Export and Import of Substances

List of Prohibited Substances

100. (1) The Governor in Council may, on the recommendation of the Ministers, make an order adding to the List of Prohibited Sub stances in Part I of Schedule III any substance the use of which is prohibited in Canada by or under an Act of Parliament and may, in the same manner, delete any substance from that List.

Prohibition of export

(2) No person shall export any substance specified on the List of Prohibited Substances in Part I of Schedule III except for the purpose of destroying the substance or complying with a direction under subparagraph 99(b)(iii).

List of Substances Requiring Export Notification

101. (1) The Governor in Council may, on the recommendation of the Ministers, make an order

    (a) adding to the List of Substances Requir ing Export Notification in Part II of Sched ule III any substance where the Governor in Council is of the opinion that

      (i) the uses of the substance are substan tially restricted by or under an Act of Parliament or the substance is subject to an international agreement that requires the consent of the importing country before the substance is exported from Canada, and

      (ii) a notice should be given under subsection (3) in respect of the proposed export of the substance; and

    (b) deleting any substance from that List.

List of Substances Authorities

(2) The Minister shall compile a list, to be known as the List of Substances Authorities, and the List shall specify each country in respect of which a notice is required under subsection (3) and the authority, body or person to whom the notice shall be given.

Notice of export of substances

(3) A person shall give notice of the proposed export of a substance specified on the List of Substances Requiring Export Notification in Part II of Schedule III where the person proposes to export the substance to a country specified on the List of Substances Authorities and the export of the substance by that person is to be for the first time after

    (a) the name of the substance is added to the List of Substances Requiring Export Notifi cation in Part II of Schedule III;

    (b) any regulation is made or amended under this or any other Act of Parliament restricting or further restricting any activity relating to the substance; or

    (c) the government of the country of destination takes any action to prevent the import of the substance to that country and the Minister has published a notice of that action in the Canada Gazette.

Form and manner of notice

(4) A notice under subsection (3) shall be given in accordance with the regulations to the Minister and to the authority, body or person specified on the List of Substances Authori ties.

Information to accompany export

(5) Where a person exports a substance as described in subsection (3), the substance shall be accompanied in the prescribed man ner by the prescribed information.

Conditions governing export of substances

102. Except in accordance with the pre scribed conditions, no person shall export a substance in respect of the export of which a notice is required to be given under section 101.

Publication of List of Substances Authorities

103. (1) The Minister shall publish in the Canada Gazette the List of Substances Autho rities and any amendments to that List.

Publication of notices re substances

(2) Where the Minister receives a notice of the proposed export of a substance under section 101, the Minister shall publish in the Canada Gazette or in any other manner that the Minister considers appropriate the name or specifications of the substance, the name of the exporter and the country of destination.

Regulations

(3) The Governor in Council may make regulations

    (a) prescribing the contents of a notice required to be given under section 101, the period within which it shall be given and the manner in which it shall be given;

    (b) prescribing the information that shall accompany any export of a substance for which a notice is required to be given under section 101 and prescribing the manner in which the information shall accompany the substance;

    (c) prescribing the conditions under which a person may export a substance in respect of the export of which a notice is required to be given under section 101; and

    (d) generally for carrying out the purposes of sections 101 and 102.

PART VI

BIOTECHNOLOGY

Definitions

104. The definitions in this section apply in this Part.

``living organism''
« organisme vivant »

``living organism'' means a substance that is an animate product of biotechnology.

``significant new activity''
« nouvelle activité »

``significant new activity'' includes, in respect of a living organism, any activity that re sults in or may result in

      (a) the entry or release of the living organism into the environment in a quantity or concentration that, in the Ministers' opinion, is significantly great er than the quantity or concentration of the living organism that previously en tered or was released into the environ ment; or

      (b) the entry or release of the living organism into the environment or the exposure or potential exposure of the environment to the living organism in a manner and circumstances that, in the Ministers' opinion, are significantly dif ferent from the manner and circum stances in which the living organism previously entered or was released into the environment or of any previous exposure or potential exposure of the environment to the living organism.

Adding living organisms to Domestic Substances List

105. (1) The Minister shall, for the purposes of sections 74 and 106, add to the Domestic Substances List maintained pursuant to sec tion 66 any living organism where the Minis ter is satisfied that, between January 1, 1984 and December 31, 1986, the living organism

    (a) was manufactured in or imported into Canada by any person; and

    (b) entered or was released into the environ ment without being subject to conditions under this or any other Act of Parliament or of the legislature of a province.

