Vol. 145, No. 21 — October 12, 2011
SOR/2011-212 September 30, 2011
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999
P.C. 2011-1117 September 29, 2011
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 September 20, 2008, a copy of the proposed Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999, 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 (voir référence 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:
120. Chlorinated alkanes that have the molecular formula CnHxCl(2n+2–x) in which 10 ≤ n ≤ 20
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.)
Issue and objectives
Canadians depend on chemical substances that are used in the manufacturing of hundreds of goods, from medicines to computers, fabrics and fuels. Unfortunately, some chemical substances can negatively affect our health and environment when released in a certain quantity or concentration or under certain conditions 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 life and/or to the environment as per the criteria set out under section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act).
The Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 (hereinafter referred to as the Order) made pursuant to subsection 90(1) of CEPA 1999 adds chlorinated alkanes with 10 to 20 carbon atoms inclusively to the List of Toxic Substances in Schedule 1 to CEPA 1999.
This addition enables the development of regulatory instruments for this substance under CEPA 1999. The Minister of the Environment and the Minister of Health (the Ministers) may, however, choose to develop non regulatory instruments to manage human health and environmental risks posed by these substances.
Description and rationale
Chlorinated alkanes were previously identified as chlorinated paraffins. The use of the term paraffins to identify these substances was changed to alkanes to harmonize with more current nomenclature that is recognized by other jurisdictions and international bodies. For clarity, when citing documents the terminology used in that particular document is maintained.
Substances description and use
Chlorinated alkanes are chlorinated hydrocarbons that have carbon (C) chain lengths ranging from 10 to 38. This group can be divided into three classes of substances: chlorinated alkanes containing 10 to 13 carbon atoms (short-chain), chlorinated alkanes containing 14 to 17 carbon atoms (medium-chain) and chlorinated alkanes containing 18 or more carbon atoms (long-chain). Long-chain chlorinated alkanes are in turn divided into three sub-groups: liquid long-chain chlorinated alkanes (18–20 carbon atoms), liquid long-chain chlorinated alkanes (containing more than 20 carbon atoms) and solid long-chain chlorinated alkanes (containing more than 20 carbon atoms).
Although chlorinated alkanes are no longer produced in Canada, approximately 2.8 kilotonnes of these substances were used in 2000 and 2001. Currently, the majority of chlorinated alkanes consumed in Canada are long-chain chlorinated alkanes, however most (approximately 96%) of the long-chain chlorinated alkanes consumed are those containing 21 to 38 carbon atoms, which are not considered harmful. If we consider only those chlorinated alkanes which are harmful to the environment and human health (10 to 20 carbon atoms), medium-chain chlorinated alkanes account for the largest percentage of consumption in Canada.
The total amount of chlorinated alkanes imported into Canada varies from year to year depending on market demands. In 2009 about half of imports were medium-chain, slightly less than half were long-chain (18 to 38 carbon atoms) and a small amount of short-chains. From 2009 the amount of short-chain chlorinated alkanes in the market continued to drop and by the end of 2010 the use of short-chain chlorinated alkanes was phased out. The use of short-chain chlorinated alkanes has at least been partially substituted with the use of medium-chain chlorinated alkanes. Products containing short-chain chlorinated alkanes, including paints, adhesives, sealants, rubber and plastics may be imported into Canada; however, the amount of such imports is believed to be small.
In Canada, the two end-use applications that account for the majority of use of chlorinated alkanes are the manufacturing of rubber and the formulation of metalworking fluids (i.e. cutting fluids, high pressure lubricating oils). Other uses include as a plasticizer or flame retardant in various plastics or formulated chemical products (e.g. adhesives, paints, sealants).
In 2001, approximately 15 metalworking fluid formulators in Canada consumed an estimated 1.2 kilotonnes of chlorinated alkanes. Approximately 15–25 companies in the polyvinyl chloride processing sector consumed an estimated 1.2 kilotonnes of chlorinated alkanes. In the same year approximately 0.4 kilotonnes of chlorinated alkanes were used in the Canadian paints and coatings, adhesives and sealants, and rubber and elastomer sectors.
