PowerPoint Presentation

Sampling Agreements & SurveillanceMaria Ishida, PhDBureau Chief

March 10, 20141:45 pmMatt ColsonEnvironmental Administrator

Richard StephensEnvironmental Scientist III

Florida Department of Agriculture and Consumer Services

Department Overview and Jurisdiction

The Florida Department of Agriculture and Consumer Services (FDACS) is one of several food regulatory authorities in the stateOver 46,000 permitted food establishments ranging from mobile vendors to major food processors and distribution centers2

Department Overview and Jurisdiction

Bureau of Food and Meat Inspection Responsible for inspecting retail and manufactured food establishments~ 5,000 manufactured food establishmentsMajority are storage and distribution, but also a large variety of processors Grocery stores, convenience stores, food processors and distributors, etc. More on slide 5.

3

Map of Districts

Florida has 67 counties, and the Bureau is divided into 14 districts

4

Map of Manufactured Food Firms

GIS map of processors from 2012. Doesnt list bottled water- 44 currently permitted. Good visual of manufactured food firms. 5

Department Overview and Jurisdiction

110 field inspectorsAll inspectors conduct retail and manufactured food inspectionsOnly inspectors with appropriate training conduct processing and specialized inspectionsAll inspectors collect samples

Inspectors start in retail and then begin manufactured food training. Everyone at least does warehouses. 6

State Food Contract Overview

Conduct contract inspections under State authorityFDA food contract breakdown360 Food Safety/ GMP inspections130 seafood HACCP inspections200 environmental samples34 state contract audits per year

Have adopted CFRs so we do contract inspections under our own authority. Entered phase II of audit program this year. Goal is to merge the state contract audits with standard 4 7

Department MFRPS Background

One of original 9 RRT states, enrolled in the MFRPS in 2008 First PAVA conducted in May 2010FDA contract MFRPS option 2011MFRPS cooperative agreement 2013Most recent audit in January 2014

Enrolled in retail standards in 2002. Received draft report from recent audit in February, currently preparing response. 8

Food Laboratories Overview

Bureau of Food Laboratories is part of Division of Food SafetyLaboratories are onsiteISO/IEC 17025:2005*Receive ~ 10,000 samples per year

*The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02Standard 10 was one of the first standards met because of the ISO accreditation. Sampling ties into all of the standards as Dan Rices presentation last year pointed out.

9

Sampling Program - Overview

Regular meetings between lab and inspection staff to develop surveillance sampling planSamples are collected for many reasons:SurveillanceFollow-up due to prior adulterated/ misbrandedInspection indicate need for collectionConsumer complaints FBI investigationEnvironmental samples for food contractOtherUnder MOU with DOH, may collect food/ environmental sample as part of a foodborne illness investigation. 10

Sampling Program - Overview

All samples input into our food inspection database (FIMS)FIMS communicates with laboratory management system (FSLIMS)Laboratory receives sample and pulls sample information from FIMS to FSLIMSLaboratory runs analysesResults input into FIMS/ FSLIMS

Lab receives sample, and looks up sample in FIMS by sample number. 11

FIMS Sample Collection Screen

Screenshot of sample collection screen in FIMS12

FIMS Sample Collection Laboratories notifies inspections staff of priority sample resultsViolative sample results appear as alert on FIMS dashboardLaboratory liaison coordinates compliance actionsLab liaison will also notify other regulatory authorities if necessary. 13

FIMS Sample Collection

Screenshot of dashboard showing adulterated/ misbranded sample alerts14

Sample Collection Report

15

Sample Statistics(FY 2011 - 2012)Total number of samples collected: 10,2706,512 regulatory samples2,470 USDA MDP 1,288 Others Number of analysis performed: 41,370Adulterated/Misbranded: 496 Compliance Rate: 92.38%Compliance Rate is for regulatory samples only.16

Types of SamplesRoutine/Survey Finished ProductEnvironmental SwabsElectronic (pictures)Foodborne Illness

Overview of sample types:

ROUTINE: Majority of samples. Collected at retail and manufacturing facilities. Finished Products, mostly RTE.

