education and outreach needs. The high degree of collaboration and cooperation in both the Leafy Greens and Tomato Safety Initiatives will play a significant role in allowing these initiatives to achieve their goals. The findings of the 2007 Leafy Greens Safety Initiative will be shared publicly upon completion of the effort, to allow state officials and members of the industry to maximize their food-safety efforts.


TK: This audio file of the Oct. 4 teleconference focused on the FDA's desire for more data sharing from the industry and some of the concerns the industry has with the assessment process. Is the assessment window appropriate for the harvest timetable? Are the assessments voluntary? "They are definitely not a regulatory visit; it is voluntary." Will FDA take samples from the farms? Non product, environmental samples be taken, and those only "for cause," the FDA said.

Note that the FDA states that the information they gather will be shared with the public, though company specific information will not be released --- except for perhaps in the case of a Freedom of Information Act request (this point was not resolved in the teleconference). "We understand concerns and hesitancy(about participating in voluntary assessments) ; I wouldn't anticipate anyone getting into regulatory trouble unless they honestly deserve to be in that kind of trouble in the first place," one FDA official said.

One off topic question raised by an industry members addressed environmental issues raised by GAP guidance and how growers should deal with conflicting demands for different government agencies. "Who prevails, FDA or EPA?"