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Scientific Panel on Biological Hazards : Approach to Cases John D. Collins Panel Chair. Scientific Panel on Biological Hazards. Outline Responsibilities; tasks Protocol for dealing with mandates and formulation of Opinions Opinions: examples relating to - infant formulae

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slide1

Scientific Panel on Biological Hazards :

Approach to Cases

John D. Collins

Panel Chair

slide2

Scientific Panel on Biological Hazards

  • Outline
  • 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
slide4

In addition to its nine Scientific Panels, The EFSA also has

  • its Scientific Committee (SC) which is responsible for
  • the provision 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-ordination necessary to ensure
  • Consistency in the scientific opinions of the different Panels.
slide5
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.
scientific panel on biological hazards
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 onVeterinaryMeasuresrelated toPublicHealth (DG Sanco C2-SCVMPH).
  • Scientific Committee on Foods (DG Sanco C2-SCF) on Food Microbiology
protocol for mandates and opinions
Protocol for Mandates and Opinions

EFSA

Scientific Secretariat

Clarification process

Assignment of Mandate to Panel(s)

Request from COM EP MS

With assistance of the COM/EFSAInterface Unit

protocol for mandates and opinions1
Protocol for Mandates and Opinions

EFSA

Scientific Secretariat

Clarification process

Assignment of Mandate to Panel(s)

Establishment of Panel’s WG

WG Meetings to produce Report and draft Opinion

Request from COM EP MS

With assistance of the COM/EFSAInterface Unit

Deadline for

Completion of Opinion agreed

Liaison with

other Panel(s),

as appropriate

Options re invited experts, outsourcing,

EFSA SES

protocol for mandates and opinions2
Protocol for Mandates and Opinions

EFSA

Scientific Secretariat

Clarification process

Assignment of Mandate to Panel(s)

Establishment of Panel’s Working Group

WG Meetings to produce Report and draft Opinion

Consideration by Panel

Adoption (Yes/No/Amend) Opinion

Request from COM EP MS

With assistance of the COM/EFSAInterface Unit

Deadline for

Completion of Opinion agreed

Liaison with

other Panel(s),

as appropriate

Options re invited experts, outsourcing,

EFSA SciUnit

Before deadline

biohaz panel
BIOHAZ Panel

New challenges: See Scientific Committee documents.

Include -

  • Transparency
  • Emerging risks
  • Qualified Presumption of Safety (QPS)
  • Nanotechnology
  • --------------
composition of the panel
Composition of the panel
  • Veterinary
  • Microbiology
  • Food Technology
  • Risk Assessment
  • Human Medicine
slide15
Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae.

Adopted on 9 September 2004

slide16
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

slide17
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

EXPOSURE ASSESSMENT

- inactivation and growth of pathogens during

processing;

         - recontamination, preparation of infant formula

after reconstitution;

- contamination rate

slide18
Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004

CONTROL MEASURES

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

arenot breast-fed,would be to use commercial sterile liquid formula.

slide19
Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004

OTHER CONTROL MEASURES

Apply

- at the manufacturing level; and

- during preparation and reconstitution

slide20
Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004

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 inhospitals are developed.
slide21

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

The Commission consulted the EFSA

on the use of antimicrobials and vaccines

for the control of salmonella in poultry.

slide22
Opinion of BioHaz the use of vaccines for the control ofSalmonella in poultry.

Adopted on 21 October 2004

opinion of biohaz on the use of vaccines for the control of salmonella in poultry 21 october 2004
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

opinion of biohaz on the use of vaccines for the control of salmonella in poultry 21 october 20041
Opinion of BioHaz on the use of vaccines for the control of Salmonella in poultry.21 October 2004
  • 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 option since it does not eliminate the shedding.
opinion of biohaz on the use of vaccines for the control of salmonella in poultry 21 october 20042
Opinion of BioHaz on the use of vaccines for the control of Salmonella in poultry.21 October 2004
  • 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 option 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 option since the other serotypes are not covered by commercial vaccines available at the moment.
slide26
Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry.

Adopted on 21 October 2004

slide27
Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry. Adopted on 21 October 2004
  • From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has little justification.
  • Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.
slide28
Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry. Adopted on21 October 2004
  • From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has 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 discouraged.
  • Their use should be subject to formally defined conditions that would ensure protection of public health.
slide29

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

slide30

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

Regarding Antimicrobials:

“….Therefore, on the basis of the opinion of the EFSA, it is appropriate to provide that antimicrobials should not be used as part of national control programmes 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….”

slide31

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

Regarding Vaccines:

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

continued……

slide32

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

  • 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.
slide33
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.

slide34

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
slide35

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.
slide36

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
slide37

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 Trichinella-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

slide38

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

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

slide39

Quantitative Assessment of the Residual BSE Risk in

Bovine-Derived ProductsEFSA 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).

slide40

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 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
slide41

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

slide42

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

  • 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
slide43

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

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, appears at

about 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

earliest infectivity would have to be assumed at 26 months.

However, this would reflect uptake of the BSE agent via the

gut only.

slide44

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

  • 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.
slide45

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
draft opinion on microbiological testing criteria and other objectives
Draft opinion on microbiological testing, criteria and other objectives

12 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
draft opinion on microbiological testing criteria and other objectives1
Draft opinion on microbiological testing, criteria and other objectives

Some examples of comments:

  • The relation between ALOP, FSO, PO, PC and MC/microbiological testing
  • The examples on ALOP and the assessment whether an ALOP is met
  • The role of food business to set POs and PCs
  • The use and establishment of microbiological criteria by the regulatory authorities and the industry
joint afc biohaz guidance document on antimicrobial treatments
Joint AFC/BIOHAZ guidance document on antimicrobial treatments

7 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
joint afc biohaz guidance document on antimicrobial treatments1
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

for the evaluation of the safety and the efficacy of substances for

the removal of microbial surface contamination of foods of animal

origin. Adopted on 13 July and 28 August 2006.

slide50
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

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 the possible role of migratory birds in the spread of highly pathogenic avian influenza”. 12 May 2006. The EFSA Journal (2006) 357: 1 – 46.

slide51
BioHaz Panel’s scientific report on food as a vehicle

for Avian 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.

slide52

BioHaz Panel’s scientific report on food as a vehicle

for Avian Influenza virus

Observations, continued

  • 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
slide53

Current activities of the BIOHAZ Panel:

TSE and related ABP issues

  • 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
slide54

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

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

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 continued
Current activities of the BIOHAZ Panel: examples of non-TSE/non-ABP issues,continued
  • Salmonella 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