Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

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SECTION 9 - Processing a New Substances Notification (NSN)

• 9.1 Overview of the NSN Assessment Process
• 9.2 Receipt of a New Substances Notification (NSN) Package
  • 9.2.1 Assessment Period
  • 9.2.2 Mail Log Number
  • 9.2.3 NSN Reference Number
• 9.3 Correspondence
  • 9.3.1 Notice of Initiation
  • 9.3.2 Notice of Acknowledgement of Complete Package
  • 9.3.3 Notice of Missing Information
  • 9.3.4 Notice of Rejection
  • 9.3.5 Notice of Early Termination of Assessment Period
  • 9.3.6 Final Assessment Outcome Letter
  • 9.3.7 Notice of Extension of Assessment Period
  • 9.3.8 Withdrawing an NSN Package
• 9.4 Assessment of the NSN Package
  • 9.4.1 Information Review
  • 9.4.2 Determination of Toxicity
• 9.5 Assessment Conclusions
  • 9.5.1 No Suspicion of Toxicity and No Action Taken
  • 9.5.2 Significant New Activity (SNAc) Notices
  • 9.5.3 Risk Management Measures
    • 9.5.3.1 Conditions under Paragraph 84(1)(a) of the Act
    • 9.5.3.2 Prohibitions under Paragraph 84(1)(b) of the Act
    • 9.5.3.3 Request for Additional Information under Paragraph 84(1)(c) of the Act

This section describes the administrative procedures and responsibilities of the NS program when an NSN package is received.

9.1 Overview of the New Substances Notification (NSN) Assessment Process

The attached flow chart (Figure 9-1) gives an overview of the assessment process from the day the NSN package is received by the NS program to the day the substance is added to the DSL or risk management measures are taken on the substance.

9.2 Receipt of a New Substances Notification (NSN) Package

9.2.1 Assessment Period

The assessment period refers to the allotted time in calendar days that the NS program has to assess an NSN package. The number of days for an assessment period is indicated in Table 1-1.

Day 1 of an assessment period is the day on which the complete NSN package is received by the NS program. The starting day of the assessment period may be affected by missing or incomplete information. For example:

1. if an NSN package is submitted without the required fees or with an unacceptable method of payment for the fees (see Appendix 3 of these Guidelines), the entire package will be returned, and the assessment period will not begin until a corrected package is received;
2. if an NSN package is grossly inadequate or incomplete, the entire package will be returned, and the assessment period will not begin until a complete package is received;
3. if proprietary information is being sent directly to the NS program by a foreign supplier, the assessment period will not start until all the required information has been received;
4. if an NSN package is missing minor information, the notifier will be contacted to provide this information. The assessment period will not begin until a complete package is received;
5. if, during the assessment period, minor information is found to be missing or erroneous, the assessment period will continue, provided the correct information is supplied by a date specified by the program (usually within a couple of working days); or
6. if during the assessment period, the information within the NSN package is found to be incomplete or erroneous the NSN package will be deemed incomplete and the assessment period will be restarted on day 1 once a complete NSN package has been submitted

9.2.2 Mail Log Number

When an NSN package is received by the NS program and where no fee is provided or where an incorrect method of payment is used, the package is stamped with a mail log number and is immediately returned to the notifier with a letter indicating the error. This mail log number must be referenced when resubmitting the NSN package to the NS program.

9.2.3 NSN Reference Number

When an NSN package is received by the NS program including the appropriate fee (see Appendix 3 of these Guidelines), an NSN reference number will be assigned. This number will appear on all correspondence issued by the NS program concerning that NSN package and should be used in any subsequent communication regarding that NSN package. It is important to note that the NSN reference number is not an approval by the NS program, nor can it be used by notifiers as proof of compliance for customers.

Figure 9-1 Overview of the New Substances Notification Assessment Process (See section 9.1 of the Guidelines)

9.3 Correspondence

Official correspondence between the NS program and the notifier or the "Canadian Agent" will occur throughout the assessment process. When speed of communication is important, facsimile transmission will be used, with the original following by mail. Notifiers may also request to have all correspondence sent only by facsimile; in these cases, originals will not be sent by mail. The NS program will not send CBI by facsimile transmission unless consent has been given by the notifier either verbally or by marking the appropriate box in block A.1 of the NSN reporting form. The NS program also advises notifiers not to send CBI by facsimile transmission. The following are types of correspondence a notifier may receive.

