Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 1
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Risk Assessment of BiocidesRisk Assessment of Biocides
Chaido LENTZA-RIZOS
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Biocides• Formerly known as non-agricultural pesticides • Regulated with “Directive 98/8/EC of the
European Parliament and of the Council concerning the placing on the market of biocidal products”(BPD)
• Biocidal products definition: Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy , deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological action (article 2 of BPD)
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 2
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ANNEX V OF 98/8/EC DIRECTIVE
BIOCIDAL PRODUCT TYPES23 Product Types (PT) divided over 4 Groups:
• I DISINFECTANTS & GENERAL BIOCIDES
• II PRESERVATIVES• III PEST CONTROL PRODUCTS• IV OTHER BIOCIDES
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Product-type 1:: Human hygiene biocidal productsProduct-type 2: Private area and public health area disinfectants
and other biocidal productsProduct-type 3: Veterinary hygiene biocidal productsProduct-type 4: Food and feed area disinfectantsProduct-type 5: Drinking water disinfectantsProduct-type 6: In-can preservativesProduct-type 7: Film preservativesProduct-type 8: Wood preservativesProduct-type 9: Fibre, leather, rubber and polymerised materials
preservatives.Product-type 10: Masonry preservativesProduct-type 11: Preservatives for liquid-cooling and processing
systemsProduct-type 12: SlimicidesProduct-type 13: Metalworking-fluid preservativesProduct-type 14: RodenticidesProduct-type 15: Avicides
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 3
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Product-type 16: Molluscicides.
Product-type 17: Piscicides
Product-type 18: Insecticides, acaricides and products to control other arthropods
Product-type 19: Repellents and attractants
Product-type 20: Preservatives for food or feed stocks
Product-type 21: Antifouling products
Product-type 22: Embalming and taxidermist fluids
Product-type 23: Control of other vertebrates
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Conditions for issue of an authorisationto a biocidal product (article 5.1. (b) (iii and iv)
It has no unacceptable effects itself or as a result of its residues
On human or animal health directly or indirectly (e.g. through drinking water, food or feed) On the environment, having particular regard to fate and distribution and its impact on non-target organisms
RISK ASSESSEMENT
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 4
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RISK ASSESSMENT
• The comparison of a predicted human dose from undertaking a task or tasks with appropriate toxicological endpoints values or NOAELS (TNsGon Human Exposure)
• A process intended to calculate or estimate the risk to a given target organism, system or (sub)population, including the identification of attendant uncertainties, following exposure to a particular agent, taking into account the inherent characteristics of the agent of concern as well as the characteristics of the specific target system (joint OECD/IPCS survey)
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Risk Assessment:
Comparison of exposure
with
effects
Final outcome: Risk characterization
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 5
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Hazard Characterization
(Effects Assessmentor
Dose-Response Assessment)
Risk Characterization
RISK ASSESSEMENT(fist componentin a risk analysis
process)
Hazard Identification
Exposure Assessment
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HAZARD IDENTIFICATION
Hazard: the inherent property of an agent or situation having the
potential to cause adverse effects when an organism is exposed to
that agent
(neurotoxicity, carcinogenicity, etc)
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 6
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High hazard
High hazard
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Risk• The probability of an adverse effect
in an organism, system or (sub) population caused under specified circumstances by exposure to an agent
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 7
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High hazard, … low risk
High hazard
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Set of datafor a Biocide (dossier)
Hazard identified
Hazard Characterization (Effects assessment
Dose/responseAssessment)
(NOAEL*)
Exposure Assessment
(TDI* mg/kg bw day)
Risk CharacterizationIncidence and severity
TDI< NOAELTDI> NOAEL
*NOAEL=No Observed Adverse Effect Level
* TDI =total daily intake
Risk assessment
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 8
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Part I: Risk Assessment for Human Health
Part II: Environmental Risk Assessment
Part III: (Q)SARs/Use Categories/RA Report Format
Part IV: Emission Scenario Documents
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Technical Notes for Guidance (TNsG)
Five Technical Notes for Guidance (TNsG) have specifically been developed for biocides:
1. TNsG on Data Requirements:This document provides guidance on the data requirements and waiving arguments that are required for biocidal active substances and products.2. TNsG on Annex I Inclusion:This document identifies criteria for unacceptable/acceptable effects and associated conditions for inclusion of active substances onto Annex I (or IA or IB).3. TNsG on Product EvaluationThis document provides guidance on how to perform the administrative and scientific evaluation of applications for authorisation and registration.4. TNsG on Human Exposure:This document provides guidance on the estimation of Human Exposure to biocidal products for all Product Types.5. TNsG on Dossier Preparation and Study Evaluation:This guidance focuses primarily on applications for the inclusion of active substances onto Annex I (or IA or IB). It is intended to give guidance on how the documentation to be submitted by the applicant should be prepared and presented.
