scientific panel on biological hazards : approach to cases john d. collins panel chair

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Scientific Panel on Biological Hazards : Scientific Panel on Biological Hazards : Approach to CasesApproach to Cases

John D. Collins John D. Collins Panel ChairPanel Chair

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Scientific Panel on Biological Hazards

OutlineOutline

- Responsibilities; tasks

- Protocol for dealing with mandates and formulation of Opinions

- Opinions: examples relating to- infant formulae- salmonella in poultry- trichinella in pork- TSE issues- avian influenza (scientific report)

- Current activities

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In addition to its nine Scientific Panels, The EFSA also has its Scientific CommitteeScientific Committee (SC) which is responsible for the provision of scientific adviceprovision of scientific advice on - multi-sectorial issues falling within the competence of more than one Panel, and - on issues which do not fall within the competence of any of the Panels, along with the general co-ordinationgeneral co-ordination necessary to ensure Consistency in the scientific opinions of the different Panels.

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The Scientific Panel on Biological Hazards (BioHaz) deals with questions on biological hazards relating to food safety and food-borne disease, including

food-borne zoonoses and transmissible spongiform encephalopathies,

microbiology,

food hygiene, and associated waste management.

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Scientific Panel on Biological Hazards

……took over the tasks of the previous TSE/BSE ad hoc group previously under the

Scientific Steering Committee (DG Sanco C1-SSC).

Scientific Committee on Veterinary Measures related to Public Health (DG Sanco C2-SCVMPH).

Scientific Committee on Foods (DG Sanco C2-SCF) on Food Microbiology

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Protocol for Mandates and Opinions

Request from COM EP MS

EFSA

Scientific Secretariat

Clarification process

Assignment of Mandate to Panel(s)

With assistance

of the COM/EFSA

Interface Unit

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EFSA




Establishment of Panel’s WG

WG Meetings to produce Report and draft Opinion

With assistance

of the COM/EFSA

Interface Unit

Deadline forCompletion of Opinion agreed

Options re invited

experts, outsourcing,EFSA SES

Liaison with other Panel(s), as appropriate

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EFSA




Establishment of Panel’s Working Group

WG Meetings to produce Report and draft Opinion

Consideration by Panel

Adoption (Yes/No/Amend) Opinion

With assistance

of the COM/EFSA

Interface Unit

Deadline forCompletion of Opinion agreed

Before deadline

Options re invited

experts, outsourcing,

EFSA SciUnit

Liaison with other Panel(s), as appropriate

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BIOHAZ Panel

New challenges: See Scientific Committee documents.

Include -

Transparency

Emerging risks

Qualified Presumption of Safety (QPS)

Nanotechnology

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Composition of the panel

Veterinary Microbiology Food Technology Risk Assessment Human Medicine

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Opinions adopted to date by the BIOHAZ Panel May 2003 – May

2006ABP and Waste Management 8

BSE 18

Decontamination Treatments 3

Food Hygiene 9

Food Microbiology 4

Foodborne Zoonoses 4

AHAW chapters on food safety 4

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Opinion of BioHaz related to the microbiological risks in infant

formulae and follow-on formulae.

Adopted on 9 September 2004

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Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004

HAZARD IDENTIFICATION : Salmonella and E. sakazakii

- formulation and processing; - isolation and identification

HAZARD CHARACTERIZATION - epidemiology and pathogenicity;

- dose/response relationships

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HAZARD IDENTIFICATION : Salmonella and E. sakazakii· - formulation and processing; isolation and identification HAZARD CHARACTERIZATION - epidemiology and pathogenicity; dose/response relationships

EXPOSURE ASSESSMENT - inactivation and growth of pathogens during processing; - recontamination, preparation of infant formula after reconstitution; - contamination rate

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CONTROL MEASURES

The most effective control measure to minimise risks in high-risk infants who

are not breast-fed, would be to use commercial sterile liquid formula.

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OTHER CONTROL MEASURES

Apply- at the manufacturing level; and

- during preparation and reconstitution

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RECOMMENDATIONS that a Performance Objective (PO) for powdered infant

formula and follow-on formula is introduced and that verification of compliance is confirmed by testing for Enterobacteriaceae in the environment and in the product.

that guidelines for preparation, handling, storage and

use of infant formula in the home and in hospitals are developed.