ENVIRONMENTAL SWABS: Per contract with FDA. 200 samples, split between two firms (100 per firm.)

ELECTRONIC: Pictures of labels for misbranding issues. Very efficient -no need to send in a physical sample for some misbranding.

FBI and Consumer Complaints: Covered in detail on slide #7.17

Survey SamplesPlan developed in conjunction with laboratory and inspectionsQuarterly meeting to discuss needs, capabilities, projects, etcAgree on samples types, and amounts, and create draft planFinal review and dissemination to district supervisors

For routine/survey samples. Example of plan on next slide.

Starting Point of Lab/Inspection coordination lab is integral in developing overall plan.

Coordinate with lab and inspection staff.

Contact with lab supervisors/section heads several times a week to ensure operations are running as smooth as they can.

Frequently what can be sampled changes during the quarter necessitates timely update and publishing of new plan.18

Quarterly Sampling Plan

Example of quarterly sampling plan/schedule.

Outlines what district is to sample each week, as well as what to collect for.

Usually around 6 pages; split between MICRO, CHEMISTRY, and a few other unique sample types (water, ice, species ID.)19

Environmental SamplesFDA Contract200 samples total per yearSplit as 100 samples X 2 eventsGenerally conduct at a firm tied to an adulterated productRequires prior coordination with laboratoryPerformed by RRT members under ICS

Overview of environmental samples

Almost always conduct at a firm which has been tied to adulterated product.

MUST MUST MUST have good coordination with the lab. They CANNOT be surprised by 100 swabs.

Coordination with lab has directly affected our environmental sampling procedures for example, only sample on Monday or Tuesday to facilitate follow up in lab.

Sampling event is done by personnel on our Rapid Response Team, under an ICS structure.

20

Environmental SamplingSampling Team 6 members, each with a unique rolllead swabber, assistant swabber, scribe, photographer, data entry, runnerICS StructureEach team member is assigned an ICS positionPrimary Positions: Incident Commander, Logistics Chief, Planning ChiefPre-event meeting and AAR

Sampling conducted using methods and materials outlined in the Siliker Manual and DFI Bulletin and FDA video.

Without getting into the weeds to much, here is an outline of a sampling event. Weve found (through trial and error) that this system works well for us.

Describe team rolls first 4 are outlined in Manual, DFI, FDA Video. Bottleneck at data entry has been an issue (hope to be smoother under new system.) Importance of runner to keep work moving (no needto stop sampling to allow someone to run back and drop samples off with the data entry person,) AND as a Point of Contact for the firm to answer any questions that may have.

ICS reminder all rolls not filled roll up to the previous level.

Primary duties (for these events) of each ICS position.IC over all lead. Approves plan, guides operation, and keeps us on track.LCS transport of samples and people. Identify several sample drop off points and alternatives. May be more efficient to drive them to lab personally or to pony express them. Responsible for Medical Plan (usually just dial 911, but in some rural areas, may need backup. Identify nearest hospital facility/emergency room.PCS recon report, map of facility, pictures of equipment. Develops overall timeline for event (operational period.)

21

Food Borne Illness InvestigationsMultiple agencies involvedCoordination with state Department of Health for epidemiological servicesStatutory authorityMOU to meet requirements of Standard 5Sample collection is coordinated between other agencies, laboratory, and inspections

Agencies = FDACS, DOH, DBPR, possible law enforcement.

DOH has authority/responsibility for epi services in Florida.

Sampling required as part of a FBI requires constant coordination between agencies/bureaus. 22

Example L. mono in SandwichesOverview of one case that encompassed multiple facets of the overall program. 23Outlines

Bureau of Food Laboratories

LocationOrganizationCollaboration & Cooperative AgreementsLaboratory Capacity Analytical Methods ReportingHow ISO CAP Sampling Agreement will Affect Us

Tallahasseewww.city-data.comLocation Conner Complex

Bureau of Food and Meat InspectionsBureau of Food Laboratorieshttps://maps.google.comOrganization

Bureau of Food Laboratories Chemistry Section Microbiology SectionFood Safety TestingConsumer Protection Testing

