Auditing and Inspection Checklist for Sprouting Facilities


Auditing and inspection checklist for sprouting facilities




Firm’s Information:                                                  Auditor Information:                       


Firm Name: _____________________________    Name:  ____________________________


Address: ________________________________   Agency: ___________________________


Phone: _________________________________     Phone: ____________________________


Date of audit: ________


Most Responsible Individual: _______________________________________




This program is intended to assess a sprouting facility’s efforts to minimize the risk of microbial contamination of sprouts.  The questions are designed based on HACCP principles and include elements of Good Manufacturing Practices and recommendations provided by international food safety guidelines for sprouts as listed below.


  1. U.S. Food and Drug Administration. 1999. Guidance for industry: Reducing microbial food safety hazards for sprouted seeds. Fed. Regist. 64:57893-57896. Available at:


  1. U.S. Food and Drug Administration. 1999. Guidance for industry: Sampling and microbial testing of spent irrigation water during sprout production. Fed. Regist.64:57896-57902. Available at:


  1. Codex Alimentarius Committee. 2003. Code of hygienic practice for fresh fruit and vegetables. Annex II: Annex for sprout production. Available


  1. Canadian Food Inspection Agency. 2007. Code of practice for the hygienic production of sprouted seeds. Available at:


  1. Canadian Food Inspection Agency. 2008. Food safety practices guidance for sprout manufacturers. Available at:


Table of Contents:


A. Documentation and Records

1. Production Facility & Equipment

2. Cleaning & Sanitation

3. Pest Control

4. Waste Management

5. Personal Hygiene

6. Control of General Operations

7. Control of Sprouting Operations

a. Seed Purchasing, Receiving & Storage

b. Seed Disinfection/Treatment

c. Sprout Production

d. Post Harvest Washing, Dehulling and Dewatering

e. Packing & Labeling

f. Spent Irrigation Water Testing for Pathogens

8. Storage & Distribution

9. Traceback & Recalls

10. Food and Facility Security Defense Program

11. Training

B.Site Inspection

1. Establishment for Sprout Production (Sprout Production Facility & Equipment

2. Cleaning and Sanitation

3. Pest Control

4. Waste Management

5. Personal Hygiene

6. Control of General Operations

7. Control of Sprouting Operations

a.  Seed Purchasing, Receiving and Storage

b.  Seed Disinfection/Treatment

c. Sprout Production

d.  Post Harvest Washing, Dehulling, and Dewatering

e. Packing & Labeling

f. Spent Irrigation Water Testing for Pathogens

8. Storage and Distribution

9. Traceback and Recalls

10. Food and Facility Security Defense Program

11. Training


Sprout Specific Auditing and Inspection Check List

Stage I – Basic Requirements


To the Sprout Grower:

Have the following ready before the inspector arrives

1.      List all the different sprouts and sprout mixes you grow

–         Classify them into methods of seed sanitation used

–         Classify them into spent irrigation water sampling methods

–         For each product indicate which days you harvest per week (See attached sample grid)

–         For each product indicate the approximate # of pounds of seed planted per harvest

–         For each product indicate the approximate yield in lbs of sprouts per one lb of seeds

2.      Have written instructions available for:

–         Each seed sanitation method you use

i.     Which seeds or mixes are treated with each sanitation method

ii.     Which sanitizer and what concentration used for each method

iii.     How much sanitizer used per quantity of seed and water

iv.     Length of time and amount of stirring or agitation

–         Every Batch Hold and Release Program:

i.     Each method of sampling spent irrigation water and

1.      Which seeds are sampled by each method

2.      The upper limit of # of pounds of seed in each lab sample

3.      If/when more than one seed is sampled for a single sample, which seeds are pooled together

ii.     Sample preparation for lab, including

1.      lot code marking and tracking through from supplier to consumer

2.      name, address & phone # of lab

3.      rapid test method used

4.      confirmation method used in case of a presumptive positive

5.      Remediation required in case of a non-confirmed presumptive positive

6.      Remediation required in case of a confirmed positive

7.      System for holding finished product until lab results are returned before release to market.

Sample Grid for Sprout product harvest day, approx lbs, and Batch/Pool for sampling


Sample BatchSeedYieldSunMonTuesWedThursFriSat


















Flavors Pooled:



































To the Inspector:

1       Check the above list of sprouts grown and the instructions for sanitizing, sampling and lab preparation.  Are written instructions adequate and complete?