9.3.1 Notice of Initiation

When a Foreign Supplier (see section 5.2 of these Guidelines) is involved in an NSN package the notifier must submit a partial NSN package to initiate the process. Initiation letters are issued to the notifier to acknowledge receipt of this partial information that is required to complete the NSN package. They are also issued to acknowledge receipt of an initial package for 4CA requests (see section 2.2.3.3 and Appendix 9 of these Guidelines).The assessment period does not start until all of the prescribed information has been provided by the foreign supplier or the international agency. Once the complete package of information has been received, a notice of acknowledgement of the complete package is issued (see section 9.3.2 of these Guidelines), and the assessment period will start.

9.3.2 Notice of Acknowledgement of Complete Package

After receipt and acceptance of the information provided in the NSN package, an acknowledgement letter will be issued specifying the starting date of the assessment period and the NSN reference number. An acknowledgement letter indicates that the administrative information is satisfactory and that all prescribed information including the prescribed fees have been received, but the file has not yet been assessed. The acknowledgement letter also provides the expected end date of the assessment period. Acknowledgement letters are also issued once all the information has been received for international sharing of information packages (e.g., 4CA request and Canada-Australia sharing request, see section 2.2.3.3 and Appendix 9 of these Guidelines).

A notifier may, either at the time of filing or after an NSN package has been filed, request an early termination of the assessment period (subsection 83(6) of the Act) specified for that specific Schedule in the Regulations. If such a request is received, the acknowledgement letter would indicate that the NS program will consider the request during the assessment period. However, a request made for early termination by the notifier does not automatically guarantee accommodation (see section 9.3.5 of these Guidelines).

9.3.3 Notice of Missing Information

A missing information notice will be issued if the NSN package contains omissions or errors in the mandatory prescribed information requirements. This notice will describe all deficiencies in the NSN package. When minor information is missing or incorrect, the notifier will be contacted by telephone to resolve the problems before a missing information notice is issued. The assessment period does not start until all the required information has been received and accepted.

9.3.4 Notice of Rejection

A rejection notice will be issued if the NSN package contains significant omissions or errors in the mandatory information requirements. This notice will describe all deficiencies in the NSN package. Original documentation may be returned. If the erroneous information is determined during the assessment period, the evaluators will attempt to contact the notifier by telephone to resolve the difficulties before a rejection notice is issued. If the file is rejected during the assessment period, the assessment period will be restarted on day 1 when the additional or corrected information is received.

9.3.5 Notice of Early Termination of Assessment Period

Manufacture or import of a new substance is not allowed until the period for assessment, as established in the Regulations, has expired. However, subsection 83(6) of the Act, for chemicals and polymers, allows for assessment periods to be terminated at an earlier time; as a result, manufacture or importation of a substance may commence on the date indicated in the letter.

All NSN packages and SNANs are eligible for consideration for early termination if the evaluations are completed by the NS program prior to the end of the assessment period. The notifier will be informed by telephone that the assessment period will be ending early, and a final assessment outcome letter (see section 9.3.6 of these Guidelines) indicating the day on which the assessment period ends will be sent to the notifier.

These provisions enable the NS program to take advantage of opportunities that could result in early completion of the assessment of an NSN package (e.g., when the substance has already been assessed). Administrative procedures have been implemented to identify those NSN packages that have been completed early, thereby facilitating the application of the provisions to these files.

9.3.6 Final Assessment Outcome Letter

If the assessment period for the notified substance concludes or is terminated early, as indicated above, and the assessment of the substance determined that there is no suspicion that the substance is toxic or capable of becoming toxic, no action will be taken. A final assessment outcome letter will be sent to the notifier, once the environmental and human health assessment reports have been completed. This letter also provides information on any additional notification requirements that are necessary for the substance to become eligible for listing on the DSL. The notifier may begin manufacturing or importing the substance in amounts exceeding the quantity that triggered the notification after the end of the assessment period, even without receipt of the final assessment outcome letter.

