FDA Survey of Imported Fresh Produce - REVISED Imported Produce Assignment - FY 99 DOEP # 99-4
March 25, 1999; Modified May 20, 1999; Revised November 1, 1999
FINAL Imported Produce Assignment - FY 99 DOEP # 99-4
|A. Sample Collection|
|B. Sample Analysis|
|C. Regulatory/Administrative Follow-up|
|D. Reporting Requirements|
|E. Start/Completion Dates|
The Imported Produce Assignment will be extended until December 31, 1999.
- Effective IMMEDIATELY, discontinue sampling of all produce from Canada under this assignment. Imports of Canadian produce may continue to be collected under other compliance programs (e.g., imported pesticides, etc.).
- The following commodities have been deleted from this assignment: loose-leaf ettuce (e.g., romaine, mesculin, escarole endive, withloof chicory leaf, lamb's lettuce mache, radicchio) and broccoli.
- Shigella Method Modification: the Shigella method WILL NOT be utilized for the following commodities only, cilantro and strawberries.
There is a modification under section A (Sample Collection), part 2. Please read carefully:
NOTE: Notice to the Importer
Sample(s) collected from this shipment will be tested for the presence of pathogenic microorganisms. 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. Negative preliminary analytical findings will result in the release of that shipment. Positive preliminary analytical findings will result in further analytical testing by FDA. The shipment, however, remains under U.S. Custom's redelivery 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.
- Each time a sample is collected (sampling schedule), include sample for CFSAN according to the instructions in the assignment.
|Date:||May 20, 1999|
|From:||Consumer Safety Officer, Imports Branch (HFS-606)|
Division of Enforcement and Programs
|Subject:||FINAL Imported Produce Assignment - FY 99 DOEP # 99-4|
|To:||All Regional Food and Drug Directors|
All District Directors
Director, Regional Laboratory: SRL, NRL
All Directors, Investigations Branch
All Directors, Laboratory Branch
All Directors, Compliance Branch
Field Food Committee Members
Import Program Managers
Field Food Program Contacts
|NOTE: All attachments have been removed from this document.|
American consumers enjoy one of the safest supplies of food in the world. However, over the last several years the proportion of food borne illnesses associated with domestic and imported fresh fruits and vegetables has increased. In January of 1997, President Clinton announced a Food Safety Initiative to improve the safety of the nation’s food supply. The Department of Health and Human Services, the Department of Agriculture, and the Environmental Protection Agency sent a report to the President, in May of 1997 that identified fresh produce as an area of concern. In October 1997, President Clinton announced a plan entitled "Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables" (Produce Safety Initiative) to provide further assurance that fruits and vegetables consumed by the American public meet the highest health and safety standards.
Most fresh fruits and vegetables are grown in fields and orchards that are non-sterile environments. Growers have less control over conditions in the field compared to an enclosed processing facility. The surfaces of produce have a microflora which is generally composed of microorganisms that are not of human health significance. Occasionally, low level, sporadic, contamination of produce may occur. Usually, such contamination is not of public health significance. For example, the pathogen may not survive until harvest; harvest workers may be instructed to avoid harvesting produce with obvious contamination, such as bird droppings, or post-harvest treatments, such as washing, cooking, or peeling, may remove or inactivate pathogens. The processes involved in further commercial manipulation (e.g., washing, cutting, slicing, packaging) of fresh produce offers additional opportunities for product contamination with pathogens.
On the other hand, although the incidence of food borne illnesses linked to fresh produce is still low, there is evidence that it is increasing. In response to the President’s Produce and Imported Food Safety Initiative, FDA recently released a guidance document entitled "Guidance for Industry – Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables". This document sets out good agricultural and good manufacturing practices (GAPs and GMPs) that may reduce the risk of microbial contamination of fresh produce. Areas covered by the guide include manure management, water quality, worker training, and facility sanitation. In the absence of GAPs and GMPs, the risk of microbial contamination increases along with the likely extent of the contamination. For example, contaminated produce, cooled in a hydrocooler that recirculates water without adequate water treatment controls may contaminate the entire lot of produce.
Fresh produce is of special concern because it is likely to be consumed raw without any type of microbiologically lethal processing. Due to complex supply and distribution patterns, when an outbreak does occur, it may be widespread. Complex distribution patterns and a relatively short shelf life make traceback of fresh produce particularly difficult. In FY 97 and 98, the FDA has conducted multiple surveys of domestically produced fresh fruits and vegetables including:
the "Assignment to Inspect Sprout Growers and Collect Samples of Alfalfa, Radish, Broccoli and Mung Beans",
the "Assignment to Inspect Manufacturers of Fresh, Unpasteurized Apple Juice/Cider",
the "Assignment to Assure Unpasteurized Juice Manufacturers and Imported Juice Products Provide Required Label Warnings, Placards, and/or Meet the 5-Log Pathogen Reduction Requirement", and
- the "Prepared Cut Vegetable Salad Manufacturers Survey".
