Information
March 2002
The proposed new Pest Control Products Act - pest management regulation in the 21st century
The Pest Control Products Act (PCPA) is the primary federal legislation to control
the import, manufacture, sale and use of all pesticides, including insecticides, herbicides
and fungicides, in Canada. The new pesticide legislation will strengthen Canada's rigorous
safeguards against the risks to people and the environment from the use of pesticides.
Canadians will have access to more information and new opportunities for input into major
pesticide registration decisions. A modernized, strengthened and clarified law on pesticide
regulation will provide the solid legislative foundation needed to reduce risks posed by
pesticides and facilitate the availability of newer, safer products and the removal of
older products that might pose greater risks.
What's New
- A mandate that sets out the primary objective of the legislation, that is, health and
environmental protection.
- A clear framework for a regulatory system that is even more comprehensive than the
current law. The proposed new Pest Control Products Act (PCPA 2002) incorporates
modern risk assessment concepts, including special consideration of children and other
vulnerable groups, and the need to assess aggregate exposure and the cumulative effects
of pesticides that act in the same way.
- Opportunities for informed public participation in the regulatory system through consultation
prior to major registration decisions, mechanisms to review decisions (e.g., review panels
to reconsider major decisions for full registrations, special reviews of existing registrations)
and access to information supporting pesticide registrations.
- The proposed new Act also improves post-registration control of pesticides by requiring
adverse effects reporting and strengthening the provisions for re-evaluation and Special
Review; as well as enhancing enforcement capability through clearly defined offences,
increased powers of inspectors and higher maximum penalties.
- A clear legislative foundation for reducing pesticide risks that incorporates the principles
of sustainable development.
- A preamble that sets the tone for the substantive provisions of the legislation by
recognizing the wide variety of factors that affect the manner in which pesticides are
regulated in Canada.
Why Introduce New Legislation
Introduction of the proposed new PCPA ushers in the final chapter in a comprehensive process
to reform pesticide regulation in Canada and provide a solid legislative foundation for
pest management regulation in the 21st century.
In October 1994, the federal government issued the Government Proposal for the Pest
Management Regulatory System, outlining its plans to implement the recommendations
of the multistakeholder Pesticide Registration Review. Provincial and stakeholder comments
on the Government Proposal, along with the federal government's response, accompanied
the government's February 1995 announcement that it was proceeding with the reforms.
In 1999, stakeholders and provinces / territories reiterated their support for the legislative
proposals. In May 2000, the House of Commons Standing Committee on Environment and Sustainable
Development tabled a report: Pesticides: Making the Right Choice for the Protection
of Health and the Environment, which called again for renewal of Canadian pesticide
legislation. The Government has refined its legislative proposals in light of the Standing
Committee's recommendations and, in its October 2000 response to the report, reiterated
its commitment to proceed.
Risk management and the Pest Control Products Act
The Pest Management Regulatory Agency (PMRA) of Health Canada administers the PCPA on
behalf of the Minister of Health and manages the regulation of pesticides at the federal
level in Canada. A major component of the federal regulatory system is the pre-market evaluation
of potential health risks, environmental risks and value of products proposed for use in
Canada. To fulfil this role, the PMRA requires that pesticide manufacturers provide extensive
information on which to base these evaluations.
The legislation sets out the broad requirements for registration of pesticides in Canada.
The regulations provide further details regarding the types of information that must be
submitted to satisfy the Minister that a product is acceptable for the Canadian market.
Guidelines are published to give specific instructions on the conduct of studies and the
reporting of information. This hierarchy gives the necessary guidance to pesticide manufacturers
while providing the regulators with sufficient capability to stay current with changes
in technology and scientific knowledge.
Registration
The PCPA 2002 will provide authority to evaluate the health risks, environmental risks
and value of pest control products proposed for use in Canada. This is similar to the requirement
in the current Pest Control Products Regulations for applicants to establish the safety,
merit and value of pest control products. However, in the current legislation, the terms
are not defined. In the PCPA 2002, health and environmental risk will be defined as the
possibility of harm (to human health or the environment, including its biological diversity)
resulting from exposure to or use of the product, taking into account its conditions or
proposed conditions of registration. This definition will be sufficiently broad to include
the possibility of harm from formulants and transformation products. Value will be defined
in terms of the product's actual or potential contribution to pest management, including
its efficacy, host tolerance, health, safety and environmental benefits and social and
economic impact. These definitions of risk and value are essentially equivalent to current
operational definitions of safety, merit and value.
