Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999: SOR/2019-115
Canada Gazette, Part II, Volume 153, Number 10
SOR/2019-115 May 6, 2019
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
P.C. 2019-415 May 3, 2019
Whereas, pursuant to subsection 332(1) footnote a of the Canadian Environmental Protection Act, 1999 footnote b, the Minister of the Environment published in the Canada Gazette, Part I, on June 17, 2017, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Order or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection;
And whereas, pursuant to subsection 90(1) of that Act, the Governor in Council is satisfied that the substances set out in the annexed Order are toxic substances;
Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of the Canadian Environmental Protection Act, 1999 footnote b, makes the annexed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
1 Schedule 1 to the Canadian Environmental Protection Act, 1999 footnote 1 is amended by adding the following in numerical order:
- 147 Benzene, 1,1′-methylenebis[4-isocyanato-, which has the molecular formula C15H10N2O2
- 148 Benzene, 1,1′-methylenebis[2-isocyanato-, which has the molecular formula C15H10N2O2
- 149 Benzene, 1-isocyanato-2-[(4-isocyanatophenyl)methyl]-, which has the molecular formula C15H10N2O2
- 150 Benzene, 1,1′-methylenebis[isocyanato- (non-isomeric-specific), which has the molecular formula C15H10N2O2
- 151 Isocyanic acid, polymethylenepolyphenylene ester, which has the molecular formula C15H10N2O2•[C8H5NO]n in which 0≤n≤4
Coming into Force
2 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) completed a screening assessment on five Methylenediphenyl Diisocyanate (MDI) substances, hereafter referred to as “the five MDIs” and determined that the five MDIs meet the human health criterion for toxicity as set out in paragraph 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). footnote 2 Therefore, the Government is adding the five MDIs to the List of Toxic Substances in Schedule 1 of CEPA. The five substances are as follows:
- 1. Benzene, 1,1′-methylenebis[4-isocyanato- (Chemical Abstracts Service Registry Number [CAS RN] 101-68-8), known as “4,4′-MDI”;
- 2. Benzene, 1,1′-methylenebis[2-isocyanato- (CAS RN 2536-05-2), known as “2,2′-MDI”;
- 3. Benzene, 1-isocyanato-2-[(4-isocyanatophenyl)methyl]- (CAS RN 5873-54-1), known as “2,4′-MDI”;
- 4. Benzene, 1,1′-methylenebis[isocyanato- (non-isomeric-specific) (CAS RN 26447-40-5), known as “mixed MDI”; and
- 5. Isocyanic acid, polymethylenepolyphenylene ester (CAS RN 9016-87-9), known as “pMDI.”
The Chemicals Management Plan (CMP) was launched by the Government in 2006 to assess and manage chemical substances that may be harmful to human health or the environment in Canada. Under the CMP, the five MDIs were identified as priorities for action, as they either met the categorization criteria set out in section 73 of CEPA footnote 3 or were considered as priorities for assessment based on human health concerns.
Substances description and sources of release
Based on information collected in response to a mandatory survey carried out in June 2012 under section 71 of CEPA (Notice with respect to certain methylenediphenyl diisocyanate and diamine, and phenol, methyl- substances), industry stakeholders submitted data to the Government on the activities and uses related to the five MDIs. The five MDIs were reported to be used in the manufacturing of flexible and rigid polyurethane foam, elastomers, coatings, adhesives and sealants, which are then used in construction, the automotive sector and the manufacturing of furniture as well as in Do-It-Yourself (DIY) products. The use of the five MDIs was also reported in the manufacturing of items such as oriented strand board (OSB), particle board and other wood products that are produced in Canada for further use in construction. There were no reports of the five MDIs being manufactured above the reporting threshold of 100 kg per year. However, the combined quantity of the substances imported into Canada in 2011 was in the range of 10 million to 100 million kilograms.
The five MDIs are primarily released to air through industrial use in the manufacture of polyurethane and OSB or engineered wood products. However, inhalation of the five MDIs can also result from the use of DIY products in construction projects.
Existing Canadian and international risk management activities
Existing risk management actions targeting MDIs in Canada are mostly related to the industrial use of the substances, which includes their presence in ambient air and tracking releases to the environment. For example, at the federal level, 4,4′-MDI and polymeric MDI are substances reportable to the National Pollutant Release Inventory. Further, the Hazardous Products Regulations established under the Hazardous Products Act require that 4,4′-MDI be disclosed on the Safety Data Sheet (a document that contains information on the potential hazards and how to work safely with the chemical product) that must accompany workplace chemicals when they are present at a concentration of 0.1% or higher.
