SCREENING ASSESSMENT OF LIVING ORGANISMS ON THE DOMESTIC SUBSTANCES LIST (DSL)

The New Substances Program of Environment Canada and Health Canada will be conducting "screening assessments" of all living organisms listed on the Domestic Substances List (DSL).

Screening assessments are a requirement under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Under Section 74(b), the Minister of the Environment and the Minister of Health are required to conduct screening assessments of the living organisms listed on the DSL in order to determine whether the latter are "toxic" or capable of becoming "toxic" as defined under the Act. Section 64 of the Act states that a substance is "toxic" if it is entering or may enter the environment in a quantity or concentration or under conditions that:

1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
2. constitute or may constitute a danger to the environment on which life depends; or
3. constitute or may constitute a danger in Canada to human life or health.

WHO WILL CONDUCT THE SCREENING ASSESSMENTS?

The New Substances Program of Environment Canada and Health Canada will jointly conduct the screening assessments for all living organisms listed on the DSL. Chemicals listed on the DSL are assessed by the Existing Substances programs at Environment Canada and Health Canada.

WHAT IS THE DOMESTIC SUBSTANCES LIST (DSL)?

The DSL is a compilation of all known substances, chemicals and living organisms, that were present in Canadian commerce between January 1, 1984, and December 31, 1986, or that were added to the DSL in accordance with the CEPA, 1999. The DSL currently lists about 23,000 chemicals, 44 microbial strains and one complex microbial culture.

WHAT IS A SCREENING ASSESSMENT?

A screening assessment is a scientific evaluation of whether an existing substance is or may become harmful to human health or the environment. Living organisms on the DSL will be evaluated according to:

• their ability to persist and to survive within aquatic and terrestrial environments;
• their invasiveness; and
• their ability to elicit pathogenicity and/or toxicity to humans and to aquatic and terrestrial organisms (invertebrates and vertebrates).

WHAT IS THE SCREENING ASSESSMENT PROCESS?

The following diagram gives a summary of the screening assessment process and its steps:

Diagram 1: PROPOSED SCREENING ASSESSMENT PROCESS

All living organisms listed on the DSL will be assessed in order of priority. Priority levels will be based on:

• pathogenicity or toxicity for humans.
• pathogenicity or toxicity to non-human species.
• invasiveness.

Information used in the course of a screening assessment includes:

• In-depth literature review, including peer-reviewed scientific journals.

• Decisions from other domestic or international jurisdictions.

• Industry and other stakeholder-supplied data on entry points into the environment.

• Laboratory and/or field studies through collaborations with partners in government and academic institutions.

The screening assessment conclusion is science-based and considers the Precautionary Principle. This conclusion is reached in consideration of any decisions made by other Canadian jurisdictions as well as by regulatory bodies from other member countries of the Organization for Economic Co-operation and Development (OECD) under Section 75 of CEPA 1999.

WHAT HAPPENS AFTER THE SCREENING ASSESSMENT IS COMPLETE?

After the screening assessment is complete, the report will undergo an internal and external scientific peer-review. Environment Canada and Health Canada will then publish a joint summary of the peer-reviewed screening assessment report in the Canada Gazette, Part I, along with the proposed measure. The proposed measure could be:

• A recommendation that the Governor in Council (the federal Cabinet) add the organism in question to the List of Toxic Substances (Schedule 1). The organism would be added to Schedule 1 if it were determined that it met the criteria for "toxic" substance under the Act and that regulatory or pollution prevention measures, or environmental emergency planning risk-management measures should be taken under CEPA 1999.

• No further action under CEPA 1999. This measure will typically be recommended for organisms found not to be "toxic" under the Act. No further action under CEPA 1999 may also be proposed for organisms found to be "toxic" under the Act, but for which actions being taken or about to be taken under other federal acts or by provincial, territorial or Aboriginal governments are sufficient to manage the risks effectively and in a timely manner.

