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U.S. Department of Health and Human Services

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FDA Survey of Imported Fresh Produce (FY 2001 assignment)

January 18, 2001

 

Imported Produce Assignment FY 2001 - HIGH Priority DOEP # 01-07

 

DateJanuary 18, 2001
FromConsumer Safety Officer, Imports Branch (HFS-606)
Division of Enforcement and Programs
SubjectImported Produce Assignment FY 2001 - HIGH Priority DOEP # 01-07
ToAll Regional Food and Drug Directors
District Directors
Directors, Regional Laboratory
Directors, Investigations Branch
Director, Laboratory Branch
Directors, Compliance Branch
Field Food Committee Members
Import Program Managers
Field Food Program Contacts

NOTE: Attachments have been removed from this document.

BACKGROUND

Recent foodborne illnesses associated with consumption of imported fresh produce (i.e., fresh fruits and vegetables) have raised concerns about microbial safety hazards associated with agricultural and manufacturing practices for the production of fresh produce. Illnesses associated with the consumption of contaminated fresh produce range from serious to low-grade infections. However, the actual number of foodborne illnesses associated with the consumption of contaminated fresh produce is difficult to estimate because some illnesses, such as low-grade infection, are often not reported.

Fresh fruits and vegetables are grown in fields and orchards. Consequently, surfaces of produce during growth become contaminated with non-pathogenic and possibly pathogenic microorganisms. In addition to natural growth conditions, further processing (e.g., washing, cutting, slicing, packaging), when poorly practiced, offers additional opportunities for contamination of harvested produce with pathogens. Therefore, fresh produce is of special concern because it is likely to be consumed without further treatment to inactivate microorganisms.

Due to the high rate of pathogens (Salmonella and Shigella) recovered from cilantro, culantro, and cantaloupe samples in the 1999 Imported Produce Assignment, this assignment focuses on collection of additional samples of those products. Cilantro and culantro are popular herbs used to flavor and decorate foods. Although they are two different plant species, both are leafy vegetables that grow close to the ground and are subject to contamination with pathogens in the soil. Cantaloupe is susceptible to microbiological contamination because the crevices on the cantaloupe's outer surface have the potential to harbor pathogens that can contaminate the edible portion of the fruit when cut. Tomatoes were not covered in the original import assignment but are currently being collected in the domestic produce assignment. Imported tomatoes are being collected to augment the information collected by the domestic produce assignment

The purpose of this assignment is to obtain additional information on the incidence and the extent of pathogen contamination for imported fresh cilantro, culantro, cantaloupe, and tomatoes. FDA will use the additional information in the development of its policy to improve the safety of fresh produce under the Produce and Imported Food Safety Initiative.

OBJECTIVE

To collect and analyze samples of imported fresh cilantro, culantro, cantaloupe, and tomatoes.

To determine the presence of pathogenic microorganisms on these commodities.

APPROACH

THIS ASSIGNMENT IS TO BE IMPLEMENTED UPON RECEIPT. ALL COLLECTIONS ARE TO BE COMPLETED BY AUGUST 31, 2001. ALL SAMPLE ANALYSES ARE TO BE COMPLETED BY SEPTEMBER 28, 2001.

  1. SAMPLE COLLECTION
    1. Collecting Districts
      Collections are to reflect as many country/producer combinations as possible.
    2. Products to be collected:
      • Cilantro
      • Culantro
      • Cantaloupe
      • Tomatoes
      NOTE: Fresh cilantro was one of eight commodities collected in the FY99 Imported Produce Assignment. However, culantro was also collected under the same product code as cilantro. To avoid any confusion, culantro has been assigned its own product code. Please verify that you are collecting the correct product. Visually examine the shipment to be collected. See photos below.

      CFSAN prodsu7a Cilantro.jpgCFSAN prodsu7b Culantro.jpg

      NOTE: Districts can collect any combination, of the commodities listed for collection, to meet your total number of samples.

      Districts are to collect all samples in import status. For the purpose of this assignment, products targeted for collection are to be treated as "nonsuspect perishables". The Regulatory Procedures Manual (RPM) Chapter 9-73 dated 7/10/89 and entitled, Perishable Foods Sampled by the Food and Drug Administration (Attachment A) and the following Notice to the Importer should be used. Inform importers that preliminary analytical results (negative or presumptive positive for the pathogens) should be available within 72 hours of sample receipt by the FDA servicing laboratory. Any distribution of sampled product is done at the importer's risk.

