the life of a new substances notification - registration · pdf filepart 3 introduction to the...

The Life of a

New Substances Notification

Webinar Series

Presentation Outline

Part 1 The New Substances Program and its Authority

Part 2 Key Aspects of the Regulations

Part 3 Introduction to the NSN Reporting Form

Part 4 The New Substances Process

Part 5 Human Health and Ecological Risk Assessment

Part 6 Post Notification Obligations

Part 1

The New Substances Program

and its Authority

The New Substances Program

• The New Substances Program is jointly administered by the

Program Development and Engagement Division of Environment

Canada (EC) and the New Substances Assessment and Control

Bureau of Health Canada (HC)

• The roles and responsibilities for a New Substances Notification are

shared by:

– Client Services Unit (EC);

– Notification Processing and Controls Unit (EC);

– The Ecological Assessment Division (EC); and

– The New Substances Assessment and Control Bureau (HC)

• There is another unique Unit at Health Canada called the

Environmental Assessment Unit.

The Law

The Canadian Environmental Protection Act,1999

• It is an important part of Canada's federal environmental legislation

aimed at preventing pollution and protecting the environment and

human health

• Defines Substance

• Defines the criteria of s.64

• Outlines the Domestic Substances List and the Non-domestic

Substances List

• Outlines New Substances Provisions

Substance

Defined as:

• Any distinguishable kind of organic or inorganic matter whether

animate or inanimate

Items that are not included:

• Mixtures (hydrates, homogeneous and heterogeneous alloys)• Manufactured items• Wastes

S.64 of CEPA 1999

Defined as:

• A substance that is entering or may enter the environment

in amounts that may pose a risk to:

• The environment (such as fish or wildlife);

• The environment on which life depends (such as water,

air & soil); or

• Human health

The Lists

• Domestic Substances List (DSL)

• Non-domestic Substances List (NDSL)

• All additions or deletions are published in the Canada Gazette

Listed by Chemical Abstracts Service (CAS) number on public list

Listed by Confidential Accession Number and Masked Name on

confidential list

Domestic Substances List

• List of substances existing in Canadian commerce• Substances that were manufactured or imported into Canada between

January 1, 1984 to December 31, 1986

• Substances added through the New Substances provisions

• Substances can be listed with a flag• S flag indicates a Significant New Activity provision

• P flag indicates Reduced Regulatory Requirements version of polymer is on

• Currently over 27,300 substances listed

Non-domestic Substances List

• List of substances existing in international commerce (based

on US EPA -Toxic Substances Control Act - inventory)

• Currently almost 49 000 substances on the Non-domestic

Substances List (NDSL)

- 10 -

New Substances Provisions

• Ensures that no new substance is introduced into the Canadian marketplace before an assessment of its potential risks has been completed

• No person can import or manufacture a new substance until:

• the prescribed information is provided; and

• the period for assessing the information has expired; or

• The restriction or prohibition is rescinded

• Required information and assessment periods are outlined in the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations]

- 11 -

The Regulations

• There are two New Substances Notifications Regulations:• Organisms

• Chemicals and Polymers

• Industry responsibility to submit prescribed information and all

information in their possession or which they should have access prior

to manufacture or import

• Government responsibility to assess information and take action where

warranted within prescribed timeframes

- 12 -

Not subject to the Regulations

• Substances on the DSL

• Existing substances; not new to Canadian commerce

• Low volumes

• Annual activities below prescribed trigger quantities

• Transient reaction intermediates

• Impurities

• Incidental reaction products

• Substances occurring in nature

- 13 -

Not subject to the Regulations

• Substances carried through Canada

• Polymers specified on the DSL modified by < 2%

• Substances regulated under federal Acts listed on Schedule 2 of

CEPA 1999

• Pest Control Products Act & Pest Control Products Regulations

• Feeds Act & Feeds Regulations

• Fertilizers Act & Fertilizers Regulations

- 14 -

Food & Drugs Act

• Food & Drugs Act (F&DA) is not listed in Schedule 2 of CEPA 1999

• New substances in F&DA products are subject to the Regulations

• Notification not currently being requested for substances that:

• are on the Revised In Commerce List (R-ICL), AND

• are imported/manufactured solely for F&DA use

http://www.hc-sc.gc.ca/ewh-semt/contaminants/person/impact/list/revised-

icl_lsc-revisee-eng.php

- 15 -

Part 2

Key Aspects of the Regulations

- 16 -

Who is Required to Notify?

