New Substances Notification Advisory
Note 01-99

Renewal of the Agreement for Sharing of InformationBetween the U. S. Environmental Protection Agency (USEPA), and Environment Canada (EC) and Health Canada (HC)
(Four Corners Agreement)

This note is intended to inform companies about the renewal of the Four Corners Agreement and the potential benefits that may result for new substances notifications in Canada.

On July 1, 1994, the New Substances Notification (NSN) Regulations of the Canadian Environmental Protection Act (CEPA) came into force. Under these Regulations, chemicals and polymers that are new to Canada require notification and submission of information sufficient to make an initial assessment of risk to human health and the environment, prior to manufacture or importation into Canada. Any substance not listed on the CEPA Domestic Substances List (DSL) is considered "new" to Canada and subject to notification.

Substances that appear on the US EPA Toxic Substances Control Act (TSCA) Inventory of 1985 but not on the DSL, form the basis for a second list, the Non-domestic Substances List (NSDL). Substances that appear on the NSDL have reduced information requirements for notifications in Canada. Since 1995, the NSDL has been undergoing annual revisions which add or delete all substances incorporated into, or removed from the TSCA Inventory five or more years before the date of the NSDL revision. By way of example, the 1994 additions to the TSCA inventory were eligible for inclusion, and were added to the NSDL in January 1999. The 5-year interval is significant because during this time, it can be reasonably expected that information based on actual use of the chemical in the U.S. will have accumulated that might assist with the substance's assessment in Canada. Furthermore, companies required to notify substances that are not on the NSDL are subject to full notification and associated testing costs even though relevant information may already be available from U.S. authorities.

For this reason, Canadian and American chemical industries have explored with both governments, ways in which the interval can be reduced, and benefits of reduced information requirements can be achieved. One way to do so is to facilitate sharing of information used by the U.S. EPA's New Chemicals Program with their counterparts in Canada, and vice versa.

The result of these consultations has been an information sharing pilot project and associated agreement between the governments of the United States (U.S. Environmental Protection Agency) and Canada (Environment Canada and Health Canada), the Industry Coordinating Group for CEPA, and the U.S. Chemical Manufacturers Association (the "4 Corners" parties). The procedures laid out in the agreement have encouraged voluntary sharing of information between countries while protecting the confidentiality of any information and providing industry with opportunities to reduce testing costs, assessment fees and time to market.

The pilot began in 1996 and lasted until 1998. In September 1998, the "4 Corners" parties met and generally agreed that there were enough positive outcomes to shift from a pilot project to an on-going program, and to renew the agreement with a number of constructive modifications. These include establishing target timelines for completing the review of industry submissions by Environment Canada and Health Canada, and calling for a biennial review of the program, its costs and benefits and improvements. The renewed agreement took effect June 23, 1999 and will continue indefinitely unless modified or terminated.

Embodied in the new agreement is a recognition that while having a substance added to the NSDL is the greatest benefit, it is not the only one. Due to the significant and rising costs of testing, individual companies that make Four Corners submissions may also benefit by obtaining waivers for some of the additional information requirements that they would face for substances not yet appearing on the NSDL.

The Four Corners Agreement will be of greatest benefit to companies having a genuine intent to manufacture or import substances in such quantities and within timelines where there will be a clear advantage over waiting 5 years for the routine updates based on the TSCA Inventory. Where this is not the case, government agencies are not encouraging submissions since the effort required to respond represents a significant resource burden with consequences for other aspects of their programs.

A number of documents are available that will facilitate completion of Four Corners submissions including:

• Administrative Procedures for Data Sharing;
• US and Canadian application forms;
• US and Canadian "Limited Permission to Disclose" forms; and
• Guidelines for Canadian Importers and Manufacturers for Implementation of EPA/EC Information Exchange Agreement.

Based on consultations that have been taking place in Canada on cost recovery fees for government services under the CEPA New Substances Program, the government will be proposing a fee of $2000 for all Four Corners Agreement submissions. These fees will be required once New Substances Notification Cost Recovery Regulations are proposed and promulgated. This fee for service will facilitate completion of the reviews within the target timelines described in the agreement thus affording industry the greatest opportunity to benefit.

If you are interested in making a submission, or you have any questions or comments about the agreement, procedures or the proposed fees for this service in Canada, please contact us by mail at:

Four Corners Agreement,
New Substances Division,
Environment Canada,
14th Floor, Place Vincent Massey,
351 St. Joseph Blvd., Hull, Quebec, K1A 0H3

You can also reach us by facsimile at (819) 953-7155 or through the New Substances Notification Information Line at (800) 567-1999 (in Canada) or at 819 953-7156 (outside Canada).

