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Role of the EFSA in Exposure Assessment

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Scientific Panel on Biological Hazards : Approach to Cases John D. Collins Panel Chair – PowerPoint PPT presentation

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Title: Role of the EFSA in Exposure Assessment


1
Scientific Panel on Biological Hazards
Approach to Cases John D. Collins Panel Chair
2
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

3
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4
  • 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.

5
  • 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.

6
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

7
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/EFSAInterface Unit
8
Protocol for Mandates and Opinions
  • Request from COM EP MS

EFSA
Scientific Secretariat
Clarification process
Assignment of Mandate to Panel(s)
Establishment of
Panels WG WG Meetings to produce
Report and draft Opinion
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
9
Protocol for Mandates and Opinions
  • Request from COM EP MS

EFSA
Scientific Secretariat
Clarification process
Assignment of Mandate to Panel(s)
Establishment of Panels
Working Group WG Meetings to
produce Report and draft Opinion Consideration
by Panel Adoption (Yes/No/Amend)
Opinion
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
10
BIOHAZ Panel
  • New challenges See Scientific Committee
    documents.
  • Include -
  • Transparency
  • Emerging risks
  • Qualified Presumption of Safety (QPS)
  • Nanotechnology
  • --------------

11
Composition of the panel
  • Veterinary
  • Microbiology
  • Food Technology
  • Risk Assessment
  • Human Medicine

12
Opinions adopted to date by the BIOHAZ Panel May
2003 May 2006
ABP and Waste Management 8
BSE 18
Decontamination Treatments 3
Food Hygiene 9
Food Microbiology 4
Foodborne Zoonoses 4
AHAW chapters on food safety 4
13
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14
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15
  • Opinion of BioHaz related to the microbiological
    risks in infant formulae and follow-on formulae.
  • Adopted on 9 September 2004

16
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

17
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

18
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
  • are not breast-fed, would be to use commercial
    sterile liquid formula.

19
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

20
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
    in hospitals are developed.

21
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.
22
  • Opinion of BioHaz the use of vaccines
    for the control ofSalmonella in poultry.
  • Adopted on 21 October 2004

23
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
  •  

24
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.

25
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.

26
  • Opinion of BioHaz the use of antimicrobials
    for the control ofSalmonella in poultry.
  • Adopted on 21 October 2004

27
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.

28
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.
  • 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.  

29
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
30
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.
31
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
32
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.

33
  • 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.

34
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

35
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.

36
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

37
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
38
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 Justificati
on to eventually change the age limit on the
basis of the results of pathogenesis
studies and epidemiological data 3.
Recommendations
39
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).
40
  • 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

41
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
42
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

43
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.
44
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.

45
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

46
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

47
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

48
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

49
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.
50
  • REPORT
  • BioHaz Panels 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.

51
  • BioHaz Panels 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.

52
BioHaz Panels 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

53
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

54
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.

55
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
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