might deem necessary. At this point, it would be premature to speculate on any potential impact on the produce industry. Mr. Farr: Will the resulting data be used in a risk assessment that would involve the potential sources of microbial contamination from farm to table? Response: Within the level of funding that has been provided, the MDP program will be able to gather and analyze samples in a manner that yields statistically reliable results at the national level, and will allow meaningful estimates of exposure and assessments of risk. This, in turn, will permit more precise focus on the types of produce and kinds of microbial contamination for which potential sources within the marketing chain could be further examined. Mr. Farr: Will the resulting data estimate consumer exposure to pathogens of various produce? Response: Yes, the MDP data will support the estimation of consumer exposure at the national level to particular microorganisms on various types of produce. Moreover, the MDP data will enable public health authorities to make such exposure estimates based on national, statistically-based data, in addition to the more typical analyses conducted using epidemiological data gathered when an illness outbreak has been traced. Mr. Farr: How will laboratory personnel be trained to ensure consistent and accurate data reporting by numerous laboratories that will be analyzing the MDP samples? Response: MDP samples will be tested by experienced microbiologists at AMS and State laboratories. To ensure consistency and accuracy, the MDP program has developed standard operating procedures that cover sample collection, testing and data reporting requirements that all laboratories must follow. Adherence to these procedures is verified by three levels of review: on-site reviews by the technical program manager; oversight reviews by a designated quality assurance officer; and a further oversight review by an AMS quality assurance microbiologist. Laboratory performance will be monitored through proficiency samples, with laboratories also being subject to an annual on-site review by microbiologists trained as lead auditors to AOAC International food laboratory criteria. Mr. Farr: Does the sampling point at various terminal markets and distribution centers accurately represent the risk caused by production methods or the actual consumer risk since this sampling point would be somewhere in the middle of the distribution chain? Response: The sampling design for MDP provides for the collection of samples at wholesale markets and supermarket distribution centers on a year-round random basis and over at least two growing seasons. Samples thus will be collected as close to the consumer level as is practicable. The number of samples collected by each of the participating states will reflect State population and permit estimation of consumer exposure to microorganisms of interest. Mr. Farr: Since the public does not understand the difference between generic E. coli and pathogenic E. coli, and generic E. coli is not a public health threat and is an unreliable indicator of pathogens on produce, why is generic E. coli testing included in the program? Response: As suggested by this question, it is the pathogenic E. coli that are of particular interest. Generic E. coli are of interest as a screen to determine whether samples should be subjected to further testing for pathogenic serotypes. Mr. Farr: If generic E. coli data is collected, will the information be included in the final annual report? If yes, what purpose would it serve towards the goal of safer produce? Response: Final annual reports will focus on the results for pathogenic E. coli. Mr. Farr: Is it appropriate to "uniform" sampling protocols across all produce products included in the program, methods for microbial detection can vary greatly by produce product types and characteristics? Response: The purpose of uniform sampling protocols is to ensure that samples are collected in a manner that will yield national, statistically defensible results. In addition, uniform sample collection protocols are necessary to safeguard the integrity of the samples by ensuring that aseptic conditions are followed for all sampled products and to prevent accidental contamination during sample collection, shipping and handling. Laboratory testing protocols are specific to each of the pathogens and products under evaluation. Mr. Farr: What efforts has AMS made to obtain appropriate input from affected public and private stakeholders including scientists? Response: In addition to a Congressionally-mandated public meeting that was held on January 10, 2002, we have provided the following MDP outreach activities to stakeholders: February 1999 -- We sent a survey to 44 microbiologists in the February 5, 2001 - We issued Media Advisory Press Announcement - January 29, 2001 We met with industry representatives: UFFVA; March 16, 2001 We presented an MDP outline at the National - April 2001 We met with representatives from Northwest June 20, 2001 - AMS, FDA and CDC held a joint meeting with industry groups represented by the Food Marketing Institute, FMI; UFFVA; and other organizations. We sent draft Standard Operating Procedures for