New Substances Program Operational Approaches Manual

1. Operational Approach for Administering the Domestic Substances List and the Non-Domestic Substances List

Purpose

This document describes the operational approach for administering the Domestic Substances List (DSL) and Non-domestic Substances List (NDSL) as utilized by the New Substances Program (NS Program) of Environment Canada and Health Canada.  The NS Program operates under the Canadian Environmental Protection Act, 1999 (the Act) and the New Substances Notification Regulations (Chemicals and Polymers)and the New Substances Notification Regulations (Organisms) [collectively referred to as the Regulations].

Application

This document applies to all substances on the DSL as well as new substances, including those listed on the NDSL.

Context

DSL

The DSL is a list of substances that were identified as being in use in Canada between January 1, 1984 and December 31, 1986, as well as substances that were notified under the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms), and that have met the listing criteria set out in the Act.

The DSL is the sole basis for determining whether a substance is new to Canada for the purposes of the Act and the Regulations. In principle, substances listed on the DSL do not require notification under the Regulations before being manufactured or imported; however, they are subject to scrutiny under the Act as existing substances.1

NDSL

The NDSL is a list of substances that are not on the DSL, but are identified as being in commercial use internationally. It does not include living organisms.  Environment Canada uses the United States Toxic Substances Control Act (TSCA) as a basis for this list. Substances on the NSDL require notification under the New Substances Notification Regulations (Chemicals and Polymers), but have reduced prescribed information in the New Substances Notification (NSN) packages than those substances not listed on the NDSL.

Operational Approach

Amendments to the DSL

Amendments to the DSL, whether via additions or deletions, are published in the Canada Gazette, Part II, approximately ten times a year. The DSL is amended from time to time for the following reasons:

  1. Substances notified under the Regulations meeting DSL Eligibility Criteria

    The Minister of the Environment must add the substance to the DSL and, if it appears on the NDSL, delete it from that list, within 120 days after all of the following conditions are met:
    • For chemicals, biochemicals, polymers, biopolymers:
      • The information prescribed for the purposes of section 81 or 82 of the Act and any additional information or test results required under subsection 84(1) of the Act have been provided;
        • Any substance for which the full complement of information requirements was reduced as a result of granting a waiver under paragraph 81(8)(b) of the Act may not satisfy this criterion2
      • The assessment period has expired;
      • No conditions specified under paragraph 84(1)(a) of the Act remain in effect on the substance; and
      • A Notice of Excess Quantity or Notice of Manufacture or Import has been submitted and the Ministers are satisfied that the substance has been manufactured or imported into Canada in the quantities mentioned in paragraph 87(1)(b) of the Act
    • For living organisms:
      • The information prescribed in section 106 or 107 of the Act and any additional information or test results required under subsection 109(1) of the Act have been provided;
        • any living organism for which the full complement of information requirements was reduced as a result of limited use or exposure, or for which waivers were granted under paragraph 106(8)(b) of the Act may not satisfy this criterion
      • The assessment period has expired;
      • No conditions specified under paragraph 109(1)(a) of the Act remain in effect on the living organism; and
      • The notifier has submitted a notice that the living organism has been manufactured in or imported into Canada.

  2. Corrections to the DSL

    If the Minister of the Environment subsequently determines that a substance on the DSL does not meet the eligibility criteria of the Act, the substance will be deleted from the DSL, and if eligible, added to the NDSL. Such corrections may be required if, in the course of a follow-up audit, the nominator of a substance is unable to provide documentation to substantiate DSL eligibility. Amendments to the DSL may also be made to correct naming and other errors. The information and supporting data must be kept for a period of five years after the year in which the information is provided.

Amendments to the NDSL

The NDSL is amended periodically for the following reasons:

  1. Annual updates based on the United States Environmental Protection Agency’s (US EPA) Toxic Substances Control Act (TSCA) inventory

    The NDSL is based on substances that have been on the public portion of the US EPA's TSCA inventory for a minimum period of one year (e.g. the 2010 NDSL was based on the 2009 TSCA Inventory). Substances for which the US EPA or the NS Program have identified a concern, implemented risk management measures, or imposed a Significant New Use Rule (SNUR), or a Significant New Activity notice (SNAc) are not included in the updates of the NDSL. Amendments to the NDSL, based on the TSCA inventory, are published in the Canada Gazette, Part I, on a bi-annual basis.

