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Salmonella Control: Tighter Regs – New Realities

Salmonella Control: Tighter Regs – New Realities

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Page 1: Salmonella Control: Tighter Regs – New Realities

Salmonella Control:Tighter Regs – New Realities

Page 2: Salmonella Control: Tighter Regs – New Realities

HOST Bill KinrossGroup Publisher,

Meatingplace

MODERATOR Ann Bagel StorckManaging Editor,

Meatingplace

Page 3: Salmonella Control: Tighter Regs – New Realities

Regulatory DiscussionElizabeth KrushinskieDVM, PhDDirector of QA and Food SafetyMountaire Farms, Inc.

Page 4: Salmonella Control: Tighter Regs – New Realities

Overview

• Setting the Stage• Current Features• Coming Attractions• Foreign Dramas

Page 5: Salmonella Control: Tighter Regs – New Realities

Poll Question

Are you aware of the Healthy People 2010 initiative and could you explain it to someone else? Yes No

Page 6: Salmonella Control: Tighter Regs – New Realities

Setting the Stage

• In 2000, HHS set objectives related to foodborne illness reduction in their Healthy People 2010 document– Salmonellosis infections were projected to be

reduced from 13.7 in 1997 to 6.8/100,000 by 2010• Preliminary FoodNet data for 2009 reported a

Salmonella infection rate of 15.19/100,000, well above the 2010 goal

Page 7: Salmonella Control: Tighter Regs – New Realities

Setting the Stage

• USDA’s Response– FSIS contributes to meeting this objective

by regulating the Salmonella burden of meat, poultry, and egg products through the Pathogen Reduction/Hazard Analysis Critical Control Point (PR/HACCP) System implemented in 1996

Page 8: Salmonella Control: Tighter Regs – New Realities

Setting the Stage

• In 1996, the Agency established a Performance Standard for the incidence of Salmonella on broiler carcasses post-chill (per 9 CFR 381.94)

• In 2006, FSIS classified establishments according to their performance relative to the Performance Standard (Category I, II, or III)

Page 9: Salmonella Control: Tighter Regs – New Realities

Current Features

• Salmonella Performance Standard - Broilers (9 CFR 381.94)

Class of Product Performance Std

No of Samples Tested

Max No of Positives

Broilers – Category II

20.0% 51 12

Broilers – Category I

10.0% 51 6

Page 10: Salmonella Control: Tighter Regs – New Realities

Setting the Stage

• 4th Quarter CY2009 results of FSIS testing have shown that only 3.5% of samples from large plants were positive, 18.4% of small, and 25.0% of very small with an overall average of 8.6%

Page 11: Salmonella Control: Tighter Regs – New Realities

Setting the Stage

• In addition, 82% of establishments were considered to be in Category I (achieving consistent process control) in Q4FY2009– FSIS’ goal is 90% by October 1, 2010– Only 2% were in Category III (failing to meet the

performance standard)

Page 12: Salmonella Control: Tighter Regs – New Realities

Current Features

• At this time, pathogen control in processing is governed by five key regulations :– On-line Reprocessing (OLR)

• 9 CFR 381.3(b)

– Off-line Reconditioning for Contamination• 9 CFR 381.91

– Zero Tolerance for Fecal Contamination• 9 CFR 381.65(e)

Page 13: Salmonella Control: Tighter Regs – New Realities

Current Features

• Chiller Chlorination and Water Reuse– FSIS Notice 45-03 Use of Chlorine to Treat Poultry

Chiller Water• Salmonella Performance Standard post-chill

Page 14: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Salmonella Initiative Program (SIP) • Revised post-chill Performance Standard• Revised Salmonella criteria for Stuffed, Raw,

Not-Ready-To-Eat (NRTE) that appear to be Ready-To-Eat (RTE)

• Control of S. Enteriditis in broilers• Raw Chicken Parts Baseline

Page 15: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Salmonella Initiative Program (SIP) – Announced in a January 2008 Federal Register