The evaluation process focuses on whether the health and environmental risks posed by
a pesticide, when used as directed, are likely to be acceptable, and whether the product
offers a worthwhile contribution to pest management. The acceptability of each of these
parameters is key, regardless of whether the product is chemical, biological or biotechnological.
Unlike the current PCPA, the PCPA 2002 will specify some of the considerations that must
be taken into account in order to incorporate the most modern risk assessment concepts
when conducting evaluations of health risk. These concepts have already been adopted in
current PMRA practices but, until now, they have not been specified in the law. The PCPA
2002 will specify that:
- the variability of the sensitivities of major identifiable groups, including infants
and children, must be considered;
- an additional margin of safety must be applied to protect infants and children from
risks posed by pesticide residues in food and when pesticides are used in and around
homes and schools; and,
- cumulative effects of pesticides that act in the same way and aggregate exposure from
food, drinking water and domestic use of pesticides must be considered, in particular,
when determining maximum residue limits.
As well, the PCPA 2002 will specify that government policies, such as the Toxic Substances
Management Policy, must be taken into account. Consistent with the so-called "substitution
principle", the PCPA 2002 will also provide authority to consider the availability of safer
alternatives when evaluating risks and value.
If the risks and value are deemed acceptable after the evaluations are completed, the
application must be granted. However, if any of the risks or the value are considered unacceptable,
the application must be denied. No risk, even though small, would be acceptable if the
value was not also acceptable. The authorities for this risk management approach to decision
making will be more clearly reflected in the PCPA 2002 than in the current legislation.
Regulation of Products After Registration
Registration does not confer unrestricted rights respecting the marketing, sale and use
of pesticides. On the contrary, the registration includes detailed instructions on how
the pesticide must be used in order to comply with the law - known as "conditions of registration" in
the PCPA 2002. Mechanisms are available to monitor compliance with the conditions of registration
in order to ensure that the risks and value are acceptable when the product is in use.
As well, maximum residue limits (MRLs), which are established at the time of registration,
are enforced to ensure that the Canadian food supply is safe.
The PCPA 2002 will specify two new conditions of registration for all pest control products:
(1) that product safety information, including a material safety data sheet, must be provided
to work places where the product is used or manufactured; and (2) that information on sales
of the product must be provided to the Minister. The PCPA 2002 also includes specific provisions
for mandatory reporting of new information on health and environmental risks and value
of pesticides which could identify the need for a re-evaluation or special review. These
provisions are designed to ensure that the risks and value of registered products remain
acceptable in light of new knowledge and public policy. Label improvement programs, which
are a less formal means of adjusting conditions of use to address minor concerns regarding
risks or value, will continue.
A re-evaluation is initiated when there has been a change in the information required
or the procedures used for the evaluation of risks and value or, at the latest, 15 years
after the product was registered. A special review is initiated when there is reason to
believe that risks or value may be unacceptable, when a member country of the Organisation
for Economic Co-operation and Development has banned all uses of a product or when information
provided by another federal or provincial / territorial department reveals that risks or
value may be unacceptable. Once a re-evaluation or Special Review has been initiated, federal
and provincial / territorial departments will be invited to provide any relevant information
about the risks and value of the product.
The PCPA 2002 provides the legislative authority to remove products from the market or
modify their conditions of use, upon completion of or during a re-evaluation or Special
Review, if the evaluations indicate that the risks or value are unacceptable. Under the
current PCPA, a number of options are available for regulatory action on registered products.
The PCPA 2002 will clarify the actions that are available and add certain instances in
which the registration of a pesticide could be cancelled or amended.
The PCPA 2002 will also specify that in determining appropriate actions during re-evaluations,
the precautionary principle must be taken into account. The precautionary principle states
that "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."