More recent information suggests that in 2009 approximately 65% of all chlorinated alkanes use in Canada was in mine conveyor belt/rubber applications, 20% was in metalworking fluids, 12% was in plastics/vinyl applications and 3% was in coatings/ paints/sealants.
Releases and exposure
The presence of chlorinated alkanes in the environment is a result of human activity. The major sources of release of chlorinated alkanes into the Canadian environment are likely the formulation and manufacturing of products containing the substances. The possible sources of releases to water from manufacturing include spills, facility wash-down and drum rinsing/disposal. Chlorinated alkanes in metalworking/metal cutting fluids may also be released to aquatic environments from carry-off and spent bath. These releases are collected in sewer systems and may end up in the effluents of sewage treatment plants.
Another possible source of release to the environment is from losses during the service life and disposal of polymeric products (PVC, other plastics, paints, sealants). Although leaching from landfill sites is likely to be negligible owing to strong binding to soils, emissions of chlorinated alkanes, which are effectively dissolved in polymers, could occur following disposal.
Risk assessments summary
Priority Substances List Assessment Report, chlorinated paraffins, 1993
Chlorinated paraffins were included on the first Priority Substances list under the 1988 Canadian Environmental Protection Act (CEPA) for assessment of potential risks to the environment and human health. Substances on this list had to be assessed within five years of the listing. Chlorinated paraffins were initially assessed in 1993 and an assessment report was published (see www.hc-sc.gc.ca/ewh-semt/pubs/contaminants/psl1-lsp1/paraffins-paraffines/index-eng.php) which concluded that short-chain chlorinated paraffins constitute or may constitute a danger to human health or life. However, data identified at that time were considered insufficient to conclude whether short-, medium- or long-chain chlorinated paraffins are harmful to the environment or whether medium- or long-chain chlorinated paraffins are considered a danger to human health. Further risk assessment activities were deferred, pending the generation of new information concerning the risk of these substances to human health and the environment.
Canadian Environmental Protection Act, 1999 follow-up report, 2005–2008
Following the publication of the first assessment report research was undertaken to address the data gaps. Through a Canada Gazette Notice in 2002, an industry survey regarding the Canadian manufacture, import and uses of chlorinated paraffins was conducted for the years 2000 and 2001. During that time, literature was also reviewed for new exposure and toxicological data.
Following receipt and review of the new information, Environment Canada and Health Canada conducted a follow-up assessment on chlorinated paraffins pursuant to section 68 of CEPA 1999.
On June 11, 2005, the ministers of the Environment and Health published a draft follow-up assessment report on chlorinated paraffins for a 60-day public comment period in the Canada Gazette, Part Ⅰ. Comments were received from industry and industry associations. Their input was carefully reviewed and taken into account when finalizing the follow-up assessment report.
On August 30, 2008, a notice with respect to the final follow-up assessment report was published in the Canada Gazette, Part Ⅰ, concluding that
- Chlorinated paraffins containing up to, and including, 20 carbon atoms meet the criteria set out in paragraph 64(a) of CEPA 1999, and are predominantly anthropogenic and the available data regarding their persistence and bioaccumulation potential indicates that they satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations, (see footnote 2) made under CEPA 1999.
- All chlorinated paraffins are harmful to human health as per paragraph 64(c) of CEPA 1999. Based principally on the weight of evidence from the published literature, the assessment determined that all chlorinated paraffins may cause cancer in laboratory animals. Other non-cancer effects were also observed in experimental animal studies (see final follow-up assessment report on the website mentioned earlier). Although the confidence in estimated exposure levels to long-chain chlorinated paraffins from food was low due to significant analytical limitations in estimating exposure and the application of the precautionary principle, which resulted in very conservative estimates of exposure through foods, exposure levels for infants were within the order of magnitude for human health risks. It was on this basis that long-chain chlorinated paraffins were determined to be harmful to human health as defined in CEPA 1999.
