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Registration

SOR/2012-115 June 1, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-112-04-14 Amending the Domestic Substances List

Whereas the substances set out in the annexed Order are specified on the Domestic Substances List (see footnote a);

Whereas the Minister of the Environment and the Minister of Health have conducted a screening assessment of each of those substances under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

Whereas the Ministers are satisfied that those substances are not being manufactured in or imported into Canada by any person in any one calendar year;

And whereas the Ministers suspect that the information concerning a significant new activity in relation to any of those substances may contribute to determining the circumstances in which the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (see footnote c);

Therefore, the Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 (see footnote d), hereby makes the annexed Order 2012-112-04-14 Amending the Domestic Substances List.

Gatineau, May 28, 2012

PETER KENT
Minister of the Environment

ORDER 2012-112-04-14 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 5 of the Domestic Substances List (see footnote 1) is amended by deleting the following under the heading “Organisms/Organismes”:

Pseudomonas aeruginosa

ATCC 31480

Pseudomonas aeruginosa

ATCC 700370

Pseudomonas aeruginosa

ATCC 700371

2. Part 6 of the List is amended by adding the following in alphabetical order:

Column 1


Living Organism

Column 2

Significant New Activity for which living organism is subject to subsection 106(3) of the Act

Pseudomonas aeruginosa

ATCC 31480 S′

1. Any activity involving the living organism other than its use as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), with a volume of less than 250 L present at any one time.

2. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the living organism is manufactured, imported or used:

  • (a) a description of the proposed new activity in relation to the living organism;

  • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 to the New Substances Notification Regulations (Organisms);

  • (c) when the living organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;

  • (d) when the living organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and

  • (e) when the living organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.

3. The above information will be assessed within 120 days after the day on which it is received by the Minister.

Pseudomonas aeruginosa

ATCC 700370 S′

1. Any activity involving the living organism other than its use as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), with a volume of less than 250 L present at any one time.

2. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the living organism is manufactured, imported or used:

  • (a) a description of the proposed new activity in relation to the living organism;

  • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 to the New Substances Notification Regulations (Organisms);

  • (c) when the living organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;

  • (d) when the living organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and

  • (e) when the living organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.

3. The above information will be assessed within 120 days after the day on which it is received by the Minister.

Pseudomonas aeruginosa

ATCC 700371 S′

1. Any activity involving the living organism other than its use as a research and development organism in a contained facility, as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), with a volume of less than 250 L present at any one time.

2. For each significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the living organism is manufactured, imported or used:

  • (a) a description of the proposed new activity in relation to the living organism;

  • (b) subject to paragraphs (c) to (e), the information specified in Schedule 1 to the New Substances Notification Regulations (Organisms);

  • (c) when the living organism is to be used inside a contained facility as defined in subsection 1(1) of those Regulations, the information specified in Schedule 2 to those Regulations;

  • (d) when the living organism is to be used in an experimental field study as defined in subsection 1(1) of those Regulations, the information specified in Schedule 3 to those Regulations; and

  • (e) when the living organism is to be used at the site from which it was isolated, the information specified in Schedule 4 to those Regulations.

3. The above information will be assessed within 120 days after the day on which it is received by the Minister.

COMING INTO FORCE

3. This Order comes into force on the day on which it is registered.

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Order.)

1. Background

Micro-organisms are broadly defined as bacteria, archaea, fungi, yeasts, protozoa, algae, viruses, eukaryotic cell culture, and any culture other than a pure culture. (see footnote 2) As of September 2010, there are 68 micro-organisms on the Domestic Substances List (DSL): one complex microbial culture and 67 microbial strains, including the three strains of Pseudomonas aeruginosa.

Under section 105 of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act), living organisms can be added to the DSL if they were manufactured in or imported into Canada between January 1, 1984, and December 31, 1986, and if they entered or were released into the environment without being subject to conditions under CEPA 1999 or any other federal or provincial legislation. The Minister of the Environment and the Minister of Health are therefore required to conduct screening assessments of these living organisms under section 74 of CEPA 1999 in order to determine whether they present or may present a risk to the environment or human health. A prioritization (see footnote 3) was performed in September 2010 in order to ensure that micro-organisms with the greatest potential for hazard are assessed first. Accordingly, the following micro-organisms (hereinafter, the three micro-organisms) were identified as a high priority for assessment based on known pathogenicity or toxicity to humans and non-human species:

  • Pseudomonas aeruginosa (American Type Culture Collection [ATCC] 31480);
  • Pseudomonas aeruginosa (ATCC 700370); and
  • Pseudomonas aeruginosa (ATCC 700371).