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 9
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Assessment of Human Exposure
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Human Exposure • Occupational (at workplace) (professional
users, workers) (industrial workers are covered by other EU legislation) (primary exposure)
• Non-professional users (consumers/users of any consumer product purchased from retail outlets) (primary exposure)
• Bystanders and others indirectly exposed via the environment (general public) (secondary
exposure)
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 10
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HUMAN EXPOSURE
PRIMARY(direct)
SECONDARY(indirect)
Occupational (Professional
users)
Non-professionaluses
(consumers)
•Bystanders•General public
Indirectly exposedvia environment
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ROUTES of EXPOSURE/PATHWAYS OF EXPOSURE
Inconsistent use of terms in the TGD and TNsG
EFSA adopted in 2008 the EPA terminology• Source of exposure: manner of use or intended
purpose (PPP, biocide, veterinary, etc)• Pathway: food, drinking water, residential,
occupational)• Route: Inhalation, dermal, ingestion (oral??)
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 11
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Human exposure
NON-PRO
FESSIONAL
(consu
mer)
Via Environment
air water food soil
oral dermalinhalation
professional
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Pathways of Exposure (USDA)Food
ResidentialWater
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 12
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Human indirect (secondary) Human indirect (secondary) exposure exposure routesroutes (from TGD Part I)(from TGD Part I)
Are they Are they routesroutes or pathways?or pathways?Air
fish
meat
dairy products
crops
drinking water
HUMANS
cattle
Soil
Groundwater
Surfacewater
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Exposure Scenarios(assessment through
modelling)
Chemical residues in food and water; challenges for a future sustainable agriculture
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Assessment of occupational (professional)
exposure(TGD)
• EASE model (Estimation and Assessment of Substance Exposure): inhalation and dermal exposure from normal use (UK HSE)
• Other models developed by USA EPA
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Assessment of non-professional (consumer) exposure
(TGD scenarios)• Inhalation (aerosols, gases, evaporation of
dusts, etc)• Dermal (from a substance contained in the
product or from migration of a non-volatile substance from an article, i.e. newsprint from paper)
• Oral (ingestion) (from unintentional swallowing during normal use of a product or from migration
of a substance into food or drink from an article, i.e. cups, plates)
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 14
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Assessment of non-professional (consumer) exposure
(several computer models )• EUSES (screening)• CONSEXPO • EPA • CEM (Consumer exposure model of the USA Office of Pollution
Prevention and Toxics)• MCCEM• SHEDS• Calendex• Lifeline• Notitia/CARES• BEAT
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Assessing risks fromAssessing risks from migration of a substance into migration of a substance into food or drink from an food or drink from an article, i.e. cups, plates)article, i.e. cups, plates)
HERA HERA Human and Environmental Risk AssessmentsHuman and Environmental Risk Assessmentson ingredients of household cleaning productson ingredients of household cleaning products
A voluntary European industry programme
Chemical residues in food and water; challenges for a future sustainable agriculture
MGPR 2008 - Piacenza (Italy), 13 and 14 November 15
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Assessment of indirect exposure via the environment
Fish(BCF) Drinking water
(TNG)
Estimating exposure through
FOOD
Products of Plant Origin (PLANTX model)
Products of Animal Origin (Travis and Arms 1988)
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ENVIRONMENTAL EXPOSURE
COMPARTMENTS ORGANISMS
Terrestrial(Soil)
Acquatic(GroundSurface Water/
Sediment)
Aquatic organismsTerrestrial vertebratesSoil microfloraEarthwormsNon-target arthropodsHoneybeesNon-target higher plants
Atmo-sphere
Non compartment
-specificexposurerelevant
to food chain(secondary poisoning)
Chemical residues in food and water; challenges for a future sustainable agriculture
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European Union Biocides Environment Emission Scenarios
(Gathering, review and development of Environment Emission Scenarios for Biocides)
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Applicability of estimation models
• Theoretical background is OK• All underlying assumptions together
drastically reduce the applicability of the models
Chemical residues in food and water; challenges for a future sustainable agriculture
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European Chemical Bureau
Joint Research CentreIspra Italy
http://ecb.jrc.it
DG Environment(http://ec.europa.eu/environment/biocides)