Vol. 145, No. 9 — February 26, 2011
ARCHIVED — Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
Canadian Environmental Protection Act, 1999
Department of the Environment and Department of Health
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Order.)
Issue and objectives
Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics, and fuels. Unfortunately, some chemical substances can negatively affect our health and the environment when released in a certain quantity or concentration in the environment. Scientific assessments of the impact of human and environmental exposure have determined that a number of these substances constitute or may constitute a danger to human health or to the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999).
The objective of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the proposed Order), made under subsection 90(1) of CEPA 1999, is to add the following substance to the List of Toxic Substances in Schedule 1 to CEPA 1999:
- Hydrazine (Chemical Abstracts Service [CAS] Registry Number [RN] (see footnote 1) 302-01-2)
This addition enables the development of regulatory risk management proposals for this substance under CEPA 1999. The Ministers may, however, choose to develop non-regulatory instruments to manage human health and environmental risks posed by this substance.
Description and rationale
Approximately 23 000 substances (often referred to as “existing” substances) were in use in Canada between January 1, 1984, and December 31, 1986. These substances are found on the Domestic Substances List (DSL), but many of them have never been assessed as to whether they meet any of the criteria set out in section 64 of CEPA 1999. Section 73 of CEPA 1999 requires that substances on the DSL be categorized to determine which of them pose the greatest potential for exposure to the general population. Categorization also determines which of these substances are persistent or bioaccumulative in accordance with the Regulations and inherently toxic to human beings or to non-human organisms. Pursuant to section 74 of CEPA 1999, substances that were flagged during the categorization process must undergo an assessment to determine whether they meet any of the criteria set out in section 64 of CEPA 1999. Assessments may also be conducted under section 68 of CEPA 1999 for substances identified as high priorities for action, but which do not meet the categorization criteria set out under section 73 of CEPA 1999.
The Minister of the Environment and the Minister of Health (the Ministers) completed the categorization exercise in September 2006. Of the approximately 23 000 substances on the DSL, about 4 300 were identified as needing further attention.
As a result of categorization, the Chemicals Management Plan (the Plan) was launched on December 8, 2006, with the objective of enhancing the protection against hazardous chemicals.
A key element of the Plan is the collection of information on the properties and uses of approximately 200 substances identified as high priorities for action. This includes substances
- that were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms, and that are known to be in commerce, or of commercial interest, in Canada; these substances are considered to be high priorities for assessment of ecological risk; and/or
- that were found either to meet the categorization criteria for greatest potential for exposure of Canadians or to present an intermediate potential for exposure, and were identified as posing a high hazard to human health based on available evidence on carcinogenicity, mutagenicity, developmental toxicity or reproductive toxicity; these substances are considered to be high priorities for assessment of risk to human health.
This information is being used to make decisions regarding the best approaches to be taken in order to protect Canadians and their environment from the risks these substances might pose. This information-gathering initiative is known as the “Challenge.”
To facilitate the process, Environment Canada and Health Canada have organized the approximately 200 substances into 12 “batches” of approximately 15-19 substances. A batch was released every three months between 2007 and 2009. Stakeholders were required to report information such as quantities imported, manufactured or used in Canada via a mandatory survey issued under section 71 of CEPA 1999. Affected parties are required to submit this information to better inform decision making, including determining whether a substance meets one or more of the criteria set out in section 64 of CEPA 1999 — that is to say, whether the substance is entering or may enter the environment in a quantity or concentration or under conditions that
- have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- constitutes or may constitute a danger to the environment on which life depends; or
- constitutes or may constitute a danger in Canada to human life or health.
Based on the information received and other available information, screening assessments are conducted in order to assess whether substances meet one or more of the criteria of section 64. The screening assessments are peer-reviewed and additional advice is also sought, as appropriate, through the Challenge Advisory Panel. The Panel, made up of experts from various fields such as chemical policy, chemical production, economics and environmental health, was formed to provide advice to the Government on the application of precaution and weight of evidence to screening assessment in the Challenge. The screening assessments are then published on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca along with notices that are published in the Canada Gazette, Part I, that signal the Ministers’ intent with regard to further risk management.
