Presented at Gowlings Toronto office on September 24, 2014. With the ongoing evolution of chemical substance regulation in Canada and abroad, manufacturers and importers face significant and highly technical compliance challenges. Failure to adequately navigate the complex chemicals management regimes can result in costly disruptions to business, customer relation issues, and potential regulatory liability.

1. Environmental Law for
Business: Chemicals &
Substances Management
Wednesday, September 24, 2014

2. Board of Review for Siloxane D5
Presented by: Harry Dahme
Certified Specialist (Environmental Law)

3. Introduction
• Board of Review, established by Minister of the
Environment under ss. 333(1) of CEPA, 1999
• Siloxane D5
• Odourless, colourless liquid
• Used in personal care products and industrial cleaning
• In use for more than 30 years
3

4. Legislative Background
• CEPA, 1999
• S. 73 required Ministers of Environment and Health to
categorize the substances on the Domestic Substances
List (DSL) within seven years in order to identify
substances that may:
- present greatest potential for exposure
- are persistent or bioaccumulative (in accordance with the
regulations), and may be inherently toxic
• December 2006
• Completion of categorization of 23,000 substances on DSL
• Identification of approximately 200 substances as high priority
for action
4

5. Legislative Background
• Industry Challenge
• Substances released in 12 Batches with dates for submission of
information, publication of draft Screening Assessment Reports and
final Screening Assessment Reports)
• S. 64 “toxic” means immediate or long-term harmful effect on
the environment, danger to the environment, danger to
human health
• S. 68 Minister may collect information on whether a
substance is toxic
• S. 71: Notice requiring submission of information for purpose
of assessing whether substance is toxic or capable of
becoming toxic
• S. 74 Screening Assessment
5

6. Legislative Background
• Options upon completion of screening assessment
• No further action
• Addition to the Priority Substances List
• Addition to the Toxic Substances List if a substance is “toxic”
(mandatory where substance is toxic, has long-term harmful
effect on the environment, persistent and bioaccumulative,
inherently toxic and present due to human activity)
• Virtual elimination (persistent and bioaccumulative, inherently
toxic and present due to human activity, not naturally
occurring)
6

7. Legislative Background
• Decision made based on the application of:
• Weight of evidence approach
• Precautionary principle
• Persistence and Bioaccumulation Regulations
apply
• Numeric half-life values for different media
• Numeric values to BAF, BCF, Kow
7

8. Screening Assessment and Notice of Objection
• Screening Assessment concluded D5:
• Met the criteria for persistence and bioaccumulation and
• Was entering the environment in a quantity or concentration or under
conditions that had the immediate or long-term harmful effects on the
environment or its biological diversity
• Notice of objection by SEHSC provided new studies and
requested a Board of Review
• Section 333 – Ministers may establish a Board of Review to
inquire into the nature and extent of the danger posed by the
substance in respect of which the decision is made
• Board of Review granted based on new scientific information
regarding D5 having been made available since conduct and
publication of the final Screening Assessment
8

9. Board of Review
• 3 internationally recognized toxicologists
• Scope of the hearing
• Nature and extent of the danger posed by D5 to the
environment (not health)
• Not whether substance is “toxic” pursuant to section 64
• De novo risk assessment
9

10. Issues
• Characteristics of D5
• Chemical characteristics of D5 are well understood
• Chemical characteristics are unusual compared to other
PBT substances (for example very large vapour pressure
for such a high molecular weight, very low water
solubility…)
• There was general agreement on its physical properties
with the exception of sediment half-life
10

11. Issues
• Is D5 persistent and bioaccumulative?
• Environment Canada – if D5 was persistent and
bioaccumulative and used in substantial quantities, then D5 is
“toxic” notwithstanding that there may be no harmful effects
caused by D5 in the concentrations at which it was entering the
environment
• Persistence and Bioaccumulation Regulations
• Persistence in different media determined by half-life
• Whether a substance is bioaccumulative depends on:
- whether bioaccumulation factor (BaF) equal to or greater than 5000
- where the BaF cannot be determined, one of the bioconcentration
factor (BcF) equal to or greater than 5000; and
- if neither BaF or BcF can be determined, then where the octanol-water
partition coefficient (Kow) is greater than 5
11

12. Issues
• Subsection 5
• Determination to be made based on generally recognized
methods “taking into account the intrinsic properties of the
substance, the ecosystem under consideration and the
conditions in the environment”
• Bioaccumulation (BcF)
• One out of four studies showed a BcF of greater than 5000
• Biomagnification
• D5 does not bio magnify (confirmed by depuration and
biotransformation)
• Biota-sediment accumulation factors (BSAF)
• Express the distribution of a substance between organism
and sediment
• Comparative studies between D5 and PCBs (which do
bioaccumulate)
12

