Categorization and Screening of the Domestic Substances List

Path forward towards ecological prioritization of substances for

assessment

Existing Substances BranchEnvironment Canada

The results (April 2005) Quantity reported in 1986(# on HC Maximal list)

Preliminary Ecological Categorization

Decisions

0 to >1T 1T to >1000T

>=1000T Unknown quantity

Total

Meets Categorization criteria

188 (20) 319 (40) 100 (32) 20 (2) 627 (94)

high confidence (blue) (yellow) (purple) (orange)

Meets Categorization criteria

507 (12) 768 (23) 178 (39) 48 (2) 1501 (76)

medium confidence (blue) (yellow) (purple) (orange)

Meets Categorization criteria

495 (0) 690 (7) 104 (25) 21 (1) 1310 (33)

low confidence (blue) (yellow) (purple) (orange)

Uncertain 312 (8) 354 (42) 390 (288) 4 (0) 1060 (338)

and data poor (green) (green) (purple) (orange)

Under review 810 (0) 1604 (115) 295 (116) 47 (2) 2756 (233)

for PBiT (green) (green) (green) (green)

P and/or B, not iT 3,658 (442) 3658 (442)

to non-human organisms (white)

Not P and Not B 8,290 (416) 8290 (416)

  (red)

Low Concern 3,236 (146) 3236 (146)

  (red)

Total Substances   22,438 (1778)

Timelines / Next StepsDate Milestone

July 28, 2005 Multi-stakeholder meeting on prioritization.

July, 2005 Updated Categorization CD. Preliminary categorization decisions for all but the uncertain substances.

Aug/ Sept, 2005 Discussion paper on prioritization (post September 2006)

September, 2005 Deadline for submitting experimental data to support the categorization of discrete organic and inorganic substances.

October, 2005 Updated Categorization CD. Decisions on uncertain substances & changes based on industry submissions.

December, 2005 Deadline for submitting experimental data to support the categorization of polymers, organometallics, and UVCBs.

January, 2006 Updated Categorization CD. Changes based on industry submissions.

April, 2006 Final draft Categorization CD.

July, 2006 Final Categorization CD.

September, 2006 Statutory deadline for publishing the results of the Categorization of the DSL.

Deadlines for Data Submission September 2005: Discrete organics & inorganics December 2005: Other substances If data cannot be submitted by these dates,

extensions may be requested. Requests must include a plan outlining the work

being undertaken, status, next steps, and timelines. Requests must be submitted well in advance of

these deadlines, and will be available for public review (Categorization CD).

Data received after the deadline may not be processed in time for the September, 2006 deadline.

Categorization Results to Date

Of the 19,700 (of 22,400) substances for which we have preliminary categorization decisions, there is evidence that 3400 meet ecological categorization criteria 100 PBiT with data of high certainty 200 PBiT with data of low certainty 400 High volume PiT or BiT 1000 Medium Volume PiT or BiT with data of high

or medium certainty 700 Medium Volume PiT or BiT with data of low

certainty 1200 Low Volume PiT or BiT (<1000kg)

A further 1000 substances are Uncertain because they have no data

Some Of These Substances Are Already Being Addressed

For many of these substances actions have already been taken, or will be taken under CEPA

Many others are already undergoing testing in HPV Programs

Some of the substances meeting ecological categorization criteria also meet health categorization criteria, though the overlap is not high

Characteristics Context # on April 2005 CD

[category]

# HPV program (US/OECD/ICCA)

# HC Maximal list

CEPA (PSL,Schedule 1, PFA survey)

Pilot Project(other SA)

P (air) B iT Global Issues: POPS Stockholm, UNECE

21[0]

8 3 4 1(+ 10 )

P (other) B iT Regional Issues: Great Lakes, SMOC

295[57]

25 7 27 22

High Volume

{Uncertain, data poor, model difficult}

Data Collection is ongoing: US HPV and OECD/ICCA

382[351]

{390}[11]

<130*(Organics)

129

{288}

12

4

8

6

Medium VolumeHigh & medium confidence

Priority setting with Stakeholders

1087[301]

<133*(Organics)

47 15 21

Low Volume Low Priority or Set aside 1190[126]

<28*(Organics)

16 21 4

Uncertain, data poor, {Low confidence medium volume}

Reverse OnusInternational collaboration to fill data gaps

666[171]

{690}[159]

x 47

9

27

15

12

3

Health Canada priorities

Maximal list 1892

* Preliminary numbers; X means not available

Ongoing Actions and Linkages

Setting The Context For Communicating Categorization Results

There is much interest in understanding what will happen after categorization is complete as it is clear that the results of categorization will require a long term response from government, industry and public interest groups

Communicating the results of categorization will be facilitated if these results are set in the context of next steps

Assessment is not the only next step for many substances

Therefore, a mechanism must be developed to group substances according to the anticipated actions by government, industry and stakeholders in 2006

What Are The Possible Next Steps After Categorization?

