Assessment of environmental risks of biocides focus on emission scenarios

1
Assessment of environmental risks of biocides -
focus on emission scenarios

• EU course on Environmental Exposure Scenarios in
  Risk Assessment

2
EU Regulations and Directives

• new chemicals EC Directive 67/548/EEC
• existing chemicals EC Council Reg. 793/93
• pesticides EC Directives 91/414/EEC
• biocides EC Directive 98/8/EEC
• veterinary drugs EC Regulation 2377/90
• feed additives EC Directive 70/524/EEC
• food additives 89/107/EEC
• cosmetics SCP/803/90
• packaging material EC Directive CS/PM/1025

3
Elements of Chemicals Control

• Data collection and exchange of information
• Classification and labelling
• Risk assessment
• Risk management (a.o. authorisation)

4
The EU Biocidal Products Directive (1998)

• Why ? Risk Management !
• Whereas 1 .. 1993 .. Council .. need for risk
  management of non-agricultural pesticides ..
• How ? (1) Authorisation procedure
• Whereas 4 .. rules for placing on the market
  .. taking as a condition a high level of
  protection for humans, animals
• and the environment ..
• How ? (2) Risk Assessment
• Whereas 7, 8, 9, 11 Article 5 Annex VI
• TGDs data requirements, risk assessment of
  active substances, ...

5
Environmental Risk Assessment Basic Framework
6
Life cycle
7
Local emission and distribution routes
Air
Deposition
Agricultural
Local emissions
Grassland
soil
Volatilization
Leaching
Sludge application
Groundwater
Surface
STP
water
Dilution
Sedimentation
Sediment
8
Indicative food chains
SOIL POREWATER
PREDATORS
earthworm
SURFACE WATER
fish
9
Exposure assessment (results)

• Protection target PEC
• __________________________________________
• micro-organisms STP effluent
• aquatic organisms surface water
• terrestrial organisms agricultural soil
• sediment organisms sediment
• predators fish or earthworms
• __________________________________________

10
Effects assessment

• laboratory testing (single species
  standardised test)
• various trophic levels

11
PNEC derivation (water)
Data Assessment factor Short-term
L(E)C50 from each of three trophic levels
of 1000 the base-set (fish, daphnia, algae)
One long-term NOEC (either fish or Daphnia)
100 Two long-term NOECs from species
representing two 50 trophic levels (fish
and/or Daphnia and/or algae) Long-term NOECs
from at least three species representing
10 three trophic levels (normally fish, Dapnia,
algae) Field data or model ecosystems
case by case
12
EU TGD importance of emission estimation

• The TGDs were to be revised, and to also
  incorporate aspects which are specific for risk
  assessment of biocides
• For biocides, the addition of specific emission
  and exposure scenarios had a high priority
  (Biocides TM, 1999)
• why ?
• uses are the most prominent difference with other
  chemicals
• emission has most significant influence on the
  final outcome of risk assessment

13
Experience of initial vs. refined RAs

• Uncertainty Factor
• __________________________________________
• PNEC 10
• emission rates 10 - gt 1000
• STP emission estimation lt 10
• biodegradation in surface water lt 10
• exposure assessment PEC 10 - gt 10,000
• __________________________________________

14
E
m
i
s
s
i
o
n
S
c
e
a
r
i
s
o
n
15
Definition of ESD

• An Environmental Emission Scenario Document is
• A set of conditions about sources, pathways,
  production processes and use patterns that
  quantify the emissions (or releases) of a
  chemical from production, formulation,
  processing, private use (or use in the household)
  and recovery/disposal into water, air and solid
  waste
• (OECD 2000)
• In general, an ESD should cover all aspects of
  the life-cycle. An ESD may cover only some parts
  of the life-cycle, if remaining parts are not
  relevant or covered by another ESD.

16
Life Cycle Risk Assessment
Local Regional Scale
Local Scale
17
Local scale
(1 point source for each life cycle stage)
Process
Next stage of life cycle
SOIL
18
Regional scale
(all sources all stages of l.c.)
I
I
I
I
I
Production Formulation Industrial use
I
I
P
I
I
I
F
I
I
F
F
I
I
P
19
Factors of Importance

• Industrial category
• Function of substances

• Quantity of product
• Content in product
• Emission factor(s)

20
Concept of Emission Estimation

• Elements
• Description of the industry or use area
  (process)
• Description of the types of substances used and
  their function in the industry area
• Identification of points of release and emission
  factors
• Information on the scale/size of operations
• Information on emission control measures
• Instruction on how to use the information in ESD
• and examples of calculations

21
Emission Scenario 1 Tonnage of Substance
EF Emission factor (-) Tem Number of
emission days (d.yr-1)
INPUT
Q Tonnage (tonnes.yr-1)
Fms Fraction of the main source (-)
Emission Q Fms EF / Tem 10-3 (kg.d-1)
22
Emission Scenario 2 Scale of Process
INPUT
Qp Tonnage of product (tonnes.d-1)
Qs Quantity of substance (kg.tonne-1 product)
EF Emission factor (-)
Emission Qp Qs EF (kg.d-1)
23
Emission Scenario 3 Average consumption
INPUT Qi Consumption per inhabitant (l.d-1)
Cs Content of the substance in product (kg.l-1)
Fpc Fraction of product with substance (-)
EF Emission factor (-) Ni Number of inhabitants
(-)
Emission Qi Ni Fpc Cs EF (kg.d-1)
24
A Biocide is a new or existing substance but
a new or existing substance is not (always) a
biocide

• A Biocide has a specific function
• Disinfectant
• Preservative
• Insecticide, acaricide, avicide, piscicide, . .
  .