• Canadian manufacturers and importers

Note: if the importer is not a resident, a Canadian agent is required

- 17 -

What is Prescribed in the Regulations

The Regulations prescribe the following:

• Manufacture or import volume trigger quantities

• Timeframe for notifier to submit regulatory requirements via notification package

• Timeframe for New Substances program to review and assess the notification package

• Information requirements specific to each Schedule

- 18 -

Regulations: Key Aspects

• Tiered Approach used for notification requirements

• Regulatory Information requirements listed in various Schedules

• Notification under each schedule is dependent on:

• Type of substance

• Volume to be manufactured or imported (and NDSL status)

• Proposed use

- 19 -

At a Glance Decision Flow Chart

• The Decision Flow Chart was created as an aid in determining one’s obligation when notification is required. It shows:

• The types of substances;

• The Schedule of information;

• The regulatory triggers; and

• The timeline to supply the information

- 20 -

The Life of a New Substances Notification

- 21 -

Part 3

Introduction to the NSN Reporting Form

- 22 -

Structure

The NSN Reporting Form is divided into four parts and two appendices:

• Part A: Administrative & Substance Identity Information

• Part B: Technical Information

• Part C: Biochemical or Biopolymer Information

• Part D: Additional Information

• Appendix I: Manufacture, Import, Use, Exposure and Release

Information (Known & Anticipated)

• Appendix II: NS Fee Payment Form

- 23 -

General Comments

• Type or print clearly

• Fill in all boxes that apply

• Electronic Submission is acceptable and encouraged

• Provide a cover letter indicating:

• what schedule you are submitting

• trade name

• previous submissions

• special requests

• Provide two copies of NSN reporting form AND attachments

• Submissions to be sent to address on NSN reporting form

- 24 -

Part A – Administrative Information

Special attention to the following boxes:

• Signatures (A.1)

• Notifier and the Canadian Agent (if applicable)

• Original signature required

• Resident and non-resident Corporate Headquarters/Canadian

Agent (A.2 - A.4)

• Canadian Agent required when importer of record is a foreign resident

• Foreign Supplier (A.5)

• Only required if the technical information is supplied by a third party

- 25 -

• Technical Contact (A.6)

• Person familiar with NSN content, including technical data (not

required to be a Canadian resident)

• Port of Entry/Site of Manufacture/Toll Manufacturer (A.7)

• Import: where it will enter Canada (city/province)

• Manufacture: where it will be made in Canada

• Toll Manufacturer: Company contracted to process the raw materials

and create a new substance on behalf of the manufacturer

- 26 -

• Amount (A.11)• Import/manufacture quantity that triggered the notification (kg/yr)

• Date (A.12)• Estimated date of when you expect to import or manufacture the

quantity in A.11

• Substance Information (A.13)• Check all that apply

• Uses of the substance (A.15)• Details of known anticipated, historical and other likely uses• Note, check “Solely for F&DA” use (if applicable)

- 27 -

• Information Sharing Agreement (A.18)

• Exchange of data through the use of an ISA

• Substance information (A.19 to A.22)

• Valid CAS number must be provided• Chemical name in accordance with nomenclature rules• Masked Name according to Masked Name Regulations (if

applicable)

- 28 -

• Structure, formula and weight (A.23 to A.25)

• Structure must correspond to the specific substance name and

CAS Registry Number

• Molecular Formula of the substance

• Molecular Weight in Grams of the substance (Chemicals)