Most Pseudomonas aeruginosa (P. aeruginosa) strains can cause a wide range of respiratory diseases, hospital-acquired infections and skin infections. They have the ability to spread and acquire antibiotic resistance genes which may compromise the effectiveness of antibiotics that are currently used for the treatment of infections. P. aeruginosa is recognized by the Public Health Agency of Canada (PHAC) as a Risk Group 2 human pathogen. (see footnote 4)

With respect to the environment, P. aeruginosa is recognized as a Risk Group 2 pathogen (see footnote 5) by the Animal Pathogen Import Program of the Canadian Food Inspection Agency (CFIA). Many studies have reported that P. aeruginosa can behave as an opportunistic pathogen in a range of plants, invertebrates and vertebrates when, for example, the host has been stressed or weakened by another factor. However, under normal circumstances, P. aeruginosa is unlikely to be a serious environmental hazard.

Use profile

According to historical information used to compile the DSL (data from the years 1984 to 1986), the three micro-organisms imported into Canada were used in a variety of waste, water and wastewater treatments, bioremediation, and biodegradation products. More recently, no industrial activities were identified for the three micro-organisms for the reporting years 2007 and 2008, according to information obtained through various approaches (voluntary questionnaire, information from federal regulatory and non-regulatory programs, and section 71 surveys under CEPA 1999). The three micro-organisms are deemed to be not in commerce in Canada and, therefore, the likelihood of exposure to these micro-organisms is negligible. However, the three micro-organisms have potential uses in various industrial and commercial sectors, including in waste degradation (oil refineries), and in textile, pulp and paper, mining and explosives industries. They can also be used in commercial and household drain cleaners and degreasers, septic tank additives, general cleaning products, and odour control products.

Screening assessment conclusion

A screening assessment for the three micro-organisms was conducted to determine whether they meet the criteria set out in section 64 of CEPA 1999 — that is, whether they are entering or may enter the environment in a quantity or concentration or under conditions that

  • (a) have or may have an immediate or long-term harmful effect on the environment or its biological diversity;

  • (b) constitute or may constitute a danger to the environment on which life depends; or

  • (c) constitute or may constitute a danger in Canada to human life or health.

Based on available information, the three micro-organisms are not in commerce in Canada. Therefore, the screening assessment concluded that the three micro-organisms do not meet any of the criteria as set out in section 64 of CEPA 1999. The final screening assessment on the three micro-organisms was published on the Chemical Substances Web site (see footnote 6) along with the notice published in the Canada Gazette, Part Ⅰ, on June 2, 2012.

Should exposure increase through new activities, there is a potential risk to human health and the environment based on the pathogenicity or toxicity of these strains of P. aeruginosa to susceptible humans and non-human species. There is concern that new activities which have not been identified or assessed under CEPA 1999 could lead to the three micro-organisms meeting the criteria as set out in section 64 of the Act. For this reason, it is recommended that these micro-organisms be subject to the Significant New Activity (SNAc) provisions to ensure that any new manufacture, import or use of these micro-organisms will undergo ecological and human health assessments prior to the micro-organisms being considered for reintroduction into Canada.

On July 2, 2011, the Government of Canada published a Notice of Intent in the Canada Gazette, Part Ⅰ, to indicate that the SNAc provisions under CEPA 1999 will be applied to the three micro-organisms. (see footnote 7)

Existing risk management actions in Canada and other jurisdictions

There are existing legislation and regulations in Canada (which are listed under Schedule 4 of CEPA 1999) that could potentially capture various activities related to these micro-organisms. These include the Pest Control Products Act and Pest Control Products Regulations; the Feeds Act and Feeds Regulations; the Fertilizers Act and Fertilizers Regulations; and the Health of Animals Act and Health of Animals Regulations. In addition, the Human Pathogens and Toxins Act and the Human Pathogens Import Regulations apply to these micro-organisms as Risk Group 2 pathogens in the laboratory.

No risk management measures were identified in any other jurisdictions with respect to the three P. aeruginosa strains on the DSL.

2. Issue

A screening assessment on the three micro-organisms concluded that they do not currently pose a risk to the environment or human health because they are deemed not to be currently in commerce in Canada. However, new activities involving these micro-organisms, which have not been identified or assessed under CEPA 1999, could increase the potential for exposure and may lead to these strains meeting the toxicity criteria set out in section 64 of CEPA 1999 due to their pathogenicity or toxicity.

