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Vol. 138, No. 15 — April 10, 2004
Schedule 1 Chemicals Regulations (Chemical Weapons Convention)
Statutory Authority
Chemical Weapons Convention Implementation Act
Sponsoring Department
Department of Foreign Affairs and International Trade
REGULATORY IMPACT
ANALYSIS STATEMENT
Description
The Schedule 1 Chemicals Regulations (Chemical Weapons Convention) are designed to control the production, possession, use, acquisition and transfer of chemicals included in Schedule 1 of the Convention.
Canada adopted the Chemical Weapons Convention Implementation Act (brought into force January 1, 2001, with the exception of section 8; TR/2001-3) in 1995, in order to meet its international obligations with regard to the disarmament and non- proliferation of chemical weapons under the Convention. The proposed Regulations — made under sections 8, 11 and 18 of this Act — set out a series of rules covering such issues as the national limit on Schedule 1 chemicals that can be held at any time in Canada, authorized activities not requiring a licence, activities requiring a licence, conditions governing licence applications, information required by the National Authority for a new licence or renewal applications, and time limits. The Regulations set out the obligations of licence holders, particularly as regards the discontinuation of activities, domestic transfers, exports and imports and conditions under which licences will be suspended or cancelled. It should be noted that no person shall import or export a Schedule 1 chemical without a permit issued under the Export and Import Permits Act [subsection 8(2) of the Act].
The main users of regulated Schedule 1 chemicals are governments, universities
and pharmaceutical and medical research facilities. Governmental users
include facilities involved in the government-wide Chemical, Biological,
Radiological and Nuclear Research and Technology Initiative (CBRN RTI)
and involve Health Canada, Environment Canada, Natural Resources Canada,
the RCMP, CSIS, and Defence Research and Development Canada Suffield.
These Regulations are to come into force the day on which section 8 of the Chemical Weapons Convention Implementation Act comes into force.
Alternatives
Because Schedule 1 chemicals (Chemical Weapons Convention) can be used in the manufacture of chemical weapons, it is vital that Canada take the measures necessary to exert tight control over the activities surrounding these types of chemicals. In these circumstances, Canada cannot allow those involved with these chemicals to set their own standards of control.
Benefits and costs
The proposed Regulations in their present form will make it possible for Canada to control the production, possession, use, acquisition and transfer of chemicals included in Schedule 1 of the Convention, while minimizing the direct costs — especially administrative — for businesses and departments or other organizations involved in their application.
Consultation
Consultations were conducted in both the private and public sectors with such organizations as the Canadian Chemical Producers Association and Canada's Research-based Pharmaceutical Companies (formerly the Pharmaceutical Manufacturers Association of Canada). The Canadian National Authority's Science Advisor provided the perspective of Canada's academic community and representatives from federal government laboratories were asked for their opinion. Representatives from the Department of National Defence were supportive and closely involved in developing these draft regulations.
Compliance and enforcement
The National Authority will closely monitor observance of the terms and conditions of the licences issued. Any violation of these terms and conditions may result in the suspension or cancellation of a licence. Moreover, breach of any provision of the Chemical Weapons Convention Implementation Act constitutes a criminal offence and could result in prosecution.
Inspection teams from the Technical Secretariat of the Organization for the Prohibition of Chemical Weapons are authorized under the Chemical Weapons Convention Implementation Act to conduct inspections in Canada on behalf of the Organization.
Contact
Mr. Allen R. Brown, National Co-ordinator, Canadian National Authority —
Chemical Weapons Convention, Nuclear and Chemical Disarmament Implementation
Division, Department of Foreign Affairs and International Trade, Lester
B. Pearson Building, 125 Sussex Drive, Ottawa, Ontario K1A 0G2, (613)
944-0473 (telephone), (613) 944-1835 (facsimile), allen.brown@dfait-maeci.gc.ca
(electronic mail).
PROPOSED REGULATORY TEXT
Notice is hereby given that the Governor in Council, pursuant to sections 8, 11 and 18 of the Chemical Weapons Convention Implementation Act (see footnote a), proposes to make the annexed Schedule 1 Chemicals Regulations (Chemical Weapons Convention).
Interested persons may make representations with respect to the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Allen R. Brown, National Coordinator, Canadian National Authority, Nuclear and Chemical Disarmament Implementation Division, Department of Foreign Affairs and International Trade, 125 Sussex Drive, Ottawa, Ontario K1A 0G2 (tel.: (613) 944-0473; fax: (613) 944-1835; E-mail: allen.brown@dfait-maeci.gc.ca).
Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.
Ottawa, March 30, 2004
EILEEN BOYD
Assistant Clerk of the Privy Council
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SCHEDULE 1 CHEMICALS REGULATIONS
(CHEMICAL WEAPONS CONVENTION) |
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INTERPRETATION |
| Definitions |
1. (1) The following definitions apply in these Regulations. |
"Act"
« Loi » |
"Act" means the Chemical Weapons Convention Implementation Act. |
"CAS registry number"
« numéro » d'enregistrement CAS " |
"CAS registry number" means the identification number assigned to a chemical substance by the Chemical Abstracts Service Division of the American Chemical Society.
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"IUPAC"
« UICPA » |
"IUPAC" means the International Union of Pure and Applied Chemistry. |
"Schedule 1 chemical"
« produit du tableau 1 » |
"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. |
| Interpretation |
(2) For the purpose of these Regulations, "facility" means the plant site, plant or unit where the activities authorized under these Regulations are carried out. |
| Electronic transmission |
(3) Any notice or application that is required to be given in writing under these Regulations may be given by electronic means. |
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NATIONAL LIMIT |
| National limit |
2. The maximum aggregate quantity of Schedule 1 chemicals authorized in Canada at any given time shall not exceed one tonne. |
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AUTHORIZATIONS BY LICENCE |
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Authorization |
| Authorization |
3. (1) Subject 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:
(a) public health and safety, the environment, international relations or national defence or security is unlikely to be compromised;
(b) the activities are for research, medical, pharmaceutical or protective purposes;
(c) the aggregate quantity of Schedule 1 chemicals produced does not exceed 10 kg per year per facility; and
(d) the quantities authorized are consistent with the intended purpose referred to in paragraph (b). |
| Production for protective purposes |
(2) There shall be only one licensed facility in Canada for the production of Schedule 1 chemicals for protective purposes. |
| Term of licence |
(3) The term of a licence shall not exceed three years. |
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Applications |
| Licence application |
4. (1) A written application for a licence in respect of each facility shall be submitted to the National Authority by the individual who would be responsible for the activities requested in the application, shall be signed by that applicant and by the individual responsible for the facility, if they are not the same individual, and shall contain
(a) the applicant's full name, aliases, if any, addresses for the last five years, citizenship, date and place of birth, relevant education and work history and a copy of his or her birth certificate or other evidence that establishes the applicant's date and place of birth;
(b) the name, address, position, citizenship and date and place of birth of the individual responsible for the facility and the name and address of the entity, if any, for which they work;
(c) a list of all individuals who would have access to a Schedule 1 chemical in carrying out the activities requested in the application, including their name, citizenship, date and place of birth, position, business address, telephone number, facsimile number and electronic mail address;
(d) the facility name and address;
(e) the aggregate quantity of Schedule 1 chemicals that is to be authorized by the licence in respect of each calendar year;
(f) a description of the activities to be carried out and the purpose of each activity;
(g) for each Schedule 1 chemical that is to be authorized by the licence,
(i) its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned),
(ii) the quantity to be authorized in respect of each calendar year,
(iii) the quantity to be produced in respect of each calendar year and the production method to be employed, if applicable, and
(iv) 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 to be used for the production of the Schedule 1 chemical in respect of each calendar year, if applicable;
(h) 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; and
(i) the proposed term of the licence. |
| Information communicated |
(2) The 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 submit |
(3) An application for a licence shall be submitted to the National Authority
(a) with 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; and
(b) with respect to activities proposed to be carried out at a facility,
(i) 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, and
(ii) in any other case, at least 60 days before the day on which those activities are proposed to start. |
| New licence |
5. An application for a new licence shall be submitted to the National Authority in the following circumstances:
(a) to change the licensee, the individual responsible for the facility or the entity, if any, for whom they work;
(b) to carry out the activities set out in the existing licence at a facility other than the one set out in the licence;
(c) to authorize the production, use, acquisition or possession of Schedule 1 chemicals other than those set out in the existing licence; or
(d) to authorize an increase in the aggregate quantity of Schedule 1 chemicals produced to more than 100 g during each calendar year. |
| Amended licence |
6. (1) An application to amend a licence is
required if a change is proposed to any of the
following:
(a) the aggregate quantity of Schedule 1 chemicals set out in the licence in respect of any calendar year;
(b) the activities carried out at the facility or the purpose of any of those activities;
(c) the facility name or, owing to a municipal decision, any element of its address; and
(d) in 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 amend |
(2) An application to amend a licence shall
contain
(a) the name of the licensee; and
