Questions and Answers - The updated Pest Control Products Act

• 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?

How does the new Act strengthen health and environmental protection?

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.

How does the new Act increase transparency?

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.

What is the Register?

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.

What is the Public Registry?

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.

What is the Reading Room?

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.

How does the new Act strengthen post-registration control of pesticides?

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.

What impact will the new Act have on Canadian farmers' access to pesticides registered in the United States but not yet in Canada?

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.

Why was it necessary to update the Pest Control Products Regulations?

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.

Why did it take so long to put the new Act into effect?

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.

Does the new Act meet the requirements of the Government of Canada's Smart Regulation initiative?

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.

Is there an enforcement impact to the users of pesticides once the new Act comes into force?

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.