Environmental Monitoring

FSMA TRAINING:

ENVIRONMENTAL MONITORING

Environmental Monitoring

Deann Akins-Lewenthal - ConAgra

Listeria Monitoring:

Frozen Food Industry

Environmental Monitoring EMPC- Whole Genome Sequencing

Challenges in manufacturing environments have led to new opportunities to use Next Generation Tools

• Whole Genome Sequencing reveals the DNA makeup of organisms

• Determine persistence of pathogens in environments and help to drive towards root cause and appropriate corrective actions

Two examples of using WGS with Environmental Listeria spp.

• Both manufacturing facilities produce products that don’t support the growth of Listeria spp.

Environmental Monitoring Plant 1: Driving Change with

New Tools

• 2 drains in the roasting room reported as positive for Listeria species; CA

and vectoring began

• Vectors + and investigative swabbing showed many floor sites were positive

• Multiple re-cleanings and verification swabs collected

• Roasting commenced and operational swabs taken

• Days 1, 2, 3 - Of 33 swabs taken each time: 6, 29, 17 consecutive positives

Environmental Monitoring Timeline cont.

Full clean, chlorinated floor (1,800 ppm)

10 swab results were +

2 frame sites +

Increased chlorine ppm on floor (2,000 ppm)

40 swab results were NEGATIVE

Days 1, 2 – Of 31 swabs taken: 10, 22 consecutive positives

Later, another full clean and chlorine flood >2000 ppm.

3 of 33 swabs were +

Finally, swabbed inside bearings

and found them positive

(Total period of about three months)

Vector and investigative swabbing

indicated corrective actions were not

successful

Environmental Monitoring Whole Genome Sequencing…

WGS performed on 66 isolates recovered

from Roaster room

isolates with 98% similarity with Listeria innocua 54

isolate grouped with Listeria marthii 1

isolates atypical for Listeria species 11

Environmental Monitoring Outcome

Sanitary design modifications initiated once harborage site identified

New sealed bearings Removed the sandwich

areas for the legs Made cut-outs for clean-

ability

Environmental Monitoring Example 2

Routine EMP program was initiated by Enterprise Microbiology

First positives detected, 2nd set of follow up swabs showed

few Listeria spp. positive

Additional CA’s were performed. Follow-up swabs were negative

During routine swabbing, Listeria positives were detected again, CA’s were

performed, 2nd set of follow-up swabs detected few Listeria spp. positives

Increased Swabbing was performed, 34 positives were detected. Line was

shut down, Corporate team was involved and an action plan was

proposed. Plan included: (1) WGS analysis of the isolates (2) Change in

sanitation practices (3) Capital improvements and (4) Traffic controls

Root-cause found and fixed. 3 months of negative results. Plant continues

to implement best practices identified during the root-cause investigation

process

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Environmental Monitoring Example 2

Environmental Monitoring

Maintenance Cart was going to/from outside of

the facility to production areas

Group 1 Listeria spp. Group 2 Listeria spp.

Environmental Monitoring Key Accomplishments

Re-surfaced the floors where the Listeria was detected and in the sanitation room

Listeria spp. harborage sources (ex: cracks in floors) were sealed

Roll-up door was removed and replaced with a wall

Restricted usage of water-DRY CLEANING AND SANITATION ONLY

Re-designed traffic controls

Instituted foot sanitation for employees before entering into the area

Environmental Monitoring Take Home Message

A robust EMPC program is designed

to find potential pathogens and eliminate them.

Seek and Destroy

Definitions of EMPC terms may not be universal to all of industry; Ask for

clarity

Routine versus investigational,

zones

Important to focus on the corrective action

plan and follow through after a

suspect result is determined.

WGS will not be used in every

situation.

Resolution does not happen over night.

Environmental Monitoring Acknowledgments

Joan Menke

Steve Hermansky, Ph.D.

Bala Kottapalli, Ph.D.

Nancy Dobmeier

Brad Ziebell