Vol. 150, No. 14 — July 13, 2016

Registration

SOR/2016-159 June 22, 2016

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2016-112-21-01 Amending the Domestic Substances List

Whereas the living organism set out in the annexed Order is 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 the living organism under section 74 of the Canadian Environmental Protection Act, 1999 (see footnote b);

And whereas the Ministers suspect that a significant new activity in respect of the living organism may result in the living organism becoming toxic within the meaning of section 64 of the Act;

Therefore, the Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 (see footnote c), makes the annexed Order 2016-112-21-01 Amending the Domestic Substances List.

Gatineau, June 15, 2016

Catherine McKenna
Minister of the Environment

Order 2016-112-21-01 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 fluorescens
ATCC 13525

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 fluorescens ATCC 13525 S′
  • 1 Any activity involving the use of the living organism Pseudomonas fluorescens ATCC 13525:
    • (a) in a health care facility such as a hospital, doctor’s office, walk-in clinic, mobile health clinic, long-term care facility and nursing home; or
    • (b) in a blood donor clinic, whether in a vehicle or a public space.
  • 2 Any activity involving the use of the living organism Pseudomonas fluorescens ATCC 13525, in a contained facility, within a health care facility or blood donor clinic, that provides a level of containment that is in accordance with the requirements of containment level 2 or a higher level of containment, as set out in the Canadian Biosafety Standard and Canadian Biosafety Handbook, as amended from time to time, is not a significant new activity for which the living organism is subject to subsection 106(3) of the Act.
  • 3 For each proposed significant new activity, the following information must be provided to the Minister at least 120 days before the day on which the organism is manufactured, imported or used:
    • (a) a description of the significant new activity in relation to the living organism;
    • (b) the information specified in paragraphs 1(a) and (g), items 2 and 3, paragraph 6(e), and item 7 of Schedule 1 to the New Substances Notification Regulations (Organisms);
    • (c) all other information and test data in respect of the living organism that are relevant to identifying hazards to the environment and human health and that are in the possession of the person proposing the significant new activity, or to which the person ought to have access;
    • (d) the name of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided notice in respect of the living organism and the purpose of that notification;
    • (e) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person proposing the significant new activity and, if any, the person authorized to act on their behalf;
    • (f) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and
    • (g) a certification stating that the information is accurate and complete, dated and signed by the person proposing the significant new activity if they are resident in Canada or, if not, by the person authorized to act on their behalf.
  • 4 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.)

Issues

A screening assessment (see footnote 2) was conducted for a strain of Pseudomonas fluorescens ATCC (see footnote 3) 13525 that is listed on the Domestic Substances List (DSL), (see footnote 4) hereafter referred to as the DSL strain of P. fluorescens, to determine whether the micro-organism (see footnote 5) has the potential to be harmful to human health or the environment. The assessment concluded that exposure levels from current activities using the DSL strain of P. fluorescens do not pose a risk to human health or the environment in Canada.

However, as it is possible for future activities to use the DSL strain of P. fluorescens in certain products, there is a potential for harm, particularly if these products are used in health care settings in Canada, as they could increase exposure of susceptible individuals through the contamination of medical devices or stored blood products.

Therefore, the Minister of the Environment and Climate Change (the Minister) is applying the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 (CEPA) to the DSL strain of P. fluorescens to require notification to the Government of Canada (the Government) of any potential significant new activity associated with the micro-organism before it can be undertaken in Canada. (see footnote 6)

Background

As of February 2016, 68 micro-organisms had been added to the DSL under subsection 105(1) of CEPA, including the DSL strain of P. fluorescens. A prioritization was performed in September 2010 in order to ensure that micro-organisms of greatest potential concern were assessed first. (see footnote 7) Under the Chemicals Management Plan (CMP), (see footnote 8) the DSL strain of P. fluorescens was identified as a high priority for assessment because it has the potential to cause disease in susceptible humans. (see footnote 9)

As a result, the Minister of the Environment and Climate Change and the Minister of Health (the Ministers) conducted a screening assessment to determine whether the DSL strain of P. fluorescens met the human health or environmental toxicity criteria under section 64 of CEPA.

