Bill C-32
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ANIMATE PRODUCTS OF BIOTECHNOLOGY |
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Definitions
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104. The definitions in this section apply in
this Part.
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``living
organism'' « organisme vivant »
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``living organism'' means a substance that is
an animate product of biotechnology.
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``significant
new activity'' « nouvelle activité »
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``significant new activity'' includes, in respect
of a living organism, any activity that
results or may result in
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Adding living
organisms to
Domestic
Substances
List
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105. (1) The Minister shall, for the purposes
of sections 74 and 106, add to the Domestic
Substances List maintained under section 66
any living organism if the Minister is satisfied
that, between January 1, 1984 and December
31, 1986, the living organism
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Amendment
of List
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(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
requirements set out in paragraphs (1)(a) and
(b) were not met, the Minister shall delete the
substance from the List.
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Publication of
List
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(3) The Minister shall publish in the
Canada Gazette the Domestic Substances List
and any amendment to the List.
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Designation
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(4) The Minister may, by order, designate
any person or class of persons to exercise the
powers and perform the duties and functions
set out in this section.
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Manufacture
or import of
living
organisms
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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
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Transitional
provision
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(2) Where a person has, between January 1,
1987 and June 30, 1994, manufactured or
imported a living organism that is not
specified 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.
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Notification
of significant
new activity
in respect of
living
organism on
List
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(3) Where a living organism is specified on
the Domestic Substances List with an
indication 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
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Notification
of significant
new activity
in respect of
living
organism not
on List
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(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
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Transfer of
rights in
respect of
substance
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(5) Where prescribed information with
respect to a substance has been provided under
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.
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Application
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(6) Subsections (1) to (4) do not apply to
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Ministers may
amend
Schedule 4
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(7) For the purposes of the administration of
this section, the Governor in Council has the
exclusive responsibility for determining
whether or not the requirements referred to in
paragraph (6)(a) are met by or under an Act of
Parliament referred to in that paragraph, or
regulations made under that Act, and
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Waiver of
information
requirements
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(8) 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 under that subsection if
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Publication of
notice of
waiver
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(9) 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.
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Compliance
with waiver
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(10) Where the Minister waives any of the
requirements for information under paragraph
(8)(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 by regulations made under
paragraph 114(1)(f) or at the location
specified in the request for the waiver, as the
case may be.
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Correction of
information
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(11) A person who has provided
information under this section, including for
the purposes of a request for a waiver under
subsection (8), or under section 107 or 109
shall notify the Minister of any corrections to
the information as soon as possible after
learning of them.
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Request for
information
previously
waived
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(12) Where the Minister is notified of any
corrections to information that was provided
for the purposes of a request for a waiver under
subsection (8), the Minister may, after
consideration by the Ministers of those
corrections, 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.
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Application of
section 109
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(13) Where the Ministers suspect, after
considering
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that a living organism is toxic or capable of
becoming toxic, the Minister may exercise
any of the powers referred to in paragraphs
109(1)(a) to (c).
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Prohibition of
activity
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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 expiry
of the period for assessing the information
under section 108.
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Prohibition of
activity
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(2) Where the Minister has reasonable
grounds to believe that a person has
manufactured or imported a living organism
in contravention of subsection 106(2), the
Minister may, in writing, prohibit any activity
involving the living organism until the
prescribed information is provided to the
Minister.
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Waiver of
information
requirements
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(3) On the request of any person required
under subsection (1) or (2) to provide
information, the Minister may waive any of
the requirements for prescribed information if
one of the conditions specified in paragraphs
106(8)(a) to (c) is met and, in that case,
subsections 106(9) to (13) apply with respect
to the waiver.
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Assessment of
information
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108. (1) Subject to subsection (4), the
Ministers shall, within the prescribed
assessment period, assess information
provided under subsection 106(1), (3) or (4) or
paragraph 109(1)(c) or otherwise available to
them in respect of a living organism in order
to determine whether it is toxic or capable of
becoming toxic.
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Assessment of
information
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(2) Subject to subsections (3) and (4), the
Ministers shall assess information provided
under subsection 107(1) or otherwise
available to them in respect of a living
organism in order to determine whether it is
toxic or capable of becoming toxic.
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Time for
assessment
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(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.