Notice– Described as a “voluntary” incentive-based

program for meat and poultry establishments that is intended to yield “significant data on attribution of human illness to FSIS-regulated products”

Page 16: Salmonella Control: Tighter Regs – New Realities

Coming Attractions• Salmonella Initiative Program (SIP)

– The Agency developed the SIP to “offer waivers to existing regulations (ie for increased line speed, changes to chilling of carcasses, etc) in return for increased process control efforts for Salmonella and Campylobacter”

– Industry is concerned that changes to current waivers would require participation in SIP

– Also concerned about having the micro data collected used against us

Page 17: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Revised Post-Chill Salmonella Performance Standard– FSIS initiated a new young chicken baseline in June

2007– We are still waiting for the results to be published– Anticipate the Performance Standard to be

significantly reduced from the current 20%– Will add a new PS for Campylobacter

Page 18: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Possibly revised Salmonella Performance Standard - Broilers (9 CFR 381.94)

Class of Product Performance Std

No of Samples Tested

Max No of Positives

Broilers – Category II

8.0% 51 4

Broilers – Category I

4.0% 51 2

Page 19: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Revised Salmonella criteria for Stuffed, Raw, Not-Ready-To-Eat (NRTE) that appear to be Ready-To-Eat (RTE)– FSIS has been informally discussing new policies to

address Salmonella in retail, non-RTE, frozen stuffed poultry products

• In effect, FSIS would like to declare Salmonella to be an adulterant in these products

Page 20: Salmonella Control: Tighter Regs – New Realities

Coming Attractions

• Control of S. Enteriditis (SE) in broilers– 2009 FoodNet results showed that SE infections

were the most common of the Salmonella serotypes identified

• It also showed that there was a 32% increase in SE compared to 1996-1998

– FSIS data has also shown an increase in the proportion of SE recovered from post-chill regulatory samples

Page 21: Salmonella Control: Tighter Regs – New Realities

Coming Attractions• Raw Chicken Parts Baseline

– In January 2010, FSIS published FSIS Notice 08-10 announcing the implementation of a nationwide raw chicken parts microbiological baseline data collection program for one year

– This will include all cut-up chicken parts: skin on, skinless, bone in, and boneless plus giblets

– May result in a Performance Standard at point of packaging

Page 22: Salmonella Control: Tighter Regs – New Realities

Foreign Dramas• Russian ban on the use of chlorine in

processing– The Russian Parliament banned the sale of raw

chicken products that have been treated with chlorine effective January 1, 2010

– Since that time, USDA and the U.S.A. Poultry & Egg Export Council (USAPEEC) have been in continuing negotiation with Russia trying to get a finalized trade agreement

Page 23: Salmonella Control: Tighter Regs – New Realities

Mike MullenCorporate Account ManagerFor more information contact:[email protected] www.ecolab.com or 800-392-3392

Page 24: Salmonella Control: Tighter Regs – New Realities

Pre-Harvest Salmonella Interventions: Value and Methods

B.M. HargisDVM, PhDProfessor and DirectorUniversity of Arkansas Poultry Health LaboratoryTyson Endowed Chair for Sustainable Poultry Health

Page 25: Salmonella Control: Tighter Regs – New Realities

Purpose of Presentation• To demonstrate that the source of Salmonella

contamination of poultry carcasses is from pre-slaughter infections of poultry

• To provide evidence that ante-mortem interventions can markedly reduce post-mortem contamination

• To compare available ante-mortem intervention strategies with regard to efficacy

Page 26: Salmonella Control: Tighter Regs – New Realities

No “Silver Bullet” for Salmonella• Salmonella is Amazingly Frustrating• Many Strains (serotypes) – vaccination difficult• Differ in Ability to Cause Disease• Transmitted Vertically and Horizontally• Many Sources of Infection – many carriers – most

broilers are infected from the breeder flocks through the hatchery

• Maintaining Zero Infections is Expensive• Difficult to Maintain Free Status

Page 27: Salmonella Control: Tighter Regs – New Realities

Salmonella – Live Production Source

• Food Borne Pathogens Do Not Originate from Spontaneous Generation!

