Technical Bulletin

US Foreign Supplier Verification Program (FSVP)
and Pall Corporation’s Detection and ProtectionSolutions
by Kelly Bebee and Martha Folmsbee

The US ‘Food Safety Modernization Act’ (FSMA) was signed into law by President Obama,changing the emphasis from a ‘reactive’ approach to food contamination events in the US, to oneof ‘prevention’. One important consideration being the quality of foodstuff imported into the US
from other countries. This is the driver behind the Foreign Supplier Verification Program (FSVP)
rules, currently proposed in the US to implement FSMA section 301.
The FDA published its first version of the FSVP rules on 23rd January 2013, and now following
receipt of comments on that proposal, has now put forward its revised proposal for consideration.
It appears the proposal would mean food importers to the USA (other than of alcoholic beverages,
juices, R&D / personal use or materials for further processing) should perform certain risk based
activities to show the imported food ‘provides the same level of public health protection as that
required of domestic food producers’.
If adopted, it appears the proposal would mean many food importers to the USA (other than ofalcoholic beverages, juices, R&D / personal use or materials for further processing) should perform
certain risk based activities to show the imported food ‘provides the same level of public healthprotection as that required of domestic food producers’. This risk evaluation should include ahazard analysis for:• nature of the hazard in the food and• supplier procedures / practices related to food safety
A key driver is concern over microbial contaminationof food imports.
It is the food importers responsibility to meet thefood quality requirements in the country he wishes
to supply. Pall Corporation products offer importers
the tools to identify the presence of certain key
food contamination microorganisms, plus filtrationand separation equipment to achieve the microbial
control they desire.
Figure 1: Hazard analysis and critical control points

Detection Solutions
Pall aims to provide an expanding portfolio of innovative solutions to simplify food producers’
microbiological controls. GeneDisc® solutions provide the food industry with real time monitoringof variety of foodborne pathogens by PCR (Polymerase Chain Reaction) employing a range oforganism specific consumables, the GeneDisc plates, with the GeneDisc Cycler PCR system.
• Accelerated batch release — The high sensitivity of the GeneDisc method enables a shortenrichment time, as only a few bacteria are required to generate a result. Combined withsimplified sample preparation protocols and a reduced run time, the GeneDisc solution is anextremely fast method for foodborne pathogen detection.

1• Brand protection — Using dedicated reagents, GeneDisc assays guarantee a high specificityof detection and a minimum rate of false results. Performances are AFNOR and AOAC tested.
• Adaptive solution — Users can make their own system corresponding to their throughput.
Flexibility can be achieved thanks to the GeneDisc Cycler subunits that can be connected to asingle central base unit. Furthermore, multiplex applications provide multiple results for a same
sample without additional hands-on time. With a full configuration system, up to 96 samples canbe processed at once providing up to 576 results in an hour.
• Cost effective — All GeneDisc applications use one step enrichment protocols and minimal
sample preparation procedures, drastically reducing operator time per sample. Ready-to-use
reagents also minimize hands-on time and reduce your logistic workflow. Decisions are also
simplified by an automated data interpretation by the GeneDisc Cycler.
One microorganism of concern is Listeria monocytogenes. This is an opportunistic foodborne
pathogen that can affect a wide range of food products and can cause listeriosis with potentiallyhigh mortality rates in susceptible populations for example, the elderly, immunodepressed, pregnantwomen and newborns. L. monocytogenes can grow at refrigeration temperatures and has beenfound in a variety of foods particularly dairy products, ready-to-eat meats and fish products.
There is evidence suggesting the presence of other non-pathogenic Listeria spp. can be an early
indication of L. monocytogenes contamination, highlighting the importance of its detection as well.
As part of the GeneDisc plate portfolio, Pall provides flexible solutions for food processors in need of
rapid detection and quantification of L. monocytogenes and/or Listeria spp. risks, enabling detectionof L. monocytogenes and Listeria spp. individually or simultaneously.
Another major concern for food processors is pathogenic Escherichia coli as it is mainly transmitted
to humans through contaminated foods.
E. coli are common in human bacterial flora. Most E. coli are harmless, but Shiga Toxic E. coli or STEC
can cause severe food borne illnesses. Among these STEC, several serogroups are more commonly
related to human diseases. The United States Department of Agriculture’s Laboratory Guidebook
defines the STEC Top 7 serogroups as E. coli O157, O26, O45, O103, O111, O121 and O145.
Pall GeneDisc technology provides a complete range of options for a reliable control of O157 andnon-O157 STEC risk. These options include an enhanced solution for the detection of STEC Top 7 which
provides a lower rate of presumptive positive results than any other available method and minimizes riskof false positive results. This is achieved thanks to a unique method principle, based on the detection ofvirulence factors, that allows discrimination of pathogenic strains from non-pathogenic ones.

