9.00 12.00 - 2 - mon. june 1st - garden room - ann mason

1. Tools 101
Overview of
Two Pilot
Projects:
• 7-Chemical Hazard
Screening Comparison
• Exposure Feasibility
June 1, 2015

2. Customers Ask:
“What’s In Products?”
. . . and “Is It Safe for Me to Use?”

3. Source for ingredient list http://jameskennedymonash.files.wordpress.com/2014/01/
All Natural Blueberries
INGREDIENTS: AQUA (84%), SUGARS (10%) (FRUCTOSE (48%), GLUCOSE (40%), SUCROSE
(2%)), FIBRE E460 (2.4%), AMINO ACIDS (<1%) (GLUTAMIC ACID (23%), ASPARTIC ACID
(18%), LEUCINE (17%), ARGININE (8%), ALANINE (4%), VALINE (4%), GLYCINE (4%),
PROLINE (4%), ISOLEUCINE (3%), SERINE (3%), THREONINE (3%), PHENYLALANINE (2%),
LYSINE (2%), METHIONINE (2%), TYROSINE (1%), HISTIDINE (1%), CYSTINE (1%),
TRYPTOPHAN (<1%)), FATTY ACIDS (<1%) (OMEGA-6 FATTY ACID: LINOLEIC ACID (30%),
OMEGA-3 FATTY ACID: LINOLENIC ACID (19%), OLEIC ACID (18%), PALMITIC ACID (6%),
STEARIC ACID (2%), PALMITOLEIC ACID (<1%)), ASH (<1%), PHYTOSTEROLS, OXALIC ACID,
E300, E306 (TOCOPHEROL), THIAMIN, COLOURS (E163a, E163b, E163e, E163f, E160a)
FLAVOURS (ETHYL ETHANOATE, 3-METHYL BUTYRALDEHYDE, 2-METHYL
BUTYRALDEHYDE, PENTANAL, METHYLBUTYRATE, OCTENE, HEXANAL, DECANAL, 3-
CARENE, LIMONENE, STYRENE, NONANE, ETHYL-3-METHYLBUTANOATE, NON-1-ENE,
HEXAN-2-ONE, HYDROXYLINALOOL, LINALOOL, TERPINYL ACETATE, CARYOPHYLLENE,
ALPHA-TERPINEOL, ALPHATERPINENE, 1,8-CINEOLE, CITRAL, BENZALDEHYDE),
METHYLPARABEN, 1510, E300, E440, E421 and FRESH AIR (E941, E948, E290).
Note: highlighted ingredients are on hazard list
Ingredients

4. Exposure
What is the safe range?
Aspirin
Ethanol
Oxygen
Vitamin A
Botulinum
Beneficial Range Toxic dose
300 – 1,000 mg 15,000 mg
1 oz. 20 oz.
20% Air 50-80% Air
700 μg / day >3,000 μg / day
1-2 vials (injected) 20-30 ng (ingested)

5. Science
Decisions Based on…
Perception

6. • Evaluate function, test feasibility of concept
using existing tools to provide for quality
information for risk-screening.
• Demonstrate addition of exposure & risk
• Pilot & exploratory in nature
• Focus on methods & frameworks
• No conclusions offered about tools
themselves
Design of Pilot Projects

7. Current perception:
Leading hazard
screening tools
• Are similar,
• Yield similar results,
• Equally useful for
judging ingredients
in consumer
products
Pilot 1: Hazard Screening Tools

8. Pilot undertaken to test the perception
If correct: Screening level hazard should
produce similar results if they share a
common objective and are based on similar
science, data, and assumptions.
Hypothesis: 7-Chemical Comparison
Project

9. Conducted a screening level hazard analysis to:
• Apply the protocol specified by each tool
provider
• Understand the approach for each hazard
screening tool
• Clarify the source of data for each chemical
• Compare resulting hazard screening analysis
Objectives: 7-Chemical Comparison
Pilot Project

10. Methods
• Hazard Tools Evaluated
• Chemicals Evaluated
• Endpoint Comparison
• General Observations
• Specific Tool Findings
7-Chemical Comparison Methods

11. Candidate Tools
Selected hazard screening tools from earlier 32 tool
criteria-based evaluation (Gauthier et al., 2014)
• GreenScreen® (full assessment)
• GreenScreen® (list translator)
• Green Suite
• GreenWercs™
• Design for the Environment (DfE) Alternative
Assessment (AA) Criteria for Hazard Evaluation
Added another tool
• SciVera Lens™ Chemical Safety Assessment
Candidate Tools

