Jointly organised by and - DTU Research Database...Malyka Galay Burgos ECETOC Tala Henry US...
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WORKSHOP PROGRAM Developing a strategy to improve the environmental risk assessment of difficult to test multi-component substances 2-4 November 2016 Gaylord Palms 6000 West Osceola Parkway Kissimmee, Florida 34746 European Centre for Ecotoxicology and Toxicology of Chemicals Research Institute for Fragrance Materials Jointly organised by and
Transcript of Jointly organised by and - DTU Research Database...Malyka Galay Burgos ECETOC Tala Henry US...
WORKSHOP PROGRAM
Developing a strategy to improve the environmental risk assessment of difficult to test multi-component
substances
2-4 November 2016
Gaylord Palms
6000 West Osceola Parkway
Kissimmee, Florida 34746
European Centre for Ecotoxicology and Toxicology of Chemicals
Research Institute for Fragrance Materials
Jointly organised by
and
Contents INTRODUCTION ..................................................................................................... 1
PROGRAMME DAY 1: DEFINING SUBSTANCE COMPOSITION AND CHARACTERIZATION 2
PROGRAMME DAY 2: SUBSTANCE AND EXPOSURE ASSESSMENT/DATA GENERATION
AND ANALYSIS – FATE AND ECOTOXICITY ............................................................... 4
PROGRAMME DAY 3: RISK ASSESSMENT ............................................................... 9
LIST OF PARTICIPANTS ........................................................................................ 12
ORGANISING COMMITTEE
Daniel Salvito (Chair) RIFM
Romanas Cesnaitis European Chemicals Agency
Joop de Knecht RIVM
Derek Knight European Chemicals Agency
Karen Eisenreich US Environmental Protection Agency
Marc Fernandez Environment and Climate Change Canada
Malyka Galay Burgos ECETOC
Tala Henry US Environmental Protection Agency
Sylvia Jacobi Albemarle
Karen Jenner Givaudan
Miriam Leon Paumen ExxonMobil
Delina Lyon Shell
Diederik Schowanek P&G
Joy Worden Shell
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INTRODUCTION
BACKGROUND INFORMATION
This Workshop was planned to address challenges in risk assessing complex mixtures of substances (e.g., multi-constituent substances (MCS), unknown variable composition and biological substances (UVCBs)). International regulatory schemes (specifically REACH, Canada’s DSL Categorization and Chemicals Management Plan assessments, and USEPA’s PMN process) have highlighted the complexities of registering, characterizing fate and exposure, and risk assessing complex chemical mixtures whether from manufacturing environments or plant derived materials. Several industrial sectors (e.g., petrochemicals, personal care) have developed schemes for characterization and analysis of these complex substances.
WORKSHOP AIM
This Workshop was designed to identify best practices and key research needs to support environmental risk assessment.
Breakout sessions will be focused on priority areas leading to best practice recommendations.
WORKSHOP STRUCTURE
A two-day workshop is proposed. The major areas to be covered are:
1. Existing Regulatory Schemes
2. Substance Composition
3. Fate (including how does one define P and B for a UVCB)
4. Environmental Toxicity (including appropriate methods for developing a PNEC)
5. Risk Assessment
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PROGRAM DAY 1: DEFINING SUBSTANCE COMPOSITION AND CHARACTERIZATION
MODERATOR: DAN SALVITO
RAPPORTEUR: MARC FERNANDEZ EMERALD 2
12:00 – 1:00 Registration (Emerald 2) and Lunch (Wreckers)
The purpose of this first day is “stage setting”: Introducing the participants to the state-of-the-science and issues as conceived by the Organizing Committee with opportunity for identifying additional key areas that may have been missed.