9.3.7 Notice of Extension of Assessment Period

All NSN packages and SNANs are eligible to have their assessment periods extended when additional time is required to complete an assessment. The notifier will be advised by telephone and facsimile of the extension of the assessment period before the end of the initial assessment period. The original extension letter will be sent to the notifier via courier. The Ministers may extend the assessment period only once, for a length of time not exceeding the time prescribed for the initial assessment period.

9.3.8 Withdrawing an NSN Package

A notifier may request to withdraw an NSN package if it is determined that:

1. the substance has been previously notified by the same company;
2. the substance is already listed on the DSL; or
3. the notifier no longer intends to continue manufacturing or importing the substance and the notifier did not exceed the trigger volumes for the specified Schedule of the Regulations to which the NSN package refers.

Withdrawal requests for NSN packages can be mailed or faxed to the NS program. Withdrawal requests will not be accepted if the notifier has been informed of a proposed decision to take risk management measures or issue a SNAc Notice for the substance. Fees will be refunded for withdrawn NSN packages only if the request for withdrawal is received prior to the assessment period commencing. The notifier will be advised in writing if the withdrawal request has been accepted or rejected.

9.4 Assessment of the NSN Package

The purpose of the assessment and risk management process is to ensure that, either because of the inherent properties of the substance or because of measures taken to mitigate exposure to the substance, the use of the substance will not pose a significant risk to human health or the environment.

9.4.1 Information Review

Evaluators within the NS program will assess the NSN package to determine the acceptability of:

• the substance identity and masked names;
• claims for CBI;
• test protocols and procedures;
• test data;
• rationales for requests for waivers of information;
• rationales for use of alternative test protocols or surrogate information; and
• exposure information.

Deficiencies in the submitted information that cannot be easily resolved may result in the rejection of the NSN package and termination of the assessment period (see section 9.3.4 of these Guidelines).

9.4.2 Determination of Toxicity

The purpose of the NSN assessment process is to determine whether or not the substance is, or is suspected of being, "toxic" or capable of becoming "toxic" as per any of the criteria set out in section 64 of the Act and stated below:

64. A substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions

1. having or that may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or
3. constitute or may constitute a danger in Canada to human life or health.

Consequently, the determination of whether a substance is, or is suspected of being, toxic or capable of becoming toxic involves assessment of the potential for exposure of humans and components of the environment and of the adverse effects of the substance on humans or the environment (including other living organisms, interacting natural systems and the abiotic components of the environment).

The potential for exposure to a substance depends on the quantity, rate, frequency and conditions of release of the substance into the environment at all points in its life cycle, as well as the mobility, environmental compartmentalization and persistence of the substance. The exposure assessment considers the use of the substance identified by the notifier, as well as other possible ways in which the substance might be used if it were listed on the DSL without restrictions.

The assessment of adverse effects on humans and other living organisms considers endpoints such as lethality, mutagenicity, reproductive effects and organ toxicity, whereas adverse effects on the abiotic components of the environment include consequences such as depletion of the ozone layer, global warming and production of acid rain.

A substance may be "suspected" of being toxic if either the adverse effects of a substance or the potential exposure to a substance is of concern. For example, substances with considerable potential for exposure because of continuous release of high quantities or persistence in the environment may be suspected of being toxic, although there may be uncertainty regarding any biological or environmental hazard from the information available for the initial assessment. When an assessment has led to a "suspicion of toxicity", the Act has a unique provision, under subsection 84(1), which permits the Minister to undertake one of several risk management measures (see section 9.5 of these Guidelines).

9.5 Assessment Conclusions

There are three possible outcomes of an assessment:

1. There is no suspicion of toxicity, and no action is taken.
2. There is no suspicion of toxicity for the current activities associated with the substance, and a SNAc Notice is published for the substance (see section 9.5.2 of these Guidelines).
3. There is a suspicion of toxicity, and risk management measures are imposed (see section 9.5.3 of these Guidelines).

The notifier will be advised in writing, before the end of the assessment period or extended assessment period, if the NS program suspects that the substance is toxic or capable of becoming toxic, and what action will be taken. The notifier will also be advised in writing, before the end of the assessment period, if the NS program intends to develop a SNAc Notice in relation to the substance (see section 9.5.2 of these Guidelines).

