Vol. 146, No. 21 — October 10, 2012
Registration
SOR/2012-189 September 20, 2012
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2012-1090 September 20, 2012
Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), the Minister of the Environment published in the Canada Gazette, Part Ⅰ, on February 26, 2011, a copy of the proposed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, 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 substance set out in the annexed Order is a toxic substance;
Therefore, His 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 (see footnote c), hereby makes the annexed Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999.
ORDER ADDING A TOXIC SUBSTANCE TO SCHEDULE 1 TO THE CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
AMENDMENT
1. Schedule 1 to the Canadian Environmental Protection Act, 1999 (see footnote 1) is amended by adding the following in numerical order:
126. Hydrazine, which has the molecular formula N2H4
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.)
1. Background
Canadians depend on chemical substances that are used in the manufacture of hundreds of goods, such as medicines, computers, fabrics and fuels. Unfortunately, some chemical substances, such as hydrazine, can have detrimental effects on the environment and/or human health when released into the environment.
Hydrazine, Chemical Abstracts Service Registry Number (CAS RN) (see footnote 2) 302-01-2, is an industrial chemical that was assessed as a high priority on the basis of concern for potential risk to human health. (see footnote 3) Although the presence of hydrazine in the environment is primarily due to human activities, the substance also occurs naturally in algae and in tobacco plants.
According to information submitted in response to a survey published under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), no company manufactured hydrazine in Canada above the reporting threshold of 100 kg in 2006. Based on the same survey, 10 000 to 100 000 kg of hydrazine was imported in the same year. In Canada, 87% of the reported uses for hydrazine in 2006 were as an oxygen scavenger or corrosion inhibitor in the boiler water system of power generating plants.
While hydrazine is used for industrial purposes, it is not identified in consumer products as an ingredient. Hydrazine may also be found as an unintended residual in particular polymers, which may in turn be used in cosmetics, personal care products, natural health products, pharmaceuticals, food packaging materials, food additives and pesticides. Although hydrazine may be a residual in polyvinyl pyrrolidone (PVP), a permitted food additive in Canada, exposure to hydrazine via food is expected to be negligible.
Based on data from the National Pollutant Release Inventory (NPRI) for the period from 2004 to 2008, hydrazine was released mainly into water, primarily from nuclear power generating plants. During this period, between 1 900 and 6 400 kg were released to water annually. Since hydrazine is primarily used in industrial settings, exposure of the general population is expected to be low. Hydrazine is not intentionally added to products, but may be present as a by-product or as a residual of the manufacturing process. Canadians may also be exposed from inhalation of tobacco smoke. Exposure to these sources is expected to be low.
Given its use in power generating plants, hydrazine tends to be dispersed widely in the Canadian environment, where it is demonstrated to have an elevated potential for toxicity to aquatic organisms. Based on measured and modelled concentrations in effluent outfalls, concentrations in surface water near nuclear and fossil-fuel power generating plants across Canada are estimated to be higher than or close to the predicted no-effect concentrations.
Screening assessment under the Chemicals Management Plan
On December 8, 2006, the Chemicals Management Plan (CMP) was announced by the Government of Canada to manage chemicals that are harmful to human health or the environment. A key element of the CMP is the collection of information on the properties and uses of approximately 200 substances, including hydrazine, identified as high priorities for action. This information-gathering initiative is known as the “Challenge.”
Environment Canada and Health Canada have organized the approximately 200 substances into 12 batches, with each batch containing approximately 15 substances. A batch was released every three months and 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. Hydrazine is in the 10th of the 12 batches. Affected parties were 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 — whether the substance is 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.
Based on the information received through the Challenge and other available information, a draft screening assessment for hydrazine was conducted in order to assess whether this substance met the criteria of section 64 of CEPA 1999. The draft screening assessment was peer-reviewed and additional advice was also sought, as appropriate, through the Challenge Advisory Panel. (see footnote 4) The draft screening assessment was then published on the Chemical Substances Web site along with notices published in the Canada Gazette, Part Ⅰ, on June 26, 2010, that signalled the ministers’ intent with regard to further risk management. (see footnote 5)
After considering public comments and new available information, a final screening assessment report was published on the Chemical Substances Web site along with notices that were published in the Canada Gazette, Part Ⅰ, on January 15, 2011. The final screening assessment found that hydrazine may be found in aquatic ecosystems as a result of its release from power plants at concentrations that may be harmful to aquatic organisms. The assessment has concluded that hydrazine meets the criteria 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, combined with the potential for general population exposure, it is also concluded that hydrazine meets the criteria set out in paragraph 64(c) of the Act.
The final screening assessment, the proposed risk management approach document and the responses to comments received on hydrazine may be obtained from the Chemical Substances Web site, or from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec K1A 0H3, 819-953-7155 (fax), substances@ec.gc.ca.
2. Issue
According to the conclusions of the scientific assessment as summarized above, hydrazine constitutes or may constitute a danger in Canada to human life or health at any level of exposure on the basis of carcinogenicity and genotoxicity; it is also found to be harmful or potentially harmful to the environment or its biological diversity because it is widely dispersed in the Canadian environment with the estimated concentrations in surface water higher than or close to the estimated no-effect levels.
Given these assessment conclusions, action should be taken to ensure that control measures are available to the ministers to appropriately manage the risks posed by hydrazine.
3. Objectives
The objective of the Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to enable the ministers to develop risk management instruments under CEPA 1999 to manage human health and environmental risks posed by this substance.