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Pursuant to Article 15 of Regulation (EC) No 2160/2003,

The Commission consulted the EFSA The Commission consulted the EFSA on the use of antimicrobials and vaccines on the use of antimicrobials and vaccines

for the control of salmonella in poultry.for the control of salmonella in poultry.

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Opinion of BioHaz the use of vaccines for the control ofSalmonella in

poultry.

Adopted on 21 October 2004

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Opinion of BioHaz on the use of vaccines for the

control of Salmonella in poultry. 21 October 2004

ASSESSMENT

1. BACKGROUND INFORMATION

2. VACCINES AVAILABLE FOR POULTRY

3. ADVANTAGES AND DISADVANTAGES OF THE

USE OF VACCINES

4. USE OF VACCINES IN CONTROL PROGRAMMES

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If a control programme is targeting to eradicate the serovars S. Enteritidis and S. Typhimurium in breeders of layers/broilers or laying hens, vaccination is not an optionnot an option since it does not eliminate the shedding.

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If a control programme is targeting to eradicate the serovars S. Enteritidis and S. Typhimurium in breeders of layers/broilers or laying hens, vaccination is not an vaccination is not an optionoption since it does not eliminate the shedding.

If a control programme is targeting serovars other than S. Enteritidis and S. Typhimurium in breeders, layers, broilers or turkeys, vaccination is not an appropriate vaccination is not an appropriate optionoption since the other serotypes are not covered by commercial vaccines available at the moment.

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Opinion of BioHaz the use of

antimicrobials for the control ofSalmonella in poultry.


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Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry.


From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has little justification.has little justification.

Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.

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Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry.


From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has has little justification. little justification.

Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.

The use of antimicrobials for Salmonella control in poultry should be discouragedshould be discouraged.

Their use should be subject to formally defined conditions that would ensure protection of public health.

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Commission Regulation (EC) No. 1177/2006: requirements for

the use of specific control methods in the framework of the

national programmes for the control of salmonella in poultry

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Regarding Antimicrobials:

“…“….Therefore, on the basis of the opinion of the Therefore, on the basis of the opinion of the EFSA, it is appropriate to provide that antimicrobials EFSA, it is appropriate to provide that antimicrobials should not be used as part of national control should not be used as part of national control programmesprogrammes to be adopted pursuant to Article 6 of Regulation (EC) No 2160/2003, other than in the exceptional circumstances referred to by the EFSA in its opinion….”

Commission Regulation (EC) No 1177/2006 requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry

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Regarding Vaccines:

On the basis of the opinion of the EFSA, it is On the basis of the opinion of the EFSA, it is appropriate to provide that currently available live appropriate to provide that currently available live vaccines should not be used as part of national control vaccines should not be used as part of national control programmesprogrammes to be adopted pursuant to Article 6 of Regulation (EC) No 2160/2003, in laying hens during production.

continued……


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Regarding Vaccines, continued:

• Live vaccines should not be used if the manufacturer does not provide an appropriate method to distinguish bacteriologically wild-type strains of salmonella from vaccine strains.

• Based on the current scientific evidence, the use of live or inactivated vaccines against Salmonella enteritidis should be mandatory in Member States with a high prevalence in order to improve public health protection.


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Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals

in areas with low prevalence of Trichinella”.

Adopted on 10 March 2005.

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Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low

prevalence of Trichinella”. Adopted 10 March 2005. INTERPRETATION OF TERMS OF REFERENCE HAZARD IDENTIFICATION and CHARACTERISATION In humans and in pigs and other species EXPOSURE ASSESSMENT

RISK CHARACTERISATION OF TRICHINELLA INFECTION Suggested semi-quantification of probabilities

DETECTION OF INCREASED TRICHINELLA RISK OR EXPOSURE Reservoir surveillance; emerging trichinellosis CONCLUSIONS AND RECOMMENDATIONS

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Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. The request for opinion refers only to Trichinella-

free farms complying with the requirements in the SCVPH opinion

Since the risk of Trichinella infections is negligible in pigs originating from farms classified as Trichinella-free, the additional risk reduction contributed by individual Trichinella testing is also negligible.

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Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. The request for opinion refers only to Trichinella-free

farms complying with the requirements in the SCVPH opinion

Since the risk of Trichinella infections is negligible in pigs originating from farms classified as Trichinella-free, the additional risk reduction contributed by individual Trichinella testing is also negligible.

Compliance with the regulations for Trichinella -free farms is crucial for maintaining this negligible risk level

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Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005.

“….The problem as to how to define the geographical regions or areas in which there is Trichinella absence or negligible prevalence in wildlife reservoirs is not trivial…..”