The Center for Food Safety and Applied Nutrition needs more data on the incidence and extent of pathogen contamination for selected fresh imported produce to assist in the development of additional policy for the Produce Safety Initiative. Our purpose is not to attempt to detect every incidence of low, level sporadic contamination. Our purpose is to detect those levels of contamination that might result from a failure to follow adequate GAPs and GMPs.
To collect and analyze samples of imported fresh produce
To determine the incidence of microbial contamination on these commodities to reduce food borne illnesses from contaminated fresh product where known illnesses have previously occurred.
THIS ASSIGNMENT IS TO BE IMPLEMENTED UPON RECEIPT. ALL COLLECTIONS ARE TO BE COMPLETED BY SEPTEMBER 30, 1999. ALL SAMPLE ANALYSES ARE TO BE COMPLETED BY OCTOBER 16, 1999.
A. SAMPLE COLLECTION
- Collecting Districts
See Attachment A for the sample collection schedule.
Collections are to reflect as many country/producer combinations as possible.
Note: Where indicated, simultaneously collect the sample listed under Attachment D, "Additional Sampling Schedule". These will be sent to CFSAN for further analysis. These samples should be collected from the same lot/entry as a sample collected to fulfill the District sampling obligation.
- Products to be collected:
- Loose-leaf Lettuce - includes intact bunches (e.g., Romaine) or already separated leaves from the loose-leaf variety (e.g., mesculin, escarole, endive, withloof, chicory leaf, lamb's lettuce, mache, radicchio)
- Scallion (Green Onions)
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 B) and the following "Notice to the Importer" should be followed. Inform importers that preliminary analytical results (negative and 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. Preliminary analytical results may be available within four (4) days following the date of sample(s) collections. 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 redelivery bond. Distribution prior to FDA written release is at the importer’s risk and 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 mitigate liquidated damages down to the value of the shipment. Districts may use their enforcement discretion to further mitigate down to a minimal dollar amount if the importer attempts to redeliver/recall refused product.
It is imperative that the District coordinate sample collection and shipment with their servicing laboratories in order to ensure that the sample will be analyzed expeditiously.
The intent of the assignment is to collect approximately 125 samples of each product from a large number of shippers over the time span of the assignment. Collecting district sampling obligations were developed using OASIS entry data from the previous year. We are not certain that import entries will follow the same pattern with regard to products and numbers of entries during the time frames of the present assignment. Therefore, in consultation with the analyzing laboratory districts may substitute specific products for others assigned to the district if it appears that not enough entries of an assigned product will be available for sampling during the assigned month, or that the entries received are from only one or a very few shippers. If a District alters the sampling schedule due to produce unavailability, the District should make every attempt to correct the substitution later in the year, when the unavailable product becomesavailable. CFSAN, with the assistance of DIOP and DFS, will examine the sample schedule at the end of six weeks and if necessary make adjustments to the products to be sampled during the duration of the assignment. The field will be consulted before any revisions are made and analytical obligations for the laboratories will not be altered if at all possible.
If you have any questions regarding the above procedures contact Joe McCallion, Marvin Blumberg or Linda Wisnowski at 301-443-6553.
See Attachment B entitled "Perishable Foods Sampled by the Food and Drug Administration" document dated 7-10-89.
One of the objectives of this assignment is to collect samples representing as many product/growers as possible. Districts should not collect repeat sample 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 appropriate compliance program. If the grower is not identified by the filer at the time of entry, every effort should be made to determine the grower and enter that information into OASIS.
Collect all samples ASEPTICALLY, see IOM, Chapter 4, Section 426. Ship samples refrigerated by the fastest means possible to your Districts’ servicing laboratory (see Attachment C).
Sampling containers for whole produce head/bunches samples, only: Commercial small garbage or trash bags can be used. Previous experience indicated that the interiors of these bags have been analyzed and do not support the growth of bacteria. Note: These are only to be used for the collection of the "whole" raw produce samples where normal size sterile bags (whirl-packs) cannot accommodate the size of the raw produce.
Note: If these containers are used, then a sample of the bag must also be submitted to the laboratory as a control.
Ensure that the coolant used does not come in direct contact with the commodity.
Take sub samples at random to ensure that the sample is representative of the lot.
Send a copy of the collection report(s) on an as completed basis to the address listed under the "REPORTING REQUIREMENTS".
Each sample will consist of ten (10) – 454g (16oz.) sub samples.