The Minister of the Environment is required under section 91 of CEPA 1999 to publish in the Canada Gazette a proposed regulation or other instrument establishing preventive or control actions within two years of publishing a statement under paragraph 77(6)(b) of CEPA 1999 indicating that the measure the Ministers propose to take, as confirmed or amended, is a recommendation that the substance be added to the List of Toxic Substances in Schedule 1 of CEPA 1999. Section 92 then requires that the regulation or other instrument be finalized and published within 18 months following the publication in the Canada Gazette, Part I.
The addition of a substance to Schedule 1 of CEPA 1999 allows the Ministers to develop risk management instruments in order to meet the obligations under CEPA 1999 (develop proposed regulation or other instrument within two years and a final instrument 18 months later). CEPA 1999 enables the development of risk management instruments (such as regulations, guidelines or codes of practice) to protect human health and the environment. These instruments can be developed for any aspect of the substance’s life cycle from the research and development stage through manufacture, use, storage, transport and ultimate disposal or recycling. A proposed risk management approach document, which provides an indication of where the Government will focus its risk management activities, has been prepared for hydrazine and is available on the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php.
The draft screening assessments for the tenth batch of the Challenge comprising 13 substances (see footnote 2) were published on the Chemical Substances Web site, and the statement recommending addition to Schedule 1 for hydrazine was published in the Canada Gazette, Part I, on June 26, 2010, for a 60-day public comment period (reference Web site listed above).
Of the 13 substances assessed in Batch 10, hydrazine has been concluded to meet paragraph 64(a) of CEPA 1999 as it is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. Also, it has been concluded that hydrazine met the criteria set out in paragraph 64(c) of CEPA 1999 as it constitutes or may constitute a danger to human life or health.
A summary of the assessment and conclusion and an overview of the public comments received during the public comment period on the draft assessment report regarding hydrazine are presented below.
Substance description, assessment summary and conclusion
Hydrazine is normally purchased in aqueous solution. It is generally assumed that in commercial aqueous solutions of hydrazine, all the hydrazine is present as the hydrate. The hydrated form is not considered to be chemically different from the anhydrous substance, but can be considered to represent a mixture of the substance with water. Therefore, hydrazine and hydrazine hydrate were assessed as the same substance in the draft and final screening assessments.
Hydrazine could occur naturally in algae and in tobacco plants, although its presence in the environment is primarily due to human activities. Hydrazine is also formed during the combustion of tobacco products.
In Canada, hydrazine was mainly used (87% of the usage) as an oxygen scavenger or corrosion inhibitor in the boiler water system of power generating plants. As hydrazine was used for industrial purposes, it was not identified in consumer products as an ingredient. However, hydrazine may be found in final consumer products, such as cosmetics, licensed natural health products, pharmaceutical products, and pesticides, as a residual at very low level when it was used as a raw or an intermediate material in the production of these consumer products. In addition, as hydrazine is a residual in the polymer polyvinylpyrrolidone (PVP) which is a permitted food additive in Canada, trace amounts of hydrazine may be present in food as a result of the use of PVP. Nevertheless, exposure to hydrazine via food is expected to be negligible.
According to submissions received under section 71 of CEPA 1999, there is no indication that any company manufactured hydrazine in Canada in quantities above the reporting threshold of 100 kg in 2006. Based on the same submissions, hydrazine was reported to have been imported to Canada in the range of 10 000 kg to 100 000 kg in the same reporting year.
Based on data from the National Pollutant Release Inventory (NPRI), hydrazine was released mainly into water primarily from nuclear facilities and fossil-fuelled power generating plants between 2004 and 2008.
As hydrazine is mainly used for industrial purposes in Canada, the general population is not expected to be exposed to hydrazine as a result of these uses. Also, exposure of the general population to products containing residual quantities of hydrazine is predicted to be low.