  2. Nomination of substances to the confidential portion of the NDSL

    Substances on the confidential portion of the TSCA inventory are not automatically added to the NDSL through the annual update process.  They are added to the NDSL only after a company provides the appropriate information required in a DSL Reporting Form C, including documentation demonstrating that the substance has existed on the confidential portion of the TSCA inventory for at least one year. Amendments to the NDSL, based on nominations through a Form C, are published in the Canada Gazette, Part I, on a bi-annual basis, simultaneously as the amendments to the NDSL based on the TSCA inventory.

  3. DSL amendments

    Substances are deleted from the NDSL when they are added to the DSL.  Amendments to the NDSL are normally published in the Canada Gazette, Part I, when there is an amendment to the DSL published in the Canada Gazette, Part II.

2. Operational Approach for Processing New Substances Notifications

Purpose

This document describes the operational approach for processing New Substances notifications as utilized by the New Substances Program (known as the NS Program) of Environment Canada and Health Canada. The Program operates under the Canadian Environmental Protection Act, 1999 (the Act) and the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [collectively referred to as the Regulations].

Application

This document applies to all New Substances Notification (NSN) packages.

Context

Under sections 81 and 106 of the Act, manufacturers and importers of new substances must provide the prescribed information so that the NS Program can assess the new substances to determine if they are “toxic” (in accordance with the criteria set out in section 64 of the Act) or capable of becoming “toxic”. A substance is considered “new” to Canada if it is not listed on the DSL. The information requirements are prescribed in the Regulations.

Notifiers of new chemicals and polymers are required to pay a fee according to the New Substances Fees Regulations (NSFR).

The NS Program’s approach for processing an NSN package is shown in Figure 1 and described in the following steps.

Figure 1: Processing New Substances Notification Packages

Figure 1: Processing New Substances Notification Packages (See long description below)
Description of Figure 1

This flow chart outlines the important steps in processing New Substances Notification (NSN) packages. Upon receipt of an NSN package, the payment is deposited or charged on a credit card. If there is no payment accompanying the package, the NSN package is returned to the notifier. If payment is included, or if the Fees Regulations do not apply, the package undergoes a preliminary content screen. The completeness of a package is determined during the preliminary content screen. The NSN package is considered incomplete if it is missing information and/or insufficient payment is included. If the deficiencies are minor, a request for missing information or fees is made. The NSN package is rejected if it contains substantial deficiencies. If upon a preliminary content screen the NSN package is considered complete, the NSN package is acknowledged and the assessment period starts the day after the complete NSN package is received. The information in the package is then assessed by the evaluators in the New Substances Program. The evaluators in the New Substances Program also determine the “toxicity” of the substance. If the information is not acceptable, a request for the missing information is made or the NSN package is rejected if substantial deficiencies are determined. If the information is acceptable, the assessment outcomes are presented. Please refer to the “Operational Approach for Taking Action after an Assessment” for additional details on this process.

Receipt of Submission

When a NSN package is received by the NS Program, payment will be deposited or charged on a credit card, even if other prescribed regulatory information is found missing during the information review process. An NSN reference number will then be assigned. This number will appear on all correspondence issued by the NS Program and should be used in any subsequent communications regarding that notification.

Preliminary Content Screen

  1. Notification Evaluators with the NS Program will review the NSN package to determine the following:

    • if information prescribed by the Regulations has been included in the NSN package, or in the case of a Significant New Activity Notification (SNAN)3 all information prescribed in the Significant New Activity notice;
    • if fees prescribed by the NSFR have been submitted and are correct;
    • if substance has been identified correctly and the name is valid for substance submitted; and
    • if claims for confidential business information and masked name requests have been substantiated/supported.