• List other components (A.26 to A.28)

• List all monomers and reactants (even if <2%) with a valid CAS

(Polymers)

• Ensure total % of monomers by weight equals 100 (Polymers)

• List all Additives, Stabilizers and Solvents and their

concentration

• List all Impurities and their concentration

- 29 -

• Degree of Purity (A.29)

• Degree expressed in % of the chemical less the impurities - this

is not required for polymers

• Material Safety Data Sheet (MSDS) (A.30)

• Must be provided as an attachment (if available)

- 30 -

Part B – General Comments

• Type or print clearly

• Fill in all boxes that apply

• Data codes are found on Page 2 of the form;

• If required, provide a value on the form

• If linking the test data from a previous notification, provide

attachment number of the previous NSN

• Electronic Submission is acceptable

• Provide two copies of the test data

• Submissions to be sent to address on NSN Reporting Form

- 31 -

• Listed in the order of appearance in the Regulations

• Schedules requiring each test are clearly indicated

• Footnotes to clarify the specific test requirements

Part B – Technical Information

- 32 -

Addressed by the submission of:

• Experimental Data

• Surrogate Data

• Waiver Requests

- 33 -

• Experimental Data:

• Preferred option

• Use appropriate test design

• Test the notified substance, not a formulated product

• Provide full test reports and methods used

• Trade name in test reports must be listed as a trade name on

the NSN reporting form (block A.22)

• GLP required for many tests

• If referencing a literature paper – submit a copy in full

- 34 -

There are 3 pieces of information needed for a Gel Permeation

Chromatography (GPC) to be acceptable:

• test procedures and conditions

• chromatogram

• calibration curve

- 35 -

Good Laboratory Practice (GLP) compliance:

The following test data must be developed in compliance with GLP

as set out by the Organisation for Economic Co-operation and

Development (OECD):

• Acute Mammalian Toxicity Tests

• Repeated-Dose Mammalian Toxicity Tests

• Genotoxicity Tests

• Tests to Assess Skin Irritation

• Skin Sensitization Tests

• Ecotoxicity Tests

• Biodegradation Tests

- 36 -

• Surrogate Data

• Provide rationale as to why surrogate substance is an

appropriate “stand-in” for notified substance

• Provide the structure of the surrogate substance

• If referencing a literature paper - submit a full copy

- 37 -

• Waiver Requests

• Provide scientific rationale describing how one of the

legislative criteria for granting a waiver is met:

• Data impractical to obtain

• Information is unnecessary for assessment

• Limited use or exposure

NOTE: If surrogate or modelled data is used to address a

requirement, a waiver is not necessary

- 38 -

• Additional information required for biochemical/biopolymers

• Footnotes added to give clarity to specific test requirements

Part C – Biochemical or Biopolymer

- 39 -

• Information is required for all substances subject to any Schedules

• Information may be provided in the language in which the

information was originally prepared with a summary in English or

French

• Clearly reference attachments by page number or tab numbers

Part D – Additional Information

- 40 -

• Created for all information prescribed in the Regulations, known and

anticipated

• Each section of the Appendix references sections of the guidelines

for additional information on what should be provided

Appendix I – Manufacture, Import, Use,

Exposure and Release Information

Exposure data to be submitted by the notifier

not by the foreign supplier

- 41 -

• Provided to aid in determining the fee required for the notification and

includes a credit card authorization form if this is the preferred

method of payment

• Use acceptable method of payment

• Certified cheque, money order (made out to the Receiver

General for Canada)

• Visa, MasterCard or American Express

• Provide Sales Report if submitting reduced fees based on low

annual sales in Canada

Appendix II – New Substances Fee

Payment Form

- 42 -

Part 4

The New Substances Process

- 43 -

Receipt of Notification Package

• All New Substances Notification (NSN) packages are submitted to

Environment Canada:

• Industrial use

• Solely for a Food and Drugs Act use

• Dual use (industrial and Food and Drugs Act uses)