• Poultry from Salmonella-free farms arrive at processing - free of Salmonella

• Poultry that enter the processing plant free of Salmonella, exit the processing plant without contamination in facilities not contaminated by previously infected flocks

Page 28: Salmonella Control: Tighter Regs – New Realities

Evidence for Live Production Source

• Scheduling of infected flocks for the end of the shift has greatly reduced post-chill contamination

• Flocks that are not infected, when processed as the first flock of the day, are Salmonella free

• Effective live production interventions have resulted in marked reductions in contaminated carcasses in numerous published studies

Page 29: Salmonella Control: Tighter Regs – New Realities

Hargis, B. M., D. J. Caldwell, and J. A. Byrd. 2001. Microbial pathogens of poultry: Live bird considerations. Pages 121–136 in

Poultry Meat Processing. • Non-infected flocks are processed as

Salmonella negative• Carcass contamination increases markedly

after crop removal – crop is the primary source

• Once a plant is contaminated, negative flocks may be contaminated during processing

Page 30: Salmonella Control: Tighter Regs – New Realities

First 2 flocks of a Processing DaySalmonella positive/Total samples

Pre-Chill

Pre-Chill

Pre-Chill

Post-Chill

Flock Swab Skin C.R. C.R. 1 0/45 0/45 0/45 0/45 2 0/30 0/30 0/30 0/30

When flocks identified as Salmonella negative entered a processing plant as the firstFlocks of a shift – no Salmonella was detected at pre- or post-chill

Page 31: Salmonella Control: Tighter Regs – New Realities

EXPERIMENT 2Flock 1 - Low Level Detection Antemortem

0

5

10

15

20

25

30

Sampling Points

% S

alm

on

ella

Po

siti

ve

Post-Pick

Post-Evis.

Post-Crop

Pre-Chill

Post-Chill

Page 32: Salmonella Control: Tighter Regs – New Realities

EXPERIMENT 2Flock 2 - High Level Detection Antemortem

0

10

20

30

40

50

60

70

80

Sampling Points

% S

alm

on

ella

Po

siti

ve

Post-Pick

Post-Evis.

Post-Crop

Post-Trim

Pre-Chill

Post-Chill

Page 33: Salmonella Control: Tighter Regs – New Realities

EXPERIMENT 2Flock 3 - Low Level Detection Antemortem

0

10

20

30

40

50

60

70

80

Sampling Points

% S

alm

on

ell

a Po

sit

ive

Post-Pick

Post-Evis.

Post-Crop

Post-Trim

Pre-Chill

Post-Chill

Page 34: Salmonella Control: Tighter Regs – New Realities

Hargis, B. M., D. J. Caldwell, R. L. Brewer, D. E. Corrier, and J. R. DeLoach. Evaluation of the chicken crop as a source of

Salmonella contamination from broiler carcasses. Poult. Sci 74:1548–1552.1995.

• The crop was found to be several times more frequently contaminated with Salmonella than the ceca

• The crop ruptured during processing 80x more frequently than the ceca

Page 35: Salmonella Control: Tighter Regs – New Realities

Ramirez, G. A., L. L. Sarlin, D. J. Caldwell, C. R. Yezak, M. E. Hume, D. E. Corrier, J. R. DeLoach, and B. M. Hargis. Effect of feed withdrawal on the incidence of

Salmonella in the crops and ceca of market age broiler chickens. Poult. Sci 76:654–656.1997.