  2. If deficiencies in the NSN package are identified, there are three possible courses of action:
    • If the deficiencies are minor in nature and can be remedied by telephone, e-mail, or facsimile, the notification evaluator will attempt to do so. The assessment period does not start, and the NSN package will be retained by Environment Canada until such time as the notifier supplies the missing information; or
    • If the deficiencies are more numerous or will require additional information to be generated by the notifier, then a “request for missing information” letter will be sent to the notifier specifying the deficiencies. The assessment period does not start, and the NSN package will be retained by Environment Canada until such time as the notifier supplies the missing information; or
    • If the NSN package is substantially deficient, a rejection letter will be sent outlining all of the deficiencies, fees charged will be refunded, and the NSN package will be returned to the notifier. It should be noted that missing or insufficient fees according to the requirements of the NSFR are considered a substantial deficiency.  The assessment period does not start until the appropriate fees and all other missing information has been supplied.

  3. If there are no deficiencies in the NSN package, an acknowledgment letter will be issued specifying the date on which the assessment period began, the date on which it concludes, and the NSN reference number. The acknowledgment letter indicates that the administrative information and the prescribed fees (if applicable) are satisfactory and the prescribed technical information has been received but not yet assessed.

Assessment of New Substances Notification Package

  1. Validation

    Assessment Evaluators in the NS Program assess the NSN package to determine the acceptability of:
    • test protocols and procedures;
    • test data and surrogate data;
    • rationales for requests for waivers of information; and
    • exposure information.

    If any questions arise, evaluators will attempt to contact the notifier or technical contact to resolve them.  When the information, supplied to address a prescribed information requirement, remains unsatisfactory, the NSN package is deemed to be incomplete. The assessment period stops and a letter superseding the Acknowledgement letter is written identifying the deficiency and indicating that the assessment period has stopped. The NSN package is retained until the notifier supplies the missing information, at which time the assessment period restarts from the beginning.

  2. Assessment of Toxicity

    The purpose of the assessment process is to determine whether the substance is suspected of being “toxic” or capable of becoming “toxic” in accordance with the criteria set out in section 64 of the Act. Consequently, evaluators assess the potential for exposure to humans and components of the environment, and the potential for adverse effects (i.e. hazard) of the substance on humans, the environment, or biological diversity.

    When the substance is suspected to be toxic, the NS Program will, before the end of the original assessment period, inform the notifier that the assessment period is being extended to develop control measures.  An assessment period may be extended only once, for a length of time not exceeding the initial assessment period. Note: If there is a concern with the substance, the notifier cannot withdraw the NSN package. Even if the notifier decides not to import or manufacture the substance for which there is a concern, the minister will nevertheless adopt the control measure.

Assessment Outcomes

Please refer to the “Operational Approach for Taking Action after an Assessment” for additional details.

3. Operational Approach for Processing Fees and Refunds

Purpose

This document describes the operational approach for processing fees and refunds as utilized by the New Substances Program (known as the NS Program) of Environment Canada and Health Canada. The Program operates under the Canadian Environmental Protection Act, 1999 (the Act) and the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [collectively referred to as the Regulations].

Application

This approach applies to the assessment of New Substances Notification (NSN) packages and other services for new chemicals and polymers. Other services include:

  • searching for confidential substances appearing on the Domestic Substances List (DSL) or Non-domestic Substances List (NDSL) that have been published under masked names;4 and
  • developing masked name applications.

At this time the New Substances Fee’s Regulations and this approach does not apply to:

  • biochemicals, biopolymers, living organisms and research and development substances that are regulated under the Regulations;
  • substances that are manufactured or imported for a use that is regulated under any other Act of Parliament or regulations, including the Food and Drugs Act, the Fisheries Act and the Health of Animals Act;
  • Significant New Activity Notifications (SNAN); or
  • submission of additional information required for special category Schedule 1 or 3 notifications (at 10 000 kg/yr) and for high release to the aquatic environment or significant public exposure to the substance (at 50 000 kg/yr).

Context

Under sections 81 and 106 of the Act, manufacturers and importers of new substances must provide prescribed information so that the NS Program can assess the new substances to determine if they are “toxic” (in accordance with the criteria set out in section 64 of the Act) or capable of becoming “toxic”. A substance is considered “new” to Canada if it is not listed on the DSL. The information requirements are prescribed in the Regulations.