(b) any applicable change referred to in subsection (1). |
| Time to submit |
(3) An application to amend a licence shall be submitted to the National Authority
(a) in 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; and
(b) in any other case, at least 60 days before the day on which the proposed amendment is to take effect. |
| Application to renew |
7. (1) An application to renew a licence shall contain
(a) the name of the licensee;
(b) 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; and
(c) the proposed term of the licence. |
| Time to submit |
(2) The application shall be submitted to the National Authority at least 60 days before the licence expires. |
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Conditions Applicable to Licensees |
| Obligations of licensee |
8. The licensee
(a) shall meet the requirements of the Act and these Regulations and ensure that the activities authorized by the licence are carried out safely and in compliance with those requirements;
(b) shall ensure that any individual referred to in paragraph 4(1)(c) who produces or uses a Schedule 1 chemical is adequately supervised in the course of that production or use;
(c) shall not transfer, assign or otherwise dispose of a licence;
(d) shall notify the National Authority in writing, no later than seven days before any change, of the change
(i) of name of the licensee, of the individual responsible for the facility, of the facility or of the entity, if any for whom they work, or
(ii) in the list of individuals referred to in paragraph 4(1)(c);
(e) shall control access to the Schedule 1 chemicals set out in the licence;
(f) shall inform the National Authority as soon as practicable of any loss or unintended release of a Schedule 1 chemical; and
(g) shall 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. |
| Cessation of activities |
9. In the case of a cessation of the activities authorized by the licence, the licensee shall
(a) notify the National Authority in writing of the cessation of activities, at least seven days before the activities cease;
(b) take measures to destroy or transfer the Schedule 1 chemicals immediately after the cessation of activities;
(c) if it is intended to destroy the Schedule 1 chemicals,
(i) 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,
(ii) destroy the Schedule 1 chemical using methods that comply with relevant safety standards and applicable environmental regulations,
(iii) provide the National Authority with documentation, no later than 30 days after the cessation of activities, that confirms the destruction, and
(iv) bear the costs of the destruction;
(d) if it is intended to transfer the Schedule 1 chemical,
(i) 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,
(ii) provide the National Authority with documentation, no later than 30 days after the cessation, that confirms the transfer, and
(iii) bear the costs of the transfer;
(e) return the licence to the National Authority no later than 30 days after the cessation of activities;
(f) ensure that all documents, records and reports related to the licence are retained at the facility for five years after the cessation of activities; and
(g) if a facility ceases to exist within five years after the cessation of activities, provide the National Authority with a copy of all documents, records and reports related to the licence as soon as practicable. |
| Documents, records and reports |
10. A licensee shall ensure that a record is kept and maintained at the facility 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 and provide the National Authority with a copy of the record on request. |
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Domestic Transfers, Exports and Imports |
| Domestic transfers |
11. If 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 imports |
12. (1) Subject 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 contains
(a) the name, address and telephone number of the licensee, as well as the number and date of issuance of the licence;
(b) the date of the licensee's application under the Export and Import Permits Act, if applicable;
(c) 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;
(d) the purpose of the export or import;
(e) the anticipated date of shipment;
(f) 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; and
(g) in 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. |
| Saxitoxin |
(2) If 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. |
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Public Health and Safety, International Relations,
Environmental and National
Defence or Security Risks |
| National Authority may issue or amend |
13. (1) Despite section 3, if public health and safety, the environment, international relations or national defence or security is threatened and immediate measures involving a Schedule 1 chemical are required, the National Authority shall issue or amend a licence to authorize those measures. |
| Validity |
(2) A licence issued or an amendment made
under subsection (1) is valid for no more than
30 days. |
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Refusal, Suspension or Cancellation of a Licence |
| Conditions for suspension |
14. (1) The National Authority shall suspend a licence if public health and safety, the environment, international relations or national defence or security is likely to be compromised by
(a) the licensed activity or the manner in which the licensed activity is carried out; or
(b) any of the following situations, namely,
(i) the licensee or any individual acting on the licensee's behalf fails to comply with the Act or the regulations made under it,
(ii) the licensee or any individual acting on the licensee's behalf is convicted of an offence under the Act, or
(iii) an activity that is not authorized by the licence is carried out. |
| Effect of suspension |
(2) When 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. |
| Conditions for cancellation |
15. (1) The National Authority shall cancel a licence if public health and safety, the environment, international relations or national defence or security is compromised by