1:00 – 1:20 Introduction Dan Salvito
RIFM
Existing Regulatory Frameworks
1:20 – 1:45 ECHA Romanas Cesnaitis/Joop de
Knecht ECHA/RIVM
1:45 – 2:10 Environment and Climate Change Canada Marc Fernandez
Environment and Climate Change Canada
2:10 – 2:35 US EPA Karen Eisenreich
USEPA
Substance Profiling
2:35 – 3:10 Recently developed methodology for structural description / prediction of UVCBs
Saby Dimitrov
LMC
Standard Guideline studies and their applicability to UVCB substances
3:10 – 3:35 Challenges for difficult to test mixtures Hank Kreuger
EAG
3:35 – 4:00 Updated Guidelines Chris Mead
Envigo (Via Webinar)
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4:00 – 5:00 Panel Discussion
Moderator: Dave Carroll Thought Starters:
What are some of the hurdles (technical or legal) in getting access to substance composition and how can these be lowered? What are some of the considerations for applicability of read-across information from known discrete or UVCB to unknown UVCB for:
1. Phys-chem data 2. Toxicity data 3. Biodegradation data 4. Bioaccumulation data
What are some of the challenges that need to be addressed in testing required for the risk assessment of UVCBs?
5:00 Close of first day
6:30 – 8:30 Dinner Villa de Flora
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PROGRAM DAY 2: SUBSTANCE AND EXPOSURE ASSESSMENT/DATA GENERATION AND ANALYSIS – FATE AND
ECOTOXICITY
Environmental Fate Moderator: Miriam Leon-Paumen
Rapporteur: Karen Jenner EMERALD 2
In the context of risk and exposure assessment, substance properties (e.g. vapour pressure, water solubility, log Kow, Log Koc) and information on biodegradation are needed to estimate the distribution of releases in environmental compartments and to calculate Predicted Environmental Concentrations (PECs) for each compartment. To assess secondary poisoning in predators and via the food chain, information on bioaccumulation is also required. Multi-constituent and UVCB substances may be comprised of individual substances with different physico-chemical and fate properties meaning that the environmental risk assessment should ideally be based on a constituent approach i.e. either based on groups of constituents with similar environmental fate and toxicity properties or on individual constituents that contribute most to the potential hazard and risk of the mixture. This will be challenging for substances that are not well characterised and/or have a significant fraction of “unknown” constituents. For a UVCB composed of constituents expected to have similar environmental, fate and ecotoxicity properties, the whole substance approach may be appropriate. Environmental fate data (degradability and bioaccumulation) in combination with acute aquatic toxicity data is also used to assess the potential long-term aquatic hazard of substances in determining classification when adequate chronic toxicity data is not available. The session explores whether standard tests used to generate environmental fate information for single substances might be appropriate for testing mixtures; how such systems might be modified to provide information on the individual constituents / blocks of constituents and what the relevance of the output data is for environmental classification and environmental risk assessment.
9:00- 9:25 Environmental Fate Assessment of Fragrance Natural Complex Substances
Karen Jenner Givaudan
9:25 – 9:50 Environmental Fate Assessment of Resin Products
Richard Guinn Eastman Chemical
9:50 – 10:15 Biodegradation testing of mixtures – challenges and relevance of output data: Petroleum Substances
Chris Hughes
Shell (via webinar)
10:15 -10:40 Bioaccumulation assessment of natural complex substances
Matt MacLeod/Michael
McLachlan Stockholm University
10:40 – 11:05 Passive Dosing Methods
Philip Mayer Technical
University of Denmark
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Breakout Sessions Approaches to blocking, categories and read-across The role of biodegradation testing of mixtures
Screening tests on biodegradability have been developed for single substances. Although
the standard output data (CO2 evolved or O2 consumed) does not provide information on
the biodegradability of individual constituents, results from a ready test can be used for
classification purposes when a substance consists of “constituents with different chain-
lengths, degree and/or site of branching or stereo-isomers, even in their most purified
commercial forms” (OECD 2006). Similar language can be found in the REACH guidance.
For the purpose of environmental exposure estimation, extrapolation from screening test
results (e.g. readily, readily but failing 10-d window, inherently, not biodegradable) is used
for single substances to obtain default rate constants and half-lives for biodegradation.
