Guidelines for the Notification and Testing of New Substances:
Organisms
SECTION 9 PROCESSING A NOTIFICATION
- 9.1 RECEIPT OF A NEW SUBSTANCES NOTIFICATION
- 9.2 CORRESPONDENCE
- 9.3 ASSESSMENT OF THE NOTIFICATION
- 9.3.1 Information review
- 9.3.2 Assessment for toxic
- 9.4 ACTION TAKEN AFTER AN ASSESSMENT
This section describes the government's administrative procedures and responsibilities when a New Substances Notification (NSN) is received.
9.1 Receipt of a New Substances Notification
9.1.1 Assessment time clock
The assessment time clock refers to the allotted time (calendar days) the government has to assess a NSN (see Section 3.3 of these Guidelines).
Day 1 of an assessment period is the day the NSN is received by the New Substances Division of Environment Canada. The assessment time clock may be affected by missing or incomplete information. For example:
- If a notification package is grossly inadequate or incomplete, the entire package will be returned and the assessment will begin when a corrected package is received.
- If information in the NSN is found to be erroneous and the assessment in progress is invalidated, the assessment will be terminated and reset at Day 1 when the correct information is received.
- If information in the NSN is found to be erroneous, but does not invalidate the assessment in progress, the assessment time clock will be stopped at Day X and will continue at Day X + 1 when the correct information is received.
- If 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 an assessment officer.
- If proprietary information is being sent directly to Environment Canada by a foreign supplier, the time clock will start when all the required information has been received.
9.1.2 New Substances Notification Reference Number
When a New Substances Notification (NSN) is received by Environment Canada, an NSN Reference Number will be assigned. This number will appear on all correspondence issued by the government concerning that notification and should be used in any subsequent communications regarding that notification.
9.2 Correspondence
Official correspondence between Environment Canada and the notifier or 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. However, Environment Canada will not send confidential business information (CBI) by facsimile and also advises notifiers not to send CBI by facsimile. The types of correspondence a notifier may receive include:
9.2.1 Acknowledgment
After receipt and preliminary screen of the NSN, an acknowledgment will be issued specifying the start date of the assessment period and the NSN Reference Number. Acknowledgment indicates that the administrative information is satisfactory and that all required information has been received but not yet reviewed.
9.2.2 Notice of interruption or rejection
A rejection or interruption notice will be issued if the NSN contains significant omissions or errors in the mandatory information requirements. These notices will describe all deficiencies in the NSN. Original documentation may be returned.
A rejection notice will be issued if the NSN contains erroneous information that invalidates the assessment in progress. In this case, the assessment will be terminated and reset at Day 1 when the correct information is received.
If the erroneous information does not invalidate the assessment, an interruption notice will be issued indicating that the assessment time clock was stopped at Day X (e.g., Day 14 of a 90-day assessment period). Upon receipt of the correct information, the assessment will continue with the time clock set at Day X + 1 (e.g., Day 15).
Evaluators will attempt to contact the notifier by telephone to resolve difficulties before issuing a rejection or interruption notice.
9.2.3 Notice of extension of assessment period
When additional time is required to complete an assessment, as permitted under subsection 108(4) of CEPA 1999, the notifier will be advised of an extension before the end of the initial assessment period. The government may extend the assessment period only once, for a length of time not exceeding the initial assessment period.
9.2.4 Statement of assessment conclusions
Before the end of the assessment period, the notifier will be advised in writing whether the government suspects that the organism is toxic or capable of becoming toxic, and what action, if any, will be taken (see Section 9.4 of these Guidelines).
9.2.5 Notice of termination of assessment period
In some cases the risk assessment of the organism may be completed in advance of the expiry of the prescribed period for assessing the information. Subsection 108(6) of CEPA 1999 allows the Minister to terminate the prescribed period for assessing the information provided. This will allow the notifier to commence import, manufacture of an organism, subject to the outcome of the assessment, provided the assessment has been completed. If this provision is utilized, the notifier will be advised in writing before the end of the prescribed assessment period.
9.3 Assessment of the Notification
9.3.1 Information review
Environment Canada and Health Canada evaluators will assess the notification package to determine the acceptability of identification of the micro-organism or organism other than a micro-organism, proposed explicit biological name (where applicable) or masked name (where applicable), claims for confidential business information, test protocols and procedures, test data, rationales for requests for waivers of information, and effects and exposure information. Deficiencies in the submitted information that cannot be easily resolved may result in the rejection of the notification or interruption of the assessment (see Section 9.2.2 of these Guidelines).
9.3.2 Assessment for toxic
The purpose of the New Substances Notification assessment process is to determine whether or not the organism is suspected of being toxic or capable of becoming toxic as defined in section 64 of CEPA 1999:
...a substance is toxic if it is entering or may enter the environment in a quantity or concentration or under conditions that
(a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
(b) constitute or may constitute a danger to the environment on which life depends; or
(c) constitute or may constitute a danger in Canada to human life or health.
Consequently, determining whether an organism is, or is suspected of being toxic or capable of becoming toxic involves assessing the potential for exposure to humans and components of the environment, and the potential for adverse effects of the organism on humans, the environment or biological diversity (including other living organisms, interacting natural systems, and the abiotic components of the environment).