25
Biocides (Use Category 39)
Biocidal Products Directive 98/8/EG Annex V 23
biocidal product types
26
EU Biocidal Products Directive
23 Product Types divided over 4 Groups I
DISINFECTANTS GENERAL BIOCIDES II PRESERVATIVES
III PEST CONTROL PRODUCTS IV OTHER BIOCIDES
27
I DISINFECTANTS GENERAL BIOCIDES
1 Human hygiene biocidal products 2 Private
public-health area disinfectants and other
biocidal products 3 Veterinary hygiene biocidal
products 4 Food and feeding area
disinfectants 5 Drinking water disinfectants
28
II PRESERVATIVES
6 In-can preservatives 7 Film preservatives 8 Wo
od preservatives 9 Fibre, leather, rubber and
polymerised materials preservatives 10 Masonry
preservatives 11 Preservatives for liquid
cooling and processing systems 12 Slimicides 13
Metalworking-fluid preservatives
29
III PEST CONTROL PRODUCTS
14 Rodenticides 15 Avicides 16 Molluscicides 17 Pi
scicides 18 Insecticides, acaricides products
to control other arthropod species 19 Repellents
and attractants
30
IV OTHER BIOCIDES
20 Preservatives for food or feedstocks 21 Antifou
ling products 22 Embalming and taxidermist fluids
23 Control of other vertabrates
31
Example 1
Pt 1 Human Hygiene Biocidal Products

• For example
• Deodorants, antiperspirants
• Anti-dandruff shampoo
• Antimicrobial soap
• Etc.

• Skin application

• Short term

• Bathing

32
Example 1 Pt 1 Human Hygiene Biocidal Products
Emission Scenarios of New Existing
Substances a) Tonnage b) Average consumption per
inhabitant
33
Example 2
Pt 3 Veterinary Hygiene Biocidal Products
3.1 Disinfection of animal housing 3.2 Disinfectio
n of footwear and animalsfeet 3.3 Disinfection
of milk extraction systems 3.4 Disinfection of
means of transport 3.5 Disinfection of
hatcheries 3.6 Disinfection of fishfarms
34
Example 2 Disinfection of animal housing


35
Example 2 Disinfection of animal housing
36
The EUBEES projects

• In 1999, a number of EU Member States, the
  European Chemicals Bureau and the European
  chemical industry (CEFIC), and supported by the
  European Commission, set up the EUBEES working
  group to develop environmental emission scenarios
  for environmental risk assessment of biocides in
  the framework of the Biocidal Products Directive.

• EUBEES 1 project January 2000 until June 2001
• EUBEES 2 project January 2002 until November
  2003

37
EUBEES 1 Results (1)

• Report Development of emission scenario
  documents for 23 product groups of the EU
  biocidal products directive 98/8/EG, INFU/UBA,
  D.
• Emission scenario document for product type 2
  private and public health area disinfectants and
  other biocidal products (sanitary and medical
  sector), RIVM, NL.
• Emission scenario document for biocides used in
  paper coating and finishing (product type
  6,79), INERIS, F.
• Emission scenario document for biocides used as
  preservatives in the leather industry (product
  type 9), INERIS, F.

38
EUBEES 1 Results (2)

• Emission scenario document for biocides used as
  preservatives in the textile processing industry
  (product type 918), INERIS, F.
• Emission scenario document for biocides used in
  taxidermist and embalming processes (product type
  22), INERIS, F.
• Report Proposal for the formats of names,
  parameters, variables, units and symbols to be
  used in emission scenario documents , RIVM, NL.

39
EUBEES 2 objectives and results (1)

• 1 Development of harmonised ESDs
• PT 11 preservatives liquid cooling processing
• PT 12 slimicides
• PT 13 metal working fluid preservatives
• PT 21 antifouling products (in OECD)
• 2 Check ESDs for existing substances on their
  suitability for biocides
• PT 1 human hygiene biocidal products
• PT 6 in-can preservatives
• PT 7 film preservatives
• PT 9 fibre, leather, rubber, polymerised
  material pres.

40
EUBEES 2 objectives and results (2)

• 3 Provide a framework for EU discussion and
  agreement of new ESDs developed by the members,
  eg.
• PT 5 drinking water disinfectants
• PT 10 masonry preservatives
• PT 14 rodenticides
• PT 18 insecticides (in stables and manure)
• 4 Test the scenarios for wood preservatives
  developed by OECD and rodenticides developed by
  the Nordics in the framework of EUBEES, primarily
  with regard to usability.