2        Request report from previous inspection. Check deficiencies.

3        Randomly select one week in the period since the last inspection. For each seed batch produced that week, examine:

a.      Sales records for quantities of each seed lot sold

b.     Seed sanitation records – do they match written instructions?

c.      Lab records – is there a negative result for each batch sold that week?

d.     Hold and release records – are they adequate to insure no contaminated product will get into the marketplace?

4        Based on the average yield for each sprout batch, check quantities sold against quantities sampled

5        Make sure the lot codes on invoices match codes on sanitation, sampling and test result records and confirm that the trace back is complete to the seed supplier.

6        Ask for most recent lab report of presumptive positive. Check the following: (Answer in I6q)

a.      Did the test go on to confirmation?

b.     Was it positive or negative?

c.      If positive or unconfirmed presumptive positive, check records for proper disposition of all product in that batch of seeds.

7        Examine purchasing records of sanitizers. Request two consecutive purchases to check quantities of sanitizers purchased to match the approximate volume of sprouts sold between the purchases. Use sprout sales records for random week to estimate amount used between purchases.

8        Examine Employee Training Program:

a.      Check training materials for sanitizing and Every Batch Testing, Hold and Release program

b.     Check signed records of training sessions

c.      Check training records for recent hires

d.     Check training records for regular refresher training for all employees.

9        Ask to observe a sanitation demonstration, a spent irrigation water sampling procedure, and sample preparation for lab. Note the following:

a.      Measurements of sanitation

b.     Confirmation of concentration

c.      Method of agitation

d.     Length of time of contact

e.     Method of disposal of sanitation material

f.       Cleanliness of sampling container

g.      Method of pooling sampling water

h.     Volume of sample – (should be 1 liter per sample)

i.        Accuracy of lab documentation (tracking sheet)

A. Documentation and Records


A1Is there one person responsible for keeping and validating safety documentation records?    
A1With the responsible person, assess the company’s record keeping system. Is it well organized and easy for multiple users to get forms, fill them out and save them for future inspection when necessary?    
A2Are records legible, accurate and signed and dated by individuals responsible?    
A3Do records include written procedures, controls, limits, monitoring results, corrective actions and follow-up documents, maintained for a minimum of one year, for each of the following?
 seed sources and lot numbers

Source water analysis results

Sanitation checks

Pest control monitoring

Sprout lot codes

spent irrigation water analysis results

production volumes

storage temperature monitoring

product distribution and consumer complaints

A5Are records retained for at least one year for each lot of sprouts?    


B. Establishment for Sprout Production


B1Assess facility cleanliness  (e.g., food residues on floor, insufficient draining of excess water on floor, dripping from ceiling or light fixture, moldy wall, rusted equipment, water from floor contacting product)Inspection
B2Are buildings and surrounding areas designed, constructed and maintained in a manner which prevents conditions that may result in the contamination of food? (e.g., exterior has no unprotected openings to prevent entry of contaminants and pests, the roof, walls and foundation are maintained to prevent leakage, the surrounding land is maintained to control sources of contamination such as pest harborage areas, the building is not located in close proximity to any environmental contaminants, etc).   Inspection
B3Does the facility layout permit good hygienic practices, including protection against cross-contamination between operations and during cleaning and sanitation of utensils and equipment?   Inspection
B4Is the facility fully enclosed and protected from outside contaminants?   Inspection
B5If the firm grows in green houses or screen houses, are they fully enclosed and protected from rodent or bird intrusion?   Inspection
B5Are storage, seed disinfection, germination and packaging areas separated from each other or has the potential for cross contamination between them been otherwise adequately addressed.?   Inspection
B6Are floors smooth, non porous, impervious to water and sufficiently sloped to permit proper drainage?   Inspection
B7Are walls, doors and ceilings smooth, non porous, non-chipping and impervious to water?   Inspection
B8Is there a glass and brittle plastic program in place?   Document
B9Are light bulbs and fixtures protected to prevent contamination of sprouts in case of breakage?   Inspection
B10Is there a metal contamination prevention program in place (i.e. to prevent nuts &bolts from equipment from entering finished product)?   Document
B11Are equipment and containers coming in contact with sprouts made of materials which have no leaching toxic effects?   Inspection
B12Are equipment and utensils used during sprout production clean and well maintained and stored in such a manner as not to become contaminated?   Inspection
B13Are equipment and utensils inspected to determine adequacy of cleaning and records of the sanitizing treatments and inspections kept?   Document
B14Are food-contact surfaces clean and free from potential contamination from dripping ceilings, floors, etc.   Inspection
B15Does the facility have written programs to ensure water quality?   Document
B16Is water used for irrigation and finished produce washing from a potable source?   inspection

Describe the water source/sources used for sprout production and processing and include any microbiological or chemical test results within the last 12 months.


