Order 2018-112-20-01 Amending the Domestic Substances List: SOR/2018-96
Canada Gazette, Part II, Volume 152, Number 11
May 10, 2018
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the living organisms set out in the annexed Order are specified on the Domestic Substances List footnote a;
Therefore, the Minister of the Environment, pursuant to subsection 112(3) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order 2018-112-20-01 Amending the Domestic Substances List.
Gatineau, April 23, 2018
Minister of the Environment
Order 2018-112-20-01 Amending the Domestic Substances List
1 Part 5 of the Domestic Substances List footnote 1 is amended by deleting the following under the heading “Organisms/Organismes”:
- Aspergillus oryzae
- ATCC 11866
- Pseudomonas putida
- ATCC 12633
- Pseudomonas putida
- ATCC 31483
- Pseudomonas putida
- ATCC 31800
- Pseudomonas putida
- ATCC 700369
2 Part 6 of the List is amended by adding the following in alphabetical order:
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.)
The Government of Canada (the Government) conducted screening assessmentsfootnote 2 of five strains of living organisms on the Domestic Substances List (DSL)footnote 3 to determine if they could pose a risk to human health or the environment in Canada.
The five living organisms are the following:
- Aspergillus oryzae strain ATCC 11866;
- Pseudomonas putida strain ATCC 12633;
- Pseudomonas putida strain ATCC 31483;
- Pseudomonas putida strain ATCC 31800; and
- Pseudomonas putida strain ATCC 700369.
The screening assessments determined these five living organisms, hereafter referred to as “the DSL strains of A. oryzae and P. putida,” do not meet the criteria for a toxic substance as defined in section 64 of the Canadian Environmental Protection Act, 1999 (CEPA) as exposure from current activities associated with them do not pose an environmental or human health concern in Canada.footnote 4 However, it was determined that increased exposure to the five living organisms could pose a risk for human health. As a result, the Minister of the Environment (the Minister) applied the significant new activity (SNAc) provisions of CEPAfootnote 5 to the DSL strains of A. oryzae and P. putida.
The Chemicals Management Plan (CMP)footnote 6 is a federal government program that aims to assess and manage chemicals, polymers, and living organisms that may be harmful to human health or the environment in Canada. The DSL strains of A. oryzae and P. putida were assessed under the CMP as available information suggested they have the potential to be harmful to human health.
Under section 71 of CEPA, industry was compelled to submit information associated with these living organisms. The DSL strain of A. oryzae was not reported to be in Canadian commerce in 2008 and based on available information, it is still expected to be the case today. In other countries such as China and Japan, the DSL strain of A. oryzae is known to have been used to ferment rice and soy products. With respect to the DSL strains of P. putida, their uses in Canada are associated with
- wastewater and waste treatment;
- custodial, cleaning, and other related products;
- septic tank or recreational vehicle tank additives;
- water conditioners;
- pond or aquarium treatment;
- drain cleaning or degreasing;
- biodegradation and bioremediation; and
- research and development.
Summary of the screening assessments for current and future uses
The screening assessments for the DSL strains of A. oryzae and P. putida were conducted to determine whether they meet the toxicity criteria under section 64 of CEPA. This involves determining whether the living organisms 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.
According to the information presented in the screening assessments, exposure from current activities involving the DSL strains of A. oryzae and P. putida do not pose an undue risk to human health or the environment in Canada and thus the five living organisms did not meet any of the criteria set out in section 64 of CEPA.
The risk to human health from potential future uses of the DSL strains of A. oryzae and P. putida is expected to be low.footnote 7 Since these organisms have hazardous properties that have the potential to be harmful to human health, the Government is concerned about the risks associated with new uses of the DSL strains of A. oryzae and P. putida in products that could be used in the health care setting.footnote 8
The DSL strain of A. oryzae is capable of causing fatal disease in immunocompromised individuals and can also cause eye or sinus infections in otherwise-healthy individuals.
The DSL strains of P. putida are hazardous to immunocompromised individuals and can grow at temperatures typical of refrigerated storage. Therefore, if the DSL strains of P. putida are exposed to stored blood products they can contaminate them and may cause sepsis in transfused patients.footnote 9
Exposure to the five organisms from current activities does not pose a human health concern. However, given that there are risks associated with potential future uses, it was recommended that the SNAc provisions of CEPA be applied to these living organisms.
