Backgrounders
	The Proposed New Pest Control Products Act: Pest Management Regulation in the 21st Century
	A Comparison of the Proposed and Existing Pest Control Products Acts

Information

March 2002

Questions and answers about the proposed new Pest Control Products Act

Introducing the new PCPA

1. What is the Pest Control Products Act?

The Pest Control Products Act (PCPA) is the federal law that controls the import, sale, manufacture and use of pesticides in Canada. The focus of the PCPA is on managing risks to people and the environment posed by pesticides. All pesticides proposed for use in this country are subject to a pre-market assessment to ensure that only products that pose acceptable risks and have value (serves a useful purpose in pest management) are registered.

2. What is a pest control product?

Pest control products, also called pesticides, are chemicals, organisms and devices designed to control, destroy, attract or repel pests. They play an important role, not only in maintaining Canada's abundant food supply, but in many other sectors of the economy, such as forestry, health protection and improved quality of life. For example:

• herbicides control weeds;
• insecticides control insects;
• fungicides control mould and other fungi;
• algaecides control algae in swimming pools; and,
• preservatives control the decay of wood and other materials.

3. Why is a new Pest Control Products Act required?

The current act is 33 years old, and although the PMRA has continually adopted the most up-to-date pesticide assessment methods to ensure the protection of Canadians' health and environment, some changes to the pesticide regulatory system could not be accomplished without legislative renewal. The most important change to be made in the proposed new PCPA is to open up the pesticide regulatory system so that it is more transparent, can provide detailed information to the public on pesticides and allows the public to have more say on pesticide registration decisions.

4. Who was consulted in the process of developing a new Pest Control Products Act?

The concerns expressed by agriculture groups, pesticide manufacturers and public interest groups have been taken into account throughout the process to reform the pesticide regulatory system. Growers wanted more timely access to cost-effective pest control products; pesticide manufacturers were concerned about the time and cost of the registration process; and, public interest groups were concerned about the safety of pest control products, the extensive use of chemical pesticides and the limited opportunities for the public to influence policy and registration decisions. Drafting of the proposed new PCPA was designed to complete the reform process by incorporating those aspects that could only be accomplished through legislative change.

Representatives of these groups appeared before the House of Commons Standing Committee on Environment and Sustainable Development and their concerns were reflected in the May 2000 report on pesticides from that Committee. The proposals for the new legislation were refined based on the recommendations of that report.

5. How will the PCPA change?

The proposed new PCPA includes many changes. Some of the key changes include:

• clear requirements for the Minister to give special consideration to children and to assess aggregate exposure and cumulative effects;
• clearer authority for the Minister to refuse to consider an application or to maintain a registration if the applicant or registrant does not provide the information necessary to substantiate claims that the risks and value of the product are acceptable;
• mandatory reporting of adverse effects of registered pesticides;
• new opportunities for informed public participation in pest
• management regulation; and,
• strengthened measures to encourage compliance.

Protecting health and the environment

6. How will the proposed new PCPA provide protection for people and the environment?

The proposed new PCPA provides a legal foundation for the risk management approach to regulating pesticides. The essence of the risk management approach is to prevent the registration of products that pose unacceptable risks to human health or the environment and to manage the use of registered pesticides in a manner that will preclude unacceptable risks.

Products that do not work or have no value will not be registered. This will help to reduce risks by preventing products that have no value from reaching the market. Consideration of value also serves to minimize risks by ensuring that only the lowest use rates and frequencies needed for effective pest control under a broad range of normal use conditions are permitted.

In addition, the proposed new PCPA will include other authorities to protect human health and the environment, such as mandatory reporting of adverse effects, new provisions for special review, support to the re-evaluation of older pesticides and stronger measures to enforce all provisions.

7. How does the Minister decide if the risks posed by pesticides are acceptable?

Decisions are made using science-based criteria that are generally consistent worldwide. The criteria used in Canada are very similar to those which are used in most countries belonging to the Organisation for Economic Cooperation and Development (OECD), including the United States.