12. Tools Vary in Approach
• Framework—tool provides procedure for
professional to use during analysis
• Lists—tool uses published lists of substances
• Hazard Analysis—tool uses combination of
procedure and data for hazard evaluation
Hazard Tools Vary in Approach

13. Overview of Tools Assessed
Tool Creator Objective Approach Data Source
DfE Alternative
Assessment (AA)
Criteria for Hazard
Evaluation
US EPA
Identify safer
alternatives
Framework Toxicological data
GreenScreen
Clean
Production
Action
Chemical use
decision guide
Lists, Framework,
professional
judgment
Lists, toxicological
data
GreenSuite
Chemical
Compliance
Systems
Chemical use
decision guide
Hazard analysis Toxicological data
GreenWERCS
The Wercs
Ltd/Wal-
Mart
Customization
based on user
preferences
Lists Lists
SciVera Lens
Chemical Safety
Assessment
SciVera LLC
Assess hazards
and risks of
chemicals
Hazard analysis,
Risk analysis
Lists, toxicological
data
Overview of Hazard Approaches

14. Chemical Selection for the Pilot
• Identify a small group of chemicals having:
• Differing toxicity profiles
• Differing production sources, natural versus
synthetic, versus degradation products
• Known to have robust data sets for the analysis
• Known to be ingredients in consumer products
• Represent a broad set of chemistries
Pilot – Chemical Selection

15. Chemicals Selected for Pilot
CAS Chemical Name Rationale
58-08-2 Caffeine Natural
77-92-9 Citric acid Naturally derived preservative on
DfE Safer Chemicals List
107-21-1 Ethylene glycol Degrades to glycolic acid (79-14-1),
a natural metabolite
79-14-1 Glycolic Acid Degradation product of EG
84-74-2 Dibutyl phthalate (DBP) Well characterized, on regulatory
ban lists
2634-33-5 Benzisothiazolinone (BIT) Antimicrobial
3194-55-6 HBCD (1,2,5,6,9,10-
Hexabromocyclo-dodecane)
End of life issues (PBT)
Pilot – Selected Chemicals

16. Hazard Endpoints for Evaluation
• Number of endpoints varied among tools, n=9 to 28
• Endpoints matched well across most tools
• A few endpoints were not exactly the same:
• Single persistent value vs persistent value for each
environmental compartment (air, water, soil)
• Differing measures for systemic toxicity:
• single dose vs RfC, RfD
• repeat dose vs TLV
Pilot - Hazard Endpoints

17. Tool Endpoints Driving Score Score Tools’ Scoring System Hazard
Conversion
GreenWERCS
Walmart Scoring
Model
0 0-2500 (preferable)
2500-6000 (acceptable)
6000-8500 (avoid)
Low
Moderate
Very High
GreenWERCS
GreenScreen Scoring
Model
Persistence; Bioaccumulation;
Multiple endpoints
2500 0-5000 (preferable);
5000-15000 (acceptable);
15000-20000 (avoid)
Low
Moderate
Very High
GreenScreen Full
Assessment
vB, T vH BM4 best;
BM3 use but seek improvement;
BM2 use but search for alternatives;
BM1 avoid
Low
Moderate
High
Very High
GreenWERCS
GreenScreen List
Translator
Persistence; Bioaccumulation vH LT-U = BM Unspecified;
LT-P1 = avoid, possible BM1;
LT-1 = BM1 avoid
High
Very High
GreenWERCS
ChemRisk Scoring
Model
Persistence 5000 0-5000 (preferable);
5000-15000 (acceptable);
15000-20000 (avoid)
Low
Moderate
Very High
GreenSuite
(Adjusted-weighting)
Water persistence; Water toxicity;
Air persistence; Soil persistence;
Soil exposure
83% 90-100% (Grade A, green)
80-89%; (Grade B, yellow)
70-79%; (Grade C, orange)
0 -69% (Grade D (red)
Low
Moderate
High
Very High
USEPA DfE AA Criteria
for Hazard Evaluation
High – Developmental toxicity &
persistence
Very High – Acute & chronic
aquatic toxicity & bioaccumulation
H, VH Based upon score for endpoints of concern:
Very High, High, Moderate, Low
Low
Moderate
High
Very High
SciVera Lens Acute aquatic toxicity;
bioaccumulation; chronic aquatic
toxicity
vH low hazard (le) or (l)
moderate hazard (me) or (m);
high hazard (h) or (he)
Very high hazard (vh) or (vhe):
insufficient data (nd); unassessed (u)
Low
Moderate
High
Very High
1,2,5,6,9,10-Hexabromocyclo-dodecane (HBCD) 3194-55-6