      The following should be included with the Notice of Sampling.

      Note: Notice to the Importer

      Sample(s) collected from this shipment will be tested for the presence of pathogenic microorganisms. In the event the article is found violative and refused admission, preliminary analytical results may be available within four (4) days following the date of sample collection. FDA will attempt to provide the importer with preliminary analytical results as soon as they are available. The shipment, however, remains under U.S. Custom's entry bond. Distribution prior to FDA written release is at the importer's risk and may result in the assessment of liquidated damages by the U.S. Customs Service for that part of the shipment that is not redelivered in the event the article is found violative.

      If Customs initiates a bond action, Districts should generally consider mitigating the penalty. The degree of mitigating can vary depending on the district's evaluation of the facts in the petition.

      It is imperative that the Districts coordinate sample collection and shipment with their servicing laboratories to ensure that the sample will be analyzed expeditiously.

      The intent of the assignment is to collect samples of each product from a large number of shippers over the time span of the assignment and to collect samples representing as many product/growers as possible. Districts should not collect repeat samples of the same product/grower combination under this assignment without prior CFSAN concurrence. Once a product/grower combination has been found violative, subsequent shipments should either be detained without physical examination or sampled as "suspect" products under the section C entitled, REGULATORY/ADMINISTRATIVE FOLLOW-UP. If the filer does not identify the grower at time of entry, every effort should be made to determine the grower and enter that information into OASIS.

      If you have any questions regarding the above procedures contact the Division of Import Operations and Policy (DIOP), Linda Wisniowski at 301-443-6553.

      Collect all samples ASEPTICALLY; see IOM, Chapter 4, Section 426. Ship samples refrigerated by the fastest means possible to your District's servicing laboratory.

      Sampling containers for cantaloupe samples, only:

      Commercial small garbage or trash bags can be used. Previous experience indicated that the interiors of these bags do not support the growth of bacteria. If these containers are used, then a sample of the bag must also be submitted to the laboratory as a control.

      NOTE: These are only to be used for the collection of cantaloupe samples where normal size sterile bags (whirl-packs) cannot accommodate the size of the raw produce

      Ensure that the coolant used does not come in direct contact with the commodity.

      Collect sub samples at random to ensure that the sample is representative of the lot.

    3. Sample size

      A sample will consist of ten (10) sub samples.

      cilantro, culantro, and tomatoessub = 16 oz.(s) (multiple bunches)
      cantaloupe:sub = one fruit
  2. SAMPLE ANALYSIS
    1. Analyzing laboratories

      NOTE: The Division of Field Science contact, Marsha Hayden, will handle all changes to the laboratory analysis schedule.

      NOTE: Due to the perishable nature of these products it is critical that analyses should start as soon as the samples arrive in the laboratories. Samples should not be frozen at any time prior to analysis.

      Culantro, cantaloupe and tomatoes will be analyzed for the following: E. coli, EHEC (E. coli O157: H7), Shigella, and Salmonella. Enumeration of Salmonella will be performed when this pathogen is detected.

      Cilantro will only be analyzed for E. coli, EHEC (E. coli O157: H7) and Salmonella

      Presumptive positive findings at 72 hours may be used to initiate regulatory action. Call assignment contact, Patricia Sherrod at 202-205-2261 and the compliance contact in the collecting district. 

    2. Pre-Sample Preparation

      In order to conduct meaningful bacterial analyses, the samples must be prepared for analysis in a manner that closely simulates the actions typically taken by consumers who provide minimal preparation (e.g., washing and/or trimming) prior to consumption.

      cilantro and culantro -- if root is still attached, aseptically remove the root prior to "sub sample rinse". Perform a light rinse to remove visible dirt. "Light rinse" means to place produce commodity under running tap water.

      cantaloupe and tomatoes: Perform a light rinse to remove visible dirt. "Light rinse" means to place produce commodity under running tap water.

    3. Sub Sample Rinse Preparation

      For each individual sub sample (e.g., 454g of a commodity), place contents into a sterile plastic bag. Add 454 ml of Butterfield's phosphate buffer solution (1:1 dilution). Gently shake the bag with contents for 5 minutes using a shaker (e.g., orbital) at 100 rpm. This is considered to be the "sub sample rinse". Do not discard the "sub sample rinse" until the entire analysis is completed.

