Consultations on the CEPA New Substances Notification ......CEPA1 was promulgated in 1988. Following...

New substancessubstances nouvelles

Pursuant toThe New Substances Notification Regulations

of theCanadian Environmental Protection Act, 1999

December 2001 — EPS M-464

Consultations on the CEPA New Substances Notification Regulations

and New Substances Program

Final Report of theMultistakeholder Consultations

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AG AgricultureAN Anaerobic TechnologyAP Airborne PollutantsAT Aquatic ToxicityBT Biotechnology CC Commercial ChemicalsCE Consumers and the EnvironmentCI Chemical IndustriesFA Federal Activities FP Food ProcessingHA Hazardous WastesIC Inorganic ChemicalsMA Marine PollutantsMM Mining and Ore ProcessingNR Northern and Rural RegionsPF Paper and FibresPG Power GenerationPN Petroleum and Natural GasRA Refrigeration and Air ConditioningRM Reference MethodsSF Surface FinishingSP Oil and Chemical SpillsSRM Standard Reference MethodsTS Transportation SystemsTX TextilesUP Urban PollutionWP Wood Protection/Preservation

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© Her Majesty the Queen in Right of Canada (Environment Canada) 2002

Pursuant toThe New Substances Notification Regulations

of theCanadian Environmental Protection Act, 1999

December 2001 — EPS M-464

HealthCanada

Santé Canada

Consultations on the CEPA New Substances Notification Regulations

and New Substances Program

Final Report of theMultistakeholder Consultations

National Library of Canada cataloguing in publication data

Main entry under title:

Consultations on the CEPA new substances notification regulations and new substances program: final report of the multistakeholder consultations

Issued also in French under title: Consultations au sujet du Règlement sur les renseignementsconcernant les substances nouvelles et du Programme des substances nouvelles prévus aux termes de la LCPE.

Co-published by Health Canada.

ISBN 0-662-66343-8Cat. No. En40-653/2002EPS M-464

1. Chemicals -- Law and legislation -- Canada.2. Hazardous substances -- Risk assessment -- Canada.3. Pollutants -- Government policy -- Canada.4. Environmental monitoring -- Canada.5. Environmental law -- Canada.I. Canada. Environment Canada.II. Canada. Health Canada.III. Title: Consultations au sujet du Règlement sur les renseignements concernant

les substances nouvelles et du Programme des substances nouvelles prévus aux termes de la LCPE.

TD196.C45C65 2002 344.71'04633 C2002-980034-XE

Disclaimer

This report is the result of the Multistakeholder Consultations. It is based on the reports prepared by NSN Multistakeholder Table members and technical subcommittees and the deliberations and recommendations that were agreed to at Table meetings. The consultations and the publication of this report were sponsored by Environment Canada; however, the contents of this report do not necessarily reflect the views and policies of Environment Canada. This report will be considered “final” when it is available in both official languages.

iii

Table of Contents

1. Introduction ............................................................................................................1

2. Background and Context of MultiStakeholder Consultations on the NSN Regulations and NS Program .......................................................................3

2.1 Introduction to the NSN Regulations ......................................................3

2.2 Focus of the Consultations on the NSN Regulations and NS Program..........................................................................................3

2.3 Guiding Principles of the NSN Table Deliberations..............................4

3. Themes and Issues.................................................................................................7

3.1 Improving the Environmental and Health Assessments for New Substances ....................................................................................7

3.1.1 Principles and Policies Affecting the Assessment and Management of New Substances .........................................................7

3.1.2 Adequacy of the Risk Assessment Methodology..................................9

3.1.3 Mechanism for Requiring Additional Information for the Risk Assessment .....................................................................12

3.1.4 Endocrine Disrupting Substances (EDSs) ........................................14

3.1.5 Occupational Exposure ......................................................................18

3.1.6 Data Requirements.............................................................................19

3.1.7 Evaluation and Validation of Data Quality in the NS Program .......................................................................................27

3.2 The Regulatory Framework ....................................................................28

3.2.1 General Discussions and Recommendations .....................................28

3.2.2 Proposed Framework for the New Regulations .................................32

3.2.3 Special Categories...............................................................................42

3.2.4 Assessment Periods ............................................................................46

3.2.5 Facilitation of Waivers for Substances Used for a Prescribed Purpose ..........................................................................48

3.2.6 Record-keeping and Enforcement.......................................................48

3.3 Transparency of the NSN Regulatory Process......................................52

3.4 Improving Responsiveness of the NSN Regulations and NS Program in the Global Context ........................................................55

3.5 Service Delivery ........................................................................................57

4. Endnotes................................................................................................................61

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List of Tables

Table 2.1: Boundaries for the Amendments to the NSN Regulations Consultation Process ..................................................................................5

Table 3.0: Target Dates for Completion of Development and Validation of Specific Tests .........................................................................................16

Table 3.1: Recommended Regulatory List of Data Elements for Chemicals and Polymers.............................................................................................22

Table 3.2: Examples of Data Elements to be included in the NSN Guidelines ..................................................................................................23

Table 3.3: Exemptions for Health Hazard Toxicity Data......................................37

Table 3.4: Waivers for Health Hazard Toxicity Data for Polymers with No Molecular Weight Species Below 1000 Daltons (i.e., <0.1%) .......37

Table 3.5: Proposed Assessment Periods for New Substance Notifications .....47

Table A.1: Sunrise Clause Scoring System for Select Indicators ..........................75

List of Figures

Figure 3.1: Notification Under the Modified Sunrise System...............................30

Figure 3.2: Proposed Chemical Framework.............................................................49

Figure 3.3: Proposed Polymer Framework ..............................................................50

Figure 3.4: Proposed Polymer Framework Including Data Requirements .........51

Appendices

A.1 Table Members ....................................................................................................63

A.2 Procedural Guidelines Adopted by the Table Members ..............................65

A.3 Background and Supporting Documents .......................................................67

A.4 List of Acronyms and Definitions ....................................................................68

A.5 Description of the “New Substances” Industry Sector in Canada .............70

A.6 Proposed Requirements for Non-GLP Studies ..............................................70

A.7 Additional Information on the Assessment of Degradation Products.......72

A.8 Test Criteria for the Sunrise Approach — from the Public Advocacy Group Representatives Discussion Paper, August 2000...............................74

Consultations on the CEPA New Substances Notification Regulations and New Substances Program

1. IntroductionThe New Substances Notification (NSN)Regulations for Chemicals and Polymers havebeen in place under the Canadian EnvironmentalProtection Act (CEPA) since July 1, 1994. Whenthe Regulations were promulgated, a commit-ment was made by Environment Canada andHealth Canada to review them following threeyears of implementation. To fulfil this commit-ment, these departments established a multi-stakeholder consultative process in June 1999.Representatives from industry, public advocacygroups (PAG) and the federal government par-ticipated in the process.

The NSN Multistakeholder Table (hereafterreferred to as the Table or the NSN Table) heldeight meetings and numerous subcommitteeand other meetings between November 1999and August 2001 to produce this report. At itsfirst meeting, the Table agreed that the objec-tive of this consultation would be “to identify,discuss and develop consensus recommenda-tions on ways to improve the NSN Regulationsand the Program.”

This report details the background, context,deliberations and final recommendations of theNSN Multistakeholder Consultations. Section 2provides the background and context of theconsultations, including an introduction to theNSN Regulations and the New Substances(NS) Program and the guiding principles usedby the NSN Table in its discussions. The focusof this report and the extensive deliberations ofthe NSN Table in developing recommendationsfor improving the Regulations and Programare captured in Section 3. The Table organizedits discussions around five themes and severalissues relating to each theme. The five themesare:

• Improving the Environmental and HealthAssessments for New Substances;

• The Regulatory Framework;

• Transparency of the NSN RegulatoryProcess;

• Improving Responsiveness of the NSNRegulations and NS Program in the GlobalContext; and

• Service Delivery.

Section 3 provides a description of eachtheme and associated issues, details about the Table deliberations and, where appropriate, the recommendations of theTable with respect to those themes andissues. The appendices to this report providebackground information and references pertaining to the consultation process and the NSN Regulations and NS Program.

1

Final Report of the Multistakeholder Consultations

2


2. Background and Context of MultistakeholderConsultations on the NSNRegulations and NS ProgramThe NSN Regulations apply to chemicals, polymers and inanimate and animate productsof biotechnology. These consultations did notaddress or make recommendations related toanimate products of biotechnology becausethis was beyond their scope.

For the purposes of this report, the term “sub-stances” will include only chemicals, polymersand inanimate products of biotechnology.

2.1 Introduction to the NSN Regulations

CEPA1

was promulgated in 1988. Following afive-year review, it was replaced with a revisedAct (CEPA’99) on March 31, 2000. Unlessexpressly stated to the contrary, all referencesto CEPA in this report are to CEPA’99. One ofthe objectives of CEPA is to ensure that no new substance is imported into or manufac-tured in Canada without a formal review, priorto market introduction, of its potential risks tohuman health and to the environment. The“Substances and Activities New to Canada”provisions in Part 5 of CEPA2 are the authorityunder which the NS Program performs the riskassessments and manages chemicals and poly-mers when risks are identified. The NSNRegulations, which came into effect on July 1, 1994, are the principal means by which the authority is enacted.

The NSN Regulations require importers andmanufacturers to notify Environment Canadaof substances and activities new to Canada.The information that notifiers must submit to government is described in regulatory“schedules.” The notification packages typicallyinclude test data relating to physicochemicalproperties, environmental fate and behaviourand/or toxicity. A detailed description of theNS Program, including the role of theDomestic Substances List (DSL) and the Non-Domestic Substances List (NDSL), is availableon Environment Canada’s NS Program website at www.ec.gc.ca/substances.

Environment Canada is responsible for the administration of the NS Program, theassessment of potential risks to the environ-ment, development and implementation ofcontrols, compliance promotion and enforce-ment. Health Canada carries out the assess-ment of potential risks to human health.Notifiers are responsible for providing theinformation packages and any associated costs.NS Program costs are currently borne byEnvironment Canada and Health Canada;however, a cost recovery initiative is being pursued3 to recover some of the costs fromnotifiers. Table members agreed that, becauseof this other initiative, cost recovery would notbe part of its deliberations. However, the Tablerecognizes that fees associated with cost recovery may need to be reexamined depen-ding on the extent of the amendments to theNSN Regulations.

Multistakeholder consultations and review of the NS Program, procedures and practiceshave been, and continue to be, critical to the successful implementation of the NSNRegulations. The current NSN Regulationsincorporate recommendations of the Environ-mental Contaminants Act AmendmentsConsultative Committee,4 a multistakeholderbody. When the NSN Regulations were prom-ulgated, a commitment was made on the partof Environment Canada and Health Canada toreview the NSN Regulations following threeyears of their implementation. This exercisefulfils this promise.

2.2 Focus of the Consultations on theNSN Regulations and NS Program

In June 1999, Environment Canada and HealthCanada established a multistakeholder consul-tative process to work towards commonunderstanding of the NSN Regulations and NSProgram and to provide consensus recommen-dations for their improvement. An indepen-dent facilitator and a Secretariat were contrac-ted to design and implement the consultativeprocess. Following discussions with severalstakeholders, invitations to participate in theprocess (i.e., sit at the Table) were acceptedby individuals representing EnvironmentCanada (two seats), Health Canada (twoseats) and Industry Canada (one seat),representatives of a broad range of industries affiliated with

3


4


the NS Program (seven seats in total) and PAG representatives (three from the CanadianEnvironmental Network, two from Labour, onefrom the Consumers Association of Canadaand one from the Canadian Public HealthAssociation). A listing of individual partici-pants and their affiliations is provided inAppendix A.1. Several stakeholder groupsdeclined a seat at the Table but requested thatthey be kept informed of the progress of theconsultations (e.g., provinces, territories andAboriginal associations).

The NSN Table held eight meetings andnumerous subcommittee and other meetingsbetween November 1999 and August 2001 toproduce this report. At its first meeting, theTable agreed that the objective of this consulta-tive process would be “to identify, discuss anddevelop consensus recommendations on waysto improve the NSN Regulations and theProgram.” The Table also agreed on a set of“procedural rules” to guide its deliberations(see Appendix A.2). One of the rules states thateach participant has an obligation to strive toconsensus; however, where consensus cannotbe reached on a particular issue despite bestefforts, the differing views relating to that issuewill be clearly articulated. This report reco-gnizes this agreement.

The NSN Table acknowledges that consensusrecommendations pertaining to amendmentsof the current NSN Regulations cannot bindthe Parliamentary process (Cabinet is res-ponsible for, and accountable for, makingRegulations). Nevertheless, all Table membershave agreed to support the consensus recom-mendations as a package. Government repre-sentatives in particular have undertaken to dotheir best to ensure that consensus recommen-dations will be reflected in any ensuingchanges to the NSN Regulations and NSProgram. Where this may not occur,Environment Canada and Health Canada representatives will report back to all Tableparticipants any deviations from the consensusand the reasons therefor.

During its deliberations, the NSN Table consi-dered information available in the publicdomain as well as information provided orgenerated by Table members, consultants orexperts invited to attend specific sessions. Key documents used by the Table are referencedin the Endnotes (see Section 4) and in

Appendix A.3 of this report. A list of acronymsand definitions for technical and commercialterms used in this report are included inAppendix A.4. The remaining appendices areas follows: A.5 — Description of the “NewSubstances” Industry Sector in Canada; A.6 —Proposed Requirements for Non–GoodLaboratory Practice (GLP) Studies; A.7 —Additional Information on the Assessment ofDegradation Products; and A.8 — Test Criteriafor the Sunrise Approach.

2.3 Guiding Principles of the NSN TableDeliberations

The NSN Table members agreed that there arecertain fundamental principles that the NSNRegulations and NS Program must incorporateand that, consequently, must always beweighed by the Table in developing its recom-mendations. The expectation of the Table members is that the NSN Regulations and NS Program will:

• promote high standards in the protection ofhuman health and the environment;

• incorporate methodology and processimprovements that allow better use ofindustry and government resources to achieve health and environmental objectives;

• enable government departments to providea timely, predictable and transparent NS Program; and

• support the ability of Canadian industry to compete in a global marketplace.

The main focus of these consultations was ondeveloping recommended amendments to theNSN Regulations and NS Program. However,it was necessary to set some boundaries on thescope of the consultations. These were dis-cussed and agreed to at the first and secondmeetings. Table 2.1 describes the boundariesfor the scope of the consultations on the NSNRegulations and NS Program set by the Table.


5

CEPA • Minor technical amendments may be possible

• Applications of principles in CEPA to the NSN Regulations

• CEPA and authorities in general

Substance Types • Chemicals and biochemicals (inanimate)

• Polymers and biopolymers (inanimate)

• Animate products of biotechnology

NSN Regulations Anything relevant to above substancetypes, including:

• information and administration requirements

• schedule and composition

• assessment periods

• volumes and triggers

• handling of polymers (high/low concern)

• transitional substances

• definitions

• Portions of the Regulationsrelating to animate productsof biotechnology

Policy • GLP and conducting tests

• Toxic Substances Management Policy(TSMP) relating to data requirements

• Endocrine disrupting chemicals relating to data requirements

• Precautionary principle

• TSMP in general

• Persistence, bioaccumulationand inherent toxicity:Inherent toxicity

Program Efficiencies and Issues

• Program processes and operations

• NDSL

• Publication of information

• Flagging DSL substances

• Minor organizational changes

• Major organizational changes

• Cost recovery

Assessment Methods • Quantitative structure–activity relationships (QSARs), surrogate data

• Guidance manual (transparency)

Mutual Acceptance ofNotifications (MAN)

• MAN relating to Program efficienciesand CEPA authorities if related to NSN Regulations amendments

• Government policy on international initiatives (e.g.,Organisation for EconomicCo-operation andDevelopment [OECD])

Table 2.1: Boundaries for the Amendments to the NSN Regulations Consultation Process

Issue INCLUDEDin Consultation Process

EXCLUDEDfrom Consultation Process

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7

3. Themes and IssuesThe focus of this report and the extensivedeliberations of the NSN Table in developingrecommendations for improving the NSNRegulations and the NS Program are capturedin this section. The Table organized its delibe-rations into five themes with several relatedissues. The remainder of this section providesa brief description of each theme and associat-ed issues and details the deliberations and recommendations of the Table with respect to those issues.

3.1 Improving the Environmental andHealth Assessments for NewSubstances

3.1.1 Principles and Policies Affecting theAssessment and Management of NewSubstances

The Table identified a number of principlesand policies that could have a bearing on dis-cussions about improving the environmentaland human health assessments of new sub-stances. These include the pollution preventionprinciple, the precautionary principle and theTSMP.5

(i) Pollution PreventionSection 3 of CEPA defines pollution preventionas “the use of processes, practices, materials,products, substances or energy that avoid orminimize the creation of pollution and wasteand reduce the overall risk to the environmentor human health.”

Table DeliberationsThere was agreement that the purpose of theNS Program is to prevent pollution by asses-sing and responding to toxic substances veryearly in the substances’ life cycles. As such,pollution prevention is a fundamental tenet ofthe NS Program. The intent is to ensure that nonew substance is introduced into the Canadianmarketplace before proponents provide anadequate set of data and an objective asses-sment of its potential environmental andhuman health risk is made. Substances sus-pected of being “toxic,” as interpreted in CEPA(see section 84(1), “suspicion of toxic”), can besubject to controls authorized under the Act.

While this represents one view of pollutionprevention in the context of CEPA, expe-rience from the United States, which includesconsideration of the comparative benefits ofsubstances, provides a broader perspective ofpollution prevention. The U.S. EnvironmentalProtection Agency (EPA) has the option of con-sidering whether a new substance presents areduced risk compared with an existing chemi-cal used in the same, or a similar, application.In the context of the NS Program and CEPA,currently there is no obligation to carry outsuch a review following notification. However,for substances where there is a “suspicion oftoxic,” there is adequate opportunity for noti-fiers to provide additional information aboutthe substance to Health Canada andEnvironment Canada. The departments thenuse this information to develop appropriatecontrols for that substance.

Pollution prevention planning as authorized inPart 4 of CEPA was briefly discussed but wasnot considered directly relevant to the NSProgram.

Table RecommendationsNone.

(ii) The Precautionary PrincipleCEPA has several references to the precautio-nary principle, including the preamble, whichstates the government’s commitment to“implementing the precautionary principlethat, where there are threats of serious or irre-versible damage, lack of full scientific certaintyshall not be used as a reason for postponingcost-effective measures to prevent environ-mental degradation.” In addition, the precau-tionary principle is referenced in theAdministrative Duties section and in section76(1), where assessments or reviews conductedin specific sections of Part V pertaining toexisting substances (Control of Toxics) mustapply the precautionary principle.

There is evidence that the principle isapplied to a considerable extent within theNS Program. Environment Canada andHealth Canada are empowered to makedecisions to impose controls based on“suspicion of toxic” rather than on adetermination of “toxic” as defined insection 64. For a discussion of additional


8


regulatory actions that may be taken uponestablishing a “suspicion of toxicity,” the reader should refer to Section 3.1.3. Acting on a “suspicion of toxic” reflects the reality that fornew substances, the amount of evidence maybe considerably less than that used to assessexisting substances. This is particularly truewith respect to exposure-related information,which, for the majority of new substances, isbased on intended use and location, details ofcontainment and waste processing, knowledgeof existing and similar substances, generic scenarios and conservative assumptions ofexposure. Professionals from both departmentslook for evidence of serious and irreversible damage among all the data reported with thenotification, from in-house data sources,including other similar notifications, from predictive tools and from contacts with colleagues in other jurisdictions, where thismay be warranted. Assessment methodologiestake a conservative approach using predictivescenarios and uncertainty factors and reach a conclusion based on available evidence.

Where the evidence compiled during theassessment is reasonably suggestive of signifi-cant risk, CEPA provides the authority to actdecisively with the notifying company (e.g., prohibition of or conditions on use, processing, handling). Where such action istaken, substances will not be added to theDSL, and, as a consequence, no other companycan import or manufacture the substance with-out complying with the NSN Regulations. In the face of cost-effective controls, notifiershave the option of generating and providingadditional information.

With its adoption at the 1992 Earth Summit inRio de Janeiro, the precautionary principle hasimplications for all toxic substances programs,including new substances programs. A conse-quence of this is a mushrooming dialogue onthe interpretation and application of the principle within the Canadian federal government (within and between depart-ments) and other national governments andinternational organizations. Other stakeholdersare also discussing and documenting theirviews.

Table DeliberationsThe Table acknowledges that the application of this important principle to new substancesmay be impacted by the broader discussionsnoted above.

The Table agrees that Environment Canadaand Health Canada are often successful inapplying the precautionary principle asdescribed above; however, Table membersremain concerned about the predictive capabilities of the current data set for certaintypes of assessments, e.g., when effects occurat very low levels. Endocrine disrupting substances (EDSs) were cited as an exampleand represent effects that are further compli-cated by the absence of adequate testingmethodology for the foreseeable future (discussed in Section 3.1.4).

Table RecommendationsNone.

(iii)Toxic Substances Management Policy(TSMP)The TSMP is a policy of the federal govern-ment that “provides a framework for makingscience-based decisions on the effective mana-gement of toxic substances that are of concernbecause they are or may be used and releasedinto the environment or because Canadiansmay be exposed to them through the environment.”6

The policy has two key management objectivesthat distinguish between Track I substances,which are to be ”virtually eliminated from theenvironment,” and Track II substances, whichare to be managed throughout their entire lifecycles to prevent or minimize their release tothe environment. The applicability of the policy to existing toxic substances is quiteclear, and an implementation strategy has beenmade publicly available on EnvironmentCanada’s web site. The substantive content ofthe TSMP has been incorporated into CEPA,Part 5.


9

Table DeliberationsDiscussion of the Table indicated a need toclarify whether the TSMP applies to new sub-stances where there is a suspicion of toxicityand, if so, how it ought to be applied. The fol-lowing documentation was made available tothe Table: Toxic Substances Management Policy —Environment Canada Implementation Strategy forNew Substances (Draft, April 2001).7

There was general agreement that the TSMPaddressed the management of new substancesat the stage found in section 84 of CEPA (i.e.,Action following Assessment). Decisions takenunder the NS Program were considered sup-portive of the TSMP, since prohibitions consti-tute an equivalent to “virtual elimination” andimposing conditions constitutes an equivalentto “life cycle management.” However, someTable members felt that further clarificationwas necessary about the meaning of virtualelimination and the impact it has on the selec-tion of control actions.

Discussions about the four criteria used in theTSMP to distinguish Track I substances fromTrack II substances confirmed that all new substances meet the criterion for “predomi-nantly anthropogenic.” Also, for the most part,the criteria cut-offs for persistence andbioaccumulation are dictated by the TSMP andthe Regulations and cannot be adjusted for new substances purposes.

The criterion causing the greatest difficulty forinterpretation was “CEPA-toxic or equivalent,”and the Table discussed various aspects of theissue in order to offer clarification. It was notedthat the TSMP is silent on new substances butmakes reference to substances that “may beused or released.” This is inclusive text thatsuggests the TSMP should apply to new substances. CEPA is less clear. The Table notedthat within the “Substances and Activities Newto Canada” portion of the Act, section 84authorizes the Ministers to take action, inclu-ding prohibition, on the basis of a suspicion oftoxic. A prohibition remains in force for up totwo years to enable time to put a Regulation inplace under section 93. On the other hand, to access section 93, an order has to be madeby the Governor in Council adding the substance to the List of Toxic Substances. This triggers a process outside the new sub-stances provisions that is aimed at confirming

the recommendation of the Ministers to contin-ue the prohibition and extend it to all compa-nies. This potentially signifies a distinctionbetween “toxic” and a “suspicion of toxic.”The information-gathering authorities undersections 71 and 72 offer a similar distinction.

Table Recommendation1. Points of clarification should be

summarized and included in the docu-ment Toxic Substances Management Policy— Environment Canada ImplementationStrategy for New Substances (Draft, April 2001). This draft document shouldthen be finalized and made public.

3.1.2 Adequacy of the Risk AssessmentMethodology

The Table addressed whether the assessmentmethodology and process employed byEnvironment Canada and Health Canada areadequate to protect the environment andhuman health.

Currently, Health Canada and EnvironmentCanada use a semiquantitative risk assessmentmethodology that they have developed to esti-mate whether a new substance has the poten-tial to cause harm to human health or the environment. The human health risk assessment of new substances is conducted byHealth Canada. The environmental risk assess-ment is conducted by Environment Canada. As a generalization, the risk assessmentprocess used by both departments attempts topredict the risk based on an examination of theavailable data and information on hazard oreffects and estimates of exposure. Once the riskassessment is completed and a decision ismade to intervene, risk management processesare then used. Quantitative risk assessmentassumes that the risk of harm is a function ofthe hazard (conducted by Health Canada) orthe effects (conducted by EnvironmentCanada) potential of a substance and the esti-mated exposure of humans to the substance orits concentration in various environmentalmedia. Both departments draw on the knowledge of many scientific disciplines, supplemented by professional judgement, in the process of estimating risk.