Figure 2: GeneDisc unit and a detection plate2GeneDisc Option

Organism of Concern

Validation

Min. Total Timeto PCR Result

GeneDisc Plate Salmonella
spp.

Detection of Salmonella spp.

AOAC, NF Validation 10h

GeneDisc Plate
Pathogenic E. coli O157

Detection of Pathogenic E. coli O157
with stx, eae genes

AOAC, NF Validation

GeneDisc Plate STEC

Detection of STEC (stx, eae genes)
including Pathogenic E. coli O157

AOAC, NF Validation(for E. coli O157)

GeneDisc Plate STEC Top 7

Detection of virulence genes andE. coli O157, O26, O103, O111, O145,O45, O121 serogroups.

AOAC, NF Validation(for E. coli O157)

GeneDisc Plate Salmonella
spp. and Pathogenic
E. coli O157
or
GeneDisc Plate Salmonella
spp. and STEC

Combined detection of Pathogenic
AOAC, NF Validation
E. coli O157 with stx, eae genes and(for E. coli O157)
Salmonella spp.
orCombined detection of STEC (stx, eaegenes) including Pathogenic E. coli O157
and Salmonella spp.

GeneDisc Plate Listeria spp.
or
GeneDisc Plate Listeria
monocytogenes
or
GeneDisc Plate Listeria DUO

Detection of Listeria monocytogenes
and/or Listeria spp.

AOAC, NF Validation 20 h

GeneDisc Plate Listeria ID

Simultaneous identification of Listeria
species (L. monocytogenes, L. ivanovii,
L. innocua, L. welshimeri, L. seeligeri,
L. grayi subsp. grayi and L. grayi
subspmurrayi)

AOAC

1h

For further details on these and other GeneDisc plates,
please visit http://www.pall.com/main/food-and-beverage/product.page?id=20120614103141.

Protection Solutions
Principal contributors of microbial hazards in food include water used in the product or for cleaning,
air / gas, and organisms from ingredients, or introduced by plant personnel. Microfiltration removes orreduces microbial contamination (yeast, bacteria, protozoans, and viruses) rather than killing themwithin the product (e.g. by pasteurization, UV or ozone sanitization). This reduces the risk of bacterial
spores germinating in the final product, removes the source of heat stable toxins (present in somepathogenic bacteria), and removes microbial contents (lipopolysaccharide/endotoxin, nucleic acids,and enzymes).
Regardless of the nature of the organism (pathogenic, opportunistic pathogen, economic risk,non-economic risk) or the method of introduction filtration can remove this type of contamination.
Filtration can be implemented at various stages during a production process and is applied to achievea defined level of microbial removal using qualified procedures. The broad array of food products
manufactured requires each manufacturer to determine the appropriate processing level to control
microbial status.
http://www.pall.com/main/food-and-beverage/enhancing-food-safety-management-by-unde53722.page3

Microorganism Type

Removal Rating

Comments

Protozoan (e.g. Giardia andCryptosporidium)1 micron

Validation is sometimes performed with latex beadchallenges due to safety risk of working with this class oforganisms. Validation may also be performed with killed orlive organisms.

Yeast and molds(e.g. Saccharomyces)

0.65 micron

Most vegetative yeast are removed efficiently with a
0.65 micron membrane filter. However, some yeast in
stationary phase or early lag phase may penetrate 0.65
micron membrane filters. As these yeast do not pose healthrisks but only economic risk, we recommend reducing thefilter rating to 0.45 micron if this condition exists.

Spore forming bacteria(e.g. Bacillus species)

0.45 micron

Bacterial spores have been shown to be removed by
0.45 micron membrane filters.

Coliform bacteria and0.45 micron
bacteria with heat-stabletoxin virulence factors(e.g. Escherichia coli, Serratia,Shigella, Salmonella,Campylobacter)

Microbial challenge data is available for specific organisms,
or model organisms, demonstrating complete removal orproviding a titer reduction.