Hydrazine was assessed as a high priority on the basis of concern for potential risk to human health. Based principally on the weight-of-evidence-based assessment of international or other national agencies (U.S. Environmental Protection Agency, International Agency for Research on Cancer, U.S. National Toxicology Program, and European Chemical Substances Information System), a critical effect for the characterization of risk to human health from hydrazine is carcinogenicity. Increased incidences in tumour and genotoxicity were observed in long-term bioassays in rodents.
Given its use in power generating plants, this substance tends to be dispersed widely in the Canadian environment. In some cases, concentrations in surface water near nuclear and fossil-fuel power generating plants across Canada, estimated based on measured and modelled concentrations in effluent outfalls, are higher than or close to the estimated level at which no harm is expected for aquatic organisms.
The levels of hydrazine reached in aquatic ecosystems as a result of its release from power plants exceed the levels that are considered safe for aquatic organisms. Therefore, the final risk assessment has concluded that hydrazine is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends as set out in paragraph 64(a) of CEPA 1999.
On the basis of carcinogenicity, for which there is a probability of harm at any level of exposure, it is concluded that hydrazine may be entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999. Hydrazine is thus proposed to be recommended for addition to Schedule 1 to CEPA 1999.
The final screening assessment report, the proposed risk management approach document and the complete responses to comments received on hydrazine were published on January 15, 2011, and may be obtained from the Chemical Substances Web site at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php, or from the Program Development and Engagement Division, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), or by email at firstname.lastname@example.org.
The following measures can be taken after an assessment is conducted under CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine if a substance meets the criteria in section 64 or not);
- taking no further action in respect of the substance; or
- recommending that the substance be added to the List of Toxic Substances in Schedule 1, and where applicable, recommending the implementation of virtual elimination.
It has been concluded in the draft screening assessment report that hydrazine is entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity as set out in paragraph 64(a) of CEPA 1999. It was also concluded that hydrazine is entering, or may enter, the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health as set out in paragraph 64(c) of CEPA 1999. Adding hydrazine to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
Benefits and costs
Adding hydrazine to Schedule 1 enables the Ministers to develop risk management proposals for this substance under CEPA 1999, which may be regulatory and/or non-regulatory (such as pollution prevention plans, environmental emergency plans, guidelines, codes of practice or regulations), to help protect human health and the environment. The Ministers will assess costs and benefits and consult with the public and other stakeholders during the development of these risk management proposals.
On June 26, 2010, the Ministers published a summary of the scientific assessment for the 13 substances of Batch 10 in the Canada Gazette, Part I, for a 60-day public comment period. A risk management scope document was also released on the same date, outlining the preliminary options being examined for the management of hydrazine proposed to be toxic under section 64 of CEPA 1999. Prior to this publication, Environment Canada and Health Canada had informed the governments of the provinces and territories through the CEPA National Advisory Committee (NAC) of the release of the Screening Assessment reports on the 13 substances, the risk management scope document, and the public comment period mentioned above. No comments were received from CEPA NAC.
During the 60-day public comment period, a total of 13 submissions were received from 9 industry stakeholders, 3 environmental non-governmental organizations (NGOs), and 1 industry association on the screening assessment report for hydrazine. All comments were considered in finalizing the screening assessment.
Comments were also received on the risk management scope document for hydrazine. These were considered when developing the proposed risk management approach document, which is also subject to a 60-day public comment period.
Below is a summary of some key comments received on the hydrazine assessment and new comments relevant to the overall process, as well as their responses. In cases where comments have been made concerning whether or not hydrazine meets the criteria of section 64 of CEPA 1999 due to the lack of information or uncertainty, the Government has indicated that it will proceed to take precautionary action to protect the health of Canadians and their environment. The complete responses to comments documents are available via the Government of Canada’s Chemical Substances Web site, address, fax number or email listed above.
Summary of general comments and responses
Two environmental NGOs commented that exposure estimates need to be more thorough, using information derived through environmental monitoring. Similarly, in assessments where there is a high degree of reliance on modelling rather than empirical data, long-term monitoring data should be used to validate the conclusions.