13. Issues
• Trophic Magnification Studies
• Trophic dilution occurs as D5 moves up the food chain
• The use of UK or EU studies
• “Weight of evidence approach”
• Not defined
• It must be readily evident or possible to recreate the
conclusion based upon the information which was
reviewed
13

14. Issues
• Releases to the environment
• Need to consider “real world emission characteristics” (9.5%
the sanitary sewers, 90.5% being released to air)
• Clear evidence that D5 is entered into a steady state in the
environment
• Partitioning to different media
• 94.5% to air
• 0.8% to water
• 4.7% to soil
14

15. Issues
• Atmospheric fate, ozone destruction, snow scavenging
• Soil exposure (including application of bio solids)
• Not persistent in soil
• Water and sediment exposure
• Rleases to surface water and use of “Mega Flush”
• Sewage treatment plant removal efficiency
• Long Range Transport
• Air
• Water (inappropriate use of model)
15

16. Issues
• Conclusion
• All predicted and measured concentration of D5 are less
than the matrix solubility
• No matter how much D5 is released into the environment,
the maximum concentration cannot exceed solubility in the
media
• Primary medium of concern is sediment (and then only
close to sewage treatment plant outfall)
16

17. Issues
• Toxicity
• Not toxic up to its solubility limit in various media (water, soil,
sediment, air)
• Toxicity measured by narcosis (therefore no need for a broad
range of species being analyzed)
• Risk
• The No Observable Effect Concentrations far exceed the D5
concentrations in media - therefore no risk
• Weight of evidence (see the next slide)
17

18. INSERT TEXT
18

19. Conclusion, Comments and Recommendations
• Comprehensive and extensive record of studies
relating to D5
• D5 exceeded regulatory threshold for persistence
• D5 did not exceed regulatory threshold for
bioaccumulation
• D5 does not biomagnify (but can accumulate in an
organism)
• D5 not toxic up to solubility limits
• Will not accumulate in concentrations sufficient to
cause adverse effects
• Does not pose a danger to the environment
19

20. Conclusion, Comments and Recommendations
• Environment Canada suggested the review should not
be based on “average or standard use of chemicals”
but if a pure product poses a danger then it must form
part of the Board’s assessment
• Periodic review of the Persistence and
Bioaccumulation Regulations
• Making models available and make the use of the
models transparent
20

21. Thank You
Harry Dahme
Certified Specialist (Environmental Law)
Tel: (416) 862-4300
Email: harry.dahme@gowlings.com
montréal  ottawa  toronto  hamilton  waterloo region  calgary  vancouver  moscow  london

22. New Substance Notifications:
An Overview
Presented by: Gatlin Smeijers
Associate

23. Overview: New Substance Notification (NSN)
• NSN Regulatory Framework
• Notifiable Substances
• Key Exemptions
• Volume Splitting
• Compliance Tips
Is it a “new substance”?
Is there any applicable exception?
We’ve reached the import limit,
what can we do?

24. NSN Overview
• Purpose is control of new substances
• New = Post 1984
• Program designed to put burden of assessing potential
health/environmental impact on industry
• Level of assessment increases with quantity put into
commerce
• Program administered by Environment Canada
and Health Canada
• Places restrictions on import and manufacture
• Applies to:
• Chemical substances
• Polymers/Biopolymers
• Organisms

25. DSL / NDSL
• Domestic Substances List (DSL)
• Non-Domestic Substances List (NDSL)
• Polymers and Biopolymers
• Reduced Regulatory Requirement Polymers

26. NSN Regulatory Framework
Domestic Substances List (DSL)
CEPA Prohibition
Substance not on DSL = Importation & Manufacture Prohibited
CEPA Exception
Notification Provided = Importation & Manufacture Permitted
NSN Regulations – Notification Requirements
Quantity Level 1 Data Level 1
Quantity Level 2 Data Level 2
Quantity Level 3 Data Level 3

27. Notifiable Substances
If not on the DSL, must notify in respect of:
• Any chemical with a unique CAS#
• Unknown or variable composition, complex reaction products
and biological materials (UVCBs)
• substances that have no definite molecular formula representation and
either partial structural diagrams or no structural diagrams
• Nanomaterial form of substance
(1) having one or more dimensions (or internal or surface structure) at the
nanoscale (1-100 nanometers inclusive);
(2) exhibiting nanoscale-related phenomena above or below the nanoscale.

28. Key Exemption – Impurities and Contaminants
For exemption to apply substance must:
• Be found in minimal concentration in the starting
materials; or
• Be a result of secondary reactions that occur during the
manufacturing process.
and must NOT:
• Be necessary to the end use of product;
• Have been intentionally added to the product; or
• Enhance the value of the product.