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Extension of
assessment
period
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(4) Where the Ministers are of the opinion
that further time is necessary to assess any
information, the Minister may, before the
expiry 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.
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Notification
of extension
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(5) Where the Minister extends the period
for assessing information, the Minister shall,
before the expiry of the assessment period
referred to in subsection (1) or (3), notify the
person who provided the information.
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Termination
of period
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(6) The Minister may, before the expiry of
the assessment period referred to in subsection
(1) or (3), terminate the period for assessing
information and, immediately before doing
so, shall notify the person who provided the
information.
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Action to be
taken after
assessment
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109. (1) Where the Ministers have assessed
any information under section 108 and they
suspect that a living organism is toxic or
capable of becoming toxic, the Minister may,
before the expiry of the period for assessing
the information,
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Additional
information or
testing
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(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
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Variation of
conditions
and
prohibitions
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(3) The Minister may vary or rescind a
condition or prohibition specified or imposed
under paragraph (1)(a) or (b).
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Expiry of
prohibition
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(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 expiry 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 the regulations come into
force.
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Publication of
conditions
and
prohibitions
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(5) Where the Minister specifies, imposes,
varies or rescinds any condition for or
prohibition on the manufacture or import of a
living organism, the Minister shall publish in
the Canada Gazette a notice setting out the
condition or prohibition and the living
organism in respect of which it applies.
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Significant
new activity
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110. (1) Where the Ministers have assessed
any information under section 108 in respect
of a living organism that is not on the
Domestic Substances List and they suspect
that a significant new activity in relation to
that living organism may result in the living
organism becoming toxic, the Minister may,
within 90 days after the expiry of the period
for assessing the information, publish in the
Canada Gazette and in any other manner that
the Minister considers appropriate a notice
indicating that subsection 106(4) applies with
respect to the living organism.
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Variation or
revocation
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(2) The Minister may, by notice published
in the Canada Gazette, vary the significant
new activities in relation to a living organism
in respect of which a notice has been given
under subsection (1) or indicate that
subsection 106(4) no longer applies with
respect to that living organism.
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Contents of
notice
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(3) A notice referred to in subsection (1) or
(2) shall indicate, by inclusion or exclusion,
the significant new activities in relation to the
living organism in respect of which subsection
106(4) is to apply, and where regulations in
respect of those significant new activities are
not made under paragraphs 114(1)(c), (d) and
(g), specify the information to be provided to
the Minister under that subsection, the date on
or before which it is to be provided and the
period within which it is to be assessed under
section 108.
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Notification
of persons
required to
comply
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111. Where a notice is published in the
Canada Gazette under subsection 110(1) in
respect of a living organism, every person who
transfers the physical possession or control of
the living organism shall notify all persons to
whom the possession or control is transferred
of the obligation to comply with subsection
106(4).
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Amendment
of List
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112. (1) The Minister shall add a living
organism to the Domestic Substances List
within 120 days after the following conditions
are met:
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Amendment
of List
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(2) Where the Minister adds a living
organism to the Domestic Substances List and
subsequently learns that the living organism
was not manufactured or imported as
described in subsection (1), the Minister shall
delete the living organism from the List.
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Significant
new activity
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(3) Where a living organism is on the
Domestic Substances List or is to be added to
the List under subsection (1), the Minister may
amend the List in respect of the living
organism to indicate that subsection 106(3)
applies with respect to the living organism or
that it no longer applies or by varying the
significant new activities in relation to the
living organism in respect of which subsection
106(3) is to apply.
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Contents of
amendment
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(4) An amendment referred to in subsection
(3) shall indicate, by inclusion or exclusion,
the significant new activities in relation to the
living organism in respect of which subsection
106(3) is to apply, and where regulations in
respect of those significant new activities are
not made under paragraphs 114(1)(c), (d) and
(g), specify the information to be provided to
the Minister under that subsection, the date on
or before which it is to be provided and the
period within which it is to be assessed under
section 108.
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Publication of
masked name
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113. Where the publication under this Part
of the explicit biological name of a living
organism would result in the release of
confidential business information in
contravention of section 314, the living
organism shall be identified by a name
determined in the prescribed manner.
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Regulations
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114. (1) The Governor in Council may, on
the recommendation of the Ministers, make
regulations
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