Based on conclusions of the final follow-up assessment report, a proposed Order adding all chlorinated paraffins (10 to 38 carbon atoms) on Schedule 1 to CEPA 1999 was published in the Canada Gazette, Part Ⅰ, on September 20, 2008. A proposed Risk Management Approach document was also released on August 30, 2008, for a 60-day public comment period (see www.chemicalsubstanceschimiques.gc.ca/challenge-defi/chlor-alkanes-eng.php).
Update on the Human Health Assessment of long-chain chlorinated alkanes, 2011
In 2009, an environmental risk assessment report was published by the United Kingdom (UK) Environmental Agency dividing long-chain chlorinated paraffins into three groups (liquid chlorinated paraffins with 18 to 20 carbons, liquid chlorinated paraffins containing more than 20 carbon atoms, and solid chlorinated paraffins containing more than 20 carbon atoms). The assessment concludes that all long-chain chlorinated paraffins present a low risk to humans exposed via environmental routes. In addition, a study from Iino et al. (2005) (see footnote 3) was published in the peer-reviewed literature detailing an improved analytical protocol for short-chain chlorinated paraffins, including the use of a significantly lower limit of detection relative to the study used in Environment Canada and Health Canada’s earlier risk assessment. This important additional information led to a revision of the human health assessment conclusions.
In light of the new approach used by the UK Environmental Agency to model and subdivide the long-chain chlorinated paraffins into three sub-groups and the subsequent ‘low risk’ conclusion, Health Canada re-assessed the initial human health conclusions for long-chain chlorinated alkanes.
The new exposure estimates from long-chain chlorinated alkanes were found to be significantly lower than the level at which human health risks were observed. Therefore, long-chain chlorinated alkanes (containing 18 and more carbon atoms) are no longer considered harmful to human health. Chlorinated alkanes containing 10 to 17 carbon atoms are considered harmful to human health as per paragraph 64(c) of CEPA 1999. The results of this reassessment were published in July 2011.
Based on the weight of evidence, there is sufficient scientific information to support a recommendation to add chlorinated alkanes containing up to, and including, 20 carbons to Schedule 1 of CEPA 1999. This group of substances meets one or more of the criteria under section 64 of CEPA 1999, and therefore constitutes or may constitute a danger to human life or health or to the environment.
The Update on the Human Health Assessment of long chain chlorinated alkanes, the proposed risk management approach document, and responses to comments received may be obtained from the Chemical Substances Web site at www. chemicalsubstanceschimiques.gc.ca 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(s) 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 to the substance(s); or
- recommending that the substance(s) be added to the List of Toxic Substances in Schedule 1, and where applicable, the implementation of virtual elimination.
It has been concluded that chlorinated alkanes containing up to and including 20 carbon atoms are entering, or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to the environment as defined under paragraph 64(a) of CEPA 1999. It has also been concluded that chlorinated alkanes containing 10 to 17 carbon atoms are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to human life or health under paragraph 64(c) of CEPA 1999. Adding chlorinated alkanes containing 10 to 20 carbon atoms to Schedule 1, which will enable the development of regulations or other risk management instruments, is therefore the best option.
In addition, chlorinated alkanes containing 10 to 20 carbon atoms are predominantly anthropogenic and the available data regarding their persistence and bioaccumulation potential indicates that they satisfy the criteria outlined in the Persistence and Bioaccumulation Regulations, made under CEPA 1999.
Benefits and costs
Adding chlorinated alkanes containing 10 to 20 carbon atoms to Schedule 1 enables the Ministers to develop regulatory risk management proposals for these substances under CEPA 1999. The Ministers may, however, choose to develop non-regulatory measures (such as pollution prevention plans, guidelines or codes of practice) 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.