Notifiers of new chemicals and polymers must pay a fee as established in the New Substances Fees Regulations (NSFR). The fees for a notification assessment range from $50 to $3500, with reductions available for previously submitted, matched, or consolidated notifications, and for notifiers having total annual sales in Canada of $40 million or less. In addition to fees for notification assessments, the regulations include fees for other services, including confidential searches of the DSL or the NDSL and masked name applications.

Operational Approach

The fees and refunds operational approaches are summarized in Tables 1 and 2 and are described in the following sections.

Table 1: Summary of Operational Approach for Fees - Company’s Annual Sales in Canada (in million of Canadian dollars) 1a
NSNR Schedule, Notification, or Service  less than or equal to $13 greater than $13 - less than or equal to $26 greater than $26 - less than or equal to $40 greater than $40
Schedule 1 (except R&D) $500 $1 000 $1 500 $2 000
Schedule 3 (except R&D) $500 $1 000 $1 500 $2 000
Schedule 4 $50 $100 $150 $200
Schedule 5 $500 $1 000 $1 500 $2 000
Schedule 6 $875 $1 750 $2 625 $3 500
Schedule 9 $125 $250 $375 $500
Schedule 10 $875 $1 750 $2 625 $3 500
Schedule 11 $875 $1 750 $2 625 $3 500
Schedule 5 final1b,1c $750 $1 500 $2 250 $3 000
Schedule 9 finalFootnote[c],1d $375 $750 $1 125 $1 500
Matched1e $200 $200 $200 $200
Consolidated1f ___ × $250 ___ × $250 ___ × $250 ___ × $250
Confidential search of DSL and NDSL $62.50 $125 $187.50 $250
Masked name application $150 $300 $450 $600
Table 2: Summary of Operational Approach for Refunds
  Status of Payment Effect on Services Applicable Refund
No payment with NSN package   NSN package is returned to notifier. Not applicable
Insufficient payment Service(s) for the same substance All services are suspended until full payment is received. Not applicable
Insufficient payment Services for different substances            
Insufficient payment Fees clearly identified for each service Services are rendered for fully paid requests; other services are suspended until payment is received. Not applicable
Insufficient payment Fees not clearly identified for each service All services are suspended until payment is received. Not applicable
Exact payment   Services are rendered. Payments are not refundable once full services are rendered.
Overpayment   Services are rendered. Overpayment is refunded by cheque2a
Valid withdrawal request or Rejection of NSN Services not rendered Services are terminated. Full payment is refunded by cheque2a
Valid withdrawal request or Rejection of NSN Partial or full services rendered Services are terminated. Payments are not refundable once partial or full services are rendered.
Unnecessary services   NSN package is returned to notifier. Full payment is refunded by cheque2a
Previous NSN packages received before January 1, 2003   Services are rendered. Not applicable

Payment Conditions

Payment will be expected in full upon receipt of notification.

Payment for a Masked Name application is only required to be paid once per substance per notifier.

Payment Processing

If payment is made by cheque or money order, the payment is deposited upon receipt of the NSN package by the NS program. Any refunds required will be issued by cheque.

If payment is made by credit card, the exact payment for the services rendered will be charge upon issuance of the first letter of correspondence. Any refunds required will be issued by cheque.

No Payment

If the payment is not received with the NSN package, Environment Canada will telephone the notifier once and give the notifier one week to supply the fee. If it is not received within the timeframe the services will not be rendered and the submission will be returned to the notifier (notice of rejection).

Insufficient Payment

Single or Multiple Services for the Same Substance

Payment for all services rendered is expected in full; however, if the payment is insufficient to cover the service(s) associated with a single substance, all services, including assessments of NSN packages, will be suspended until full payment is received.

Multiple Services for Different Substances

If the NSN package clearly identifies the fees associated with each substance, only the services for which full payment was received will be rendered. Other services will be suspended until full payment is received.