Amendment of List

(2) Where the Minister includes a living organism on the Domestic Substances List and subsequently learns that, between January 1, 1984 and December 31, 1986, the require ments set out in paragraphs (1)(a) and (b) were not met, the Minister shall delete the sub stance from the List.

Publication of List

(3) The Minister shall publish in the Cana da Gazette the Domestic Substances List and any amendment to the List.

Manufacture or import of living organisms

106. (1) Where a living organism is not specified on the Domestic Substances List and subsection (2) does not apply, no person shall manufacture or import the living organism unless

    (a) the prescribed information with respect to the living organism, accompanied by the prescribed fee, has been provided by that person to the Minister on or before the prescribed date; and

    (b) the period for assessing the information under section 108 has expired.

Transitional provision

(2) Where a person has, between January 1, 1987 and June 30, 1994, manufactured or imported a living organism that is not speci fied on the Domestic Substances List, no person shall manufacture or import the living organism after June 30, 1994 unless, within 180 days after that date or on or before the prescribed date, the prescribed information has been provided to the Minister with respect to the living organism by that person.

Notification of significant new activity in respect of living organism on List

(3) Where a living organism is specified on the Domestic Substances List with an indica tion that this subsection applies with respect to the living organism, no person shall use, manufacture or import the living organism for a significant new activity that is indicated on the List with respect to the living organism, unless

    (a) the person has provided the Minister with the information, on or before the date, that is specified by the Minister or pre scribed, accompanied by the prescribed fee; and

    (b) the period for assessing the information specified by the Minister or provided under section 108 has expired.

Notification of significant new activity in respect of living organism not on List

(4) Where a living organism is not specified on the Domestic Substances List, and the Minister publishes a notice in the Canada Gazette indicating that this subsection applies with respect to the living organism, no person shall use the living organism for a significant new activity that is indicated in the notice, unless

    (a) the person has provided the Minister with the information, on or before the date, that is specified by the Minister or pre scribed, accompanied by the prescribed fee; and

    (b) the period for assessing the information specified by the Minister or provided under section 108 has expired.

Transfer of rights in respect of substance

(5) Where prescribed information with respect to a substance has been provided pursuant to subsection (1), (2), (3) or (4) by a person who subsequently transfers the right or privilege in relation to the substance for which the information was provided, the information is, subject to any conditions that may be prescribed, deemed to have been provided by the transferee of that right or privilege.

Application

(6) Subsections (1), (2), (3) and (4) do not apply in respect of

    (a) a living organism that is manufactured or imported for a use that is regulated under any other Act of Parliament that provides for notice to be given prior to the manufac ture, import or sale of the living organism and for an assessment of whether it is toxic;

    (b) a living organism that is manufactured, used or imported under the conditions and in the circumstances prescribed as exempt from this section; or

    (c) impurities and contaminants related to the preparation of a living organism.

Determina-
tion for listing on Schedule VI

(7) For the purposes of the administration of this section, the Minister responsible for the administration of another Act of Parliament referred to in paragraph (6)(a) is responsible for determining that the requirements referred to in that paragraph are met.

Schedule of Acts

(8) An Act of Parliament or any regulations listed in Schedule IV have been determined by the Minister responsible for the administration of that Act to meet the requirements referred to in paragraph (6)(a).

Governor in Council power to amend Schedule

(9) Where the Minister responsible for the administration of another Act of Parliament referred to in paragraph (6)(a) has determined that the requirements referred to in that paragraph are met or are no longer met by or under that other Act, the Governor in Council may, on the recommendation made by the responsible Minister after consulting the Min ister, by order, add the name of that other Act or any regulations made under that Act to the list of Acts set out in Schedule IV or delete the name, as the case may be.

Waiver of information requirements

(10) On the request of any person to whom subsection (1), (2), (3) or (4) applies, the Minister may waive any of the requirements to provide information pursuant to that subsec tion if

    (a) in the opinion of the Ministers, the information is not needed in order to determine whether the living organism is toxic;

    (b) a living organism is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the person requesting the waiver is able to contain the living organism so as to satisfactorily protect the environment and human health; or

    (c) it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.

Publication of notice of waiver

(11) The Minister shall publish in the Canada Gazette a notice stating the name of any person to whom a waiver is granted and the type of information to which it relates.