If the water source is wells or cisterns, are they tested at least twice a year? Check documentation.


If the facility is on a municipal water supply, is there a current document (within 12 months) on file from the supplier that verifies that the water is of adequate quality?


Does the facility have adequate ventilation to prevent condensation, dust, and minimize entry of contaminated air?


Is the ventilation system constructed to avoid air flow from contaminated to clean areas?


Is the ventilation system designed to be adequately maintained and cleaned?


Are ventilation openings equipped with close-fitting screens or filters to reduce risk of contaminated air intakes?


Are sewage, effluent and waste storage and disposal systems designed, constructed and maintained to prevent contamination?


Are draining and sewage systems equipped with appropriate traps and vents?


Is there evidence of cross-connection between the sewage system or other waste effluent systems and the sources of potable water?



C. Cleaning and Sanitation 


C1Does the firm have written cleaning and sanitation program for the premises (production and storage areas)?   Document
C2Does the firm have written cleaning and sanitation program for all equipment?   Document
C3Does the written cleaning and sanitation program for facility, equipment and utensils include the following?   Document    
       – name of the responsible person

– the frequency of the activity

– the procedures for cleaning, sanitizing and rising

– chemicals and concentrations used

– temperature requirements

– the type and frequency of inspection to verify the  effectiveness of the program

equipment and utensils used during sprout production

-disassembly/re-assembly instructions



C4How often does the firm clean and sanitize each of the following, review records: Are the records consistent the written documentation? Document    

– seed storage area/room and equipment

– seed disinfection area/room and equipment

– sprouting area/room  and equipment

– packaging area/room and equipment

– sprout Coolers, drip pans and other cooler equipment


Comments how often

C5What chemicals and concentrations are used to sanitize the following areas/rooms? Does documentation verify that chemicals are used in accordance with manufacturer’s instructions?    

– seed storage area/room and equipment

– seed disinfection area/room and equipment

– sprouting area/room  and equipment

– packaging area/room and equipment

– sprout Coolers, drip pans and other cooler equipment

– equipment and utensils used during sprout production

yesChemical / concentration
C6Is the sprouting area and food contact surfaces clean and well maintained?.   Inspection
C7Does the firm have written procedures for routine verification of its cleaning and sanitation procedures?   Document
C8Is a method in place to verify the effectiveness of cleaning and sanitation?   Document
C9Is there a written procedure for at least weekly sampling of equipment, floors, drains, cooler pans, etc. for Listeria sp?   Document
C10Are there records for regular Listeria sp testing?   Document
C11Does the firm have written SOPs for cleaning and disinfecting facility and equipment after contamination was found? 
C12Does the firm have written procedures to verify the effectiveness of their cleaning and sanitation procedures?   Document
C13Does the firm have written SOPs for corrective actions before resuming production after contamination is found?   Document



D. Pest Control


D1Does the facility have a written pest control program?   Document
D2Does the firm use properly trained and licensed pest control technicians, whether internally employed or externally hired on at least a monthly basis?   Document
D3Does the pest control service and/or the person applying chemicals or servicing the facility have a current license/permit

on file?


Check that the name of the responsible person, copies of applicators licenses for each application, name of pest control company and contact person and a copy of certificate of insurance for responsible entity, as applicable, are on file.

D4Does the facility have a complete list of pesticides approved for use and the designated areas where they are approved for application?   Document
D5Are dilution and application information for chemicals on file?   Document
D6Are Material Safety Data Sheets (MSDS) for chemical use on file?   Document
D7Review the service report. Are chemicals applied appropriately?

Are usage levels as recommended?

