May 19, 2000
Participants: *Phone Participants
Donna Garren & Diane Cullo, United Fresh Fruit and Vegetable Association
Al Yamada, Masaoka & Associates (for Fresh Produce Association of the Americas)
* Wally Ewart, Washington Horticultural Council
*John McClung, Texas Produce Association
*Stephanie Grunefelder, International Fresh Cut Produce Association
*Daniel Funk, Del Monte Fresh Produce
*Lee Frankel, Fresh Produce Association of the Americas
*Linda Cherry, Colorado Dept of Agriculture
*Dan Sowards, Association of Food and Drug Officials
*Bill Brook, South Carolina Dept of Agriculture
Susan Alpert, Center for Food Safety and Applied Nutrition(CFSAN)/Director, Food Safety Initiative Staff
Marion Allen, CFSAN/ Food Safety Initiative Staff
Mary Ayling, CFSAN/ Food Safety Initiative Staff
Camille Brewer, CFSAN/ Food Safety Initiative Staff
Bernice Friedlander, CFSAN/ Food Safety Initiative Staff
Terry Troxell, CFSAN/Office of Plant and Dairy Foods and Beverages
Nega Beru, CFSAN/Office of Plant and Dairy Foods and Beverages
Quynh-Anh Nguyen, CFSAN/Office of Plant and Dairy Foods and Beverages
Joe Baca, CFSAN/Office of Field Programs
Ronald Roy, CFSAN/Office of Field Programs
Dennis Dignan, CFSAN/Office of Field Programs
William Correll, CFSAN/Office of Field Programs
Cathy Carnevale, CFSAN/Office of Constituent Operations
*Paul Raynes, Office of Regulatory Affairs/Division of Federal State Relations
*Tina Harper, Office of Policy, Planning, and Legislation
Karen Deasy, Centers for Disease Control and Prevention/Liaison to CFSAN
CFSAN held a briefing with industry and other interested constituents to discuss the Domestic Produce Sampling Survey and to address their issues and concerns involving this survey.
THE FOLLOWING ISSUES CONCERNING THE APPLICATION OF THE ASSIGNMENT WERE DISCUSSED:
Sample Selection and Collection:
- Samples will not be collected directly from the grower. When possible, samples will be collected at packers. Samples may be collected at wholesale but only if the grower can be identified. Because the products are perishable, FDA will not collect a duplicate portion of the lot for later use by the owner. FDA will not notify the grower that a sample has been collected at packing or wholesale.
- Only one sample of a product/grower combination should be collected. If more than one sample of a product per grower is needed, sample collection will be spaced over time to reflect a different growing season or growing conditions. Samples of different products may be collected from the same grower.
- Samples will be collected using aseptic sampling techniques and will consist of 10/approximately 1 lb. portions collected randomly throughout a lot. Whole units or packages will be collected; no products will be cut nor will portions of retail containers be collected. The code or lot number and the grower will be identified on the sample collection report. Accurate owner/grower information, including contact names and phone/FAX numbers, is essential to assure rapid communication after preliminary analysis is completed.
Sample Shipment, Preparation, and Analysis:
- Samples will be shipped under refrigeration via the fastest means possible to the FDA laboratory. Samples will be prepared for analysis in a manner that closely simulates the typical preparation by consumers, e.g. washing and/or trimming. Collectors will coordinate the timing of sample collection with the laboratory; no undue delays are anticipated.
- All products will be analyzed for E.coli , Salmonella and E.coli 0157:H7; only cantaloupe, celery, parsley, scallions and tomatoes will be analyzed for Shigella. Lettuce, strawberries, and cilantro may be analyzed for Shigella at a later date. The assignment will be updated at that time. Information on the analytical methodology can be found in the assignment.
- Presumptive analytical results should be available within 72 hours after the sample arrives at the laboratory for testing (approximately 96 hours after collection). The FDA laboratory will notify the FDA district compliance office when the preliminary results reveal possible contamination.
- The FDA District Office will notify the dealer or grower of analytical results showing pathogen contamination and, if necessary, appropriate regulatory action will be initiated. Unless specifically requested, FDA will not notify the owner (or grower) if no pathogens of pubic health concern are found.