  • Example: A submission contains separate NSN packages for substances A and B, an exact payment for one NSN package, and a fee form clearly indicating that the payment applies to substance A. The service for substance A will be rendered. The service for substance B will be suspended until the full payment is received.

If one payment is sent for multiple services without clearly identifying the fees associated with each substance, all services will be suspended until full payment, or clarification, is received.

  • Example: A submission contains separate NSN packages for two different substances and a payment for only one NSN package. Since it is not clear that the payment applies to a specific NSN package, all services will be suspended until the full payment is received or until receipt of the fee form indicating to which NSN package the fees apply.
Problematic credit card charges

If the information provided on the credit card authorization is wrong or if there are insufficient funds to cover the price of the services, Environment Canada will telephone the notifier to inform them and will request corrected information. The assessment period for the NSN package will start on the day after the full fees are provided and successfully processed.

Overpayment

If the payment exceeds the fee prescribed by the NSFR, the service will be rendered and the overpayment will be refunded. Overpayments will not be retained “on account” as deposits for future NSN packages or other services.

Valid Withdrawal Request

If the notifier withdraws an NSN package or other service request(s) before any service has been rendered, a full refund will be issued. If the notifier withdraws an NSN package or other service request(s) and partial or full services have been rendered, no refund will be issued. In the case of the assessment of an NSN package, the NS Program considers that the sending of a letter of acknowledgment constitutes a partial service. Therefore, no refund will be issued if a letter of acknowledgment has been written for an NSN package.

Unnecessary Services

If an NSN package is not required by the NSNR (Chemicals and Polymers) (e.g. if the substance is already listed on the DSL1), the service will not be rendered and the NSN package will be returned to the notifier along with a full refund.

4. Operational Approach for Using Third-Party Information

Purpose

This document describes the operational approach for using third-party information as utilized by the New Substances Program (known as the NS Program) of Environment Canada and Health Canada. The Program operates under the Canadian Environmental Protection Act, 1999 (the Act) and the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [collectively referred to as the Regulations].

Application

This document applies to all New Substance Notification (NSN) packages.

Context

Under section 81 and section 106 of the Act, importers and manufacturers of new substances must provide prescribed information so that Environment Canada and Health Canada can assess new substances to determine if they are “toxic” or capable of becoming “toxic” in accordance with the criteria set out in section 64 of the Act.  A substance is considered “new” to Canada if it is not listed on the Domestic Substances List (DSL). The information requirements are established in the Regulations.  Following an assessment, the Minister of the Environment may take one of several possible actions under the Act. 

Third-party information can be useful in supplementing the information received from the notifier, thus helping to build a weight of evidence for an assessment.

Operational Approach

Use of Third-Party Information

The NS Program may use all available information when assessing a substance, including notified information and third-party information. Third-party information is from any available source, as long as it meets the quality standards of the NS Program. It can include information in the possession of the NS Program, such as data from other NSN packages for the same or similar substances. Third-party information is used to augment notified information and support assessment conclusions by building the weight of evidence. Third-party information is not used to relieve notifiers of their obligations to provide information under the Act and the Regulations.

Third party information can support the validity of the notified data, or in cases where data is contradictory, it can help to determine the factors that may have influenced the test results. In some cases, third-party information may provide additional insight into the understanding of a substance’s behavior in the environment.

  • Example: When conducting an exposure assessment, evaluators use the notified information as well as third-party information, such as scientific literature, emission scenarios, monitoring data, and notified information for a substance with similar use and exposure patterns. Quantitative information from a third-party may be used to help determine a predicted environmental concentration. Third-party information may also be used to assist in identifying other possible uses of the substance or to support assumptions in the exposure assessment, such as typical volumes employed in an application.

Confidentiality of Third Party Information

If third party information has to be treated confidentially under the Act, it will be removed from assessment reports prior to being released to the notifier or the public. It will, however, be referenced in the assessment report for transparency. The removal of confidential third party information also applies to all requests for information from the Australian government, under the Arrangement between New Industrial Chemical Notification and Assessment Scheme (NICNAS) and the New Substances Program.