29. Key Exemption – Incidental Reaction Products
Exemption applies to:
1. Substances produced when a product
undergoes a chemical reaction that is incidental
to its use; or
2. Substances resulting from storage or from
environmental factors.

30. Other Exemptions
• 2 % Rule Polymers and Proteins
• Transient Reaction Intermediates
• Substances Occurring in Nature
• Manufactured Items
• Wastes
• Low Volume

31. Volume Splitting
Environment Canada Advisory Note:
…any regulatee who has reached the maximum manufacture or import quantity
to obtain additional quantities of the new substance from another
regulatee who has already manufactured or imported the new
substance into Canada for his own use and has not reached its
maximum quantity.
However, a regulatee may not obtain additional quantities of the new
substance from another regulatee by contracting the person to
manufacture or import the new substance on his behalf…

32. Compliance Tips
• Tracking program is key
• 90% of issue arise due to late identification of issue
• Can cause issues with commercial supply arrangements
• Inquiries to suppliers re: regulatory status of
product components
• Disclosure to customers re: regulatory status of
product components
• Do not assume REACH or TSCA registration is
sufficient

33. Thank You
Gatlin Smeijers
Toronto office
Tel: 416-862-3511
Email: gatlin.smeijers@gowlings.com
montréal  ottawa  toronto  hamilton  waterloo region  calgary  vancouver  beijing  moscow  london

34. The International Trend Toward
Hazard-Based Regulation:
Navigating the New Reality
Robert P. DeMott, PhD, DABT
Principal Toxicologist
Presented for:
Gowling Lafleur Henderson LLP Toronto
September 24, 2014

35. 35
Outline
• Overview of hazards and risks
• Toxicology Primer – dose and exposure
• International landscape of hazard and risk-based
regulations for products
• Implications, Responses, Realities

36. 36
Risk Analysis Basics
• Risk Analysis 101 – in three bullets
– Hazard – inherent characteristic
– Risk – requires exposure to a hazard
– Pathway – connecting hazards to exposed people
Example: Migration of chemical from packaging onto exterior
surface of toy handled by child who puts hands in mouth
• Starts with Assessing Hazards
– New hazards necessitate new evaluation
– Should we stop there?

37. 37
Risk-Based Decision Making
• Guiding concept is making environmental cleanup
decisions based on:
– Potential health risks to humans or other species
• Sounds obvious and desirable, what else would we use
– Specified concentration limits (“Standards”)
– Technological feasibilty
– Background
– Hazard Avoidance

38. 38
We Have an Intuitive Grasp of Hazard vs.
Healthful…
Which scene above do you
associate with the following?

39. 39
“Good Chemicals” and Hazardous
Chemicals
List A
Arsenic
Lead
Trichloroethylene
Mercury
Warfarin (D-con rat
bait)
List B
Oxygen
Water
Chromium (piccolinate)
Vitamin A
Digoxin

40. 40
Toxicological Reality
• List A are all “medicines”
Arsenic – Fowlers solution (1809-1950s)
and other formulations
• treat asthma, diabetes, malaria, syphilis
Lead – various historical uses, folk
remedies continue in use
• for colic, menstrual disorders
TCE
• general anesthetic; orally, as treatment for worms

41. 41
A Modern Example: Rat Poison or Heart
Medication?
Source: www.coumadin.com

42. 42
Mercury – Historically
Significant, and …
• Used to treat
– Syphilis
– Various GI upsets, skin conditions
– historical experimentation lead to Paracelsus’ recognition:
There are no substances which are not
poisons, it is the dose that makes the poison

43. 43
The “Good Chemicals” are Toxic too
• Everything in List B is also
associated with toxicity List B
Oxygen
Water
Chromium (picolinate)
Vitamin A
Digoxin

44. 44
Dose-Response Characteristics
• How changes in dose cause changes in response
• Generally have flat region and region where responses
increase with dose
• Steepness of
increasing segment
corresponds to
potency of chemical
Response
Dose
Threshold

45. 45
Critical Concept # 1
• No matter how “good” or “bad” the
associations
with a given chemical:
The relevant or potential
dose determines the risk of
undesired outcomes

46. 46
Risk-Based Regulation
• Risk analysis incorporates:
– Toxicity assessment (dose-response) AND
– Exposure assessment (describe pathways) TO
– Characterize risks
• Product uses, ingredients, environmental conditions
prioritized based on estimated risk and controls – Botox
Paradox
• Exposure and toxicity assumptions intentionally biased
to be protective