The public will be invited to comment on the proposed conclusion for a 60-day period, after which, the public's comments will be reviewed and addressed. Environment Canada and Health Canada will then publish the final assessment conclusion and proposed measure in Canada Gazette, Part 1.

In addition, a Significant New Activity (SNAc) Notice can be issued for living organisms that were initially found not to be "toxic" under CEPA 1999. A SNAc can be issued when the use of a substance or other activity will result or may result in:

• a significantly greater quantity or concentration of the substance in the environment; or
• a significant change in the manner or conditions of exposure to the substance.

SNAc notices are published when there is a suspicion that an alternative use of the living organism may result in the organism becoming toxic. The Notice communicates the criteria under which the government must be re-notified. The government assesses the new information on the substance to determine if it is toxic in relation to the significant new activity. Significant new activities can apply to existing substances on the Domestic Substances List or to new substances.

WHAT ARE SOME EXAMPLES OF INDUSTRIAL APPLICATIONS WHERE THESE MICRO-ORGANISMS MAY BE IN USE?

(Note: This is not an exhaustive list)

Examples of possible applications for DSL living organisms are:

• Bioremediation
• Biosensing
• Biofiltration
• Mineral leaching
• Fuel production
• Enhanced oil recovery
• Fossil fuel or natural gas desulfurization
• Pulp and paper
• Biological waste treatment
• Products for RV holding tanks
• Septic tank starter
• Compost starter
• Cleaners/detergents
• Odour control products
• Biomass conversion
• Wax separation
• Janitorial cleaning products
• Drain cleaning/degreasing
• Field trials
• Chemical production
• Enzyme production

WHAT ARE THE TIMELINES FOR COMPLETING THE SCREENING ASSESSMENTS?

There is no mandated deadline for the completion of screening assessments of living organisms on the DSL. However, considering that these organisms are already being used in Canada, Environment Canada and Health Canada consider it a priority to proceed expeditiously with their assessments in order to determine if they pose any potential risks to the environment and human health.

WHAT IS THE ROLE OF STAKEHOLDERS IN THE SCREENING ASSESSMENT PROCESS?

Stakeholders from industry, academia, non-governmental organizations, and federal/provincial/municipal governments are invited to comment on the process and to contribute their scientific and technical expertise to individual assessments. The contribution of industry stakeholders is particularly important for exposure characterization. For example, interested industry will be asked to supply any available information pertaining to their use of living organisms on the DSL, such as:

• whether they manufacture or import any of the living organisms listed on the DSL.
• basic use pattern information.

Additional information may subsequently be requested if needed for the screening assessment conclusion. This information forms a critical part of the screening assessment and participation by affected parties is critical to reaching an informed decision.

HOW TO PARTICIPATE IN THIS INITIATIVE?

The New Substances Program of Environment Canada and Health Canada is planning to set up a Technical Expert Group to contribute to the development of this initiative. If you are interested in participating on this committee, or if you would like to contribute to this initiative on an individual basis, please provide your name and contact information at the address below before the end of February 2007. Please note that Environment Canada and Health Canada will make the final decision on participants to ensure effective functioning and balanced representation.

WHERE TO GET MORE INFORMATION OR MAKE COMMENTS?

Fact sheets:

• Information Note 2006-06 - Screening Assessment of Living Organisms on the Domestic Substances List
  View in PDF Format or View in HTML Format
  
  

Proposed guidelines:

• Proposed Guidelines for the Prioritization of Living Organisms on the Domestic Substances List (DSL) prior to the Screening Assessment - Now available for public comments
  View in PDF Format or View in HTML Format

To get more information, please contact:

The New Substances Notification Information Line
Environment Canada
Place Vincent Massey, 14th Floor
Gatineau QC K1A 0H3
Telephone:
(800) 567-1999 (Toll Free in Canada)
(819) 953-7156 (Outside of Canada)
Fax: (819) 953-7155
E-mail: nsn-infoline@ec.gc.ca

Comments on this initiative are welcome at any time by mail, email or facsimile. We would appreciate receiving your first comments by the end of February 2007 in order to consider them for the initial phase of the project.