• The incidence of crop contamination pre-slaughter was greatly increased by pre-slaughter feed withdrawal

• The longer the feed withdrawal period, the greater the incidence of crop Salmonella recovery

• Several subsequent papers also confirmed this and linked to increased processing plant contamination

Page 37: Salmonella Control: Tighter Regs – New Realities

Thoracic Cavity With Visible Contamination -Lights Off - with Black Light

• Note: zero tolerance for visible ingesta caused a common response of extended pre-slaughter feed withdrawal – resulting in greater Salmonella (and Campylobater contamination of crops pre-slaughter

Page 38: Salmonella Control: Tighter Regs – New Realities

Poult Sci. 2001 Mar;80(3):278-83.Effect of lactic acid administration in the drinking water during preslaughter feed

withdrawal on Salmonella and Campylobacter contamination of broilers.Byrd JA, Hargis BM, Caldwell DJ, Bailey RH, Herron KL, McReynolds JL, Brewer RL,

Anderson RC, Bischoff KM, Callaway TR, Kubena LF.

• Treatment of chicks with high levels of certain organic acids during the feed withdrawal reduced carcass contamination post-chill by more than 50%

• Issue of reduced water consumption, carcass shrinkage, and cost of organic acid treatment

• A commercial product, developed at the University of Arkansas, uses a blend of acids and flavoring agents overcomes water refusal issue

Page 39: Salmonella Control: Tighter Regs – New Realities

Hargis, B. M., D. J. Caldwell, and J. A. Byrd. 2010. Microbial pathogens of poultry: Live bird considerations, C. Owens, Ed.

• Vaccination generally only has modest effects on intestinal colonization

• Vaccination is complicated by the more than 30 serovars of Salmonella that commonly infect poultry – relatively serotype specific

• While injected killed vaccines often protect against disease, only live vaccines have the potential to reduce enteric infection through development of mucosal immunity

Page 40: Salmonella Control: Tighter Regs – New Realities

Current USDA-sponsored Research Project at the UA - PHL

• We have developed a methodology for incorporating Salmonella and Campylobacter antigens (epitopes) into a non-pathogenic Bacillus vector

• This vector co-presents selected highly conserved antigens with an immunostimulatory molecule – oral application is possible

• Early research indicates that Campylobacter constructs are nearly 100% effective for eliminating infection in broiler chickens

• Current Salmonella constructs elicit moderate protection, research is ongoing

Page 41: Salmonella Control: Tighter Regs – New Realities

Bacillus-vectored Vaccine AgainstCampylobacter

Page 42: Salmonella Control: Tighter Regs – New Realities

Bacillus-vectored Vaccine

• Cell surface expression of epitopes and immunostimulatory molecules.

• Similar to expression system previously evaluated in Salmonella.

Page 43: Salmonella Control: Tighter Regs – New Realities

Campylobacter jejuniEnumeration by qPCR

0

1

2

3

4

5

6

7

Day 24 Day 36

log

CF

U/g

m Ilia

l C

on

ten

t

Saline

BSBB

BS/Campy IEII 10 6̂

BS/Campy IEII 10 8̂

Page 44: Salmonella Control: Tighter Regs – New Realities

Campylobacter jejuni-specificIgG Antibody Levels

0

0.1

0.2

0.3

0.4

0.5

0.6

Day 21 Day 36

S/P

Ra

tio

Saline

BSBB

BS/C IEII 10^6

BS/C IEII 10^8

Page 45: Salmonella Control: Tighter Regs – New Realities

Campylobacter jejuni-specificIgA Antibody Levels

0

0.1

0.2

0.3

0.4

0.5

Day 21 Day 36

S/P

Ra

tio

Saline

BSBBBS/C IEII 10 6̂

BS/C IEII 10 8̂

Page 46: Salmonella Control: Tighter Regs – New Realities

A Probiotic/DFM Developed at the University of Arkansas

• This lactic acid-based culture, laboratory designation “B11”, has been evaluated in more than 26 refereed papers during the last 7 years and reduces Salmonella in both laboratory and field studies

• Application in field trials has resulted in more than 80% reductions in Salmonella entering processing plants

• Commercial product (FloraMax® )is limited by drinking water administration

• Current field trials with in-feed application of a new Spore-based culture are promising