NOTE: scallions, parsley, loose-leaf lettuce (e.g., romaine, mesculin, escarole, endive, withloof, chicory leaf, lamb’s lettuce, mache, radicchio) and cilantro: collect enough bunches to equal a minimum 16 oz. sub sample. cantaloupe, celery, and broccoli: a sub sample will consist of one head/bunch of produce. strawberries: if bulk shipments are encountered, a sub sample will consist of 16 oz of product. If product is shipped in retail size containers, then collect enough retail containers to equal 16 oz.
- Additional Sampling Schedule for CFSAN Analyses
See Attachment D for the additional sampling collection schedule. The samples for shipment to CFSAN should be collected from the same entry/lot as a sample collected to fulfill the District sampling obligation for the month assignment
It is imperative that the Districts coordinate the additional sample collection and shipment with CFSAN in order to ensure that the samples will be analyzed expeditiously. Attempt to ensure a weekly sample shipment flow to CFSAN. Contact Tony Tran as necessary at 202-205-5253.
Additional sampling will be used by CFSAN for a research project. CFSAN results will not be forwarded back to the collecting districts. Therefore, it is not necessary to use official FDA seals on these samples.
- Products to be collected:
- Loose-leaf Lettuce - includes intact bunches (e.g., Romaine) or already separated leaves from the loose-leaf variety (e.g., mesculin, escarole endive, withloof, chicory leaf, lamb’s lettuce mache, radicchio).
- Scallions (Green Onions)
Each sample will consist of 10-2 lb. sub samples. Collect samples ASEPTICALLY, see IOM, Chapter 4, Section 426. Ship samples refrigerated by the fastest means possible to:FDA/CFSAN/Sample Custodian, HFS-516Sampling containers for whole produce head/bunches samples, only: see above.
ATTENTION: James Bland
200 C Street, SW
Washington, D.C. 20204
B. SAMPLE ANALYSIS
ANALYZING LABORATORIES: SRL, DEN, LOS, CLMI, NRL, SAN, SEA
Note: The perishable nature of these products is critical. Therefore, the analyses should start as soon as the samples arrive in the laboratories. Samples should not be frozen at any time prior to analysis.
Refer to Attachment C for the number of samples projected for each analyzing laboratory.
All commodities will be analyzed for the following: Aerobic Plate Counts (APC), coliforms, E. coli, EHEC (E. coli 0157:H7), Salmonella, and Shigella.
Note: Laboratories are to perform the E. coli 0157:H7, Salmonella, and Shigella analysis first if at all possible.
Presumptive positive findings at 72 hours may be used to initiate regulatory action. Call assignment contact, Patricia Sherrod at 202-205-4238 and also the compliance contact in the collecting district.
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 which provide minimal preparation (e.g., washing and/or trimming) prior to consumption.
broccoli, strawberries, cantaloupe – none required.
scallions, cilantro, parsley – if root is still attached, aseptically remove the root prior to "sub sample rinse".
loose-leaf lettuce – aseptically remove damaged outer leaves (visible dirt) prior to preparation of "sub sample rinse".
celery – aseptically remove 3-4 outer "stalk leaves" (ribs). (Perform a light rinse to remove visible dirt. "Light rinse" means to place produce commodity under running tap water.). Next use these "stalk leaves" (ribs) to prepare the "sub sample rinse".
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".
APC, coliforms, E. coliEHEC (E. coli 0157:H7)
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 APC, coliform, and E. coli. Note: Prepare dilutions for APC and coliforms as follows:
APC analysis: dilutions will be prepared from 10-1 to 10-6 and plates will be prepared reflecting each dilution of the sub samples. It will not be necessary to go beyond 10-6.
Coliform/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.
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 0157: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 0157: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 0157:H7
Submit two positive isolates of E. coli 0157:H7 recovered from each sub sample. Submit culture on Trypitcase Soy agar slants in screw cap tubes (13x100mmx125mm) with caps secured tightly.
Label each tube with sample number and sub sample number.
Submit copies of the collection report and analytical worksheets.
Place cultures in culture container with official FDA seal. Place accompanying records inside shipping carton but not within officially sealed culture container. Prepare cultures for shipment according to requirements for shipment of etiological agents. Label secondary shipping container with the address of the CFSAN scientific contact for EHEC. Send container by most rapid mail service available. Maintain duplicate cultures of those submitted for all cases, which are under consideration for legal action. These isolates will be used by CFSAN for Pulsed Field Gel Electrophoresis (PFGE) analysis and submission to the CDC-Pulse Net system.
Submit E. coli 0157.H7 isolates for PFGE analysis to:FDA/CFSAN/OSRS/DMS/MEB
ATTN: Farukh M. Khambaty, Ph.D., HFS-517
200 – C Street, SW
Washington, DC 20204
PHONE #: (202) 205-4830
Note: It is recommended that only those microbiologists previously trained in PCR be utilized to perform the Shigella analysis.