Pesticide manufacturers are required to submit extensive data on the potential risks posed by the pesticide. Government evaluators critically review the data and evaluate risks by combining assessments of the hazards posed by the pesticide and the potential exposure of humans and the environment. The new legislation incorporates modern risk assessment concepts, including special consideration of children and other vulnerable groups, and the need to assess aggregate exposure and cumulative effects of pesticides that act in the same way. The legislation does not include specific criteria for determining if a risk is acceptable because these criteria are constantly evolving as scientific knowledge changes. These criteria are provided in publicly-available documents. The PCPA does provide stakeholders and the public with the opportunity to comment on the criteria used for each major decision for full registration before it is made.

8. How will the "value" of a product influence the decision-making process?

The proposed new PCPA defines value as the product's actual or potential contribution to pest management, taking into account its efficacy, its effect on the plant or animal on which it is to be used, its health and environmental benefits and its economic impact. All products registered in Canada must have acceptable value. Products that do not have value (i.e., do not serve a useful purpose bearing in mind other available pest management strategies) will not be registered. Value assessment contributes to the encouragement of sustainable pest management because the product's contribution to sustainability can be taken into account in determining if the value is acceptable. Value assessments do not override health and environment assessments.

9. Will the new legislation support reducing the risks associated with pesticides as well as reducing the use of pesticides?

The overall goal of the legislation is to minimize the risks associated with pesticides. Risk reduction is a much broader concept than use reduction and comprises many strategies, from education of applicators in using pesticides safely, to registration of products that may be safer than ones registered in the past, to use of alternative pest management strategies, including those that do not rely on pest control products.

Use reduction usually refers to reducing the volume of use of specific products or overall pesticide use on specific crops. However, reduction in the quantity of pesticides used does not necessarily lead to a proportionate reduction in risk, because pesticides differ significantly in their potency. The government supports a risk reduction approach because it ultimately leads to better health and environmental protection and can encompass use reduction as appropriate.

The new legislation supports risk reduction by ensuring not only that risks are acceptable but that they are minimized. Important provisions for this are:

• even if risks are acceptable, products are not registered unless they have value;
• products are registered subject to conditions related to their manufacture, use, and disposal so that risks are minimized;
• strengthened enforcement provisions help to ensure that conditions of registration are respected; and,
• provisions for special review and re-evaluation of registrations,
• followed by amendment or cancellation as necessary, ensure that risks and value remain acceptable.

10. How does the proposed new PCPA support sustainable development?

The preamble of the PCPA recognizes that the regulatory system for pest control products should facilitate sustainable development and encourage sustainable pest management which is based on principles of sustainable development. The pre-market assessment of products through a national registration system, which protects health and the environment while allowing access to pest control products, is consistent with those principles. Consideration of value in registration decision-making contributes directly to sustainable pest management. Value, which is defined as a product's contribution to pest management, must be acceptable before a product can be registered. Provisions to regulate products after registration, such as mandatory reporting of adverse effects, special review and reevaluation, as well as the enforcement provisions, also support sustainable development.

Public participation

11. How does the legislation provide opportunities for stakeholders and the public to participate in the regulatory system?

Key features of the statute which promote public participation are:

• provision for public comment prior to major decisions for full registration;
• access to information supporting pesticide registrations;
• opportunity to request a Review Panel to reexamine a major registration decision; and, opportunity to request a special review of a registration.

The documentation which will be used as the basis for public consultation will contain a description of the product and its intended uses, as well as a summary of the risk and value assessments, the proposed decision, and the rationale for it.

The proposed new PCPA will require the Minister of Health to establish a Public Registry which 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.

The public will also be able to inspect the test data, i.e., the results of scientific studies submitted in support of pesticide registrations. 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 legislation also provides authority to establish a multi stakeholder advisory council to advise the Minister of Health on an on-going basis. As well, the Minister will be required to make an annual report to Parliament on the administration and enforcement of the new Act.

