The USDA’s Microbiological Data Program has come into sharp focus in recent weeks, and the industry appears to be in the crossfire.
First of all, the ax-wielding House Appropriations Committee removed funding for Microbiological Data Program its fiscal year 2012 budget.
Budgets must be cut, and why not start with MDP?
As it turns out, cutting the MDP program may invite more industry bashing, akin to the negative characterizations coming about from the Dirty Dozen list of pesticide tainted produce.
The industry has had reservations about the program since 2002, when Larry Waterfield wrote this for The Packer:
Produce groups have taken their concerns about the U.S. Department of Agriculture’s microbial testing of fresh produce directly to A.J. Yates, administrator of the USDA’s Agricultural Marketing Service.
In a meeting with Yates, the groups raised questions about whether the program duplicates work done by the Food and Drug Administration and about how the AMS data will be used and interpreted.
Donna Garren, science vice president of the United Fresh Fruit & Vegetable Association, said the testing raises "serious scientific policy concerns" and that produce groups have been "frustrated" in trying to give feedback to AMS about the testing.
AMS has received a $6 million appropriation to test produce for microbial contamination, but the produce industry says the program is not needed and duplicates work already being done by FDA.
"The presence of generic E. coli in produce tells people very little about the safety of produce," Garren said.
In September 2002, I wrote this:
On one hand, the U.S. Department of Agriculture’s Microbiological Data Program could show that fresh produce is relatively unhindered by problems with salmonella, shigella or E. coli.
On the other hand, members of a key industry advisory committee appointed by the Secretary of Agriculture aren’t sure if the program will truly define potential problems or merely set up the industry for negative publicity.
Finding U.S. Department of Agriculture justifications for the Microbiological Data Program unsatisfactory, the 23-member Fruit and Vegetable Industry Advisory Committee on Sept. 4 recommended the USDA suspend the MDP until its purpose and methods were clarified.
The recommendation was a follow up to questions raised in the first meeting of the committee, held in early April.
At the time, the advisory expressed concerns about:
* the objective of MDP
* how information could be misunderstood or misused
* the risk basis for choosing produce items
* the validity of the process of sampling and collecting.
The USDA’s Agricultural Marketing Service responded in writing to the group’s April comments, and distributed those responses before the Sept. 4 meeting.
The response stated, in regard to the objective of the program, that the number of foodborne illnesses associated with domestic and imported fresh fruits and vegetable has increased in recent years.
"Some microorganisms once thought under control may be adapting to their environments, developing resistance to certain food processing operations and re-emerging with increased pathogenicity," the response said.
The AMS noted Congress appropriated funds to AMS for a microbiological data collection program on domestic and imported fruits and vegetables.
"The program is designed to provide nationally valid microbiological baseline data for selected produce," the AMS stated.
The AMS downplayed the possibility that the information gathered by MDP will be misinterpreted and defended the choice of commodities. The AMS said it will present the results of the sampling simply; the data will likely tally the presence of pathogens like E. coli and salmonella on domestic and imported produce.
While acknowledging funding limitations that restrict sampling to wholesale markets and distribution centers, the AMS said the program will be able to yield statistically reliable results at the national level, and will allow meaningful estimates of exposure and assessments of risk.
Bob Epstein, deputy administrator of the Science and Technology Programs, emphasized the program is not an enforcement program. The program tests celery, leaf lettuce, romaine, tomatoes and cantaloupe; the first data on 2001 tests is expected to be released next year.
Epstein only gave a hint of the findings to the group, noting only five salmonella positives were noted out of thousands of samples.
Committee member Mahipal Kunduru, director of food safety for Dole Fresh Vegetables Inc., Salinas, questioned whether the program will truly represent a national baseline.
What’s more, he said any results of the program won’t help growers or processors identify problems since the data is being collected at distribution centers, not at the point of origin. It will be impossible from the data to know when the problems occur.
Meanwhile, committee member Tom Stenzel, president of the Alexandria, Va.-based United Fresh Fruit & Vegetable Association, said thought must be given into how to prevent the information from being used against the industry.
"I would appreciate the continuing dialogue," he said.
A.J. Yates, administrator of the AMS, said Sept. 12 that he is willing to work with the committee to address concerns about the MDP.
"Since I’ve been here since the first of October, I’ve met numerous times with industry leaders from throughout the United States," he said.
"Nearly all the questions raised by the committee have been raised before."
Yates emphasized the 10-state effort to collect sample for testing is blind as to the origin of the product (except for domestic and import designations) and is not an enforcement tool.
While the AMS believes they have addressed the committee’s concerns, Yates said will continue to entertain discussions on any issue relating to the program. But he said the program was underway.
"If you look at the success of the Pesticide Data Program, that program has turned out to be a model for the rest of the world and basically showed that agriculture is doing a far better job than anybody thought they were," he said.
TK:Fast forward to 2011. What Yates described as only a monitoring program has now triggered at least 19 produce recalls over the last two years, according to a report in the Chicago Tribune.