10


Table DeliberationsTable members discussed several of the aspectsof the current risk assessment methodologiesin an attempt to arrive at some agreementrelating to their adequacy for protectinghuman health and the environment. A primaryfocus of the discussions involved the accuracy/reliability of the information and data used toassess the hazard and the exposure potential ofa new substance. Table members generallyagree that the scientific disciplines that arebrought to bear in characterizing risk are quali-fied by uncertainties due to theoretical andpractical limitations in scientific knowledge,data collection and interpretation, modellingprotocols, and the selection and interpretationof analytical methodologies. Many aspects ofthe risk assessment process require the exerciseof judgement, upon which various segments ofsociety can have equally legitimate but diffe-ring perspectives. Compounding assessmentuncertainties are limitations in scientific under-standing of interactions within and betweenecosystems, levels of human and environmentalexposure to specific chemicals, the potential fortransgenerational impacts, and determiningthe extent and significance of interactionsamong substances that are released into theenvironment. For example, “intended use” and“volume” information is used by the regulatorsto predict the eventual concentrations of a newsubstance in the environment. There is a signi-ficant degree of uncertainty associated withthis information. This is in part due to the factthat a “new substance” has not yet entered intothe Canadian environment in significant quan-tities, thus necessitating that levels in the air,water, food or soil be predicted rather thanmonitored directly.

Currently, this uncertainty is dealt with, inpart, by building “uncertainty factors” into thehazard assessment and conservative assump-tions into the exposure assessment. The Tablediscussed several approaches to reduce thepotential that an inaccurate exposure predic-tion would be of such magnitude as to cause the risk assessment to be erroneous.Discussions focused on “weighting” the infor-mation used in the risk assessment so thatexposure information is given less weight thanthe more “fact-based” information relating tothe hazard/effects assessment. One such alternative approach that was explored was based upon the former Accelerated

Reduction/Elimination of Toxics (ARET)process.8 ARET was established in the early1990s as an approach to the selection of higher-priority substances for industry to reduce oreliminate their use in Canada without firstgoing through a resource-intensive, compre-hensive risk assessment process, as is doneunder CEPA with the Priority Substances List(PSL). In this ARET-based approach, criteriawould be established to prioritize substancesfor reduction/elimination based on their toxici-ty, bioaccumulation/bioconcentration and per-sistence potential. Substances were categorizedbased on a scoring process for six criteria(acute lethality, chronic/subchronic toxicity[non-mammals], chronic/subchronic toxicity[plants], chronic/subchronic toxicity [mam-mals], teratogenicity and carcinogenicity). A highest score on any one toxicity elementwas used as a basis for inclusion in the ARETprocess, independent of other toxicologicalproperties.

The Table members could not come to agree-ment on whether a “weighted” process couldbe used instead of the current semiquantitativerisk assessment process to determine whetheror not a new substance should be controlledprior to first import into or manufacture inCanada. The unresolved Table discussionsrelating to developing a proposed weightingscheme that would meet the needs of all Tablemembers reflect broader philosophical diffe-rences among the Table members concerningthe adequacy of the current risk assessmentmethodologies.

Table members agree that future use and expo-sure data requested in NSNs (see Section 3.1.6)should include information regarding alterna-tive uses possible for the notified substance, aswell as identification of any “old” substance(s)being replaced by the new substance. Thisinformation provides regulators with animproved opportunity to predict both futureuse patterns and potential future chemical usevolumes of the new substance. Based on thisdiscussion, a submission template inspired bythat used by the U.S. EPA, but incorporatingthese additional data elements, has been deve-loped and is being tested by some industry representatives.


11

PAG Position on the Adequacy ofCurrent Risk Assessment MethodologiesPAG representatives oppose the current tech-niques of quantitative risk assessment. In theview of the PAG representatives, most of thescientific disciplines that are brought to bear incharacterizing risk are qualified by substantialuncertainties due to theoretical and practicallimitations in scientific knowledge, data collec-tion and interpretation, modelling protocols,and the selection and interpretation of analyti-cal methodologies. They feel that many aspectsof the risk assessment process require the exer-cise of subjective human value judgement,upon which various segments of society canhave equally legitimate but differing perspec-tives. Compounding these uncertainties aredifficulties in understanding the complex webof interactions within and among ecosystems,in determining levels of human and environ-mental exposure to specific chemicals, and indetermining the significance of, and effectivemanagement options for, interactions amongsubstances that are released into the environ-ment. Formalized risk assessment too oftenskirts complex ethical issues surroundingtransgenerational impacts for certain sub-stances, the inability of many individuals tounderstand and voluntarily assume risks asso-ciated with exposures to certain substances,and the inequitable distribution of risks andbenefits associated with the manufacture anduse of a new substance. Contrary to what isdescribed in Section 3.1.1(ii), the PAG believethat the current risk assessment approach failsto adopt a precautionary principle in caseswhere scientific evidence is inconclusive orincomplete.

PAG representatives proposed, as an alter-native to the current risk assessment process, a “Sunrise” protocol, which is described ingreater detail in Section 3.2.1 and Appendix A.8.One possible application of the Sunrise proto-col could involve a scoring system (similar to that used by ARET) whereby each data element would be “weighted” by a certainnumber of points, the total of which, exceedinga threshold, would trigger regulatory action. In this way, an error in any one (or even a few)piece(s) of data would not be absolutely fatalto the decision-making, and hence the regula-tory, process. The Sunrise protocol utilizes aprecautionary and preventative approach andin so doing reflects the advances made in

scientific understanding of environmental contaminants in a socially responsible manner.PAG representatives do not believe that sections 64 and 84(1) of CEPA’99 preclude theadoption of some version of the proposedweighting scheme, as it meets the requirementsand definition of a formalized, quantitativerisk assessment process.

The Government and Industry Views on the Adequacy of Current RiskAssessment MethodologiesGovernment and industry representatives bothsupport the continuing use of the current pro-cedures utilized in the risk assessment of newsubstances. Government representatives inter-preted that CEPA’99 legally mandates a for-malized, quantitative risk assessment processthat requires an analysis of prescribed informa-tion to assess both the potential hazard/effectsand the exposure to a new substance. Theybelieve that the methodology and premises uti-lized are generally consistent with those uti-lized by similar regulatory agencies in Canadaand abroad. As described in Section 3.1.1, government and industry share the view thatthe precautionary principle is applied in theNS Program based on government’s ability totake action on a suspicion of toxicity prior toobtaining scientific certainty.

Government and industry representatives recognize that scientific uncertainty is a signifi-cant, variable and ongoing reality in the riskassessment process, but prefer to focus onimproving the reliability of the current assess-ment process rather than developing a diffe-rent assessment scheme. Given that quantita-tive risk assessment processes are used bymost jurisdictions around the world to assessrisks associated with new and existing sub-stances, a great deal of coordinated global scientific research is aimed at improving the underlying knowledge base and specificprinciples, policies and practices associatedwith risk assessment as a tool for evaluatingchemical safety. The existing risk assessmentprocess can be improved by developing impro-ved modelling tools, as well as by requestingadditional information to supplement theuse/exposure information currently suppliedfor new substances.

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3.1.3 Mechanism for Requiring AdditionalInformation for the Risk Assessment

Background/ContextIn the new substances scheme laid out inCEPA’99, the normal means for identifying andrequesting information from companies isthrough the NSN Regulations. The prescribeddata requirements of these Regulations areintended to provide the information needed bygovernment scientists to enable them to recom-mend scientifically sound decisions to theirMinisters. Following assessment, CEPA’99 pro-vides regulators with the authority, under sec-tion 84, to take a number of actions followingthe determination of a “suspicion of toxic,”including requests for further information.

As predictable as this approach appears, theTable identified certain purposes for whichit could be inadequate and inefficient. Forexample, PAG and industry representativesexpressed the opinion that government regula-tors should have a clear authority upon whichto base requests for additional data when asuspicion of toxicity arises and the availableinformation is insufficient to adequately charac-terize the risk(s). The PAG members felt thatthis authority was important in the protectionof human health and the environment; forinstance, it would allow government torequest, among other data, (sub)chronic testsnot currently in the Regulations, but for whichscientific justification could be made, sincethey bear on the department’s ability to assessthe long-term effects from a substance.Industry believed that this authority should beused as an alternative to prescribing, in theRegulations’ schedules of information, thosestudies that have applicability to a narrowergroup of substances, thereby avoiding a costly,broad-brush approach being applied to all sub-stances. Government expressed its preferencefor a system whereby a predictable set of data(i.e., including longer-term toxicity) would beobtained through the schedules, waivers couldbe used to “subtract” unnecessary informationon a case-by-case basis and, in addition, regu-lators would have the ability to request addi-tional data on a more select basis.

The Table was unable to identify any provi-sions outside of section 84(1)(c) that grantedgovernment the authority to require additionaldata of the type envisaged by the perspectivesabove. For that reason, the Table focused onthis section and its legal interpretations todetermine whether it represented a means ofaddressing their needs. Sections 84(1) and 84(2)are stated as follows:

84(1)Where the Ministers have assessed anyinformation under section 83 and they sus-pect that a substance is toxic or capable ofbecoming toxic, the Minister may, beforethe expiry of the period for assessing theinformation,

(a) permit any person to manufacture orimport the substance, subject to any conditions the Ministers may specify;

(b) prohibit any person from manufacturing orimporting the substance; or

(c) request any person to provide any additio-nal information or submit the results of anytesting that the Ministers consider neces-sary for the purpose of assessing whetherthe substance is toxic or capable of beco-ming toxic.

84(2)Where the Minister requests additionalinformation or test results under paragraph(1)(c), the person to whom the request isdirected shall not manufacture or importthe substance unless

(a) the person provides the additional informa-tion or submits the test results; and

(b) the period for assessing information under section 83 has expired or a period of90 days after the additional information ortest results were provided has expired,whichever is later.

Since its inception, the NS Program has usedsection 84(1)(c) to request additional testing ononly one occasion, in part due to the fact that,in the face of a decision of “suspicion of toxic”and possible control/prohibition measures,notifiers typically request that the assessmentperiod be paused while they obtain scientificinformation that could influence this outcome.


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Table DeliberationsWhen discussing section 84(1)(c) in the contextof new substances provisions, Table membersagreed that a threshold of “suspicion of toxic”has to be met in order to access this authority.However, it became apparent that there couldbe a range of interpretations about the know-ledge needed to meet this threshold and therole that the requested information should playin decision-making. At one end of the spec-trum, “suspicion of toxic” was viewed as acommon threshold that would need to be metequally in order to access any one of the threeauthorities referenced in sections 84(1)(a),84(1)(b) and 84(1)(c). In other words, the samedegree of “suspicion” would be required inorder to support decisions for each of a condi-tion, prohibition and request for further infor-mation. Accordingly, section 84(1)(c) would beinvoked only where there was already enoughscientific evidence available to warrant thatone or both of the other two measures (condi-tion/prohibition) be taken. Some degree of toxicity would need to have already beenestablished, and the assessment of furtherinformation would be meant to verify thedegree of toxicity and therefore the degree of control that should be imposed.

At the other end of the spectrum, section84(1)(c) was viewed as a mechanism thatwould be used when the available informationwas not considered sufficient to adequatelycharacterize the risk(s) associated with the sub-stance, but the information was sufficient tosuggest that there may be a hazard and thepossibility of exposure could not be ruled out.In these cases, there would be concern regar-ding the substance based on its inherent attri-butes (structure, physicochemical properties,toxicological effects), which, together with thepossibility for exposure, could present a risk.

The application of section 84 being proposedby the Table more closely resembles the latterof these two interpretations, yet emphasizesprecautionary measures to an even greaterdegree. According to this proposal, section 84could be used, for example, to require testsadditional to those found in the Regulations orto require that regulatory tests be conducted atlower-volume triggers. Examples of circums-tances under which these actions may be war-ranted could be the presence of enough data toraise a suspicion of toxicity, but insufficient

information to adequately characterize the sub-stance, or the presence of structural featuresassociated with adverse effects, combined withthe possibility of exposure. It is important tonote that, in keeping with this more liberalcharacterization of suspicion of toxicity in section 84, a substance may no longer be sus-pected to be toxic after the assessment of follow-up data.

It is acknowledged that section 84 was notdesigned for the purpose of routinely requiringinformation in cases where the Regulations donot sufficiently address the evaluators’ generalinterests. Rather, it is a mechanism that needsto be operable when they have a suspicion oftoxicity. In order to better address the Table’sconcerns and provide heightened legal clarity,the recommendation to amend CEPA to incor-porate information-gathering authorities of thetype discussed above is envisaged as the ulti-mate goal. However, recognizing the length oftime required to attain this objective, Tablemembers felt that broadening the interpreta-tion of section 84(1)(c) would provide a work-able alternative.

The Table is interested in ensuring that the pro-posed interpretation of “suspicion of toxicity”is consistently and predictably applied.Although it must allow evaluators the flexibi-lity to selectively decide when additional testsare needed in connection with a suspicion oftoxicity, the criteria upon which these decisionsare based should be consistent and transparent.In other words, the interpretation of section84(1)(c) should not be left to the discretion ofeach individual evaluator. It is not the intent ofthe Table to in any way erode or compromisethe authority that is already exercised by government under section 84. In developingthe new interpretation, government should satisfactorily address possible negative impactsthat could be had upon the integrity of thethreshold for “suspicion of toxic” findings thatwill continue to be used in support of decisionsto impose conditions on or prohibit substances.

The Table emphasizes that the ability ofEnvironment Canada and Health Canada toutilize section 84 in this manner will be crucialto the successful implementation of the mainrecommendations in this report. The develop-ment of a clear government guidance docu-ment that will facilitate this mechanism, therefore, must be given highest priority.

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Table Recommendations2. The next review of CEPA should clarify

the authority for regulators to require additional information when the pres-cribed information suggests a suspicion of toxicity, but is considered insufficient to adequately characterize the risk.

3. In the meantime, Environment Canada and Health Canada should adopt the proposed interpretation of section 84 and should develop a guidance documentthat describes how authorities under section 84 (and/or other mechanisms) canbe accessed and used to obtain additionalinformation (beyond that prescribed in the notification scheme) required to complete the assessment. This guidancedocument should provide criteria for use by evaluators in accessing thesemechanisms. The intent is that these criteria enable health, ecotoxicity hazardsor exposure concerns to be addressed.

3.1.4 Endocrine Disrupting Substances(EDSs)

BackgroundThe endocrine system consists of the ovaries,testes, breasts, pancreas, hypothalamus and thepituitary, adrenal and thyroid glands. Theendocrine organs and glands secrete hormones,such as estrogen, testosterone and thyroxin,that act as chemical messengers of instructionsfor neural development, growth, sexual diffe-rentiation, the development of the immunesystem, sperm production and ovulation andregulate most other components of metabolismand growth. Because distantly related groupslike reptiles, insects, birds, humans and othermammals share some similar endocrine sys-tems, including hormones, receptors and simi-lar biological responses, effects observed in onespecies may convey important informationwith respect to potential impacts on anotherspecies.

Over the past few years, a growing body of scientific evidence has indicated that certaindrugs, pesticides, industrial chemicals and natu-ral compounds can alter the normal function ofendocrine systems. Effects such as eggshellthinning in raptor birds, possibly mediatedthrough disruption of normal endocrine

function, have been observed in wildlifespecies due to exposure to certain organochlo-rine compounds. Data from laboratory experi-ments suggest that many substances may causeadverse biological effects at much lower levelsthan were previously considered to presentminimal risk to the environment and humans.Examples of effects from low-level exposuresinclude adverse effects on development andreproduction of aquatic life resulting fromexposure to tributyltin, feminization of fishexposed to municipal effluents and depressedimmune and thyroid function in fish-eatingbirds. Some epidemiological evidence suggestsa potential for effects in humans from environ-mental exposure.

There is considerable scientific debate as towhether ambient environmental concentrationsof certain substances are sufficiently high toexert adverse effects on the general population.There is disagreement over the occurrence ofadverse effects resulting from low-level expo-sures to purported EDSs that may produceminor changes in hormone levels, receptor levels or both. In particular, scientific inquiryhas been focused on:

• what classes of chemicals may affect theendocrine system;

• how much exposure to these chemicals ittakes to produce adverse effects;

• how humans and wildlife are exposed;

• the combined effects of exposure to multi-ple EDSs; and

• the effects that are actually occurringamong exposed humans and wildlife.

The Table viewed endocrine disruption as animportant facet for assessment and decision-making about new substances because it iden-tifies a chronic endpoint that is more sensitivethan endpoints currently considered in theassessment process. It is recognized thatendocrine disruption is a mechanism, not a sin-gle (toxicological) endpoint, and that attentionshould focus on development and growth during critical life stages rather than on mecha-nisms such as receptor-mediated responses.

At this time, there are no internationallyaccepted, validated screening methods that canbe used consistently to test whether a new sub-stance disrupts the endocrine system.


Although no OECD test methods are specifi-cally designed to detect alterations in normalendocrine function, a substance with signifi-cant hormone-disrupting activity causingadverse effects may be manifested in certainexisting mammalian tests. For example, thecurrent OECD test guideline for the 28-dayrepeated-dose test (OECD Test Guideline 407 9)requires examination of organs associated withendocrine activity. Significant toxicity observedin these tissues may indicate alterations of nor-mal hormone function. However, currentexperimental design is unlikely to detect subtleeffects.

Enhancements to OECD Test Guideline 407,intended to increase the sensitivity of the testto endocrine disrupting activity, are under-going international validation under the OECDTest Guideline Program. Enhancements mayinclude an increase in the number of organ/tissue (e.g., prostate, ovaries, thyroid) weightsmeasured, histopathology on an increasednumber of tissues (e.g., pituitary, ovaries andmammary gland), measurements of thyroidhormones and an examination of sperm morphology.

Currently, there are no ecotoxicity tests in theRegulations that address endocrine disruptingpotential. While there is concern aboutendocrine disrupting potential and the need toflag potential EDSs in assessments, until scien-tific tools are validated and found applicable inregulatory programs, endocrine effects cannotbe directly addressed. Environment Canada isexamining the feasibility of collecting informa-tion on substances suspected of elicitingendocrine disruption effects and how informa-tion on such analogues can be incorporatedinto its regulatory programs. The applicabilityof structure–activity relationships (SARs) oranalogues to identify substances will be inves-tigated as they become available. These toolsare not yet appropriate for application to regu-latory programs for EDSs.

Section 44(4) of CEPA imposes a legal obligation on the Ministers of Health andEnvironment to “conduct research or studiesrelating to hormone disrupting substances,methods relating to their detection, methods todetermine their actual or likely short-term orlong-term effect on the environment andhuman health, and preventative, control and abatement measures to deal with those

substances to protect the environment andhuman health.” To this end, Canada isinvolved in the examination and validation oftest methods currently being conducted by theU.S. EPA and OECD to address endocrine dis-rupting potential. In partnership with HealthCanada, Environment Canada manages theToxic Substances Research Initiative, whichincludes support for research on EDSs. Projectscurrently funded include analyzing EDSs inmunicipal sewage effluents, determining theeffects of pesticides on terrestrial and aquaticwildlife and investigating effects of endocrinedisruption on fish reproduction. In addition,Environment Canada has included research onEDSs in each of the major Regional EcosystemInitiatives and has established a national multi-disciplinary research program in collaborationwith other government agencies, universitiesand industry. Similarly, multidisciplinaryresearch into endocrine disrupting potential inHealth Canada cuts across many branches ofgovernment. Staff of the NS Program activelykeeps abreast of current research activities andis involved in the development of someresearch projects.

Environment Canada and Health Canada regu-lators are of the view that the scientific screensand tests proposed for assessing endocrine dis-rupting potential are not yet ready for legallymandated, routine use in regulatory programs.Substantial test development has been con-ducted; however, validation of appropriatetests continues. Many of the tests proposed forthe screening program have been used inresearch, but have never been formally stan-dardized or validated through interlaboratorycomparisons for the purposes of screening forendocrine disrupting potential. Standardi-zation and validation are necessary to establishthe relevance, reliability and reproducibility ofmethods.

In February 2000, the Canadian NaturalResource Departments Endocrine DisruptingSubstances (5-NR EDS) Working Group hosteda multistakeholder workshop to address theemerging issues associated with the scientificassessment of EDSs in the Canadian environ-ment. The workshop identified knowledgegaps and research needs that are specific tomeeting the needs of scientists and regulators.10

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The development of screening and testmethodology is recognized as an importantresearch and policy area both within Canadaand internationally. Substantial efforts are cur-rently under way in other countries to developand validate screening and testing methods forEDSs. For example:

• The U.S. EPA held a meeting in June 2000 toidentify and set priorities for evaluatingchemicals. Substances will be categorizedbased on such information as environmen-tal release, receptor binding or the frequen-cy with which a chemical is found in envi-ronmental media. In 2002, the U.S. EPAanticipates having mammalian tests vali-dated and internationally accepted, withecotoxicity tests following in 2005.

• The OECD, in which Canada is an activepartner, has also initiated a program to har-monize testing and screening of EDSs. TheOECD Task Force on Endocrine DisrupterTesting and Assessment (EDTA), whichincludes scientists from Health Canada andEnvironment Canada, is currently review-ing three screening tests for mammalianeffects. These are the Hershberger Assay,the Uterotrophic Assay and the Repeated-Dose Oral Toxicity Test. A committee is alsobeing created to address ecotoxicity tests.

The following table is an excerpt from theOECD Draft Workplan 2000–2001 and givestarget dates for completion of developmentand validation of specific tests.

• In March 2000, a meeting of the OECDExpert Consultation on endocrine disruptertesting in fish took place in Tokyo. Withrespect to the assessment of endocrine dis-rupters in wildlife, the Task Force reviewedcurrently available screening and testingmethods for non-mammalian species andidentified areas for further research. It wasgenerally recognized that the developmentof methods for the detection of endocrinedisrupting effects on wildlife is in the preli-minary stages (i.e., defining endpoints and test approaches) and that additionalresearch into non-mammalian endocrino-logy is needed to assist in selecting themost appropriate endpoints for endocrinedisruption in fish and other taxa.

Once valid test methods have been identified,it is likely that further research will need to beconducted to determine critical life stages oforganisms.

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Development and Validation of the Hershberger Assay

Fish-Screening Test

Development and Validation of Methods in Amphibians

Development and Validation of the Uterotrophic Assay

OECD Test Guideline 407

March 1998

1998

Late 2000

March 1998

Under validation

2003

2004–2005

2003–2004

2002

Not yet determined

Project Title Start Date Expected Date of Submission to WNT* for Approval

* National Coordinators for OECD Test Guidelines Program.

Table 3.0: Target Dates for Completion of Development and Validation of Specific Tests(Excerpt from the OECD Draft Workplan 2000 - 2001)


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Table DeliberationsThe essence of the Table deliberations revolvedaround the extent to which screens and testsfor assessing the endocrine disrupting poten-tial of a new substance could be included inthe NSN Regulations and NS Program and, ifso, whether or not those current screens andtests should be regulatory requirements.

Table members agree and recommend that assoon as internationally accepted, validatedscreening and testing protocols become avai-lable, they should be incorporated into the NS Program by the most appropriate means(Regulations or Guidelines). The tests have tobe suitable for a new substances regulatorysystem. Given the international cooperation onthe development of the science in this area,these tests should be agreed to internationallyas required for testing new substances (e.g.,OECD). Under the present regulations, noti-fiers submitting substances identified as having endocrine disruptive potential can be requested to conduct additional testingdeemed appropriate in alleviating any concerns, on a case-by-case basis.

The difficulty for the Table involved the extent to which the revised NSN Regulationsand/or NS Program should deal with EDSsuntil validated screening methodologies havebeen accepted. Options the Table discussedincluded:

• screening new substances for endocrine dis-ruptive potential through the application ofthe U.S. EPA Tier 1 and Tier 2 models;

• waiting until tests have been validated andinternationally accepted (e.g., OECD). Suchtests should be appropriate for use in a newsubstances context, including reasonablecost and time frame for completion. Therationale for this option is that if the testsare not validated, the results cannot be usedby regulators in a reliable and predictablemanner. It is inappropriate to conductunvalidated studies for “routine” regula-tory purposes. Moreover, there is the viewthat in vitro receptor-binding assays andSAR models currently under discussion inthe scientific community to delineateendocrine-active effects are insufficient todetermine adverse effects necessary for riskassessment; and

• not requiring testing for endocrine disrupt-ing potential in the NSN Regulations butinforming notifiers through the Guidelinesthat for notifications of certain classes ofsubstance where there is reason to look forendocrine disrupting potential, notifiersmay be asked to provide additional testdata.

All Table members recognize that the viewsarticulated above are legitimate and worthy ofconsideration by the regulators. However,members also recognize that the opposingviews do not assist the regulators in movingthis complex and sensitive issue forward.Therefore, in the spirit of the Table’s man-date to develop consensus recommendationswherever possible, and following a great dealof debate, the Table agrees to and recommendsthe following process for dealing with screen-ing and testing protocols to assess new sub-stances for endocrine disrupting potential.