Chemical analysis presents an opportunity to provide information on the primary degradation
of individual constituents.
1. Is it possible to use results from a screening test
performed on a complex substance to generate suitable
data for exposure assessment purposes?
2. If so what specific conditions would need to be met (e.g.
structural similarity) and/or what modifications to the test
would be required?
3. Are there other methods available which could be
adapted to determine the relative biodegradation half-
lives of constituents / blocks of constituents in a complex
substance?
What mixture effects may occur in biodegradation studies (e.g. co-metabolism, competitive effects) and how would they influence the results and their interpretation? Approaches to test bioaccumulation of multi-constituent substances
Tests for bioaccumulation have been developed for single substances. Testing of multiple components in one experiment is feasible, but when a substance becomes too complex targeted testing of the most relevant components might be the only feasible approach. Many multiconstituent substances have low water solubility and the most appropriate test to perform would be a dietary bioaccumulation test, however, there are still uncertainties regarding the interpretation of dietary data.
1. What are the most relevant approaches to test bioaccumulation of multi-constituent substances?
2.
3. What is the role of dietary bioaccumulation data in exposure assessments for complex
substances?
4.
How can a relevant fraction be picked for bioaccumulation testing, and how will data for a fraction allow determination of whole substance bioaccumulation for exposure assessment?
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Breakout Sessions
11:05 – 12:00
Approaches to blocking, categories and read-across EMERALD 1
Damia Barcelo
Chang'er Chen
Saby Dimitrov
Dave Carroll
Paul Thomas
Richard Guinn
Eric Van Genderen
Delina Lyon
Joop de Knecht
Marc Fernadez
Akina Takamatsu
The role of biodegradation testing of mixtures
EMERALD 2
Philip Mayer
Dieter Hennecke
Karen Jenner
Aurelia Lapczynski
Peter Fisk
Todd Gouin
Paul DeLeo
Lee Sayers
Aaron Redman
Romanas Cesnaitis
Yoshitaka Imaizumi
David Tobias
Approaches to test bioaccumulation of multi-constituent substances
EMERALD 3
Matt MacLeod
Thomas Backhaus
Sylvia Gimeno
Ed Salinas
Michelle Embry
Ming Fan
Hank Kreuger
Miriam Leon-Paumen
Masashi Horie
Karen Eisenreich
Michal Skowron
12:00 - 12:30 Breakout Session Report Backs
12:30 – 1:30 Lunch Wreckers
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Environmental Toxicity
Moderator: Michelle Embry Rapporteur: Karen Eisenreich
EMERALD 2
Environmental Toxicity serves two roles in the assessment of a material for environmental
safety and regulatory requirements. The data, in and of itself, are used to assess ecotoxicity
classifications, but are also used to derive PNECs for environmental risk assessment.
UVCBs present unique challenges in their testing and interpretation of the data generated in
standard studies.
1:30 – 1:55 Fate and exposure driven toxicity testing David Tobias
USEPA
1:55 – 2:20 Dosing methodologies Lee Sayers
Smithers Viscient
Aquatic toxicity testing of mixtures –Challenges and ecological relevance:
2:20 – 2:45 Towards a new method of determining environmental
risk of complex substances
Paul Thomas
Kreatis
2:45 – 3:10 Approaches to Additivity
Thomas Backhaus
University of
Gothenburg
Breakout sessions
Modelling approaches: e.g., the role of EqP methods
Approaches to ecotoxicity testing of multi-constituent substances
1. The WAF presents an opportunity for whole substance testing providing information on the
substance itself and complementary information on constituent specific data. What
methodological considerations should be discussed to improve the
accuracy/precision/relevance of this test?
2. If the components of UVCBs are not water soluble WAFs may not be the best method for
assessing hazard. Testing in sediments should be considered. What methods are available to
describe hazard of UVCBs in sediment.
3. Interpretation of UVCB hazard testing results can be challenging. What are the best practices
available for interpretation?
How can fate data be used to determine the most appropriate hazard testing?