Internationally, a number of assessment and management actions are being undertaken in other jurisdictions. In the United States, MDIs are part of the Toxic Substances Control Act Action Plan and options are being considered to address the potential health risks. MDIs are also subject to California’s Safer Consumer Products Regulations and performance standards under the federal Clean Air Act. MDIs are substances reportable to Australia’s National Pollutant Inventory. MDIs are also identified as substances that pose a health risk in several countries in the European Union. footnote 4
Screening assessment summary
The Government conducted a screening assessment to determine if the five MDIs meet one or more of the criteria for a toxic substance as set out in section 64 of CEPA. Specifically, this involves determining whether the five MDIs 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.
Human health assessment
The risk to human health associated with exposure to the five MDIs includes cancer, respiratory problems, and dermal (skin) sensitization, based on the collective information and classifications by other international regulatory agencies. The European Commission has classified MDIs as Category 1 respiratory sensitizers and Category 1 skin sensitizers. footnote 5 Animal laboratory studies, human case reports and epidemiological studies all indicate that the five MDIs are associated with sensitization of the respiratory tract.
The potential risk to human health from exposure to the five MDIs was evaluated by comparing the concentration levels at which the five MDIs become a hazard to human health (including carcinogenicity) to the estimated current level of exposure of the general population of Canada. footnote 6
A potential source of exposure to the five MDIs is inhalation of ambient air for the general population residing in the vicinity of industrial sites (e.g. wood product manufacturing plants using MDIs). Another potential source of exposure to the five MDIs for the general population of Canada is the use of DIY products (e.g. low-pressure two-component spray polyurethane foam, one-component foam sealant, and polyurethane sealant). Exposure to these products is short-term and may occur through inhalation and dermal routes.
It was estimated that the application of low-pressure two-component spray polyurethane foam products by homeowners for insulation and sealing may result in levels of inhalation that could pose a danger to human health. For all other uses, including one component spray foams and adhesives, it was determined that exposure levels are low enough that they do not pose any human health concern.
Based on the estimated levels of exposure to the five MDIs from certain DIY products, and the associated risks to human health, the screening assessment concluded that the five MDIs meet the criterion set out in paragraph 64(c) of CEPA.
The five MDIs belong to a highly reactive class of chemicals. They are known to hydrolyze quickly and, as a result, have only a brief existence in environmental media such as water or soil, where a degree of moisture is typically present. For this reason, it is considered that the five MDIs tend not to be present in appreciable concentrations in the environment for prolonged periods of time; they are therefore not available for uptake by non-human organisms and are very unlikely to biomagnify in aquatic or terrestrial food webs. Available empirical evidence in fish from exposure to 4,4′-MDI over 28 days suggests that the five MDIs do not bioaccumulate in fish either. In addition, ecotoxicity studies were available for various aquatic organisms along with a soil invertebrate (the earthworm) and two plant species. For all studies, very low toxicity was observed in organisms based on a short-term exposure to the five MDIs.
Based on the empirical ecotoxicity data and levels of exposure in various environmental compartments (i.e. air, water, soil and sediment), it was determined that at current concentration levels, the five MDIs are unlikely to cause harm to aquatic, benthic or soil-dwelling organisms or terrestrial wildlife. Considering all available lines of evidence presented in the screening assessment, it is concluded that the five MDIs do not meet the environmental criteria set out in paragraphs 64(a) and (b) of CEPA.
On June 10, 2017, the final screening assessment report for the five MDIs was published on the Government’s Chemical Substances website. On June 17, 2017, the proposed Order recommending the addition of the five MDIs to Schedule 1 of CEPA was published in the Canada Gazette, Part I. footnote 7
The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 is to enable the Government to propose risk management activities for a toxic substance under CEPA to manage potential risks to human health associated with the five MDIs.
The Order adds the five MDIs to Schedule 1 of CEPA.
The “One-for-One” Rule does not apply, as the Order does not impose any administrative burden on business.
Small business lens
The small business lens does not apply, as the Order does not impose any compliance or administrative costs on small business.