In summary, under the PCPA 2002, the registration of a pesticide could be cancelled or
amended in the following circumstances:
- failure of the registrant to comply with a data call-in or other notice;
- upon completion of a re-evaluation or Special Review, if any of the risks or value
are considered unacceptable;
- in the course of a re-evaluation or Special Review, to deal with a situation that endangers
human health or the environment;
- breach of a condition of registration by a registrant;
- upon request of the registrant (to ensure that the request is not being made in order
to avoid regulatory action or disclosure of an adverse effect, the registrant could be
obliged to provide the reasons for the request);
- non-payment of fees by a registrant; or,
- implementation of international agreements.
New under the PCPA 2002 will be a Pest Control Products Export Control List which will
identify those products for which permission must be granted before export will be allowed.
The criteria used to determine which pesticides will be identified on the Export Control
List will be specified in the Regulations. This will allow implementation of the Rotterdam
Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals
and Pesticides in International Trade, by including chemicals subject to PIC on the Export
Control List.
Provinces and Territories
Since pest problems tend to be of a local or regional nature, pest management is a matter
of significant provincial / territorial concern. Provinces and territories play a major
role in regulating pesticides under their own legislation. Provincial and territorial legislation,
which focusses on the sale, transportation, storage, use and disposal of products registered
by the PMRA, may add to federal restrictions but may not relax them. Provincial / territorial
training and certification programs ensure that vendors and applicators can comply with
both federal and provincial / territorial requirements. The PMRA and provincial / territorial
regulators collaborate in various ways, including ensuring compliance with their respective
pesticide legislation. Through its provisions to strengthen health and environmental protection
and to increase openness and transparency, the PCPA 2002 provides the foundation for more
effective collaboration.
Public participation in pesticide regulation
Even though public participation in the regulatory system is not required by the current
legislation, the PMRA recognizes the importance of informed public participation in the
regulatory system and consults on proposed decisions for full registration of new active
ingredients, if the application was received after April 1, 1995.
Under the PCPA 2002, the regulatory system will be open to public participation through
a program of public consultation complemented by public access to information. A more transparent
and open system will enhance public confidence in the federal regulatory system for pesticides.
Codifying public participation in the Act will create certainty and predictability for
stakeholders and the general public. The following list briefly describes the primary PCPA
2002 provisions for public participation:
- Original registration decision: The public will be consulted before a major
registration decision is made final. Major registration decisions include any decision
to grant full registration or deny an application for a new active ingredient and any
amendment to a full registration that might result in a significantly increased health
or environmental risk.
- Special Review and re-evaluation: As indicated above, a Special Review or re-evaluation
will be initiated if there is a reasonable belief that the risks or value of the product
are no longer acceptable (Special Review) or there has been a change in information requirements
or evaluation procedures since the product was registered (reevaluation). The PCPA 2002
will allow any person to request of the Minister that a special review of a product be
carried out. The public will be consulted about any registration decision following a
re-evaluation or special review before the decision is made final.
- Reconsideration of a registration decision: Under the PCPA 2002, any member
of the public will have the opportunity to file a notice of objection to a major registration
decision or a decision to issue, amend or cancel an export permit taken after the new
Act comes into force. The filing of such a notice could lead, at the discretion of the
Minister, to establishment of a review panel to reconsider the registration decision.
The review panel process will be open to the public with many opportunities for public
participation during the reconsideration, and access to much of the information received
by the review panel. Under current legislation, only an applicant or registrant may object
to a negative registration decision.
- Public Registry: The public registry will include information about registrations,
applications, re-evaluations and Special Reviews, including the PMRA's detailed evaluations
of the risks and value of pesticides. Subject to the requirement to protect confidential
business information (CBI) and test data, all information in the registry will be available
to the public either electronically, whenever possible, or in hard copy. CBI will be
defined very narrowly in the PCPA 2002 to include only financial information, manufacturing
processes, and formulant ingredients that are not of health or environmental concern.
This will mean that the identity and concentration of formulants that are of health or
environmental concern will not be held in confidence and thus can be made available to
the public on labels or material safety data sheets or through the public registry.