    4. Sample Preparation/Method

      E. coli

      From each sub sample rinse (10 analysis/sample):

      Prepare decimal dilutions by removing 50 ml (of sub sample rinse) into 450 ml of Butterfield's phosphate buffer solution (1:10). Then follow methodology as outlined in the BAM, 8th Ed., Revision A, 1998, for E. coli.

      NOTE: E. coli analysis: inoculation of the LST tubes will be conducted from 10-1 to 10-5 dilutions, only. It will not be necessary to prepare/use tubes for dilutions greater than 10-5 for an end-point. Therefore, the maximum result that can be encountered would be >110,000 MPN/g.

      EHEC (E. coli O157:H7)

      From each sub sample rinse (10 analysis/sample):

      Remove 125 ml (of sub sample rinse) and place in a sterile beaker/flask with 125 ml 2X EEB to perform the E. coli O157: H7 analysis. Then follow methodology as outlined in BAM, 8th Ed., 1998, Revision A, Chapter 4, page 4.22, step 2. "Enrichment, b. incubate". This method is to be used for detection and confirmation.

      6-HOUR ENRICHMENT STEP FOR EHEC SHOULD BE OMITTED FOR THIS ASSIGNMENT ONLY.

      NOTE: Since the normal flora levels are not anticipated to be high in these products, the level of antibiotic cefixime to be used in the EEB enrichment is recommended to be reduced to one-fourth of that stated in the BAM, to avoid the inhibition of any E. coli O157: H7 that may be present.

      Modification to the preparation of EEB (EHEC enrichment broth): See BAM, Ch. 4, page 4.22. Media Preparation in lieu of using 0.05 mg/L cefixime; use 0.0125 mg/L.

      DO NOT USE THE DYNA BEADS METHOD.

      Positive E. coli O157: H7

      One (1) isolate from each E. coli O157:H7 positive composite is to be sent simultaneously to each of the specified laboratories per the instructions for PFGE and ribotyping.

      All laboratories are to send isolates for PFGE and/or ribotyping analyses within 24 hrs after completion of the analytical portion of the sample analysis.

      All cultures should be shipped by FedEx overnight and should conform to the rules and regulations regarding the shipment of infectious agents. Consult your supervisor if you have any questions.

      Ensure that the appropriate servicing laboratory is selected and identified in FACTS -- MIC screen.

      Submit E. coli O157:H7 isolates for Pulse Field Gel Electrophoresis (PFGE) assay to:

      For SAN: FDA/ORA/Pacific Southwest
      Regional Laboratory (HFR-PA260)
      1521 W. Pico Blvd
      Los Angeles, CA 90015-2486

      For SRL: FDA/ORA/Southeast
      Regional Laboratory (HFR-SE600)
      60 Eighth Street, N.E.
      Atlanta, GA 30309

      For NRL: FDA/ORA/Northeast
      Regional Laboratory (HFR-NE500)
      158-15 Liberty Avenue
      Jamaica, NY 11433-1034

      Salmonella

      Salmonella analysis will be done on a composite basis (i.e., 2 composites per sample). Each composite for Salmonella analysis will consist of 375 ml.

      Prepare each composite by removing 75 ml from each of five (5) sub sample rinses into a sterile beaker/flask. Add 3375 ml of lactose broth.

      Incubate 24±2 h at 35° C. Then follow the methodology as outlined in BAM, 8th Ed., Revision A, 1998, for Salmonella, Chapter 5.

      Screen all samples for Salmonella using rapid methods listed in the memo entitled, "Guidance for the Use of Rapid Methods for Food Microbiology" dated April 24, 1998. If the laboratory does not have a copy of the memo, they should request a copy from the Division of Field Science, HFC-140.

      If there is a presumptive positive based on the test kit, then perform:

      [1] Confirmation analyses as outlined in the BAM and

      [2] Most Probable Number Test (MPN) as per Attachment B: Determination of Most Probable Number of Salmonella in Rinse Water from Selected Produce. The original rinse composite should be used for all tests. While waiting for the test results needed to determine if subsequent tests are required, refrigerate the rinse. The MPN procedure must to be initiated within 3 days of obtaining the presumptive positive results.

      Salmonella Positive Isolates

      One (1) isolate from each Salmonella positive composite or subsample is to be sent simultaneously to each of the specified laboratory per the instructions for serotyping (speciation) and PFGE.

      Following speciation, one slant from each serotyped isolate will be sent for antibiotic resistance testing.