D8If pest control chemicals are stored on site, are they secured in a locked cabinet or room?   Inspect
D9Does the facility have a current plot diagram schematic that documents the locations, description and identifies markers of all stations (live traps, bait stations, glue boards ketchalls, tin-cats, & insectocutors)?   Document
D10Are there inside rodent traps (ketchalls, tin-cats or glue boards etc.) against the wall on both sides of all  outside pedestrian, cooler and dock doors and every 30-40′ (9-12m) against the inside of all exterior walls in thedry storage areas, boiler rooms, etc.?.   Inspect
D11Is the inspection of these traps documented weekly?   Document
D12Do records indicate that the firm’s management is doing their own inspection at least monthly?   Document
D13Do the Pest Control Service reports show the conditions found and the corrective actions needed to prevent future pest problems?   Document
D14If insect light traps are installed are they cleaned and operating properly, and do they have shields to prevent glass cross-contamination?   Inspect
D15Are the locations of traps away from exposed food, food packaging materials and food processing equipment?   Inspect
D16Is there a provision in the program for determining the effectiveness and servicing of traps weekly to remove dead pests and to try to identify the source of infestation?   Document
D17Is there a perimeter maintained around the inside of exterior walls of the seed storage areas so as to facilitate the ability to do pest control?   Inspect
D18Are interior walls, floors and ceilings well maintained and free of major cracks and crevices that could be entry points?   Inspect
D19Check outside traps or bait stations. Are stations clean, filled with fresh bait, undamaged, secured to the ground, free from dead rodents and properly serviced, with bait secured inside the station?   Inspect
D20Are the bait stations positioned every 50-70′ (15-21m) against the outside walls of the facility all the way around?   Inspect
D21Are there gaskets around dock levelers to reduce all gaps to less than 0.25″ (6mm) to prevent rodent entry?   Inspect
D22Are there screens on doors, windows and louvered ventilation fans?   Inspect
D23Is there a lack of standing water on the outside perimeter of the building to prevent pest harborage?   Inspect
D24Have trees, overhanging beams, ledges, etc. been treated to discourage birds from roosting near the facility?   Inspect
D25To prevent pest harborage is there an 24″ open area maintained around the perimeter of the building with no items stored up against the building?   Inspect
D26Is the outside of the facility free of rodent burrows?   Inspect
D27Are dumpsters in good repair and stored away from building?   Inspect



E. Waste Management


E1Does the firm have written SOPs for the storage and removal of waste from production and outside areas, including the frequency of removal?   document
E2Are waste storage areas separated from the plant? Away from seed and sprout handling and storage areas?   inspect
E3Are all waste containers clearly labeled, leak-proof and where appropriate, covered?   inspect



F. Personal Hygiene


F1Does the facility have adequate and conveniently located changing facilities and toilets?   Inspect
F2Are toilet facilities designed to allow hygienic removal of waste and be segregated from production and storage areas?   Inspect
F3Are toilet facilities maintained under sanitary conditions and good repair?   Inspect
F4Does the facility provide adequate means of washing and drying hands, including wash basins, soap, disposable towels and a supply of hot and cold water adjacent to toilets?   Inspect
F5Are hand washing and hand sanitizing stations located at all entrances and throughout sprouting and packaging rooms and properly maintained?   Inspect
F6Are boot sanitizing troughs or mats placed at all entrances to post seed disinfection areas?   Inspect
F7Are sanitizer chemical levels checked and documented at a frequency sufficient to maintain the specified levels?   Inspect
F8. Does the firm have a written worker health policy that:     Document
 – Restricts employees and visitors with symptoms of potentially infectious illness such as diarrhea, fever, or vomiting from working with or being in the vicinity of seeds/sprouts or food-contact surfaces?

– Instructs employees to report any active case of illness to their supervisor before beginning work?

– Requires employees with open sores, cuts, burns, boils, and similar conditions report the conditions, and to not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g., rubber gloves)?

– Has corrective action for instances of contamination?

F9Does the firm have written requirements for cleanliness and personal behaviors that include:

–        Protective clothing, hair covering, footwear and gloves should be worn and maintained in a sanitary manner

–        Workers must wash and sanitize their hands before starting work each day, after visit to toilet facilities or blowing their nose, after other absence from the work station, and after handling contaminated materials (e.g., picking objects off the floor).

–        Waterproof gloves should be washed and sanitized similarly to hand washing.