PCR primers and the positive control will be supplied to each District. If the District has not received their primers and the positive control by March 1, 1999, please notify Keith Lampel, 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 100 ml (of sub sample rinse) and place into centrifuge tubes and spin at 2000 rpm for 3 min to pellet plant material. Then follow methodology as outlined in Attachment E 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, the CFSAN Scientific contact for Shigella for DNA sequencing.Salmonella Positive Isolates
Salmonella 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 confirmation analyses as outlined in the BAM.
CLMI will submit two positives Salmonella isolates from each sub sample to DEN microbiology laboratory for antibiotic sensitivity assay. Isolates, which were found to be multi-drug resistant, will be shipped to CFSAN for PFGE analysis and submission to the CDC-Pulse Net system.
Submit cultures on BHI agar slants in screw-cap tubes (13x100mmx125mm) with caps secure tightly. Label each tube with sample number and sub sample number. Submit copies of the collection report and analytical worksheets. Place cultures in culture container with official FDA seal. Please accompanying records inside shipping carton but not within officially sealed culture container. Prepare cultures for shipment according to requirements for shipment of etiological agents. Label secondary shipping container with the address below. Send container by most rapid mail service available. Maintain duplicate cultures of those submitted for all cases, which are under consideration for legal action.
Submit Salmonella isolates for serotyping to:HHS/FDA/CLMI
ATTN: Al Schwab, HFR-MW400
240 Hennepin Avenue
Minneapolis, MN 55401
CLMI submit Salmonella isolates for antibiotic sensitivity assay to:FDA/ORA/DEN
ATTN: Jeffery Cutting/Connie Kiessling
P.O. Box 25087
DFC BLDG. 20
Denver, Colorado 80225-0087
Submit each Collection Report to the Assignment Monitor, Patricia Sherrod. Also complete Attachment F and send to the address listed under the "REPORTING REQUIREMENTS" of this assignment on an as completed basis. Record this information into MICRO-IS. Also use Attachment F to record results that will be used to correlate data with the collection report.
C. REGULATORY/ADMINISTRATIVE FOLLOW-UP
If any of the following microorganisms are detected and confirmed:
- E. coli 0157:H7;
further action should be considered. Please include the original entry number with each sample submitted for regulatory review. Contact Patricia Sherrod, CFSAN/DOEP, Imports Branch, HFS-606, at (202) 205-4238 immediately. Imports Branch will confer with the District to determine appropriate follow-up which could include recall, detention without physical examination, or assistance/educational efforts.
D. REPORTING REQUIREMENTS
- Hard Copy Reporting
- Collection Reports (Please submit legible copies)
- Attachment F
Send all hard copies of the collection report and attachment F on an as completed basis to:
ATTENTION: Patricia S. Sherrod
200 C Street, SW
Washington, D.C. 20204
FAX # 202-260-0208
PODS REPORTING REQUIREMENTS
Loose-leaf Lettuce 24T( )B32
Mesculin (& other loose-leaf varieties) 24T( )B47
Escarole, Endive 24T( )B30
Withloof, Chicory Leaf 24T( )B34
Lamb’s Lettuce, Mache 24T( )B35
Radicchio 24T( )B36
Salad mixes 24T( )B99
Strawberries 20A( )B14
Cantaloupe 22A( )B01
Parsley 24T( )B21
Celery 24T( )B11
Scallions/Green Onions 25J( )B04
Cilantro 24T( )B46
Broccoli 24T( )B05
Begin: Upon receipt of assignment
Completion: Sample collection – September 30, 1999
Sample analysis - October 16, 1999
CFSAN Assignment Contact:
Patricia S. Sherrod, Office of Field Programs, Division of Enforcement and Programs, Imports Branch, HFS-606 at (202) 205-4606, Fax number (202) 260-0280.
CFSAN Scientific Contact:
E. coli and EHEC 0157:H7
Peter Feng, CFSAN, Office of Special Research Skills, Division of Microbiological Studies, Microbiological Methods Development Branch, HFS-516 at (202) 205-4518.
APC, Coliforms, and Salmonella
Wallace H. Andrews, CFSAN, Office of Special Research Skills, Division of Microbiological Studies, Microbiological Methods Development Branch, HFS-516 at (202) 205-4462.
Keith Lampel, CFSAN, Office of Plant, Diary Foods, and Beverages, Division of Virulence Assessment, Virulence Mechanisms Branch, HFS-327 at (202) 205-4515.
Import Alert and Import Procedures Inquires:
Division of Import Operations and Policy, HFC-170 at (301) 443-6553.
ORA Analytical Inquiries:
- This assignment has HIGH priority and the concurrence of ORA.
Patricia S. Sherrod