Table Recommendations4. Environment Canada and Health Canada

must continue to work diligently withstakeholders nationally and internationallyto develop internationally accepted, validated screening and testing protocolsto assess new substances for endocrinedisruption potential.

5. As internationally accepted, validatedscreening and testing protocols becomeavailable that are suitable for a new substances regulatory system, they shouldbe incorporated into the NS Program bythe most appropriate means (Regulationsor Guidelines). It is noted that the initialavailability of the current projected schedule of validated tests (2002–2005) isconsistent with the timing for promulgatingamendments to the NSN Regulations.

6. The NSN Guidelines Document11 will be revised, subsequent to these consulta-tions, to include a section dealing withendocrine disruption. In particular, thesection will describe Environment Canadaand Health Canada’s approach to incorporating endocrine disrupting considerations in the course of conductingan assessment and proposed risk management outcomes. This will include

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development of a database of substancesthat have shown evidence of endocrinedisrupting effects. This database, alongwith other available information, will beused by evaluators to identify whethersubstances under review are structurallyrelated to substances shown to haveendocrine disrupting activity. Dependingupon the severity of the effect and thecloseness of the analogue fit, this analogueinformation may form the basis for a suspicion of toxicity. The guidelines willalso indicate that as applicable validatedSARs become accessible, they will be usedappropriately in the assessment process.Furthermore, where this informationleads to a suspicion of toxicity, appropri-ate control measures will be imposed, orrequests for further test data under sec-tion 84(1)(c) of CEPA will be made as vali-dated test procedures are determined.Lastly, the section on endocrine disrup-tion will inform stakeholders of the intent to amend the NS Program(Regulations or Guidelines) to include data requirements for determiningendocrine disrupting potential as they become available.

3.1.5 Occupational Exposure

The Table addressed the question of whetherthe scope of the human health assessmentshould be expanded within the limits of theNSN Regulations to address worker healthand, if not, whether the NS Program can domore to promote worker safety.

Under the NSN Regulations, the notifier mustsubmit all available information, includingexposure and hazard information, when thisinformation is available. This includes informa-tion on adverse effects (i.e., hazards), or possi-ble adverse effects, in persons exposed to thesubstance in the workplace. Health Canadauses this information as part of the risk assess-ment, but this risk assessment is done for thegeneral population and is not specific to theworkplace setting. Risk in the occupationalenvironment would not trigger action underCEPA, since Health Canada does not have theauthority under this Act to specify workplacecontrols.

Information on occupational hazards receivedby Health Canada under the NS Program isnot automatically shared at this time, althoughattempts to establish mechanisms haveoccurred in the past. No mechanism tofacilitate the transfer of this information isemployed, even between federal departments.

There are jurisdictional concerns that havebeen voiced regarding the lack of appropriatecoordination of federal/provincial/territorialefforts germane to this process. The manage-ment of hazardous substances is the jurisdic-tional responsibility of other authorities inmany cases.

Table DeliberationsSeveral issues were identified that point toopportunities to improve the way in whichoccupational exposure information is managedwithin Health Canada and the way in whichthese data are transferred between depart-ments or other agencies. The current processshould be more proactive in ensuring thatoccupational health information is actively pro-vided to those agencies that may need to act inorder to ensure adequate protection of workerhealth.

Table Recommendations7. If Health Canada has information on a

hazard pertaining to a notified substance,there is an obligation for Health Canadato share that information with theCanadian agency or agencies that havejurisdictional authority over the work-place. A protocol or process must be identified or developed to share informa-tion. The notifier should also be informed.This is consistent with the overriding obligation of due diligence. HealthCanada must identify who should receivethe information at the time Health Canadaidentifies the hazard and the specificinformation.

8. If Health Canada has information on ahazard pertaining to a notified substancethat is not known by the notifier of thesubstance, there is an obligation forHealth Canada to share that informationwith the notifier.

9. The sharing of information with the notifierand/or another Canadian agency or


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agencies that have jurisdictional authorityshould occur at the time that HealthCanada identifies the hazard.

10. The Guidelines should be revised to specifythe information “which the notifier has intheir possession or might reasonably haveaccess to” that will be required of thenotifier (when submitting their notifica-tion) with respect to any occupationalhazards associated with the notified substance. There is a recognition that fortruly new substances, this data set willnot normally be available or easilyaccessed.

11. Health Canada must work closely withappropriate federal authorities (e.g.,Human Resources and DevelopmentCanada and Labour Canada) that regulatefederal workplaces based on hazard infor-mation and proposed use patterns providedby the notifier. CEPA seems to allow forthis. (Interdepartmental cooperation isrequired as per section 2 of CEPA.)

12. Health Canada and Environment Canadamust work with appropriate federal andprovincial/territorial authorities to ensurethat the data received by the NS Programare used to conduct occupational risk assessments.

13. Health Canada should facilitate a multi-stakeholder consultation in relation tonew substances in the occupational envi-ronment. Among other things, this con-sultation should identify ways in which:

• new substances notified under the NSNRegulations will be assessed for risksassociated with the occupational environment; and

• a process for the identification of pre-ventative and control measures can beimplemented by the responsible agencies.

3.1.6 Data Requirements

(i) Suite of Data Requirements forChemicals and Polymers

Background The NSN Regulations contain prescribed information elements for new chemical and

polymeric substances submitted to the NSProgram. Part of the mandate of the Table was to review the existing regulatory informa-tion elements and propose changes that willoptimize the use of scientific information in therisk assessment carried out on substances newto Canada while maintaining or improvingprotection of the environment and humanhealth.

To facilitate this discussion, the Table used theconcept of a data “toolbox” to describe theentire suite of tests used to determine the iden-tity, physical/chemical and toxicological dataelements that are normally used in conductingrisk assessments. To the extent possible, teststhat are recommended for inclusion in theNSN Regulations should follow internationallyaccepted test protocols (e.g., OECD, AmericanSociety of Testing and Materials [ASTM]) andthe Principles of GLP (see Section 3.1.6(iv)).Some tests described in the Guidelines to theNSN Regulations may not have internationallyaccepted protocols; therefore, acceptable proto-cols will need to be outlined in the Guidelines.

The Guidelines to the NSN Regulations will beused to describe test requirements in the “tool-box” that are not required in the Regulations,but may be requested by the Minister undercertain circumstances. The Guidelines also provide guidance on when a notifier may wantto submit a test or the circumstances underwhich an evaluator is likely to request a test. It became clear to Table members that theGuidelines play a critical role in enabling eva-luators to request information that they feel isneeded to make a thorough risk assessment,without requiring this information to be sub-mitted in every circumstance.

Although the items in the “toolbox” areintended to cover the information needed toassess the vast majority of substances, the pro-gram would not be limited to these data, asCEPA allows the Ministers to request any addi-tional data they consider necessary for asses-sing the substance following the finding of a“suspicion of toxic” (refer to sections 84(1)(c)and 84(2) of CEPA).

The information contained in the “toolbox”includes data relevant to assessing

• identity;

• environmental fate;

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• persistence;

• bioaccumulation;

• intrinsic toxicity; and

• exposure.

The exposure assessment of a substanceincludes the evaluation of the overall environ-mental persistence of a substance and itsdegradation products. In the context of the NSProgram, biodegradation and hydrolysis arekey elements in determining the residence timeof a substance in various environmental media(air, water, soil and sediment). However,depending upon the circumstances, otherdegradation/disposal processes may be con-sidered, such as photodegradation, thermolysisand incineration.

The biodegradation/hydrolysis half-lives of asubstance are evaluated using experimental,surrogate or predicted data. Substances withshorter half-lives and not released on a conti-nuous basis may not reside in a medium for asufficient period of time to allow for chronicexposure of organisms. However, biotic andhydrolytic degradation products are consi-dered on an equal basis with the parent com-pound during the assessment, in order todetermine the long-term potential toxicity ofthe breakdown products, as well as the poten-tial toxicity of the parent compound. In gene-ral, these breakdown products tend to be lesstoxic, more water-soluble and, hence, morebioavailable to organisms; however, in somecircumstances, degradation products possessgreater toxicity than the parent compound.

In cases where data (ultraviolet/visible absorp-tion spectrum) or the presence of certain func-tional groups (e.g., polycyclic aromatic hydro-carbons, nitroaromatics, aromatic amines, azo)suggests that photodegradation is occurring,the potential physical/chemical properties andecotoxicity of the degradation product(s) willbe examined further. In addition, dependingon the type of substance (e.g., ethers, halo-genated aromatics), volatilization during inci-neration may occur. Incinerators are subject toprovincial/territorial regulations and have tofollow regulatory requirements, including recommended emission limits (e.g., for dioxins)to ensure protection of public health and theenvironment. However, where a new substanceis anticipated to form degradation productsthat are likely to lead to impacts not mitigatedby emission standards, then the NS Programwill respond with requests for additional

information and/or impose restrictions.Additional information on the assessment ofdegradation products is available in Appendix A.7.

The current data requirements for polymersuse OECD test methods applicable to discretechemicals. The OECD test guidelines for thesedata elements may not be applicable to poly-meric substances. Experience has shown thatconcepts such as water solubility andoctanol/water partition coefficients (Kow) asrelated to polymers are not always meaningfulin the context of performing an environmentaland human health risk assessment.

A technical subgroup investigated the issues of polymer behaviour in water and lipids. The group was asked to recommend methodsthat would generate more meaningful informa-tion for notifiers and evaluators.

Table DeliberationsThe Table discussed each individual informa-tion element in the context of why the data areneeded, how the data would be used during anassessment and when it would be relevant toprovide the data. The detailed technical infor-mation on the individual data elementsreferred to in the “toolbox” will be found in thedocument Information Elements for Chemicalsand Polymers Submitted to the NSN Program.This document will include a description ofeach information element, whether it is in thecurrent regulations or on the OECD MinimumPre-Market Data Set (MPD),12 and whether it isproposed for regulations or guidelines. It willalso contain background information on howthe data are used and a rationale for proposedchanges. This document will be located on theNS Program web site: www.ec.gc.ca/substances.

The Table agreed that applying all informationelements to all chemical and polymeric sub-stances cannot be justified scientifically. Someinformation elements pertain to only a smallsubset of the substances. In other cases, theneed for more information is based on theresults of data from another test or the resultsof an evaluation of its environmental partitioning.

The Table recognized the important role of theNSN Guidelines. The ability of the NSN eva-luators to request additional information whenthey do not have sufficient information todetermine risk is vital to ensuring that neces-sary tests are done when they are warranted.


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The Table discussed the application of section84(1)(c) of CEPA to enable evaluators torequest additional information (see Section 3.1.3).

Table Recommendations14. Only the information elements that have

wide applicability in assessing substancesand have internationally accepted test protocols should be included in theRegulations.

15. Revised Guidelines should address addi-tional data elements, stating the need forthese data and articulating the “profile”of substances where this information may take on significance. It is intended thatthis would alert notifiers to the potentialneed for generating these data. Notifierswould be encouraged to contact theProgram for a pre-notification consultationwhere these issues could be discussed. If the Program believes that these data are necessary for the assessment and the data are not forthcoming from the notifier, provision of the data could be required under sections 84(1)(c) and84(2) of CEPA.

16. The NSN Guidelines should be refer-enced in the NSN Regulations. Therevised Guidelines will be developed bygovernment and industry representatives.All stakeholders should be given theopportunity to comment on the revisedGuidelines.

17. The NSN Regulations should contain the information in Table 3.1 for chemicalsand polymers.

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Table 3.1: Recommended Regulatory List of Data Elements for Chemicals and PolymersChemicals Polymers

chemical name chemical name

trade names trade names

Chemical Abstracts Service (CAS) # CAS #

molecular formula molecular formula

structural formula structural formula

reaction schemea

gram molecular weight number average molecular weight (Mn) and % below 500 and 1000 daltons

degree of purity

impurities polymer composition and additives

additives/stabilizers

spectrum

Material Safety Data Sheet (MSDS) MSDS

melting point (-25°C – 300°C) physical state of the polymer

boiling point (-50°C – 300°C)

density

vapour pressure

is the polymer formulated for dispersal in water?

water solubility water availabilityb

octanol/water partition coefficientc octanol/water partition coefficient

adsorption/desorptiond

hydrolysis as a function of pHd hydrolysis as a function of pHe

ready biodegradation ready biodegradationf,g

acute fish toxicity acute fish or daphnid toxicityf

acute daphnid toxicity

acute algal toxicity acute algal toxicityf

acute mammalian toxicity study acute mammalian oral toxicity studyh

2nd acute mammalian toxicity studyi

sufficient information to assess skin irritation sufficient information to assess skin irritationh

skin sensitization study skin sensitization studyh

one in vitro gene mutation study one in vitro gene mutation studyh

in vitro chromosomal aberration study in vitro chromosomal aberration studyh

in vivo mutagenicity or micronucleus assay in vivo mutagenicity or micronucleus assayh

28-day repeated-dose mammalian 28-day repeated-dose mammaliantoxicity study toxicity studyh

manufacture, use, disposal and exposure manufacture, use, disposal and exposureinformation information

all other information and test data on hazard all other information and test data on hazard and exposure and exposure

identification of other agencies notified identification of other agencies notified and risk management actions taken and risk management actions taken


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Note: Regulatory Exemption Criteriaa Required for polymers of low concern

(PLCs), except current Schedule X polymers.

b Amount of polymer available in solution(dissolved, dispersed, or as an emulsion).At pH 7 for anionic and neutral polymers,at pH 2 and 7 for cationic polymers and atpH 2, 7 and 9 for amphoteric polymers.

c Required only for chemicals having watersolubility of less than or equal to 5 g/L.

d Required only for chemicals having watersolubility of greater than or equal to 200 µg/L.

e Testing will be required at the pH wherewater availability was determined to begreater than 2%.

f Not required for polymers that have wateravailability at pH 7 less than or equal to 2%.

g Not required for branched silicone andsiloxane polymers.

h Not required for polymers described inTable 3.3 (see Section 3.2 below).

i Not required for substances that boil below0ºC and that have been tested for acuteinhalation toxicity.

Table Recommendations18. The data elements described in Table 3.2

should be included in the revisedGuidelines. Notifiers will be advised thatdata from these tests are suggested in certain circumstances and may be requested to address evaluators’ concernsabout “suspicion of toxic.”

Table 3.2: Examples of Data Elementsto be included in the NSN Guidelines

Data Element

global warming potential (GWP)

ozone depleting potential (ODP)

mitigation of toxicity to algae

mitigation of toxicity to fish by humic acid

suite of benthic tests

chronic aquatic toxicity tests

bioconcentration/bioaccumulationfactor

particle size

other mammalian toxicity tests (including chronic tests)

tests to determine endocrine disruption potential

available information on occupational exposure and hazards

Table Recommendations19. The revised Guidelines document should

contain text that addresses the need forthis information and how it will be usedin an assessment. The Guidelines shoulddescribe the categories or profiles of substances that may be covered by addi-tional tests in order to assist notifiers inidentifying specific issues with a new substance and to allow notifiers to contact Environment Canada in advance of the notification.

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(ii) Class Considerations

BackgroundAs a result of the Program’s experience inassessing new substances, a body of know-ledge now exists on a number of classes of sub-stances that can be applied to newly notifiedsubstances. The revised Guidelines will beused to identify those classes of substances thatwill usually require specific additional testinformation and those classes where prescribedtest information is not needed and waiverrequests will be granted. An example of a class of the latter is acid dyes, which arealready well characterized and understood.Environment Canada and Health Canada have determined that generating certainphysical/chemical (e.g., octanol/water partitioncoefficient, ready biodegradation, dissociationconstant) data for highly water-soluble aciddyes will not provide additional insight intothe substances’ behaviour in the environment.Furthermore, some acid dyes have been shownto be of low concern in the aquatic environ-ment; therefore, these would be eligible forwaiver requests for all ecotoxicity tests and theacute oral/dermal toxicity test.

An example of a class of substances whereadditional information will likely be requestedis those substances with a chemical structureindicating that the substance may have thepotential to damage stratospheric ozone.Notifiers will be required to submit additionalinformation on ozone depleting potential.Possible tests that may be asked for certainclasses of substances are listed in Table 3.2.

Table Recommendations 20. The revised Guidelines should identify

classes of substances where test require-ments will be waived upon request andalso the classes where additional testinformation is recommended.

21. The revised Guidelines document shouldcontain information to be used by notifiers to promote the use of waivers for specific data elements for certain classes of substances. This informationshould be developed in conjunction with the revised Guidelines.

(iii)Good Laboratory Practice

BackgroundGLP principles are intended to promote thequality and validity of test data and to esta-blish a basis for mutual acceptance of data(MAD). They cover the organizational proces-ses and conditions under which studies areplanned, performed, monitored, recorded andreported. The OECD has developed a series ofdecisions and guidelines relating to GLP.13

Canada, as a member of the OECD, has made acommitment that test data submitted underfederal regulations should comply with GLP.

The OECD Council Decision states that datagenerated in a Member country in accordancewith OECD Test Guidelines and Principles ofGLP shall be accepted in other Member coun-tries for assessment purposes. This is the cor-nerstone of the OECD work on MAD. Should a company choose not to conduct physical orchemical tests in compliance with GLP, thedata would not be covered by the OECD deci-sion on MAD. This implies that the companyrecognizes that data generated without GLPmay not be accepted by other OECD countriesand that it understands the potential need torepeat these tests for other jurisdictions.

Although the primary intent of the OECDPrinciples of GLP was to define the way inwhich toxicity studies are undertaken and documented, the principles are not specific toany particular type of test or testing discipline.The OECD has recently made a distinction forshort-term studies and has set out guidance tothis effect. The guidance leaves it to regulatorybodies in Member countries to specify whichtests should be conducted in accordance withGLP. All other studies must comply.

Environment Canada participates in accredi-tation programs such as those of the CanadianStandards Council (CSC)/CanadianAssociation of Environmental AnalyticalLaboratories (CAEAL) and the Ministère del’Environnement du Québec. Accreditationprovides for national and international reco-gnition of laboratory results. Accreditation is asystematic approach that ensures minimum,agreed-to quality standards, but the client canrequire more stringent standards, such as GLP.An increasing number of Canadian labora-tories are seeking accreditation.


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The current NSN Regulations (section 31(2))require that “The laboratory practices to be fol-lowed in developing test data…shall be consis-tent with the practices set out in the ‘Principlesof Good Laboratory Practice’…of the OECDGuidelines for Testing of Chemicals.”

The recommended provisions allow Canada tocomply with OECD Council Decisions on GLP,without putting Canadian notifiers at a disad-vantage.

Table DeliberationsMost toxicological tests are performed by inde-pendent laboratories capable of performingGLP-compliant studies, whereas many tests forphysical or chemical properties are done in-house by the notifier, whose laboratories arenot necessarily set up for GLP-compliant stu-dies. The Table considered requiring full GLPcompliance for all studies, including physicalor chemical properties. A significant deterrentto this was the realization that data previouslygenerated by industry would no longer meetregulatory standards and would need to beregenerated in a facility capable of performingGLP studies.

Industry representatives recognize that the use of GLP approaches for many toxicologicaland environmental fate studies is a long-established practice to assure regulators thatstudies reported are valid and can be ade-quately audited for validity. Industry, however,feels that the use of GLP approaches for physi-cal or chemical tests is “an unnecessary andonerous imposition” in terms of administrationand certification.

The PAG representatives are not averse to the suggestion that GLP is not necessary forphysical or chemical tests so long as enoughinformation is provided to EnvironmentCanada and Health Canada to determine thatthe data on physical or chemical properties arereliable and established in a predictable andtransparent manner.

The government representatives recognize thevalue in having tests for physical and chemicalproperties conducted by laboratories that aremost familiar with, and capable of analyzing, a given substance. Table members agree thatthis will provide the most reliable and accuratedata on the substance’s physical and chemicalproperties.

Table Recommendations22. Toxicological and biodegradation studies

required by the Regulations must complywith the compliance monitoring require-ments of OECD principles or the GLPregulations of the OECD Member countryin which the testing was originally performed. These studies include acuteand repeated-dose mammalian toxicity,genotoxicity, skin irritation, skin sensitiza-tion, ecotoxicity and ready biodegradation.

23. Tests for, and reporting of, physical orchemical properties must either complywith compliance monitoring requirementsof OECD GLP for short-term tests of thecountry in which the testing was performedor provide enough information to evaluatethe reliability and adequacy of data (seeAppendix A.6). Full reports for non-GLPtests will be required in order to assessthe quality of these studies and theirresults.

24. If the laboratory that is generating datasubmitted to the Program is accredited,the status of that accreditation must bestated and identified.

(iv) Toxicity Testing Using Animals

BackgroundA number of regulatory agencies have alreadyrecognized the necessity of considering the ethical issues surrounding animal testing,including the European Union (EU) and the Member countries of the OECD.

The Commission and Member States of the EUencourage research aimed at developing andtesting other techniques able to provide thesame level of information as that obtained byexperiments carried out on animals, but thatuse fewer animals or less painful procedures.

Concerning the use of animals in regulatorytoxicity tests, the OECD endorses the princi-ples of the three Rs, as defined by Russell andBurch,14 which include “replacement” of cons-cious living higher animals by insentient mate-rial; “reduction” of animals used to obtaininformation of given amount and precision;and “refinement” or decrease in the incidenceor severity of inhumane procedures to thoseanimals that still have to be used. Three test

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methods (OECD Test Guidelines 420, 423 and42515) have been recently adopted by the OECDto replace the traditional acute oral toxicity test(OECD Test Guideline 40116), as these new testsrequire fewer animals. OECD Test Guidelines429,17 423 and 425 are currently being revised toachieve further reduction in the numbers ofanimals while improving their performancecharacteristics. The OECD emphasizes theimportance of collecting as much informationas possible about the substance to be testedprior to designing the toxicity study, in orderto meet the intended objectives of testing usinganimals, while minimizing pain, distress andsuffering.18

The NS Program supports the principles of thethree Rs, as indicated in the current Guidelinesfor the Notification and Testing of New Substances:Chemicals and Polymers (p. 52), which states that“the government supports the use of testingmethods that reduce the number of animalsused and that minimize animal suffering,when the quality of data generated is notaffected. Consequently, the use of limit testsand validated in vitro test methods, whereappropriate, is encouraged.”

Table Recommendations25. Government should encourage the

development of alternative testing techniques able to provide the same utility of information as that provided by experiments carried out on animals,but that use fewer or no animals or less painful procedures. These should be developed through international (e.g., OECD) scientific cooperation, andadequate resources should be allocated to support these efforts.

26. Alternative methods, once validated,should be available for use for the assessment of new substances under the NSN Regulations. It is proposed that wording to this effect be added to the revised Guidelines.

27. When data developed using alternativemethods are submitted for the purposesof notification, the onus will be on thenotifier to demonstrate the same utility ofinformation. Pre-notification consultationsare encouraged in such situations. In addition, the government commits to setting service standards to respond tothis type of request.

(v) Exposure Template

BackgroundIn conducting a risk assessment, the full lifecycle of a new substance is examined, captu-ring environmental releases “from cradle tograve.” Exposure from the intended use pat-tern supplied by the notifier and other poten-tial uses is assessed.

The current Regulations address informationelements germane to assessing exposure.However, these tend to be general in nature,resulting in a wide range of reporting, inclu-ding many brief “one line” responses. Thisinformation has been identified as one of themain areas where evaluators find it necessaryto go back to notifiers seeking additional infor-mation or clarification in order to complete therisk assessment.

The need for increased detail and standardiza-tion of release information for chemicals andpolymers new to Canada has led to a review ofthe information needed. It has resulted in theconsolidation of this information in a template,facilitating its use by notifiers and evaluators.

A draft of this template is currently undergo-ing testing by industry and government. Theresults of this testing will be used to refine theinformation requested and improve the utilityof the template.

Table Recommendations28. The template for providing exposure

information should be developed in aseparate process from this consultation.

29. The obligatory exposure informationrequired by the Regulations should be incorporated into a template.

30. A reduced list of exposure data and information should be required for PLCsand entry level chemicals.


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3.1.7 Evaluation and Validation of DataQuality in the NS Program

Background and Context A number of methods are used in the NSProgram to examine and validate data quality,including comparison of notified results withsurrogate and modelled data, application ofGLP in the laboratories conducting the testsand scrutiny by experienced evaluators. Thepossible deterrent effects of penalties for sub-mission of false or misleading information(section 273 of CEPA) and product liability areother potential factors for consideration in thisissue.

The Table identified three main questions rela-ting to the quality and validity/credibility ofdata submitted as part of an NSN:

• Is the current NSN process dealing adequately with data quality andvalidity/credibility?

• What are the appropriate tools to validatedata quality?

• How should GLP be addressed in theProgram?

In addressing these issues, the Table lookedclosely at the following factors that influencethe quality and validity/credibility of datasubmitted to the regulators:

• scrutiny by NS Program evaluators;

• verification of testing; and

• GLP (addressed in Section 3.1.6).