• NSN package should include:

• Completed NSN Reporting Form (including appendices)

• Attachments (if any)

• Fee (if required)

- 44 -

Preliminary Screening

• Notifications and Client Services Section reviews the NSN package

to ensure that it meets the regulatory requirements under the

Regulations:

• Complete NSN package

• Incomplete NSN package

• Unacceptable NSN package

Note: acceptability of waivers, surrogate data and test data are not reviewed at this stage

- 45 -

Risk Assessment

• Assessment occurs after the NSN package has been acknowledged

• Review and determination of data quality, acceptability of any waiver requests, surrogate data and alternate data proposals

• Assessment of potential risk to human health and the environment

NOTE: Pre-notification Consultation may

be requested to avoid delays

- 46 -

Final Assessment Outcomes

• No suspicion that the substance meets the criteria of S. 64 of CEPA

1999 for the proposed uses, but may for other potential uses or

activities

• Suspicion that the substance meets the criteria of S. 64 of CEPA

- 47 -

Significant New Activity

If the assessment for the notified substance determines that there is

no suspicion that the substance meets one of the criteria set out in

S. 64 of CEPA 1999 for the notified activities but there is a suspicion

that a significant new activity in relation to the substance may result

in the substance meeting the criteria, the substance can be subject

to a SNAc Notice.

- 48 -

Risk Management Measures

• Risk management measures applied to minimize any risk to human health and/or environment:

• Ministerial Condition - restrictions placed on manufacture or import activities

• Ministerial Prohibition - manufacture or import prohibited in any amounts

• Ministerial Request for additional information - prohibition of manufacture or import pending required testing

NOTE: The assessment period can be extended if there is a potential concern and more time is required to develop a risk management measure

- 49 -

Part 5

Human Health & Ecological

Risk Assessment

- 50 -

Presentation Objectives

• To communicate concepts and approaches to Risk Assessment of

new substances

• Information Collection and Evaluation

• Characterization of Entry, Fate and Exposure

• Effects Characterization

• Characterization of Risk

• Assessment Outcomes and Next Steps

- 51 -

Overview of Assessment Process

- 52 -

Information Collection

• Types of information used in evaluating new substances

– Chemical identity

– Physical-chemical properties

– Exposure information

– Effects information

• Sources of information

– Provided by Industry

– Publicly available data e.g. open literature

– “Read Across” Data

– Predictions

- 53 -

Evaluation of the Information

• Review data for quality and reliability

• Data Preference. In general, the usual order of data preference for

a particular endpoint:

1. acceptable experimental data for the substance

2. acceptable experimental data from a close structural analogue

3. reliable model predictions

4. expert judgment: in the absence of reliable data, used to provide a

qualitative description of an endpoint

- 54 -

Exposure:

• Characterization of Entry, Fate and Exposure

• Environmental Entry, Fate and Exposure

• Direct human exposure

• Indirect human exposure

• Quantification of exposure

Hazard:

• Human health effects

• Ecological effects

• Abiotic effects

Risk Assessment

Hazard x Exposure = Risk

Characterization of Entry, Fate

and Exposure

- 56 -

Environmental Entry, Fate and Exposure

• The objective is to determine how a substance enters the

environment and to understand its fate in order to establish the

exposure of humans and ecological receptors to the substance.

• Main Steps:

1. Entry characterization into the environment

2. Characterization of environmental fate and distribution

3. Quantification of exposure

- 57 -

Entry Characterization

- 58 -

Direct Human Exposure

- 59 -

• Assess direct human exposure for the notified use

• Also need to consider potential uses

• Exposure calculations based on exposure for intended or potential

Indirect Human Exposure

• Calculate human exposure level via environmental media (water,

air, soil)

• Correlate PEC with mammalian subchronic toxicity results during

the hazard assessment

- 60 -

Exposure Assessment - Example

• Fragrance additive in laundry detergents

• Direct human exposure through washing laundry by hand and/or

residue on washed clothing

• Release occurring “down the drain” from use

• High removal rate by Waste Water Treatment Plant (e.g. 90%

removed, via adsorption to sludge)