Based on the information submitted under the authority of CEPA, the assessment determined that exposure from current activities associated with the micro-organism are not of concern to the population, including susceptible individuals or to the environment, and, therefore, are not of concern to human health in Canada. (see footnote 10) However, since future activities associated with the micro-organism may occur and have the potential to harm susceptible individuals in the health care setting in Canada, the Government is applying the SNAc provisions under CEPA to the DSL strain of P. fluorescens. It was also determined that releases of the micro-organism from current activities are not of concern to the environment in Canada. Therefore, the DSL strain of P. fluorescens did not meet any of the criteria under section 64 of CEPA.

SNAc provisions of CEPA

Given that the DSL strain of P. fluorescens is listed on Part 5 of the DSL, activities associated with the micro-organism could be carried out without an obligation for a person (individual or corporation) to notify the Government under CEPA. However, when the Government is concerned that significant new activities in relation to a micro-organism may result in an increased risk to human health or the environment, the Minister may impose notification requirements to monitor those activities. (see footnote 11)

Description and uses of the DSL strain of P. fluorescens

The micro-organism has the ability to adapt and thrive in many aquatic and terrestrial ecological niches. Multiple potential uses of the DSL strain of P. fluorescens in various industrial and commercial sectors exist. These include pulp and paper and textile processing, in municipal and industrial wastewater treatment, for waste degradation (particularly in petroleum refineries), bioremediation and biodegradation, as well as in commercial and household drain cleaners and degreasers, enzyme and chemical production, septic tank additives and general cleaning and odour-control products. Other uses include pest control, plant growth promotion and use as an anti-frost agent on plants. A variety of environmental, industrial, and household applications using the DSL strain of P. fluorescens were reported in response to a notice published under section 71 of CEPA. According to the information submitted, less than 1 000 kg of the DSL strain of P. fluorescens was imported into or manufactured in Canada in 2008.

As the DSL strain of P. fluorescens has properties that make it suitable for use in a variety of products, there is reason to expect potential new uses of the micro-organism in products that could be used in the health care setting in Canada. (see footnote 12) As a result, there is a potential risk of increased exposure of susceptible individuals undergoing medical treatment from future new uses of the micro-organism.

Assessment conclusion summary

The DSL strain of P. fluorescens is capable of causing infection in susceptible individuals such as those with compromised immunity, or infection through contact with contaminated medical devices and fluids. As the micro-organism can grow at temperatures typical of refrigerated storage, it is able to proliferate in stored blood products and may cause sepsis in transfused patients. Although the risk to human health from certain future new uses of the DSL strain of P. fluorescens is expected to be low, the Government is concerned that other future new uses, specifically, those associated with the health care setting in Canada, could potentially increase exposure to susceptible individuals, particularly through the contamination of medical devices or stored blood products.

It is therefore recommended that subsection 106(3) of CEPA be applied to the micro-organism to require any person (individual or corporation) to notify the Minister of any proposed significant new activity associated with the DSL strain of P. fluorescens before it is undertaken.

Risk management actions summary

The DSL strain of P. fluorescens is recognized as belonging to Risk Group 1 (RG1) [low individual and community risk micro-organism] by the Public Health Agency of Canada. The Canadian Biosafety Standard defines RG1 micro-organisms as either (1) not capable of causing human or animal disease; or (2) capable of causing human or animal disease, but unlikely to do so. Those capable of causing disease are considered pathogens that pose a low risk to the health of individuals and/or animals, and a low risk to public health, livestock or poultry. However, RG1 pathogens can be opportunistic and may pose a threat to individuals with compromised immunity.

Objectives

The objective of the Order is to contribute to the protection of human health by requiring submission of information on significant new activities associated with the DSL strain of P. fluorescens before they are undertaken. The information collected will assist the Government of Canada in assessing the substance in relation to the significant new activity and in determining whether further risk management actions are necessary.