Compliance with waiver

(12) Where the Minister waives any of the requirements for information pursuant to paragraph (10)(b), the person to whom the waiver is granted shall not use, manufacture or import the living organism unless it is for the purpose prescribed pursuant to regulations made under paragraph 114(1)(f) or at the location specified in the request for the waiver, as the case may be.

Correction of information

(13) A person who has provided informa tion under this section, including for the purposes of a request for a waiver under subsection (10), or under section 107 or 109 shall notify the Minister of any corrections to the information as soon as possible after learning of them.

Request for information previously waived

(14) Where the Minister is notified of any corrections to information that was provided for the purposes of a request for a waiver under subsection (10), the Minister may, after con sideration by the Ministers of those correc tions, require the person to whom the waiver was granted to provide the Minister with the information to which the waiver related within the time specified by the Minister.

Application of section 109

(15) Where the Ministers, after considering the information provided under subsection (14), suspect that a living organism is toxic, the Minister may exercise any of the powers referred to in paragraphs 109(1)(a) to (c).

Prohibition of activity

107. (1) Where the Minister has reasonable grounds to believe that a person has used, manufactured or imported a living organism in contravention of subsection 106(1), (3) or (4), the Minister may, in writing, require the person to provide the information referred to in that subsection and prohibit any activity involving the living organism until the expira tion of the period for assessing the information under section 108.

Prohibition of activity

(2) Where the Minister has reasonable grounds to believe that a person has manufac tured or imported a living organism in con travention of subsection 106(2), the Minister may, in writing, prohibit any activity involv ing the living organism until the prescribed information is provided to the Minister.

Waiver of information requirements

(3) On the request of any person required under subsection (1) or (2) to provide informa tion, the Minister may waive any of the requirements for prescribed information if one of the conditions specified in paragraphs 106(10)(a) to (c) is met and, in that case, subsections 106(11) to (15) apply with respect to the waiver.

Assessment of information

108. (1) Subject to subsection (4), the Ministers shall, within the prescribed assess ment period, assess information provided under subsection 106(1), (3) or (4) or para graph 109(1)(c) or otherwise available to them in respect of a living organism in order to determine whether it is toxic.

Assessment of information

(2) Subject to subsections (3) and (4), the Ministers shall assess information provided under subsection 107(1) or otherwise avail able to them in respect of a living organism in order to determine whether it is toxic.

Time for assessment

(3) An assessment of information under subsection (2) shall be made following the date on which the information is provided within a period that does not exceed the number of days in the prescribed assessment period.

Extension of assessment period

(4) Where the Ministers are of the opinion that further time is necessary to assess any information, the Minister may, before the expiration of the assessment period referred to in subsection (1) or (3), extend the period for assessing the information, but the extension shall not exceed the number of days in the prescribed assessment period.

Notification of extension

(5) Where the Minister extends the period for assessing information, the Minister shall, before the expiration of the assessment period referred to in subsection (1) or (3), notify the person who provided the information.

Termination of period

(6) The Minister may, before the expiration of the assessment period referred to in subsec tion (1) or (3), terminate the period for assessing information and, immediately be fore doing so, shall notify the person who provided the information.

Action to be taken after assessment

109. (1) Where the Ministers have assessed any information under section 108 and they suspect that a living organism is toxic, the Minister may, before the expiration of the period for assessing the information,

    (a) permit any person to manufacture or import the living organism, subject to such conditions as the Ministers may specify;

    (b) prohibit any person from manufacturing or importing the living organism; or

    (c) request any person to provide such additional information or submit the results of such testing as the Ministers consider necessary for the purpose of assessing whether the living organism is toxic.

Additional information or testing

(2) Where the Minister requests additional information or test results under paragraph (1)(c), the person to whom the request is directed shall not manufacture or import the living organism unless

    (a) the person provides the additional information or submits the test results; and

    (b) the period for assessing information under section 108 has expired or a period of 120 days after the additional information or test results were provided has expired, whichever is the later.

Variation of conditions and prohibitions

(3) The Minister may vary or rescind a condition or prohibition specified or imposed under paragraph (1)(a) or (b).

Expiration of prohibition

(4) Any prohibition on the manufacture or import of a living organism imposed under paragraph (1)(b) expires two years after it is imposed unless, before the expiration of the two years, the Governor in Council publishes in the Canada Gazette a notice of proposed regulations under section 114 in respect of the living organism, in which case the prohibition expires on the day on which the regulations come into force.