      All laboratories are to send Salmonella isolates for serotyping and PFGE analyses within 24 hrs after completion of the analytical portion of the sample analysis.

      All cultures should be shipped by FedEx overnight and should conform to the rules and regulations regarding the shipment of infectious agents. Consult your supervisor if you have any questions.

      For Salmonella serotyping, all bacterial cultures should be prepared and submitted according to the directions specified in the Bacteriological Analytical Manual (BAM), 8th Edition (Revision A), Chapter 5, 5.19 "Submission of cultures for serotyping."

      Ensure that the appropriate servicing laboratory is selected and identified in FACTS -- MIC screen.

      The serotyping (speciation) laboratory should ship isolates of Salmonella within 24 hours of completion of the analysis to the identified laboratory for antibiotic resistance testing. Follow step # 3, above for shipment of infectious agents.

      An electronic mail should be sent to the recipient before the shipment.

      Ensure that the appropriate servicing laboratory is selected and identified in FACTS -- MIC screen.

      Submit Salmonella isolates for serotyping to:

      HHS/FDA/ARL
      ATTN: Doris Farmer, HFR-SW500
      3900 NCTR Road
      Jefferson, AR 72029-9502
      (870) 543-4071

      Submit Salmonella isolates for antibiotic sensitivity assay to:

      FDA/ORA/DEN
      ATTN: Jeffery Cutting/Connie Kiessling
      6th Avenue & Kipling Street
      DFC BLDG. 20
      Denver, Colorado 980225-0087
      303-236-9601/9602

      Submit Salmonella isolates for Pulse Field Gel Electrophoresis (PFGE) assay to:

      For SAN: FDA/ORA/Pacific Southwest
      Regional Laboratory (HFR-PA260)
      1521 W. Pico Blvd
      Los Angeles, CA 90015-2486

      For SRL: FDA/ORA/Southeast
      Regional Laboratory (HFR-SE600)
      60 Eighth Street, N.E.
      Atlanta, GA 30309

      For NRL: FDA/ORA/Northeast
      Regional Laboratory (HFR-NE500)
      158-15 Liberty Avenue
      Jamaica, NY 11433-1034

      Shigella

      If the District laboratories do not have primers and the positive control from the previous assignment, please notify Keith Lampel, Ph.D., the CFSAN scientific contact for Shigella.

      Shigella will be done on a composite basis (i.e., 2 composites per sample). Each composite for Shigella analysis will consist of 250 ml.

      Prepare each composite by removing 50 ml from each of five (5) sub sample rinses into a sterile beaker/flask and mix thoroughly.

      Remove 100ml (of each composite) and place into centrifuge tubes and spin at 2000 rpm for 3 min to pellet plant material. Then follow methodology as outlined in Attachment C entitled, Detection of Shigella by the Polymerase Chain Reaction.

      This method is to be used for detection. For confirmation, send the remaining PCR product to Keith Lampel, Ph.D., the CFSAN Scientific contact for Shigella for DNA sequencing.

      NOTE: Presumptive positive findings at 72 hours may be used to initiate regulatory action. Call assignment contact, Patricia Sherrod at 202-205-2261 and the compliance contact in the collecting district.

    5. Reporting

      Report all analytical finding into FACTS using PAF = MIC (problem code MICROID, PFGE, SERO as appropriate); secondary PAF = SAL, ABR.

  3. REGULATORY/ADMINISTRATIVE FOLLOW-UP

    Further action should be considered if any of the following microorganisms are detected and confirmed:

    • Salmonella
    • E. coli O157:H7
    • Shigella

    Please include the original entry number with each sample submitted for regulatory review. Please refer to the guidance outlined below:

    Human Source Pathogens in Foods (e.g. Shigella)

    Contamination of a product with human source pathogens is considered a significant risk to health. This type of contamination is also indicative of a direct human-to-food contamination. It is likely that the cause of the contamination is a result of inadequate controls of the manufacturing, packing, storage or shipping process. It is likely that subsequent lots may also be contaminated unless such conditions are corrected.

    If one positive sample, subsample, or composite is detected, detain the shipment with positive sample results and recommend the grower/shipper be placed on detention without physical examination (DWPE), Import Alert # 99-23.

    NOTE: All detention without physical examination recommendations need the concurrence of CFSAN and ORA headquarters prior to implementation.