4:15 – 4:45 Breakout Session Report Backs
5:00 Close of second day
6:30 – 8:30 Dinner MOOR
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Breakout sessions
3:15 – 4:15
Modelling approaches: e.g., the role of EqP methods
EMERALD 1 Saby Dimitrov
Matt MacLeod
Paul Thomas
Richard Guinn
Peter Fisk
Michelle Embry
Todd Gouin
Aaron Redman
Joop de Knecht
Marc Fernadez
Yoshitaka Imaizumi
Approaches to ecotoxicity testing of multi-constituent substances
EMERALD 2 Chang'er Chen
Philip Mayer
Dieter Hennecke
Aurelia Lapczynski
Sylvia Gimeno
Ed Salinas
Ming Fan
Hank Kreuger
Miriam Leon-Paumen
Masashi Horie
Karen Eisenreich
Michal Skowron
How can fate data be used to determine the most appropriate hazard testing?
EMERALD 3 Damia Barcelo
Thomas Backhaus
Dave Carroll
Karen Jenner
Eric Van Genderen
Paul DeLeo
Lee Sayers
Delina Lyon
Akina Takamatsu
Romanas Cesnaitis
David Tobias
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PROGRAM DAY 3:
RISK ASSESSMENT
Moderator: Joop de Knecht Rapporteur: Romanas Cesnaitis
EMERALD 2 Risk assessment of chemicals as a tool enables various interested parties (researchers,
industry, authorities etc.) to estimate the magnitude of risk to the protection target and to
make necessary decisions, and take actions in restricting and controlling the use and/or
release of chemicals. It is known that UVCB substances cannot be sufficiently identified by
their chemical composition which creates the complications for the risk assessment of such
substances as traditional hazard and exposure assessments for the whole substance in
most cases is not possible
Risk Assessment Approaches
9:00- 9:25 Weight of Evidence Approaches – Regulatory
Recommendations
Mark Bonnell Environment and Climate
Change Canada (via
webinar)
9:25 – 9:50 Practical Applications/Examples – Industry
Example
Miriam Leon-Paumen
ExxonMobil
Uncertainty in Substance Composition: Case Studies
9:50 – 10:15
Advancements in analytical chemistry
which help elucidate composition of
multiconstituent substances
Damia Barcelo
Catalan Institute for Water
Research
10:15 -10:40 Risk assessment of UVCB/multi-constituent
metals
Eric Van Genderen/Hugo
Waeterschoot International
Zinc/Eurometaux
10:40 – 11:05 Variability in Data Sets – effect on risk
assessment
Aaron Redman
ExxonMobil
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Breakout Sessions
OECD guidance has been developed to characterize relatively simple UVCBs, i.e.
oleochemicals and hydrocarbon solvents, for which the constituents are known. How
can more complex UVCBs, for which the composition are not be fully identified, be
characterized?
Various approaches for RA of UVCBs 1. What should be considered to be the best RA approach for the specific UVCB
substance? 2. What type of information would be needed to perform a risk assessment of UVCB, in
relation to both the toxicity and fate of the substance? How can information on one of more of the constituents of the UVCB be used to assess the risk of the UVCB as a whole?
3. How can the hydrocarbon block methods be used in the RA and how can constituents be selected as representatives of the hydrocarbon block.
When a Water Accommodated Fractions: how can they be used in a risk assessment? This
should address both aquatic (water and sediment) and soil compartments. The complexity
of the water system is predicted to be simpler than that of the soil system. Further
considerations to be given to the use of WAF for sediments.
How to deal with uncertainty and variability of UVCBs in RA? What type of information
is needed to cover the variability and related uncertainty?
2:00 – 2:30 Breakout Session Report Backs
2:30 – 4:00 Plenary Closure: Facilitated Panel Discussion (Industry,
Academic, Regulatory Perspectives)
4:00 Close of Workshop
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Breakout Sessions
11:05 – 12:30 Lunch 1:30 -2:00 (if needed)
How can more complex UVCBs, for which the composition are not be fully identified,
be characterized?