Food Safety TestingPreparedness/Molecular Testing

26Collaboration & Cooperative Agreements

FDA ContractFDA MFRPS CAP (Standard #10)FDA RRT CAP

Cooperative AgreementsFSIS FERN CAP (Microbiology)FDA FERN CAP (Microbiology)FDA ISO Accreditation*

Laboratory Capacity

44,000 analyses/year

Analytical Methods

61 analytical methods (chemistry, microbiology, and molecular testing)

Biological Testing (16)*The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02

Chemistry Testing (15)Analytical Methods*The Bureau of Food Laboratories maintains A2LA accreditation to ISO/IEC 17025 for the specific tests listed in A2LA certificates 2534.01 and 2534.02Reporting

Reporting

How FDA ISO CAP Sampling Agreement Will Affect Us?

Sample Type(ISO CAP Sampling Agreement )Sample Type (Bureau of Food Laboratories)Manufactured Foods Under the Purview of FDASandwichEnvironmental Samples of Manufactured Food (MF) production/storage and transport facilities. Environmental Swaps (RRT and MFRPS CAP) Routine Manufactured Food Samples Prepared Salad, Sandwich, Canned Food, Dried Fruit or Vegetables, CandiesSeafood samples Smoked fish, FishProcessed Shellfish XXXBottled Water only (not municipal water)Vended Water and Ice Non-routine Manufactured Food Samples Planned for and Collected During Alleged Illness Investigations and Complaints. YES???ProduceFresh Produce, Sprouts and VegetablesHow FDA ISO CAP Sampling Agreement Will Affect Us?

Analytes(ISO CAP Sampling Agreement )Analytes(Bureau of Food Laboratories )ChemicalArtificial Colors*, Fat Analysis*, Total Arsenic, Organic Acid, Coumarin, Ethyl Vanillin, Vanillin, Sugars*, Total Protein*, Sulfite*, Total Moisture*PesticidesXXX BiologicalBacillus cereus, Escherichia coli (generic*, STEC, EHEC*), Listeria monocytogenes*, Salmonella*, and Staphylococcus aureus*, VibrioPhysical Foreign Material (Filth)AllergensAllergens/ Label reviewMetalsHeavy Metals ToxinsAflatoxin*, Staphylococcal Enterotoxin BContaminants ???Species Substitution/ConfirmationFish Speciation*Confirmation of Product Identity Label review, Standard of Identity * Method on ISO 17025 scopeSome Questions

What is the minimum of acceptable sample type to be include into the FDA ISO sampling agreement? What is the minimum of acceptable analytes to be include into the FDA ISO sampling agreement?Does the testing need to be under ISO 17025?How report samples from this agreement?What paperwork do we need to capture/retain for this sampling agreement under Sampling Agreement Addendum?

Acknowledgements

Contact InformationMatt Colson Environmental Administrator of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer ServicesMatthew.Colson@freshfromflorida.com Richard Stephens Environmental Specialist III of Bureau of Food and Meat Inspections Florida Department of Agriculture and Consumer ServicesRichard. Stephens@freshfromflorida.com Maria L. IshidaBureau Chief of Food LaboratoriesFlorida Department of Agriculture and Consumer ServicesMaria.Ishida@freshfromflorida.com 2013 SURVEY SAMPLES

Quarter 2DATESDISTRICT

April 01 - 05 01

April 08 - 1206

April 15 - 1907

April 22 - 2608

April 29 - May 0309

May 06 - 1002

May 13 - 1703

May 20 - 2404

May 27 - 3105

June 03 - 0710

June 10 - 1411

June 17 - 2112

June 24 - 28TBD

If you are ever unable to synch after sample collection please immediately notify Rich Stephens richard.stephens@freshfromflorida.com and cc. Robert Docket robert.docket@freshfromflorida.com and Sun Kim sun.kim@freshfromflorida.com If the lab knows that the sample information has not been uploaded they can adjust accordingly.