41
OECD ESD on antifouling products

• Antifoulants inhibit growth of organisms on ship
  hulls, fishing nets, marine structures. (several
  definitions!)
• Aim OECD-wide harmonisation of available
  emission scenarios for anti-fouling applications.
• Most antifoulings, ie. 95 are used on ship
  hulls. Almost all available scenarios deal with
  the estimation of releases of antifoulings during
  the service life.
• The EESAF steering group will have its third
  meeting in November 2003. The draft ESD is
  intended to be finalised early 2004 and submitted
  to the OECD JM end 2004.

42
ESDs for Main Group 1 (disinfectants)

• PT 01 Human hygiene biocidal products ? (RIVM,
  EUBEES2)
• PT 02 Private and public health area
  disinfectants
• Medical equipment ? (EU)
• Accomodation ? (RIVM)
• Industrial areas ?
• Swimming pools ? (RIVM)
• Air-conditioning ?
• Chemical toilets ?
• Wastewater treatment ? (RIVM)
• Hospital waste ?

43
ESDs for Main Group 1 (disinfectants)

• PT 03 Veterinary hygiene biocidal products (?)
  (RIVM)
• PT 04 Food and feed area disinfectants ?
• PT 05 Drinking water disinfectants (? ) (UBA ?
  EUBEES 2 ? CA)

44
ESDs for Main Group 2 (preservatives)

• PT 07 Film preservatives
• Paints coatings (PT 06) ?
• Plastics (PT 09) ?
• Glues adhesives ? (RIVM)
• Paper cardboard ? (RIVM)
• PT 08 Wood preservatives ? (OECD)

45
ESDs for Main Group 2 (preservatives)

• PT 09 Fibre, leather, rubber polymer pres.
• Textiles fabrics ? (EU)
• Leather hides ? (EU)
• Paper cardboard ? (EU)
• Rubber, polymers, etc. ?
• PT 10 Masonry preservatives (?) (EUBEES 2 ? CA)

46
ESDs for Main Group 2 (preservatives)

• PT 11 Preservatives for liquid cooling
  processing systems
• Cooling systems (?) (EUBEES 2 ? CA)
• Processing water liquids ?
• PT 12 Slimicides
• Paper pulp (?) (EUBEES 2 ? TM)
• Mineral oil extraction (?) (EUBEES 2 ? TM)
• PT 13 Metalworking-fluid preservatives (?)
  (EUBEES 2 ? CA)

47
ESDs for Main Group 3 (pest control)

• PT 14 Rodenticides (?) (DK ? EUBEES 2 ? CA)
• PT 15 Avicides (?) (F ? EUBEES 2 ? TM)
• PT 16 Molluscicides ?
• PT 17 Piscicides ?

E c
pond
48
ESDs for Main Group 3 (pest control)

• PT 18 Insecticides, acaricides and products to
  control other arthropods
• Manure stables (?) (RIVM)
• Refuse dumps ?
• Fumigants ? (RIVM)
• PT 19 Repellents and attractants ?

49
ESDs for Main Group 4 (other products)

• PT 20 Preservatives for food feedstocks ?
• PT 21 Antifouling products (?) ongoing
• PT 22 Embalming and taxidermist fluids ? (EU)
• PT 23 Control of other vertebrates ?

50
EU Risk Assessment TGD new version

• Harmonised Approach to Risk Assessment of
• New Chem, Existing Chem and Biocides
• Harmonised Approach to Risk Assessment in the
• Marine Environment (N.E.B. and OSPAR)
• Include in Guidance what has been learned in the
• Existing and New Chemicals areas
• Include specific guidance for Biocides
• (i.e. emission scenarios!)
• Reducing discussion time and disagreements
• through increasing the extent of guidance

http//ecb.jrc.it gt documents
51
Revised TGD (2003) relevant exposure
assessment issues

• More complete life cycle assessment
• Release estimation
• emissions from long-life articles
• emissions from waste disposal including recovery
• Unintentional uses calculation of background
  concentrations

52
Nice questions! (1)

• Should the waste stage be included in the
  exposure assessment of biocides?
• Yes, the BPD in principle covers also waste stage
• However the TGD (2003) and the OECD PT8 ESD do
  not contain models to quantify emissions from
  waste stage. Relevant assumptions would include
  (wood preservatives)
• how much wood enters the waste stage
• how much of that goes to landfill, resp.
  incineration
• how much of the a.i. is still left in the wood
• etc..

53
Nice questions! (2)

• How to use the new (TGD) long-life article
  emission scenario for wood preservatives and what
  is the relation to the OECD wood in service
  scenario?
• The TGD approach deals with constant emissions
  over a long time and relates to the regional
  scale.
• The OECD scenarios should be followed for wood
  preservatives. The scenario for wood in service
  has a different approach. The TGD scenario does
  not apply for wood preservatives.

54
Nice questions! (3)

• How should background concentrations and PEC
  regional be calculated for biocides? Which
  releases should be taken into account?
• Biocides emissions generally pertain to local
  emissions and result in calculations of PEC
  local.
• Background concentrations and PEC regional can
  therefore normally not be determined.