(i) Scrutiny by NS Program EvaluatorsFor study reports, evaluators scrutinize, amongother things, the provided information todetermine whether:

• the methodology is consistent with stan-dard procedures (e.g., under OECD, ASTM,U.S. EPA Toxic Substances Control Act[TSCA] Protocols);

• the study is conducted in an adequate manner;

• the method is appropriate for the test material;

• there is an adequate level of reportingdetails; and

• the results are consistent within the study,between studies and with what is knownabout the class of substance.

When surrogate data (test results from a simi-lar substance) are provided in a notification,evaluators scrutinize the rationale prepared bythe notifier regarding the suitability of the sur-rogate substance and review the studyreport(s) as above. Professional judgement ofthe evaluator is used in determining theacceptability of the surrogate. Data on similarsubstances and modelled values can be usefulin extrapolating data for the notified substance.

For QSAR estimates, evaluators assess the ade-quacy of the method and whether the estimatefor that substance or class is considered reli-able. Where possible, cross-validation (use ofdifferent methods) is carried out. For informa-tion on use(s), releases and potential exposure,the evaluator checks provided informationagainst what is known for that type of sub-stance (standard use/release scenarios, othernotifications on same/similar substance).

In cases where the data are judged to be inade-quate, the evaluator will first consult withinand outside the Program, as appropriate, toconfirm or alleviate concerns. If the data arestill considered to be inadequate, the evaluatorwill contact the notifier to resolve the situation.When data are judged to be erroneous, notmeaningful or not of sufficient quality to satis-fy the evaluator, the notification is consideredincomplete, and the assessment does not con-tinue until the problems with the data areresolved.

All assessment reports are reviewed andapproved internally by managers in the respec-tive departments. At Environment Canada, forinternal quality assurance purposes, officials ofthe National Water Research Institute (NWRI)have reviewed some assessments. It has beenproposed that a biennial review by NWRI ofselected assessments be conducted beginningspring 2002.

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Table DeliberationsConfidence was expressed in the work done byevaluators in the NS Program at EnvironmentCanada and Health Canada to assess the quali-ty and validity of information.

It was noted that as the field of modelling datafor assessment purposes develops better me-thods, evaluators will have more opportunitiesand tools to identify uncertain or equivocaldata than is currently the situation and to justi-fy further action by the notifier. This wouldrequire the acquisition or development of databases of information and predictivetools/software.

Table Recommendations31. Environment Canada should continue

its periodic review, and Health Canadashould initiate a practice of periodicreview of its assessment reports bygroup(s) outside the NS Program. The methodology and results of these reviews should be made public.

(ii) Government Verification of Test Results Replicate testing by government (either in its own laboratories or through contract laboratories that are suitably qualified; seeSection 3.1.6(iv)) of some of the data providedin notifications was suggested as a supplementto existing efforts to verify the validity of dataused in decision-making.

Table DeliberationsSome members of the Table drew attention tothe possibility that bias can creep into test datawhen the tests are conducted by or for a noti-fying company. In extreme cases, intentional misrepresentation of data, as typified by theIndustrial Bio-Test scandal in the United Statesin the early 1980s, is also possible. These mem-bers encouraged discussion of other measuresthat may be warranted to achieve the goal of ensuring use of the most credible data indecision-making under the NSN Regulations.Government-funded repetition of some testswas identified as one such means that has beenused successfully in food safety and other pro-grams to spot-check the accuracy of data beingsubmitted to governments. Implementing avalidation testing component to the NSProgram was viewed by these Table members

as a critical component for increasing publicconfidence in Program decisions.

The Table discussed many aspects of this pro-posal, ranging from the strategy for selectingrandom samples to the costs of implementingsuch a program and the means for paying forthese additional tests. It was clear from the dis-cussion that there was a diversity of viewsabout how such a program could be imple-mented and about the role that it would playalongside other measures already being imple-mented or proposed in relation to validationand public confidence. The absence of specificfacts, expertise and analysis (e.g., options,costs) impeded resolution of the issue withinthe time frame of this consultation.


should undertake a feasibility study thatdescribes the key elements of an efficientand effective government-funded verifica-tion testing program, options and costsfor implementation and an evaluation ofthe benefits it would bring to the othermeasures undertaken by the Program toaddress data validity. The results of thisstudy should be made public beforedeciding whether to include this type of testing within the NS Program.

3.2 The Regulatory Framework

3.2.1 General Discussions andRecommendations

Background/ContextThere is general consensus among the govern-ment, industry and PAG representatives thatthere is a need to reduce the complexity of theRegulations and improve the administrativeefficiency of the Program. This simplificationshould aim at improving efficiencies and easecompliance without compromising the protec-tion of human health and the environment.

The Table identified three major issues for discussion:

• whether there is an alternative approach to using volume-triggered tiered schedules;


• whether a tiered approach can be simplified,made more responsive and made easier to understand and implement; and

• whether the NDSL continues to play a roleand, if so, what the test requirementsshould be.

(i) Alternative Approach to a Tiered SystemA fundamental discussion for the Table was onan alternative to the volume-triggered tieredapproach. Currently, the Regulations provide atiered approach to notification that links infor-mation requirements to factors such as quan-tity, special categories (e.g., research and deve-lopment [R&D] substances, site-limited inter-mediates), intrinsic properties and substanceclasses (e.g., chemicals, polymers). The pres-cribed information depends on a combinationof these factors and is specified in notificationschedules.

Table DeliberationsIndustry and government members share the view that the tiered system has proven tobe successful in the past and have agreed tosupport its continuation, with greater attentionbeing paid to those substances that are import-ed/manufactured in higher volumes, asincreased volume can be correlated withincreased exposure. Industry supports the cur-rent system because it allows for the level oftesting to increase in step with increases inusage and commercial viability.

Some PAG members have consistently promo-ted an interpretation of toxic that is based on“hazard” assessment rather than “risk” asses-sment. This argument has been presentedthroughout the last decade, including therecent CEPA review discussions, and providedthe basis for the PAG position during theseNSN consultations as well. However, therevised CEPA did not adopt a hazard-baseddefinition; rather, it interprets toxic in terms ofboth intrinsic properties and exposure poten-tial. The existing NSN Regulations were alsostructured around a set of volume-triggeredtiered testing requirements, thus incorporatingthe notion of exposure by requiring moreextensive assessments for larger exposurepotential.

Some of the PAG members take issue with volume triggers and an interpretation of toxicthat includes exposure. First, they may allow

pollution to accumulate through small, incre-mental releases. Second, they mean that sub-stances may not be restricted until after somedegree of damage has been done. The PAGpropose a hazard-based system that they assertwould be more preventative due to its empha-sis on assessing and controlling substancesfrom the onset. The assessment would bebased solely on the intrinsic properties of thesubstances and would not allow harmful conta-minants to be released into the environmenteven in small amounts. During these consulta-tions, this system is referred to as the “Sunrise”approach.

While strict compliance with the Sunrise sys-tem would have required that full assessmentof substances be conducted at the lowest possi-ble volume, the PAG representatives haveassented to an entry level trigger of 100 kg/year.

The PAG have come to a compromise and havesuggested a revised approach to the notifica-tion system as illustrated in Figure 3.1.

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30


Figure 3.1: Notification Under the Modified Sunrise System100 kg/year

Entry level:Same entry level tests as those currentlyproposed under Section 3.2.2

Between 100 kg/year and 1000 kg/year, industry maymanufacture and import a substance, subject to anygovernment restrictions, as is currently the case.

Sunrise level: Same tests as those used for the evaluationof “CEPA-toxic,” with the addition of testsfor ODP and GWP where appropriate

Between 1000 kg/year and 10 000 kg/year, industrymay market and utilize a substance, subject to anygovernment restrictions, as is currently the case. If the substance does not satisfy Sunrise criteria (seeAppendix A.8), it becomes ineligible for DSL listingand may be used only in extreme circumstances (i.e., if necessary to protect life).

Tests at this level could include the same intermedi-ate-level tests as those currently proposed underSection 3.2.2, as well as an in vivo genotoxicitystudy, 28-day repeated-dose study and a test for teratogenicity.

Exempt

1000 kg/year

10 000 kg/year

Final level: Any remaining tests from the list of thosecurrently proposed under Section 3.2.2 (i.e., all those left over from the proposedintermediate and final levels)

Only after passing through the final level of testingdoes a substance become eligible for the DSL.

Tests at this level could include spectrum, adsorp-tion/desorption, remaining two ecotoxicity studies,second in vitro genotoxicity study, second acutemammalian toxicity study, sufficient information toassess skin irritation and a skin sensitization study.

100 kg/year

<100 kg/year


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The difference between the government andindustry proposal and the revised PAG posi-tion occurs at the 1000 kg/year trigger level.The issue at the heart of the two approaches isthe evaluation of chronic toxicity. The PAG alsohave concerns about the lack of comprehensivegenotoxicity testing and testing for teratogeni-city and carcinogenicity at this 1000 kg/yeartrigger level. Government has suggested that section 84(1) of CEPA’99 provides oneapproach to request any additional informationnecessary to address concerns raised under theauspices of “suspicion of toxic.” Section 3.1.3provides additional context on the use of section 84(1).

Table Recommendation33. An entry level trigger for non-NDSL

chemical notifications should be establishedat 100 kg/year.

(ii) Simplifying and Improving theEffectiveness of the Tiered ApproachThe Table addressed both the complexity of thetiered approach and the user friendliness of theschedules themselves. The complexity of thecurrent approach is a major concern for allstakeholders. There was consensus by theTable that the current tiered approach could besimplified. As a first step, the volume triggerscould be simplified for non-NDSL substances.

There are currently three different types of volume triggers: annual, cumulative and “inpossession.” In total, nine volume triggers areassociated with the current regulatory frame-work. It is proposed that triggers based onannual import/manufacture volume be conti-nued and that cumulative and “in-possession”triggers be eliminated.

The elimination of cumulative triggers meansthat Environment Canada and Health Canadawill no longer be able to identify those inter-mediate-volume chemicals that have signifi-cant long-term activity in Canada. However,Environment Canada and Health Canadabelieve that the assessment process would bebetter served by addressing issues of long-termenvironmental and human health risks atlower tiers, rather than by delaying receipt ofinformation until quantities accumulate overmany years. This has meant that as datarequirements were considered for the

schedules, care was taken to ensure that dataelements that address persistence, bioaccumu-lation and toxicity are included in lower-levelschedules.

In determining which tests are required at eachtier (populating the schedules), industry repre-sentatives made the case that testing is expen-sive in terms of dollars, time and animals,whereas the tiered approach permits the pha-sing-in of test requirements and associatedcosts in a way that allows notifiers to absorbthe costs. Government representatives usedtheir experience with past notifications to helpthem to determine what information they needto be able to make sound risk assessments. Theframework of “populated” schedules that isproposed by government and industry inSection 3.2.2 was reached after lengthy discus-sion and analysis of past notifications. For thereasons described in Section 3.2.1(i), the PAGdo not support the proposed framework.Rather, they recommend including chronic toxi-city, teratogenicity, genotoxicity and carcino-genicity testing at the 1000 kg/year level in theRegulations so that those substances exhibitinga range of toxic effects may be identified earlyin the assessment process and prevented fromaccumulating in the environment.

In order to make the tiered approach easier touse for PLC notifications, the Table discussedthe development of a computer software-based“smart system” to help notifiers through theprocess (Section 3.2.2(iii)). The Table alsoaddressed the schedules for special categoriesin the current Regulations and has proposedrecommendations for simplifying their applica-tion in Section 3.2.3.

Table Recommendations34. Cumulative and “in-possession” triggers

should be eliminated. The elimination of these triggers will not affect the abilityof the regulators to assess persistence,bioaccumulation and toxicity.

(iii)Administration of the NDSLThe NDSL specifies substances that are not onthe DSL but are in international commerce. Itoriginates from the obligation of the Ministerof the Environment, under section 25(2) ofCEPA, 1988 (section 66(2) of CEPA’99), to com-pile a list of substances not on the DSL but

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believed to be in international commerce. As abasis for this list, Environment Canada chosethe U.S. TSCA Inventory of 1985. The NDSLwas first published on January 26, 1991, andconsisted of the 1985 version of the TSCA listminus the substances on the Canadian DSL.Substances on the NDSL require less detailednotification packages for assessment under thecurrent NSN Regulations than substances thatare new to both the Canadian marketplace andworld commerce.

Beginning in 1995, the NDSL has undergoneannual revisions that add or delete all sub-stances incorporated into, or removed from,the TSCA Inventory five or more years beforethe date of the NDSL revision. The 2001 NDSLupdate was, therefore, based on the TSCAInventory of 1996.

Notification experience suggests that there arecases where there is a need to obtain additionaldata to better understand or validate concernsthat are raised during the assessment of thesesubstances. This may be due in part to the dif-ferences in the Canadian and U.S. systemsused to evaluate new substances and the wayin which the data are requested. Based on theProgram experience until October 1999, cove-ring 1877 NDSL substances, 21 substances werecontrolled in Canada but not controlled in theUnited States. Three of these substances wereassessed in the United States, but their assess-ment did not result in known controls on theirmanufacture or use. The remaining 18 sub-stances had not been assessed in the UnitedStates.

Table Deliberations The administration of the NDSL was esta-blished with annual updates based on the ver-sion of the TSCA Inventory that existed fiveyears earlier. The five-year lag was adopted toallow for adequate experience in use, with thepresumption that any concerns would becomeapparent during the lag period. In practice, thishas not been proven to be a factor. Rather, thefive-year lag has caused a degree of complexityin the management of the necessary records toeffect accurate updates.

The experience of NS Program reviewers sincethe inception of the NSN Regulations in 1994has shown that there are instances in whichmore data are required for NSNs covering

NDSL substances. These particular needs havebeen addressed, as explained in subsequentsections (see Sections 3.2.2(ii) and 3.2.2(v)), by a proposed restructuring of the schedulesthat would apply to NDSL substances.

In consideration of the past seven years ofexperience and the proposed changes to theschedules, the government has suggested thatit would be appropriate to alter the annualNDSL update to incorporate a one-year lag inrelation to the TSCA Inventory.

Table Recommendation35. The NDSL should be updated annually,

based on the U.S. TSCA Inventory of the previous year.

3.2.2 Proposed Framework for the NewRegulations

New substances fall into five categories thatare considered here for the purpose of assign-ing test requirements to schedules: non-NDSLchemicals; NDSL chemicals; PLCs; non-NDSLpolymers; and NDSL polymers. Additionally,there are special categories that include sub-stances intended for R&D, for product deve-lopment, for export only or for use as site-limited intermediates.

Although all three stakeholder groups startedfrom different positions, industry and govern-ment were able to reach agreement on pro-posed frameworks for all five categories ofnew substances and the special categories.During these discussions, specific concerns ofthe PAG were taken into consideration, butoverall the PAG still favour the Sunriseapproach. However, in light of the fact that thetwo proposed “NDSL” schedules (Sections3.2.2(ii) and 3.2.2(v)) represent significantimprovements over the status quo, the PAG areprepared to agree with them as outlined below.

Furthermore, it is recognized that, in all cate-gories, additional data can be requested of thenotifier at each stage in the process to satisfy aconcern relative to a “suspicion of toxicity”under section 84(1)(c). As well, notifiers mayrequest waivers for data elements if they cansatisfy certain criteria.


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(i) Proposed Framework for Non-NDSLChemicalsThree schedules are proposed by industry andgovernment, as outlined below. The PAGfavour the adoption of the Sunrise approach asdescribed in Section 3.2.1, due to concernsregarding the absence of regulatory require-ments for chronic (and other) toxicity dataearly in the assessment process.

• Entry Level: It is proposed that the annualtrigger for these substances be raised from20 kg/year to 100 kg/year. This volume isnot likely to pose a risk to human health orthe Canadian environment. The trigger islow enough that an “inventory” of sub-stances in commerce in the country can bemaintained and effectively captures the“cradle” in cradle to grave management ofsubstances.

• Intermediate Level: The volume trigger for this level is proposed to remain at 1000 kg/year.

• Final Level: This schedule is to be requiredprior to reaching 10 000 kg/year and mustbe completed prior to DSL listing. Thecumulative volume trigger of 50 000 kg nolonger applies.

Information in SchedulesEntry Level for Non-NDSL Chemicals (100 kg/year)

• chemical name

• trade names

• CAS #

• MSDS

• a summary of all other information and testdata on hazard and exposure (that are inthe person’s possession)

• exposure data and information

• identification of other agencies notified andrisk management actions taken

Intermediate Level for Non-NDSL Chemicals(1000 kg/year)

• entry level information

• molecular formula

• structural formula

• gram molecular weight

• degree of purity

• impurities

• additives/stabilizers

• melting point

• boiling point

• density

• vapour pressure

• water solubility

• octanol/water partition coefficient

• one acute mammalian study

• one in vitro gene mutation study

• one acute fish, daphnid or algae study

• ready biodegradation

• manufacture, use, disposal and exposureinformation

• a summary of all other information and testdata on hazard and exposure (to which theperson ought reasonably have access)

Final Level for Non-NDSL Chemicals (10 000 kg/year, DSL eligible)

• intermediate-level information

• spectrum

• adsorption/desorption

• hydrolysis

• remaining two ecotoxicity studies

• second in vitro genotoxicity study

• in vivo genotoxicity study

• second acute mammalian toxicity study

• sufficient information to assess skin irritation

• skin sensitization study

• 28-day repeated-dose study

(ii) Proposed Framework for NDSLChemicals Three schedules are proposed by the Table:

• Entry Level: The proposed entry level trigger volume remains unchanged at 1000 kg/year.

• Intermediate/Final “A” Level: The pro-posed intermediate/final trigger volume is10 000 kg/year.

• Final “B” Level: The proposed final-leveltrigger volume is 50 000 kg/year.

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Information in SchedulesThe proposed entry level data requirements areidentical to those for non-NDSL chemicals. Theproposed intermediate/final data requirementsmatch the intermediate non-NDSL chemicalproposal. The proposed final-level schedulewill apply only to certain NDSL chemicals thatmeet specific criteria that are indicative of sig-nificant human exposure.

Entry Level for NDSL Chemicals (1000 kg/year)

• chemical name

• trade names

• CAS #

• MSDS


• exposure data and information as specifiedin an exposure template in the Guidelines


Intermediate/Final Level “A”* for NDSLChemicals (10 000 kg/year, some chemicalsDSL eligible)






• impurities


• melting point

• boiling point

• density

• vapour pressure

• water solubility


• one acute mammalian study

• one in vitro gene mutation study

• one acute fish, daphnid or algae study


• manufacture, use, disposal and exposureinformation


Final “B” Level for NDSL Chemicals (50 000 kg/year, DSL eligible)

For those chemicals likely to have a release to the environment after wastewater treatment of >3 kg/day per site averaged over a month, including envisioned future uses by multiple usersand/or a variety of applications:

• adsorption/desorption

• hydrolysis

• 28-day repeated-dose mammalian toxicitystudy

For those chemicals considered likely to be presentin consumer products where significant exposuresare likely:

• 28-day repeated-dose mammalian toxicitystudy

• an in vitro study for chromosomal aberra-tions; if an in vivo study is already avail-able, it will be considered as alternativedata

(iii)Proposed Framework for Polymers ofLow ConcernThis proposal retains the distinction betweenPLCs and other polymers.

There are several issues related to PLCs:

• the ability of industry to properly identifyPLCs (it has been the experience of regula-tors that approximately 20% of polymerssubmitted as “low concern” do not meetthe criteria);

*NDSL chemicals that are not anticipated to be used inconsumer products or released to the environment inexcess of an average (on a monthly basis) of 3 kg/dayper site, after wastewater treatment, will be candi-dates for addition to the DSL at this point, providedtheir assessment does not lead to "suspicion of toxic."All other NDSL chemicals will be subject to therequirements of the "Final ‘B’ Level," below, prior toattaining a volume of 50 000 kg/year (see Figure 3.2at the end of Section 3.2).


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• the amount of effort and time required fortheir notification and assessment; and

• what is done with the information.

In an effort to address the first issue,Environment Canada is exploring the develop-ment of a computer software-based “smart system” to assist notifiers in the identificationof PLCs.

A contractor is being sought to develop a“query” system, where the user is prompted torespond to a series of questions. When suffi-cient information has been gathered to deter-mine whether a substance meets the “low concern” criteria or not, the questioning stops. The Table supports this approach.

PLCs are notified solely in the entry levelschedule of the polymer notification frame-work. The assessment period associated withPLCs is discussed as part of Section 3.2.4.

The government expressed concern that PLCseligible for listing on the DSL could subse-quently be manufactured/imported in varia-tions with characteristics outside the low concern boundaries. The risk assessments con-ducted for PLCs are based on the low concerncriteria and use reduced data requirements,compared with the data prescribed for theother categories of polymers. Polymers intro-duced subsequently that do not meet the PLCcriteria could have significantly different pro-perties from the PLCs assessed and would,therefore, present a different risk profile fromthe low concern version. This concern was gen-erally accepted by all members of the Table.

Table members agreed that PLCs (excludingcertain polyesters)* be listed on the DSL via amechanism to be developed (e.g., flagging) toindicate that they have been assessed based onthe low concern criteria. Import or manufac-ture of these substances would be unrestrictedas long as they continued to meet the low concern criteria set out in the Regulations.Prior to the import or manufacture of a desig-nated PLC that does not meet the low concerncriteria, a higher-level notification would berequired.

Information in Schedule (see Figures 3.3and 3.4 at the end of Section 3.2)Entry Level (1000 kg/year)

• chemical name

• trade names

• CAS #



• reaction scheme

• polymer composition and additives

• MSDS

• number average molecular weight and %below 500 and 1000 daltons

• reduced manufacture, use, disposal andexposure information



(iv) Proposed Framework for Non-NDSLPolymers — Excluding Low concernPolymers and Those with All MonomersListed on the DSL/NDSL (seeGovernment and Industry Perspectivesbelow)Two schedules are proposed by industry andgovernment. The PAG favour the adoption of the Sunrise approach (as described inSection 3.2.1 and in Section 3.2.2, TableDeliberations) due to concerns regarding theabsence of regulatory requirements for chronic(and other) toxicity data early in the asses-sment process. The PAG also recommend thatthe regulatory status of monomers not affectthe notification scheme, and that notifiers mayutilize waivers where appropriate to reducethe requirements for this category of substance.

• Entry Level: This entry level schedule iscurrently required at 1000 kg/year. It isproposed that this be maintained.

• Final Level: Under the present notificationsystem, final polymer notification occurs at10 000 kg/year. It is proposed that this trig-ger be maintained.

*Polyesters manufactured from monomers and reactantsdefined in Schedule 10 of the current NSN Regulations.

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Information in SchedulesThe proposed entry level data requirements areidentical to those proposed for PLCs, whereasthe proposed final-level data requirements arebased on a combination of data requirementsfrom the current (1994 Regulations) ScheduleVII and VIII notifications. This proposal simpli-fies the Regulations by reducing the number ofschedules for non-NDSL polymers from 3 to 2.

Entry Level (1000 kg/year)

same as for PLCs above

Final Level (10 000 kg/year, DSL eligible)


• physical state of the polymer

• is the polymer formulated for dispersal inwater?

• water availability


• hydrolysis as a function of pH


• two acute toxicity tests for the most sensi-tive species (defaults are acute algae toxici-ty and acute fish or daphnid toxicity)

• acute mammalian oral toxicity study*

• sufficient information to assess skin irritation*

• skin sensitization*

• 28-day repeated-dose mammalian toxicitystudy*

• one in vitro gene mutation study*

• in vitro chromosomal aberration study*

• in vivo chromosomal aberration or genemutation or other indicator of genotoxicity*

• remaining manufacture, use, disposal andexposure information


*Exemptions for specified polymer classes will beallowed when the notifier demonstrates that certaincriteria have been met. See Tables 3.3 and 3.4 for thelist of these polymer classes and guidance on possiblewaiver conditions.


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Table 3.4: Waivers for Health Hazard Toxicity Data for Polymers with No MolecularWeight Species Below 1000 Daltons (i.e., <0.1%)

Conditions for which Waivers for Health Conditions for which Waivers for HealthToxicity Tests Can Be Requested Toxicity Tests Cannot Be Requested

If information on hydrolysis, biodegradation If information on hydrolysis, biodegradationpotential or toxicity supports the rationale potential or toxicity does not supportthat the polymer will not be broken down the rationale that the polymer will not beand will not be biologically absorbed. broken down and will not be biologically

absorbed.Requests to waive the acute toxicity test should be accompanied by information that supports the rationale that the polymer is not biologically absorbed.

Table 3.3: Exemptions for Health Hazard Toxicity Data

The following polymer classes are exempt from all health toxicity tests (OECD 401 to OECD 476). This list is subject to change as more information becomes available.

Polymer Class Definition

Low Concern As defined in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Cationic Polymers that do not meet the low concern criteria solely due to the presence of the following cationic or potentially cationic groups: primary, secondary, tertiary or quaternary amine groups, carbodiimides and sulphoniums. Although the following cationic groups are not included — hindered amines, isocyanates (free and blocked) and phosphoniums — waivers may be considered on a case-by-case basis.