47. 47
Hazard-Based Regulation
• Toxicity assessment (dose-response) – all we need
• Benchmarks used to prioritize chemicals
– Potency
– Type of effect
– Associations and perceptions
• Use lists/scorecards as basis for
– Notification/disclosure
– Reformulation/substitution
– Restriction

48. 48
The Lure of Regulating Hazards
• Fast and easy
– Find it with your iPhone
– Explain it to non-specialists
• Pre-determined list
– Controlled by interested parties
– Use the threat of being listed
• Eliminate discussion/debate about risk complexities

49. 49
International Trend to Toward Hazard-
Based Decisions
• Initial voices were primarily advocacy groups (90’s)
– Adopted “precautionary principal” concept
– Highlighted supposedly limited evaluations
• In the US, dismissed by regulatory bureaucracy and
professionals
• Gained traction mid ‘00’s
– REACH
– Greener product initiatives.

50. 50
EU – REACH
• Registration, Evaluation, Authorisation and Restriction–
– Registration – gatekeeping process, incentivizes hazard-based
management, substitution
– Hazard alone documented initially – presumed risky
“Substances of Very High Concern”
– Authorisation step – provides for risk assessment, but you are
way into 6-digit costs to get there, plus “prove it’s safe to our
satisfaction” burden
– Intended to impose chemical specific restrictions
Risk-Hazard Continuum – leaning hazard

51. 51
Korea– K-REACH
• Modeled on REACH
– Registration timelines still in future (comes in force Jan, 2015)
Risk-Hazard Continuum – promoting hazard

52. 52
US – Federal
• Current programs (TSCA, FIFRA, RCRA/CERCLA, FDA
– Strong risk-based framework
– Criticized for demonstration of risk, not demonstration of safety
paradigm
– Not significantly changed in decades
• Updates in the offing
– Advocates pushing REACH-like approach (with a mission)
– National Academy of Sciences reiterating value of risk-based
decision-making
Risk-Hazard Continuum – pendulum swinging from risk

53. 53
US – State of Washington
• Children’s Safe Products Act
– Notification, not prohibition framework
– Hazard-based listing – “Chemicals of High Concern”
• Scarlet-letter problem incentivizing substitution
• Draft Guidance on Alternatives Analysis (July 2014)
“The safest alternative and, by definition, the alternative with
the lowest risk has both the lowest hazard and exposure
potential.”
Risk-Hazard Continuum – pushing hazard

54. 54
US – State of California
• Safer Consumer Products Regulations
– Directly focused on substitution
– Hazard-based lists developed by agency and reviewed to
require further action
– If you make the finals – “Alternatives Analysis” with risk
assessment options
– If not, stuck in limbo with the label
• Open statements and pressure to re-formulate of risk
incurring effort of engaging on AA and subsequent
restrictions
Risk-Hazard Continuum – pushing hazard

55. 55
Canada – Pragmatic authority, no chemical-directed
prohibitions
• New Substances Notification Regulations –
– 2005 concept, lists revised routinely
– Domestic Substance List – no need to join a consortium like
REACH
– NDSL – requires information submittal, specifies toxicity AND
exposure information
• Consumer Product Safety Act (2011)
– general prohibition against “unreasonable danger”
– Focus on monitoring, notification and recalls, no pre-approval of
products
Risk-Hazard Continuum – leaning risk

56. 56
Implications for Safer Products
• “More study needed”
• Prudence in the face of uncertainty
• Non-traditional, quick-cycle information release will exert
more pressure – internet science
• “Prove it’s safe” paradigm will have room to keep
moving the finish tape in face of uncertainty

57. 57
Responses to Hazard-Based Issues
• For naturally occurring and ubiquitous constituents
– Background in the environment
– Routine dietary exposure
• For readily substituted ingredients
– Cost/risk/benefit evaluation
– Protection of the brand image as priority
• For products/ingredients not readily de-selected – force
the conversation to risk

58. 58
Realities of Business in a Hazard-Based
Landscape
• Years to decades for positioning and planning will no
longer be the norm in the blogosphere age
• Understanding vulnerabilities and options can provide:
– Easier, cheaper, better compliance
– Competitive advantage – BPA-free bottles
– Plans to respond to internet/social media inititiatives
• Careful analysis required to avoid unfortunate
substitutions – down side of acting rapidly

59. 59
Take-Away Messages
• Hazard-based regulations and pressures are here and
increasing
• Perception is reality – If you’re fighting over the risk
science, you’re in a battle you lose one way or the other
• Look for strategies to adapt and turn competitive
advantages, e.g., first to adopt safer, greener alternative
• Risk-based concepts will not be completely supplanted
in complicated situations

60. 60
Thank You
Robert P. DeMott
rdemott@environcorp.com