SOR/2004-155200406
21
20196
22
CHEMICAL WEAPONS CONVENTION IMPLEMENTATION ACTSchedule 1 Chemicals Regulations (Chemical Weapons Convention)P.C.2004-769 200406
21
Her Excellency the Governor General in Council, on the recommendation of the Minister of Foreign Affairs, pursuant to sections 8, 11 and 18 of the Chemical Weapons Convention Implementation Acta, hereby makes the annexed Schedule 1 Chemicals Regulations (Chemical Weapons Convention).S.C. 1995, c. 25Interpretation
DefinitionsThe following definitions apply in these Regulations.Act means the Chemical Weapons Convention Implementation Act. (Loi)CAS registry number means the identification number assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society. (numéro d’enregistrement CAS)IUPAC means the International Union of Pure and Applied Chemistry. (UICPA)Schedule 1 chemical means a toxic chemical or precursor listed in Schedule 1 of the Schedules of Chemicals set out in the Annex on Chemicals in the Convention. (produit du tableau 1)InterpretationFor the purpose of these Regulations, facility means the plant site, plant or unit where the activities authorized under these Regulations are carried out.Electronic transmissionAny notice or application that is required to be given in writing under these Regulations may be given by electronic means.
National Limit
National limitThe maximum aggregate quantity of Schedule 1 chemicals authorized in Canada at any given time shall not exceed one tonne.
Authorizations by LicenceAuthorization
AuthorizationSubject to these Regulations, the National Authority shall authorize, by the issuance, amendment or renewal of a licence, an individual who ordinarily resides in Canada to produce, use, acquire or possess a Schedule 1 chemical if the following conditions are met:public health and safety, the environment, international relations and national defence and security are unlikely to be compromised;the activities are for research, medical, pharmaceutical or protective purposes;the aggregate quantity of Schedule 1 chemicals that may be produced does not exceed 10 kg per year per facility; andthe quantities authorized are consistent with the intended purpose referred to in paragraph (b).Production for protective purposesThere shall be only one licensed facility in Canada for the production of Schedule 1 chemicals for protective purposes.Term of licenceThe term of a licence shall not exceed three years.LicenceThe National Authority shall assign a number and a date of issue to each licence.SOR/2018-202, s. 1
Applications
Licence applicationA written application for a licence in respect of each facility shall be submitted to the National Authority by the individual who will be responsible for the activities requested in the application. It shall be signed by that applicant and by the individual responsible for the facility, if they are not the same individual, and shall containthe following information in respect of the applicant:their full name and any aliases,their addresses for the last five years,their citizenship,their date and place of birth and a copy of their birth certificate or other document that establishes their place and date of birth,a summary of their relevant education and work experience,the name and address of any entity for which they work and their position, andtheir business telephone number, facsimile number and email address;the following information in respect of the individual responsible for the facility:their full name and any aliases,their addresses for the last five years,their citizenship,their date and place of birth and a copy of their birth certificate or other document that establishes their place and date of birth,the name and address of any entity for which they work and their position, andtheir business telephone number, facsimile number and email address;the following information in respect of each individual who will have access to a Schedule 1 chemical in carrying out the activities requested in the application:their full name and any aliases,their addresses for the last five years,their citizenship,their date and place of birth and a copy of their birth certificate or other document that establishes their place and date of birth,the name and address of any entity for which they work and their position, andtheir business telephone number, facsimile number and email address;the facility name and address;the aggregate quantity of Schedule 1 chemicals that is to be authorized by the licence in respect of each calendar year;a description of the activities to be carried out and the purpose of each activity;for each Schedule 1 chemical that is to be authorized by the licence,its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned),the quantity to be authorized in respect of each calendar year,the quantity to be produced in respect of each calendar year and the production method to be employed, if applicable, andthe IUPAC name, CAS registry number (or structural formula if no CAS registry number has been assigned) and quantity of each precursor listed in Schedule 1, 2 or 3 of the Schedules of Chemicals set out in the Annex on Chemicals in the Convention to be used for the production of the Schedule 1 chemical in respect of each calendar year, if applicable;in the case of a licence that would authorize the production of an aggregate quantity of more than 100 g of Schedule 1 chemicals during each calendar year, a detailed technical description of the facility; andthe proposed term of the licence.Information communicatedThe application shall include the consent of the applicant and of the individuals referred to in paragraphs (1)(b) and (c) to share the information required under paragraphs (1)(a), (b) and (c) in order to verify it.Time to submitAn application for a licence shall be submitted to the National Authoritywith respect to activities being carried out at an existing facility as of the date of coming into force of these Regulations, not later than 60 days after that date; andwith respect to activities proposed to be carried out at a facility,if the proposed aggregate quantity of Schedule 1 chemicals to be produced per calendar year exceeds 100 g, at least 200 days before the day on which those activities are proposed to start, andin any other case, at least 60 days before the day on which those activities are proposed to start.SOR/2018-202, s. 2
