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| Additional
information
|
12. (1) The Minister may, by delivering a
notice in writing, require a registrant
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|
(a) to compile information, conduct tests
and monitor experience with the pest
control product for the purpose of obtaining
additional information with respect to its
effects on human health and safety or the
environment or with respect to its value;
and
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(b) to report the additional information to
the Minister within the time and in the form
specified in the notice.
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| Condition of
registration
|
(2) A requirement under subsection (1) is a
condition of registration.
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| Mandatory
reporting
|
13. An applicant for registration of a pest
control product, a person who makes an
application under subsection 10(2) or a
registrant shall report any prescribed
information that relates to the health or
environmental risks or the value of the pest
control product to the Minister within the
prescribed time and in the form and manner
directed by the Minister.
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| Determination
by Minister
|
14. After considering any information
reported under section 12 or 13, the Minister
shall determine whether a special review of
the registration of the pest control product
should be initiated.
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| Public
availability
|
15. After considering any information
reported under section 13, the Minister shall
make public his or her conclusions if, in the
Minister's opinion,
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(a) the pest control product poses a
significant health or environmental risk; or
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(b) it is in the public interest to do so.
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| Minister's
discretion to
initiate
re-evaluation
|
16. (1) The Minister may initiate the
re-evaluation of a registered pest control
product if the Minister considers that, since
the product was registered, there has been a
change in the information required, or the
procedures used, for the evaluation of the
health or environmental risks or the value of
pest control products of the same class or kind.
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| Minister
required to
initiate
re-evaluation
|
(2) Without limiting the generality of
subsection (1),
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(a) if a decision of a type referred to in
paragraph 28(1)(a) or (b) was made in
relation to a pest control product on or after
April 1, 1995, the Minister shall initiate a
re-evaluation of that product no later than
one year after 15 years have elapsed since
the most recent decision of that type; and
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(b) if the most recent decision of a type
referred to in paragraph 28(1)(a) or (b) was
made in relation to a pest control product
before April 1, 1995, the Minister shall
initiate a re-evaluation of that product no
later than April 1, 2005 or the date that is
one year after 15 years have elapsed since
that decision, whichever date is later.
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| Notice
requesting
information
|
(3) Re-evaluation of a pest control product
is initiated by the Minister delivering a notice
in writing to the registrant explaining the
reasons for initiating the re-evaluation and, if
considered necessary by the Minister,
requiring the registrant to provide information
in the form and within the period specified in
the notice.
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| Request for
information
from
departments
and provinces
|
(4) After the re-evaluation is initiated, the
Minister shall deliver a notice to federal and
provincial government departments and
agencies whose interests and concerns are
affected by the federal regulatory system
requesting them to provide, in the form and
within the period specified in the notice,
information in respect of the health and
environmental risks and the value of the
product that is under re-evaluation.
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| Provision of
information
when more
than one
registrant
|
(5) If there is more than one registrant
whose registered pest control products have
active ingredients that the Minister has
determined to be equivalent,
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(a) two or more registrants may provide the
information required under subsection (3)
or paragraph 19(1)(a) jointly; and
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(b) where the Minister is satisfied that the
information required under subsection (3)
or paragraph 19(1)(a) has been provided by
one or more registrants, the Minister shall,
subject to and in accordance with the
regulations made under paragraph 67(1)(h),
permit another registrant to use or rely on
that information to meet the requirements
of those provisions.
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| Evaluation of
pest control
product
|
(6) After the re-evaluation is initiated, the
Minister shall, in accordance with the
regulations, if any, conduct any evaluations
that the Minister considers necessary with
respect to the health or environmental risks or
the value of the pest control product and shall
carry out the consultations required by section
28.
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| Initiation of
special review
by Minister
|
17. (1) The Minister shall initiate a special
review of the registration of a pest control
product if the Minister has reasonable grounds
to believe that the health or environmental
risks of the product are, or its value is,
unacceptable.
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| Special
review where
O.E.C.D. ban
|
(2) Without limiting the generality of
subsection (1), when a member country of the
Organisation for Economic Co-operation and
Development prohibits all uses of an active
ingredient for health or environmental
reasons, the Minister shall initiate a special
review of registered pest control products
containing that active ingredient.
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| Special
review where
information
from
department or
province
|
(3) Without limiting the generality of
subsection (1), the Minister shall initiate a
special review of the registration of a pest
control product if a federal or provincial
government department or agency has
provided information to the Minister that
relates to the health or environmental risks or
the value of the product and if, after
considering the information provided, the
Minister has reasonable grounds to believe
that the health or environmental risks of the
product are, or its value is, unacceptable.