–        Proper maintenance and cleaning of reusable gowns, aprons, boots and gloves?

–        Eating, using tobacco, chewing gum, or unhygienic practices such as spitting in food handling areas is prohibited

–    Jewelry shall not be worn

F10Are access by non plant personnel and visitors controlled to prevent contamination?   Inspect – redundant F11?
F11Does the firm have a written policy to ensure good hygienic practices are followed by visitors?    Document


G. Control of general operations


G1Does the firm have a written description and procedures for control of entire production processes including

– Process flow diagram

– Incoming material control

– Packaging control

– Production preparation

– Product coding control

– Process control

– Labeling control

– Deviations and corrective actions

– Verification of product safety

G2Does the firm have written procedures for incoming material controls? (including incoming seed control?)   Document
G3Does the firm have controls in place to prevent the presence of undeclared allergens, including prevention of cross-contamination or carry-over?   Document
I3dAre production lines and equipment dedicated to one seed type where allergens are present?   Inspection
G4Does the firm have effective systems to prevent the use of contaminated, damaged or defective containers (e.g., receiving and storage controls, visual examination prior to use)?   Document
G5Are packaging materials new (or sanitized if reusable), clean and non toxic, posing no threat to the safety and suitability of sprouts under specified conditions of storage and use?   Document
G6Is each lot of packaging material examined for physical damage, signs of contamination (e.g., stains, bird droppings, insect) and foreign material at receiving? Check receiving logs   Document
G7When defects occur or limits of acceptability are exceeded, does the firm have written procedures to identify, isolate and evaluate affected products.   Master document
G8Does the firm have written procedures for corrective actions following any deviation that include:
 -Investigation to determine the cause of the deviation

-Preventative measure to prevent recurrence of deviation

-Verification of the effectiveness of the corrective action taken

   Master document
G9Does the firm use supplementary methods of evaluation to verify the conformance and effectiveness of controls affecting product safety. Methods of verification may include:
 – Review all specifications for incoming ingredients and materials as well as letters of agreement at an adequate frequency.

– Development of a sampling plan to ensure the consistent collection of samples (e.g., spent irrigation water)

– On-site assessment of the monitoring procedures

– Review of records for completeness

– Review of deviation records to ensure that appropriate corrective actions are taken

– Independent external or internal audits

– Analysis of consumer complaint trends

   Master document? Covered in individual sections?


H: Control of Seed Supplier Sources


H1Does the firm have a letter from each of its seed suppliers stating that they obtain their seed from growers following Good Agricultural Practices?   Document
H2Does the firm have confirmation that each seed supplier has a documented food safety program?   Document
H3Does the firm have a letter from each of its seed suppliers stating that they are planning to, or have already obtained annual 3rd party audits for GMPs?   Document
H4Does the firm have documentation of seed supplier testing results as part of a certificate of analysis (COA) from the seed supplier for every seed lot received?   Document


I. Control of sprouting operations


I.1. Seed Receiving and Storage


I1aDoes the firm have a written SOP for seed receiving and storage?   Document
I1bDoes the firm have written procedures for visual evaluation of seed shipments when seeds reach the sprouting facility?  For example, black light or visual exam examination of bags for evidence of rodents.   Document
I1cDoes the firm maintain a seed log with seed lot used on each day to track seed (and lot #) through receipt, use, shipping or return to suppliers?   Document
I1dHow are seeds stored?
 Is storage area dry and clean?

Is there a dedicated seed storage area?

Stored off the floor and away from walls?

Are opened bags of seed stored in containers?

Are containers emptied and sanitized between lots?

Are seed lot numbers clearly marked on storage containers?

Are seed storage containers covered/closed?


I1eAre seed lots ever mixed? During Storage?


If so, are records kept?




I.2. Seed Disinfection/Treatment – This section has not been examined in total.