New licenceAn application for a new licence shall be submitted to the National Authority in the following circumstances:to change the licensee, the individual responsible for the facility or the entity, if any, for whom they work;to carry out the activities set out in the existing licence at a facility other than the one set out in the licence;to authorize the production, use, acquisition or possession of Schedule 1 chemicals other than those set out in the existing licence; orto authorize an increase in the aggregate quantity of Schedule 1 chemicals produced to more than 100 g during each calendar year.Invalidity of previous licenceOn the issuance of a new licence, the previous licence becomes invalid.SOR/2018-202, s. 3
Amended licenceAn application to amend a licence is required if a change is proposed to any of the following:the aggregate quantity of Schedule 1 chemicals set out in the licence in respect of any calendar year;the activities carried out at the facility or the purpose of any of those activities;the facility name or, owing to a municipal decision, any element of its address; andin the case of a licence that authorizes the production of more than 100 g of Schedule 1 chemicals during each calendar year, the detailed technical description of the facility.Application to amendAn application to amend a licence shall containthe name of the licensee; andany applicable change referred to in subsection (1).Time to submitAn application to amend a licence shall be submitted to the National Authorityin the case of an amendment to the detailed technical description referred to in paragraph (1)(d), at least 200 days before the day on which the proposed amendment is to take effect; andin any other case, at least 60 days before the day on which the proposed amendment is to take effect.
Application to renewAn application to renew a licence shall containthe name of the licensee;any changes to the information required under subsection 4(1) since the most recent previous licence application was made or since the most recent previous application to renew was made; andthe proposed term of the licence.Time to submitThe application shall be submitted to the National Authority at least 60 days before the licence expires.
Conditions Applicable to Licensees
Obligations of licenseeThe licenseeshall ensure that the activities authorized by the licence are carried out safely;[Repealed, SOR/2018-202, s. 4]shall not transfer, assign or otherwise dispose of a licence;shall notify the National Authority in writing, no later than seven days before any change, of the changeof name of the licensee, of the individual responsible for the facility, of the facility or of the entity, if any for whom they work, orin the list of individuals referred to in paragraph 4(1)(c);shall control access to the Schedule 1 chemicals set out in the licence;shall inform the National Authority as soon as practicable of any loss or unintended release of a Schedule 1 chemical; andshall immediately inform the National Authority of any theft of a Schedule 1 chemical or any attempt by an unauthorized individual to obtain a Schedule 1 chemical.SOR/2018-202, s. 4
Cessation of activitiesIn the case of a cessation of the activities authorized by the licence, the licensee shallnotify the National Authority in writing of the cessation of activities, at least seven days before the activities cease;take measures to destroy or transfer the Schedule 1 chemicals immediately after the cessation of activities;if it is intended to destroy the Schedule 1 chemicals,notify the National Authority of that intent and of the proposed method of destruction at least seven days before the day on which destruction is proposed to take place,[Repealed, SOR/2018-202, s. 5]provide the National Authority with documentation, no later than 30 days after the cessation of activities, that confirms the destruction, andbear the costs of the destruction;if it is intended to transfer the Schedule 1 chemical,notify the National Authority in writing of the intent to transfer and of the name, address, telephone number and fax number of the recipient of the transfer at least seven days before the day on which the transfer is proposed to take place,provide the National Authority with documentation, no later than 30 days after the cessation, that confirms the transfer, andbear the costs of the transfer;return the licence to the National Authority no later than 30 days after the cessation of activities;ensure that the record referred to in section 10 is retained for five years after the cessation of activities; andif a facility ceases to exist within five years after the cessation of activities, provide the National Authority with a copy of the record referred to in section 10 within 30 days after the day on which the facility ceases to exist.SOR/2018-202, s. 5
RecordA licensee shall ensure that a record is kept and maintained showing the IUPAC name, CAS registry number (or structural formula if no CAS registry number has been assigned) and quantity of each Schedule 1 chemical produced, used, acquired, possessed, transferred, exported, imported or destroyed.SOR/2018-202, s. 6
Domestic Transfers, Exports and Imports
Domestic transfersIf a Schedule 1 chemical is transferred within Canada, it shall only be transferred to the holder of a licence issued under these Regulations, to the single small-scale facility referred to in section 19 or to an individual referred to in paragraph 18(c).