Response: The screening assessments are based on available data. Canadian monitoring data are often not available for substances at the time of assessment; however, when monitoring data are available, this information is considered in determining exposure estimates. In addition, future monitoring may be used to support verification of assumptions used during the screening assessment phase. Monitoring and surveillance for specific substances in the environment will be considered under a comprehensive monitoring and surveillance strategy under the Chemicals Management Plan.
Summary of comments and responses specific to hydrazine
An industry stakeholder commented that in the classic understanding of the criteria of harmful to the environment under CEPA 1999, a substance should be persistent, bioaccumulative, and inherently toxic (PBiT). The assessment indicates that hydrazine is neither persistent nor bioaccumulative, but recognizes that hydrazine may impact the ecosystem. When the overly conservative nature of the models is considered and when applying the precautionary principle, a negative impact on an ecosystem can be questioned.
Response: A substance may be determined to be harmful to the environment under CEPA 1999 without necessarily meeting the criteria for persistence and bioaccumulation in accordance with the Persistence and Bioaccumulation Regulations. Hydrazine is concluded to be harmful to the environment under CEPA 1999 because the levels of hydrazine reached in aquatic ecosystems as a result of its release from power plants are close to or exceed the levels that are considered safe for organisms.
An industry stakeholder indicated that the effluent stream flow rates for thermal and nuclear stations had been largely underestimated.
Response: The underestimation of the effluent stream flow rates for exposure characterization is recognized and the new information submitted has been considered in the final risk assessment.
In the revised assessment, estimations of effluent flows made for nuclear power generation stations are based on the factual information, which is supported by statistics on water use for electric power generation generated by Statistics Canada, and a similar approach is taken for fossil-fuel power generating stations.
An industry stakeholder commented that exposure to hydrazine may result from drug and/or food applications.
Response: Food, food packaging and pharmaceuticals were reported in the assessment as unlikely to be a significant source of hydrazine exposure.
Hydrazine is not known to occur naturally in food. Although it may become concentrated in some fish living in contaminated water, the substance is quickly digested and excreted.
Hydrazine may be found in the polymer PVP (not more than one part per million), which has food uses. However, food uses for PVP are limited.
Although hydrazine is an impurity in a coating used to manufacture one laminated film used to package a variety of foods, because of its physico-chemical properties and its highly reactive nature, the substance is not expected to remain in the finished product.
Implementation, enforcement and service standards
The proposed Order would add hydrazine to Schedule 1 of CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other management instruments no later than December 26, 2012, and finalize them no later than June 26, 2013. Developing an implementation plan, a compliance strategy or establishing service standards are not considered necessary without any specific risk management proposals. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of a proposed regulation or control instrument respecting preventive or control actions for this substance.
Program Development and Engagement Division
Substances Management Information Line
Telephone: 1-800-567-1999 (toll-free in Canada)
Telephone: 819-953-7156 (outside of Canada)
Risk Management Bureau
PROPOSED REGULATORY TEXT
Notice is hereby given, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), that the Governor in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 90(1) of that Act, proposes to make the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
Any person may, within 60 days after the date of publication of this notice, file with the Minister of the Environment comments with respect to the proposed Order or a notice of objection requesting that a board of review be established under section 333 of that Act and stating the reasons for the objection. All comments and notices must cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent by mail to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819-953-7155 or by email to email@example.com.
A person who provides information to the Minister of the Environment may submit with the information a request for confidentiality under section 313 of that Act.
Ottawa, February 10, 2011
Assistant Clerk of the Privy Council
ORDER ADDING A TOXIC SUBSTANCE TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 3) is amended by adding the following:
Hydrazine, which has the molecular formula N2H4
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.
An additional substance, cobalt sulfate (CAS No. 10393-49-4), was added to the Notice with respect to Batch 10 Challenge substances and was assessed concurrently with other Batch 10 substances.
S.C. 1999, c. 33