I2aDoes the firm have written seed disinfection procedures?   Document
I2bDoes the firm have written seed disinfection logs?   Document
I2cDoes the firm have copies of invoices for disinfection chemicals purchased that approximate their written disinfection procedures?   Document
I2dIs at least one effective antimicrobial treatment applied to seeds immediately before sprouting?. This treatment must be from a list of treatments suggested by industry, published in the scientific literature, peer reviewed and accepted by a review panel made up of scientists expert in the field.   Reservations.. what is effective?  How can we define it?
I2eHave the firm re-create an actual seed disinfection process from mixing of chemicals to actual disinfection of seeds while you observe and record data.
 a.    Describe process and observations

b.    Test the strength of the solution

c.    What volume of seed to what volume of solution is used?

d.    Is the seed/solution agitated during treatment?

e.    Method of agitation?

f.     How long is the treatment?

g.    Potable water being used?

h.    Are seeds pre-rinsed, prior to any antimicrobial treatment?

i.    Rinse after treatment?

j.    Method of disposal of sanitation material?

I2fObtain the following information on antimicrobial treatment(s) used by the firm for each seed type:
 Type of seed

Biocide (include brand)


Treatment method

Duration of treatment

I2gIs the firm able to demonstrate that the concentration of the solution was within the established target range?   Inspect
I2hHow often does the firm check to verify that the concentration of antimicrobial was prepared according to the firm’s SOP and is within the target range established by the firm? (daily, weekly, etc.)Document
I2iWhat method and procedures are used by the firm to check the concentration (e.g., test strips)?  Include brand, model and test range.Document
I2jHow are the disinfected seeds transferred/transported to sprout production?Inspect



I.3. Sprout Production


I3aDoes the firm have a written SOP for sprout production?   Document
I3bDoes the firm have written sprout production logs working in conjunction with the seed log, to show what seed lots were used on what production days?    
I3cWhat types of seeds are sprouted at the facility? List all:




I3eWhat is the source of water used for irrigation (e.g., municipal, well)? Potable water? 
I3fIs there a microbial control program for irrigation water?

Is it chlorinated or otherwise disinfected by the firm? If yes, what level of chlorine is used?

(note: chlorination of irrigation water may affect microbial testing of spent irrigation water)

I3gDoes the firm capture and reuse spent irrigation water?  If so,  does it have adequate treatment to prevent cross-contamination? 


I.4. Post harvest washing, dehulling, and dewatering


I4aDoes the firm have a written SOP for the dehulling, washing, and dewatering processes?   document
I4bIs the wash water recycled?

If so, is the sanitizer level tested prior to use?



I.5. Packing & Labeling– This is partially handled under hygiene, partly under traceback, partly under labeling for allergens. Do we want to discuss other labeling issues such as washing before use, accurate portrail of contents on the main panel, etc?


I5aDoes the firm have a written SOP for packing finished product?     document
I5bIs the packing area clean and protected from potential cross contamination. ?   inspect
I5cDoes the firm have controls in place to ensure that labels are complete and accurate?   Document
I5dAre sprouts labeled with the statement “Keep refrigerated”?   Inspect
I5eAre pre-packaged sprouts identified with sell-by, use by or best before on the label or container to allow the identification of product in the event of a recall?   inspect
I5fIs the list of ingredients complete for each product?   Inspect
I5gIs it clear from the name on the main identification panel what is in the product, based on the list of ingredients or the actual ingredients? (ie. labels are not misleading)   Inspect


I.6. Spent Irrigation Water Testing for Pathogens


I6aDoes the firm have a written SOP for microbial sampling and testing of spent irrigation water?   Document
I6bAre there separate and appropriate spent irrigation water sampling procedures for drum grown, tray grown, or bin grown sprouts?

·         Are mung or soy bean bins sampled in such a way that a small amount of water has passed over the whole bin and been collected for testing?

·         If sprouts are grown in a rotary drum, is water sampled from each of the quads?

·         If sprouts are grown on trays, is water sampled from each of the trays in the tower?

I6cIf the firm is growing sprouts in soil, is there a sampling protocol in place for soil grown sprouts or microgreens?   Document
I6dDoes the firm’s written SOP have procedures for holding finished product until lab results (either preliminary or confirmed results) are returned before release to market? If yes, review copies of procedures   Document
I6eAre soil grown sprouts or microgreens tested in a regular hold and release program?   Document
I6cDoes the firm have written microbial testing logs?  If yes, review test records for last year   Document
I6dDoes the firm collect spent irrigation water for microbiological testing? If yes, describe the procedure
 ·         Is spent irrigation water collected for microbiological testing for all sprouts grown every day? If not, comment which batches are not and how often.