    Other Pathogens in Foods (e.g., Salmonella, E. coli 0157:H7)

    Contamination of produce with other pathogens is considered a significant risk to health. Presence of these pathogens may be the result of animal-to-food contamination that is out of control of the grower, processor, or manufacturer because other pathogens may be a natural part of the products. Therefore, the cause of a single instance of contamination may be the result of an unavoidable solitary occurrence. However, if more than a solitary occurrence of contamination occurs, either in the same lot or in subsequent lots, it is indicative of inadequate controls and additional lots are likely to be contaminated.

    If any of the following are detected:

    Two positive subsamples or composites in the initial sampling from one entry, or one positive subsample or one positive composite in more than one related entry or an outbreak epidemiologically traced to a specific product and firm without confirmatory analysis.

    • Detain the violative shipment/entry.
    • Initiate intensified sampling. Sample the next ten- (10) shipments/entries of that product from that grower/shipper. Ten (10) subsamples will be collected and individually analyzed. Do not composite subsamples. If a second positive is detected, this will result in the shipper/grower being recommended for DWPE. If a second positive is not confirmed in the ten- (10) shipments/entries, discontinue intensified sampling.
    • Identify the grower. If the grower cannot be identified, recommend the shipper for DWPE.

    NOTE: All DWPE recommendations need the concurrence of CFSAN and ORA headquarters prior to implementation.

    REMOVAL FROM DETENTION WITHOUT PHYSICAL EXAMINATION

    FDA decisions to remove a product, shipper, grower, or importer from DWPE should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the Agency has confidence that further entries will be in compliance with Act.

    The following criteria are required in the evaluation for the removal from DWPE: (1) Documentation of an investigation into causes of the violation, including an evaluation of the growing, manufacturing, packing, and/or transportation processes; (2) The evaluation needs to be confirmed by a reputable source (FDA, another government agency, accredited certification/inspection body); (3) The source of the problem must be identified; (4) A corrective action plan must be developed and implemented. In addition, documentation verifying that the action plan has corrected the problem is required. CFSAN concurrence is necessary before removing the product/firm from DWPE.

    Recommendations for removal from DWPE should be forwarded to DIOP for review when the district or other interested parties' present documentation, which established that the appearance of a violation has been removed.

  4. REPORTING REQUIREMENTS
    1. Report all analytical finding into FACTS using PAF = MIC (problem code MICROID, PFGE, SERO as appropriate); secondary PAF = SAL, ABR.
    2. Data Reporting Requirements
    Cilantro24T() B46
    24T() C46
    Culantro24T() B48
    24T() C48
    Cantaloupe22A() B01
    22A() C01
    Tomato24F() B50
    24F() C50

    PAC 03F098

  5. START/COMPLETION DATES

    Begin: Upon receipt of assignment

    Completion:

    Sample collection -- August 31, 2001
    Sample analysis -- September 28, 2001

  6. SUMMARY/EVALUATION

    The Office of Plant, Dairy Foods, and Beverages will prepare a summary and evaluation of the findings within 120 days of the completion of the assignment.

  7. CONTACTS

    CFSAN Assignment Contact:

    Patricia S. Sherrod, Office of Field Programs, Division of Enforcement and Programs, Imports Branch, HFS-606 at (202) 205-2261, Fax number
    (202) 260-0208.

    CFSAN Scientific Contact:

    E. coli and EHEC O157:H7
    Peter Feng, Ph.D., Office of Plant, Dairy Foods, and Beverages, Division of Microbiological Studies, Microbiological Methods Development Branch, HFS-516 at (202) 205-4518.

    Salmonella
    Wallace H. Andrews, Ph.D., Office of Plant, Dairy Foods, and Beverages, Division of Microbiological Studies, Microbiological Methods Development Branch, HFS-516 at (202) 205-4462.

    Shigella
    Keith Lampel, Ph.D., Office of Applied Research and Safety Assessment, Division of Virulence Assessment, Virulence Mechanisms Branch, HFS-327 at (202) 205-4515.

    ORA Import Alert and Procedures Inquires:

    Linda Wisniowski
    Division of Import Operations and Policy, HFC-170 at (301) 443-6553.

    ORA Analytical Inquiries:

    Atin Datta, Ph.D.
    Division of Field Sciences, HFC-141 at (301) 827-1030.

  8. PRIORITY

    This assignment has HIGH priority and the concurrence of ORA.

Patricia S. Sherrod