EMERALD 1 Saby Dimitrov Chang'er Chen
Damia Barcelo
Richard Guinn
Paul Thomas
Ed Salinas
Ming Fan
Lee Sayers
Joop de Knecht
Marc Fernadez
Masashi Horie
Delina Lyon
Various approaches for RA of UVCBs EMERALD 2
Miriam Leon-Paumen
Matt MacLeod
Philip Mayer
Aurelia Lapczynski
Karen Jenner
Michelle Embry
Eric Van Genderen
Todd Gouin
Karen Eisenreich
Akina Takamatsu
Romanas Cesnaitis
How to deal with uncertainty and variability of UVCBs in RA? What type of information
is needed to cover the variability and related uncertainty?
EMERALD 3 Dieter Hennecke
Thomas Backhaus
Dave Carroll
Sylvia Gimeno
Peter Fisk
Paul DeLeo
Hank Kreuger
Aaron Redman
Yoshitaka Imaizumi
Michal Skowron
David Tobias
12:30 – 1:30 Lunch Wreckers
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LIST OF PARTICIPANTS
Name Affiliation Country Email Address
Thomas Backhaus University of Gothenburg
Sweden [email protected]
Damia Barcelo Catalan Institute for Water Research
Spain [email protected]
Mark Bonnell ECCC Canada [email protected]
Dave Carroll RIFM USA [email protected]
Romanas Cesnaitis ECHA Finland [email protected]
Chang'er Chen Stockholm University Sweden [email protected]
Joop de Knecht RIVM/OECD NL [email protected]
Paul DeLeo ACI USA [email protected]
Saby Dimitrov LMC Bulgaria [email protected]
Karen Eisenreich USEPA USA [email protected]
Michelle Embry HESI USA [email protected]
Ming Fan P&G USA [email protected]
Marc Fernadez ECCC Canada [email protected]
Peter Fisk Peter Fisk Associates UK [email protected]
Sylvia Gimeno Firmenich Switzerland [email protected]
Todd Gouin Unilever UK [email protected]
Richard Guinn Eastman Chemical USA [email protected]
Dieter Hennecke Fraunhofer Institute Germany [email protected]
Tala Henry USEPA USA [email protected]
Masashi Horie NITE Japan [email protected]
Chris Hughes Shell UK [email protected]
Yoshitaka Imaizumi National Institute for Environmental Studies
Japan [email protected]
Karen Jenner Givaudan UK [email protected]
Hank Kreuger EAG USA [email protected]
Aurelia Lapczynski RIFM USA [email protected]
Miriam Leon-Paumen
ExxonMobil Belgium [email protected]
Delina Lyon Shell USA [email protected]
Matt MacLeod Stockholm University Sweden [email protected]
Philip Mayer Technical University of Denmark
Denmark [email protected]
Chris Mead Envigo USA [email protected]
Alan Poole ECETOC Belgium [email protected]
Aaron Redman ExxonMobil USA [email protected]
Ed Salinas BASF Germany [email protected]
Daniel Salvito RIFM USA [email protected]
Lee Sayers Smithers Viscient USA [email protected]
Michal Skowron ECHA Finland [email protected]
Akina Takamatsu NITE Japan [email protected]
Paul Thomas Kreatis France [email protected]
David Tobias USEPA USA [email protected]
Eric Van Genderen International Zinc USA [email protected]
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NOTES
Logistics
VENUE
Gaylord Palms 6000 West Osceola Parkway Kissimmee, Florida 34746
REGISTRATION AND ENQUIRIES
ECETOC, attention of Christine Yannakas Av. E. Van Nieuwenhuyse 2, Box 8, B-1160 Brussels, Belgium Tel. +32 2 675 3600 E-mail: [email protected] RIFM, attention of Dan Salvito 50 Tice Boulevard Woodcliff Lake, NJ USA Tel. +1 201 689 8089 ext 114 E-mail: [email protected]