Exception to the exemption: cationic polymers with Mn > 10 000 daltons whose intended or expected use was likely to result in direct inhalation exposure of the general population would not qualify for the exemption.

Aldehyde Polymers that do not meet the low concern criteria solely due to the presence of aldehydes that exceed the functional group equivalent weight of 1 in 1000.

Vinyl Ether Polymers that do not meet the low concern criteria solely due to the presence of vinyl ethers that exceed the functional group equivalent weight of 1 in 5000.

Sulphonic Acid Polymers that do not meet the low concern criteria solely due to the presence of sulphonic acids that exceed the functional group equivalent weight of 1 in 5000.

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(v) Proposed Framework for NDSL Polymersand Non-NDSL Polymers with AllMonomers Listed on DSL/NDSL —Excluding Low concern Polymers

Three schedules are proposed by the Table:

• Entry Level: The proposed entry level trigger volume is identical to those proposed for PLCs and non-NDSLpolymers, 1000 kg/year.

• Intermediate/Final “A” Level: The pro-posed intermediate/final trigger volume isidentical to the final trigger level proposedfor non-NDSL polymers, 10 000 kg/year.

• Final “B” Level: The proposed final-leveltrigger volume is identical to the final trig-ger level proposed for NDSL chemicals, 50 000 kg/year.

Information in SchedulesThe proposed entry level data requirements areidentical to those for PLCs and the proposednon-NDSL polymers. The proposed intermedi-ate/final data requirements will be reducedrelative to the final non-NDSL polymer pro-posal. The proposed final-level schedule willbe similar to that for chemicals, in that it willapply only to certain polymers that meet spe-cific exposure criteria.

Entry Level (1000 kg/year)

identical to non-NDSL polymers above

Intermediate/Final “A” Level (10 000 kg/year,some polymers DSL eligible)



• is the polymer formulated for dispersal inwater?

• water availability


• hydrolysis as a function of pH

• one aquatic toxicity test for the most sensi-tive species (fish, daphnia, algae); defaultacute algae toxicity

• acute mammalian oral toxicity study*

• remaining manufacture, use, disposal andexposure information


NOTE: Polymers in this section that are notanticipated to be used in consumer products orreleased to the environment in excess of anaverage (on a monthly basis) of 3 kg/day persite, after wastewater treatment, will be candi-dates for addition to the DSL at this point, pro-vided their assessment does not lead to “suspi-cion of toxic.” All other polymers of this sec-tion will be subject to the requirements of the“Final Level,” below, prior to attaining a volume of 50 000 kg/year.

Final “B” Level (50 000 kg/year, DSL eligible)

For those polymers likely to have a release to the environment after wastewater treatment of >3 kg/day per site, averaged over a month,including envisioned future uses by multiple users and/or a variety of applications:


• one in vitro study, either gene mutation orchromosomal aberration*

For those polymers considered likely to be present inconsumer products where significant exposures arelikely:


• one in vitro gene mutation study*

• one in vitro chromosomal aberration study*(if an in vivo study is already available, itwill be considered as alternative data)

Table Deliberations

Government PerspectivesNDSL Framework

The Environment Canada and Health Canada representatives feel that the proposeddata requirements for NDSL substances represent an improvement over the existingdata requirements for these substances.

*Exemptions for specified polymer classes will beallowed, or waivers may be possible, when the notifierdemonstrates that certain criteria have been met. See Tables 3.3 and 3.4.


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The proposed changes include a 28-day repeated-dose toxicity study that would berequired prior to the substance exceeding atrigger volume of 50 000 kg/year, where theaverage daily release (after waste treatment) is estimated to be 3 kg/day per site or wheresignificant consumer exposure is expected. In addition, in situations where significant consumer exposure to the chemical is expected,two in vitro tests for examining mutagenicity orchromosomal aberration (or equivalent testing)will be required prior to exceeding the abovetrigger volume. Further elaboration of the criteria for “significant consumer exposure”is necessary and will be carried out and published in the revised Guidelines.

The 3 kg/day release value was derived basedon outcomes of standard quantitative riskassessment procedures using conservativeassumptions that are routinely utilized by theNS Program for assessing “suspicion of toxic.”

The 28-day repeated-dose mammalian toxicitystudy is capable of identifying adverse effectsfollowing multiple exposure to the notifiedsubstance and serves to provide significantlymore information on the various systemic toxiceffects that cannot be detected reliably in an acute study. The repeated-dose study, in conjunction with other studies, is expected to identify indications of toxicity that couldlead to “suspicion of toxic,” and further testingto characterize intrinsic toxicity or specifichealth hazards may be necessary. Its inclusionrepresents a significant improvement over the current data requirements for assessingsubstances that are on the NDSL.

The inclusion of the genotoxicity tests in situa-tions where widespread or significant con-sumer exposure is anticipated improves thescope and robustness of the data package forassessing potential health risks such as cancerand developmental defects in the general popu-lation resulting from exposure to the new sub-stances.

It is notable that many of the NDSL notifica-tions submitted to the Program in the pasthave included several genotoxicity studies; thecurrent proposal would subject all substancesthat meet the criteria outlined above (listed on NDSL; prior to exceeding 50 000 kg/year;

>3 kg/day per site; significant consumer expo-sure) to more complete testing than is currentlyrequired.

From an environmental perspective, the pro-posed changes for NDSL polymers include theprovision of one acute toxicity test (regardlessof charge) for the most sensitive species (acutealgal toxicity by default) and hydrolysis as afunction of pH. For NDSL chemicals, the pro-posed changes include the addition of oneacute fish, daphnid or algae study and a readybiodegradation test. The proposed changes willprovide a better characterization of the toxicityof the notified substance by reducing uncer-tainty in the assessments. Furthermore, data onhydrolysis and ready biodegradation willreveal whether the notified substances can bedegraded and, if so, identify environmentaldegradation products.

Overall, the Environment Canada and HealthCanada representatives believe that the pro-posed data requirements for NDSL substanceswill provide for a more robust assessment ofhuman health and the environment.

Monomer Status

Initially, it was the view of EnvironmentCanada and Health Canada that there is no scientific justification for the current system of modifying data requirements based onwhether or not monomers are listed on theDSL or NDSL. Further, accounting formonomer status would add complexity to thepolymer framework.

A review of impacts by Environment Canadaand Health Canada determined that environ-mental and human health will remain protect-ed even if the current provisions remain inplace, since data are likely to be provided at alater date, if warranted. Environment Canadaand Health Canada recognize that there is anindustry sector that is dependent upon creat-ing new polymers with existing monomers,and that a niche for this activity has been crea-ted by existing provisions in the current NSNRegulations. Environment Canada and HealthCanada agree, therefore, with industry’s pro-posal to maintain the regulatory status ofmonomers for polymers that do not fall intothe PLC category.

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Industry PerspectivesNDSL Framework

Industry initially proposed that the treatmentof the NDSL should be strengthened within the context of MAN. The original premise wasthat the NDSL was based on the U.S. TSCAInventory and that the history of NDSL notifi-cations did not suggest that there were overar-ching concerns with the reduced data require-ments imposed on these substances. From thisknowledge base, industry originally proposedthat the notification requirements for NDSLsubstances were adequate and additional relaxation of data requirements could be considered.

Industry had further proposed that the scopeof the NDSL should be enhanced by recogni-zing other international inventories, like theEuropean Inventory of Existing ChemicalSubstances (EINECS) and European List ofNew Chemical Substances (ELINCS), thus con-tinuing to promote MAN. Inclusion of a broa-der inventory base would provide considerableopportunities to make reviews more efficientand timely without any loss of protection ofhuman health and the environment. Theexpansion of the NDSL beyond the TSCAInventory would allow greater access to theCanadian market while still providing thedepartments the opportunity to assess thesenewer substances.

Based on evidence provided by HealthCanada, demonstrating that chronic toxicityendpoints were not adequately addressed insome cases, industry has acceded to the government proposal to provide certain dataelements based on considerations for signifi-cant consumer exposure or release to theaquatic environment. This compromise wasagreed to in view of the rationale provided by government that for specific release scenarios, additional health endpoints should be examined.

Consistent with the above points, industry con-tinues to strongly advocate that opportunitiesto improve international cooperation on theassessment of new substances should be pur-sued, as outlined in Section 3.4 of the Tablereport.

Monomer Status

Industry believes that NSN Regulations ofCEPA treat polymers more severely than war-ranted, based on the low intrinsic toxicity asso-ciated with these substances and in compari-son with other jurisdictions. The current regu-latory framework recognizes the inventory status of monomers in determining the testprogram. Furthermore, Canadian industry hasestablished ongoing commercial activities inthe polymer field based on the inventory statusof the monomers. Additionally, a segment ofindustry has already been negatively impactedby the current data requirements, since thesebusinesses are based on European sourceswhere polymer notifications are not requiredas long as all monomers are listed. An appre-ciable increase in the data requirements woulddestroy the commercial viability of this type ofpolymer.

The revised proposal continues to recognizethe important role that inventory status playswithin the regulatory framework, while pro-viding government with additional humanhealth endpoints where warranted. This repre-sents a clear increase in the data available forassessment where the use pattern may lead tosignificant consumer exposure or release to theaquatic environment.

PAG Perspectives NDSL Framework

The PAG acknowledge that the NDSL chemicaland NDSL polymer proposals represent signifi-cant improvements over the status quo and arethus willing to compromise on their initial“Sunrise” position in order to reach consensuson these two schedules.

However, the PAG still have numerous con-cerns with the proposals as outlined. They feelthat the decision to accept reduced datarequirements for NDSL substances is not scien-tifically based and may therefore result inheightened health risks. In particular, the PAGare concerned that chronic health concerns arenot adequately addressed by this proposal. The only longer-term toxicity test being proposed is the 28-day repeated-dose mam-malian test, and even this is only selectivelyrequired at the 50 000 kg/year level for those substances meeting certain exposure/consumer criteria. By government’s own


admission, systemic toxicity is not well predict-ed by toxicity tests with a time frame less than28 days or by QSAR models. Additionally,since the U.S. EPA does not automaticallyreview this or subchronic/chronic toxicity testsfor all substances placed on its inventory, therecan be no heightened confidence in the safetyof NDSL substances in this area. Accordingly,the PAG argue that NDSL substances shouldbe subject to the same testing requirements asnon-NDSL substances, particularly withrespect to systemic health effects.

The PAG also take issue, for numerous reasons,with the exposure cut-off that has been intro-duced as a decision point prior to final sche-dule testing. First, the reliance on exposure atthis critical juncture runs directly counter tothe PAG’s Sunrise philosophy and its emphasison hazard-based judgements. Rather, the expo-sure-based proposal gives no consideration tothe relative potencies of substances; for exam-ple, substance A may exhibit twice the chronictoxicity of substance B, and yet both wouldneed to meet the same exposure criteria inorder to warrant the 28-day test. Second, littlethought has been given to the implementationand enforcement of the 3 kg/day per site cut-off limit. The very real possibility exists that,once a low-exposure substance has been placedon the DSL, its cumulative releases will risedue to new-found uses, a surge of multipleusers or simply an increase in use by the origi-nal notifier. It is unclear how these changeswill be monitored and regulated for DSL sub-stances. The use of the Significant NewActivities (SNAcs) provisions in CEPA’99 (seesections 80 and 81) has been proposed as ameans of addressing these concerns; however,the implementation of this proposal may beproblematic due to the fact that SNAcs havebeen neither designed nor previously utilizedfor this purpose. Third, the exposure measure-ment itself is of questionable accuracy, since itis often based on projections rather than directmeasurements. As a result of these concerns,the PAG feel that it is highly inappropriate touse exposure as a criterion for requiring final-level health tests.

Monomer Status

The PAG do not accept the non-NDSL polymerframework and the accompanying reduction intest requirements that has been proposed forthose polymers with all monomers listed onthe DSL or NDSL. First, the PAG feel that thisrecommendation by industry and governmentis not scientifically based and allows for poten-tially harmful polymers to gain access to theDSL without receiving complete assessments.Second, the complexity of the polymer frame-work is further heightened by the requirementthat an additional regulatory procedure beintroduced for this class of polymers. Third,government workload will necessarily increasedue to the fact that, in cases where suspicionsof toxicity exist, regulators will need to specifi-cally request all of the data elements thatwould otherwise have been routinely providedunder a regular polymer notification. Fourth,this has the added disadvantage of reducingtransparency. Due to these disadvantages withthe government/industry proposal, the PAGinstead recommend that the regulatory statusof monomers not affect the notification scheme,and that notifiers may utilize waivers whereappropriate to reduce the requirements for thiscategory of substance.

Table RecommendationsThe Table did not reach complete consensuson a proposed framework for data schedules.The perspectives of each sector are articu-lated above.

36. The framework as outlined in the proposedframework for NDSL Chemicals (Section3.2.2(ii)) and the proposed framework forNDSL polymers and non-NDSL polymerswith all monomers listed on theDSL/NDSL (Section 3.2.2(v)) shouldreplace the current requirements for therelevant categories of substances.

37. The NS Program should revise its internalprocedures to ensure that, wherever war-ranted, additional data are requested atearlier stages in the assessment process.For example, such requests could be madein the assessment of NDSL polymers orthose polymers with all monomers on the DSL/NDSL.

41

42


38. Health Canada and Environment Canadashould utilize SNAcs in cases where there is uncertainty that the substance may beused in a consumer application or that the3 kg/day per site criterion may be exceededas a result of future activities. Thesefuture activities would include multipleusers and/or a variety of applications.

39. A more streamlined method should bepursued as an alternative to SNAcs.

40. A mechanism should be developed (e.g., a flag) when listing PLCs (excluding certain polyesters* that have been assessedaccording to low concern criteria) on the DSL.

41. A “smart system” to simplify the notifica-tion of PLCs should be developed andimplemented.

3.2.3 Special Categories

Currently, there are five special schedules:three for polymers (Export-only/Site-limitedIntermediate, R&D and Product Development)and two for chemicals (Export-only/Site-limited Intermediate and ProductDevelopment).

The use of the schedules for these special cate-gories has been limited, representing less than2% of the total number of new notifications.Schedule IV, for product development chemi-cals, has been used 13 times (0.3% of all notifi-cations). Schedule V, for site-limited interme-diate chemicals and export-only chemicals, hasbeen used 39 times (1% of all notifications).

(i) Research and Development and ProductDevelopment Substances

The current regulations contain separate defini-tions for R&D and product development sub-stances, with specific schedules for each. TheTable proposes that these definitions be amal-gamated, resulting in a single R&D category.

Under the amalgamated definition for R&Dand product development, there is a need to beable to recognize that the activity concerning

a substance truly qualifies for the R&D specialcategory. This determination is rather easy tomake during the early stages of the R&Dprocess. It becomes more complex, however, asthe substance moves into the product develop-ment mode, especially when volumes areincreased in order to conduct efficacy trials inthe facilities of potential customers. Test mar-keting, however, is accepted as a boundarycondition, which clearly denotes when the spe-cial provisions of the R&D category have beenrelinquished.

Table DeliberationsThe current definition of “test marketing,” ascontained in the NSN Regulations (“the explo-ration of the market capability of a product in acompetitive situation where the creation orimprovement of the product is not the primaryobjective”), adequately describes the movementof a substance into a commercial mode and isproposed to be left intact.

A parallel program exists for R&D in theUnited States under the TSCA. The parametersgoverning the R&D exemption under theTSCA have been well described over the morethan 20 years that this legislation has been ineffect, through various information bulletinsand other less formal communications. Due tothe significant level of experience and the closesimilarity of the TSCA provisions to those pro-posed for the revised NSN Regulations, it isproposed that the TSCA guidance be used as areference in developing the CEPA R&D gui-dance (see the EPA New Chemical InformationBulletin19).

The recommended requirements for R&D sub-stances provide an equivalent level of environ-mental and human health protection as cur-rently available and also recognize the natureof R&D substances. They allow for the deferralof test data, yet simplify the Regulations byeliminating separate categories for R&D andproduct development substances.

In summary, the manufacture and import ofR&D substances would be subject to the proposed intermediate and final notifications,with no requirement to submit test data untilthe substance is commercialized (i.e., when thesubstance no longer meets the definition ofR&D). If the substance is not commercialized,

*Polyesters manufactured from monomers and reactantsdefined in Schedule X of the current NSN Regulations.


43

there would not be any ongoing notificationresponsibilities.

The PAG acknowledge that this proposal is notconsistent with the “Sunrise” protocol but areprepared to agree with it as outlined.

Table Recommendations42. The definitions for R&D and product

development substances should be amalgamated to “research and develop-ment substance” as follows:

“Research and development substance”means a substance that is undergoing systematic investigation or research, by means of experimentation or analysisother than test marketing, the primary objective of which is:(a) to create or improve a product or

process, or

(b) to determine the technical viability or performance characteristics of aproduct or process, or

(c) to evaluate a substance prior to its commercialization, which includes pilot plant trials, production trials or customer trials other than test market-ing, in order to modify the technicalspecifications in response to the per-formance requirements of potentialcustomers.

43. The current schedules for special cate-gories should be replaced within theframework outlined in Section 3.2.2 with the following:

a) R&D — Chemicals

Table Recommendations44. For chemicals meeting the definition of an

R&D substance, there would be no report-ing requirements necessary below 1000kg/year. This is consistent with the current regulations.

45. Prior to exceeding 1000 kg/year, the following data will be required:

• chemical name

• trade names

• CAS #

• MSDS





• impurities


• a summary of all other information andtest data on hazard and exposure

• identification of other agencies notifiedand risk management actions taken

• (manufacture, use, disposal and exposure information)

These data elements are equivalent to theproposed intermediate schedule (Section3.2.2(i)), but with no requirement to notifytest data.

46. The notification of the “final” schedule (as outlined in Section 3.2.2(i)) will be required prior to exceeding 10 000 kg/year. This will informEnvironment Canada and Health Canadaof the increased volume of the R&D sub-stance and provide an opportunity for thenotifier to update information supplied inthe first notification. There would be noadditional infor-mation requirements atthat time beyond the “correction of infor-mation” provision of CEPA (section 81(11)).

b) R&D Polymers

Table Recommendations47. The recommendation for R&D polymers

is similar in structure to that for R&Dchemicals; however, the data requirementsand trigger volume are based on those forpolymers. The following is a list of datarequired prior to exceeding 10 000 kg/year(trigger volume maintained from currentregulations):

• polymer name

• trade names

• CAS #

• MSDS



• composition of the polymer, includingmonomers/reactants, impurities, additives and solvents

44



• whether the polymer is formulated for dispersal in water

• number average molecular weight and % <500 daltons and % <1000 daltons (R&D substances are exempt from this data requirement; instead the target number average molecular weight must be indicated)*

• a summary of all other information andtest data on hazard and exposure

• identification of other agencies notifiedand risk management actions taken

• manufacture, use, disposal and expo-sure information

These data elements are equivalent to the proposed intermediate/final schedule(Section 3.2.2(iv)), but with no requirementto develop test data.

(ii) Site-limited Intermediate Substances andExport-only Substances

BackgroundBy definition, site-limited intermediates andexport-only substances will not be distributedwithin Canada. Site-limited intermediate andexport-only substances are not eligible for listing on the DSL. Changes to the originalnotice (e.g., changes in the site or release con-ditions) must be submitted to the Minister, sothat the information may be reviewed to see if the assessment outcome still applies (section 81(11)). To become eligible for the DSL,renotification using the normal notificationprocess would be necessary. As a consequence,risk assessment will focus on exposure frommanufacturing, processing and transit facili-ties. Because there may be limited opportunityfor release and exposure, Table membersbelieve that the regulations for site-limitedintermediate and export-only substances canbe simplified if “sufficient containment” can bedemonstrated and other issues raised can beaddressed appropriately.

In considering export-only substances, it isimportant to recognize that EnvironmentCanada is currently developing regulations toimplement the requirements of the Rotterdam

Convention on the Prior Informed Consent(PIC) Procedure for Certain HazardousChemicals and Pesticides in International Trade.This Convention requires, among other things,that receiving countries of a given chemical benotified if a final regulatory action prohibitingor severely restricting the use of this chemicalhas been taken. This includes chemicals thathave been refused approval for use in thedomestic market as a human health or envi-ronmental protection measure. The notice sent to the receiving country must indicate theassessment outcome and the regulatory actiontaken. Operationalizing the PIC provisionswithin the context of the assessment of newsubstances becomes an integral element inCanada’s ability to fulfil its obligations interna-tionally. There are other requirements relevantto new substance evaluations. For instance, if a substance is banned or severely restrictedas a result of these evaluations, Canada mustnotify the PIC Secretariat of this action.

Table DeliberationsAs a means to eliminate special categories forthe management of these types of substances,an attempt was made during these consulta-tions to identify the use of waiver requestsunder section 81(8)(b) as a way of handling theassociated data requirements. Based on legalopinion, it was determined that there is nopractical mechanism to use these waiverrequests to simplify the structure of theRegulations for all site-limited intermediatesand export-only substances. Section 81(8) indi-cates that waiver of information requirementscan be granted as follows:

On the request of any person to whom subsection (1), (2), (3) or (4) applies, theMinisters may waive any of the require-ments to provide information under thatsubsection if

(a) in the opinion of the Ministers, the infor-mation is not needed in order to deter-mine whether the substance is toxic orcapable of becoming toxic;

(b) the substance is to be used for a pre-scribed purpose or manufactured at alocation where, in the opinion of theMinisters, the person requesting thewaiver is able to contain the substance soas to satisfactorily protect the environ-ment and human health; or

*The revised Guidelines will indicate the type of information (e.g., reaction scheme) that will aid in the characterization of R&D polymers.


45

(c) it is not, in the opinion of the Ministers,practicable or feasible to obtain the testdata necessary to generate the infor-mation.

The “Manufactured at a Location …” portionof section 81(8)(b) is applicable only to sub-stances manufactured in Canada and cannot be applied to imported substances. It may beapplied to all substances manufactured inCanada, including export-only and site-limitedintermediate substances. The “PrescribedPurpose” portion of section 81(8)(b) relatesspecifically to the type of use to which the sub-stance will be subject. Environment Canada’slegal services have interpreted this to simplymean the “use” of the substance (see Frenchversion for clarity). The “Prescribed Purpose”provision is applicable to both imported andmanufactured substances. Based on the con-flicting waiver requirements under this section,export-only or site-limited intermediate sub-stances could not be captured uniformly by a“Prescribed Purpose” regulation as required insection 89(1)(f) of CEPA. Government pro-posed that further discussions be pursued toidentify the potential to apply the “PrescribedPurpose” portion of section 81(1)(b) of CEPA tospecial categories (see also Section 3.2.5 of thisreport).

Proposed Definitions for Site-limitedIntermediate and Export-only SubstancesThe proposed definitions for chemicals andpolymers that would qualify for the site-limited intermediate and export-only provi-sions are:

“Contained Site-limited Intermediate Substance”means a substance that is not an animateproduct of biotechnology and that, in theMinisters’ opinion, is contained so as to satisfactorily protect the environment andhuman health in Canada and is:

(a) manufactured and consumed at the siteof manufacture;

(b) involved in two sites by being manufac-tured at one site, transported to the sec-ond site, and consumed; or

(c) imported, transported directly to the siteof consumption, and consumed.

“Contained Export-only Substance” means asubstance that is not an animate biotechno-logy product and is manufactured or im-ported for export only and that, in theMinisters’ opinion, is contained so as to satis-factorily protect the environment andhuman health.

The Table agreed to a cut-off for “sufficientcontainment” of an absolute release limit of 1 kg/day per site to the aquatic environment.The type of information that would berequired should sufficiently characterize thetotal quantity released, waste treatment methodsbeing employed, the media to which the sub-stance is discharged and the dilution factorsthat apply. The stewardship practices asso-ciated with handling, cleaning and disposingof packaging associated with the substancemust also be addressed. All processes invol-ving the notified substance must be addressed.

Management of Site-limited IntermediateSubstancesThe proposed framework for notifying site-limited intermediates would be identical tothat for the R&D substances (Section 3.2.3(i)).

The structure proposed by governmentincludes a requirement to demonstrate “suffi-cient containment” and the elimination of datarequirements (hydrolysis as a function of pH,ready biodegradation, acute mammalian toxici-ty). The overall notification scheme followsthat laid out for R&D substances, includingdata requirements and structure (see Section 3.2.3(ii)). Government has stated thatthe “sufficient containment” criteria providebetter overall protection of human health andthe environment in a Canadian context.

Management of Export-only SubstancesDuring these consultations, the treatment ofexport-only substances demonstrated thatthere were both policy and regulatory frame-work issues that require careful consideration.These concerns were summarized by the PAG.

The PAG has expressed concern about theethics of the proposal to reduce data require-ments for export-only substances. More specifically, the PAG questions the justification for eliminating any requirements for test data from the final notification schedule of

46


export-only substances. The PAG believes thatthis move may weaken the scientific informa-tion available for the substances’ assessments,as well as send a symbolic message thatCanada is subscribing to the “not in my backyard” philosophy.