3. Objective

The objective of the Order 2012-112-04-14 Amending the Domestic Substances List (the Order) is to subject the three micro-organisms to the SNAc provisions specified under subsection 106(3) of CEPA 1999. This action will provide the Minister of the Environment (the Minister) with information on any new manufacture, import or use activities involving the three micro-organisms, and will enable ecological and human health assessments prior to the micro-organisms being considered for reintroduction into Canada.

4. Description

The Order, made under subsection 112(3) of CEPA 1999, deletes the three micro-organisms from Part 5 of the DSL and adds them to Part 6 of the DSL. The addition of the letter S′ following the ATCC numbers indicates that these micro-organisms are subject to the SNAc provisions specified under subsection 106(3) of CEPA 1999.

This Order requires any person who intends to use, import or manufacture any of these three micro-organisms to provide, 120 days in advance, a notice to the Minister. The Order outlines the information requirements, including a description of the new activity and other required information. The Order provides an exemption for organisms used in research and development that are not for introduction outside a contained facility.

The Order provides that the information supplied to the Minister will be assessed within 120 days after it is received to determine if the new activity requires further risk management considerations. The Order comes into force on the day on which it is registered.

5. Consultation

On July 2, 2011, a notice of intent to amend the DSL was published to propose that SNAc provisions of the Act be applied to the three micro-organisms, and a summary of the draft screening assessment was published for a 60-day public comment period in the Canada Gazette, Part Ⅰ.

No public comments were received on either the notice of intent to amend the DSL or the draft screening assessment.

Environment Canada and Health Canada have also informed the governments of the provinces and territories through the National Advisory Committee of CEPA 1999 (CEPA NAC) about the Order via a letter, with an opportunity to comment. There were no comments from CEPA NAC.

6. Rationale

As described in the “Background” section of this document, the three micro-organisms have potential uses in various industrial and commercial sectors but are deemed not in commerce in Canada. Should exposure increase through new activities, there is a potential risk to human health and the environment based on the pathogenicity and toxicity of these micro-organisms to susceptible humans and non-human species.

Alternatives

Status quo

The three micro-organisms are currently listed on Part 5 of the DSL and are subject to a variety of federal laws and regulations as noted above. Although the screening assessment concluded that the three micro-organisms do not currently pose a risk to the environment or human health, it was also determined that they possess pathogenicity and toxicity characteristics and new uses of them may lead to potential risks which will not be adequately addressed by existing controls. If no further risk assessment of these activities is undertaken, these micro-organisms could be used for any activity and in any quantity without any requirement to report to the Minister, provided that they do not trigger the control actions of existing regulations. Given the hazardous properties of these micro-organisms, allowing widespread future use without appropriate assessment could pose the risks identified above.

For these reasons, maintaining the status quo has been rejected.

Regulatory instrument

Modifying the DSL to apply SNAc provisions allows the Government of Canada to be informed of new activities or uses. The submitted information will assist the Government of Canada in conducting a risk assessment in relation to these activities or uses and the potential for the micro-organisms to impact the environment and health of Canadians.

For these reasons, the Government of Canada has determined that applying SNAc provisions to the three micro-organisms is the preferred option for managing any health and environmental risks that the new activities may pose.

Benefits and costs

Benefits

The Order contributes to the protection of human health and the environment by enabling an assessment of any new manufacture, import or use of the three micro-organisms. Information submitted as per the requirements of the Order will allow the Government of Canada to evaluate potential harm so that new activities do not pose risks to human health or the environment.

Costs

As the three micro-organisms are not currently in commerce in Canada, the Order is not expected to have any negative impact on businesses. However, in the event that any person wishes to use, import or manufacture any of the three micro-organisms for a new activity in Canada, the information referred to in the Order will need to be provided. There is no notification cost associated with submitting a package to the New Substances Program, which administers the New Substances Notification Regulations (Organisms). However, costs associated with generating data and supplying other information may be incurred by the notifier. The magnitude of these costs would depend on several factors, including the level of exposure linked to the new activity (e.g. the complexity of laboratory work). As a result, providing a total estimate of the cost to industry to meet the notification requirements is not possible at this time.

Additionally, in the near future, there may be costs to some companies beyond the costs of submitting the required information in terms of lost revenue. For example, if new products containing any of the three micro-organisms are ready, or nearly ready, to go into commerce at the time the Order is published, the company will have to delay marketing of the product, submit the required information to the Minister and wait for a decision. Since it is not possible to predict what, if any, new activities may be proposed in the short term, it is not currently possible to estimate the impact (opportunity costs) that may result from the 120-day assessment requirement under this instrument.