Comments received following publication of the draft follow-up Assessment Report
In accordance with the Act, on June 11, 2005, the Minister published in the Canada Gazette, Part Ⅰ, for a 60-day public comment period, the summary of the scientific results of the draft follow-up assessment on chlorinated paraffins and a statement indicating the measures they propose to take on the basis of scientific considerations (www.ec.gc.ca/toxiques-toxics/Default.asp? lang=En&n=98E80CC6-1&xml=148DE7B6-5B9A-42D8-884F-920978DC3C99). In this publication, it is concluded that all chlorinated paraffins meet one or more of the criteria as set out in section 64 of CEPA 1999. Prior to this publication, the CEPA National Advisory Committee was informed about the release of the follow-up Assessment Report and the public comment period on chlorinated paraffins.
During the 60-day public comment period, submissions were received from industry and industry associations on the scientific assessment. No comments were received from non-governmental organizations, members of the public or academia. Technical comments on the assessment report submitted by stakeholders were carefully reviewed by Environment Canada and Health Canada. The final follow-up assessment report was revised based on these comments.
Below is a summary of some key comments specific to the assessment conclusions for toxicity and the departments’ responses to them. Where comments have been made concerning whether or not a substance meets the criteria of section 64 of the Act due to the lack of information or uncertainty, the Government errs on the side of precaution to protect the health of Canadians and their environment. The complete responses to comments document is available via the Government of Canada’s Chemical Substances Web site, address, fax number or email listed above.
Comment: Industry stakeholders acknowledged that the toxicity of short-chain chlorinated paraffins is well documented, but were concerned about the uncertainty in the assessment with regard to medium- and long-chain chlorinated paraffins. Considering the state of science and current international work on these substances, industry stakeholders believe that the conclusion on whether medium- and long-chain chlorinated paraffins meet the criteria set out in paragraph 64(a) of CEPA 1999 is premature.
Response: As a result of a thorough scientific review of experimental and modelled data, Environment Canada and Health Canada indicate that there is sufficient information to conclude that short- and medium-chain chlorinated alkanes, as well as liquid long-chain chlorinated alkanes containing up to, and including, 20 carbon atoms meet the criteria set out in paragraphs 64(a) and (c) of CEPA 1999. However, based on the limited information available at that time, the assessment conclusions for long-chain chlorinated alkanes containing 21 carbon atoms or more had been revised with the finding that these substances met the criteria set out in paragraph 64(c) of CEPA 1999, but not the criteria set out in paragraph 64(a) of the Act.
Comment: Industry stakeholders criticized the use of non-Canadian, outdated or conservative data and assumptions for estimating effects and exposure. Industry stakeholders also questioned the validity of some calculation methods and modelling used to determine the persistence and bioaccumulation.
Response: Environment Canada indicates that data used in the assessment are selected on the basis of their relevance to Canadian conditions. The data used and assumptions made about the exposure, persistence and bioaccumulation potential were updated to reflect current international practices used in risk assessment. In addition, the department modified the approach for the assessment of long-chain chlorinated alkanes by subdividing them further into three groups (chlorinated alkanes containing between 18 and 20 carbon atoms, liquid chlorinated alkanes containing more than 20 carbon atoms and solid chlorinated alkanes containing more than 20 carbon atoms) and recognizing their different physical and chemical properties. New information in support of the bioaccumulation conclusion on all chlorinated alkanes was also added.
Comment: Finally, industry stakeholders proposed that the modes of action by which some tumours are induced in animals exposed to short-chain chlorinated paraffins are not relevant to human health.
Response: With respect to the comment pertaining to human health, Health Canada indicates that there is insufficient information to rule out concerns of tumour induction for humans similar to those stated for animals. As short-chain chlorinated alkanes already meet the criteria under paragraph 64(a), which will lead to development of risk management actions, further research is unnecessary.
Comments received following pre-publication of the Order in the Canada Gazette , Part Ⅰ
On September 20, 2008, 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, for a 60-day public comment period. This proposed Order included chlorinated paraffins containing between 10 and 38 carbon atoms.