Exports and importsSubject to subsection (2), if a licensee intends to export or import a Schedule 1 chemical, the licensee shall, at least 45 days before the export or import, provide a written notice to the National Authority that containsthe name, address and telephone number of the licensee, as well as the number and date of issuance of the licence;the date of the licensee’s application under the Export and Import Permits Act, if applicable;for each Schedule 1 chemical, its IUPAC name, its CAS registry number (or its structural formula if no CAS registry number has been assigned) and its quantity;the purpose of the export or import;the anticipated date of shipment;in the case of an export, the name and licence particulars of the exporter, if different from the licensee, and the name and address, including the country, of the ultimate recipient and of the individual or entity for which that recipient acts, as well as their telephone and fax numbers; andin the case of an import, the name and licence particulars of the importer, if different from the licensee, and the name and address, including the country, of the originating sender and of the individual or entity for which that sender acts, as well as their telephone and fax numbers.SaxitoxinIf a licensee intends to export or import 5 mg or less of the Schedule 1 chemical saxitoxin for medical or diagnostic purposes, the licensee may provide the notice required under subsection (1) at any time before the export or import.
Public Health and Safety, International Relations, Environmental and National Defence or Security Risks
National Authority may issue or amendIf immediate measures involving a Schedule 1 chemical are required in order to prevent the compromising of public health and safety, the environment, international relations or national defence and security, the National Authority shall issue or amend a licence to authorize those measures.ValidityA licence issued or an amendment made under subsection (1) is valid for no more than 30 days.SOR/2018-202, s. 7
Refusal, Suspension or Cancellation of a Licence
Suspension of licenceThe National Authority shall suspend a licence if public health and safety, the environment, international relations or national defence and security is likely to be compromised bythe licensed activity or the manner in which the licensed activity is carried out; orany of the following situations, namely,the licensee or any individual acting on the licensee’s behalf fails to comply with the Act or the regulations made under it, orthe licensee or any individual acting on the licensee’s behalf is convicted of an offence under the Act.[Repealed, SOR/2018-202, s. 8]Effect of suspensionWhen a licence is suspended, the licensee shall comply with the obligations established by the licence, but shall cease the activities authorized by the licence for the duration of the suspension.SOR/2018-202, s. 8
Cancellation of licenceThe National Authority shall cancel a licence if public health and safety, the environment, international relations or national defence and security is compromised bythe licensed activity or the manner in which the licensed activity is carried out; orany of the following situations, namely,the licensee or any individual acting on the licensee’s behalf fails to comply with the Act or the regulations made under it, orthe licensee or any individual acting on the licensee’s behalf is convicted of an offence under the Act.[Repealed, SOR/2018-202, s. 9]Effect of cancellationIf a licence has been cancelled, the licensee shallimmediately cease the activities authorized by the licence;comply with paragraphs 9(b) to (e); andno later than 30 days after the cancellation, provide to the National Authority a copy of the record referred to in section 10.SOR/2018-202, s. 9
Written noticeThe National Authority shall notify, in writing,the applicant for a licence or for its renewal or amendment of the reasons for refusing to issue, renew or amend the licence; andthe licensee of the reasons for a decision to suspend or cancel the licence.