- Test Data: The public will also be able to inspect the results of scientific
studies submitted in support of pesticide registrations and on which the evaluations
of risk and value are based (test data). These data will remain confidential and will
not be available in hard copy, but the public will be able to view them in a reading
room.
The PCPA 2002 specifies that consultation on proposed registration decisions will be on
the basis of a document that includes a summary of the risk and value assessments, as well
as the proposed decision and rationale. For original registrations, this document is the
Proposed Regulatory Decision Document (PRDD) that is currently used. Consultation through
PRDDs will improve decision-making and will provide all interested persons, including the
applicant, certainty and predictability regarding the consultation process. A similar process
will be used for proposed decisions following completion of a reevaluation or special review.
Existing non-legislated public participation mechanisms, such as consultation on proposed
policies and guidelines, will be continued by the PMRA.
Enforcement and compliance
Compliance with legislation is achieved through education and enforcement. Enforcement
must be fair, nationally consistent and predictable. A full range of compliance techniques
and measures for promoting and facilitating compliance with the PCPA are used. The primary
goal of compliance programs is to ensure that registered products are used safely.
Enforcement is the action taken to compel compliance. Enforcement activities include:
- investigation of complaints or suspected violations;
- measures that encourage compliance without resorting to formal court action; and,
- measures that compel compliance through formal court action.
The role of inspectors under the PCPA is to:
- encourage and facilitate compliance;
- encourage voluntary reporting of suspected violations;
- inspect for compliance;
- investigate non-compliance situations; and,
- institute enforcement measures.
Enforcement responses can be categorized as actions with respect to persons: education,
warning, prosecution (administrative monetary penalties are also available); to products:
seizure and detention, forfeiture, denial of entry into Canada; or to registrations: suspension,
cancellation, non-renewal of registration.
The PCPA 2002 will increase the tools available for enforcing compliance. Under the PCPA
2002, an inspector will be able to shut down an activity, require disposal of product,
or require any measures necessary to prevent health or environmental risk. Further, the
PCPA 2002 will allow for increased penalties. High penalties have been proposed as a deterrent.
The PMRA does not receive these monies. Other modern environmental protection legislation,
such as the Canadian Environmental Protection Act, also has high penalties.
There are two categories of penalty under the PCPA 2002. Penalties for summary conviction
offences (less serious) include a fine of not more than $200,000 and/or up to 6 months
in prison, or both. Penalties for indictable offences (more serious) include a fine of
not more than $500,000 and/or up to 3 years in prison, or both. Penalties for very serious
offences can go up to $1million.
The Standard for Pesticide Education, Training and Certification in Canada is an
effective mechanism to increase compliance and ensure that products are used according
to the directions on the label. This standard was developed jointly by the federal and
provincial / territorial governments and is being implemented by the provinces and territories.
Reform of the federal pest management regulatory system
The October 2000 Government Response to the Report of the Standing Committee on Environment
and Sustainable Development described how the government:
- places protection of human health and the environment as its top priority in regulating
pesticides using a fundamentally precautionary approach;
- is developing a sustainable pest management approach with its partners; and
- recognizes the importance of having an open and transparent regulatory system.
The PCPA 2002 will provide the statutory foundations for a stronger pest management regulatory
system in Canada.
Glossary
Transformation Products
When the pesticide degrades, it results in a number of transformation products. These transformation
products may be less/same/more toxic than the pesticide. Because of this, we must consider
the potential toxicity and environmental effects of the transformations products when
we evaluate a pesticide.
Formulant or Non-Active Ingredient
Any substance or group of substances other than an active ingredient that is intentionally
added to a pest control product to improve its physical characteristics, e.g., sprayability,
solubility, spreadability, and stability.
Lowest Effective Rate (LER) = Label Rate
Where the efficacy of a pesticide is acceptable, the assessment serves to establish appropriate
label claims or directions and the lowest application rate (or rate range) that is required
to provide effective and consistent pest control, without unacceptable damage or injury
to the host or crop and subsequent hosts or crops, under normal use conditions. In some
cases, the objective is to attain the lowest overall amount of pesticide required to
control the pest during a use season, rather than the lowest single application rate.
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