Send an e-mail stating the type and amount of samples collected to the sample ship distribution list: _TLFS_SampleShip.Individual members of the distribution list are as follows

Richard Stephens: richard.stephens@freshfromflorida.com (850)245-5541

Robert Dockett: robert.dockett@freshfromflorida.com (850)617-7575Sun Kim: sun.kim@freshfromflorida.com (850)617-7562

Patricia Hanson: patricia.hanson@freshfromflorida.com (850)617-7563

Mark French: mark.french@freshfromflorida.com (850)617-7556

Maria Ishida: maria.ishida@freshfromflorida.com (850)617-7559Amy Bryant: amy.bryant2@freshfromflorida.com (850)617-7558

Jason Crowe: jason.crowe@freshfromflorida.com (850)617-7577Microbiology SamplesAll samples collected for microbiological analysis must be shipped CHILLED.Product: Smoked FishAnalysis: Listeria monocytogenesAmount Needed per Sample: 4 oz.

Schedule: 3/week (3 subs each)

Special Instructions: When possible, collect from a Florida Processor.

Product: Cheese Analysis: L. mono., Staph. aureus, Salmonella, E. coli.

Amount Needed per Sample: 8 oz

Schedule: 5/week Special Instructions: Imported and domestic soft, white cheeses. We are especially interested in unripened, unpasteurized, soft cheese from Mexico, Nicaragua and Honduras. Include Feta, Brie, Camembert, blue-veined cheeses, queso blanco, queso fresco, Queso Panela, Asadero and Mexican-style soft cheese.Product: Store or Factory-made SandwichesAnalysis: L. mono., Staph aureus, E. coli.Amount Needed per Sample: Whole SandwichSchedule: 3/week (3 subs each)

Special Instructions: Each sample should consist of 3 identical sandwiches, with identical code (sell by date). Collect : (1) sandwiches manufactured by Type 341 (sandwich processing) firms in your district or (2) sandwiches produced by out-of-state sources or (3) if none of the former are available, collect more store made sandwichesProduct: Lunch/Deli Meat (sliced in store)Analysis: L. mono., Staph. aureus, Salmonella, E. coli.Amount Needed per Sample: 8 oz

Schedule: 5/week

Special Instructions: Meats sliced in the deli area of the food entity. Include in your sample collection report, the manufacturers establishment number, usually found in the USDA shield of the bulk meat being cut, and lot code numbers. Consider collecting, turkey, ham, roast beef, & unusual deli sliced products. Avoid dried, salted meats (salami, pepperoni.)

Product: Fresh Squeezed Orange Juice (seasonal)Analysis: Salmonella, E. coli, and Aerobic Plate CountAmount Needed per Sample: 8 oz

Schedule: 5/week

Special Instructions: Collect from Juice Processors when in season.

Water Samples

Collect on MONDAY and TUESDAY ONLYItem# SamplesProduct

AnalysisMinimum Amt

A. 15/wk

Vended WaterColiforms

100 ml

Sampling Instructions Write Vended Water in the product description of your sample collection report to distinguish it from bottled water. Use VW as the product code #. Ship chilled. Conspicuously mark outside of shipping container, Vended Water so container will be given lab priority. These samples only have 30 hours for analysis.Item# SamplesProduct

AnalysisMinimum Amt

B.15/wk

Ice

Coliforms

8 oz

Sampling Instructions If you use the 8 oz plastic sterile cup, collect 2 cups per sample. If you used the plastic sterile bags collect until the bag is 75% full and make sure you seal the bag properly. Please call headquarters if you have any questions.

Inspectors Discretion Survey Sampling - MicrobiologyThe collection of Inspectors Discretion samples is voluntary. Therefore, Districts are not asked to collect any of the following samples, unless they have the interest and want to spend the time during this Sample Survey. If collected, they can be submitted Tuesday thru Thursday, for Wednesday thru Friday arrival in the laboratory.Inspectors Discretion Survey Sampling - ChemistryThe collection of Inspectors Discretion samples is voluntary. Therefore, Districts are not asked to collect any of the following samples, unless they have the interest and want to spend the time during this Sample Survey. If collected, they can be submitted Tuesday thru Thursday, for Wednesday thru Friday arrival in the laboratory.Special Requests:(1) Label Review (Misbranding)(2) Bakery samples (Filth)(3) Import Honey from India (Lead)(4) Soft Shell Crab (Metals)Chemistry Samples