• Not biodegradable but remains in biosolids

• Releases into the environment (mode of entry):

– 90% in biosolids of WWTP which are applied to land (Soil)

– 10% WWTP effluent to river (Water). Indirect human exposure through

drinking water

- 61 -

Exposure Assessment - Example

- 62 -

Quantification of Exposure

Environmental fate

Mode of entry into

the environment

Releases

Identify compartment of

concern

Calculate a PEC

Calculation of a

Predicted Environmental Concentration

is used for ecological exposure and

indirect human exposure.

- 63 -

Effects Characterization

- 64 -

• Human Health Hazard

• Ecological Hazard

Effects Characterization• Biotic Effects:

• Determine the threshold concentration of a substance that is expected to elicit adverse effects.

• Determine how the effects vary with exposure

• Evaluating information from toxicity tests measuring the effects of the substance on one or more species

• Ideally, toxicity information consists of data from different species that cover a range of food-chain levels

• Main Steps:

1. Gather and Review Effects Data

2. Select Critical Toxicity Value

3. Derive ecological Predicted No-Effects Concentration (PNEC)

4. Derive human Provisional Tolerable Daily Intake (PTDI)

• Abiotic Effects: e.g. Ozone Depleting Potential, Global Warming Potential

- 65 -

Risk Characterization

- 66 -

Risk Characterization

• Risk characterization involves using a combination of qualitative

and quantitative approaches to understand and describe the risk a

substance may pose to the environment or human health.

• Various lines of evidence are considered in a weight-of-evidence

approach to evaluate the potential for adverse effects of a

substance.

– Risk Quotients

– Margin of exposure

– Significant hazard

– Persistence and bioaccumulation

– Evidence of widespread presence and increasing concentration

– Abiotic effects

- 67 -

Outcome of Assessment and Next Steps

• Ultimately the outcome of an assessment is a recommendation

whether the substance meets the definition of “Toxic” as described

in Section 64 of the Act.

- 68 -

Outcome of Assessment and Next Steps

Submission received by Environment Canada and

content Screened for required information

(Regulatory assessment)

Environment Canada Evaluation (Environmental Risk Assessment)

and Health Canada Evaluation

(Human Health Risk Assessment)

Substance is not suspected of being toxic

Respond to Notifier. Import or manufacture may

proceed/resume

Add substance to the DSL when listing criteria are met

Substance is suspected of being toxic

Respond to Notifier and publish appropriate notice in the Canada

Gazette

Impose Conditions

Request Additional information

Prohibit the importation / manufacture and

develop regulations

Suspicion that a Significant New Activity may result in the

substance becoming toxic

Respond to Notifier and publish the the SNAc Notice in the

Canada Gazette

Add substance to the DSL when listing criteria are met

- 69 -

Part 6

Post Notification Obligations

- 70 -

Post-notification Responsibilities

• Correction of information (subsection 81(11) of the CEPA 1999)

• Section 70 of CEPA 1999

• Notice of Excess Quantity (NoEQ) or, alternatively Notice of

Manufacture / Notice of Import (NoMI)

- 71 -

Inspection & Enforcement

• Environment Canada enforcement officers may carry out

inspections under CEPA 1999

• If convicted, possible penalties are:

• Fine and/or imprisonment

• Discussed in further detail in the Enforcement and

Compliance Policy for the Canadian Environmental

Protection Act, 1999:

http://www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5082BFBE-1

- 72 -

Final Comments

If you have any questions, contact:

The Substance Management Information Line Experts:

E-mail: substances@ec.gc.ca

Telephone: 1-800-567-1999 (toll free in Canada)

(819) 938-3232 (outside of Canada)

Facsimile: (819) 938-3231

Website: http://www.ec.gc.ca/subsnouvelles-newsubs/

- 73 -

Questions

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