- How does the new Act strengthen health and environmental protection?
- How does the new Act increase transparency?
- What is the Register?
- What is the Public Registry?
- What is the Reading Room?
- How does the new Act strengthen post-registration control of pesticides?
- What impact will the new Act have on Canadian farmers’ access
to pesticides registered in the United States but not yet in
Canada?
- Why was it necessary to update the Pest Control Products Regulations?
- Why did it take so long to put the new Act into effect?
- Does the new Act meet the requirements of the Government
of Canada’s Smart Regulation initiative?
- Is there an enforcement impact to the users of pesticide once the new Act comes into force?
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Q1) How does the new Act strengthen health
and environmental protection?
A. The new Act provides for stronger protection of human
health and the environment. In 1998, as a matter of policy,
Health Canada established safety factors that considered additional
protection for children and pregnant women and took into account
pesticide exposure from all sources, including food and water.
These policies are now formalized into law under the new Act.
The new Act provides the authority for new regulations that
require mandatory reporting of incidents of adverse effects,
as well as regulations that require safety information be
provided to workers.
The new Act also requires that the Government of Canada’s
Toxic Substances Management Policy (TSMP) be applied to pesticide
regulation. Under the TSMP, a pesticide’s potential
for toxicity, bioaccumulation and persistence are taken into
account when conducting environmental risk assessments as
part of the pre-market evaluation for pesticide registration.
If a newly proposed pesticide is found to meet the criteria
for toxicity, bioaccumulation and persistence, it will not
be registered. This policy has been applied in pesticide regulation
since 1999.
The new Act also provides a mandate to minimize health and
environmental risks by encouraging the development and implementation
of sustainable pest-management strategies and by facilitating
access to reduced-risk pesticides.
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Q2) How does the new Act increase transparency?
A. The new Act requires the
establishment of an electronic Public Registry which is an
electronic database of non-confidential information on pesticides
or the pesticide regulatory system, accessible through the
PMRA’s
website.
The new Act mandates the establishment of a Reading Room
where interested parties can inspect the confidential test
data on which pesticide evaluations are based. The reading
room is located at the PMRA’s
headquarters in Ottawa.
The new Act also formalizes into law the current practice
of consultation on major registration decisions to ensure
continued public participation in decision-making.
Requests for reconsideration of decisions and special reviews
of existing registered products are also new provisions in
the Act that will further increase transparency.
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Q3) What is the Register?
A. The new Act requires Health
Canada to establish a Register of Pest Control Products, which
is a collection of information on pesticides, including applications,
registrations, re-evaluations and special reviews. Most of
the information contained in the Register will be accessible
through either the Public Registry on the PMRA’s website
or the Reading Room. Confidential business information—manufacturing
processes, methods for determining the composition of the
product, financial or commercial information, and the identity
and concentration of formulant ingredients and contaminants
that do not pose a health or environmental concern—will
not be available for inspection.
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Q4) What is the Public Registry?
A. The Public Registry is an electronic database of information
available to any interested party through the PMRA’s
website. It is the first place to go when searching for information
on pesticides or the pesticide regulatory system. The information
contained in the Public Registry is mandated in the new Act.
It includes non-confidential information such as:
- information relating to a pesticide;
- information relating to an application to register or
amend the registration of a pesticide;
- PMRA consultation statements and decision statements;
- evaluation reports;
- citations to research used in evaluation;
- conditions of registration;
- research authorizations;
- Own-Use Import certificates;
- memoranda of understanding among federal government departments
relating to pesticides;
- reports of international harmonization activities; and
- regulations, policies, guidelines and codes of practice,
both proposed and final.
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Q5) What is the Reading Room?
A. The Reading Room, located
at the PMRA’s headquarters
in Ottawa, is the location where interested parties can inspect
confidential test data supporting a decision to register or
amend a pesticide.
Because the data available for inspection are confidential
test data, they may not be copied or otherwise removed from
the Reading Room. Additionally, to further protect the confidentiality
of the data, persons wishing to view the data must first provide
a signed affidavit or statutory declaration attesting that
the data will not be used, or made available for others to
use, to register or amend the registration of a pesticide
in Canada or elsewhere.
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Q6) How does the new Act strengthen post-registration control
of pesticides?
A. The new Act now requires that all pesticides be re-evaluated
on a 15-year cycle. In 1998, as a matter of policy, the PMRA
began re-evaluating all pesticides that were registered prior
to 1995 using modern scientific approaches to determine if
they remain acceptable for use by modern standards.
Furthermore, the new Act modernizes enforcement and compliance
provisions, and provides the regulatory authority to require
registrants to report sales data and any incident of potential
or actual adverse effects.
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Q7) What impact will the
new Act have on Canadian farmers’ access
to pesticides registered in the United States but not yet
in Canada?
A. The new Act supports Canadian growers by facilitating
programs that support the access to newer, safer pesticides
so farmers can be competitive in international markets. As
well, the new Act provides greater flexibility in the area
of minor-use registration and improves access to lower-risk
products.
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Q8) Why was it necessary to update the Pest
Control Products Regulations?
A. The PCP Regulations were revised to maintain cohesion with
the new Act and provide the regulatory framework for many
authorities in the Act. The revised PCP Regulations have been
modernized using plain language as much as possible. The revisions
do not introduce new policy or procedural changes in how pesticides
are regulated under the current framework so as to minimize
the economic impacts or burden on business while allowing
the new Act to come into force.
New regulations to support the reporting provisions of the
Act and outline the details of how incidents of adverse effects
and sales data will be reported, previously proposed in Canada
Gazette Part I, are planned for publication in the fall of
2006.
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Q9) Why did it take so long to put the new Act into effect?
A. It has taken considerable time and effort to bring the new
Pest Control Products Act into force as Health Canada had
to develop the infrastructure needed to implement the transparency
provisions of the new Act, establish the list of formulants
and contaminants of health or environmental concern, and revise
the Pest Control Product Regulations to support the new Act.
These tasks are now complete, allowing the new Act to come
into force. The health of Canadians and their environment
was not, however, compromised as key provisions to strengthen
health and environmental protection in the new Pest Control
Products Act had already been implemented in the late-1990s
by Health Canada as a matter of policy.
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Q10) Does the new Act meet the requirements of the Government
of Canada’s Smart Regulation initiative?
A. The new Act supports greater openness and transparency
in the Canadian regulatory system as well as the principle
of international regulatory cooperation and regulatory efficiency,
which are key aspects of Smart Regulation.
Under the new Act, information and data can be shared with
pesticide regulators in other countries, which will foster
work-sharing and cooperation.
The new Act improves on efficiency by facilitating a new
process for setting maximum residue limits that eliminates
the need for regular amendments of the Food and Drug Regulations
and shortens the time required to establish maximum residue
limits, which currently takes up to two years.
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Q11) Is there an enforcement impact to the users of pesticides
once the new Act comes into force?
A. The transition from the old to the new Act will be seamless
for the users of pesticides. The new Act strengthens the consequences
for actions that contravene the law. Essentially, the rules
don’t change for the user; as long as the law is followed,
there will be no enforcement consequences.
Under the new Act, PMRA will now have access to new enforcement
tools and powers of inspection such as the ability to shutdown
an activity, require disposal of product, or require any measures
necessary to prevent health or environmental risk. Further,
the new Act would allow for increased penalties of up to $1
million. These high penalties have been set as a deterrent.
The PMRA does not receive monies collected through these penalties.
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