Bacteria used in orcontaminating fermentation
processes (e.g. Oenococcus
oeni, Pediococcus,Lactobacillus)

0.45 micron

Microbial challenge data is available for validated filtersdemonstrating removal or reduction of commoncontaminants.

Waterborne bacteria(e.g. Pseudomonas species)

0.2 micron

Microbial challenge data is available for validated filtersdemonstrating removal or reduction of commoncontaminants.

Virus in liquid products or(e.g. Caliciviridae, Poliovirus,Adenovirus, Coxsackie virus,Echovirus)

Ultra or nanofiltration

Specific microbial challenge tests are not yet available. Thisis partially due to virus detection problems including inability
to culture and difficulties with laboratory contamination).

Virus in gas products orvents (e.g. bacteriophages,aerosolized viruses fromplant personnel)

0.2 micronhydrophobicmedium

Microbial challenge data is available for validated filtersdemonstrating removal or reduction of common
contaminants.

Figure 3: Microbes

Microbes may be introduced from the environment during process and storage steps. To prevent
environmental contamination of storage tanks and fermentation vessels Pall recommends ‘sterilizing’
grade gas and vent filters. Emflon® PTFE membrane filters are made of fixed/stable membranes,
with integrity testing that can be performed by the manufacturer and which is correlated withmicrobial removal capability data. Emflon filters have been proven cost-effective solution in numerous
installations around the globe due to their reliability and efficiency in the protection of tanks and gaslines from bacteria and bacteriophage contamination.

4• Product protection — 0.2 micron sterilizing grade membrane rating even in humid conditions.
• Based on laboratory testing for liquid 0.2 micron bacteria removal and dry gas testing for
sodium chloride aerosol particle removal to 0.003 micron.
• Provides excellent product protection.
• Reliable performance — Hydrophobic PTFE membrane, resists wetting out in humid conditions,even after repeated use and steaming cycles, allowing for unimpeded gas throughput. Integrity
testable by the user to demonstrate continued removal capability in use.
• Cost effective — Robust construction resistant to multi-cycle in situ steam challenged in forward
and reverse direction, together with high area pleated, robust double-layer membranes —provides
high throughputs and low pressure drops, with sizing resulting in compressor energy cost savings.
This is just one of the wide range of microbial and particulate removal filters which Pall F&B offers aspart of its comprehensive filtration and separation ‘FCC’ product portfolio, made from food contact
materials, specifically for food and beverage applications. The most up to date information on theUS regulatory food contact compliance position of the materials of construction of Pall’s FCC
products is available on the Pall Corporation website at http://www.pall.com/main/food-andbeverage/food-compliance-products-apps.page.
There is on-going debate on the FSVP rules regarding food contact materials needs for ‘production
equipment’ used in contact with US imported foodstuff. Pall’s FCC products offer importers filtrationand separation equipment which negate the outcome of this ‘production equipment’ materials
debate. With GeneDisc products, Pall offers importers the tools to identify the presence of certain
key food contamination microorganisms, plus filtration and separation equipment to achieve themicrobial control they desire.
Should you have questions regarding microbial detection and protection please contact your local
Pall representative or contact us at Julie_Tutton@europe.pall.com and Lisa_Madsen@pall.com.

5Pall Food and Beverage

Visit us on the Web at www.pall.com/foodandbev

25 Harbor Park Drive
Port Washington, NY 11050+1 516 484 3600
telephone+1 866 905 7255
toll free US

Pall Corporation has offices and plants throughout the world. For Pall representatives
in your area, please go to www.pall.com/contact

foodandbeverage@pall.com

Please contact Pall Corporation to verify that the product conforms to your national
legislation and/or regional regulatory requirements for water and food contact use.
Because of technological developments related to the products, systems, and/orservices described herein, the data and procedures are subject to change without notice.
Please consult your Pall representative or visit www.pall.com to verify that thisinformation remains valid.
© Copyright 2014, Pall Corporation. Pall,, GeneDisc, and Emflon are trademarks of PallCorporation. ® Indicates a trademark registered in the USA. Filtration. Separation. Solution.SM and
BETTER LIVES. BETTER PLANET. are service marks of Pall Corporation.

FBTBFSVPENNovember 2014