SNAc provisions of CEPA
Under CEPA, when living organisms are listed on Part 5 of the DSL, activities involving the living organism can be carried out without an obligation for the person (individual or corporation) to notify the Minister. However, when there is a concern that significant new activities in relation to a living organism may result in an increased risk to human health or the environment in Canada, the Minister may apply the SNAc provisions of subsection 106(3) of CEPA to the living organism in order to require notification of any potential significant new activities involving the living organism before they can be undertaken in Canada.
Risk management actions summary
The DSL strains of A. oryzae and P. putida are recognized by the Public Health Agency of Canada as belonging to Risk Group 1 (RG1; low individual and community risk). The Canadian Biosafety Standard defines RG1 living 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 or animals, and a low risk to public health. However, RG1 pathogens can be opportunistic and may pose a threat to immunocompromised individuals. The Canadian Biosafety Handbook footnote 10 recommends that due care should be exercised and safe work practices (e.g. good microbiological laboratory practices) should be followed when handling these materials.
The objective of the Order is to contribute to the protection of human health by requiring the submission of information for the assessment of significant new activities associated with the DSL strains of A. oryzae and P. putida in order to determine whether or not future risk management actions may be necessary to mitigate potential risks associated with such activities, before these can be undertaken in Canada.
The Order amending the DSL, made by the Minister pursuant to subsection 112(3) of CEPA is in force at the time of publication. It is therefore mandatory to meet all of the requirements of the Order should a person (individual or corporation) wish to import, manufacture, or use the DSL strains of A. oryzae or P. putida for a significant new activity.
The Order deletes A. oryzae strain ATCC 11866 and P. putida strains ATCC 12633, ATCC 31483, ATCC 31800, and ATCC 700369 from Part 5 of the DSL and adds them to Part 6 of the DSL; and indicates, by the addition of the “S′” (S prime) flag, following the ATCC number, that the organisms are subject to the SNAc provisions of CEPA.
Applicability of the Order
The Order amending the DSL requires any person (individual or corporation) engaging in a significant new activity in relation to the DSL strains of A. oryzae or P. putida to submit 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 living organisms for the significant new activity.
The Order targets any activity involving the DSL strain of A. oryzae in a health care facility and any activity involving a consumer product to which the Canada Consumer Product Safety Act (CCPSA)footnote 11 applies and that contains the DSL strain of A. oryzae. The Order also targets any activity involving any DSL strain of P. putida in a health care facility or in a blood donor clinic, including a temporary or mobile clinic.
The submission of a SNAN is required for the use of the DSL strain of A. oryzae as a research and development organism in a health care facility or in an activity involving a consumer product that contains the living organism. The submission of a SNAN is also required for the use of any DSL strain of P. putida as a research and development organism in a health care facility or blood donor clinic. The term “research and development organism” is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms) [NSNR (Organisms)].footnote 12
Activities not subject to the Order
The Order amending the DSL does not apply to uses of the living organisms that are regulated under the acts of Parliament listed in Schedule 4 of CEPA, including the Pest Control Products Act, the Seeds Act, the Fertilizers Act, the Feeds Act, and the Health of Animals Act. The Order does not apply to impurities and contaminants related to the preparation of a living organism or, in some circumstances, to items such as 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 (the Guidelines)footnote 13 for more information.
Uses of the DSL strain of A. oryzae in consumer products to which the CCPSA does not apply or uses that occur outside of health care facilities are excluded from the Order. Additionally, the Order does not apply to research and development activities involving the DSL strains of A. oryzae or P. putida in contained facilities that meet the requirements for containment level 1 (basic laboratories) or a higher level of containment, and where good microbiological laboratory practices are implemented. The term “contained facility” is defined in subsection 1(1) of the NSNR (Organisms). The requirements for containment level 1 and good microbiological laboratory practices are set out in the Canadian Biosafety Handbook.
Information to be submitted
The Order sets out the requirements for information that needs to be provided to the Minister at least 120 days before the day on which the living organisms are imported, manufactured, or used for a significant new activity. The Government will use the information submitted in the SNAN to conduct assessments within 120 days after the complete information is received.