- Any questions regarding sample collections, analytical reports and follow-up to violative analytical findings should be directed to the nearest FDA district office. Visit FDA's website to obtain information on the FDA's district office nearest you at http://www.fda.gov/ora. At this site, go to ORA Field Contacts for phone numbers.
Results, Responsibilities, and Follow-Up:
- If the results of analysis reveal that pathogens are found, and the lot is in distribution, the dealer and/or grower will be responsible for identifying the distribution of the lot. The dealer and/or grower are encouraged to recover all distributed product and to initiate an investigation to determine the cause of the contamination. They are also responsible for determining the disposition of any remaining or recovered portions of the lot to remove them from commerce.
- If the product was held pending the results of the tests, reconditioning to destroy the pathogen or destruction of the lot are encouraged. The local FDA office or appropriate state agency should be given the opportunity to witness the reconditioning or destruction of the contaminated lot. Records of the reconditioning process or proof of destruction should be maintained.
- If the product was distributed, a voluntary recall is encouraged. If the product has been distributed in interstate commerce, FDA is responsible for the regulatory follow-up. However, if no interstate shipments are involved, the appropriate state officials may initiate follow-up. Regulatory follow-up may include seizure of contaminated lots.
- Regardless of the disposition of the contaminated lot, an investigation into the possible source and route of contamination is essential. Both FDA and the appropriate state officials may be involved in the investigation. The following factors may be evaluated:
- Packing facility sanitation/handling practices
- Processing water/ice
- Transportation sanitation
- Worker sanitation practices
- Manure/biosolids use
Irrigation water use/practices
The responsible firms should be involved in the investigation and are encouraged to initiate an investigation as soon as possible. The investigation should result in identification of the source/route of contamination, a corrective action plan, and verification of the success of the plan. The "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" can be used as guidance for reviewing growing, harvesting, and packing processes. The Guide can be found at http://www.foodsafety.gov. At this site, go to the National Food Safety Initiative page.
THE FOLLOWING QUESTIONS WERE ADDRESSED:
Is the owner required to hold the product after FDA samples?
Will growers be identified when the lots are commingled at the packer?
The assignment requires that the grower be identified for each sample. It is FDA's understanding from past communications with industry leaders that grower identification is possible at the packer.
Will FDA sample strawberries that are destined to be frozen or just those destined for the fresh market?
The assignment does not specify. UFFVA volunteered to provide locations of frozen strawberry packing/distribution. When the information is provided, FDA will attempt to concentrate collection of strawberries destined for freezing and jams.
Is the product released after FDA notifies the owner that the sample was negative?
FDA does not require that the lot be held after sampling. FDA does not plan to notify the owner when no pathogens are found UNLESS specifically requested to by the owner. FDA notification of a negative result indicates that no pathogens public health concern were found in the sample. FDA notification of presumptive positive findings means that the sample appears to contain a pathogen and the presence of pathogens may be confirmed by further analysis. It remains the sole decision of the owner to hold or release the shipment after receiving notification of presumptive positive results. It is also the responsibility of the owner to determine the disposition of contaminated lots.
Are weekends taken into consideration when calculating the 72 hour notification time that FDA has to inform the dealer and/or packer of a presumptive positive analysis?
FDA controls the timing of the sample collection and the collector is required to coordinate collection with the laboratory. We do not expect undue delays in analysis.
At what point will states be involved in the sampling assignment?
After FDA analysis has found pathogens of public health concern and an adulterated lot is identified. The state authorities may be involved in investigation into the causes of contamination and the disposition of the adulterated lot.
When will the assignment be posted on the Internet?
The assignment was placed on the Foodsafety.gov website on Monday, May 22nd.
When was the NASS survey completed?
Interviews conducted as part of the NASS (National Agricultural Statistical Service) survey were completed this spring. We don't expect a report from the survey until 2001.
Participants were provided a draft of a proposed information sheet that addressed the Domestic Produce Sampling Assignment and were asked to provide comments to Ms. Ayling, Ms. Allen or Ms. Brewer.
FSI Produce Inspection Lead (HFS-32)
FSI International Activity Coordinator (HFS-32)
Marion V. Allen
FSI Inspections Coordinator (HFS-32)