Review of Decision
By the National AuthorityA licence applicant whose application is refused or a licensee whose licence is suspended or cancelled may request a review of the decision by making a written request to the National Authority no later than 30 days after the date of the refusal, suspension or cancellation.Decision on reviewThe National Authority shall confirm, vary or rescind its decision and provide written reasons to the person who requested the review within 30 days after the National Authority’s receipt of the request.SOR/2018-202, s. 10
Authorizations Without a Licence
AuthorizationsThe following activities are authorized without a licence:the acquisition and possession of the Schedule 1 chemical saxitoxin occurring naturally in organisms such as shellfish and algae, if the chemical is not recovered;the acquisition and possession of the Schedule 1 chemical ricin occurring naturally in the castor bean plant (Ricinus communis) or its beans, if the chemical is not recovered; andthe acquisition, possession and use of a Schedule 1 chemical by a peace officer to the extent necessary for the administration or enforcement of the law.SOR/2018-202, s. 11
Single small-scale facilityThe production, use, acquisition and possession of Schedule 1 chemicals for research, medical, pharmaceutical or protective purposes are authorized, without a licence, subject to the following conditions:all activities are carried out at the single small-scale facility located at Defence Research and Development Canada — Suffield, in Alberta;the production is carried out in reaction vessels in production lines not configured for continuous operation;the volume of each reaction vessel does not exceed 100 L;the total volume of all reaction vessels with a volume exceeding 5 L is not more than 500 L;the following information is provided to the National Authority by the individual responsible for the single small-scale facility, namely,his or her name,a list of all individuals who will have access to a Schedule 1 chemical in carrying out the activities, including their name, citizenship, date and place of birth, position, business address, telephone number, facsimile number and electronic mail address,the maximum aggregate quantity of all Schedule 1 chemicals stored at any one time during the calendar year,a description of the activities carried out at the single small-scale facility and the purpose of each activity,a description of the measures to control access to the single small-scale facility and to the Schedule 1 chemicals,a description of the storage arrangements for Schedule 1 chemicals and precursors listed in Schedule 1, 2 or 3 of the Schedules of Chemicals set out in the Annex on Chemicals in the Convention used for the production of Schedule 1 chemicals,a detailed technical description of the single small-scale facility, including detailed diagrams and an inventory of equipment,information on any anticipated change at the facility compared to any information previously submitted under subparagraph (vii),for each Schedule 1 chemical produced, acquired, possessed, used, imported, exported or stored during the previous calendar year,its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned),the quantity produced and a description of the production methods used,the IUPAC name, CAS registry number (or structural formula if no CAS registry number has been assigned) and quantity of each precursor listed in Schedule 1, 2 or 3 of the Schedules of Chemicals set out in the Annex on Chemicals in the Convention used in the production of the Schedule 1 chemical,the quantity used and the purpose of its use,the quantities received from and supplied to other facilities in Canada, including the quantity of each shipment, its purpose and the name of the other facility,the amounts imported and exported, including the name of the source or destination country, purpose and date of transfer,the maximum quantity stored at any time during the calendar year, andthe quantity stored at the end of the calendar year, andfor each Schedule 1 chemical that is anticipated to be produced, used or stored,its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned), andthe quantity that is anticipated to be produced and the purpose of the production;if it is intended to transfer a Schedule 1 chemical within Canada, the Schedule 1 chemical is transferred only to the holder of a licence issued in accordance with these Regulations or to an individual referred to in paragraph 18(c);if it is intended to export or import a Schedule 1 chemical, the notice required by section 12 is provided;[Repealed, SOR/2018-202, s. 12]access to the Schedule 1 chemicals is controlled;the National Authority is informed as soon as practicable of any loss or unintended release of a Schedule 1 chemical; andthe National Authority is informed immediately of any theft of a Schedule 1 chemical or any attempt by an unauthorized individual to obtain a Schedule 1 chemical.Time to submitThe individual responsible for the single small-scale facility shall provide to the National Authoritythe information required under subparagraphs (1)(e)(iii) and (ix) by March 1 of each calendar year; andthe information required under subparagraph (1)(e)(x) by September 15 of each calendar year.Notice respecting certain changesThe individual responsible for the single small-scale facility shall notify the National Authority in writing of any change to the information requiredunder subparagraphs (1)(e)(i) and (ii) no later than seven days before the change; andunder subparagraph (1)(e)(viii) at least 200 days before the change.SOR/2018-202, s. 12
Retain documentsThe individual responsible for the activities at the single small-scale facility shall ensure thatany document is retained that supports the information required under paragraph 19(1)(e); anda record is retained showing the IUPAC name, CAS registry number (or structural formula if no CAS registry number has been assigned) and quantity of each Schedule 1 chemical produced, used, acquired, possessed, transferred, exported, imported or destroyed.PeriodThe documents, records and reports shall be retained for five years after the authorized activities cease.
Coming into Force
Coming into forceThese Regulations come into force on the day on which section 8 of the Chemical Weapons Convention Implementation Act, chapter 25 of the Statutes of Canada, 1995, comes into force.[Note: Regulations in force July 1, 2004, see SI/2004-71.]