Enforcement and compliance

12. How will enforcement under the proposed new PCPA change?

The proposed new PCPA will provide enhanced enforcement capability through clearly defined offences, increased powers of inspectors and higher maximum penalties. Under the current PCPA regulations, the maximum penalty for any offence is $50,000 and/or six months imprisonment on summary conviction or $250,000 and/or two years imprisonment on indictment. The proposed new PCPA will allow for increased penalties. For example, importation of an unregistered product could lead to a maximum fine of $500,000 and three years imprisonment. Recklessly or wilfully causing harm to the environment or causing serious bodily harm will carry the maximum penalty under the Act of $1 million or three years imprisonment.

13. How are Canadians protected against harmful pesticide residues in their food?

Maximum Residue Limits (MRLs) are specified by the PMRA to ensure that food is safe to eat. These MRLs will continue to be established as regulations under the Food and Drugs Act (FDA). The Canadian Food Inspection Agency (CFIA) will remain responsible for monitoring the food supply to ensure compliance with the FDA, including pesticide MRLs, but the PMRA will provide advice through mechanisms established in a Memorandum of Understanding with the CFIA.

14. Will the new system improve access to pesticides by users, especially minor use products and lower risk alternative pesticides?

Since its establishment, a key area of work for the PMRA has been to facilitate access to new technology in all sectors, including the minor use area. Under the North American Free Trade Agreement (NAFTA), the Technical Working Group on Pesticides has been working with the U.S. and Mexico to harmonize regulatory approaches in order to obtain a North American market for pesticides, for both major and minor uses.

The proposed legislation will support international harmonization because it allows flexibility in determining the information needed to make registration decisions. That information could include reviews already completed in other countries and could be tailored to the type of product and its uses (such as minor uses). These efficiencies will not be achieved at the expense of strong environmental and health protection.

The PMRA has also been working with Agriculture and Agri-Food Canada (AAFC) to address the minor use issue. The PMRA will be identifying a full-time minor use advisor, making changes to the boundaries of geographic zones to reduce the number of residue trials required, and reducing timelines for the review of applications to register reduced risk minor use products. AAFC will be strengthening its program and financial support for the development and testing of minor use products.

Working together

15. What will the role of other federal departments be in pesticide regulation?

Within the federal government, the PMRA works in collaboration with several departments and agencies to fulfill its responsibilities to regulate pest control products. This collaboration supports not only the fulfilment of the PMRA's regulatory responsibilities, but also helps its federal partners to fulfill their responsibilities, which are mainly concerned with research and monitoring relating to pesticides and pest management. The PMRA has developed Memoranda of Understanding (MOU) with federal departments with interests in pesticides or pest management (Agriculture and Agri-Food Canada, Environment Canada, Fisheries and Oceans Canada, Natural Resources Canada, Canadian Food Inspection Agency), to clearly set out areas of responsibility and to establish strong working relationships. For example, the MOUs establish mechanisms by which PMRA can obtain research and monitoring data which will be important in re-evaluating the registration status of older pesticides.

16. What is the role of the provinces and territories in pest management regulation?

Since pests tend to be of a local or regional nature, pest management is a matter of significant provincial/territorial concern. However, both the federal government and the provinces/territories recognize that effective pest management regulation depends on cooperation between them. A federal registration system provides a consistent, national approach to minimizing the risks associated with pesticides. Provincial/territorial legislation provides additional controls on the use of pesticides and measures to ensure that pesticides are used in compliance with conditions of registration.

The provinces and territories have been consulted over several years on the federal government's legislative plans. The proposed new PCPA does not change the balance of federal and provincial/territorial powers in pest management regulation. The federal government, through the PMRA, will continue to collaborate closely with the provinces and territories to support sustainable pest management and to minimize risks associated with the use of pesticides.

Distribution of Principal Responsibilities