Sincerely,

Original signed by Jim Armstrong for

J.A. Buccini
Director
Commercial Chemicals Evaluation Division
Toxics Pollution Prevention Directorate

PROPOSED ADMINISTRATIVE PROCEDURE FOR DATA SHARING UNDER THE "4 CORNERS" AGREEMENT

CONDITIONS:

Addresses:

Environment Canada:
New Substances Division, TPPD
Environment Canada
14th Floor, Place Vincent Massey
Ottawa, ON K1A 0H3

US EPA:
Document Control
Office of Pollution Prevention and Toxics
US EPA
Attn: Anna Coutlakis
EPA East - Mail Code 7405M
1200 Pennsylvania Avenue, N.W.
Washington, DC 20460

"FOUR CORNERS" AGREEMENT
Limited Permission to Disclose (NSN Notifier)

_{----------------------}[name of CEPA notifier], requests that the substance _{----------------------}[substance name or NSN # if available].

submitted pursuant to the New Substances Notification (NSN) Regulations of the Canadian Environmental Protection Act (CEPA) be considered for review in the manner specified by the "FOUR CORNERS" AGREEMENT. _{---------------------------------}, [Name of CEPA notifier] hereby gives permission to Environment Canada and Health Canada to disclose all or any part of the content of the NSN dossier, including assessment reports, and Confidential Business Information (CBI) as defined by Canadian law, to the U. S. EPA under the following terms:

1. This permission is a limited one. It is made to permit U. S. EPA to receive all test data provided within the NSN dossier as well as the Environment Canada and Health Canada assessment reports as contemplated under the bilateral agreement titled "Agreement for sharing of Information Between the U. S. Environmental Protection Agency (USEPA) and Environment Canada (EC) and Health Canada (HC) Administrative Procedures", signed June 9, 1999, effective June 23, 1999.
2. This permission is not, therefore, a general waiver of either substantiative or procedural CBI protections provided by Canadian law.
3. _{----------------------}[Name of CEPA notifier], recognizes that Environment Canada makes no representation as to the level of security that information claimed as CBI might be afforded once the information is disclosed to U. S. EPA.
4. Environment Canada will, however, inform U. S. EPA of the existence of any CBI claims under Canadian law known to Environment Canada at the time of disclosure by Environment Canada.
5. _{----------------------}[Name of CEPA notifier], furthermore, makes this permission to disclose with the understanding and belief that U. S. EPA will give this information, claimed as CBI under Canadian law, all protections to which it is entitled under applicable American law.

I have the authority to sign this Limited Permission to Disclose on behalf of _{----------------------}[Name of Company]

Signature: _{----------------------}.

Name Typed: _{----------------------}.

Title: _{----------------------}.

Date: _{----------------------}.

"FOUR CORNERS" AGREEMENT
Limited Permission to Disclose (TSCA PMN Filer)

_{----------------------}[Name of company] a company that has previously submitted to U.S. EPA a pre-manufacture notice (PMN) contest confidential business information (CBI) as defined by American law, hereby gives permission to U.S. EPA to disclose the entire contents of a U.S. EPA PMN file, including CBI, denominated as PMN _{----------------------} to Environment Canada and Health Canada under the following terms:

1. This permission is a limited one. It is made to facilitate the review of this PMN file by the two named Canadian federal agencies as contemplated under the bilateral agreement titled "Agreement for Sharing of Information Between the U.S. Environmental Protection Agency (USEPA) and Environment Canada (EC) and Health Canada (HC) Administrative Procedures," signed June 9, 1999, effective June 23, 1999.
2. This permission is not, therefore, a general waiver of either substantive or procedural CBI protections provided by American law.
3. _{----------------------} recognizes that U.S. EPA makes no representation as to the level of security that information claimed as CBI might be afforded once the information is disclosed to Environment Canada or Health Canada.
4. U.S. EPA will, however, inform Environment Canada and Health Canada of the existence of any CBI claims under American law known to U.S. EPA at the time of disclosure.
5. _{----------------------} furthermore, makes this limited disclosure with the understanding and belief that Environment Canada and Health Canada will give this information claimed as CBI under American law, all protections to which it is entitled under applicable Canadian law, I have the authority to sign this Limited Permission to Disclose on behalf of _{----------------------}[name of company]

Signature: _{----------------------}.

Name Typed: _{----------------------}.

Title: _{----------------------}.

Date: _{----------------------}.

Sharing New Chemicals information Between the United States and Canada

Dear Sir/Madam:

Below is the documentation/and or data being sent to the US EPA by the PMN filer as part of a project in shared hazard data and risk assessment between the United States and Canada:

Signature and Title of Authorized Official _{----------------------}.

Company name _{----------------------}.

Company Address _{----------------------}.

Date _{----------------------}.

Subject chemical_{----------------------}

substance identifier_{----------------------}

CE #_{----------------------}

PMN #_{----------------------}

Items included:

1. PMN Filer's Authorization letter allowing US EPA to send/discuss CBI re PMN Submission with EC _{---------------}.
2. Copy of EC Acknowledgement letter _{---------------}.
3. Data Generated Since PMN Submission _{---------------}.
4. Other _{---------------}.

Sharing New Chemicals information Between the United States and Canada

Dear Sir/Madam:

Below is the documentation/and or data being sent to Environment Canada by the NSN Notifier as part of a project in shared hazard data and risk assessment between the United States and Canada:

Signature and Title of Authorized Official _{----------------------}.

Company name _{----------------------}.

Company Address _{----------------------}.

Date _{----------------------}.

Subject chemical_{----------------------}

substance identifier_{----------------------}

PMN #_{----------------------}

Items included:

1. US TSCA PMN _{---------------}.
2. US TSCA Notice of Commencement (NOC) _{---------------}.
3. Any TSCA 5(e) or &#sect;8(e) Compliance documentation _{---------------}.
4. Any US Generated Letters of Concern (LOCs) _{---------------}.
5. All New Data on the Chemical Generated since the Original PMN was Filed _{---------------}.
6. Authorization by both CEPA Notifier and US PMN Filer allowing Environment Canada and Health Canada to Discuss Submissions and Exchange information with US EPA _{---------------}.