In the next 20 years Canada and other jurisdictions will continue to work towards understanding substances in commerce Some substances can proceed immediately to risk

assessment Other substances require additional data generation to

reduce uncertainty in their categorization decision New research needs to be conducted particularly in the

area of environmental monitoring, and model development

Meanwhile, the government needs to continue working with other jurisdictions. Results of the US & OECD HPV programs and the EU REACH program need to be taken into consideration

Industry needs to be responsible and accept the “onus” placed on them to understand the impact of substances that they produce or market

Path Forward - Implementation of ecological prioritization framework

June 1: EC/HC/ICG/CEN meeting where prioritization framework concept was introduced.

July 28: stakeholder subgroup meeting to identify mutually acceptable considerations for prioritization

Summer 2005: discussion paper outlining overall objectives for prioritization of categorized substances.

Define how to use the sorting tools in the next steps Severity scale (mechanical process) Certainty scale (mechanical process) Information from categorization Information from new substances requirements

We commit to maintain the open, transparent and consultative process we have used for categorization

The Framework For Action On Substances Meeting Categorization Criteria

Priority to Fill Data Gaps Higher severity/ lower certainty Fill information gap through

science and monitoring Actively engage international

players (influence) Challenge voluntary industry RM

action, or data generation

Priority for Assessment High certainty & severity Higher volume and or hazard Precautionary RM action where

needed

Monitor Progress Lower severity & certainty Support voluntary industry activity to fill data

gaps Passively align with existing international data

gathering or assessment activities (communicate) Implement international feeder by monitoring

RA/RM activities in other countries Implement provisions to put onus on industry (S.

70 feeder)

Low Priority for Action Lower severity / higher certainty Lower volume Low priority for assessment Generic exposure tools to set aside Communicate low expectation for

immediate action Monitor 6 feeders

Path Forward for: Substances identified as P and B (n=314)

P and B substances are the ecological highest priority for assessment to determine if these substances pose an ecological risk

For substances that are P, exposure can not easily be reduced by discontinuing production Problems caused by persistent chemicals are, therefore, long-lasting

Persistent substances that are bioaccumulative concentrate up to several orders of magnitude. They can reach concentrations where adverse effects occur even at low levels of exposure in the environment

Many P and B substances have low confidence categorization decisions so priority after 2006 is to improve the quality of the data upon which decision is made

Group substances based on chemical categories of P&Bs.

Trial Binning of 1660 Organic Substances “Categorized In” Based on

Hazard

Priority for assessment117 CAS#s(98 PBiTs)

Low priority for action117 CAS#s

Priority to fill data gaps550 CAS#s (218 PBiTs)

Monitor progress876 CAS#s

Path Forward for Purple: High volume , > 1000 tonnes (n=382)

Determine which substances have already been addressed domestically, such as PSL, schedule 1 (done)

Determine substance status in international high volume programs (done)

Those substances with SIDS datasets generated internationally can proceed to screening assessments

Verify whether the timelines for generating the SIDS data in international HPV programs are compatible with our domestic scheduling (to be done as part of phase 2 of priority setting)

Issue 1: Canada is an 80% import market. As such not many substances are originating in the country. Existing substances risk are a developed world problem.

Issue 2: Categorization has confirmed the global lack of data on chemicals, Issue 3: the lack of significant progress on important international initiatives that hold

promise is cause for concern Issue 4: We are currently at least 10 years ahead of REACH

Path Forward for Yellows: Categorized in with medium & high confidence (n= 1087)

Distributed among 4 quadrants Medium confidence = priority for data-

gap filling High confidence = higher priorities for

assessment/ further actions Rounds 1&2 = some yellows, or as part

of category approach Round 3 = larger number of yellows, or

as part of category approach

Path Forward for Yellows: Categorized in but low confidence (n= 690)

Weight of evidence points in the direction that the substance meets the categorization criteria

Simplified s.71 survey to find out which ones are not in commerce (based on new survey format)

For those in commerce, voluntary challenge to industry to fill data gap or to accept the “onus” of risk managing

For those not in commerce, consider the use of SNAc’s to ensure data gaps are filled before the substance is re-introduced on the market (trigger of 1 tonne for example?)