During the 60-day public comment period, one industry association filed a Notice of Objection and requested the establishment of a Board of Review under section 333 of CEPA 1999. Seven additional submissions were received from five industry stakeholders and two industry associations supporting the Notice of Objection. Below is the summary of comments and the Ministers’ response to them.
Comment: An industry association noted that the proposed Order fails to define the scope of the subject substances. The definition given does not specifically apply to discrete substances on the DSL. As well, the molecular formula applies both to normal and isoparaffins.
Response: Environment Canada and Health Canada clarified that the definition for chlorinated paraffins (CPs) applies to the class of compounds described as “chlorinated derivatives of n-alkanes with carbon chain lengths from 10 to 38 carbon atoms, and with varying chlorine contents,” as stated in the Follow-up Report. The assessment also notes that n-alkane feedstocks may contain minor portions of both iso- and aromatic-alkanes, and these forms may also be subject to chlorination, and thus, chlorinated n-alkanes may also contain (usually small amounts) for chlorinated iso- and aromatic alkanes. Chlorinated paraffins were nominated for assessment by an advisory panel, and are not limited to discrete substances/products on the Domestic Substances List (DSL) with an identifiable CAS number.
Chlorinated paraffin homologues were grouped into three main chemical classes based on the number of carbons: short-chain (SCCP; C10–13), medium-chain (MCCP; C14–17), and long-chain (LCCP; C≥18) chlorinated paraffins. LCCPs were further subdivided into C18–20 liquid LCCPs, C>20 liquid LCCPs, and C>20 solid LCCPs for the environmental assessment based on comments, differences in physical chemistry, and to improve consistency with other international assessments. Therefore, the assessment pertains to compounds that satisfy the chemical definition of CPs provided above and that fall within the classes defined (SCCP, MCCP, and LCCP and its three sub-classes). The assessment does not pertain to any individual commercial products.
The Government of Canada agrees that the proposed Order as worded applies to normal and iso-alkanes. It should be noted that the definition also applies to aromatic alkanes. In keeping with this rationale, the proposed Order will be modified to specify “chlorinated alkanes” to cover all substances (i.e. n-, iso- and aromatic alkanes) considered within its scope.
Comment: In the Notice of Objection, an industry association stated that there should be a sound technical basis justifying that these substances meet one or more criteria as set out under section 64 of CEPA 1999. According to the petitioner, by the Government of Canada’s own admission, there is “low” to minimal confidence in the data and analysis relied on in the assessment.
Response: As required under CEPA 1999, Environment Canada and Health Canada risk assessments are precautionary to ensure that decisions will be protective of human health and the environment. Health Canada applies precaution and weight of evidence in its scientific decision-making (see subsection 76(1) of CEPA 1999 at www.ec.gc.ca/CEPARegistry/the_act/). Accordingly, decisions are based on conservative approaches. Despite the uncertainty in some elements of the assessment, Health Canada considers that the new available information indicates potential concern for human health for chlorinated alkanes with 10 to 17 carbon atoms only.
Comment: The Notice of Objection states that concerns for human health effects are largely the result of an unrealistic, worst case assumption that food in Canada is contaminated with chlorinated paraffins, even though there are essentially no market basket data from Canada. Instead, Health Canada used a study from Campbell et al. (1980) (see footnote 4) and assumed that Canadian food is contaminated at the analytical limits from the Campbell et al. (1980) study, even though in many instances this study did not measure detectable levels of chlorinated paraffins. Additionally, there are much more reliable data such as the study from Iino et al. (2005).
Response: The departments expend considerable effort to collect information, notably through research and comprehensive searches of the peer reviewed literature. A cut-off date for collecting evidence is set so the information base can be fixed, thereby allowing the screening assessment process to be carried through to completion. Health Canada and Environment Canada acknowledge that relevant scientific information may be identified after the cut-off date and have used this information to update the assessment. However, in the absence of data, precautionary assessment methodologies recognize that upper-bounding exposure estimates, calculated using concentrations identified in limited food items from the study by Campbell et al. (1980), may need to be based on a detection limit. The screening assessment report characterized the resulting values for chlorinated alkanes as semi-quantitative. Acknowledging the limitations, exposure levels for infants were within the order of magnitude for health risks. It was on this basis that chlorinated alkanes containing 18 or more carbon atoms were initially determined to be harmful to human health as defined in CEPA 1999. For medium- and long-chain chlorinated paraffins in foods, Health Canada is unaware of analytical results other than those by Campbell et al. (1980). The Iino et al. study (2005) reports results for short-chain chlorinated paraffins only. Also, Health Canada rated the confidence in the estimates for human exposure to chlorinated alkanes as low or minimal because there were few data on which to base the estimates. There was information, however, showing that Canadians were being exposed to chlorinated alkanes. Accordingly, Health Canada used available information to develop upper-bound estimates for exposure to chlorinated alkanes using scenarios chosen to make it unlikely that estimated values were lower than actual exposures, i.e. ensuring that the estimates are protective of human health.
Comment: An industry association claimed that the exposure estimates for newborns (0–6 months old) were unrealistic. For this group Health Canada is relying on data which indicates that dairy foods are the largest source of nutrition for infants 0–6 months.
Response: Only one study by Campbell et al. (1980) provides information on the levels of long-chain chlorinated paraffins in foods. The Nutrition Canada Survey (NCS) reported results for the quantity of different food groups that solid-food-fed infants less than six months of age have been found to consume. Health Canada rated the confidence in the estimates for human exposure to chlorinated alkanes as low or minimal because of the lack of estimates. In the absence of other guidance, Health Canada developed upper-bounding exposure estimates for solid-food-fed infants based on these two sources of information in order to make it unlikely the estimated values were lower than actual exposures, i.e. ensuring that these estimates are protective of human health. Health Canada recognizes the scientific improvements presented in the study from Iino et al. (2005). These will be carefully considered as risk management moves forward.
Comment: In the Notice of Objection, the industry association claimed that the follow-up Assessment Report relies on some portions of international studies and without any explanation ignores other portions of those same assessments. Also, the petitioner claimed that Health Canada used outdated information from the UK for the assessment.
Response: Health Canada examined the comments, technical reports and information that it received after the June 11, 2005, release of the draft follow-up assessment report including unpublished literature. Except for the Iino et al. study (2005) on the levels of short-chain chlorinated paraffins in foods available in Japan, the information consisted mostly of technical reports that were neither published in the scientific literature nor peer-reviewed. Also, some information presented in the submission was inconsistent with the International Research Development Centre (IRDC) study. Finally, although the submitted information may inform any future potential risk management action, it is not considered to be sufficient for a re-examination of the conclusion for chlorinated alkanes with 18 carbon atoms or more under paragraph 64(c) of CEPA 1999.
Comment: The industry association indicated that the final follow-up Assessment Report identifies food as the primary source of exposure based exclusively on the study from Campbell et al. (1980). However, this study used a limited set of foods and many determinations were not detectable. The assessment used these concentrations in an unorthodox way to represent actual contamination of food in Canada and derive the projected exposure. This approach was used despite the fact that there is no indication that these levels are representative of actual exposure to food in Canada. Moreover, the recent data from Iino et al. (2005) found much lower levels and this further call into question the applicability of the Campbell et al. (1980) study. Also, the available information suggests that Japan and Canada have similar levels of chlorinated paraffins in the environment.
Response: Health Canada acknowledges the improvements of the Iino et al. (2005) study published after the cut-off date used to prepare the Final Follow-up Assessment Report. In the absence of any other data, Health Canada relied on studies from Campbell et al. published in 1980. Since there are no Canadian release volumes of long-chain chlorinated alkanes, European Union release volumes were used in the assessment, an improvement to the exposure estimates used earlier. Use of this release volume is considered conservative as chlorinated alkanes are no longer produced in Canada.
Comment: The Notice of Objection argues that the assessment conclusions are inconsistent with conclusions in other jurisdictions. The UK Environment Agency’s environmental assessment report for long-chain chlorinated paraffins, released in January 2009, concluded that long-chain chlorinated paraffins pose essentially no threat to inhabitants in the UK. The industry association also pointed out that only short-chain chlorinated paraffins have been the target of other regulatory jurisdictions and that those actions are based on environmental considerations.
Response: In the environmental assessment report from the UK Environment Agency (2009), environmental concentrations of each group of chlorinated paraffins were predicted using modelling based on chemical properties and European Union release data in the absence of data specific to the UK. In light of this improved modelling and approach to subdivide the long-chain chlorinated paraffins into three sub-groups, Health Canada reassessed its earlier conclusion. Similar to the situation in the UK, there are no Canadian release data. As required under CEPA 1999, Health Canada and Environment Canada risk assessments are precautionary to ensure that decisions will be protective of human health and the environment. Accordingly, a European Union release volume, an improvement to the exposure estimates used earlier, is considered together with precaution. Using the up-to-date model, resulting conservative estimates of long-chain chlorinated alkanes exposure for infants through foods were considerably lower. This new information led Health Canada to revisit its assessment conclusions.
Decision on the request for the establishment of a Board of Review
The Ministers have carefully analyzed the information from other national and international organizations. Based on the new information available and the conclusions of the updated follow-up assessment, Health Canada has concluded that chlorinated alkanes with 18 carbon atoms or more are not harmful to human life or health as set out in paragraph 64(c) of CEPA 1999. With Environment Canada having concluded that chlorinated alkanes with 20 carbons or fewer meet the criteria for harmful to the environment under paragraph 64(a) of CEPA 1999, any revision that might be made to the follow-up assessment on the health impacts from short- and medium-chain chlorinated alkanes will not alter the recommendation by the Ministers to add chlorinated alkanes to Schedule 1 to CEPA 1999.
The Notice of Objection did not provide any new information or evidence which would change the understanding of the nature and extent of the danger posed by these chlorinated alkanes. Since a Board of Review would be essentially revisiting and repeating much of the work that went into the multi-step, consultative process that led to the Order, it is reasonable for the Ministers to conclude that there is sufficient scientific information available to support the addition of chlorinated alkanes with 10 to 20 carbon atoms to Schedule 1 to CEPA 1999.
While the Minister of the Environment decided not to establish a Board of Review, the Ministers also recommended not to proceed with the addition of chlorinated alkanes with 21 carbon atoms or more to Schedule 1 to CEPA 1999. This decision will not preclude the Ministers from continuing to undertake their normal practice of carrying out additional consideration of new information as it becomes available during the risk management phase.
Implementation, enforcement and service standards
The Order adds chlorinated alkanes with 10 to 20 carbon atoms to Schedule 1 to CEPA 1999, thereby allowing the Ministers to publish proposed regulations or other instruments. Developing an implementation plan or a compliance strategy or establishing service standards is 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(s) respecting preventive or control actions for these substances.
Acting Executive Director
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
819-953-7156 (outside of Canada)
Risk Management Bureau
S.C. 2004, c. 15, s. 31
S.C. 1999, c. 33
S.C. 1999, c. 33
S.C. 1999, c. 33
The federal government’s Toxic Substances Management Policy further require virtual elimination from the environment of toxic substances that are persistent and bioaccumulative and are present in the environment primarily due to human activity and of their precursors.
Iino, T. Takasuga, K. Senthilkumar, N. Nakamura and J. Nakanishi, “Risk assessment of short-chain chlorinated paraffins in Japan based on the first market basket study and species sensitivity distributions,” Environ Sci Technol 39 (2005), pp. 859–866.
Campbell, I. and G. McConnell. 1980. “Chlorinated paraffins and the environment”. 1. Environmental occurrence. Environ. Sci. Technol. 14(10): 1209–1214.