See also: Opinion of the Scientific Panel BIOHAZ on the “Request for an opinion on the feasibility of establishing the feasibility of establishing TrichinellaTrichinella-free areas-free areas, and if feasible, on the risk increase to public health of not examining pigs from those areas for Trichinella spp.” Adopted 26 October 2005

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Procedure adopted

1. Assessment 1.1. Experimental studies 1.2. Epidemiological data 2. Conclusions

Justification to eventually change the age limit on the basis of the results of pathogenesis studies and epidemiological data

3. Recommendations

Annex to the Opinion on the assessment of the age limit in cattle assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM).for the removal of certain Specified Risk Materials (SRM).Report of the Working Group The EFSA Journal (2005) 220, 1-21

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Quantitative Assessment of the Residual BSE Risk in Bovine-Derived Products EFSA QRA Report 2004* While Quantitative Risk Assessment of food-borne pathogens is a powerful methodology for estimating how likely, and at what level, an individual or population will be exposed to a microbial hazard, the output of risk models is relatively complex.

QRA methodology based on concurrent data is applied in the context of the quantitative assessment of residual BSE risk on an ongoing basis.

*The EFSA Journal (2005) 307: 1-135. See also “Risk assessment of food-borne bacterial pathogens: quantitative methodology relevant for human exposure assessment”. (EC SSC Preliminary Report, February 21-22nd, 2002).

http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_documents/1280.Par.0001.File.dat/efsaqrareport2004_final20dec051.pdf

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EFSA QRA REPORT, 2004. Background data required included -

• input data needed for quantitative BSE risk assessments

• Species barrier for oral transmission

• The infectious load of cattle by-products

• Assumptions regarding the total infectious load of the cattle by-

products

• Assumptions regarding the yield per animal of certain by-

products,

viz. gelatine from bonesgelatine from bones, di-calcium phosphate from bones, tallow

• Probability of material from an infected animal being present

• Infectivity reduction by processing

• Human and animal consumption of certain cattle-derived

products

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Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM).

Report of the Working Group The EFSA Journal (2005) 220, 1-21

1. Assessment

1.1. Experimental studies

1.1.1. Assessment of spread of infectivity and/or PrPsc in relation to time (pathogenesis studies) and the earliest detectable infectivity in the Central Nervous System of cattle PrPsc

1.1.2. Experimental data from mouse and hamster models of pathogenesis involving infection in the oral cavity

1.1.3. Infectivity in tonsil and intestine

1.1.4. Conclusion on pathogenesis studies

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1. Assessment, continued

1.2. Epidemiological data.

1.2.1. Age dependent susceptibility at infection

1.2.2. Age distribution of BSE cases in the EU

1.2.3. Age distribution of young BSE cases outside the EU

1.2.4. Probability for the presence of BSE infected cattle with an age

under 30 months covering the EU-25

1.2.5. Possible epidemiological approaches

1.2.7. Conclusions on epidemiological data

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2. Conclusions

• On the basis of pathogenesis studies it can be assumed that in Central Nervous System (CNS) the likely detectable PrPSc, and consequently the likely detectable infectivity, likely detectable infectivity, appears at appears at about ¾ of the incubation timeabout ¾ of the incubation time.

• Based on the earliest clinical manifestation seen in pathogenesis studies and assuming that the last quarter of the incubation period would be positive for infectivity, the the earliest infectivity would have to be assumed at 26 earliest infectivity would have to be assumed at 26 monthsmonths. However, this would reflect uptake of the BSE agent via the gut only.

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3. Recommendations

• The main issue that needs to be addressed with respect to options for estimation of the age limit for the removal of Specified Risk Materials (SRM) is the likelihood of the infectivity in SRM derived from infected cattle at different age groups.

• Estimation of this likelihood of infectivity would require back calculation modelling with further assessment of experimental and epidemiological data.