·         Does the firm sample/test every homogenous production batch (ie. drum, rack of trays, bin, etc.) individually? (Pooling seed lots in less than production size batches up to 50 lbs of raw seed is considered acceptable.)

·         Are spent irrigation water samples collected after 48 hours of sprouting start?

·         If not, note the firm’s justification for other time frame?

·         What is the volume of spent irrigation water collected per sample?

·          Are sampling containers clean, sterile and free of anti-microbials?

·          Is neutralizing chemical (e.g., sodium thiosulphate) added in the sampling container (this is needed if chlorinated water is used for irrigating sprouts)?

·         How are samples stored prior to testing? (Include temperature)

·         What are the minimum and maximum amounts of time these samples are stored before arriving at the lab?

·         How are the samples transported to the testing lab?

·         Are samples clearly marked for tracking?

·         Are samples shipped refrigerated?

I6eDoes the firm have sampling records that confirm the above answers?   Automatic Failure
I6fIs spent irrigation water tested for:

E. coli O157:H7

Salmonella spp.

Others?  Specify.


I6gIs the initial microbial testing of spent irrigation water performed by a contract laboratory or the firm’s in-house lab?Document
I6hIf contract laboratory, is there documentation that the lab is A2LA and/or ISO 17025 certified?   Document
I6iDoes contract lab participate in the American Proficiency Institute “check sample program”?   Document
I6jCall the lab to confirm the lab reports: Does the lab confirm they did the testing?   Automatic Failure
I6jIf firm’s in-house lab, is the lab certification on file?   Document
I6kIs the in-house technician certified to perform the tests?   Document
I6lMethod used for initial testing? (FDA BAM method, rapid test kits, PCR, other?)This is for comment only. Are rapid test kits valid for hold and release?
I6mIf rapid test kits are used, list brand name for each test

–  Salmonella

–   E. coli O157:H7

–  Other (specify)

I6nDid the firm have any presumptive positive results?


I6oIs a confirmation test done when a preliminary positive test result is received?

If yes,  check lab report results to verify

I6pWhat is used for confirmation testing – spent irrigation water or enrichment media?Should this be stated as a requirement?
I6qIf positive or unconfirmed presumptive positive, are there records to confirm proper disposition of all product in that batch of seeds?   Fatal flaw
I6rDoes the firm keep hold and release records adequate to ensure no contaminated product has gotten into the marketplace?   Document
I6sDoes the firm notify seed suppliers of positive results?   document


J. Storage and Distribution


J1Does the firm cool their sprouts to 45 degrees Fahrenheit or below, prior to distribution? Check the core temperature of the sprouts that were placed under refrigeration at the end of the previous day’s shift.   Inspect
J2Are sprouts being cooled under sanitary conditions?   Inspect
J3Is the cooler temperature checked at least twice a day?   Document
J4Is the truck refrigeration temperature recorded on the truck log, monitoring device or invoices, etc.?   document
J5Does the firm distribute sprouts under refrigeration?   Inspect


K. Traceback and Recalls


K1Does the firm have written procedures for the recall of product?   Document
K2Has the firm tested its traceback and recall system twice a year at a minimum? Confirm with documentation.   Document
K3Was all of the product accounted for in the recall test?   Document
K4Was the traceback successful to the seed supplier and from the supplier to the farmer?    Can we trace back to the field yet?



L. Food/Facility defense (security) program Do we need this?


M. Training


M1Is management trained in GMPs?   Document
M2Is management trained in HACCP?   Document
M3Are personnel and supervisors responsible for the sanitation program trained to understand the principles and methods required for effective cleaning and sanitation?   Inspect
M4Does the firm have a training program for personnel and supervisors to have adequate technical knowledge and understanding of the operations and procedures to maintain the safety of sprouts?   Inspect
M5Does the firm have an appropriate training program in personal hygiene and hygienic handling of food?   Document
M6Does the firm have training materials for:
 seed sanitizing?

Every Batch Testing?

Hold and Release programs?

M7Are there proficiency criteria to show that the training was actually understood and retained by employees?   Inspect
M8Does the firm have signed records of training sessions?   Document
M9Does the firm have training records for recent hires?   Document
M10Does the firm have training records for regular refresher training for all employees?   Document
M11Are all training programs routinely reviewed and updated?   Document
M12Does the firm have records documenting regular self-audits?   Document