On August 16, 2014, the Government published a summary of the draft screening assessment for the five MDIs in the Canada Gazette, Part I, for a 60-day public comment period. During the 60-day public comment period, a total of 10 submissions were received from four industry stakeholders, four industry associations, one non-governmental organization and one research institute on the screening assessment for the substances. These comments were considered in developing the final screening assessment report but did not change the conclusion that the five MDIs meet the human health toxicity criterion under paragraph 64(c) of CEPA, but not the environmental toxicity criteria under paragraphs 64(a) and (b) of CEPA.
A table summarizing the complete comments received and the Government’s responses is available on the Government’s Chemical Substances website.
On June 17, 2017, the proposed Order recommending the addition of the five MDI substances to Schedule 1 of CEPA was published in the Canada Gazette, Part I, for a 60-day public comment period, which included a summary of the comments received on the draft screening assessment and the Government’s responses. During the 60-day public comment period for the proposed Order, one set of comments was received.
An industry stakeholder inquired about the format of the listing for the five MDI substances wondering if it would be a group listing that would cover all MDIs or if each of the five distinct MDI substances would be added to Schedule 1 of CEPA. The Government responded that the Order is adding each of the five distinct MDI substances to Schedule 1 of CEPA (i.e. each of the five substances will receive its own listing).
The industry stakeholder was also concerned about the clarity of identification of the substances added to Schedule 1 of CEPA, specifically for two of the entries (mixed MDI and pMDI as identified in the “Issues” section of this document). It was suggested that the proposed entries, although accurate, could be mistakenly confused for other substances and that these entries should be presented in a clear and understandable fashion for both the general and regulated community. It was also suggested that CAS RN and/or common name be used in the Schedule 1 entry to avoid any confusion.
The Government responded that it will add clarity to the listing name of one of the substances (substance mixed MDI as identified in the “Issues” section). No modifications were deemed necessary for the other substance name. In general, Government officials are confident that the listing names, which combine both the chemical name and molecular formula, are sufficiently precise to correctly identify the substances.
Prior to these publications, the Department of the Environment and the Department of Health informed the governments of the provinces and territories, through the CEPA National Advisory Committee (NAC), of the release of this document and of the related public comment period. No comments were received from CEPA NAC. footnote 8
There is evidence that the five MDIs pose a number of human health risks, including skin irritation, respiratory problems, and cancer risk. A number of DIY products contain the five MDIs. Users of these products can be exposed to the five MDIs at levels which could pose a risk to their health. Therefore, it is concluded that the five MDIs meet the toxicity criterion set out in paragraph 64(c) of CEPA as they are entering the environment under conditions that may constitute a danger in Canada to human health.
One of the following measures must be proposed after a screening assessment is conducted under CEPA:
- 1. taking no further action under CEPA with respect to the substance;
- 2. adding the substance to the Priority Substances List for further assessment; or
- 3. recommending that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA, and where applicable, recommending the implementation of virtual elimination.
Considering all available lines of evidence presented in the screening assessment, it is concluded that the five MDIs pose a risk to human health. The Government determined that choosing options 1 or 2 is not appropriate to manage potential human health risks associated with the five MDIs. Therefore, option 3, which recommends that the five MDIs be added to the List of Toxic Substances in Schedule 1 of CEPA, is the option chosen by the Government. footnote 9
The addition of the five MDIs to Schedule 1 of CEPA does not result in any incremental impacts (benefits or costs) on the public or industry, since the Order in itself does not impose any compliance requirement or administrative burden on stakeholders. Rather, the Order is an enabling instrument, which allows the Government to propose risk management activities for a toxic substance under CEPA to the five MDIs.
If the taking of risk management measures is deemed necessary for the five MDIs, the Government will consider the costs and benefits and consult with the public and other stakeholders during the development of risk management measure to address potential human health concerns associated with uses of the five MDIs in Canada.
In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a Strategic Environmental Assessment (SEA) was completed under the CMP. The detailed analysis that was completed as part of the SEA indicated that the CMP will have a positive effect on the environment and human health.
Implementation, enforcement and service standards
The Order adds the five MDIs to Schedule 1 of CEPA, thereby enabling the Government to propose regulations or instruments respecting preventive or control actions for a toxic substance. As developing an implementation plan, an enforcement strategy, or establishing service standards are only considered necessary when there is a specific risk management proposal, these measures are not necessary for this Order.
Program Development and Engagement Division
Department of the Environment
Substances Management Information Line:
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