Page 47: Salmonella Control: Tighter Regs – New Realities
Page 48: Salmonella Control: Tighter Regs – New Realities

Limitations of Lactic Acid Bacterial-Based Probiotics

• Shelf life

• Heat stability

• Application

Page 49: Salmonella Control: Tighter Regs – New Realities
Page 50: Salmonella Control: Tighter Regs – New Realities

In Vitro Antimicrobial Screening

• In Vitro Antimicrobial Activity (Overlay)– Salmonella – Clostridium – Campylobacter

Hard Agar Nutrient Media

Soft Agar Overlay w/ Pathogen

Bacillus Colony

Page 51: Salmonella Control: Tighter Regs – New Realities

Overlay: Salmonella ssp.

Page 52: Salmonella Control: Tighter Regs – New Realities

Spore Yield

• High Concentration of Spores–1011-1012 spores/g of fermentate–Highly heat resistant –survive pelleting–GRAS – safe isolates

Page 53: Salmonella Control: Tighter Regs – New Realities

In vivo Screening

P-value < 0.05

Body Weight Gain: Chick In vivo Trial

100

110

120

130

140

150

160

170

180

190

200

Candidate Isolates

BW

G (

g)

DE

DE

DE

E

CD

DE

Page 54: Salmonella Control: Tighter Regs – New Realities

In vivo Screening

*Denotes significant Difference from ControlP-value < 0.05

0

10

20

30

40

50

60

70

80

90

100

Candidate Candidates

Perc

en

t R

eco

very

Crop

Ceca

* *

*

*

*

**

Recovery of S. typhimurium: Chick In vivo Trial

Page 55: Salmonella Control: Tighter Regs – New Realities

FIELD TRIAL

Page 56: Salmonella Control: Tighter Regs – New Realities

Field Trial

650

660

670

680

690

700

710

720

730

740

750

Control Histostat Sporulin B1 MM65

Body Weight Gain Langham Field TrialDay 23 of Experiment

a

B

b

b

BW

G (

g)

P-value < 0.05

a

b

Page 57: Salmonella Control: Tighter Regs – New Realities

Field Trial

Salmonella CFU from Langham Field Trial Day 23 of Experiment

00.20.40.60.8

11.21.41.61.8

22.22.4

Control Histostat Sporulin B1 MM65

cfu

/g (

log

10)

a

ab

b

ab

P-value < 0.05

Page 58: Salmonella Control: Tighter Regs – New Realities

Necrotic Enteritis Model - Broilers

250

270

290

310

330

350

370

Control BMD Sporulin Bacillus Group 2

Body Weight Gain and Mortality 22-29 Days

BW

G (

g)

8.5%16%

0% 0%b

b

aa

Page 59: Salmonella Control: Tighter Regs – New Realities

Summary• Live birds are the source of processing plant

contamination – infections are mostly from parent flocks

• The crop is the major site of infection/contamination leading to carcass contamination

• Extended feed withdrawal increases the contamination problem

• Antemortem disinfection of the crop will reduce processing plant contamination

Page 60: Salmonella Control: Tighter Regs – New Realities

Summary- Continued• Reducing infections in live birds reduces carcass

contamination• Current vaccines can reduce vertical transmission but

only modestly affect intestinal carriage and plant contamination – new vaccine technology holds promise

• Water-based probiotics (Lactic Acid Bacteria) are commercially available with demonstratable efficacy – though not all work

• Some available probiotic products also improve production efficiency

Page 61: Salmonella Control: Tighter Regs – New Realities

Summary- Continued• New specially-developed spore-based DFM for

feed treatment hold tremendous promise – large scale field trials are ongoing

• A multipronged approach is likely the most cost-effective way for reducing Salmonella contamination of carcasses to acceptable risk levels

Page 62: Salmonella Control: Tighter Regs – New Realities

Jeb [email protected]  www.carometec.com(563) 582-4230 

Page 63: Salmonella Control: Tighter Regs – New Realities

Post-Harvest InterventionsElizabeth KrushinskieDVM, PhDDirector of QA and Food SafetyMountaire Farms, Inc.