Product: OystersAnalysis: Cadmium, LeadAmount Needed per Sample: One Oyster

Schedule: 6/weekShip: Chilled

Special Instructions:: Make a copy of the SHELL-STOCK TAG and include with the collection report that is shipped to the lab.Product: Dried Fruit and Vegetables Analysis: Undeclared Sulfites Amount Needed per Sample: 8 oz

Schedule: 4/week Ship: Dry

Special Instructions: None Product: Scombroid Fish Analysis: Decomposition Amount Needed per Sample: 8 oz

Schedule: 5 monthly

Ship: Chilled

Special Instructions:: Examples of Scombroid fish include Tuna, Mahi Mahi, Mackerel, etc. See FDA Fish and Fishery Products Hazards and Control Guidance Manual, chapter 3, table 3-2.)Product: Seasonal Candies (Easter)Analysis: Foreign Material

Amount Needed per Sample: 8 oz

Schedule: 6/week

Ship: Dry

Special Instructions: NoneElectronic Sample Collection (only 1 2/week)Electronic samples are digital images of food products submitted for label review.

Procedure:

1. Inspector collects sample by means of one or more digital photos. A collection report is generated as would be the case when collecting a physical sample. The number of images taken should be documented in the comments section of the collection report.

Please include pictures of all labeling on the product, and ensure that they are clear and legible.

2. Collecting inspector notifies the Food Lab of electronic sample collection via email to _TLFS_LabPhoto . The email should include Firm #, collection date, the collecting inspectors name, and EIS # assigned to the sample. Please name the image files with the EIS number generated for the sample. Images for only one sample are to be sent per each email. In order to maintain chain of custody, only original unaltered images may be submitted. Please see the example below:

_____________________________________________________________________________

From:

Inspectors Name

Sent:

Tuesday, June 09, 2009 8:36 AM

To:

_TLFS_LabPhoto

Subject:

FW: Sample for label review

Attachments:

34177320900251.jpg

Attached please find the photograph of the following item: Crab Salad

Firm 58312

Collected 6/8/09

By: Inspectors Name

Sample # 3417-7320-9002-51

PAGE 03/29/2013_Rev 0. 1

Microbiology SamplesAll samples collected for microbiological analysis must be shipped CHILLED.Product: Smoked FishAnalysis: Listeria monocytogenesAmount Needed per Sample: 4 oz.

Schedule: 3/week (3 subs each)

Special Instructions: When possible, collect from a Florida Processor.

Product: Cheese Analysis: L. mono., Staph. aureus, Salmonella, E. coli.

Amount Needed per Sample: 8 oz

Schedule: 5/week Special Instructions: Imported and domestic soft, white cheeses. We are especially interested in unripened, unpasteurized, soft cheese from Mexico, Nicaragua and Honduras. Include Feta, Brie, Camembert, blue-veined cheeses, queso blanco, queso fresco, Queso Panela, Asadero and Mexican-style soft cheese.Product: Store or Factory-made SandwichesAnalysis: L. mono., Staph aureus, E. coli.Amount Needed per Sample: Whole SandwichSchedule: 3/week (3 subs each)

Special Instructions: Each sample should consist of 3 identical sandwiches, with identical code (sell by date). Collect : (1) sandwiches manufactured by Type 341 (sandwich processing) firms in your district or (2) sandwiches produced by out-of-state sources or (3) if none of the former are available, collect more store made sandwichesProduct: Lunch/Deli Meat (sliced in store)Analysis: L. mono., Staph. aureus, Salmonella, E. coli.Amount Needed per Sample: 8 oz

Schedule: 5/week

Special Instructions: Meats sliced in the deli area of the food entity. Include in your sample collection report, the manufacturers establishment number, usually found in the USDA shield of the bulk meat being cut, and lot code numbers. Consider collecting, turkey, ham, roast beef, & unusual deli sliced products. Avoid dried, salted meats (salami, pepperoni.)