In the event of notification of a new activity, the Government of Canada will incur costs for processing the information in relation to the SNAc and for assessing potential health and environmental risks. However, these costs are not expected to be significant and will be covered under current funding from the Chemicals Management Plan.

Furthermore, the Government of Canada will incur costs associated with compliance with the Order by conducting compliance promotion and enforcement activities. Annual incremental costs for compliance monitoring, inspections, investigations, measures to deal with alleged violations and prosecutions are expected to be low, but cannot be accurately estimated given the lack of information regarding potential future uses. Compliance promotion activities will be delivered concurrently with other activities to encourage compliance with the Order. The costs associated with these activities are routine governmental administrative costs and are not considered incremental.

Conclusion

The Order may result in costs to industry to meet the information requirements for a new activity or use involving any of the three micro-organisms. The Government of Canada may incur some cost to conduct environmental and human health risk assessment, raise awareness and ensure compliance with the Order. However, the Order will allow the Government of Canada to obtain adequate information to conduct an assessment of any new exposure to the three micro-organisms and to determine whether appropriate government intervention is required. Although it is not possible to quantitatively estimate the benefits, they are expected to exceed the costs in the long term.

7. Implementation, enforcement and service standards

Implementation

The Order comes into force on the day on which it is registered. The compliance promotion activities to be conducted as part of the implementation of the Order will include developing and distributing promotional material, responding to inquiries from stakeholders and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.

Enforcement

The Order is made under the authority of CEPA 1999. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy implemented under the Act. The Compliance and Enforcement Policy (see footnote 8) also sets out the range of possible responses to violations, including warnings, directions, environmental protection compliance orders, ticketing, ministerial orders, injunctions, prosecution and environmental protection alternative measures (which are an alternative to a court trial after the laying of charges for a CEPA 1999 violation). In addition, the Policy explains when Environment Canada will resort to civil suits by the Crown for cost recovery.

When an enforcement officer discovers an alleged violation following an inspection or an investigation, the officer will choose the appropriate enforcement action based on the following factors:

  • Nature of the alleged violation: This factor includes consideration of the damage, the intent of the alleged violator, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives or requirements of the Act.
  • Effectiveness in achieving the desired result with the alleged violator: The desired result is compliance within the shortest possible timeframe and with no further repetition of the violation. Factors to be considered include the violator’s history of compliance with the Act, willingness to co-operate with enforcement officers and evidence of corrective action already taken.
  • Consistency: Enforcement officers will consider how similar situations have been handled in determining the measures to be taken to enforce the Act.

Service standards

The Government of Canada will assess all information submitted as part of SNAc notification and will communicate the result to the notifier 120 days after the required information is received.

8. Contacts

Nicole Davidson
Director
Emerging Priorities Division
Science and Risk Assessment Directorate
Science and Technology Branch
Environment Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-997-3253
Fax: 819-953-3604
Email: nicole.davidson@ec.gc.ca

John Worgan
Director
New Substances Assessment and Control Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-1501
Fax: 613-946-6474
Email: john.worgan@hc-sc.gc.ca

Footnote a
SOR/94-311

Footnote b
S.C. 1999, c. 33

Footnote c
S.C. 1999, c. 33

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
See subsection 1(1) of the New Substances Notification Regulations (Organisms) under the Canadian Environmental Protection Act, 1999 for a complete description.

Footnote 3
The criteria for prioritization are (1) pathogenicity or toxicity for humans; (2) pathogenicity or toxicity to non-human species; and (3) potential for adverse ecological effects. Please refer to the following Web site for more information: www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=19B91106-1.

Footnote 4
As defined in section 3 of the Human Pathogens and Toxins Act, Risk Group 2 means a category of human pathogens that pose a moderate risk to the health of individuals and a low risk to public health and includes the human pathogens listed in Schedule 2 of the Act. They are able to cause serious disease in a human but are unlikely to do so. Effective treatment and preventive measures are available, and the risk of spread is limited.

Footnote 5
Generally, Risk Group 2 pathogens are any pathogens that can cause disease but, under normal circumstances, are unlikely to be a serious risk to organisms in the environment.

Footnote 6
www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/micro-eng.php

Footnote 7
www.gazette.gc.ca/rp-pr/p1/2011/2011-07-02/html/notice-avis-eng.html

Footnote 8
The Compliance and Enforcement Policy is available at the following Web site: www.ec.gc.ca/lcpe-cepa/default.asp?lang=En&n=5082BFBE-1.