It has been noted that the government’sauthority extends only as far as those sub-stances within Canada’s borders; however, the government’s jurisdiction would not bebreached if the existing level of testing require-ments were simply maintained. That is, sincethese minimal requirements for test data were acceptable under the original NSNRegulations, then they are still within the government’s scope today.

Additionally, the Table has agreed that therecurrently exists no mechanism for sharing datawith receiving jurisdictions unless controlshave been imposed. However, maintaining the current level of rigour and testing ofexport-only substances is consistent with thestated objective of developing internationalinformation-sharing agreements.

The PAG recognize that it is desirable to haveexport-only substances manufactured in acountry such as Canada where a new chemicalassessment scheme exists. However, the PAGfeel that it would be counterproductive toweaken the effectiveness of that system in theprocess of attracting manufacturers. Anotherconcern raised by the PAG was that inadequateconsideration had been given to workplacesafety issues.

The structure proposed by governmentincludes a requirement to demonstrate “suffi-cient containment” and the elimination of datarequirements (hydrolysis as a function of pH,ready biodegradation, acute mammalian toxici-ty). The overall notification scheme followsthat laid out for R&D substances, includingdata requirements and structure (see Section 3.2.3(ii)). Government has stated thatthe “sufficient containment” criteria providebetter overall protection of human health andthe environment in a Canadian context. Therevised government proposal continues toallow for scrutiny of an export-only substance,unlike the new substance assessment systemscurrently employed by other countries. Thereis concern that if the Canadian system forassessing export-only substances is too onerous,

there will be a greater incentive for manufac-turing these materials elsewhere.

Consensus was not reached on the issue ofexport-only substances.

Table Recommendations48. The framework for the notification of

“Contained Site-limited IntermediateSubstances” should be identical to that for R&D substances.

49. A process should be initiated to exploremechanisms that enable utilization of the“Prescribed Purposes” portion as definedin section 81(8)(b) of CEPA to special categories.

50. For the purpose of defining site-limitedintermediate and export-only substances,“sufficient containment” means anabsolute release limit of 1 kg/day per siteto the aquatic environment after waste-water treatment.

51. The definitions for “site-limited interme-diate” and “export-only” substances thatthe Table has agreed to (see above) shouldbe accepted and used in the revised NSNRegulations.

3.2.4 Assessment Periods

Assessment periods for each schedule are writ-ten into the Regulations. A balance must there-fore be sought between providing the NSProgram staff with sufficient time to carry outan evaluation and not delaying the notifier’sability to carry on with business. Assessmentperiods are counted in calendar days andallowances are made for weekends and statu-tory holidays.

Table DeliberationsThe government representatives indicated thatthe actual assessment periods are short. Withthe current rate of notifications, assessmentperiods pose a significant challenge for mana-ging program resources.

Government is proposing a new scheme forassessment periods based on notification con-tents and trigger quantities in the proposed


structure of NSN schedules. Proposed changesto the assessment periods reflect more accu-rately the length of time required to processand evaluate NSNs under the new framework.Generally, the greater the volume or the closera notification is to the final tier, the more attention and therefore the more time that arerequired.

Government has consulted with NSN evalua-tors on the adequacy of the current and pro-posed assessment periods. EnvironmentCanada and Health Canada believe thatchanges to the assessment periods for the pro-posed levels of chemicals and polymers willprovide specific benefits for various proposedlevels and an overall benefit of simplifying theNSN process.

Industry representatives felt that the proposedassessment periods for entry level notificationsand PLCs are too long. They urgedEnvironment Canada and Health Canada toreview their internal procedures so that when

assessments are completed before the end ofthe assessment period, notifiers are informedimmediately, and the periods are terminated.

Table Recommendations52. The assessment periods as described

in Table 3.5 should be established.

53. Environment Canada and Health Canadashould review their procedures so that when assessments are completed before the end of the assessment period, notifiersare informed immediately, and assessmentperiods are terminated.

54. In the event that the development of the“smart system” for the characterization of PLCs proves to be successful, in termsof accurately categorizing PLCs, then a reduction in the assessment period for PLCs should be examined.

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Table 3.5: Proposed Assessment Periods for New Substance Notifications

Proposed Level Proposed Period (days)

Non-NDSLTriggers (kg/year)

NDSL Triggers (kg/year)

Chemicals 30 (NDSL) /5 (non-NDSL)

60

75

100

1 000

10 000

1 000

10 000

50 000

Entry

Intermediate

Final

Polymers Entry (non-low concern),low concern

Final(non-NDSL)

Final(NDSL only,low exposure)

30

60

60

1 000

10 000

1 000

10 000

[50 000]

SpecialCategories*

All 30 All

* Special Categories include R&D, site-limited intermediates and export-only substances.

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3.2.5 Facilitation of Waivers for SubstancesUsed for a Prescribed Purpose

It is recognized in CEPA that it may not be necessary to provide all of the information setout in schedules in every case. Information canbe waived under section 81(8)(b) of CEPA if the notified substance is to be used for a prescribed purpose. In order to utilize this pro-vision, regulations need to be in place that setout the purpose for which a substance must beused so as to permit the waiver of information(section 89(1)(f)).

The concept in this CEPA provision is that arisk assessment can be carried out in theabsence of some information that would nor-mally be required, on the basis of the inherentuse of the substance. Information that could bewaived may be associated with the assessmentof exposure or of hazard (or effect).

If the information that is requested to bewaived is related to the assessment of expo-sure, then the prescribed use must be wellcharacterized with regard to all types of expo-sure associated with this use.

If the information to be waived is related to theassessment of hazard or effect, this wouldrequire the exposure to be sufficiently low sothat the risk associated with the substancewould be negligible, making it unnecessary tocharacterize the hazard or effect further.


should work cooperatively with stake-holders to identify purposes of use thatcan be described in Regulations to facili-tate requests for waivers under section81(8)(b). Regulations under the authorityof section 89(1)(f) should be drafted at thesame time as the revised NSN Regulations.

3.2.6 Record-keeping and Enforcement

A working group was established withinEnvironment Canada (separate from this con-sultation) to address issues that had been iden-tified concerning the enforceability of the NSNRegulations over the past number of years.There was one particular issue that the work-ing group felt should be referenced in this

report. It is the need for better clarity as to thetype of information that a notifier will main-tain so that it will be readily available for anenforcement officer to review.

When the matter was presented to the Table, itbecame apparent that a relatively short addi-tion to the NSN Regulations would be suffi-cient to accommodate the need. It was agreedthat the more detailed explanations would bestbe dealt with in the Guidelines document. Thisapproach will be necessary in order to addressthe various types of notifiers, includingCanadian agents for foreign suppliers, as wellas the wide range of record-keeping systems inuse. Industry expressed the importance, fromits standpoint, of obtaining clarification as tothe type of records necessary, as well as thelength of time that they need to be maintained.

The type of wording that the working grouprecommends for inclusion in the NSNRegulations is: “The company or agent shallmaintain all appropriate records or other docu-ments on-site in Canada for at least five yearsfollowing the end of the calendar year inwhich they are made.” What is meant by thewords “appropriate” and “on-site” would beexplained in the Guidelines.

The Table is in general agreement with theinclusion of such a recommendation.

Table Recommendations56. The revised NSN Regulations should

include wording, such as that above,which states the obligation of the notifier/agent to maintain in Canada, for at leastfive years, appropriate records that areavailable for inspection.

57. The revised NSN Guidelines should clarify the type of information the notifiermust maintain.

The following three figures summarize, from Section 3.2, the proposed chemical andpolymer regulatory frameworks.


49

Figure 3.2: Proposed Chemical Framework

Schedule I

>100 kg/yr

No

YesChemical on NDSL

>1 000 kg/yr

Schedule II

>10 000 kg/yr

Schedule III

>1 000 kg/yr

Schedule I

>10 000 kg/yr

Schedule II

>50 000 kg/yr &Exposure Criteria

Met

2nd in vitroGenotoxicity

+ 28-day Repeated Dose

A/D StudyHydrolysis vs. pH28-day Repeated

Dose

No

Eligible for DSL if No Suspicion of Toxicity

>3 kg/day per site

ConsumerExposure

50


Figure 3.3: Proposed Polymer Framework

Polymer Meets Low concern Criteria

No Yes

Proposed Entry level Schedule >1 000 kg/year and

<10 000 kg/year

Proposed Entry level Schedule >1 000 kg/year

(Final)

Polymer on NDSL or AllMonomers on DSL/NDSL?

Proposed Final >10 000 kg/year

Proposed Intermediate/FinalSchedule with Certain Data

Requirements >10 000 kg/year

Does it meet one or both of the following criteria?

Consumer Exposure >3 kg/day per site

>50 000 kg/year

ConsumerExposure . >3 kg/day per site

Final Level (28-day and two

in vitro)

Final Level (28-day and one

in vitro)

DSL if No Suspicion of Toxicity

No

No

Yes

Yes


51

Figure 3.4: Proposed Polymer Framework Including Data RequirementsThis figure provides a more comprehensive presentation of the framework shown in Figure 3.3, incorporating details as to the data required at each decision point.

YesChemical Identity

Use and Exposure InformationMolecular Weight Distribution

Available Data Summary

Polymer of Low concern

>10 000 kg/yr

Water AvailabilityKo/w

Detailed Use & Exposure

Polymer on NDSLor All Monomerson DSL/NDSL

Water Dispersableor

>2% Water Available

Hydrolysis vs. pHAlgal Toxicity

2nd AquaticReady Biodegradation

Table A Polymer?(e.g., Cationic)

Table B Polymer?(i.e., High MW, Stable,

Non-Absorbed)

Acute Oral Toxicity Skin Sensitization

Skin Irritation Informationin vitro Gene Mutation

in vitro Chrom. Aberrationin vivo Chrom. Aberration

28-day Repeated Dose

Exempt fromMammalian Toxicity

testing

Request MammalianToxicity Waivers

No Further Testing

in vitro Gene Mutationin vitro Chrom. Aberration

28-day Repeated Dose

Hydrolysis vs. pHSingle Aquatic Toxicity

Water Dispersable or

>2% Water Available

Table A Polymer?(e.g., Cationic)

Table B Polymer?(i.e., High MW, Stable,

Non-Absorbed)

Acute Oral Toxity

>50 000 kg/yr &Exposure Criteria Met

in vitro Mutagenicity28-day Repeated Dose

Eligible for DSL Listing if No Suspicion of Toxicity

>1 000 kg/yr

No

YesNo

Yes

No

No

No

Yes

Yes

Yes

Yes

No

No

No

>3 kg/day per site

If Granted

If Not Granted

Yes

If Not Granted

Consumer Exposure

Yes

No

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3.3 Transparency of the NSN RegulatoryProcess

BackgroundTransparency refers to the “state of openness”of a particular system. As a generalization, an open or transparent system is one that:

• provides relatively easy access to policies,practices, procedures and decisions;

• ensures that all documents are comprehen-sive and written in plain language;

• provides appropriate opportunities forstakeholders to participate fairly, in a timelymanner and at a reasonable cost in thedevelopment, implementation and monito-ring of the laws, policies, practices, proce-dures and decisions;

• provides interested parties with access tojustifications for the decisions taken thatimpact on their well-being (e.g., legal, eco-nomic, environmental, health, social); and

• allows for appropriate cost-effectivereview/appeal mechanisms.

Principles of transparency require a delicatebalancing of economic, environmental andsocial interests. For example, PAG consideraccess to information a fundamental prerequi-site to full and effective participation in envi-ronmental law and policy development.Industry representatives argue that access toconfidential information must be considered inlight of the potential harm/economic loss thata company may sustain if information of thistype became freely available to competitors.Industry considers proprietary data anextremely valuable commodity representing along-term investment in research, manufactu-ring experience, marketing strategy and busi-ness development. Industry perspectives onthe extent of openness as it relates to access toproprietary data will undoubtedly differ fromPAG perspectives on that same issue.

The Table discussed opportunities to improvetransparency by examining (i) NSN informa-tion relating to regulations, guidelines and policy documents; (ii) confidential businessinformation and publication of risk assess-ments; and (iii) mechanisms for challengingassessment decisions.

(i) NSN Information — Regulations,Guidelines and Policy Documents

BackgroundCEPA includes provisions that address variousaspects of transparency, including informationon the NSN Regulations and NS Program,information access, CBI, information disclosureand masking the name of certain substancesbeing listed on the DSL. Most of the informa-tion that is available can be accessed throughthe CEPA Environmental Registry web site(www.ec.gc.ca/CEPARegistry) and the NSProgram web site (www.ec.gc.ca/substances/).There are also draft policy documents relatedto the NS Program that are as yet unpublished.

It is not currently possible to obtain the riskassessment reports on which decisions arebased, except through the federal Access toInformation Act.20

Table DeliberationsImplementing transparency principles requireshuman and financial resource commitments.The more transparent the system, the morehuman and financial resources and time thatare required for its administration. Resourceconsiderations are particularly acute in the cur-rent NS Program because Program managersmust allocate resources to address transparen-cy needs while meeting legally mandated time-lines for making NSN decisions. The Tableattempted to balance these legitimate conside-rations in providing recommendations on howto improve transparency within the NSProgram.

Table members agree that the current NSProgram lacks an appropriate level of trans-parency. The Table agrees that reducing thecomplexities of the current NSN Regulationsand improving administrative efficiencies areessential tools for promoting transparency inthe NS Program. Both of these concerns arediscussed elsewhere in this report, particularlyin Section 3.2.


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Table Recommendations on ImprovingTransparency of NSN Regulations andGuidelines

58. The NSN Regulations should be writtenin plain language to ensure that all stake-holders with an interest in new sub-stances provisions, including prospectivenotifiers, can understand them. Plain-language NSN Regulations will minimizenotification errors. This, in turn, willreduce administrative burdens andincrease efficiencies in the Program. A simplified, more intuitive structure forthe Regulations will improve their clarity.A simpler structure will reduce trainingtime for staff in both government andindustry.

59. The NSN Guidelines should be written in plain language by a team made up of“regulators” and the “regulated commu-nity.” Interested stakeholders should beinvited to participate in a peer reviewbefore the Guidelines are published. The redrafted Guidelines should includeon-line access to illustrative case studiesand risk assessment and risk managementdecisions for each of the case studies.

60. The CEPA Environmental Registry shouldallow users to identify all environmental/health regulations/control programs (e.g., National Pollutant Release Inventory,Schedule 1 of CEPA, PSLs) that apply to a particular substance in one easy searchoperation.

61. The NSN web site should be linked toother appropriate domestic and interna-tional sites such as those of the OECD, the International Labour Organizationand industry associations. This initiativemay best be achieved through partnershipswith stakeholders.

Table Recommendations on ImprovingTransparency of NSN Policy Documents

62. Several policy documents/statementsshould be developed in order to compre-hensively describe and explain how theNS Program operates. These include:

• a comprehensive, understandable policystatement describing the environmentaland health risk assessment methodologiesused by Environment Canada and HealthCanada for the NSN assessment phase;

• examples of exposure scenarios used forassessing potential human exposure andpotential exposure in the environment;

• how the NS Program operationalizes theprecautionary principle and pollution prevention principles;

• how the NS Program interprets “toxicity”and “suspicion of toxic” in making its riskassessments;

• the policy employed by EnvironmentCanada and Health Canada in treatingconfidential information, including CBI, inaccordance with Part 11 of CEPA (note: thisissue of how Environment Canada andHealth Canada will deal with confidentialinformation vis-à-vis the NS Program isdiscussed in Section 3.3(ii) below);

• published information relating to NSNenforcement actions. This informationcould be included in the annual Report toParliament legally mandated under section342 of CEPA and on the NS Program website;

• published information and statistics on theNS Program each calendar year, includingitems such as the number of notificationsreceived, with appropriate breakdowns bytype, number of conditions and bans, andinformation on international activities withother jurisdictions (e.g., the Four Cornerssubmissions21 [USA], exchanges with theNational Industrial Chemicals Notificationand Assessment Scheme22 [Australia]).

54


(ii) Confidential Business Information andAccess to Risk Assessments

BackgroundThe current NSN Regulations require notifiersto submit certain types of data as part of theirnotification package. Some of the informationsubmitted can be claimed as CBI by the notifi-er. Items that can be claimed as CBI includesubstance identity, company name, whetherthe substance is manufactured and/or importedand in what quantity. Information related tohealth and environmental protection cannot beclaimed as CBI. There are provisions in theMasked Name Regulations to protect thechemical name and corresponding CASNumber. To have a substance listed on the DSLwith a masked name, the claimant must pro-vide written justification and an appropriatename, to meet the requirements of the MaskedName Regulations. Environment Canada willnot accept a claim for a masked name if thesubstance name has been disclosed anywherein the public domain (e.g., inventories of othercountries).

Table DeliberationsIndustry is extremely sensitive about disclo-sure of CBI because disclosure to competitorscould easily mean the loss of a competitiveedge gained by substantial investments inR&D. The PAG argue that opportunities forpublic participation are meaningless withoutfull and fair opportunity to access informationneeded to participate effectively. The Tableagrees that the existing requirements outlinedin the Masked Name Regulations for handlingmasked name entries to the DSL are appro-priate. Similarly, the ability to claim substancevolume, company name and manufacture/import information as confidential is seen asacceptable.

The publication of assessments would informinterested parties that new substances arebeing introduced to Canadian commerce. TheTable explored creative ways of disclosure ofassessment information while still protectingCBI, including the publication of assessmentreports after confidential information has beenremoved. However, in order to remove CBI,regulators and notifiers would need to workclosely together. This alliance would be poorlyperceived by the public. This approach wouldalso be resource-intensive for both parties. TheTable did not pursue this approach further.

The Table considered the option thatEnvironment Canada and Health Canada pre-pare summaries of the assessment report witha listing of information or studies submitted.While resource implications are recognized,this is the preferred option of the Table. In thepublished assessment, the substance would beidentified either by name and CAS Number or,in the case of substances claimed confidential,by masked name and accession number andwould focus on health and environmentalinformation. The CAS Number or accessionnumber could be used as a reference by anyonewanting to challenge the assessment by sub-mitting new information under section 70 ofCEPA. Health Canada or Environment Canadacould then reassess the substance, consideringthe new information, and change the assess-ment outcome as necessary.

Summary assessment reports could be producedon some or all of the notifications received. The Table discussed which notifications shouldbe summarized and made available, cognizantof the resource implications involved.Summarizing and publishing all assessmentreports would require too many resources, andmany of the reports would not provide signifi-cant information. Publication of reports beinglisted on the DSL would provide informationon those substances that are being commercia-lized. Reports on substances subject to controlswould also be published regardless of the levelof notification. To save resources, PLCs couldbe either listed simply as PLCs without anassessment or alternatively not published at all.

Table Recommendations63. The full assessment report should be

made available to the notifier. The Tablerecognizes that this is resource-intensivebecause the government would have toremove any CBI received from anothersource.

64. Summaries of the following assessmentreports should be published in descend-ing order of priority:

• substances for which controls have beenimposed;

• substances for which final notification has been received;

• all assessments for all substances exceptPLCs; and

• PLCs.


55

(iii)Mechanisms for Challenging AssessmentDecisions

Background and Table DeliberationsCurrently, CEPA does not have a formal appealmechanism for challenging a regulatory deci-sion relating to the assessment of a new sub-stance. A section 70 submission by a personengaged in the commerce of new substancescould trigger a reassessment of the substance ifthe new information submitted were found tobe relevant. The option is always open to chal-lenge an assessment via an application for judi-cial review in the federal courts.

The Table did consider the merits of recom-mending a formal appeal mechanism but reco-gnizes that changes to CEPA would likely berequired to implement this process. The Tablerecognizes that substantive amendments toCEPA such as a new substances assessmentappeal mechanism are not likely to happenprior to the statutory review of CEPA in 2005.PAG representatives strongly believe that a for-mal appeal mechanism is vital to ensuring thecredibility and transparency of the assessmentprocess.

Table Recommendation65. Health Canada and Environment Canada

in consultation with other governmentdepartments and stakeholders shouldexamine the feasibility of an appeal mechanism and how it could be incorpo-rated into a revised CEPA.

3.4 Improving Responsiveness of theNSN Regulations and NS Program inthe Global Context

BackgroundThere are currently at least eight countries/legal jurisdictions that have instituted a uniquedomestic chemical inventory and a process forthe notification and assessment of new sub-stances. In all cases, these have been driven bythe objectives of protection of human healthand the environment. Although they have similar goals, the methods of accomplishingthem vary considerably. The proliferation and

variation of chemical control systems some-times lead to unnecessary duplication ofefforts. Many companies now market theirproducts globally, giving rise to multiple notifi-cations of the same substance. Significant effortis expended by both the notifying company inpreparing a notification dossier and the gov-ernment authority in reviewing it.

Canada has long been party to internationalcooperation on chemicals, including agree-ments on MAD and the principles of GLP.More recently, new international initiatives areemerging that are advancing concepts such asMAN in the interest of achieving improvedefficiencies while maintaining or improvinghuman and environmental health protectionwithin participating countries. Examples of theinitiatives in which Canada is involvedinclude:

• an OECD Task Force on New IndustrialChemicals that is undertaking a number ofinitiatives, ranging from information andwork-sharing, through bilateral/multilate-ral arrangements, to management of CBI;

• the “Four Corners Agreement” (4CA)between Canada and the United States thatprovides a formal mechanism for sharingdata and assessments to allow for reduc-tions in the data required for their notifica-tion in either country; and

• a Canada–Australia Bi-lateral Arrangementthat is currently being set up for purposessimilar to the 4CA and that acknowledgessimilarities in notification systems and market conditions.

Most sectors of Canadian industry depend onimports for access to current novel and lessharmful chemical technologies in order toinnovate and compete in world markets. Whilechemical production in Canada is considerable,the variety of chemicals produced is limited.Furthermore, Canada is a relatively small mar-ket in comparison with its major trading part-ners. The majority of chemical imports origi-nate in the United States or the EuropeanCommunity, where notification and assessmentwill have taken place.

56


Table DeliberationsTable members agreed on the desirability ofpursuing harmonization among national notifi-cation and assessment schemes. The potentialbenefits for Canada are many, including gaining access to sound science for decision-making, minimizing duplicative effort, greaterefficiency and effectiveness, and greater abilityof Canadian industry to compete with produc-ers of chemicals and manufactured products inworld markets. Members acknowledged thesignificant challenges that harmonization represents for Canada. It requires the coopera-tion and commitment of other countries. In addition, there are significant technical andscientific challenges that need to be addressed,including differences in data sets used inassessments, risk assessment methodology,exclusions and exemptions from notification,and protection of CBI. Table members alsonoted the significant policy challenges that harmonization poses for all countries.Harmonization must lead to a raising of healthand environmental protection standards andnot drop to the “lowest common denominator”in terms of science-based decision-making. Analternative perspective was that harmonizationprovides an opportunity for Canada to advo-cate higher standards that ensure that all newsubstances in international use receive thesame rigour in assessments. It was felt that this could be accomplished while retainingCanada’s legislative authority to make deci-sions that are most appropriate for protectionof Canadian health and environment.

The Table reviewed international efforts inwhich Canada is participating. The Tableobserved that these efforts are proceedingwithout having formally shared with stake-holders a clear vision of harmonization relatingto NSN or a strategic plan that describes near-and long-term goals, priorities and the meansto achieve them. Table members noted that thiswas a significant limitation to cooperation withstakeholders.

The Table noted that a strategic plan must beflexible and responsive to current and futureinternational initiatives (including those in theEU23). Furthermore, based on experiences withharmonization of efforts for existing sub-stances, the Table suggested that an initialobjective for new substances should be thepursuit of international harmonization of

hazard assessments rather than risk assess-ments that require a means for handling differ-ences in exposure characterization. In thelonger term, the strategic plan should clarifyCanada’s interests regarding the potential forbroader harmonization.

In the context of notifications and assessmentstaking place in other jurisdictions, the Tablenoted the opportunity for Canada to be one ofthe largest beneficiaries from the advance-ments in information and work-sharing, stan-dardization of notifications and assessmentreports, and related initiatives. Gaining accessto and utilizing assessments from other coun-tries are anticipated to result in validation ofprocesses, strengthened assessment capacity,cost savings and improved efficiencies.

In order to realize the potential benefits fromcooperation with other countries, Canada willbe required to make significant investmentsand commitments to ensure it can play ameaningful and influential role. This wouldinvolve the types of science investmentsdescribed in Section 3.5(iii) below.

The Table agrees that the current revisions tothe NSN Regulations and Guidelines should,wherever appropriate, encourage the attain-ment of international harmonization.


should develop and implement a strategicplan covering the next five years thatpositions Canada to play a leadership rolerelating to NSN in international initiativesaimed at promoting high standards in theprotection of human health and the environment in a way that permits betteruse of industry and government resources.This plan should be flexible and respon-sive to current and future initiatives, taking into consideration the followingelements:

• An initial objective of the strategic planshould be the pursuit of internationalharmonization of hazard assessments,along with clarification of Canada’sinterests regarding the potential forbroader harmonization over the longerterm.


