Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

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APPENDIX 9 - International Arrangements

1. 1.0 The Four Corners Arrangement (4CA)
   1. 1.1 The Canada-Australia Bilateral Arrangement

International arrangements are ongoing and constantly changing. The following details two currently used arrangements however it is recommended, to ensure current information, notifiers either review the NS program website at www.ec.gc.ca/substances or contact the NSN Information Line.

1.0 The Four Corners Arrangement (4CA)

The 4CA aims to achieve efficiencies of resources, for all parties, for the introduction of new substances to the North American marketplace, while continuing to protect the environment and human health. This includes, but is not limited to:

• increasing cooperation and understanding between US and Canadian governments involved in regulating new substances, notably with respect to each others' risk assessment and risk management policies and practices;
• identify and implement possible strategies for overcoming regulatory, administrative and other barriers to greater cooperation and alignment and taking appropriate actions; and
• identifying and taking appropriate actions to ensure progress toward the long term goal of greater cooperation and alignment of Canadian and US new substance regulatory schemes, for example the mutual acceptance of notifications.

A 4CA submission must be submitted to the NS program with, or after, an NSN Package has been provided. At that time the information required for the 4CA submission, including the fee, is reviewed and, if accepted, a CE# is assigned to the file and an initiation letter is sent to the notifier acknowledging receipt of the 4CA submission and the fees associated to it (see Appendix 3). The notifier is advised in the initiation letter to request a Pre- manufacture Notice (PMN) filer to authorize the USEPA to send the NS program their assessment review notes. Once the information has been provided by the USEPA an acknowledgement letter is sent to the notifier indicating that the 90-day assessment period has begun. An assessment of the complete package is conducted to determine if the substance could be added to the NDSL or if specific waivers would be acceptable for some of the prescribed information requirements. A 4CA assessment outcome letter is sent to the notifier once a decision has been made. There are three possible outcomes from a 4CA submission:

1. approval to add to the NDSL;
2. acceptance of specific waivers for some data; or
3. not approved for either addition to the NDSL or waivers.

Additional information on the 4CA can be found in advisory notes 01-1999 and 02-2004 on our website. (www.ec.gc.ca/substances/nsb/eng/cp_int_e.shtml)

1.1 The Canada-Australia Bilateral Arrangement

The cooperative arrangement between the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of Australia and Environment Canada and Health Canada aims to achieve efficiencies of new industrial chemical notification and assessment schemes by providing greater transparency in assessments. It can also lead to possible reductions in testing and resources for new industrial chemicals and accelerate the products introduction into the marketplace for some chemicals.

This Arrangement between Canada and Australia (known as the Participants) will provide a model for the cooperation envisaged with other Organization for Economic Cooperation and Development (OECD) countries and will be consistent with the initiatives undertaken by the OECD New Chemicals Task Force. Through this work, a wealth of experience will be gained by the Participants through their collaboration on the assessment of new industrial chemical notifications that will benefit the Participants, as well as Industry notifiers, and help to advance the OECD program.

Once an NSN Package has been submitted and assessed, a Canada-Australia Bilateral Arrangement form can be requested by contacting the NSN Information Line at 1-800-567-1999 (in Canada) or 819-953-7156 (outside Canada). This form allows the NS program to share the environmental and health assessments (vetted for confidential information) with NICNAS. A letter is sent by the NS program to the notifier acknowledging receipt of the Canada-Australia Information Sharing Request. NICNAS will use these assessment reports to aid in their evaluation and this may allow the notifier to be eligible for a reduction from the fees associated to a NICNAS submission.