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Public Consultations, 2005-2006

• Draft Opinion on Microbiological Testing, Criteria

and other Objectives . Under discussion, October, 2006

• Joint AFC/BIOHAZ Draft Guidance Document on antimicrobial treatments for the removal of

microbial surface contamination of foods of animal origin

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Draft opinion on microbiological testing, criteria and other

objectives12 stakeholders submitted comments: Commission (DG-SANCO) National Food Authorities and Institutes

AFSSA-France, FASFC-Belgium, RIVM-the Netherlands

Industry and associations CIAA, CLITRAVI, EDA, UNILEVER

Scientific associations ILSI Europe, ICMSF

Private experts on risk assessment

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Draft opinion on microbiological testing, criteria and other

objectives

Some examples of comments:The relation between ALOP, FSO, PO, PC and MC/microbiological testingThe examples on ALOP and the assessment whether an ALOP is met The role of food business to set POs and PCsThe use and establishment of microbiological criteria by the regulatory authorities and the industry

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Joint AFC/BIOHAZ guidance document on antimicrobial

treatments7 stakeholders submitted comments: National Food Authorities and Institutes

AFSSA-France, FASFC-Belgium Industry, associations and producers

Danisco A/S, ECOLAB, CLITRAVI Private experts on risk assessment

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Joint AFC/BIOHAZ guidance document on antimicrobial

treatments

Some examples of comments: The need of harmonisation of terminology

The requirement of the rinse step

The definition of the efficacy of the treatment

See: Joint AFC/BIOHAZ guidance document on the submission of data Joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and the efficacy of substances for for the evaluation of the safety and the efficacy of substances for the removal of microbial surface contamination of foods of animal the removal of microbial surface contamination of foods of animal origin.origin. Adopted on 13 July and 28 August 2006.

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REPORT BioHaz Panel’s scientific report on food as a vehicle for Avian Influenza virus*

* See “Food as a possible source of infection with highly pathogenic avian “Food as a possible source of infection with highly pathogenic avian influenza viruses for humans and other mammals”influenza viruses for humans and other mammals” 30 June 2006. The EFSA Journal (2006) 74: 1 – 29.

Also, see “Opinion of the Scientific Panel on Animal Health and Welfare on “Opinion of the Scientific Panel on Animal Health and Welfare on the possible role of migratory birds in the spread of highly pathogenic the possible role of migratory birds in the spread of highly pathogenic avian influenza”.avian influenza”. 12 May 2006. The EFSA Journal (2006) 357: 1 – 46.

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BioHaz Panel’s scientific report on food as a vehicle for Avian InfluenzaAvian Influenza virus

Observations

Direct transfer of H5N1 to humans occurs rarely and particularly after very close contact with infected animals.

The exact entry route(s) of the virus in humans is(are) not known but it is generally accepted that respiratory and/or oropharyngeal tissues are the entry sites

The pathogenetic basis for the observation that H5N1 virus causes infection in some humans and not others remains unknown

* See “Food as a possible source of infection with highly pathogenic avian influenza viruses for humans and other mammals”. 30 June 2006. EFSA Journal (2006) 74: 1 – 29.

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The role of several viral and host factors such as receptors, receptor binding sites, genetic make-up of viral strains, virus quantity at exposure, whether or not the GI tract is a portal of entry or a target organ, require investigation

The route(s) of entry and the cell type(s) that allow the virus to enter, and the mechanism of species barrier crossing, require further study

BioHaz Panel’s scientific report on food as a vehicle for Avian InfluenzaAvian Influenza virus

Observations, continued

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• QRA of the risk posed to humans from sheep meat and sheep meat products in terms of BSE. In progress

• Quantitative Assessment of the Residual BSE Risk in Bovine-Derived Products. Ongoing, based on QRA methodology.

• Updating of Geographical BSE Risk Assessment (GBR) Methodology. In progress

Current activities of the BIOHAZ Panel: TSE and related ABP issues

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Opinion on Review of the 2004 Community Summary Report on Zoonoses , now published.

Note: This is to be an annual task for subsequent reports.Note: This is to be an annual task for subsequent reports.

Quantitative microbiological risk assessment (QMRA) of meats

QRA on Salmonella in slaughter and breeder pigs

Public health risks involved in the consumption of reptile meats

continued….

Current activities of the BIOHAZ Panel: examples of non-TSE/non-ABP issues

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Current activities of the BIOHAZ Panel:

examples of non-TSE/non-ABP issues, continuedSalmonella in fresh meat, minced meat and meat preparations

Salmonella at primary production: influence of prevalence levels in animals to the poultry meat and products.

Campylobacter issues for improvement of food safety: ranking of intervention measures from a risk reduction perspective

Revision of the infant formulae opinion: relationship between Enterobacteriaceae and Ent. sakazakii

Self tasking issues: Food as a vehicle for the transmission of antimicrobial resistance, under consideration

scientific panel on biological hazards : approach to cases john d. collins panel chair

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