57

• Within the framework of the strategicplanning process, Canadian support for,and participation in, international initia-tives, such as those under the leadershipof the OECD Task Force on New Indus-trial Chemicals, should be strengthened.

• Stakeholders, including other govern-ment departments, should be continuallyengaged in the implementation of initiatives undertaken as part of the strategic plan.

3.5 Service Delivery

BackgroundTable members recognize that service deli-very for the NS Program operates within a legislative framework (CEPA and the NSNRegulations), and, as such, compliance ismandatory. Compliance with the legislation isachieved through compliance promotion initia-tives and enforcement. A notifier who choosesto import a new substance into, or manufac-ture a new substance in, Canada is obliged toprovide prescribed information. HealthCanada and Environment Canada are requiredto perform assessments, make decisions to pro-tect human health and the environment andensure compliance with the law. Within thisframework, those charged with the adminis-tration and enforcement of the NS Program deliver a service to a wide range of stakehold-er groups with significantly different needs.This section deals with how the regulations aredelivered, not the content of the regulations ortheir enforcement (see Environment Canada’sCEPA Enforcement and Compliance Policy,24

currently being revised).

The Table agreed that a “quality service”approach may both enhance the effectivenessof the Regulations to protect human healthand the environment and reduce the negativeperception that the Regulations are a barrier toinvestment and innovation (see the NewSubstances Notification Impact WorkingGroup Report and the Cost Recovery Report25)when balanced with improved enforcement ofthe Regulations. While outside the scope ofthese consultations, the enforcement functionis recognized by the Table as an integral partof a quality service approach to achieving theCEPA objectives for new substances.

The Table recognized that current servicedelivery efforts are generally satisfactory andnoted that Environment Canada and HealthCanada have undertaken a number of initia-tives aimed at improving service delivery.Nevertheless, all Table members agree thatvarious aspects of service delivery can beimproved. This section of the report providesrecommendations on how this may be donewithout impairing the effectiveness of the NSNRegulations in protecting health and the envi-ronment, taking into consideration the needsof all stakeholders, and at acceptable cost tothe Program and its stakeholders. It addressesthe way in which advances in leadership, themanagement of service delivery, informationtechnology and innovation might be used tomeet service delivery targets.

Table Deliberations

(i) Quality ServiceQuality service management practices todefine and meet the needs of each stakeholdergroup need to be developed across theProgram. For example, while industry repre-sentatives reported excellent technical feed-back, service delivery is not uniform across theProgram. The Program has established confi-dence in its ability to meet legislated timelines;however, measurable service/performanceindicators and a complaints resolution mecha-nism would be value-added components.These service/performance indicators forhealth and the environment must recognizethe legislated mandate and the Program’sresponsibility to the Canadian public by alsoaddressing their concerns about the effective-ness of the regulatory system. A quality serviceframework should provide for a better, cheap-er and safer system.

In reviewing quality service issues, the Table referred to the Auditor General ofCanada’s April 2000 Report on ServiceQuality26 and “Achieving Citizen/Client-Focused Service Delivery: A Framework forEffective Public Service Organizations,”27

developed by the Treasury Board Secretariatand the National Quality Institute.

Measurable service/performance indicatorsshould be employed to help identify opportu-nities for continuous improvement. These indi-cators are critical for ensuring the effectivenessof the Program in protecting the health and

58


environment of Canadians and for improvingthe internal efficiency and administration ofthe Program. These indicators must be selectedand implemented in an open, transparent andaccountable manner. They must also be perio-dically reviewed against international servicedelivery initiatives (e.g., within OECD).

While timelines are important to some stake-holders, there are other measures of servicequality. The Table recognizes that a single win-dow may not be feasible in a program wheretwo ministers share responsibility. The fact thatthere are two departments with structural andorganizational differences has sometimes beena source of frustration. Access to the datarequired for transparency of the Program couldbe handled better with a service quality stan-dard that addresses this.

The Table agrees that the NS Program is notuniformly understood by all stakeholders.Confidence in the Program could be improvedby dedicating increased resources to education,training and information provision. Differentlevels of education, training and informationwill be needed for different stakeholdergroups, and all these needs should be reco-gnized and addressed through the variousmedia available to the Program. Education andtraining should be used not only to increaseconfidence in the Program, but also to promotecompliance with the Regulations. Better educa-tion and training for industry should help raiseawareness of the need to comply with the NSProgram and create a more level playing field.A simple process, preferably electronic, forfeedback that is user-friendly, accessible, usedconstructively and well publicized would alsoimprove service delivery.

Partnerships with various stakeholder groupsshould be employed to increase the effective-ness of training and information dissemina-tion; however, there must be dedicatedresources for this activity. Secondmentsbetween the Program and industry and PAGcould create benefits for all, such as theexchange of valuable expertise and raisingstakeholder confidence in the Program.Regulators should work with stakeholders toexplore ways in which such secondmentscould be facilitated without having a negativeimpact on the confidentiality of competitivebusiness information supplied for notifications.


should implement the recommendationsof the Auditor General relating to imple-mentation of measurable service qualitystandards, service/performance indicators,measuring stakeholder satisfaction andcontinuous improvement, such as thoseoutlined in the framework developed by the Treasury Board Secretariat and the National Quality Institute.

68. Service/performance indicators should be developed and reviewed periodicallyagainst international service delivery initiatives (e.g., within OECD).

69. Education, training and information provision for all stakeholders should be treated as a priority and assigned sufficientdedicated resources to be effective.Partnerships should be utilized, includingpersonnel exchanges.

(ii) Leadership for Cultural ChangeA key concept of a quality-based approach toservice delivery is organizational developmentand the understanding of its current “culture.”This enables the strengths and challenges ofthe organization to be identified and the path-ways and opportunities for change to beplanned.

The Table recognized that NSN staff deal withtechnical, scientific and administrative issuesunder challenging legislated deadlines. Whilestakeholders report incidents of exemplaryservice, the delivery is not always uniform. A commitment to “service culture” in the pro-cessing of applications that emphasizes theimportance of quality service principles canpositively contribute to maximizing humanhealth and environmental protection.

Some industry stakeholders continue to per-ceive the NSN Regulations as a barrier to inno-vation, foreign direct investment and trade. A cultural shift that focuses on, and consistentlypromotes, quality service delivery shouldreduce these negative perceptions while main-taining or improving health and environmentalprotection.


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A cultural shift will also improve the commit-ment to openness, transparency and accounta-bility. While the issue of transparency isaddressed elsewhere in this report (see Section 3.3), it is identified here as a third areathat may benefit from cultural change. Recentimprovements to the NSN Regulations website have increased the Program’s transparency,and implementation of the Table recommenda-tions detailed in Section 3.3, including annualstatistical reporting, will provide further neededimprovement. The Table agrees that theProgram should report annually, in addition tostatistical data, on its progress in establishingand meeting service standards, continuousimprovement goals, measurable service/performance indicators, education and trainingactivities, and its impact on sustainability.These measures are cost- and resource-intensive and must be appropriately funded.

Cultural change requires senior managementvisibility, participation in communicating thevalues to all stakeholders, commitment andaccountability.

Table Recommendations70. Senior management in Environment

Canada and Health Canada should seekways to enhance quality serviceapproaches that are more open and trans-parent and centred on the principles ofsustainability, develop a mission statementthat captures these values, communicateit to all stakeholders and report annuallyon actions and results in achieving sustainability, transparency and service quality goals.

71. Senior management of both departmentsshould review the organizational optionsto deliver a more effective, timely, single-window service. The advantages and disadvantages of physically locating all of the NSN staff together as an option to improving service delivery should be considered.

(iii)InnovationThis section addresses three areas of innova-tion: information technology, science and theuse of novel strategic approaches to achievingthe goals of the NSN Regulations.

The Canadian government outlined its com-mitment in the 1999 Speech from the Throne28

to becoming a “model user of informationtechnology and the Internet,” with governmentservices available online by 2004. The Tablereviewed several innovative ways of impro-ving the effectiveness and efficiency of servicedelivery. It sought ways to:

• fully exploit the potential of the growth ininformation technologies;

• reduce the direct costs to comply with theNSN Regulations; and

• encourage broader compliance.

The NSN Regulations delivery service wasdesigned as a paper process. Information technologies have been added, but it remains a paper process facilitated by electronics.Greater use of new technologies could allowthe government and stakeholders to realizesignificant service quality improvements andefficiencies.

Most of the information supplied by applicantsis increasingly available in electronic format.Industry wants the option to file applicationselectronically with CBI fully protected, trackthe application’s progress and respond to ques-tions electronically. The feasibility of redesi-gning the whole process to one centred on elec-tronic communication should be examined andimplemented if found to be beneficial. Thiswould enable industry and government torealize considerable cost and time savings.Information sharing between Program staffwould be simplified, scheduling and trackingwould be more efficient, and it should be pos-sible to extract data for transparency and per-formance accountability automatically.

Furthermore, a “smart” system (an interactive,intuitive and responsive computer system)could facilitate electronic filings and simplifythe perceived complexities of schedules thatare currently part of the NSN Regulations bytaking a more intuitive and interactiveapproach. It should also minimize errors andomissions, reduce the need for training andreduce the perception that complexity is a barrier to compliance.

Noting that secure electronic filing and a“smart” system will require the developmentof extensive new software, the acquisition of

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hardware components and their integrationwith current systems, the Table recognizes the prudence of a phased approach, such as filing by disk until other more expensiveimprovements are in place. EnvironmentCanada and Health Canada are encouraged to pursue their efforts for obtaining funding to assist them in implementing the above-mentioned measures.

Another way of reducing the direct costs toapplicants is by facilitating the opportunity toshare data among applicants. Internationalcooperation agreements allow notifiers to haveaccess to data packages filed for the same orsimilar substances in other countries.Development of the existing elective informa-tion-sharing agreements using a “smart” sys-tem that encourages the use of common datapackages should be explored. A barrier toincreased data sharing is concern for the pro-tection of CBI. A “smart” system providing a“brokerage” between the current and an earlierapplicant should be explored.

With regard to scientific innovation, the March2001 Report of the National Round Table onthe Environment and the Economy entitledManaging Potentially Toxic Substances in Canada29

recommends significant increases in scienceexpenditures, improved coordination amonginvolved institutions and increased scientificstaffing to better understand and judge the scientific information government receives,advances in scientific knowledge and theincreasingly complex assessment issues.

The Table agrees that the scientific issues arebecoming more complex and that additionalfunding and better coordination among government agencies may be required for government to keep up with the changes anddiscoveries and fulfil its obligation to protectthe health and environment of Canadians. At the same time, the Table agrees that some fundamental changes are needed to avoid a situation where the number and complexity oftests requested by the regulators (in the evalua-tion of new chemicals) increases with thegrowth in science to the point where it beco-mes unnecessarily cumbersome. Governmentsalso have an obligation to their citizens todevelop and validate current assessment methods with a view to making them moreeffective, as exemplified by the Commission of the European Communities White Paper,Strategy for a Future Chemicals Policy.30

The Table believes that the NS Program mustseek the resources to strengthen its scientificcapacity to meet its obligations:

• to develop and validate test methods,screening procedures and modelling techniques;

• to assess the adverse effects of chemicals(e.g., low-level, long-term and interactive);

• to improve existing and develop new toxico-logical methods that better predict a chemical’shazard and do so more quickly and morecheaply than current procedures; and

• to continually simplify, improve and vali-date the effectiveness and efficiency of therisk assessment process itself.

The Table recognizes that similar efforts arealready well established or proposed elsewherein the world, so one way to achieve the newand improved methods is through work sharing with other nations with high environ-mental and human health standards and par-ticipation in international efforts. These issuesare detailed in Section 3.4 of this report. ForCanada to play a role in this process, it mustboth gain far more knowledge about the vari-ous ways in which our trading partners assesshazards and also increase the international profile of our procedures.

Table Recommendations72. The feasibility of redesigning the program

delivery to permit secure electronic filingwith access simplified by a “smart” system should be examined.

73. Information sharing should be facilitatedand international cooperation continuedand possibly expanded.

74. Opportunities for secondments among government and stakeholders should beexplored and pursued where mutually beneficial.

75. Government should work with stake-holders to examine innovative measuresfor ensuring compliance with the NSNRegulations.

76. Adequate science resources should be dedicated to addressing the increasinglycomplex hazard and risk assessment challenges, including innovative improve-ments to assessment methods that providegreater protection more efficiently.


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4. Endnotes1 Government of Canada, Canadian

Environmental Protection Act (CEPA) Part 2 —Toxic Substances: Substances New to Canada(1999); available at: www.ec.gc.ca/substances/nsb/eng/reg_e.htm

2 Government of Canada, New SubstancesNotification Regulations (July 1994); available at:www.ec.gc.ca/substances/nsb/eng/reg_e.htm

3 Environment Canada, New Substances website: www.ec.gc.ca/substances/nsb/eng/biag_e.htm

4 Environment Canada and Health andWelfare Canada, Final Report of theEnvironmental Contaminants Act AmendmentsConsultative Committee (1986); available fromthe New Substances Notification Branch,Environment Canada.

5 Environment Canada, Toxic SubstancesManagement Policy (June 1995); available at:www.ec.gc.ca/toxics/en/index.cfm

6 Environment Canada, Toxic SubstancesManagement Policy (June 1995).

7 Environment Canada, Toxic SubstancesManagement Policy: Environment CanadaImplementation Strategy for New Substances(April 2001); internal draft.

8 Environment Canada, ARET (AcceleratedReduction/Elimination of Toxics), “VoluntaryAction on Toxic Substances”; available at:www.ec.gc.ca/aret/homee.html

9 Organisation for Economic Co-operation andDevelopment (OECD), OECD Test Guideline407, Repeated Dose 28-day Oral Toxicity Studyin Rodents (Updated Guideline, adopted July 27, 1995).

10 Environment Canada, Establishing a NationalAgenda on the Scientific Assessment ofEndocrine Disrupting Substances 5NRWorkshop Report (February 2000); availableat: www.ec.gc.ca/eds/fact/index.htm

11 Government of Canada, Guidelines for theNotification and Testing of New Substances:Chemicals and Polymers (1993); available atwww.ec.gc.ca/substances/nsb/eng/gui_e.htm

12 Organisation for Economic Co-operationand Development, EnvironmentDirectorate, Environmental Health andSafety Division, OECD Minimum Pre-MarketData Set; available at: www.oecd.org/EN/home/0,,EN-home-0-nodirectorate-no-no-no-0--no-,00.html

13 Organisation for Economic Co-operation and Development (OECD), EnvironmentDirectorate, Environmental Health and Safety Division, Guidelines for Testing of Chemicals; available at:www.oecd.org/EN/document/0,,EN-document-524-14-no-15-24345-524--no-00,00.html

14 W.M.S. Russell and R.L. Burch, The Principlesof Humane Experimental Technique (London,UK: Methuen, 1959).

15 Organisation for Economic Co-operation andDevelopment (OECD), OECD Test Guideline420, Acute Oral Toxicity — Fixed Dose Method(Original Guideline, adopted July 17, 1992);OECD Test Guideline 423, Acute Oral Toxicity— Acute Toxic Class Method (OriginalGuideline, adopted March 22, 1996); OECDTest Guideline 425, Acute Oral Toxicity: Up-and-Down Procedure (Original Guideline,adopted September 21, 1998).

16 Organisation for Economic Co-operation andDevelopment (OECD), OECD Test Guideline401, Acute Oral Toxicity (Updated Guideline,adopted February 24, 1987).

17 Organisation for Economic Co-operation and Development (OECD), OECD TestGuideline 429, Skin Sensitisation: Local LymphNode Assay (Draft New Guideline, November 2000).

18 Organisation for Economic Co-operation andDevelopment, Environment Directorate,Environmental Health and Safety Division,Guidance Document on the Recognition,Assessment, and Use of Clinical Signs asHumane Endpoints for Experimental AnimalsUsed in Safety Evaluation (OECDEnvironmental Health and SafetyPublications, Series on Testing andAssessment, No. 19) (June 2000); avail-able at: www.oecd.org/EN/home/0,,EN-home-0-nodirectorate-no-no-no-0--no-,00.html

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19 U.S. Environmental Protection Agency, NewChemical Information Bulletin: Exemptions forResearch and Development and Test Marketing(1986); available at:http://www.epa.gov/opptintr/newchems/tmeranddbulletin.pdf.

20 Government of Canada, Access to Information Act (1985); available at: laws.justice.gc.ca/en/A-1/index.html

21 Environment Canada and Health Canada,New Substances Notification Advisory Note 01-99, Renewal of the Agreement for Sharing ofInformation Between the U.S. EnvironmentalProtection Agency (USEPA), and EnvironmentCanada (EC) and Health Canada (HC) (FourCorners Agreement) (1999); available atwww.ec.gc.ca/substances/nsb/eng/advisory_e.htm

22 Environment Canada and Health Canada,Canada-Australia Bi-lateral Arrangement (Draft2001); available from the New SubstancesNotification Branch, Environment Canada.

23 Commission of the European Communities,Strategy for a Future Chemicals Policy,Commission of the European Communities White Paper (February 2001).

24 Environment Canada, CEPA Enforcement and Compliance Policy (1999); available at:www.ec.gc.ca/CEPARegistry/enforcement/default.cfm

25 Environment Canada, Discussion Paper: Cost Recovery for the CEPA New SubstancesNotification Program (Chemicals and Polymers) (1998); available at:www.ec.gc.ca/substances/nsb/eng/rec_e.htm

26 Office of the Auditor General of Canada,Report of the Auditor General of Canada(Service Quality) (April 2000); available at:www.oag-bvg.gc.ca/domino/reports.nsf/html/0009ce.html

27 Treasury Board Secretariat and NationalQuality Institute, Achieving Citizen/ClientFocused Service Delivery: A Framework forEffective Public Service Organizations; availableat: http://collection.nlc-bnc.ca/100/201/301/tbs-sct/tb_manual-ef/Pubs_pol/partners/QFT1-9E.html.

28 Government of Canada, Speech from theThrone (1999).

29 National Round Table on the Environmentand the Economy, Managing Potentially ToxicSubstances in Canada (March 2001).

30 Commission of the European Communities,Strategy for a Future Chemicals Policy,Commission of the European Communities White Paper (February 2001).

31 M. Swanson and A. Socha, Chemical Rankingand Scoring: Guidelines for Relative Assessmentsof Chemicals (1997), p. 93.

32 Environment Canada, Environmental Leaders 2: Accelerated Reduction/Elimination of Toxics (ARET) (1997), p. 36.



35 For “poor” category, taken from:Environment Canada, Environmental Leaders 2: Accelerated Reduction/Elimination of Toxics (ARET) (1997), p. 34.

36 Based in part on Environment Canada,Environmental Leaders 2: AcceleratedReduction/Elimination of Toxics (ARET) (1997),p. 34; and U.S. Environmental ProtectionAgency, Proposed Category for Persistent,Bioaccumulative, and Toxic Substances (October 5, 1998); available at:www.epa.gov/opptintr/pbt/pbt-fr-o.htm



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APPENDICES

A.1:Table Members

Federal Government

Andy Atkinson (alternate for EnvironmentCanada)New Substances BranchEnvironment Canada

Ranjan Bose (alternate for Health Canada)Chemicals 2 SectionNew Substances Assessment and ControlBureauProduct Safety ProgrammeHealthy Environments and Consumer SafetyBranchHealth Canada

Irene CaldwellNew Substances BranchEnvironment Canada

Dave McBainNew Substances BranchEnvironment Canada

Gary McGee (alternate for Industry Canada)Manufacturing Industries BranchIndustry Canada

Shaunalea SavardChemicals 3 Section New Substances Assessment and ControlBureauProduct Safety ProgrammeHealthy Environments and Consumer SafetyBranchHealth Canada

Jackie SitwellNew Substances Assessment and ControlBureauProduct Safety ProgrammeHealthy Environments and Consumer SafetyBranchHealth Canada

Tony StoneManufacturing Industries BranchIndustry Canada

Industry

Ilse BacchusPPG Canada Inc.

Ernie Henderson BASF Canada

Allan JonesIndustry Co-ordinating Group for CEPA

Peter Marr Dominion Colour Corporation

David Sheppard 3M Canada Inc.

Jack SouleDupont Canada Inc.

Don Wilke Procter & Gamble Inc.

Public Advocacy Groups

Dave Bennett Canadian Labour Congress

Stephane GingrasGreat Lakes United

Jessica GinsburgCanadian Environmental Defence Fund

Jenny HillardConsumers Association of Canada

Brian KohlerCommunications, Energy andPaperworkers’ Union of Canada


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Burkhard MausbergCanadian Environmental Defence Fund

Fred Ruf Canadian Public Health Association

Observer

Yves BourassaRegulatory and Economic Assessment BranchEnvironment Canada

Secretariat

Linda Jones

Sheila McCrindle

Hajo Versteeg


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A.2:Procedural GuidelinesAdopted by the TableMembersDuring its first meeting, Table members agreedon the following set of “Guiding Principles” tohelp direct the consultative process:

• Multistakeholder Consultation (MSC)members have the right to help shape thesubstantive issues to be addressed at allMSC meetings, and the process for address-ing them.

• MSC members have a right to be heard andan obligation to listen. Members do nothave a right to dominate discussions or topromote their own particular agenda to thedetriment of the MSC mandate.

• MSC members must be prepared to presenttheir views in a constructive manner thatfosters mutual problem solving.

• MSC members must agree to build on common ground and remain flexible inorder to seek consensus in developing rec-ommendations.

• MSC members must recognize and respectthe legitimacy of views that differ fromtheirs.

• MSC members must strive to develop recommendations that can be realisticallyimplemented.

• MSC members must have timely and equalaccess to a common information base.

• By definition, a consensus-driven exercise isnot a “majority rules” exercise. When,despite best efforts, general agreement/consensus is not achieved on a particularissue/recommendation, the differing viewspertaining to that issue/recommendationwill be clearly and fairly recorded in thepublic record. For this to occur, individualmembers have an obligation to articulatetheir views clearly and concisely at MSCmeetings. In this way, the Ministers ofEnvironment and Health, who are ultimate-ly responsible for acting on the recommen-dations of the MSC, can make fullyinformed decisions.

• Where consensus is achieved, MSC mem-bers have an obligation to support that con-sensus in its entirety. It is not appropriatefor members to promote only those parts of

the consensus that meet their own particu-lar agenda.

Table Members are appointed by organiza-tions that have been invited to participate inthe consultations. Each invited organizationwas asked to nominate one or a number of del-egates. Each organization has undertaken itsown selection process and has put mechanismsin place to keep other interested partiesinformed on the progress of the consultations.MSC Members are expected to abide by theconsultation principles outlined above.

The Environment and Health Canada rep-resentatives (the Co-chairs of this MSC) areultimately responsible for delivering theresults/outputs of this MSC to their seniormanagement for full and fair consideration inamending the NSN Regulations. Where con-sensus is reached, the Co-chairs are responsiblefor vigorously promoting that consensus in itsentirety to their senior management. Whereconsensus recommendations are not incorpo-rated into the amended Regulations, the Co-chairs have a responsibility to fully explain tothe MSC members the reasons for the devia-tion(s). The Co-chairs are responsible forensuring that the MSC process has adequateresources to complete its task.

The Secretariat will undertake to:

• arrange all meeting logistics, including sub-committee meetings;

• provide secretarial services, including serv-ices at meetings;

• manage financial arrangements, includingcontracts with group members;

• contract out or conduct research if, and as,requested by the MSC;

• prepare briefing binders, including draftproposals if, and as, requested by the MSC;

• prepare draft Records of Decision/ActionItems from meetings, which, initially, willconsist of brief decision points, action itemsand follow-up activities, including assignedresponsibilities (subject to the approval ofthe MSC, detailed meeting minutes are notnecessary);

• provide information to any interested party(i.e., stakeholders not at the table, includingfederal and provincial/territorial agenciesand members of the general public); and

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• act as the clearinghouse to receive, distrib-ute and manage information. A web sitewill be established to provide participantswith electronic access to all relevant docu-ments, meeting information and records ofmeetings. The web site will also house anarea that will be accessible only by pass-word, to allow members to share restrictedinformation and to facilitate the drafting ofMSC reports.

The entire MSC Table will approve subcom-mittees and their membership. Subject todirection from the Table, subcommittees willdiscuss in detail individual substantive issuesand will draft reports/recommendations fordiscussion/approval by the MSC. The subcom-mittees will be supported by the Secretariat.

Each member (or group of members) shouldselect an alternate to act as a replacement ifnecessary. To ensure continuity, alternates will beused only as a last resort. Alternates must be ableto speak for the member/organization repre-sented. Decisions reached by the Table are notto be revisited at subsequent meetings by indi-vidual members who missed a previous meet-ing, whether or not their alternate was present.The Secretariat will ensure that alternates areprovided with all information given to themembers, including meeting information, draftminutes and reports. Alternates are expected tomaintain the confidentiality of the Table andmust abide by the principles detailed in thisdocument. Participatory funding will be paidto the alternate (if needed) as outlined in thefunding policy when the alternate is replacinga member entitled to funding at the meeting.