Description

The Order amending the DSL, made by the Minister pursuant to subsection 112(3) of CEPA, is now in force. It is therefore mandatory to meet all the requirements of the Order should a person (individual or corporation) wish to import, manufacture or use the DSL strain of P. fluorescens for a significant new activity as defined in the Order.

The Order deletes the micro-organism Pseudomonas fluorescens ATCC 13525 from Part 5 of the DSL and adds it to Part 6 of the DSL.

Applicability of the Order

The Order amending the DSL requires that any person (individual or corporation) engaging in a significant new activity in relation to the DSL strain of P. fluorescens submits a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 120 days prior to the import, manufacture or use of the micro-organism for the significant new activity.

Examples of potential activities, with respect to the DSL strain of P. fluorescens, requiring a SNAN submission will include the use of products containing the living organisms in healthcare facilities and in blood donor clinics. Products used in these settings could include hard surface cleaners, deodorizers, and products of a new category that claim to displace pathogens through the application of “probiotic” bacteria (“probiotic” cleaners). The use of such products is not known to be currently occurring in Canada.

Activities not subject to the Order

The Order does not apply to current uses of the DSL strain of P. fluorescens that are not expected to occur in the healthcare setting in Canada. These include pulp and paper and textile processing; municipal and industrial wastewater treatment; waste degradation, particularly in petroleum refineries; bioremediation and biodegradation; commercial and household drain cleaners and degreasers not used in health care settings; enzyme and chemical production; septic tank additives; and general cleaning and odour-control products.

Activities involving the use of the micro-organism in a contained facility, including for research and development purposes, are excluded from the Order since the potential exposure of concern for human health is exposure of susceptible humans through contaminated medical devices or blood products.

The Order does not apply to uses of the micro-organism that are regulated under any act of Parliament listed in Schedule 4 of CEPA, including, but not limited to, the Pest Control Products Act, the Fertilizers Act and the Feeds Act. It also does not apply to impurities and contaminants related to the preparation of a micro-organism, and in some circumstances to items such as, but not limited to, wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the Order. See subsection 106(6) and section 3 of CEPA, and section 2 of the Guidelines for the Notification and Testing of New Substances (Organisms) for additional information. (see footnote 13)

Information to be submitted

The Order sets out the information requirements that must be provided to the Minister 120 days before the day on which the DSL strain of P. fluorescens is imported, manufactured or used for a significant new activity. The Ministers will use the information submitted in the SNAN to conduct human health and environmental assessments within 120 days after the complete information is received.

The information requirements in the Order relate to general information in respect of the micro-organism, details surrounding its use, and exposure information. Some of the information requirements set out in the Order reference the New Substances Notification Regulations (Organisms), (see footnote 14) which describe in more detail the specific information being requested. Additional guidance on preparing a SNAN can be found in section 7 of the Guidelines for the Notification and Testing of New Substances (Organisms).

“One-for-One” Rule

The Order does not trigger the “One-for-One” Rule, as there are no requirements for industry on current activities associated with the use of the DSL strain of P. fluorescens, or indication that these activities may change in the future. As a result, no additional administrative costs are expected to be incurred by businesses or others.

Small business lens

The Order does not add compliance or administrative burden on small business. As a result, it does not trigger the small business lens.

Consultation

On February 14, 2015, a Notice of Intent, to amend the DSL, proposing that SNAc provisions of CEPA be applied to the DSL strain of P. fluorescens, and a summary of the draft screening assessment were published for a 60-day public comment period in the Canada Gazette, Part I. (see footnote 15) No comments were received on the Notice of Intent and only one comment was received on the draft screening assessment. This comment was considered when finalizing the screening assessment, but as it was essentially technical, it did not change the conclusion that the DSL strain of P. fluorescens was not found to meet the toxicity criteria under section 64 of CEPA. (see footnote 16)

The Department of the Environment and Climate Change and Health Canada have also informed the governments of the provinces and territories through the National Advisory Committee of CEPA (CEPA NAC) about the Order via a letter, providing them with an opportunity to comment. No comments were received from CEPA NAC.