These substances will likely be initially lower priorities for screening assessments unless data is received

P and B substances of medium volume are not included in this approach

Path Forward for Blues:Low volume, < 1 tonne (n=1190)

Select some priorities for screening assessment based on P and/or iT. (Cherry picking)

Some of these substances could be included in a category approach (determined during phase 2) based on priorities of other related substances For example, a group assessment of nitro musks would

include low volume nitro musks These substances would not be driving assessment

priorities For substances not selected as priorities and that do not

fall in a category, use a generic exposure tool such as ChemSim for a tier 1 screening assessment or to justify very low priority for assessment (set aside)

Provide industry with section 70 guidance on what types or future sources of exposure to notify

Persistent and bioaccumulative substances are not included in this approach

Generic Exposure Scenarios

Generic exposure scenarios would be used to refine binning of substances.

Combination of scenarios could be used to support the setting aside of substances that are low priority for further action. Generic exposure scenario in ChemSim

could be compared to acute toxicity data used for categorization.

Mechanical Priority Setting Activities Before 2006 Will Be Augmented

The mechanical sorting will be refined using planning tools Assessment and management activities in

other countries International HPV programs Category approaches Ongoing research and monitoring activities Potential use of Significant New Activities

Provisions Results from section 71 surveys Use of section 70

After 2006 Additional Priority Setting Will Need to Occur

Post categorization, work can begin on setting priorities for assessment within smaller groups of substances

A priority setting and scheduling process needs To be done in conjunction with Health Canada Set priorities periodically (as opposed to ongoing) Be able to accommodate emerging priorities that are

identified through mechanisms other than categorization (ie emerging science, new substances)

Be cognisant of ongoing initiatives and work in other jurisdictions

Scaled to the resources of government, industry and other stakeholders

Be transparent and have appropriate engagement

1. Categorizatio

n

2. New

Substances

Notification

3. Industry

Information

4. International

Assessment

and Data

Collection

5. Emerging

Science

6. Public

Nominations

7. Provincial or

International

Decisions

7 Feeders

S. 74

Categorized “in”

S. 68

Not Categorized “in” but further

work

•Includes uncertain

S. 68 or S. 77

Other substances identified for

further review

eg.: Organotins, BFR’s, PFOS, PFCA, PCN, CP’s, organoperoxy, organosilicon

•Could overlap with categorization

Prio

ritiz

atio

n I

(Mul

ti-st

akeh

olde

r)

Priority for Assessment

•High certainty & severity

•Higher volume and/or hazard

•Precautionary RM action where needed

Actively Fill Data Gaps

•Higher severity/lower certainty

•Fill information gap through science and monitoring

•Actively engage international players (influence)

•Challenge voluntary industry RM action, or data generation

Passively Align with Other Programs

•Lower severity & certainty

•Support voluntary industry activity to fill data gaps

•Passively align with existing international data gathering or assessment activities (communicate)

•Implement international feeder by monitoring RA/RM activities in other countries

Low Priority for Action

•Lower severity/higher certainty

•Lower volume

•Low priority for assessment

•Generic exposure tools to set aside

•Communicate low expectation for immediate action

•S. 71 Surveys

•Complete HPV Assessments in other jurisdictions

•NSN information database

•Set government research agenda

•Communicate data gaps and actively engage other jurisdictions

•Challenge industry

•S. 71 data generation

•Develop tools/methods (OECD)

•SNAC’s

•HPV Reverse onus on industry

•Industry research programs

•REACH implementation

•EPA prioritization discussions

•NSN new data

•Research programs

•S. 70

•NSN trigger and information requirement

•REACH exemptions

•S. 71 other Gazette Notices to definitely set aside

•Use 6 feeders to re-assess

7 Feeder Contribution to Next Steps

Report on results of assessment

Report on active data gap filling

Report on results of passive alignment

Report on new information from 7 feeders

Prio

ritiz

atio

n II

(M

ulti-

stak

ehol

der)

Prio

ritiz

atio

n II

I (M

ulti-

stak

ehol

der)

2006-2011

2012-2017

2018-2023

Identification of Substances

Contributing to identification of all hazardous substances

Prioritization Outcome

PBiT

PiT & BiT

•Includes low confidence

Dev

elop

men

t of m

utua

lly a

ccep

tabl

e (M

ulti-

stak

ehol

der)

set

of c

onsi

dera

tions

for

setti

ng p

riorit

ies

2005