Product: Fresh Squeezed Orange Juice (seasonal)Analysis: Salmonella, E. coli, and Aerobic Plate CountAmount Needed per Sample: 8 oz

Schedule: 5/week

Special Instructions: Collect from Juice Processors when in season.

Water Samples

Collect on MONDAY and TUESDAY ONLYItem# SamplesProduct

AnalysisMinimum Amt

A. 15/wk

Vended WaterColiforms

100 ml

Sampling Instructions Write Vended Water in the product description of your sample collection report to distinguish it from bottled water. Use VW as the product code #. Ship chilled. Conspicuously mark outside of shipping container, Vended Water so container will be given lab priority. These samples only have 30 hours for analysis.Item# SamplesProduct

AnalysisMinimum Amt

B.15/wk

Ice

Coliforms

8 oz

Sampling Instructions If you use the 8 oz plastic sterile cup, collect 2 cups per sample. If you used the plastic sterile bags collect until the bag is 75% full and make sure you seal the bag properly. Please call headquarters if you have any questions.

Inspectors Discretion Survey Sampling - MicrobiologyThe collection of Inspectors Discretion samples is voluntary. Therefore, Districts are not asked to collect any of the following samples, unless they have the interest and want to spend the time during this Sample Survey. If collected, they can be submitted Tuesday thru Thursday, for Wednesday thru Friday arrival in the laboratory.Inspectors Discretion Survey Sampling - ChemistryThe collection of Inspectors Discretion samples is voluntary. Therefore, Districts are not asked to collect any of the following samples, unless they have the interest and want to spend the time during this Sample Survey. If collected, they can be submitted Tuesday thru Thursday, for Wednesday thru Friday arrival in the laboratory.Special Requests:(1) Label Review (Misbranding)(2) Bakery samples (Filth)(3) Import Honey from India (Lead)(4) Soft Shell Crab (Metals)Chemistry Samples

Product: OystersAnalysis: Cadmium, LeadAmount Needed per Sample: One Oyster

Schedule: 6/weekShip: Chilled

Special Instructions:: Make a copy of the SHELL-STOCK TAG and include with the collection report that is shipped to the lab.Product: Dried Fruit and Vegetables Analysis: Undeclared Sulfites Amount Needed per Sample: 8 oz

Schedule: 4/week Ship: Dry

Special Instructions: None Product: Scombroid Fish Analysis: Decomposition Amount Needed per Sample: 8 oz

Schedule: 5 monthly

Ship: Chilled

Special Instructions:: Examples of Scombroid fish include Tuna, Mahi Mahi, Mackerel, etc. See FDA Fish and Fishery Products Hazards and Control Guidance Manual, chapter 3, table 3-2.)Product: Seasonal Candies (Easter)Analysis: Foreign Material

Amount Needed per Sample: 8 oz

Schedule: 6/week

Ship: Dry

Special Instructions: NoneElectronic Sample Collection (only 1 2/week)Electronic samples are digital images of food products submitted for label review.

Procedure:

1. Inspector collects sample by means of one or more digital photos. A collection report is generated as would be the case when collecting a physical sample. The number of images taken should be documented in the comments section of the collection report.

Please include pictures of all labeling on the product, and ensure that they are clear and legible.

2. Collecting inspector notifies the Food Lab of electronic sample collection via email to _TLFS_LabPhoto . The email should include Firm #, collection date, the collecting inspectors name, and EIS # assigned to the sample. Please name the image files with the EIS number generated for the sample. Images for only one sample are to be sent per each email. In order to maintain chain of custody, only original unaltered images may be submitted. Please see the example below:

_____________________________________________________________________________

From:

Inspectors Name

Sent:

Tuesday, June 09, 2009 8:36 AM

To:

_TLFS_LabPhoto

Subject:

FW: Sample for label review

Attachments:

34177320900251.jpg

Attached please find the photograph of the following item: Crab Salad

Firm 58312

Collected 6/8/09

By: Inspectors Name

Sample # 3417-7320-9002-51

PAGE 03/29/2013_Rev 0. 1