Eligible participants will be compensated fortheir travel and accommodation expenses toattend meetings and for meals not providedduring meetings. Original receipts must beprovided with expense claims, which are to besubmitted to Environment Canada (theSecretariat has all relevant information).Eligibility for funding is subject toEnvironment Canada’s guidelines for partici-patory funding, which are contained in thedocument Our Commitment to EffectiveConsultation, May 1996. This document can befound on Environment Canada’s web site atwww.ec.gc.ca/consult/policy%5Fe.html. Thefacilitator will, in close consultation with theCo-chairs, be responsible for participatoryfunding decisions. Subject to overriding

Environment Canada and Health Canada poli-cy, the criteria for granting funding are basedon demonstrable need, value for money andaccountability. All aspects of the funding poli-cy, including actual amounts granted to parti-cular MSC members and accountabilityreports, must be completely open to publicscrutiny (including the media). In the end, parti-cipatory funding decisions are subject to theprinciples of fairness, reasonableness, overallbudget constraints, government policy andrespect for public monies.

All information, except information that hashistorically been considered confidential (draftminutes, draft reports, etc.) will be made avai-lable to the public, including the media, ifrequested.

Subject to the agreement of the group,observers may sit in on meetings. Observersmay provide input at meetings, but only ifrequested by the facilitator or the group (asopposed to individual members). Observersmust respect all confidences of the process. Thenumber of observers should be kept to a mini-mum, and observers cannot be seen to be dis-rupting the flow of the meetings. The mostlikely type of observer will be a technicalexpert who is approved by the Table as a mem-ber of a subcommittee. It may be useful forthese individuals to attend some or all of cer-tain Table meetings. Any member contemplat-ing inviting an observer must first discuss theidea with the group or, at least, with the facili-tator. Observers should not necessarily expectto attend meetings if they arrive without priorapproval from the Table. Observers are not eli-gible for participatory funding.

Flexibility, understanding, respect and compas-sion are keys to the success of the MSC.


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A.3:Background and SupportingDocuments

This appendix does not duplicate the docu-ments referenced in Section 4 of the report,“Endnotes.”

1. Report of the New Substances NotificationImpact Working GroupEnvironment Canada, 1999Available at: www.ec.gc.ca/substances/nsb/eng/rec_e.htm

2. Discussion Document on Amendments to theCEPA New Substances Notification Regulations(Chemicals and Polymers)Environment Canada and Health Canada,August 1999

3. Importation and Manufacture of Chemicals andPolymers in Canada: Are You Required toNotify?Environment Canada and Health Canada,April 1998Available at: www.ec.gc.ca/substances/nsb/eng/notify_e.htm

4. Our Commitment to Effective ConsultationEnvironment Canada, 1996Available at: www.ec.gc.ca/consult/policy_e.html

5. Study to Assess the Socio-economic Impact ofthe Proposed Regulations RespectingNotification of Substances New to Canada Environment Canada, 1993Available from the New Substances Branch,Environment Canada

6. New Substances Notification ProgramRegulatory Impact Analysis StatementEnvironment Canada, 1994Available at:www.ec.gc.ca/substances/nsb/eng/reg_e.htm

7. Toxic Substances Management Policy:Persistence and Bioaccumulation CriteriaEnvironment Canada, June 1995

8. Toxic Substances Management Policy: Reporton Public ConsultationsEnvironment Canada, June 1995

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A.4:List of Acronyms andDefinitions

Glossary of Terms and Abbreviations

ARET Accelerated Reduction/Elimination of Toxics

ASTM American Society of Testing andMaterials

4CA Four Corners Agreement(Canada/U.S.)

CAEAL Canadian Association ofEnvironmental AnalyticalLaboratories

CAS Chemical Abstracts Service

CBI Confidential Business Information

CEPA Canadian Environmental ProtectionAct

CFC Chlorofluorocarbon

CSC Canadian Standards Council

DSL Domestic Substances List (Canada)

EDS Endocrine Disrupting Substance

EDTA Endocrine Disrupter Testing andAssessment

EINECS European Inventory of ExistingChemical Substances

ELINCS European List of New ChemicalSubstances

EPA Environmental Protection Agency(U.S.)

EU European Union

GLP Good Laboratory Practice

GWP Global Warming Potential

ICG Industry Co-ordinating Group

Kow Octanol/Water Partition Coefficient

MAD Mutual Acceptance of Data

MAN Mutual Acceptance of Notifications

Mn Number Average Molecular Weight

MPD Minimum Pre-market Data Set

MSC Multistakeholder Consultations

MSDS Material Safety Data Sheet

MW Molecular Weight

NDSL Non-Domestic Substances List(Canada)

5-NR EDS Canadian Natural ResourceDepartments Endocrine DisruptingSubstances Working Group

NS New Substances

NSN New Substances Notification

NWRI National Water Research Institute

ODP Ozone Depleting Potential

OECD Organisation for Economic Co-oper-ation and Development

PAG Public Advocacy Groups

PIC Prior Informed Consent

PLC Polymers of Low Concern

PSL Priority Substances List

QSAR Quantitative Structure–ActivityRelationship

R&D Research and Development

SAR Structure–Activity Relationship

SNAc Significant New Activity

TSCA Toxic Substances Control Act (U.S.)

TSMP Toxic Substances ManagementPolicy

Definitions

Domestic Substances List (DSL)The DSL is an inventory of 24 017 (in August2001) existing substances in Canada. The origi-nal list was composed of substances that werein commerce in Canada between January 1,1984, and December 31, 1986. Substances areadded to the list by meeting the requirementsof the NSN Regulations (CEPA, sections 66 and87). The List allows for a distinction to bemade between existing substances and thosethat are new to Canada.

Environmental Contaminants ActAmendments Consultative Committee(ECAACC)The ECAACC was a multistakeholder commit-tee established in 1985 by the federal Ministersof Environment and Health to review propo-sals for a number of improvements to the 1976Environmental Contaminants Act. The objectives


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of the Committee were to identify proposalsfor amendments where consensus agreementexists. The ECAACC submitted its final reportin 1986.

European Inventory of Existing ChemicalSubstances (EINECS)The list of chemical substances in commerce in Europe. In August 2001, EINECS contained100 192 substances.

National Industrial ChemicalsNotification and Assessment SchemeIn Australia, the National Industrial ChemicalsNotification and Assessment Scheme came intoeffect in 1990. It is administered by theNational Occupational Health and SafetyCommission (Worksafe Australia), managed bythe Director of Chemicals Notification andAssessment and overseen by the Minister forIndustrial Relations. As with other countries,the regulation of new chemicals is based on adistinction between established domestic sub-stances and new substances. The AustralianInventory of Chemical Substances consists ofover 40 000 substances and is an “open” inven-tory to which new substances are added fiveyears after they have been assessed. (FromDiscussion Paper: Cost Recovery for the CEPANew Substances Notification Program(Chemicals and Polymers), EnvironmentCanada, 1998)

New Substances ProgramThe statutory powers for the development ofnotification regulations within CEPA allowedEnvironment Canada and Health Canada toestablish a new assessment program recom-mended by the Environmental ContaminantsAct Amendments Consultative Committee con-sultation process. The main regulatory featuresof the program are establishment of classes ofsubstances (schedules); identification of adminis-trative and information requirements; timingof notification prior to import or manufacture;requirements for the departments to assessinformation within a set time; and specificationof conditions, test procedures and laboratorypractices to be followed when developing testdata.

Non-Domestic Substances List (NDSL)The NDSL specifies substances that are not onthe DSL but are believed to be in internationalcommerce. The NDSL is based on the U.S. ToxicSubstances Control Act Inventory of Substances.

Substances listed on the NDSL require lessdetailed notification packages for assessmentthan substances that are new to both theCanadian marketplace and world commerce(section 66 of CEPA).

Priority Substances ListThe Canadian Environmental Protection Act(CEPA) instructs the federal Ministers ofEnvironment and Health to develop a list ofsubstances that should be given priority forassessment to determine whether they are“toxic” as defined under the Act. The Ministersmay recommend controls for those substancesthat are found to be “CEPA-toxic.”Management strategies for such substances aredeveloped through a Strategic Options Processin consultation with stakeholders. (FromExecutive Summary of the Report of theMinisters’ Expert Advisory Panel on theSecond Priority Substances List (October 1995))

Schedule 1 of CEPAThe list of substances that are determined to betoxic by the Governor in Council.

ToxicUnder section 64 of CEPA, a substance isdefined as toxic as follows:

A substance is toxic if it is entering or mayenter the environment in a quantity or con-centration or under conditions that

(a) have or may have an immediate or long-term harmful effect on the environmentor its biological diversity;

(b)constitute or may constitute a danger tothe environment on which life depends;or

(c) constitute or may constitute a danger inCanada to human life or health.

Toxic Substances Control Act (TSCA)Inventory (U.S.A.)“From a regulatory standpoint, the Inventorylists chemical substances that are ‘existing’ inU.S. commerce for purposes of implementingTSCA.”* In August of 2001, the TSCAInventory contained 82 000 substances.

*Toxic Substances Control Act Chemical SubstanceInventory, "1990 Supplement to the 1985 Edition ofthe TSCA Inventory." U.S. Environmental ProtectionAgency. June 1990 (EPA560/7-90-003).

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A.5:Description of the “NewSubstances” Industry Sectorin Canada

The industry sectors most immediately affec-ted by the NSN Regulations include those thatmanufacture, import or depend on access tosubstances not on the DSL. This is primarilythe specialty chemicals industry and theirindustrial customers, especially that segmentin which product technology is rapidly chan-ging. This category includes dyestuffs, paintsand coatings, adhesives, sealants, specialtyorganics, photographics and printing, ingre-dients of plastics, etc. The NSN Regulationsalso affect a broad range of customers of thechemical specialty industry, from the produ-cers of soaps and detergents to the manufac-turers of furniture or the formulators of crankcase oils. The Industry Co-ordinatingGroup (ICG) is an umbrella group composedof representatives of many industry sectorsthat are affected by CEPA and its Regulations.The ICG acted as a coordinating body for theconsultations on the revised NSN Regulationsfor its member associations and other interest-ed industry groups. (See a list of member associations below.)

Compared with larger industrial nations,Canada can be characterized as a significantexporter of commodity chemicals generallyproduced in large volumes and an importer ofspecialty chemicals generally produced insmall volumes. In the area of specialties,Canada is not a leader in the synthesis of newsubstances; however, it is very innovative inthe application of new substances, e.g., newcoating formulations, adhesives, formulatedplastics, etc. Access to new substances is essen-tial to allow the specialty chemicals industry tocontinue to be active participants in Canadiancommerce and to provide gainful employment.

Access to new product technology from thespecialty chemicals industry is also essentialfor the continued health of manufacturingindustries, such as automobiles, trucks, textiles,formulated plastics, paper products, etc. Inmany cases, the Canadian supplier of customproducts to these industries plays an importantrole in their continued success. In other cases,

Canadian customers can obtain from foreignsuppliers finished products or articles manu-factured using new technology.

Using Standard Industrial Classifications repre-senting those chemical substances subject tothe NSN Regulations (SIC 3711-12-31-99, inor-ganic chemicals, organic chemicals, plastics,resins and specialty chemicals), StatisticsCanada data for 1996 suggest a total domesticmarket for primary chemicals and polymers of $19.8 billion (1996 $).

List of ICG Member Associations

Canadian Association of Chemical Distributors

Canadian Chemical Producers’ Association

Canadian Electricity Association

Canadian Fragrance Materials Association

Canadian Importers Association

Canadian Manufacturers and Exporters

Canadian Manufacturers of ChemicalSpecialties Association

Canadian Paint and Coatings Association

Canadian Petroleum Products Institute

Canadian Plastics Industry Association

Canadian Textiles Institute

Crop Protection Institute of Canada

Ecological and Toxicological Association ofDyes and Organic Pigments Manufacturers

Forest Products Association of Canada

Mining Association of Canada

Soaps and Detergents Association


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A.6:Proposed Requirements forNon-GLP Studies

Introduction

It has been proposed by the Table (see Section3.1.6(iii)) that requirements pertaining to GLPfor tests for physical/chemical properties beseparated into two provisions, one of whichmust be met. The first, that tests forphysical/chemical properties “comply withOECD GLP for ‘short-term’ tests or equivalentGLP regulations,” is self-explanatory, and thesecond, that such tests “provide enough infor-mation to demonstrate the reliability and ade-quacy of the data,” will be elaborated uponbelow.

What Constitutes “EnoughInformation”

During the course of an evaluation, informa-tion pertaining to how the test was conducted,deviations from standard protocols, handlingof data, etc. is necessary for an evaluator todetermine the reliability and adequacy of datareceived.

The type of information needed (most of whichwas extracted from reporting requirements ofGLP) should include, where relevant for thetest method:

• identification of the test guideline andmethodology used;

• identification of the test substance and itspurity;

• reference methods, standards and controlsemployed;

• name and address of the test facility, andperson responsible for the data;

• dates on which the study was initiated andcompleted;

• raw data;

• deviations from standard protocols;

• analytical details, including sample prepa-ration, instrument settings and calibrationstandards and methods; and

• a detailed presentation of results, calcula-tions and statistical methods.

Revised guidelines will articulate the type ofinformation required to demonstrate the relia-bility and adequacy of test data. It is intendedthat this would alert notifiers to the potentialneed for submitting these data. Notifiers willbe advised to contact the program for a pre-notification consultation to discuss any poten-tial issues.

As is current practice, in cases where the infor-mation submitted is deemed by an evaluator(s)not to be sufficient, notifiers will be advised torequest that the assessment time clock bestopped (i.e., the assessment is suspended)until the information is supplied. If the infor-mation is not forthcoming from the notifier, thenotification package will be considered incom-plete and sent back to the notifier.

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A.7:Additional Information on theAssessment of DegradationProductsThe exposure assessment of a substanceincludes the evaluation of the overall environ-mental persistence of a substance and itsdegradation products. In the context of the NSProgram, biodegradation and hydrolysis arekey elements in determining the half-life of asubstance in various environmental media (air, water, soil and sediment). However,depending upon the circumstances, otherdegradation/disposal processes may be con-sidered, such as photodegradation, thermolysisand incineration.

The biodegradation/hydrolysis half-lives of asubstance are evaluated using experimental,surrogate or predicted data. Substances withshorter half-lives and not released on a conti-nuous basis may not reside in a medium for asufficient period of time to allow for chronicexposure of organisms. Also, biotic andhydrolytic degradation products are consi-dered on an equal basis with the parent com-pound during the assessment, in order todetermine the long-term potential toxicity ofthe breakdown products, as well as the poten-tial toxicity of the parent compound. In gener-al, these breakdown products tend to be lesstoxic, more water-soluble and, hence, morebioavailable to organisms; however, in somecircumstances, degradation products possessgreater toxicity than the parent compound.

This appendix examines four cases of pre-viously notified polymers and chemicals andsummarizes Environment Canada’s concernswith degradation products. It also draws atten-tion to the type of additional information thatwas requested by the department to ensure acomprehensive risk assessment of the notifiedsubstance and its degradation product(s) andthe respective evaluation decisions.

Case Studies

1. A polymer was notified and assessed by the departments. The substance was ini-tially notified as a low concern polymer,but has subsequently been reclassified asnot low concern, based on the fact that it isexpected to degrade or decompose. It was

determined that microbial degradation ofthe polymer in anaerobic sediments wouldlead to release of a potentially toxic degra-dation product. To address these concerns,the notifier was contacted to conduct ananaerobic degradation test to ascertain thesubstance’s stability under anaerobic condi-tions. To date, the information has not beenreceived. A Schedule VIII notification willbe required, including hydrolysis and readybiodegradation data.

2. In another example, a polymer and itsdegradation products were of moderate(bordering high) toxicity in the aquaticenvironment. Information supplied in thenotification package indicated that acidtreatment (i.e., hydrolysis under acidic con-ditions) of the polymer alleviated environ-mental concerns by preventing aqueousdischarge of the oil layer containing thehydrophobic (toxic) degradation product.The notifier was requested to provide addi-tional information with respect to the effec-tiveness of the sewage treatment plant todegrade the notified polymer. The environ-mental risk assessment focused on the toxi-city, release and fate of the parent com-pound, as well as of the toxic degradationproduct. The substance was subject to aMinisterial condition; restrictions includedthat the substance be hydrolyzed prior todisposal, with the requirement that hydro-lysis efficiency remove at least 90% of thesubstance from the aqueous discharge. Theabove actions ensured that the substancewould not be released at levels resulting ina risk to humans or the environment.

3. For an alkyltin notification, the impuritiesand degradation products were determinedto be more inherently toxic than the parentcompound. The toxicity of the notified sub-stance and its degradation products wasinvestigated using toxicity data for shorteralkyl chain structural analogues (i.e., theexpected worst-case degradation product ofthe notified alkyltin), as well as availabledata from the scientific literature. The envi-ronmental risk assessment focused on thepotential release of the substance to theenvironment. Additional information wasobtained from the notifier with respect tohandling, processing and use of the sub-stance. Toxicity concerns were alleviated by


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imposing a condition on the import andmanufacture of the substance, including arestriction on the substance being releasedinto the environment, and a conditionrequiring that handling, processing and useof the substance occur only in a fully con-tained process; any unreacted substancewould have to be recovered andreprocessed.

4. A brominated flame retardant was notifiedand assessed by the departments. Threepotential routes of degradation were identi-fied, using experimental data and availabledata in the scientific literature for structuralanalogues. These were as follows: 1) degra-dation of the linear carbon chain; 2) dehalo-genation in water and sediment; and 3)hydrolysis, although the latter was deter-mined to be limited and not of concern dueto the substance’s lack of appreciable watersolubility. Sediment species were exposedto degradation products; once transfor-mation occurred in the sediment, the moresoluble degraded substances could betransported back into the water columnfrom interstitial waters. Ecotoxicity of thenotified substance and degradation prod-ucts was examined in the 1) water columnfor the parent compound, 2) sediment fordegradation products and 3) water columnfor reflux of degradation products.Sediment toxicity data were available in theliterature for a surrogate degradation pro-duct. A suspicion of toxic was determinedon the basis of release of the substance inliquid form, resulting in a risk to the aqua-tic environment, and on the basis of highlytoxic degradation products. A conditionwas imposed by Environment Canada, limiting importation of the substance toinstances where it is encapsulated in plasticpellets or flakes.

In the above cases, the notifier was contactedfor additional information, and/or supportingdocumentation/surrogate data were availableto the evaluator to assess the potential risk ofthe notified substance and its degradationproduct(s).

It is recommended that examples of the type ofadditional information requests with respect todegradation products be provided in theGuidelines rather than in the Regulations,

since the information described above wouldbe required only on a case-by-case basis. TheNS Program will continue to address toxicityof degradation products in the risk assessment,without compromising risk to the environmentand human health. The Program will respondwith requests for additional informationand/or impose conditions, when warranted.

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A.8:Test Criteria for the Sunrise Approach — from the Public Advocacy GroupRepresentatives DiscussionPaper, August 2000The various tests necessary for adequatelymeasuring the various characteristics of con-cern are outlined below. Some of these tests arealready required on the highest schedules forchemicals and polymers; others have been pro-posed to a subcommittee to the NSN consulta-tion process.

Toxicity Acute toxicity: tests for mammalian, fish,daphnia and algal toxicity.Chronic toxicity: determination of an effectiveconcentration to 50% for growth, total mass orphotosynthesis rate inhibition in higher plants,90-day mammalian, and indicators of chronictoxicity, such as a lowest-observed-adverse-effect level (LOAEL), a no-observed-adverse-effect level (NOAEL) and the maximum allo-wable toxicant concentration (MATC) in aquaticassays.31

PersistenceThose tests relating to persistence alreadyrequired by the highest schedule (such ashydrolysis and ready biodegradability),although the criteria cut-off of substances’ half-lives in the media of air, water, sediment andsoil may need to be lowered from that provi-ded by the Toxic Substances ManagementPolicy (TSMP).

Bioaccumulation Those tests relating to bioaccumulation and theoctanol/water partition coefficient (Kow)already required by the highest schedule (suchas water solubility, fat solubility, dissociationconstant), although the criteria cut-off for logKow may need to be lowered from that provi-ded by the TSMP.

Ozone Depleting Potential (ODP)Tests for 20, 100 and 500 ODP, as well as theatmospheric lifetime for those classes of sub-stances to which these measurements apply.

Global Warming Potential (GWP)Tests for 20, 100 and 500 GWP, as well as theatmospheric lifetime for those classes of sub-stances to which these measurements apply.

Endocrine Disrupting Substances (EDSs)Screening new substances for endocrine disrupting potential is possible and can add value in the NSN assessment. The U.S.Environmental Protection Agency Tier 1 andTier 2 model is proposed here:

Tier 1 ScreeningIn vitro assays include:

• an estrogen receptor binding or reportergene assay;

• an androgen receptor binding or reportergene assay; and

• a steroidogenesis assay with minced testis.

In vivo assays include:

• a rodent 3-day uterotrophic assay;

• a rodent 20-day pubertal female assay withenhanced thyroid endpoints;

• a rodent 5- to 7-day Hershberger assay;

• a frog metamorphosis assay; and

• a fish reproductive screening assay.

The assessment can evaluate the Tier 1 dataand other scientifically relevant information(e.g., high through put screenings, quantitativestructure–activity relationships, referred to as“QSARs,” or literature data) to decide if thechemical can be moved to a “hold category(needs no further analysis at this time)” orneeds to undergo Tier 2 Testing. Tier 2 testingwill determine whether it may have an effect inhumans that is similar to the effect producedby a naturally occurring hormone.

The Tier 1 assays have the necessary breadthand depth to detect all currently known chemi-cals that may affect the endocrine, androgenand thyroid systems. Therefore, after havinggone through the Tier 1 screening battery, achemical will be designated as having eitherthe potential for estrogen, androgen or thyroidactivity, which will require further analysis inTier 2 tests to verify and evaluate that poten-tial; or low or no potential for estrogen, andro-gen or thyroid activity, which will allow thechemical to be put on “hold.”


Tier 2 TestingThe Tier 2 tests are longer-term studiesdesigned to encompass critical life stages andprocesses, a broad range of doses and adminis-tration by a relevant route of exposure. Effectsassociated with endocrine disruption may belatent and not manifested until later in life ormay not appear until the reproductive periodis reached. Therefore, Tier 2 tests will usuallyencompass two generations and will includeeffects on fertility and mating, embryonicdevelopment, sensitive neonatal growth anddevelopment, and transformation from thejuvenile life stage to sexual maturity.

Tier 2 tests include:

• a two-generation mammalian reproductivetoxicity study or a less comprehensive alternative;

• a mammalian reproductive toxicity test;

• an avian reproduction toxicity test;

• a fish life cycle toxicity test;

• an opossum shrimp (Mysidacea) or otherinvertebrate life cycle toxicity test; and

• an amphibian development and reproduc-tion test.

Environment Canada and Health Canada maydecide to require less testing based on scientifi-cally relevant information showing that effectscan be adequately characterized in a one-generation assay.

Evaluation MethodsThe Sunrise clause could take the form ofeither an absolute threshold limit for each cri-terion or a scoring system wherein a substancecould not exceed a certain cumulative score forall categories combined. An example of the lat-ter approach, as applied to select indicators, isillustrated below:

Before applying such a system, careful thoughtwould have to be given to what numeric testresults would be associated with each scoreand the relationship that ranks achieved ineach category would have to one another. Forinstance, it could be decided that a substancewould be DSL-bound if it did not exceed xnumber of “poor” scores throughout the entireassessment process. Alternatively, the testscould be divided into smaller subsets accord-ing to nature of the effect, location of the effect,etc., and allocated a given number of allowable“poor” scores for each subset.

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* LC50 = median lethal concentration; ED50 = median effective dose; LD50 = median lethal dose; NOAEC = no-observed-adverse-effect concentration; CFC = chlorofluorocarbon.

Acute Aquatic Lethality (LC50 or EC50, mg/L)32 >100 100–1 <1

Chronic Aquatic Toxicity (NOAEC, mg/L)33 >0.02 0.02–0.0002 <0.0002

Acute Oral Lethality (LD50, mg/kg)34 >500 500–5 <5

Persistence (half-life in aquatic environment, days)35 <50 50–180 >180

Bioaccumulation (Bioaccumulation Factor [BAF],where log BAF = 1.07 log Kow – 0.21)36 <500 500–1 000 >1 000

Ozone Depleting Potential (ODP, relative to CFC-11 and CFC-12)37 <0.01 0.01–0.70 >0.70

Global Warming Potential (GWP, equal mass relative to CO2 over 100 years)38 <1 1–500 >500

Score* Good Moderate Poor

Table A.1: Sunrise Clause Scoring System for Select Indicators

Consultations on the CEPA New Substances Notification ......CEPA1 was promulgated in 1988. Following...

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