9.5.1 No Suspicion of Toxicity and No Action Taken

If the completed environmental and human health assessment reports on the notified substance determine that there is no suspicion that the substance is toxic or capable of becoming toxic, no action is taken. If no action is taken prior to the end of the assessment period, the notifier may, after the assessment period has expired, begin manufacturing or importing the substance in amounts exceeding the quantity that triggered the notification. A final assessment outcome letter will be sent to the notifier (see section 9.3.6 of these Guidelines).

9.5.2 Significant New Activity (SNAc) Notices

If the assessment for the notified substance determines that there is no suspicion that the substance is toxic or capable of becoming toxic for the notified activities but there is a suspicion that a significant new activity in relation to the substance may result in the substance becoming "toxic", the substance can be subject to a SNAc Notice (see section 85 of the Act). A SNAc Notice defines what is considered a significant new activity for the substance which communicates the criteria under which a notification will or will not be required. Generally, the notifier will be informed, prior to the end of the assessment period, that a SNAc Notice is being developed for the notified substance.

A new substance assessment looks at the potential risks for the notified activities and any other possible activities involving the substance. If there is a suspicion that a significant new activity may result in the substance becoming "toxic", the Act allows the Minister to issue a SNAc Notice within 90 days after the end of the assessment period. A SNAc Notice is a notice describing, by inclusion or exclusion, a significant new activity that results or may result in:

• a significantly greater quantity or concentration of the substance in the environment; or
• a significantly different manner or circumstances of exposure to the substance.

The Ministerial correspondence includes the SNAc Notice, which defines:

• the substance (by specific substance name or masked name, if claimed confidential);
• the significant new activity by inclusions (e.g., listing the new activity) or exclusions (e.g., anything other than a certain activity);
• the information that must be notified;
• the timelines for providing the information; and
• the period for assessing the information.

If a new substance is not yet on the DSL, the SNAc Notice issued to the notifier also applies to users of the substance. Once a new substance has been added to the DSL with an "S" flag (see section 2.1.4.1 of these Guidelines), the flag definition applies to all manufacturers, importers and users of that substance.

SNAc Notices oblige renotification and assessment of prescribed additional information prior to any of these parties undertaking a significant new activity which is defined in the notice.

If a SNAc Notice has been issued for a new substance, the notifier still remains responsible for submitting:

• the subsequent Schedules of information under the Regulations, if necessary;
• the prescribed additional information in subsection 7(2), 7(3), 11(2) or 11(3) of the Regulations in the case of significant exposure or high release; and
• the appropriate notice to fulfil the DSL listing criteria.

The substance will not be eligible for listing on the DSL until all of the above-mentioned information has been received, accepted and assessed as "no suspicion of toxicity". Until the substance has been added to the DSL, no other notifier may manufacture or import the new substance for any activity prior to submitting an NSN package under the Regulations. A substance subject to a SNAc Notice can still become eligible for listing on the DSL, with a specified "S" flag (see section 2.1.4.1 of these Guidelines).

When information is submitted in compliance of a SNAc Notice, it is called a SNAN (see section 1.3 of these Guidelines). The NS program must assess the SNAN within the time period specified by the SNAc Notice. From the assessment of this additional information, the SNAc Notice may be modified or rescinded, or other risk management measures can be imposed, if necessary (see below). The original SNAc Notice stands unless a notice is published in the Canada Gazette to amend or rescind the SNAc Notice based on the additional information.

9.5.3 Risk Management Measures

When a substance is suspected to be toxic,¹² or capable of becoming toxic, risk management measures may be applied to minimize any risk to human health or the environment. Notifiers will be advised, prior to the end of the assessment period, that there are concerns with the substance. Usually the assessment period is extended (see section 9.3.7 of these Guidelines), which provides time to prepare the risk management measure and obtain Ministerial approval. The notifier will be advised of the extension of the assessment period and proposed risk management measures prior to the end of the initial assessment period.