The Tribune story quoted Kathy Means of the Produce Marketing Association and David Gombas of United Fresh about MDP. Both said that MDP is duplicative with FDA efforts and life would go on without the program.
For the opposing viewpoint, the Tribune asked the notorious Ken Cook of EWG. Needless to say, Cook unleashed another one of his inflammatory quotes about the evil intent of the produce industry:
"Since when does it make sense not to check food for potentially deadly pathogens?" Cook said in the story.
Defenders of the program say its testing is more comprehensive than what the FDA conducts, and removing it would harm public health interests.
Ray Gilmer, vice president of communications for the United Fresh Produce Association, Washington, D.C., told me that the program experienced “mission creep” from merely monitoring to becoming a trigger for issuing recalls.
“Everything we have seen has shown that shown is that it doesn’t correlate with actual foodborne illness outbreaks.”
The Tribune story also referenced the USDA’s Fruit and Vegetable Industry Advisory Committee and its recommendations to Agriculture Secretary Tom Vilsack earlier this year.
From the USDA web site, here is what the committee sent to Vilsack, with asterisks and a disclaimer from the USDA:
III. Food Safety*
*Disclaimer: These recommendations from the Advisory Committee result from discussions held within the full Committee after short presentations and brief question and answer sessions with representatives of the FDA, CDC and USDA. The accuracy of the content has not been confirmed by any of the three Agencies with certain elements regarding the MDP in particular disputed by the USDA.
Pathogen Testing and Surveillance: The produce supply chain is subject to multiple layers of product testing and surveillance for pathogens of concern to the public health. These tests are conducted by State and Local agencies, the FDA at points of entry and retail establishments, and the USDA via the MDP.
Often, these tests are a duplication of expenses among the agencies since the testing is not a coordinated effort. The test results are not shared between the participants rendering the test results unless relevant in establishing baseline trends, or giving visibility to multi-geographical events. Sampling processes by the FDA at the port of entry routinely delay product movement within the supply chain impacting the ultimate taste and freshness of the produce to the consumer. Last, but not least, these test programs increase the burden on the supply chain with little apparent benefit in product safety being realized.
USDA MDP Program: In Fiscal Year 2001, the USDA was charged with implementing a monitoring program tocollect information regarding the incidence, number, and species of important foodborne pathogens and indicator organisms on domestic and imported fresh fruits and vegetables. USDA’s Agricultural Marketing Service (AMS) was appointed to undertake the creation and implementation of such a program, currently known as the MDP. MDP began collecting and analyzing samples in April 2001.
- State officials under contract to the USDA take 3-6 samples from a single lot at a distribution center location.
- The sample is tested for pathogens of concern. If any product tests positive, the test result is forwarded to the FDA.
- In practice, the source farm is contacted by FDA, and without apparent investigation, requests that all related products are recalled.
- Typically by the time the farm source has been notified, the product has passed shelf life limits and is no longer in commerce. In this instance, the benefits in protecting the public health resulting from the recall are highly questionable.
Industry concerns with MDP:
- At the time of sampling, product is not in the custody or control of the grower and may have been mishandled after leaving the grower. Yet, the grower is the subject of the recall action simply based upon a positive test result.
- A single positive test result does not provide a “reasonable probability” that produce from the entire farm source is unsafe.
- During the last three years products recalled due to a single positive test result have not been associated with any foodborne illness or outbreak.
- Unnecessary product recalls that do not contribute to the protection of public health undermine consumer confidence in the safety of the produce supply chain, discourages consumption of produce that is an important part of a healthy lifestyle and diet and damages the reputation of the farmers growing the product along with financial injury.
- The Secretary should review with the USDA the establishment of a centralized database to collect and warehouse test results for agricultural products being generated by multiple jurisdictions including the USDA, FDA, CDC and various State and local officials. The USDA would make the database available to any authorized agency in the event of a foodborne illness outbreak to assist authorities in the investigation and prompt resolution of the outbreak. The USDA would conduct an annual review of the data received in the central database and correlate any findings with outbreaks of foodborne illness to aid in the assessment of the risk to the public health associated with fresh produce consumption.
- The Secretary should commission an independent study to correlate the data collected by the USDA through the MDP with foodborne illness data collected by the CDC to determine if the historical data collected over the past ten years indicates there is a “reasonable probability” of risk to the public health resulting from a single positive test obtained through MDP sampling. It is recommended that the USDA cease using the MDP sampling activity as an enforcement tool for which it was not scientifically designed and have the Secretary evaluate the on-going benefits of continuing the MDP as it is currently designed such as:
a) Has the initial mandate for the program been achieved?
b) What will we learn the next ten years that we have not learned during the past ten years?
c) Are the funds necessary to execute the MDP better utilized elsewhere?
TK: It appears that MDP, like PDP, will be fertile ground for attacks by the EWG on the industry. The concerns that the industry had about the program have materialized, of course. The industry's view of MDP won't be embraced by the USDA or the FDA. Both agencies will perpetuate programs if possible. Only the desperate need to cut dollars from the federal budget will work in favor of eliminating the program.