An organism may be suspected of being toxic or capable of becoming toxic if there is concern about either the adverse effects of the organism or the potential exposure to the organism. For example, organisms with considerable potential for exposure because of continuous release in high quantities, or persistence in the environment, may be suspected of being toxic although there may be uncertainty regarding a biological or environmental hazard from the information available for the assessment. When an assessment has led to a "suspicion of CEPA toxic," CEPA 1999 has a unique provision under subsection 109(1), that permits the government to undertake one of several control measures (see Section 9.4.1 of these Guidelines).
9.4 Action Taken after an Assessment
After the assessment, the notifier will be advised whether there is suspicion the organism is toxic or capable of becoming toxic. If there is no suspicion, the notifier may proceed with import or manufacture after the assessment period has expired.
9.4.1 Control measures
When the government suspects that the organism is toxic or is capable of becoming toxic, control measures may be applied to minimize any risk to human health, the environment or biological diversity. The following control measures under section 109 of CEPA 1999 may be taken:
(a) permit any person to manufacture or import the living organism subject to any conditions that the Ministers may specify;
(b) prohibit any person from manufacturing or importing the living organism for a period not exceeding two years (this prohibition lapses at the end of this two-year period unless a notice of proposed regulation under section 114 of CEPA 1999 is published in the Canada Gazette before the end of this period); or
(c) Prohibit the manufacture or import of the substance until supplementary information or test results have been submitted to the government and assessed (the assessment period for this supplementary information expires 120 days after receipt of the information, or at the end of the original assessment period, whichever is later).
The government must take measures under section 109 of CEPA 1999 before the assessment period expires. The notifier must either comply with these measures or withdraw the notification.
When a condition or prohibition is issued or altered, a notice must be published in the Canada Gazette describing the action and the organism to which it applies. For the purposes of publication, the notifier will be contacted to propose an explicit biological name (see Appendix 4 of these Guidelines), if one has not already been proposed. The name of the notifier is not included in this notice. If the publication of the explicit biological name would result in the release of confidential business information, a masked name will be published (see Section 8.2.2.1 of these Guidelines).
9.4.2 Significant New Activities
In some cases, the Minister(s) may suspect that a significant new activity (SNAc) in relation to the living organisms may result in the living organism becoming toxic activity (see section 2.4.2 of these Guidelines). In these cases, section 110, and subsections 112(3) and 112 (4) of CEPA 1999 provide the government authority to impose terms of use to which a manufacturer, importer or user of the organism must adhere. These terms of use are intended to minimize any risk to human health, the environment or biological diversity.
Where the living organism is eligible for inclusion on the Domestic Substances List (DSL) in accordance with subsection 112(1), the Minister will add the living organism to the DSL within 120 days with an indication that the SNAc provision applies (subsection 106(3) of CEPA 1999).
Where the living organism is not eligible for inclusion on the DSL, the Minister will publish a notice in the Canada Gazette, Part I, within 90 days after the expiry of the assessment period, a notice indicating that the SNAc provision applies (subsection 106(4) of CEPA 1999).
Subsections 110(3) and 112(4) specify other information that must be included in the Canada Gazette notice or DSL amendment respectively including:
- the significant new activity (specified by inclusion or exclusion) in relation to the living organism in respect of which subsection 106(3) or 106(4) applies;
- the information to be provided to the Minister;
- the date before which the information must be provided to the Minister;
- the period for assessing the information provided.
Alternatively, a regulation prescribing the information specified in items 2, 3, and 4 above may be made under paragraphs 114(c), (d) and (g) of CEPA 1999.
9.4.3 Additions to the Domestic Substances List
Under subsection 112(1) of CEPA 1999, Environment Canada is obliged to add an organism to the DSL if it meets all of the following criteria:
(a) Environment Canada has been provided with the information prescribed in section 106 or 107 of CEPA 1999 and any additional information required under subsection 109(1). Because inclusion of an organism on the DSL may permit unrestricted use, any substance for which the full complement of information requirements was reduced as a result of limited exposure (i.e., notification groups specified in 29.11 (2), (4), (5) or (6) of the Regulations), or for which waivers were granted under paragraph 106(8)(b) of CEPA 1999, may not have satisfied this criterion;
(b) the Ministers are satisfied that the living organism has been imported or manufactured by the notifier2;
(c) the period for assessing the information has expired; and
(d) no conditions specified under paragraph 109(1)(a) of CEPA 1999 remain in effect.
Organisms that were suspected of being toxic in the assessment can only be placed on the DSL if they are controlled under section 114 of CEPA 1999.
For the purposes of listing on the DSL, the explicit biological name provided in the notification form (see Section 7.3.1 of these Guidelines, item A.7) will be used where an organism identity has not been claimed as confidential. Where organism identity has been claimed as confidential, the masked name will be published on the DSL (see Section 8.2.2.1 of these Guidelines).
Organisms notified under the New Substances Notification Regulations will remain new organisms (and thus notifiable for a second party) until they are added to the DSL in the Canada Gazette. Amendments to the DSL will be published in accordance with the time frames specified in subsection 112(1) of CEPA 1999 . Quarterly updates to the DSL will also be available on CD-ROM through the Canadian Centre for Occupational Health and Safety.
2 An amendment to the NSNRs must be in place in order for an organism to be added to the DSL pursuant to subsection 112(1) of CEPA 1999.
- Date Modified: