ARCHIVED — Vol. 146, No. 21 — October 10, 2012
SOR/2012-187 September 20, 2012
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2012-1088 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 August 6, 2011, a copy of the proposed Order Adding Toxic Substances 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 substances set out in the annexed Order are toxic substances;
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 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 (see footnote 1) is amended by adding the following in numerical order:
125. Polychlorinated naphthalenes, which have the molecular formula C10H8–nCln in which “n” is greater than 1
COMING INTO FORCE
2. This Order comes into force on the day on which it is registered.
(This statement is not part of the Order.)
Canadians depend on chemical substances that are used in hundreds of goods, from medicines to computers, fabrics and fuels. Some substances, such as polychlorinated naphthalenes (PCNs), a subgroup of chlorinated naphthalenes (CNs), can negatively affect the environment when they are released in a certain quantity or concentration. (see footnote 2)
Although PCNs are currently not in commercial use, and have never been manufactured, in Canada, there is a potential for an increase in their presence in the Canadian environment in the future, if they are not properly managed. (see footnote 3) Specifically, PCNs may be produced unintentionally as a byproduct of various industrial processes involving chlorine, especially in the presence of heat. (see footnote 4)
Data on environmental concentrations of PCNs in Canada are limited, but they have been detected in several environmental samples such as in Arctic and urban air, water from Lake Ontario, fish and birds from the Great Lakes and surroundings, seals and whales from the Canadian Arctic, and Vancouver Island marmots. In the Canadian environment, overall, PCN levels still appear to be relatively high, due in part to unintentional releases from industry and the resistance to degradation of these substances. As well, recent scientific studies indicate that PCNs are present in the Arctic and Antarctica, suggesting that these substances are persistent in air and subject to long-range atmospheric transport.
Ecological screening assessment
The Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act) requires that the Minister of the Environment and the Minister of Health (the ministers) categorize the substances on the Domestic Substances List. This categorization exercise was completed in September 2006 and identified the substances (approximately 4 300) requiring screening assessments for potential risks to human health or the environment.
During the categorization exercise, PCNs were identified as a high priority for an ecological screening assessment, as they were found to meet the categorization criteria for persistence, bioaccumulation potential and inherent toxicity to non-human organisms. (see footnote 5) As a result, an ecological screening assessment was conducted, in accordance with section 74 of CEPA 1999, to assess whether CNs (including PCNs) meet the ecological toxicity criteria set out in paragraphs 64(a) and (b) of the Act — specifically, to assess whether PCNs 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; or
- (b) constitute or may constitute a danger to the environment on which life depends.
Ecological toxicity data indicate that PCNs with two to five chlorine atoms may be harmful to aquatic organisms at relatively low concentrations. Also, PCNs with six to eight chlorine atoms have been found to cause harmful effects in mammals after short-term exposure at relatively low doses. Scientific evidence also indicates that all PCNs are highly persistent in the environment and can accumulate in organisms.
Based on the information presently available, it is concluded that PCNs meet the criteria for ecological toxicity set out in paragraph 64(a) of CEPA 1999. PCNs are thus recommended for addition to Schedule 1 to CEPA 1999 (the List of Toxic Substances).
In addition, the presence of PCNs in the environment results primarily from human activity; and these substances are persistent and bioaccumulative, as defined in the Persistence and Bioaccumulation Regulations under CEPA 1999. Hence, PCNs meet the criteria for the implementation of virtual elimination of releases to the environment.
The draft ecological screening assessment regarding CNs was published on the Government of Canada’s Chemical Substances Web site (www.chemicalsubstanceschimiques.gc.ca), as well as in the Canada Gazette, Part Ⅰ, on July 18, 2009, signalling the intent of the ministers to proceed with further risk management action. On July 2, 2011, the following information was published on the Chemical Substances Web site and in the Canada Gazette, Part Ⅰ: the final screening assessment report; the proposed risk management approach, which provides an indication of where the Government of Canada will focus its risk management activities; and the complete responses to public comments received on the draft ecological screening assessment. This information may also be obtained from the Program Development and Engagement Division, Environment Canada, Gatineau, Quebec, K1A 0H3, 819-953-7155 (fax), or by email at email@example.com.
The proposed Order adding PCNs to Schedule 1 to CEPA 1999 was prepublished in the Canada Gazette, Part Ⅰ, on August 6, 2011.
Based on the conclusions of the ecological screening assessment, PCNs may be harmful to the Canadian environment, as they have been shown to have the potential to harm non-human organisms. Although PCNs are no longer manufactured or used in Canada, there is a potential for an increase in their presence in the Canadian environment in the future, if they are not properly managed. Given these conclusions, action is required so that the ministers can appropriately manage the risks posed by PCNs.
The objective of the Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (the Order) is to add PCNs to Schedule 1 to the Act. This addition will enable the ministers to develop instruments under CEPA 1999 to manage the risks posed by PCNs.
The addition of PCNs to Schedule 1 would allow for the risks posed by these substances to be managed under the Prohibition of Certain Toxic Substances Regulations, 2012. (see footnote 6)
The Order adds PCNs to Schedule 1 to CEPA 1999, thereby enabling the ministers to develop regulatory risk management instruments relating to these substances to protect the environment. The ministers may also choose to develop non-regulatory instruments, such as pollution prevention plans, guidelines or codes of practice, in order to manage the environmental risks posed by these substances.
On July 18, 2009, the ministers published a summary of the draft ecological screening assessment report regarding CNs in the Canada Gazette, Part Ⅰ, for a public comment period of 60 days. The risk management scope document was released on the same date, outlining the preliminary options being examined for the management of the risks posed by PCNs. Prior to this publication, Environment Canada and Health Canada informed the governments of the provinces and territories through the National Advisory Committee of CEPA 1999 (CEPA NAC) of the release of the draft ecological screening assessment report and risk management scope document, as well as of the public comment period mentioned above. No comments were received from CEPA NAC.
During the public comment period, a total of three submissions were received from industry associations. All comments were considered in developing the final screening assessment report. Below is a summary of comments received pertaining to the draft report, as well as the responses to these comments. The complete responses to comments received may be obtained at the abovementioned Web site, address, fax number or email address.
- Comment: One chemical industry association observed that some scientific literature indicates that generation of PCNs depends on temperature. In a well-operated cement oven with operating temperatures ranging from 900°C to 1 800°C, it is likely that the PCNs generated will be destroyed within the cement oven itself, and only weakly chlorinated (and less persistent) compounds will be released by cement manufacturing operations, posing little risk to human health or the environment.
Response: PCNs are produced unintentionally as a byproduct of many industrial processes involving chlorine atoms. The amount of PCNs released into the environment from these sources has not been well characterized. The operating temperatures do not destroy all PCNs unintentionally formed during manufacturing processes, and PCNs can still be emitted into the environment. (see footnote 7) Also, in the cement manufacturing process, fine particles are swept along to the facility’s particulate matter control train where cement kiln dust is captured in dust collectors. Cement kiln dust can be problematic if it contains PCNs and is not properly managed. (see footnote 8)
- Comment: One chemical industry association mentioned that the true current balance of naturally occurring versus anthropogenic (man-made) levels of PCNs has not been clearly established; in particular, those quantities arising from non-industrial combustion sources are poorly characterized. Without a clear establishment of this balance, the addition of PCNs — not currently in commercial use in Canada — to Schedule 1 to CEPA 1999 is of questionable value.
Response: The final ecological screening assessment report concluded that PCNs are harmful to the environment as per paragraph 64(a) of CEPA 1999. Although PCNs are not currently in commercial use in Canada, they may be produced unintentionally as a byproduct of industrial processes involving heat and chlorine, such as waste incineration, cement and magnesium production, or the refining of metals such as aluminum. Also, PCNs continue to be detected in a variety of environmental samples over wide areas of Canada because of their historical use and continued unintentional releases. Based on the evidence presented in the screening assessment — particularly the evidence pertaining to persistence, bioaccumulation, and a potential to cause both acute and chronic harm at low exposure values — it has been concluded that these substances have the potential to cause environmental harm in Canada. (see footnote 9) As a consequence, scientific studies are under way to better characterize the unintentional production of PCNs. Proposed risk management options would be based on the results of these studies.
- Comment: One chemical industry association noted that a recent study found an eightfold decline of PCNs in piscivorous (fish-eating) fish in Lake Ontario, which is an indication of a decline of PCN levels in the Canadian environment and Canadian aquatic wildlife. Such downward trends should reduce the weight given to past monitoring data.
Response: Environment Canada acknowledges that concentrations of PCNs in fish tissue are declining, but this decline is species (congener) specific. There is evidence that concentrations in lake trout may still be relatively high. Also, PCN levels in the environment still appear to be relatively high, due in part to unintentional releases (e.g. from incineration, a principal source of concern). A discussion of this issue has been added to the final ecological screening assessment report referenced herein. Finally, PCNs are persistent and bioaccumulative. Hence, the weight given to past monitoring data will not be reduced, as suggested.
Consultation following prepublication of the Order in the Canada Gazette, Part Ⅰ, on August 6, 2011
On August 6, 2011, a proposed Order adding PCNs to Schedule 1 to CEPA 1999 was prepublished in the Canada Gazette, Part Ⅰ, for a public comment period of 60 days. Environment Canada and Health Canada informed the governments of the provinces and territories through CEPA NAC of the publication of the proposed Order and of the associated public comment period. No comments were received from CEPA NAC.
During the public comment period, two submissions were made: one by a non-governmental organization and another by a chemical manufacturer. Below is a summary of the comments received regarding the proposed Order, as well as the responses to these comments.
- Comment: A non-governmental organization advised the federal government to expand the listing to Schedule 1 to CEPA 1999 to include the entire CN group rather than to limit the listing to PCNs (two to eight chlorine atoms).
Response: The proposed listing to Schedule 1 is based on the conclusions of the screening assessment regarding different CN compounds. Based on the evidence collected, it was concluded that monochlorinated naphthalenes (MCNs) are neither persistent nor bioaccumulative and are not subject to long-range transport in the atmosphere. Further, MCNs have never been detected in the environment and are not currently in commercial use in Canada. Accordingly, MCNs are not proposed for listing to Schedule 1.
- Comment: A chemical manufacturer indicated that PCNs with their specific Chemical Abstracts Service Registry Numbers (CAS RNs) should be identified and that, rather than all PCNs being listed as a single entry in Schedule 1 to CEPA 1999, specific PCNs determined to meet the toxicity criteria set out in paragraph 64(a) of the Act should be listed individually in Schedule 1.
Response: The entry described in the proposed Order correctly represents the substances determined to be harmful to the environment as per paragraph 64(a) of the Act. Where appropriate, risk management instruments may list and target specific PCNs, or products or processes that use specific PCNs.
Polychlorinated naphthalenes are not currently in commercial use in Canada; however, if they are not properly managed, there is a potential for an increase in their presence in the Canadian environment in the future. Specifically, these substances are entering the Canadian environment due to unintentional formation and release as a byproduct of various industrial processes. It was concluded in the final screening assessment that PCNs may be harmful to aquatic organisms at relatively low concentrations and to mammals after short-term exposure at relatively low doses. Given these concerns, it was concluded that PCNs meet the criteria for ecological toxicity set out in paragraph 64(a) of CEPA 1999.
The following three measures can be taken after a risk assessment is conducted under CEPA 1999:
- adding the substance to the Priority Substances List for further assessment (when additional information is required to determine whether or not a substance meets the criteria set out in section 64);
- taking no further action in respect of the substance; or
- recommending that the substance be added to Schedule 1 and, where applicable, recommending the implementation of virtual elimination.
Since PCNs meet the criteria for ecological toxicity set out in paragraph 64(a) of CEPA 1999, adding these substances to Schedule 1 to the Act is the best option. The addition of PCNs to Schedule 1 does not result in any incremental impacts (benefits or costs) on the public or other stakeholders, with no additional administrative or compliance burden to be incurred by any industry or small business. This addition will enable the ministers to manage the risks associated with PCNs by means of the Prohibition of Certain Toxic Substances Regulations, 2012, which were prepublished in the Canada Gazette, Part Ⅰ, on July 23, 2011. During the finalization of the Prohibition of Certain Toxic Substances Regulations, 2012, consultations with the public and other stakeholders, and an assessment of the benefits and costs associated with these Regulations, will be undertaken.
7. Implementation, enforcement and service standards
The implementation of the Order does not require any new compliance or enforcement activities to be undertaken. Thus, developing an implementation plan or a compliance strategy, or establishing service standards, is not necessary. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of the Prohibition of Certain Toxic Substances Regulations, 2012.
Program Development and Engagement Division
Science and Risk Assessment Directorate
Science and Technology Branch
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
CNs have the molecular formula C10H8-nCln. Monochlorinated naphthalenes contain a single chlorine atom (n is equal to one), while PCNs contain two to eight chlorine atoms (n is greater than one, but less than nine).
Only one firm reported importing PCNs into Canada (for laboratory use), according to responses to a voluntary industry survey; these imports started in 2000 and ended in 2002.
These processes include waste incineration, cement and magnesium production, and the refining of metals. Other sources of PCNs in the environment include products containing these substances that have been disposed of in landfill sites or old industrial sites where these substances were used. PCNs can also be released into the atmosphere from domestic wood-burning or naturally during forest fires.
Although monochlorinated naphthalenes (MCNs) may be harmful to aquatic organisms at relatively low concentrations, they have not been detected in the environment in Canada. Available evidence also indicates that MCNs are neither bioaccumulative nor persistent in the environment. Therefore, MCNs are not expected to pose a risk to the environment in Canada.
Prohibition of Certain Toxic Substances Regulations, 2012, Canada Gazette, Part Ⅰ (July 23, 2011): www.gazette.gc.ca/rp-pr/p1/2011/2011-07-23/html/reg1-eng.html.
Existing Canadian guidelines and standards target other unintentionally-formed toxic substances, such as polychlorinated dibenzo-para-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs). PCNs exhibit similar formation pathways as PCDDs and PCDFs; as a result, PCNs are often associated with the formation of these substances. Hence, existing measures to control the unintentional release of PCDDs or PCDFs are believed to also partially control the unintentional release of PCNs in some sectors.
As indicated in the proposed risk management approach for PCNs, cement kiln dust is managed either through its reintroduction into cement products or through its disposal at licensed waste facilities. No further risk management action is proposed for the cement manufacturing sector with respect to PCNs.
In addition, in December 2009, the executive body of the United Nations Economic Commission for Europe (UNECE) adopted amendments to the Protocol on Persistent Organic Pollutants (POPs), including the addition of PCNs to this Protocol, which is an extension of the UNECE Convention on Long-range Transboundary Air Pollution. Assuming that these amendments are ratified, the amendment adding PCNs will require Parties to the Protocol on POPs to eliminate all production and use of these substances. The addition of PCNs to Schedule 1 to CEPA 1999, as well as the subsequent management of the risks posed by these substances through the Prohibition of Certain Toxic Substances Regulations, 2012, will allow the Government of Canada to consider the ratification of the amendment to the Protocol on POPs concerning PCNs.