ARCHIVED - Post-categorization of substances on the Domestic Substances List: Impacts of the Challenge for Pesticide Registrants

May 28, 2007

Purpose

The purpose of this memo is to provide an update on the categorization of substances on the Domestic Substances List (DSL) under the Canadian Environmental Protection Act, 1999 (CEPA 1999), and to outline potential impacts for pesticide registrants.

Background

When CEPA 1999 came into force, it required Environment Canada (EC) and Health Canada (HC) to categorize the approximately 23,000 substances on the Domestic Substances List (DSL) for the purpose of identifying those substances that either pose the greatest potential for human exposure, or are persistent and/or bioaccumulative, and inherently toxic to humans or non-human organisms. The Government of Canada completed this exercise - called categorization, and the results were incorporated into the Government's new Chemicals Management Plan, announced by Environment Canada and Health Canada on Friday, December 8, 2006.

The categorization exercise identified approximately 4,300 substances that met the CEPA criteria for further assessment, about 200 of which were identified as high priorities for action. The high priority substances are listed on the Chemical Substances portal.

The Government will collect information on the properties and uses of the approximately 200 high priority substances to make decisions regarding the best approach to protect Canadians and their environment from any risks these substances might pose. This initiative, known as the "Challenge", was announced on December 9, 2006 in the Canada Gazette, Part I, Vol. 140, No. 49: Notice of intent to develop and implement measures to assess and manage the risks posed by certain substances to the health of Canadians and their environment.

The Pest Management Regulatory Agency (PMRA) reviewed the list of substances subject to the Challenge and identified 3 pesticide active ingredients, 35 pesticide formulants and 8 formulant impurities, as identified in Attachment 1 Actives, Formulants and Formulant Impurities included on the Challenge List, resulting from Categorization of the DSL.

Under the Challenge, batches of 15-30 substances will be released every 3 months (over the next 3 years), along with a profile of each chemical substance, a mandatory survey (CEPA 1999, Section 71 Notice) and a voluntary questionnaire for stakeholders to provide additional information in their possession. Industry will be challenged to provide this information to facilitate risk assessment, and to provide information on best management practices associated with the use of these substances. Industry will have four to six months to respond to each batch of the Challenge.

Pesticide registrants will receive subsequent Challenge Notice documents directly from the Existing Substances Program (DSL Surveys Coordinator).

Probable Outcomes for Challenge Substances

In the absence of new information, the Government of Canada is predisposed to conclude that substances in the Challenge that were categorized on the basis of environmental concerns are "toxic" under CEPA 1999, and they may be added to the virtual elimination list and prohibited from use under the Prohibition of Certain Toxic Substances Regulations. Uses subject to the Pest Control Products Act (PCPA) may not necessarily be prohibited, however an assessment that supports an exemption would be required to maintain pesticide uses.

In the absence of new information, substances categorized on the basis of greatest potential for exposure or inherently toxic to humans will likely be declared as toxic under CEPA 1999, and subject to risk management control measures (e.g. best practices, industrial codes of practice).

Implications for Pesticide Registrants

The high priority substances subject to the Challenge are found in a wide variety of products, from household solvents to industrial manufacturing fluids. Please be advised that the Challenge applies to all chemical sectors, including those regulated under other legislative authorities such as the Pest Control Products Act. None of these high-priority substances are used exclusively as pesticides.

The Challenge has no immediate impact on pesticide registrations. However, registrants are required to respond to the Section 71 Notice if they meet the criteria for reporting. In addition, registrants are encouraged to provide additional information as specified in the Challenge questionnaire.

The active ingredients identified in the Challenge will be re-evaluated under the current Re-evaluation Program timelines.

Based on the health and environmental concerns raised by the categorization of substances on the DSL, the PMRA will reclassify any PMRA List 3 and 4B formulants subject to the Challenge to List 2. As indicated in the Formulants Policy (DIR 2006-02), List 2 formulants are those identified as potentially toxic. Although reclassification to List 2 does not have any immediate effects on the current use of these formulants, it does reflect the same level of concern associated with inclusion in the Challenge. Registrants may be requested to amend product formulations at some point in the future.

Pesticide registrants should review the mandatory Section 71 Notices when they are published every 3 months, to determine if they meet the criteria for reporting. In addition to the mandatory component of the Section 71 Notice, registrants are encouraged to complete the voluntary questionnaire as information provided could be useful for the risk assessment and risk management purposes.

The Section 71 Notice forms, the guidance document for completing the Section 71 Notice, the Challenge Questionnaire and guidance document, as well as the Declaration of Non-Engagement form and the Stakeholder Interest form.

Following the deadline for responding to each batch of the Challenge, the Government of Canada will review the completed mandatory surveys and questionnaires. A screening assessment will be conducted, followed by the development of a risk management strategy which will outline what further regulatory action may be necessary.

The PMRA will participate in the federal government risk assessment and risk management processes for any Challenge substances used in pest control products. As the risk assessment and risk management process evolves, further action by affected pesticide registrants may be required. In the future, the PMRA will communicate directly with implicated registrants on a case-by-case basis.

While there are no immediate regulatory impacts as a result of the Challenge, one possible outcome is to declare a substance toxic under CEPA 1999, add it to the virtual elimination list and possibly prohibit its use. Registrants may wish to consider the options for replacing high priority substances in their products with other substances, but preferably not ones on the moderate priority list. The PMRA welcomes comments from registrants on potential difficulties associated with reformulation.

Challenge for Batch 1 and 2 Substances

On February 3, 2007, the Government released the first batch of substances identified under the Challenge. Batch 1 contains one pesticide active ingredient, 5 formulants and one formulant impurity (Attachment 1). Pesticide registrants with products containing any of these substances should review the CEPA 1999 s.71 Notice issued on February 3, 2007 to determine if they meet the criteria obligating them to respond by June 5, 2007.

The federal government released the documentation for the second batch of substances on May 12, 2007. Any person to whom the Notice applies must respond by September 12, 2007. As identified in Attachment 1, there are 5 pesticide formulants and one formulant impurity in the list of Batch 2 substances.

Stakeholder Workshop

Environment Canada and Health Canada will be hosting workshops in Toronto on June 7, 2007 and in Calgary on June 12, 2007, to help further explain to stakeholders the Challenge, the associated documentation and how to participate. It should be emphasized that the objectives of the workshop are for federal officials to provide instructions on what information is being sought for the Challenge, how participants are to submit this information, and the associated timelines.

Discussion will focus on the documents associated with the Challenge and the release of the second batch of substances. For details on attending the workshop, please contact: katie_eberts@hc-sc.gc.ca

Questions

If pesticide registrants are unsure whether their product(s) contain a Challenge substance, please contact the PMRA via email at: pmra_formulants@hc-sc.gc.ca

Any other questions relating to the Challenge should be sent to:

DSL Surveys Coordinator, Existing Substances Program
Place Vincent Massey, 20^th Floor
351 Saint Joseph Boulevard
Gatineau, QC K1A 0H3

T: 1-888-228-0530 / 819-956-9313
F: 1-800-410-4314 / 819-953-4936
Email: DSL.SurveyCo@eg.gc.ca