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| Request for
special review
|
(4) Any person may request a special
review of the registration of a pest control
product by making a request to the Minister in
the form and manner directed by the Minister.
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| Decision
|
(5) Within a reasonable time after receiving
a request, the Minister shall decide whether to
initiate a special review and shall respond to
the request with written reasons for the
decision.
|
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| Notice
requesting
information
|
18. (1) A special review of a pest control
product is initiated by the Minister delivering
a notice in writing to the registrant explaining
the reasons for initiating the special review
and, if considered necessary by the Minister,
requiring the registrant to provide information
in the form and within the period specified in
the notice.
|
|
| Request for
information
from
departments
and provinces
|
(2) After the special review is initiated, the
Minister shall deliver a notice to federal and
provincial government departments and
agencies whose interests and concerns are
affected by the federal regulatory system
requesting them to provide, in the form and
within the period specified in the notice,
information in respect of the health and
environmental risks and the value of the
product that is under special review.
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|
| Provision of
information
when more
than one
registrant
|
(3) If there is more than one registrant
whose registered pest control products have
active ingredients that the Minister has
determined to be equivalent,
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|
(a) two or more registrants may provide the
information required under subsection (1)
or paragraph 19(1)(a) jointly; and
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|
(b) where the Minister is satisfied that the
information required under subsection (1)
or paragraph 19(1)(a) has been provided by
one or more registrants, the Minister shall,
subject to and in accordance with the
regulations made under paragraph 67(1)(h),
permit another registrant to use or rely on
that information to meet the requirements
of those provisions.
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| Evaluation of
pest control
product
|
(4) After the special review is initiated, the
Minister shall, in accordance with the
regulations, if any, evaluate the aspects of the
pest control product that prompted the special
review and shall carry out the consultations
required by section 28.
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| Burden of
persuasion
and
consideration
of information
|
19. (1) During an evaluation that is done in
the course of a re-evaluation or special review,
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(a) the Minister may, by delivering a notice
in writing, require the registrant to provide,
in the form and within the period specified
in the notice, additional information that
the Minister considers necessary for the
evaluation;
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(b) the registrant has the burden of
persuading the Minister that the health and
environmental risks and the value of the
pest control product are acceptable; and
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(c) the Minister shall consider the
information provided by the registrant in
support of the product and may consider
any additional information, but the Minister
shall give the registrant a reasonable
opportunity to make representations in
respect of the additional information before
completing the evaluation.
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| Scientific
approach
|
(2) In evaluating the health and
environmental risks of a pest control product
and in determining whether those risks are
acceptable, the Minister shall
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(a) apply a scientifically-based approach;
and
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(b) in relation to health risks,
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(i) apply appropriate margins of safety to
take into account, among other relevant
factors, the use of animal
experimentation data and the different
sensitivities to pest control products of
major identifiable subgroups, including
pregnant women, infants, children,
women and seniors, and
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(ii) in the case of a threshold effect, if the
product is used in or around homes or
schools, apply a margin of safety that is
ten times greater than the margin of
safety that would otherwise be applicable
under subparagraph (i) in respect of that
threshold effect, to take into account
potential pre- and post-natal toxicity and
completeness of the data with respect to
the exposure of, and toxicity to, infants
and children, unless, on the basis of
reliable scientific data, the Minister has
determined that a different margin of
safety would be appropriate.
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| Government
policy to be
given effect in
evaluation
|
(3) In evaluating the health and
environmental risks and the value of a pest
control product, the Minister shall give effect
to government policy.
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| Comparative
risk and value
assessment
|
(4) In determining whether the health and
environmental risks and the value of a pest
control product are acceptable, the Minister
may, in accordance with the regulations, if
any, take into account information regarding
the risks and value of other pest control
products that are registered for the same use.
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| Representatio
ns
|
(5) For the purposes of subsection (4), the
Minister shall, before making the
determination, give any registrant whose
product is under re-evaluation or special
review a reasonable opportunity to make
representations in respect of the information
referred to in that subsection.
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| Cancellation
or amendment
|
20. (1) The Minister may cancel or amend
the registration of a pest control product if
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|
(a) the registrant fails to satisfy a
requirement under subsection 16(3) or
18(1) or paragraph 19(1)(a); or
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(b) in the course of a re-evaluation or
special review, the Minister has reasonable
grounds to believe that the cancellation or
amendment is necessary to deal with a
situation that endangers human health or
safety or the environment, taking into
account the precautionary principle set out
in subsection (2).