Page 64: Salmonella Control: Tighter Regs – New Realities

Overview

• Current Strategies• Russia

Page 65: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• FSIS Directive 7120.1 Safe and Suitable Ingredients Used in the Production of Meat, Poultry, and Egg Products– Lists all of the currently approved acidifiers and

antimicrobials for use in poultry processing– Also specifies which products they can be used on

and the locations they can be used at

Page 66: Salmonella Control: Tighter Regs – New Realities

Antimicrobials

• Chlorine and chlorine-based products are the most commonly used antimicrobials– Applicable to all processing locations– Very effective– Inexpensive

Page 67: Salmonella Control: Tighter Regs – New Realities

Antimicrobials• Other products available include:

– Peroxyacetic acids– Bromine– Cetylpyridinium chloride– Trisodium phosphate

• These typically have restrictions on the product type and location where they can be used

• Expensive

Page 68: Salmonella Control: Tighter Regs – New Realities

Poll Question

Do you include your pathogen interventions in your HACCP plan or are they part of a pre-requisite program? HACCP Plan Pre-Requisite Program

Page 69: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• Most companies use more than one intervention strategy in a “multiple hurdle” approach– These interventions can be packaged together in a

pre-requisite program (ie Pathogen Management Program) that support the HACCP plan or can be included directly in the HACCP plan

Page 70: Salmonella Control: Tighter Regs – New Realities

Poll Question

Do you use a post-chill antimicrobial intervention?

Yes – If so, what kind? No

Page 71: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• The most common processing steps where antimicrobial interventions can be included:– Pre-scald brush cabinets– Scalders– Picking rails– Post-picking rinse cabinets (New York washers)

Page 72: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• The most common processing steps where antimicrobial interventions can be included:– Equipment rinses– On-line Reprocessing (OLR) brush and wash

cabinets– Off-line reprocessing and salvage (required to use

chlorine per 9 CFR 381.91)

Page 73: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• The most common processing steps where antimicrobial interventions can be included:– Chillers– Post-chill rinse cabinets– Belts or conveyors in second processing

Page 74: Salmonella Control: Tighter Regs – New Realities

Current Strategies

• The results of these efforts, as measured by the FSIS post-chill Salmonella testing, show that the large establishments reduced their post-chill positive rate to 3.5% (4QFY09)– This is a significant improvement from the 20%

positive rate reported from the baseline study in 1996

– Obviously, what we are doing is working

Page 75: Salmonella Control: Tighter Regs – New Realities

Poll Question

Are you affected by the Russian ban on the use of chlorine?

Yes No

Page 76: Salmonella Control: Tighter Regs – New Realities

Russia

• As of January 1, 2010, chlorine treated poultry products are prohibited in Russia– Largely a de facto non-scientific trade barrier– Has stopped export of U.S. leg quarters to Russia

for 4 months already• USDA and the USTR office are in negotiations

with the Russian Veterinary Service

Page 77: Salmonella Control: Tighter Regs – New Realities

Russia

• No clear guidance at this point on which antimicrobials will be approved or which locations they will be required for – chiller, eviseration equipment sprays, off-line

reprocessing, post-chill cabinets, etc

Page 78: Salmonella Control: Tighter Regs – New Realities

Russia

• At this point, the only non-chlorine chemical products that are legally approved for chiller application are:– Peroxyacetic acid blends– Bromine

• The industry is scrambling to investigate and adopt alternatives to chlorine in a vacuum of accurate information

Page 79: Salmonella Control: Tighter Regs – New Realities

QUESTIONS & ANSWERS

Page 80: Salmonella Control: Tighter Regs – New Realities

FOR MORE INFORMATION:

Beth Krushinskie: [email protected]. Billy Hargis: [email protected]

Bill Kinross: [email protected] Bagel Storck: [email protected]

Webinar recording and PowerPoint presentation available at:www.meatingplace.com/webinars