Operational Approach for Taking Action After a Risk Assessment

Purpose

This document describes the operational approach for taking action after a risk assessment by the New Substances Program (known as the NS Program) of Environment Canada and Health Canada. The Program operates under the Canadian Environmental Protection Act, 1999 (the Act) and the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) [collectively referred to as the Regulations].

Application

This document applies to all New Substances Notifications (NSN) packages.

Context

Under section 81 and section 106 of the Act, importers and manufacturers of new substances must provide prescribed information so that Environment Canada and Health Canada can assess the new substances to determine if they are “toxic” or capable of becoming “toxic” in accordance with the criteria set out in section 64 of the Act.  A substance is considered “new” if it is not listed on the DSL.Footnote[1] The information requirements are established in the Regulations.  Following an assessment, the Minister of the Environment may take one of several possible actions under the Act.

Operational Approach

The NS Program’s approach for taking action after a risk assessment is shown in Figure 1 and described in the following steps.

Figure 2: Taking Action after a Risk Assessment

Figure 2: Taking Action after a Risk Assessment (See long description below)
Description of Figure 2

This flow chart outlines the actions that can be taken after a risk assessment by the New Substances Program. If the assessment outcome concludes that there is no suspicion of toxicity with regards to the substance, the assessment period ends and the manufacture or import of the substance may proceed or continue. If the assessment outcome concludes that there is no suspicion of toxicity with regards to the substance for the notified activity but that there is a suspicion that a significant new activity may result in the substance being toxic, the assessment period ends. The manufacture or import of the substance may proceed or continue for the notified activity but a SNAc Notice will be published in the Canada Gazette. If the assessment outcome concludes that there is a suspicion of toxicity with regards to the substance, the assessment period can be extended if necessary. Control actions that can be imposed include a prohibition of manufacture or import of the substance, or the allowance of manufacture or import subject to conditions, or additional information on the substance can be requested. After the imposed control action is selected, the assessment period ends and the Ministerial Condition or Prohibition is published in Canada Gazette.

No Suspicion of Toxicity

If there is no suspicion of toxicity and the assessment period has expired, the Minister of the Environment will take no further action. When a new substance becomes eligible for addition to the DSL, the Minister must add the substance to the DSL within 120 days and, if it appears on the Non-domestic Substances List (NDSL), delete it from that list. Refer to the Operational Approach for Administering the DSL and NDSL for more information.

Suspicion of Toxicity

If the Government of Canada suspects that a substance is “toxic” or capable of becoming “toxic”, there are three actions that may be taken. Under section 84 of the Act for chemicals, biochemicals, polymers, biopolymers or section 109 of the Act for living organisms, the Minister of the Environment may:

(a) permit the manufacture or import of the substance subject to specified conditions; or
(b) prohibit the manufacture or import of the substance; or
(c) request additional information considered necessary for the purpose of assessment.  The notifier shall not manufacture or import of the substance until supplementary information or test results have been submitted and assessed.

These measures must be imposed before the expiration of the assessment period when a “suspicion of toxicity” conclusion is being considered.  Typically, the assessment period is extended, as permitted under the Act, when this conclusion is anticipated. 

Control Actions

When conditions or a prohibition are imposed, varied or rescinded, Environment Canada must publish a notice in the Canada Gazette, Part I.

Any prohibition on a substance under section 84(1)(b) will expire two years after it is imposed unless proposed regulations to manage the substance are published in the Canada Gazette. In that case, the prohibition expires on the day the regulations come into force.

Significant New Activity Notices

If the Ministers suspects that a significant new activity (SNAc) in relation to the substance may result in the substance becoming “toxic”, a SNAc Notice is published in Canada GazettePart I for the substance. SNAc Notices must be published within 90 days of the end of the assessment period.  SNAc notices require notification (called Significant New Activity Notification) of prescribed information in advance of the use of the substance for a significant new activity (as defined in the SNAc Notice). Environment Canada and Health Canada assess the substance in relation to the new activity to determine if it is “toxic” or capable of becoming “toxic”. Refer to the Operational Approach for Issuing Significant New Activity Notices for more information.

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