comment to January 30, 2002 We met with industry representatives. There were also numerous telephone conversations with interested industry representatives throughout 2001 and early 2002. various Mr. Farr: What efforts has the agency made to coordinate with existing efforts to test and research microbiological pathogens on fresh produce within the federal government, including the Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention and the private and public sectors? Response: We have had numerous meetings and phone conversations with CDC and FDA. Both agencies designated liaisons to work with AMS on MDP's program objectives and planning initiatives. We also have met with representatives of USDA's Cooperative State Research, Education, and Extension Service, or CSREES, to ensure coordination of research they fund and the MDP program. Further coordination among researchers will be realized through sharing of MDP data via the USDA and the U.S. Department of Health and Human Services Joint Institute for Food Safety Research. Mr. Farr: Do appropriate program constraints exist that will prevent AMS from expanding MDP beyond the realm as it has been currently described to the industry? If no, should there be a process to ensure full input from the produce industry on future changes that may be implemented? Response: As directed by Congress, MDP is a microbiological data program to establish baselines for the incidence, number and species of important foodborne pathogens and indicator organisms on frequently consumed fresh fruits and vegetables. Within this scope, it remains our intent to confer with the produce industry, other agencies of USDA, and other public health agencies in the design and operation of this program. Our interest is to avoid duplication of effort and to ensure that the data collected can be used by all interested parties. Mr. Farr: Does this sampling effort by AMS duplicate the work already being performed by FDA'S Center for Food Safety and Applied 79-721 D-21 Nutrition (CFSAN) and an ongoing study, funded by the USDA's Initiative for Further Agriculture and Food Systems Program are already doing? Response: No, MDP does not duplicate the work of these other agencies. MDP is a "baseline" survey program while the FDA programs are designed for public health and regulatory objectives. MDP employs statistically reliable sampling plans at terminal markets and supermarket distribution centers to develop national estimates of the presence of microorganisms on specified products based on product availability in the marketplace. FDA's surveys for imported and domestic produce tend to be designed differently with different intentions for the use of the data that are generated. The Tri-State Fruit and Vegetable Safety Consortium, USDA's Initiative for Further Agriculture and Food Systems Program, is a project that seeks to address the issue of produce safety by performing research in the major vegetable and fruit producing States of California, Florida and Texas. It is not a national survey project. Rather, it is seeking to determine the points during production and processing of specific fruits and vegetables where pathogens are or might be introduced and the effect that certain production, processing, and environmental factors may have on contamination. MDP results will be complementary to the work of this Consortium. Mr. Farr: How will this AMS program impact the current cooperative relationship the agency has with the produce industry? Response: AMS enjoys a strong working relationship with the produce industry through a wide variety of programs. While the MDP program has raised concerns, we believe it will ultimately benefit the produce industry. Therefore, we foresee no lasting impact on our cooperative relationship with the industry. Mr. Farr: What legal authority or mandate does AMS have to proceed with a microbiological sampling program of this nature? Response: MDP is conducted under the authority of the Agricultural Marketing Act of 1946. This Act promotes working relationships with States and industry using scientific approaches to solve agricultural marketing issues. In addition, the Federal Agriculture Appropriations Bill for Fiscal Year 2001 clearly directs AMS to utilize its expertise in developing baseline information on the incidence of food-borne organisms on produce. what Mr. Farr: In light of our current "zero risk" environment, legal and consumer confidence consequences will AMS and the participating states suffer if positive samples results only provided in an annual report and no regulatory action to eliminate adulterated products from the marketplace? are Response: MDP is designed as a baseline survey, not an enforcement program. It is designed to draw inferences about national exposure to microorganisms on produce, not inferences about microorganisms on individual production lots of produce. As Congressional language clearly directs, blind sampling will be conducted -- no information will be provided as to grower, packer or distributor. And, by the time a sample could be confirmed positive for a pathogen, the product would no longer be in the marketplace. FDA and CDC will be provided data quarterly, as requested. |