Rationale

While the screening assessment concluded that current uses of the DSL strain of P. fluorescens do not pose a risk to human health or the environment in Canada, it was determined that it possesses the potential to cause harm to susceptible humans with compromised immunity, or infection through contact with contaminated medical devices and fluids as the micro-organism can grow at temperatures typical of refrigerated storage. Also, P. fluorescens is able to proliferate in stored blood products and may cause sepsis in transfused patients.

Given these hazardous properties, significant new activities related to this micro-organism may lead to potential risks to human life and health of susceptible individuals in Canada; therefore applying the SNAc provisions to the DSL strain of P. fluorescens is the recommended option chosen by the Government. This option provides an opportunity for the Government to conduct human health assessments of significant new activities associated with the DSL strain of P. fluorescens before they can be undertaken.

The Order contributes to the protection of human life and health by enabling assessment prior to the DSL strain of P. fluorescens being imported, manufactured or used for a significant new activity. Information submitted as per the requirements of the Order will allow the Government to evaluate the potential risks to human life and health in relation to the proposed new activity and determine whether new risk management measures may be required.

As current uses in Canada of the DSL strain of P. fluorescens are not of concern to human health and are not affected by the Order, it is not expected to have any negative impact on businesses. However, in the event that any person wishes to use, import or manufacture the DSL strain of P. fluorescens for a significant new activity in Canada, the information referred to in the Order will need to be provided. There is no notification fee associated with submitting a notification package in response to a Significant New Activity Order to the New Substances Program of the Department of the Environment (the program). However, costs associated with generating data and supplying other information may be incurred by the notifier.

In the event that a notification is submitted, the Government will incur costs for processing the information in relation to the Order and for conducting health and environmental assessments. It is assumed that these costs are unlikely to be incurred, given that no significant new activities involving the DSL strain of P. fluorescens are expected. The Government will incur costs for conducting compliance promotion and enforcement activities associated with the Order. Annual compliance promotion and enforcement costs are expected to be negligible.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed (please see http://www.chemicalsubstanceschimiques.gc.ca/plan/sea-ees-eng.php.)

Implementation, enforcement and service standards

Compliance

When assessing whether or not a particular order applies, a person is expected to make use of information in their possession or to which they ought to have access. The phrase “to which they ought to have access” means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product, are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDS). (see footnote 17) Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to an order due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

If any information becomes available that reasonably supports the conclusion that this micro-organism is toxic or capable of becoming toxic, the person who is in possession or has knowledge of the information and is involved in activities with the micro-organism is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if the activities were covered by the original SNAN submitted by the supplier. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of CEPA provides more detail on this subject. (see footnote 18)

Any person who transfers the physical possession or control of the DSL strain of P. fluorescens should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the Order, including the obligation under subsection 106(3) of CEPA, to notify the Minister of any significant new activity and to provide all the required information outlined in the Order.

A pre-notification consultation (PNC) is available to notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Where a person has questions concerning their obligations to comply with this Order, or would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line. (see footnote 19)

Implementation

The Order is now in force and the compliance promotion activities that will be conducted as part of the implementation of the Order 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. When verifying compliance with the Order, enforcement officers will apply the Compliance and Enforcement Policy (the Policy) implemented under CEPA. (see footnote 20) The Compliance and Enforcement Policy 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 violation). In addition, the Policy explains when the Department of the Environment 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:

Service standards

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

Contacts

Nicole Davidson
Director
Emerging Priorities Division
Science and Risk Assessment Directorate
Science and Technology Branch
Environment and Climate Change Canada
Gatineau, Quebec
K1A 0H3
Telephone: 819-938-5505
Fax: 819-938-5139
Email: nicole.davidson@canada.ca

Shaunalea Savard
Acting Director
New Substances Assessment and Control Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-960-0846
Fax: 613-946-6474
Email: shaunalea.savard@canada.ca