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| Precautionary
principle
|
(2) Where there are threats of serious or
irreversible damage, lack of full scientific
certainty shall not be used as a reason for
postponing cost-effective measures to prevent
adverse health impact or environmental
degradation.
|
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| Rescission of
action
|
(3) The Minister may rescind any action
taken under subsection (1) if the
circumstances that prompted it cease to exist.
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|
| Refusal to
consider
applications
|
(4) If the registration of a pest control
product is cancelled or amended under
paragraph (1)(a), the Minister may, for a
prescribed period, refuse to consider any
application made in respect of that product by
the registrant.
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|
| Confirmation
|
21. (1) If the Minister considers that the
health and environmental risks and the value
of a pest control product are acceptable after
any required evaluations and consultations
have been completed, the Minister shall
confirm the registration.
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| Amendment
or
cancellation
|
(2) If the Minister does not consider that the
health or environmental risks or value of a pest
control product are acceptable, the Minister
shall
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|
(a) amend the registration if the Minister
considers that the health and environmental
risks and value of the product would be
acceptable after the amendment; or
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|
(b) cancel the registration.
|
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| Delay of
effective date
|
(3) The Minister may delay the effective
date of the amendment or cancellation if
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|
(a) no suitable alternative to the use of the
pest control product is available; and
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|
(b) the Minister considers that the health
and environmental risks and value of the
product are acceptable until the effective
date of the amendment or cancellation.
|
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| Conditions on
delay
|
(4) A delay is subject to any conditions that
the Minister considers necessary for carrying
out the purposes of this Act.
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|
| Continued
possession,
etc., of
existing
stocks
|
(5) When cancelling the registration of a
pest control product under this section or any
other provision of this Act, the Minister may
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|
(a) allow the continued possession,
handling, storage, distribution and use of
stocks of the product in Canada at the time
of cancellation, subject to any conditions,
including disposal procedures, that the
Minister considers necessary for carrying
out the purposes of this Act;
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(b) require the registrant to recall and
dispose of the product in a manner specified
by the Minister; or
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|
(c) seize and dispose of the product.
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|
| Discontinuati
on of sale of
product
|
22. (1) A registrant who intends to
discontinue the sale of a pest control product
for one or more uses for which it is registered
shall notify the Minister of that intention in the
form and manner directed by the Minister.
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| Reasons for
discontinuatio
n
|
(2) The Minister may deliver a notice in
writing to the registrant requiring the
registrant to explain the reasons for the
discontinuation.
|
|
| Cancellation
or amendment
of registration
|
(3) On receipt of notification under
subsection (1), the Minister shall cancel or
amend the registration, as the case may be, as
of a date to be determined by the Minister and,
pending that date, may impose any conditions
that the Minister considers necessary for
carrying out the purposes of this Act.
|
|
| Non-payment
of fees, fines,
etc.
|
23. If a registrant fails to pay a fee, fine,
penalty, charge or cost that the registrant is
liable to pay under or in relation to this Act, the
Minister may
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|
(a) cancel or amend any registration in the
registrant's name; and
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|
(b) refuse to consider any application made
by the registrant under this Act.
|
|
| Amendment
with consent
|
24. The Minister may, with the written
consent of the registrant, amend the
registration of a pest control product for the
purpose of reducing its health or
environmental risks or increasing its value.
|
|
| Breach of
conditions
|
25. The Minister may cancel or amend the
registration of a pest control product if the
registrant does not comply with the conditions
of registration.
|
|
| Violation or
offence
|
26. If a person is found to have committed
a violation or is convicted of an offence under
this Act, the Minister may, having regard to
the nature of the violation or offence and the
circumstances surrounding its commission,
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|
(a) cancel or amend the registration of the
pest control product that was involved in the
violation or offence where the person who
committed the violation or offence is the
registrant;
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|
(b) cancel or amend the registration of any
other pest control product in respect of
which the person is the registrant; or
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(c) refuse to consider any application made
under this Act by the person during any
period that the Minister considers
appropriate.
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| Implementatio
n of
international
agreement
|
27. The Governor in Council may, by order,
cancel or amend the registration of a pest
control product or a class of pest control
products if the Governor in Council considers
it necessary to do so to implement an
international agreement.
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