18. Tool
Chemical
GreenWERCS
Walmart
Scoring Model
GreenWERCS
ChemRisk
Model
GreenWERCS
GreenScreen
Scoring Model
GreenWERCS
GreenScreen
List Translator
GreenScreen
Full
assessment
GreenSuite
adjusted
USEPA DfE
AA Criteria
SciVera
Lens
Generic Hazard Designation
Caffeine Low Low Moderate Very high High Very high High High
Citric Acid Low Low Low Uncertain High High Low, High High
Ethylene Glycol Low Moderate Moderate High Very high Very high Moderate Moderate
Glycolic Acid Low Low Low Uncertain Very high High
High
Very high
Very high
DBP Low Moderate Moderate Very high Very high Very high
High
High
Very high
BIT
Low Low Low Uncertain Uncertain Very high
High
Very high
Very high
HBCD Low Low Low Very high Very high Moderate
High
Very high
Very high
(Notes: 1. Tool names are those offered by the provider; 2. Actual tool nomenclature/output presented in detailed subsequent slides
Overview of Results
Differences in Tool Frameworks Lead to Different Scores

19. How the Tools Rate Caffeine

20. How the Tools Rate Ethylene Glycol

21. Pilot 1: Key Findings*
Tools Comparison Project
• Outcome depends on tool used for screening process
• Tools use different approaches: frameworks, list, hazard
analysis
• Differences across tools included endpoints and
weighting, data sources, data gaps
• Some tools are not transparent about their
methodologies/basis for evaluation and chemical codings
(rankings)
* Note: Small study; findings relate to tools & chemicals evaluated

22. Hazard in Context: Risk
Hazard
Dihydrogen
monoxide
> 6 L / 3hr = High Risk
x Exposure = Risk
Quantity & Route
Inhalation = High Risk

23. Ingredient
Concentrations
The Way People
Use Products
Input for
Prioritization for
Product Changes
Value of Exposure as Part of
Screening
Hazard of chemical ingredient is only one
consideration in making informed decisions

24. From NAS (2014)
Conduct
Comparative
Hazard/Exposure
Analysis
Consider Life Cycle
Thinking
Consider Other
Factors:
• Performance,
• Economics
• Other

25. Current beliefs:
• Risk-based approaches are not available,
• Not cost-effective,
• Not feasible, or
• Not easy to use for consumer products.
Feasibility pilot project is designed to
address the validity of these beliefs
Why Conduct Exposure Feasibility
Project?

26. • Selected an exposure model for pilot
• Selected a hazard screening tool
• Used same hazard endpoints as 7-Chemical Pilot
• Identified 8 generic formulations for consumer
products
• Pilot project shows that hazard screening tools
can be used with existing exposure models.
Exposure Feasibility Project: Method

27. Feasibility Pilot:
Can Hazard & Exposure be Joined for
Screening Level Assessments?
Hazard Tool
Open Source Software Tool
Exposure Tool [e.g., ConsExpo]
Hazard
Analysis
(Existing Tools)
Exposure
Analysis
(Existing Tools)
Graphic
New
Product
Safety
Reports
Software
Data Entry
Template
Formulation:
• Manufacturer
• Safety Data Sheet
• Disclosure forms
Product Use:
• Manufacturer
• Safety Data Sheet
• Product Label
New

28. • Endpoints & weightings
• Reference values
• Exposure scenarios
• Easy to understand report & graphic
output
Continuing Work:
Exposure Feasibility Project

29. • Explore feasibility
of existing tools
• Add exposure &
risk
• Be pre-
competitive &
pilot/exploratory
• Focus on methods
& frameworks
(not tools)
• Publish in
scientific &
technical journals
• Foster discussion
in scientific
communities
• Catalyze risk
approaches to
advance
sustainability.
• Not develop an
‘ACC tool”
• Not recommend
or endorse any
tool
• Not supplant
regulatory risk
assessment
• Not override
existing voluntary
consensus
standards
Specifically
Designed to:
Public &
Transparent:
Not intended
to:
Design of Pilot Projects

30. Thank You
Questions?

31. WRAP-UP
What are We Looking for in a Chemical
Evaluation Tool?... revisited
What’s important and how can we all
work to improve all tools?
• What’s Important?
• Where are Improvements Needed?