SOR/2016-159: Domestic Substances List — Order 2016-112-21-01 Amending Canadian Environmental Protection Act, 1999
REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE
June 23, 2016
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... (Click for more)
Published on June 23, 2016
SOR/2016-159: Domestic Substances List — Order 2016-112-21-01 Amending Canadian Environmental Protection Act, 1999
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: 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 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. 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: [email protected] 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: [email protected] Footnote a SOR/94-311 Footnote b S.C. 1999, c. 33 Footnote c S.C. 1999, c. 33 Footnote 1 SOR/94-311 Footnote 2 The screening assessment of Pseudomonas fluorescens can be found at http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=734A97DA-1. Footnote 3 ATCC stands for American Type Culture Collection. Footnote 4 SOR/94-311 Footnote 5 A definition of micro-organisms can be found in subsection 1(1) of the New Substances Notification Regulations (Organisms) under the Canadian Environmental Protection Act, 1999 (CEPA) at http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-248/. Footnote 6 The definition of significant new activities in regard to micro-organisms can be found in section 104 of CEPA at http://laws-lois.justice.gc.ca/eng/acts/C-15.31/page-15.html. Footnote 7 More information on the prioritization of micro-organisms listed on the DSL can be found at http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=19B91106-1. Footnote 8 For more information on the CMP, please visit http://www.chemicalsubstanceschimiques.gc.ca/index-eng.php. Footnote 9 Any P. fluorescens strain other than the DSL strain of P. fluorescens is subject to the New Substances Notification Regulations (Organisms) before they can be imported into or manufactured in Canada. For more information, please see http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-248/. Footnote 10 For more information on the human health and environmental assessment, please see the screening assessment of Pseudomonas fluorescens on the Chemical Substances Web site. Footnote 11 The policy on the use of Significant New Activity provisions is available at http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=5CA18D66-1. Footnote 12 Microbial based products are not expected to meet the criteria for disinfectants or sanitizers as per Health Canada’s Guidance document-Disinfectant drugs. Please find the Guidance at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/disinfect-desinfect/disin_desin-eng.php. Footnote 13 For additional information, please see the Guidelines for the Notification and Testing of New Substances (Organisms) at http://publications.gc.ca/site/eng/9.632217/publication.html. Footnote 14 The New Substances Notification Regulations (Organisms) are available at http://laws-lois.justice.gc.ca/eng/regulations/SOR-2005-248/index.html. Footnote 15 For more information on the Notice of Intent, please see http://canadagazette.gc.ca/rp-pr/p1/2015/2015-02-14/pdf/g1-14907.pdf. Footnote 16 For more information, please visit the Chemical Substances Web site at http://www.chemicalsubstanceschimiques.gc.ca/. Footnote 17 Formerly “Material Safety Data Sheet” (MSDS). Please refer to the Regulations amending the New Substances Notification Regulations (Chemicals and Polymers) and the Export of Substances on the Export Control List Regulations for reference to this amendment (http://gazette.gc.ca/rp-pr/p2/2015/2015-02-11/html/sor-dors19-eng.php). Footnote 18 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 is available at http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=CC526AE6-1. Footnote 19 The Substances Management Information Line can be contacted at [email protected] (email), 1-800-567-1999 (toll free in Canada), 819-953-3232 (outside of Canada). Footnote 20 The Compliance and Enforcement Policy is available at https://www.ec.gc.ca/alef-ewe/default.asp?lang=en&n=AF0C5063-1.
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