The Order requires the submission of information regarding the living organisms, including details surrounding their use and exposure information. Some of the proposed information requirements are set out in the NSNR (Organisms).
Additional guidance on preparing a SNAN can be found in section 7 of the Guidelines.
The “One-for-One” Rule does not apply, as the Order does not impose any administrative burden on businesses. Based on available information, businesses are not expected to use the DSL strains of A. oryzae or P. putida for significant new activities in the future in Canada, and thus costs associated with SNAN submissions are not expected.
Small business lens
The small business lens does not apply, as the Order does not impose any compliance or administrative costs on small businesses or businesses in general.
On January 21, 2017, a notice of intent to amend the DSL footnote 14 to apply the SNAc provisions of CEPA to the DSL strains of A. oryzae and P. putida was published in the Canada Gazette, Part I, for a 60-day public comment period. No comments were received.
The Department of the Environment and the Department of Health have also informed the governments of the provinces and territories through the National Advisory Council of CEPA (CEPA NAC) about the Order via a letter, providing them with an opportunity to comment. There were no comments from CEPA NAC. footnote 15
The Government conducted screening assessments for the DSL strains of A. oryzae and P. putida to determine if they could pose a risk to human health or the environment in Canada. The assessment concluded that current exposure from activities using the DSL strains of A. oryzae and P. putida did not pose an undue risk to human health or the environment. However, given the hazardous properties of these living organisms, significant new activities involving the DSL strains of A. oryzae and P. putida may lead to potential risks to human health in Canada. Therefore, the Government applied the SNAc provisions of CEPA to these living organisms.
The Order contributes to the protection of human health by enabling the assessment of proposed significant new activities involving the DSL strains of A. oryzae and P. putida before they can be undertaken in Canada.
The Order is not expected to have a negative impact on businesses as the DSL strain of A. oryzae is not known to be in commerce in Canada and current activities involving the DSL strains of P. putida are exempt from notification requirements. However, in the event that any person wishes to import, manufacture, or use the living organisms for a significant new activity, the information referred to in the Order will need to be submitted. There is no notification fee associated with submitting a notification package in response to the Order to the Department of the Environment. 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 and conducting assessments. It is assumed that these costs are unlikely to be incurred, given that no significant new activities involving the DSL strains of A. oryzae or P. putida are expected. However, the Order is necessary to ensure that activities that could pose a risk to human health are not undertaken before undergoing an assessment. 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.
Implementation, enforcement and service standards
When assessing whether or not a living organism is subject to the SNAc provisions of CEPA,footnote 16 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 is reasonably expected to 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).
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 and might not include information on microbial hazards. Therefore, an SDS might not list all product ingredients or microbial constituents 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 comes available that reasonably supports the conclusion that any of the living organisms identified in this Order is toxic or capable of becoming toxic, the person who is in possession of the information and is involved in activities with the living 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 takes possession and control of a living organism from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999,footnote 17 provides more detail on this subject.
Any person who transfers physical possession or control of a living organism subject to an Order should notify all persons to whom the physical possession or control is transferred of the obligation to comply with the Order, including the obligation to notify the Minister of any significant new activity and to provide all the required information outlined above.
A pre-notification consultation (PNC) is available for notifiers who wish to consult 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 an Order, or believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances by contacting the Substances Management Information Line. footnote 18
The Order is now in force. Compliance promotion activities that will be conducted as part of implementation of the Order will include the development and distribution of promotional material, responding to inquiries from stakeholders, and undertaking activities to raise industry stakeholders’ awareness of the requirements of the Order.
The Order is made under the authority of CEPA. CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 (the Policy). footnote 19 When verifying compliance with the Order, enforcement officers will apply the Policy and in instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.
The Policy 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 actions based on the following factors:
- Nature of the alleged violation: This factor includes consideration of the damage, the intent of the alleged violation, whether it is a repeat violation, and whether an attempt has been made to conceal information or otherwise subvert the objectives and requirements of CEPA.
- 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 CEPA, willingness to cooperate 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 CEPA.
The Government will assess all information submitted as part of a SNAN and will communicate the result to the notifier 120 days after the complete information is received.
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
819-938-3232 (outside of Canada)
Risk Management Bureau
Department of Health