Environmental Law for Business: Chemicals &

Substances Management

Wednesday, September 24, 2014

Board of Review for Siloxane D5

Presented by: Harry DahmeCertified Specialist (Environmental Law)

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

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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

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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

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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)

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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

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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

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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

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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

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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

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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

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

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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

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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)

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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)

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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)

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INSERT TEXT

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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

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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

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montréal · ottawa · toronto · hamilton · waterloo region · calgary · vancouver · moscow · london

Thank You

Harry DahmeCertified Specialist (Environmental Law)Tel: (416) 862-4300Email: harry.dahme@gowlings.com

New Substance Notifications: An Overview

Presented by: Gatlin SmeijersAssociate

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?

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

DSL / NDSL

• Domestic Substances List (DSL)

• Non-Domestic Substances List (NDSL)

• Polymers and Biopolymers

• Reduced Regulatory Requirement Polymers

NSN Regulatory Framework

Domestic Substances List (DSL)

CEPA Exception Notification Provided = Importation & Manufacture Permitted

CEPA ProhibitionSubstance not on DSL = Importation & Manufacture Prohibited

NSN Regulations – Notification Requirements

Data Level 1Quantity Level 1

Data Level 2Quantity Level 2

Data Level 3Quantity Level 3

Notifiable SubstancesIf 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.

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.

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.

Other Exemptions

• 2 % Rule Polymers and Proteins

• Transient Reaction Intermediates

• Substances Occurring in Nature

• Manufactured Items

• Wastes

• Low Volume

Volume Splitting

…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…

Environment Canada Advisory Note:

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

Thank You

montréal · ottawa · toronto · hamilton · waterloo region · calgary · vancouver · beijing · moscow · london

Gatlin SmeijersToronto officeTel: 416-862-3511Email: gatlin.smeijers@gowlings.com

Robert P. DeMott, PhD, DABTPrincipal Toxicologist

The International Trend Toward Hazard-Based Regulation: Navigating the New Reality

Presented for:Gowling Lafleur Henderson LLP Toronto

September 24, 2014

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Outline

• Overview of hazards and risks

• Toxicology Primer – dose and exposure

• International landscape of hazard and risk-based regulations for products

• Implications, Responses, Realities

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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?

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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

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We Have an Intuitive Grasp of Hazard vs. Healthful…

Which scene above do you associate with the following?

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“Good Chemicals” and Hazardous Chemicals

List AArsenic

Lead

Trichloroethylene

Mercury

Warfarin (D-con rat bait)

List BOxygen

Water

Chromium (piccolinate)

Vitamin A

Digoxin

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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

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A Modern Example: Rat Poison or Heart Medication?

Source: www.coumadin.com

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Mercury – HistoricallySignificant, 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

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The “Good Chemicals” are Toxic too

• Everything in List B is also associated with toxicity

List BOxygen

Water

Chromium (picolinate)

Vitamin A

Digoxin

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• How changes in dose cause changes in response

• Generally have flat region and region where responses increase with dose

• Steepness of increasing segmentcorresponds to potency of chemical

Dose-Response Characteristics

Res

pons

e

Dose

Threshold

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Critical Concept # 1

• No matter how “good” or “bad” the associationswith a given chemical:

The relevant or potentialdose determines the risk of undesired outcomes

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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

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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

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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

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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.

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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

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Korea– K-REACH

• Modeled on REACH

– Registration timelines still in future (comes in force Jan, 2015)

Risk-Hazard Continuum – promoting hazard

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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

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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

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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

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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

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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

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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

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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

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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

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Thank You

Robert P. DeMott rdemott@environcorp.com