4. Description
The Order adds hydrazine to Schedule 1 of CEPA 1999 (the List of Toxic Substances).
The addition of hydrazine to Schedule 1 of CEPA 1999 allows the ministers to develop 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.
The ministers may, however, choose to develop non-regulatory measures to help protect human health and the environment. The ministers will undertake an assessment of the potential impacts, including an economic analysis, and consult with the public and other stakeholders during the development of these risk management proposals.
5. Consultation
On June 26, 2010, the ministers published a summary of the scientific assessment for hydrazine 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. 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 report on hydrazine, the risk management scope document, and the public comment period noted above. No comments were received from CEPA NAC.
During the 60-day public comment period, 13 submissions were received on the screening assessment report for hydrazine from nine industry stakeholders, three environmental non-governmental organizations (ENGOs), and one industry association. 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 was also subject to a 60-day public comment period.
Below is a summary of comments received on the draft screening assessment of hydrazine 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, or the above-noted address, fax number or email.
Summary of general comments and responses
- Two ENGOs 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 CMP.
Summary of comments and responses specific to hydrazine
- One industry stakeholder commented that a substance which is assessed as having a harmful effect on the environment should be persistent, bioaccumulative and inherently toxic (PBiT) according to the classic understanding of the criteria under paragraph 64(a) of CEPA 1999.
The stakeholder also expressed that the assessment indicates that hydrazine is neither persistent nor bioaccumulative, but recognizes that hydrazine may affect 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 hydrazine may be found in aquatic ecosystems as a result of its release from power plants at concentrations that may be harmful to organisms. - An industry stakeholder indicated that the effluent stream flow rates for thermal and nuclear stations have 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 screening assessment.
In the revised assessment, estimations of effluent flows made for nuclear power generation stations are based on the newly submitted 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 by humans.
Hydrazine may be found as an unintended residual in PVP (not more than one part per million), which has food uses. However, food uses for PVP are limited.
Although hydrazine may be found as an impurity in a coating used to manufacture a 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.
Comments received following publication of the proposed Order in the Canada Gazette, Part Ⅰ
On February 26, 2011, the ministers published a proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 in the Canada Gazette, Part Ⅰ.
No comments were received during the 60-day public comment period.
6. Rationale
Hydrazine is used in Canada mainly as a corrosion inhibitor in boiler water systems of power generating plants. Even though exposure of the general population to hydrazine is expected to be low, releases of hydrazine to the environment from industrial sources do occur.
According to the screening assessment, hydrazine is carcinogenic, and its concentrations in surface water near nuclear and fossil-fuel power generating plants are high enough to cause adverse effects on the environment and its biological diversity. Given these concerns, the screening assessment concludes that hydrazine meets the criteria set out in paragraphs 64(a) and (c) of CEPA 1999.
Three 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);
- taking no further action in respect of the substance; or
- recommending that the substance be added to Schedule 1 of CEPA 1999, and, where applicable, recommending the implementation of virtual elimination.
As hydrazine meets the criteria set out in paragraphs 64(a) and (c) of CEPA 1999, adding hydrazine to Schedule 1 of CEPA 1999, which will enable the development of risk management instruments, is therefore the best option. The addition of hydrazine to Schedule 1 of CEPA 1999 allows the ministers to develop risk management instruments in order to meet the obligations under CEPA 1999.
A proposed Order adding hydrazine to Schedule 1 of CEPA 1999 was published in the Canada Gazette, Part Ⅰ, on February 26, 2011. No concerns were raised by stakeholders on this proposed addition.
The addition of hydrazine to Schedule 1 of CEPA 1999 does not result in any incremental impacts (benefits or costs) on the public or upon industry and small business in terms of compliance or administrative burden since there are no compliance requirements. The ministers will assess costs and benefits and consult with the public and other stakeholders during the development of risk management proposals for the substance.
7. Implementation, enforcement and service standards
The Order adds hydrazine to Schedule 1 to CEPA 1999, thereby allowing the ministers to publish proposed regulations or other management instruments. Developing an implementation plan or a compliance strategy or establishing service standards are not considered necessary, as no specific risk management proposals are made. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed regulations or control instrument(s) respecting preventive or control actions for this substance.
8. Contacts
Greg Carreau
Program Development and Engagement Division
Science and Risk Assessment Directorate
Science and Technology Branch
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca
Markes Cormier
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-8166
Fax: 613-952-8857
Email: markes.cormier@hc-sc.gc.ca
Footnote a
S.C. 2004, c. 15, s. 31
Footnote b
S.C. 1999, c. 33
Footnote c
S.C. 1999, c. 33
Footnote 1
S.C. 1999, c. 33
Footnote 2
The CAS RN is the property of the American Chemical Society. Any use or redistribution, except as required in supporting regulatory requirements, or for reports published by the Government of Canada when the information in such reports is required by law or administrative policy, is not permitted without the prior written permission of the Society.
Footnote 3
Hydrazine is normally purchased in commercial aqueous solutions in which it is generally assumed that the substance is present in its hydrated form. The hydrated form of hydrazine is not considered to be chemically different from the anhydrous substance, but rather is 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.
Footnote 4
The Panel, comprising 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.
Footnote 5
The Chemical Substances Web site is located at www.chemicalsubstanceschimiques.gc.ca/challenge-defi/batch-lot-10/index-eng.php.