Section 84 of the Act states that when the Ministers suspect that a substance may be toxic or capable of becoming toxic, the following measures may be taken:

1. permit the manufacture or import of the substance subject to specified conditions;
2. prohibit the manufacture or import of the substance for a period not exceeding two years (this prohibition lapses at the end of this two-year period unless, before the end of this period, a notice of proposed regulation under section 93 of the Act is published in the Canada Gazette); or
3. prohibit the manufacture or import of the substance until additional information or test results have been submitted to the Minister (subsection 84(2) of the Act) and assessed (the assessment period for this supplementary information expires 90 days after receipt of the information or at the end of the original assessment period, whichever is the later date).

These measures must be taken by the Minister before the expiration of the assessment period. A copy of the Ministerial correspondence and notice will be faxed to the notifier, and the originals will follow by mail. The name of the notifier is not included in the Ministerial notice. When a condition or prohibition is issued or altered, the notice must be published in the Canada Gazette, Part I, describing the action and the substance to which it applies. Notifiers who have a substance that is subject to risk management measures under section 84 of the Act are not required to submit a notice of excess quantity or a notice of manufacture or import, since the substance cannot be published on the DSL unless the risk management action has been rescinded or a regulation has been developed.

9.5.3.1 Conditions under Paragraph 84(1)(a) of the Act

When a substance is suspected to be toxic or capable of becoming toxic, conditions may be imposed to mitigate any risk to human health or the environment. Conditions under paragraph 84(1)(a) of the Act allow the manufacture or importation of a substance with restrictions. Types of restrictions on the substance include, but are not limited to:

• the volume allowed;
• the physical form (e.g., must be imported as a plastic pellet);
• the use; or
• the disposal of the substance or containers that held the substance.

The notifier and, if prescribed, the notifier's customers are obliged to abide by the conditions imposed on the substance in the Ministerial correspondence and keep records as indicated. Ministerial conditions are published in the Canada Gazette, Part I, after they have been issued to the notifier. Substances that have conditions imposed on them are not eligible for addition to the DSL. Therefore, any new notifier who wishes to manufacture or import the same substance must submit an NSN package, as prescribed by the Regulations. This may result in the same or similar conditions being imposed.

A notifier may submit additional information and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this additional information and may amend or rescind the conditions. The conditions stand unless a notice is published in the Canada Gazette to amend or rescind the conditions based on the additional information.

9.5.3.2 Prohibitions under Paragraph 84(1)(b) of the Act

When a substance is suspected to be toxic or capable of becoming toxic, a prohibition may be imposed to mitigate any risk to human health or the environment. Prohibitions imposed under paragraph 84(1)(b) of the Act prohibit any person from manufacturing or importing the substance in any amounts. Ministerial prohibitions are published in the Canada Gazette, Part I, after they have been issued to the notifier. Subsection 84(4) of the Act states that this prohibition expires two years after it is imposed unless, before the expiry of the two years, the Governor in Council publishes in the Canada Gazette a notice of proposed regulations under section 93 of the Act in respect of the substance, in which case the prohibition expires on the day the regulations come into force. The substance may be added to the DSL after regulations have been developed and published in the Canada Gazette.

The notifier may submit additional information and request a re-evaluation of the decision made by the NS program. The NS program will review and consider this additional information and may amend or rescind the prohibition or take alternative risk management measures. The prohibition stands unless a notice is published in the Canada Gazette to amend or rescind the prohibition based on the additional information.

9.5.3.3 Request for Additional Information under Paragraph 84(1)(c) of the Act

When the NS program requires additional information to be provided to determine whether the substance is toxic or capable of becoming toxic, a request for additional information with a prohibition of manufacture or import pending this testing may be imposed to mitigate any risk to human health or the environment. The request for additional information is imposed under paragraph 84(1)(c) of the Act, and the prohibition of manufacture or import is imposed under subsection 84(2) of the Act. Subsection 84(2) of the Act states that the person who is required to submit the information is prohibited from manufacturing or importing the substance unless the information is provided and the regular assessment period has expired or a period of 90 days after the additional information was provided has expired, whichever is later. Once the required additional information has been submitted it will be assessed to determine if the substance is toxic or capable of becoming toxic and if it is appropriate to take alternative risk management measures.

¹² The term "toxic" refers to the interpretation in section 64 of the Act and is described in section 9.4.2 of these Guidelines.