(a) the licensed activity or the manner in which the licensed activity is carried out; or
(b) any of the following situations, namely,
(i) the licensee or any individual acting on the licensee's behalf fails to comply with the Act or the regulations made under it,
(ii) the licensee or any individual acting on the licensee's behalf is convicted of an offence under the Act, or
(iii) an activity that is not authorized by the licence is carried out. |
| Effect of cancellation |
(2) If a licence has been cancelled, the licensee shall
(a) immediately cease the activities authorized by the licence;
(b) comply with paragraphs 9(b) to (e); and
(c) no later than 30 days after the cancellation, provide to the National Authority all documents, records and reports related to the licence. |
| Written notice |
16. The National Authority shall notify, in
writing,
(a) the applicant for a licence or for its renewal or amendment of the reasons for refusing to issue, renew or amend the licence; and
(b) the licensee of the reasons for a decision to suspend or cancel the licence. |
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Review of Decision |
| By the National Authority |
17. A 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. |
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AUTHORIZATIONS WITHOUT A LICENCE |
| Authorizations |
18. The following activities are authorized without a licence:
(a) 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;
(b) 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; and
(c) the acquisition, possession and use of a Schedule 1 chemical by any individual who is required or authorized by law to do anything in the administration or enforcement of the law. |
| Single small-scale facility |
19. (1) The 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:
(a) all activities are carried out at the single small-scale facility located at Defence Research and Development Canada — Suffield, in Alberta;
(b) the production is carried out in reaction vessels in production lines not configured for continuous operation;
(c) the volume of each reaction vessel does not exceed 100 L;
(d) the total volume of all reaction vessels with a volume exceeding 5 L is not more than 500 L;
(e) the following information is provided to the National Authority by the individual responsible for the single small-scale facility, namely,
(i) his or her name,
(ii) 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,
(iii) the maximum aggregate quantity of all Schedule 1 chemicals stored at any one time during the calendar year,
(iv) a description of the activities carried out at the single small-scale facility and the purpose of each activity,
(v) a description of the measures to control access to the single small-scale facility and to the Schedule 1 chemicals,
(vi) 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,
(vii) a detailed technical description of the single small-scale facility, including detailed diagrams and an inventory of equipment,
(viii) information on any anticipated change at the facility compared to any information previously submitted under subparagraph (vii),
(ix) for each Schedule 1 chemical produced, acquired, possessed, used, imported, exported or stored during the previous calendar year,
(A) its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned),
(B) the quantity produced and a description of the production methods used,
(C) 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,
(D) the quantity used and the purpose of its use,
(E) the quantity received from or supplied to other facilities in Canada that shows the quantity of each shipment as well as its recipient and purpose,
(F) the amounts imported and exported, including the name of the source or destination country, purpose and date of transfer,
(G) the maximum quantity stored at any time during the calendar year, and
(H) the quantity stored at the end of the calendar year, and
(x) for each Schedule 1 chemical that is anticipated to be produced, used or stored,
(A) its IUPAC name and CAS registry number (or structural formula if no CAS registry number has been assigned), and
(B) the quantity that is anticipated to be produced and the purpose of the production;
(f) 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);
(g) if it is intended to export or import a Schedule 1 chemical, the notice required by section 12 is provided;
(h) any individual who will produce or use Schedule 1 chemicals at the single small-scale facility is adequately supervised in the course of that production or use;
(i) access to the Schedule 1 chemicals is
controlled;
(j) the National Authority is informed as soon as practicable of any loss or unintended release of a Schedule 1 chemical; and
(k) the 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 submit |
(2) The individual responsible for the single small-scale facility shall provide to the National Authority
(a) the information required under subparagraphs (1)(e)(iii) and (ix) by March 1 of each calendar year; and
(b) the information required under subparagraph (1)(e)(x) by September 15 of each calendar year. |
| Notice respecting certain changes |
(3) The individual responsible for the single small-scale facility shall notify the National Authority in writing of any change to the information required
(a) under subparagraphs (1)(e)(i) and (ii) no later than seven days before the change; and
(b) under subparagraph (1)(e)(viii) at least
200 days before the change. |
| Retain documents |
20. (1) The individual responsible for the activities at the single small-scale facility shall ensure that
(a) any document is retained that supports the information required under paragraph 19(1)(e); and
(b) a 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. |
| Period |
(2) The documents, records and reports shall be retained for five years after the authorized activities cease. |
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COMING INTO FORCE |
| Coming into force |
21. These 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. |
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[15-1-o] |
Footnote a
S.C. 1995, c. 25
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